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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K
(Mark One)
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☒ | ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the fiscal year ended December 31, 20192022
OR
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☐ | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
FOR THE TRANSITION PERIOD FROMTO
Commission File Number 001-37369
HTG Molecular Diagnostics, Inc.Inc.
(Exact name of Registrant as specified in its Charter)
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Delaware |
| 86-0912294 |
(State or other jurisdiction of incorporation or organization) |
| (I.R.S. Employer Identification No.) |
3430 E. Global Loop, Tucson, AZ |
| 85706 |
(Address of principal executive offices) |
| (Zip Code) |
Registrant’s telephone number, including area code: (877)289-2615
Securities registered pursuant to Section 12(b) of the Act:
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Title of each class |
| Trading Symbol(s) |
| Name of each exchange on which registered |
Common Stock, par value $0.001 per share |
| HTGM |
| The Nasdaq Stock Market LLC |
Securities registered pursuant to Section 12(g) of the Act: None
Indicate by check mark if the Registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. YES Yes ☐ NO No☒
Indicate by check mark if the Registrant is not required to file reports pursuant to Section 13 or 15(d) of the Act. YES Yes ☐ NO No☒
Indicate by check mark whether the Registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the Registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. YES Yes☒ NO No ☐
Indicate by check mark whether the Registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the Registrant was required to submit files). YES Yes☒ NO No ☐
Indicate by check mark whether the Registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definition of “large accelerated filer,” “accelerated filer,” “smaller reporting company”company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
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| Emerging growth company | ☒☐
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If an emerging growth company, indicate by check mark if hethe registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒☐
Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. ☐
If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements. ☐
Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to § 240.10D-1(b). ☐
Indicate by check mark whether the Registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). YES Yes☐ NO No ☒
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The aggregate market value of the voting and non-voting common equity held by non-affiliates of the Registrant, based on the closingprice of the shares of common stock on The Nasdaq Capital Market on June 28, 2019,30, 2022 (the last business day of the Registrant’s most recently completed second fiscal quarter), was $46,618,227.$11,333,475.
The number of shares of Registrant’s Common Stock outstanding as ofMarch 13, 202015, 2023 was58,403,9712,214,155.
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Table of Contents
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PART I
Unless the context requires otherwise, references to “HTG,” “HTG Molecular Diagnostics,” “we,” “us” and “our” refer to HTG Molecular Diagnostics, Inc.
Forward-Looking Statements
This Annual Report on Form 10-K, including the sections entitled “Business,” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Consolidated Results of Operations,” may contain forward-looking statements. We may, in some cases, use words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “continue,” “seek,” “project,” “should,” “will,” “would” or the negative of those terms, and similar expressions that convey uncertainty of future events or outcomes, to identify these forward-looking statements. Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking statements. Forward-looking statements in this Annual Report include, but are not limited to, statements about:
•our ability to successfully commercialize our products and services, including our HTG EdgeSeq assays and corresponding automation systems;
•our ability to generate sufficient revenue or raise additional capital to meet our working capital needs;
•our ability to generate revenue from our products and services and drive revenue streams;
•the impact that a resurgence of COVID-19 or another health epidemic or pandemic may have on our ability to secure regulatory clearance or approval, domestically and internationally, for the clinical use of our products;
business; •our ability to develop new technologies to expand our product offerings, including direct-target sequencing for detection of mutations in genomic DNA and/or expressed RNA (such as single-point mutations and gene rearrangements, including gene fusions and insertions);
offerings; •the activities anticipated to be performed by us and third parties under design and development projects and programs, and the expected benefits and outcomes of such projects and programs;
•the implementation of our business model and strategic plans for our business;
•the regulatory landscape for our products, domestically and internationally;
•our strategic relationships, including with holders of intellectual property relevant to our technologies, manufacturers of next-generation sequencing (“NGS”) instruments and consumables, critical component suppliers, distributors of our products, and third parties who conduct our clinical studies;
•our intellectual property position;
•our ability to comply with the restrictions of our debt facility and meet our debt obligations;
•our expectations regarding the market size and growth potential for our life sciences and diagnostic businesses;
•our expectations regarding trends in the demand for sample processing by our biopharmaceutical company customers;
•our ability to secure regulatory clearance or approval, domestically and internationally, for the impactclinical use of the COVID-19 coronavirus pandemic on our business;
products; •any estimates regarding expenses, future revenue and capital requirements; and
•our ability to sustain and manage growth, including our ability to develop new products and enter new markets.
These forward-looking statements reflect our management’s beliefs and views with respect to future events, and are based on estimates and assumptions as of the filing date of this Annual Report and are subject to risks and uncertainties. We discuss many of these risks in greater detail under “Risk Factors.” Moreover, we operate in a very competitive and rapidly changing environment. New risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this Annual Report, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Except as required by law, we undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.
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RISK FACTOR SUMMARY
Below is a summary of the principal factors that make an investment in our common stock speculative or risky. This summary does not address all of the risks that we face. Additional discussion of the risks summarized in this risk factor summary, and other risks that we face, can be found below under the heading “Risk Factors” and should be carefully considered, together with other information in this Annual Report on Form 10-K and our other filings with the SEC before making investment decisions regarding our common stock.
•There is substantial doubt about our ability to continue as a going concern. We will need to raise additional capital to fund our operations in the future. If we are unsuccessful in attracting new capital, we may be forced to delay, reduce or eliminate at least some of our product development programs or business development plans, may not be able to continue operations or may be forced to sell assets to do so. Alternatively, capital may not be available to us on favorable terms, or if at all. If available, financing terms may lead to significant dilution of our stockholders’ equity.
•We have incurred losses since our inception and expect to incur losses for the foreseeable future. We cannot be certain that we will achieve or sustain profitability.
•Payments under the instruments governing our indebtedness may reduce our working capital. In addition, a default under our SVB Term Loan could cause a material adverse effect on our financial position.
•Unstable market and economic conditions may have serious adverse consequences on our business, financial condition and share price.
•Our HTG Therapeutics business strategy is unique, may not lead to successful drug products for various reasons, may require significant investments in working capital and may not generate any revenue.
•We have a limited history of operations for our preclinical-stage platform-based drug discovery business and no products approved by regulators for commercial sale, which may make it difficult to evaluate our current and future business prospects.
•As part of our current business model, we intend to seek to enter into strategic collaborations and licensing arrangements with third parties.
•If we are unable to successfully commercialize our products, our business may be adversely affected.
•COVID-19 has adversely affected our business and a resurgence of COVID-19 or another health epidemic or pandemic may have an adverse impact on our business in the future.
•Our business operations might be disrupted or adversely affected by catastrophic events.
•Our financial results may vary significantly from quarter to quarter or may fall below the expectations of investors or securities analysts, each of which may adversely affect our stock price.
•Our sales cycle is lengthy and variable, which makes it difficult for us to forecast revenue and other operating results.
•We may not be able to develop new products or enhance the capabilities of our systems to keep pace with rapidly changing technology and customer requirements, which could have a material adverse effect on our business and operating results.
•If we do not successfully manage the development and launch of new products, our financial results could be adversely affected.
•We may not be successful in expanding our customer base and introducing new applications for our profiling business.
•Our HTG EdgeSeq product portfolio requires the use of NGS instrumentation and reagents and could be adversely affected by actions of third-party NGS product manufacturers over whom we have no control.
•If we do not achieve, sustain or successfully manage our anticipated growth, our business and growth prospects will be harmed.
•We expect to generate a portion of our revenue internationally and are subject to various risks relating to our international
activities, which could adversely affect our operating results.
•If the utility of our HTG EdgeSeq platform, proprietary profiling panels, services and solutions in development is not supported by studies published in peer-reviewed medical publications, the rate of adoption of our current and future products and the rate of reimbursement of our future products by third-party payors may be negatively affected.
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•We may provide our HTG EdgeSeq instrument and profiling panels free of charge or through other arrangements to customers or key opinion leaders through evaluation agreements or reagent rental programs, and these programs may not be successful in generating recurring revenue from sales of our systems and proprietary panels.
•If we are unable to protect our intellectual property effectively, our business will be harmed.
•We may be involved in lawsuits to protect or enforce our patent or other proprietary rights, to determine the scope, coverage and validity of others’ patent or other proprietary rights, or to defend against third-party claims of intellectual property infringement, any of which could be time-intensive and costly and may adversely impact our business or stock price.
Item 1. Business.Business.
Overview
We are a commercial stage RNA platform-based life sciences company focused on advancing the promiseprecision medicine and drug discovery through our innovative transcriptome-wide profiling and advanced drug discovery platform technologies. Building on more than a decade of precision medicine. Our product and service solutions are based onpioneering innovation, our proprietary next-generation HTG EdgeSeq technology is the basis for our tech-driven hybrid business model allowing our RNA molecular profiling applications to be more effective, efficient and relevant and also serving as a key component of the engine behind our platform-based drug discovery process. Central to our business strategy is our drug discovery engine, which uses our captive transcriptomic profiling capabilities combined with a proprietary medicinal chemistry machine learning platform to render an artificial intelligence ("AI") -driven drug candidate optimization platform. We are using this platform to innovate drug discovery with the goal of building best-in-class molecules for known pharmacologic targets across multiple disease areas, better, faster and in a more cost-effective manner.
The training data sets for our machine learning platform utilize our own primary data generated specifically for this purpose. This high quality, standardized data provides a clear advantage over other platform approaches which are typically dependent upon publicly available data. The medicinal chemistry portion of our platform allows for rapid design and in silico evaluation of large chemical libraries in order to prioritize and select compounds for synthesis and advancement into early testing. These data are then integrated and processed into an iterative loop using a series of proprietary machine learning algorithms prior to further advancing the molecules to more traditional drug discovery studies. We expect that enables fullthis will allow for rapid identification, selection and optimization of drug candidates for entrance into development. Further, we believe that our ability to rapidly iterate between primary data and computational analyses gives us valuable information and insights for candidate molecule design and selection.
To date, we have used our transcriptome-informed drug discovery engine to develop an early pipeline of drug candidate molecules for two known pharmacologic targets, both of which can target several potential therapeutic indications, but with a current focus on oncology and neurodegenerative diseases. We believe that our technology provides a differentiated and potentially disruptive approach to drug discovery, that may allow ourselves and our partners to potentially improve upon key attrition factors, namely efficacy and toxicity, early in the discovery process, thereby allowing for better chances for candidate success when entering development.
Our business strategy is to build our drug discovery pipeline in order to out-license certain drug candidates and carry other candidates into preclinical and early development ourselves. In addition, we would expect to retain and potentially capitalize upon clinical diagnostics ("CDx") rights through the clinical development and commercialization of these assets where appropriate.
We also operate a profiling business in life science tools. Our profiling product and service solutions enable targeted RNA profiling using a small amount of biological sample, in liquid or solid forms. Our menu of HTG EdgeSeq assays, including our HTG Transcriptome Panel ("HTP"), which has been designed to measure approximately 20,000 mRNA targets using our HTG EdgeSeq technology, is automated on our HTG EdgeSeq platform,system, which applies genomic sequencingNGS tools, that generateenabling the generation of gene expression data in a timely manner utilizing aour simplified workflow for customers.workflow. We seek to leverage key business drivers in molecular profiling for biomarker analysis and diagnostics, including the acceleration of precision medicine, the migration of molecular testing to NGS-based applications, the movement to smaller and less invasive biopsies, the need for greater diagnostic sensitivity, the need to conform to challenging healthcare economics and the need for automation and an easily deployable workflow, including simplified bioinformatics. For example, theseThese capabilities enable customers to extend the use of limited biological samples for retrospective or prospective analysis, gaining further understanding of the molecular drivers of disease with the goal of developing biomarker-driven targeted therapies. We also believe our HTG EdgeSeq technology can be used as a platform technology in clinical applications that will simplify, consolidate and reduce the cost of NGS-based diagnostic workflows and in commercialized companion diagnostic (“CDx”) tests.
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Our existing products include instruments, consumables including assay kits, and software that, as an integrated system,platform, automate sample processing and can quickly, robustly and simultaneously profile hundreds, thousands or tens hundreds orof thousands of molecular targets from samples which are a fraction of the size required by many prevailing technologies. Customers can access our technology by purchasing our HTG EdgeSeq system and assays for their internal use or through our Tucson, Arizona-based VERI/O service laboratory, including molecular profiling of cohorts and development of custom research use only ("RUO") panels to support early-stage clinical programs and investigational-use-only assays for clinical trials. However, with the release of our HTP, revenue from our RUO assay design services is expected to be lower than historical levels, as our RUO assay design services revenue is replaced by HTP consumables purchases and sample processing laboratory services using our HTP. Our product and service solutions have enabled us to access a number of early-stage biomarker discovery programs. We believe this approach will enable new opportunities collaborating with biopharmaceutical companies in their future drug development programs.
Our Strategy
Our objective is to establish our solutionstranscriptome-informed drug discovery process as the preferred methodology for small molecule drug discovery and our HTG EdgeSeq technology as the standard in molecular profiling, companion diagnostic development and molecular diagnostics, and to make their benefits accessible to all molecular labs from research to the clinic. We believe that our target customers desire high quality molecular profiling information in a multiplexed panel format from increasingly smaller and less invasive samples, with the ability to test and the option to analyze such information locally to minimize turnaround time and cost.
In 2014, we launched our HTG EdgeSeq technology solution, which generates a molecular profiling library for gene expression profiling using NGS. Our HTG EdgeSeq assays are automated on our HTG EdgeSeq platform. Our innovative platform and menu of molecular profiling panels are being utilized in two complimentary ways in advancing precision health. Biopharmaceutical companies and other translational research centers utilize our technology to discover and validate biomarkers and develop molecular subtypes which can identify patient populations most likely to respond to certain therapies. In addition to purchasing our technology for use in customer facilities, customers can also obtain the advantages of our proprietary technology through our service offerings. Pre-clinical services, including custom assay development and sample processing services provided by our Tucson-based VERI/O laboratory, allow customers the ability to more efficiently identify and validate biomarker signatures across their drug portfolios or patient cohorts. Our ISO 13485-2016 certified quality system and diagnostic development teams, in partnership with biopharmaceutical company customers, develop, manufacture and commercialize companion diagnostics. Although our initial focus has been oncology, we offer customers a full solution from biomarker discovery to deployment of CDx tests across numerous disease states. Utilizing NGS as our method of detection provides our customers with the benefits of our highly multiplexed and extraction-free chemistry and the sensitivity and dynamic range of the sequencers, providing a powerful value proposition and complete workflow.
Our HTG EdgeSeq platform is currently focused on RNA-based applications, which we believe is a large and growing market with significant, unmet medical needs where we have demonstrated our competitive advantages. We believe that our platform technology can enable gene expression profiling growth to accelerate as we make NGS-based gene expression analysis easier and more sample sparing.
We have two primary sources of revenue: product and product-related services revenue from the sale of research use only (“RUO”) and CE/IVD marked profiling products, sample processing services and custom assay development services to biopharmaceutical companies, academic research centers and molecular testing laboratories; and revenue from collaborative development services for companion diagnostic development programs for biopharmaceutical companies.
Profiling product and product-related services revenue includes customer purchases of our HTG EdgeSeq instrument and related assay kits, development of custom RUO assay kits for customers and the use of our HTG EdgeSeq instrument and RUO assay kits to process samples on the customer’s behalf in our VERI/O laboratory. In addition, as of December 31, 2019, we sell two internally developed proprietary CE/IVD marked assays, including our HTG EdgeSeq DLBCL Cell of Origin Assay EU and HTG EdgeSeq ALKPlus Assay EU. Several additional diagnostic tests are in early stage development in collaboration with our European customers. Our team of field-based and support services employees throughout Europe facilitate our ability to generate product revenue in Europe and to improve our responsiveness to customer needs in that region. While we have determined that we will no longer maintain an applications laboratory in Sausheim, France, we will continue to perform sample processing and collaborative development services for our global customer base in our VERI/O laboratory in the United States.
Collaborative development services revenue relates to services performed using our HTG EdgeSeq proprietary technology to develop, seek regulatory approval for, and commercialize companion diagnostic assays for biopharmaceutical drug candidates and corresponding therapeutics. Collaborative development services revenue generated to date has been generated primarily pursuant to the Master Assay Development, Commercialization and Manufacturing Agreement between us and QIAGEN Manchester Limited (“QML”) dated November 2016 (the “Governing Agreement”). These primary revenue sources are currently consumed by our customers primarily through a services-oriented model. However, we anticipate that this will be a catalyst toward an emerging product-based strategy as an increase in our menu of diagnostic panels is expected to result in increased demand for our instrument and HTG EdgeSeq consumable products in individual laboratories and customer locations. In November 2019, we terminated the Governing Agreement, effective immediately, as a result of QML’s material breach of the Governing Agreement, including QML’s failure to develop an in vitro diagnostic (“IVD”) version of its GeneReader sequencing platform for development of PDP Assays. Our termination of the Governing Agreement did not terminate active statements of work under the Governing Agreement. On a going-forward basis, we expect to enter into additional collaborative development services arrangements directly with biopharmaceutical company customers, which we believe will improve our economics from these arrangements.
In the first quarter of 2019, we announced the initiation of a program for the clinical development of a comprehensive breast cancer molecular diagnostic assay. This program is headquartered in a new development facility in the San Carlos, California. This technical center became operational in July 2019, is now fully functional, and was the result of an objective to access additional collaboration partners and talent that we believe can best support the continued development and expansion of the capabilities of our technology.
Our Strategy
Our objective is to establish our solutions as the standard in gene expression for molecular profiling and to make their benefits accessible to all molecular labs from research to the clinic. We believe HTG EdgeSeq technology is a platform that we can leverage into three primary revenue verticals: RUO profiling, molecular diagnostics and companion diagnostic collaborations. CDx development.
The key components of our strategy are:
•Leverage our existing capabilities in transcriptomic profiling, machine learning chemical library design and AI-driven drug candidate optimization to build a portfolio of best-in-class small molecule drug candidates for known targets. We are focused on improving the existing drug discovery process by using our proprietary technologies. We intend to use our transcriptomic profiling technologies, integrated with a machine learning-based chemical library design platform, to better-inform the design and selection of drug candidate molecules, resulting in candidates that are expected to have lower risk profiles and increased opportunities for development success. We believe that, in addition to being a better way to develop drug candidates, this approach will be faster and less expensive than traditional approaches. We plan to use models to identify drug candidates that may either be out-licensed to drug development partners at early stages of development or potentially retained internally for progression into later stages of development, in an effort to further increase the value of the assets prior to licensing or partnering.
•Leverage our existing transcriptome-based drug candidate optimization capabilities to partner with other biopharma companies. The same advantages that we intend to bring to our own discovery efforts would also benefit other biopharma companies. In disease areas or indications outside our primary targets, we intend to partner our proprietary transcriptome-informed platform technology to expand our drug discovery opportunity through collaborations that may provide non-dilutive capital.
•Re-establish companion diagnostic collaborations with biopharmaceutical companies potentially informed by HTG Therapeutics efforts in the future. Collaborations with biopharmaceutical companies with late-stage drug development programs have the potential to create additional companion diagnostic consumables revenue. We believe our historical experience with these collaborative arrangements coupled with our plans to improve upon the existing drug discovery processes through HTG Therapeutics can inform and drive future collaborative development programs with drug candidate molecules that are intrinsically lower risk and have a greater potential for success in development than those involved in our past collaborative development services agreements.
•Expand our position in translational medicine with our RUO molecular profiling products. We believe the market for gene expression analysis for translational medicine is large and growing quickly.growing. We have built targeted panels in oncology, immuno-oncology, autoimmuneimmune response and micro RNAmicroRNA that enable scientists to look atobserve gene expression patterns to identify molecular subtypes, study key pathways and to discover and validate biomarker hypotheses to help drive precision medicine. We plan to add toIn 2020, we expanded the utility of these panels by adding new applications to interrogate the tumor micro-environment, such as tumor inflammation cell proliferation rate and immunophenotyping and release these applications onsignatures in our HTG EdgeSeq Reveal software. Lastly,In 2021, we expect to continue developmentfurther expanded our product offerings and capabilities with the release of our whole transcriptome product for launch in 2021 which is expectedHTP, allowing customers to measure approximately 20,000 – 22,000 biomarkers.mRNA targets from the human transcriptome. Our HTP enables faster gene expression analysis of the transcriptome using significantly less sample input and allows for profiling of lower quality samples as compared to conventional testing methods. We are buildingbelieve this product for clinical use and believe it will serve asmay facilitate the expansion of our foundational product not only for RUO profiling, but also for our companion diagnostics and our own proprietary breast diagnostic products. We also expect this product to expand our product offeringstarget customer base outside of oncology and autoimmune and into markets such as transplantdiabetes, cardiology and diabetes.neurology.
•Develop new proprietary molecular diagnostic panelsContinue to establish our systems workflow as the best solution for RNA clinical sequencing. We intend to continue to establish our technology as the optimal complementary workflow with high medical utility. Ournext-generation sequencers. We believe our differentiated HTG EdgeSeq platform technology was developedchemistry will accelerate adoption of RNA biomarkers by leveraging the large and growing installed base of next-generation sequencers. We are engaged with features that we believe solve many of the challenges facing NGS-based assaysindustry and workflows. In our technology center in California we have started the processcorporate partners, including Illumina, Inc. and Thermo Fisher Scientific, Inc. to build a comprehensive NGS-based breast cancer diagnostic. This product is being designed and built to cover a multitude of currently vexing treatment decisions being faced by clinicians. We expect our whole transcriptome product in development will serve as the foundation for this assay. In addition, we believe that by using our sample sparing HTG EdgeSeq technology we will be able to work with initial core needle biopsies, thereby providing information back to the clinician more rapidly than if they need to wait for resected tissue. We plan to also leverage our core HTG EdgeSeq technology and our clinical grade whole transcriptome product to partner with other test developers and Clinical Laboratory Improvement Amendments (“CLIA”) labs.
Increase and strengthen companion diagnostics collaborations with biopharmaceutical companies. We believe collaborations with biopharmaceutical companies with late stage drug development programs will lead to us generating companion diagnostic consumables revenue. As of December 31, 2019, we had 88 active early stage development programs across leading biopharmaceutical companies which are incorporating biomarkers and potentially companion diagnostics in their drug development programs. We plan to develop novel RNA-based gene classifiers to help biopharmaceutical companies and leading translational medicine researchers better understand and predict durable response to immune checkpoint inhibitor drug candidates, such as anti-PD-L1 therapeutics, in mono and combination therapies. We also plan to develop novel RNA profiling tests that can provide important biomarker information in emerging areas of immuno-oncology, autoimmune and other disease areas. In addition, once available, we expect to develop and market a clinical grade whole transcriptome product as a new universal CDx platform for gene expression profiling to biopharma customers.
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| Establish our systems workflow as the best solution for RNA clinical sequencing. We intend to continue to establish our technology as the best complimentary workflow with next-generation sequencers. We believe our differentiated HTG EdgeSeq chemistry will accelerate adoption by leveraging the large and growing installed base of next-generation sequencers. We are engaged with industry and corporate partners, including Illumina, Inc., Thermo Fisher Scientific, Inc. and QML, to position our HTG EdgeSeq products as the benchmark for workflow in targeted sequencing applications.
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Expand the addressable market of our technology through new applications and expansion into new disease states and liquid biopsies. We have demonstrated technical feasibility for several new applications that we believe will allow us to expand our HTG EdgeSeq technologyproducts as the benchmark for workflow in targeted sequencing applications.
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Our Market Opportunities
Drug Discovery for the Biopharmaceutical Sector
The transitional drug discovery and development process is characterized by substantial financial risks for development programs that often fail to reach patients as marketed products. Historically, it has taken over ten years and average capitalized research and development costs of over $2.0 billion per approved medicine to move a drug discovery project from early discovery to an approved therapeutic. Such productivity outcomes have culminated in an expected industry success rate of 8% to 14% from discovery to commercialization, yielding a rapidly declining internal rate of return for the industry from approximately 10% in 2010 to 2.5% in 2020.
These trends create an environment that is ripe for technological innovation. Traditional drug discovery relies on basic research discoveries from the scientific community for disease-relevant pathways and targets to interrogate. Frequently, drug developers are left to make decisions on potential candidates without fully understanding the incredible complexity of systems biology. Despite decades of accumulated knowledge, the result is that drug discovery has unintentionally become almost artisanal, with little informative biological data available to those in the industry.
In an attempt to address these issues, the biopharmaceutical sector has increasingly relied on the “open science” model whereby companies pursue a diverse set of strategies leveraging internal research and development efforts as well as turning to external research and development, scientific collaborations and in-licensing opportunities to advance new drug discoveries, meet currently unmet needs and help more patients. Fully integrated pharmaceutical companies have evolved to use open science as a ground to supplement their internal pipeline efforts with new drug candidates and/or new emerging technologies. It is not uncommon among the fully integrated companies to have strategic goals where half of the pipeline is from internal efforts whereas the remaining half is populated through assets that are either in-licensed, partnered or acquired through strategic acquisitions. Some fully integrated pharmaceutical companies rely solely on external science and innovation.
We believe that our approach of utilizing our established RNA profiling capabilities, integrated into new applications. Customers are now usinga drug discovery platform with advanced medicinal chemistry technologies, will result in more well-informed molecule design and selection and potentially provide multiple revenue opportunities. These revenue opportunities may include collaboration or licensing arrangements for any small molecule drug candidates we generate, either at early- or mid-stage development, potentially out-licensing our platform technology in autoimmune disorders and diabetes. We have also shown feasibility of being able to measure RNA in exosomes, which we believe position us to expand into liquid biopsy applications. We will continue to strategically seek partners and collaborators who may be interested in partnering with us to expand the utility of our platform technology to additional areas outside ofpharmaceutical companies to enable them to implement our core focus area of oncology inadvanced drug discovery approach into their own internal discovery efforts and developing new companion diagnostic assays to support the future.
Our Market Opportunitiesrelated clinical development programs for those molecules.
Cancer Molecular Profiling and Genomics in Life Science Research
Molecular profiling is the analysis of biomarkers, including DNA, and RNA and protein, in biological samples, such as tissue, cells, blood and other biofluids, to identify gene expression patterns or genomic changes. The HTG EdgeSeq technology coupled with NGS is making it possible to perform these characterizations in unprecedented ways, resulting in a shift from the traditional approach of looking at one target at a time to the simultaneous analysis of potentially tens, hundreds or thousands of gene targets.
Among what we believe are the most promising applications of molecular profiling is the targeted sequencing of RNA from patient samples to identify gene expression patterns or molecular markers of disease that can aid in diagnosis, gauge patient prognosis or predict response to an available therapy. These applications have launched a fundamental shift towards personalized medicine where an individual patient’s molecular profile is used to guide treatment.
The supplier market for RNASeqRNA-Seq is estimated to be approximately $1.0 billion and growing annually at 10-20%. The gene expression component of that market is estimated to be approximately $820.0 million and growing at the same rate. With these metrics in mind, we expect our target market, NGS-based gene expression profiling, to be between $1.3 billion and $2.0 billion by 2024.
Therapy Driven Diagnostics - Companion Diagnostics
The World Health Organization estimates that cancer will lead to the deathdeaths of 11.5approximately 17 million people per year by 2030. As a result, biopharmaceutical companies are aggressively deploying biomarker driven strategies to improve the response rates to drugs, including existing anddrugs, new drugs in development.and combination therapies. These companies are looking for technology solutions that can more effectively identify the biological root causes of disease and aid the discovery onof biomarkers to better develop and target drugs to the rightcorrect patients. The companion diagnostic market is currently estimated at $2.6 billion and growing approximately 20% annually. We believe that the acceleration of investment into immunotherapy drugs will also be a catalyst for future companion diagnostics for combination therapies where RNA gene expression classification is expected to be important.
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When a molecular biomarker panel is used for selection of patients in a Phase 2 or Phase 3 clinical trial to demonstrate safety and efficacy of a new drug, the drug and biomarker test are often submitted to the applicable regulatory agency for approval together. In the United States, upon U.S. Food and Drug Administration (“FDA”) approval or clearance of the CDx test, the patient must be tested with the CDx test prior to being treated with the drug. Companion diagnostic tests have a clear clinical utility whichthat generally supports favorable reimbursement decisions. We believe there are currently approximately 3,100 oncology clinical trials, approximately 24% of which are interrogating RNA. This percentage has more than doubled since 2014, and we believe this percentage will approach 50% by 2025.
Molecular Diagnostics – NGS-based WorkflowsOur Technology
ComplexitiesHTG has assembled a portfolio of technology platforms to provide highly differentiated capabilities to serve our two business areas. These technologies are as follows and Challenges of Molecular Diagnostics Todayare described in further detail below:
Currently, molecular
•HTG EdgeSeq profiling typically is conducted in the clinical setting using a variety of profiling techniques and instrumentation platforms across multiple laboratory departments, and, in many situations, sent to distant labs. These techniques include immunohistochemistry (“IHC”), fluorescent in situ hybridization (“FISH”), polymerase chain reaction (“PCR”),technology provides robust whole transcriptome gene expression arrays (“GEA”)analysis with high plex and NGS. This distributed profiling approach has accelerated the use of molecular profiling and increased the needsensitivity;
•HTG EdgeSeq instrumentation to
make the process more accessible and routine. However, molecular profiling is also highly specialized because many current technologies are complex, require multiple capital-intensive workflows, and are not economically scalable to the case volume of the local laboratory. The fragmentation of methods, smaller sample sizes, sample logistics and information flow has created significant challenges for labs, physicians and patients.
Our Solution
At the core of our solution is our proprietary chemistry known as quantitative nuclease protection (“qNPA”). Our qNPA-based chemistries provide a sensitive and efficient method for analyzing RNA as it eliminates the need for nucleic acid extraction, reverse transcription, complicated bioinformatics steps and other complex processes. We designed and developed our automation platforms and software analysis tools to optimize the capabilities of our chemistries, provide fast turnaround time and enable ease of use to molecular labs. Our chemistries and automation platforms are highly adaptable, so when molecular profiling needs change or emerge, we expect to be able to efficiently add new applications to address these needs.
Our products and services are designed to work with many different biological sample types, can generate robust results from very small samples, and obviate the need for many of the sample-preparation steps associated with traditional molecular techniques. Our platforms and assays enable the simultaneous detection and quantitation of tens, hundreds or thousands of molecular targets and are capable, now or in the future, of profiling multiple parameters such as RNA expression levels, RNA-expressed gene fusions and insertions in a single testing workflow that can use NGS detection for quantitative measurement.
We believe most customers in our target markets would prefer to maintain control of their samples and perform the testing and analysis internally but are challenged by limitations in available technologies. We believe we are well positioned to democratize NGS‑based molecular profiling with the following key product benefits:
Optimize sample utilization. Our systems can analyze as many as 2,500 genes from extremely small sample volumes such as a single five-micron section of tissue or 15 microliters of plasma or serum. Our technology allows customers to do more with less, which meets the needs of clinical or pre-clinical laboratories where today there is often not enough patient sample to do all the testing desired. We believe providing customers the ability to work with extremely small sample will be a significant driver of adoption of our technology and systems.
Compatibility with multiple sample types. Our HTG systems allow customers to profile and unlock molecular information from a wide variety of biological samples such as formalin fixed paraffin embedded (“FFPE”) tissue, cells, blood serum and plasma. We have successfully demonstrated the ability to profile these and other sample types and believe we ultimately can profile most clinically relevant sample types, including cell-free circulating nucleic acids from tumors, a rapidly developing area of investigation which is referred to as a liquid biopsy. We believe that the capabilities of our system will allow us to efficiently expand applications, regardless of sample type.
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| Flexible and adaptable chemistry allows for use in multiple applications. We believe our proprietary chemistry provides the ability to measure a variety of molecular targets in many necessary applications, including RNA expression levels and expressed RNA gene rearrangements (such as gene fusions and insertions), and offers the ability to quantify these applications on a variety of NGS platforms. This flexibility provides customers the ability to optimize their use of our technologies based on their specific throughput, workflow and application needs. Our proprietary chemistry is comparatively simple, with fewer steps than competing technologies. For example, compared to RT-quantitative PCR (“RT-qPCR”), our chemistry does not require cDNA synthesis. Compared to traditional RNA sequencing, our chemistry does not require extraction, cDNA synthesis, shearing, rRNA depletion, ligation, adenylation, or size selection. We believe that the elimination of these steps helps prevent biases associated with these steps, sample degradation and increased opportunities for technician error.
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Robust data. Molecular profiling produces large amounts of information that is used, among other things, to make important decisions, such as identifying potential drug targets or selecting a patient for a therapeutic treatment. This information is valuable only to the extent it accurately represents the true biology of the test sample and the same answer can be produced under many different conditions. Our chemistries are highly specific and sensitive, meaning they can detect the right target even when very little is present in the sample. Our system produces consistent results on a replicate-to-replicate, day-to-day and instrument-to-instrument basis.
Automation provides superior workflow and ease of use. Our technologies are designed with fewer workflow steps in part due to the elimination of the need for complex sample-preparation processes such as extraction, cDNA synthesis, labeling, selection, depletion and shearing. This enables customers to limit hands-on time and the need for specialized skills, resulting in turnaround times of approximately 36 hours. Additionally,automate our HTG EdgeSeq system further integrateschemistry, enabling high volume sample preparationprocessing and improved reproducibility;
•Advanced machine learning-driven medicinal chemistry platform for targeted sequencingrapid construction of libraries to known targets; and greatly simplifies the data bioinformatics, so customers looking to leverage their NGS instrument can seamlessly add this capability to their current workflows.
•AI-driven medicinal chemistry platform to iterate chemical structures to transcriptomic data to optimize drug candidate design and selection.
Simplified bioinformatics.
Platform Technology for Drug Discovery
HTG EdgeSeq Profiling Technology
Our HTG EdgeSeq Reveal software provides data in a simple and easy to use format through a simple graphical user interface that is flexible enough for researchers yet structured enough for clinical laboratories. The HTG EdgeSeq parser software, which processes the data generated from the NGS platform, is modular so that new applications can be downloaded without any changes to hardware. We believe the simplicity of our bioinformatics solution will help drive the adoption of our platform.
Our Competitive Advantages
We believe that our HTG EdgeSeqprofiling technology provides us with a number of competitive advantages that set us apart from others in our industry and that will continue to drive new customers toward our solutions. Such advantages include:
Proprietary and patent-protected HTG EdgeSeq technology enabling researchers and clinical labs the ability to capture information encompassing up to thousands of genes from extremely small sample sizes with the sensitivity and dynamic range of next-generation sequencers;
Industry partnerships with leading NGS companies enabling the development and commercialization of next-generation molecular diagnostics utilizing the combined power of HTG EdgeSeq and NGS technology;
Partnerships with leading biopharmaceutical companies and a fast-growing pipeline of early and late stage biomarker programs expected to generate significant opportunities for companion diagnostic products; and
A highly experienced senior management team.
Current Commercial Panels Offered on the HTG EdgeSeq Platform
We currently market proprietary molecular profiling panels targeting late stage drug development programs with potential breakthrough therapies, such as immuno-oncology. We market these panels to biopharmaceutical companies, with which we collaborate in biomarker development programs. We believe these programs could facilitate our commercialization of companion diagnostic tests. In addition, our panels are used in pre-clinical and clinical research areas, which, we also believe, will facilitate our commercialization of diagnostic tests, including tumor classifiers and prognostic tests.
Our currently marketed panels are:
HTG EdgeSeq Oncology Biomarker Panel. Thismeasures RNA expression panel measures the expression of up to 2,549 genes implicated in cancer for profiling tumor tissues, analyzing cancer pathways and identifying new biomarkers across both solid tumors and hematolymphoid neoplasms. We worked with key opinion leaders to identify the genes in this panel, which we believe is a comprehensive list of genes targeting known signaling pathways and receptor gene families implicated in cancer. Representative genes in this panel include EGFR, HER2, HER3, HER4, PD-1 and FGFR. When paired with our HTG EdgeSeq miRNA Whole-Transcriptome Assay (below), we provide customers with a comprehensive solution for profiling their large sample archives for novel expression signatures.
HTG EdgeSeq Precision Immuno-Oncology Panel. The NGS-based HTG EdgeSeq Precision Immuno-Oncology Panel is designed to measure the immune response both inside the tumor and the surrounding microenvironment. By leveraging the high sensitivity and dynamic range of NGS instrumentation, this powerful tool measures 1,392 genes from a single section of FFPE tissue, extracted RNA or PAXgene samples.
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| HTG EdgeSeq miRNA Whole-Transcriptome Assay. Human microRNAs are short non-coding strands of RNA that are believed to be used by the cell for gene regulation. The HTG EdgeSeq miRNA Whole-Transcriptome Assay enables the simultaneous profiling of 2,083 microRNAs, allowing new, potentially clinically relevant miRNA profiles to be discovered. Our ability to efficiently profile small FFPE samples is a significant differentiator in the rapidly growing microRNA market.
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HTG EdgeSeq DLBCL Cell of Origin Assay EU. The HTG EdgeSeq DLBCL Cell of Origin Assay EU is an IVD assay that uses GEP to determine the cell of origin (“COO”) subtype of DLBCL tumors from FFPE tissue section. The gene expression data are assessed by a classification algorithm and the tumor samples are determined to be of the ABC, GCB or unclassified subtype. This product has obtained CE-marking in Europe where it is available for diagnostic use. It is not for sale in North America.
HTG EdgeSeq DLBCL Cell of Origin Assay. DLBCL tumors are frequently classified into either the activated B-cell like (“ABC”) or germinal center B-cell like (“GCB”) subtypes by measuring the molecular profile of the tumor. These two subtypes display different clinical pathologies, as patients with the GCB subtype of DLBCL tend to respond differently than those of the ABC subtype. With many of the large number of new DLBCL-targeting drugs appearing to have greater efficacy in one of the subtypes, a need for a reliable, FFPE-based cell of origin classification assay has emerged. The HTG EdgeSeq DLBCL Cell of Origin Assay is being utilized in numerous late stage drug programs to stratify these patients.
HTG Lung Fusions Assay. The HTG EdgeSeq Lung Fusions Assay detects fusions common in non-small cell lung cancer (“NSCLC”). Using a single section of FFPE tissue, the automated, HTG EdgeSeq chemistry uses the dynamic range of the Thermo Fisher Ion Torrent Ion S5 sequencer to detect fusions in small samples such as needle core biopsies.
HTG EdgeSeq ALKPlus Assay EU. The HTG EdgeSeq ALKPlus Assay EU is an IVD NGS-based assay sold in the EU intended to measure and analyze mRNA ALK gene fusion events in FFPE lung tumor specimens from patients previously diagnosed with NSCLC. This product has also obtained CE-marking in Europe where it is available for diagnostic use. It is not for sale in North America.
HTG Autoimmune Panel. The HTG EdgeSeq Autoimmune Panel leverages the sensitivity and dynamic range of NGS to measure genes implicated in a variety of autoimmune diseases. The panel measures 2,002 transcripts in a single well, allowing users to obtain a broad profile of genes associated with autoinflammatory and autoimmune disease, and enables multiplex profiling from PAXgene samples.
HTG EdgeSeq Immuno-Oncology Assay. One of the most promising areas of cancer therapy is immunotherapy or immuno-oncology, where new classes of oncology drugs are thought to enable or boost the host immune response towards tumors. Multiple drugs targeting the genes CTLA4, PD-1 and PD-L1 are on market with additional candidates moving into late stage trials. Profiling samples for the genes targeted by these therapies may be predictive of drug response and aid in the stratification of patients into responsive and non-responsive groups. The HTG EdgeSeq Immuno-Oncology Assay measures the expression of 549 of these immuno-oncology-associated genes.
HTG Mouse mRNA Tumor Response Panel. The HTG EdgeSeq Mouse mRNA Tumor Response Panel measures 1,659 mouse mRNA targets to measure genes implicated in preclinical mouse models of human disease. Built around core signaling pathways and immune response mechanisms in oncology and other disease states, the HTG EdgeSeq mRNA Tumor Response Panel enables multiplex profiling from a variety of sample types, including FFPE, cell lines and extracted RNA samples. Applications include modeling oncogenesis, studying the immune response to mouse and patent-derived xenografts, and investigational therapeutic response studies.
Our Technology
HTG EdgeSeq Chemistry
Our HTG EdgeSeq chemistry is shown schematically in the figure below. Specifically,using DNA nuclease protection probes or("DNA protection probes"). These DNA protection probes which include a target-specific region flanked by universal wing sequences and are hybridized in solution to targetedtheir target RNAs. Target RNA can be both soluble and cross-linked in the biological matrix. Universal DNA wingmen probes are hybridized to the wings to prevent S1 nuclease digestion. S1 nuclease is added to remove single-stranded nucleic acids, including unhybridized DNA protection probes and RNA. Following S1 nuclease treatment, the only remaining DNA protection probes in the reaction are those hybridized to targeted RNA and wingmen probes to form a hybridized complex.heteroduplex. This produces an approximately 1:1 ratio of DNA protection probes to the RNA targeted in the sample. Alkaline hydrolysis of the hybridized complexes releases the DNA protection probes from such complexes. The released DNA protection probes are ready for quantitation. DNA protection probes are labeled with sequencing adaptors and tagsmolecular barcodes in a thermocycler.PCR reaction. The labeled DNA protection probes are concentrated,cleaned up, quantified, pooled, and ready for sequencing using standard NGS protocols. Data from the NGS instrument is processed and reported by the parser software provided with the HTG EdgeSeq system.platform.
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Key Advantages of our HTG EdgeSeq ChemistryProfiling Technology
•Multiplexing tens, hundreds or thousands of gene targets. Measuring multiple genes in a single reaction can be challenging with competitive technologies due to the complex interactions of reaction components. While we are currently marketing a panel withWith our HTG EdgeSeq chemistry, thatwe can profile up to 2,560almost 22,000 genes inusing a sample, we have demonstrated feasibility on working with panels as large as 15,000.single panel. The high level of gene multiplexing allows for significantly lower amounts of tissue to be used per sample than in competitive low-plex profiling technologies.
•No RNA extraction. Competitive technologies for assessing RNA generally require RNA that is isolated and purified from other components found in the sample. These time-consuming steps may lead to some targetRNA loss and bias the test outcome. In FFPEformalin fixed paraffin embedded (“FFPE”) tissues, for example, it has been reported that a fraction of the RNA is lost in the purification process because it cannot be separated from insoluble tissue components and the fixation and embedding process or long storage times for FFPE tissue may damage the RNA and break it into smaller, more difficult to analyze fragments. This makes molecular profiling of small FFPE tissues particularly challenging and can result in testing failures and loss of precious samples due to insufficient RNA recovery.yield. These biases introduced by RNA extraction cannot be overcome and may be magnifiedpropagated throughout the subsequent analysis. Our proprietary chemistry does not require RNA extraction for FFPE samples or most other sample types (we recommend extracting RNA from fresh-frozen tissue samples to prevent processing variability) and improves utilization of precious samples, thereby improving workflow and reducing costs by eliminating a step known to bias the data.
•No cDNA synthesis. Many competitive technologies, most prominently RT-quantitative PCR (“RT-qPCR”) and traditional RNA sequencing, require conversion of RNA into complementary DNA (cDNA) for analysis. When damaged and fragmented RNA is used, these small RNA strands become increasingly difficult to convert into cDNA in an accurate and reproducible manner. Our proprietary chemistry does not require conversion of the RNA to cDNA by reverse transcription, removing a technical difficulty experienced with competitive technologies.
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| No cDNA synthesis. Many competitive technologies, most prominently RT-qPCR and traditional RNA sequencing, require conversion of RNA into DNA for analysis. This process, called reverse transcription, requires an enzyme to move along the extracted RNA to create a DNA copy of the molecule. When damaged and fragmented RNA is used, these small RNA strands become increasingly difficult to convert into DNA in an accurate and reproducible manner. Our proprietary chemistry does not require conversion of the RNA to DNA by reverse transcription, removing a technical difficulty experienced with competitive technologies.
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Short protection probes. Many samples contain RNA degraded by various combinations of heat,storage conditions, age, poor processing, and fixation. In these samples, the RNA is damaged and fragmented into smaller strands. Utilizing short protection probes of 50 bases or less, we believe our proprietary chemistry is more efficient than competitive technologies that require longer strands of RNA for quantitation.
•Simplicity. Our proprietary chemistry is simple, with fewer steps than competing technologies. Compared to RT-qPCR, our chemistry does not require extraction or cDNA synthesis. Compared to traditional RNA sequencing, our chemistry does not require extraction, cDNA synthesis, shearing, rRNA depletion, ligation, adenylation, or size selection. We believe that the accumulation of these steps required by other technologies results in amplificationthe introduction of biases, sample degradation and increased opportunities for technicianoperator error.
HTG Instrument Platform
Our assaysinstrument and instrumentsassays were developed internally and are manufactured in Tucson, AZ under ISO 13485:2016 guidelinescertified procedures using our proprietary HTG EdgeSeq chemistry to simplify multiplexed nucleic acid testing in research and clinical laboratories. The entire workflow from sample preparation to a molecular profiling report can be accomplished in as few as 36 hours for 96 samples. With the speed, flexibility, sensitivity, and accuracy of our HTG EdgeSeq platform, combined with the system’s ability to work effectively with small sample volumes, researchers can profile tens, hundreds or thousands of different genes per sample.
The HTG EdgeSeq platform (shown above) consists of a processor (shown above), a host computer and integrated software. The processor is a fully automated instrument that prepares biological samples for quantitation using proprietary, electronically barcoded, single-use consumables. The processorinstrument has barcode scanner units to process the two-dimensional barcodes printed on the consumables loaded into the instrument. The barcoded consumables are single-use in order to reduce operator errors, eliminate cross-contamination and provide chain of custody traceability for the samples. The robotic systemsliquid handling within the instrument areis engineered for reliable performance and low maintenance. The walking path of the robot is programmed to minimize any chance of contamination of the reagents or samples. One host computer supports up to six processors allowing laboratories to easily expand their capacity by adding processors.
Applications of our HTG EdgeSeq technology combine the HTG EdgeSeq processorplatform with a NGS platform to enable the quantitative analysis of tens, hundreds or thousands of targeted RNAsRNA targets in a single panel. The sample library is prepared for quantitation on the processor, then labeled with molecular sequencing adaptors and tags. The labeled samples are concentrated,cleaned up, quantified, pooled, and sequenced on a NGS platform using standard protocols. Data from the NGS instrument are processed and reported by the parser software included with the system. HTG EdgeSeq assayspanels are currently are available to process sample batches ranging from eightone to 96.96 samples in a single batch.
In addition to direct sales of our systems, we utilize several alternative arrangements to sellprovide customer access to our systems.platform. Our platform can be purchased directly by our customers, who also then purchase HTG EdgeSeq assays and other consumables from us on an as-needed basis. In some instances, we provide our instruments free of charge on a limited basis to facilitate customer evaluation.evaluation prior to acquisition. We also may choose to install instruments for our customers at no cost, in exchange for an agreement to purchase assays and other consumables from us at a stated price and volume over the term of the agreement or allow customers to rent our instrument for a monthly fee.
Our Drug Discovery Engine
Currently, approximately 90% of drugs fail in clinical development due to insufficient efficacy and/or safety issues and, in many instances, these issues are not revealed until considerable time has passed and tens or even hundreds of millions of dollars have been spent in the discovery and development stages of these programs. Through key learnings from our prior collaborative development services experiences, we have designed a new approach to drug discovery that leverages the benefits of our HTP and epitranscriptomic profiling technologies in RNA profiling, sequencing and other scientific applications, including drug discovery and development. We believe the competitive advantages provided by our technology, compared with other profiling technologies, are the ability to process smaller sample volumes of multiple sample types with faster turnaround times and a simplified workflow.
In June 2021, we announced the formation of HTG Therapeutics, with the addition of several highly experienced drug development professionals to our leadership team. Throughout 2021, we strengthened our HTG EdgeSeq technology platform and added new profiling capabilities, including epitranscriptomic profiling, which currently provides the capability to generate over 40,000 biological data points from each experimental sample. By leveraging these profiling technologies in the drug discovery process, integrated with an advanced AI and machine learning-based medicinal chemistry approach, we have established a novel transcriptome-informed small molecule discovery engine at the core of our HTG Therapeutics business unit which we believe will generate drug candidate molecules that are intrinsically lower risk and will have greater potential for clinical development success when compared to currently existing early-stage drug discovery methods in the biopharmaceutical industry. We further expect that this approach to small molecule discovery can be applied agnostically across therapeutic areas and is scalable and flexible, allowing us to adapt our strategic and therapeutic focus rapidly as new information emerges on the pathogenesis of diseases.
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We believe that our approach will potentially provide multiple revenue opportunities, including collaboration or out-licensing arrangements for small molecule drug candidates we generate from as early as lead optimization through early preclinical development, the out-licensing of our technology to pharmaceutical companies to enable them to implement our advanced drug discovery approach into their own internal discovery efforts, and potentially new companion diagnostic opportunities to support the related clinical development programs for molecules that are brought forward through this novel discovery approach.
In the first half of 2022, we released a series of white papers after demonstrating the utility of our proprietary technologies as a key component of our novel transcriptome-informed drug discovery and design approach and applying the approach to our initial therapeutic target. As anticipated, the results of our studies summarized in these white papers supported our approach and its ability to reveal indication-specific effects and potential undesirable effects in our first target through analysis of transcriptomic profiles from compound-treated human cell line test systems.
Throughout the second half of 2022, we continued to work to strengthen our drug discovery core platform technology, including advancing the machine learning component of our platform with the refinement of key proprietary algorithms while continuing to generate our own internal data supporting training sets. In addition, we made capital investments to establish internal cell culture capabilities to support the expansion of our cell-based test system models. Our medicinal chemistry effort has produced a series of chemical libraries for our first target, and our most advanced library for this target has entered preclinical characterization, with a series of data generated including early efficacy in two different disease states.
As a result of the progress made throughout 2022, we filed a patent application in December 31, 2019,2022, which included claims directed toward specific compounds, pharmaceutical compositions and methods of treating or preventing disease by administration of the compounds. Our initial therapeutic pipeline is focused on oncology and degenerative neuroscience, emphasizing pharmacologic targets with understood roles in the progression of diseases in these areas.
The most advanced discovery program in oncology is a small molecule program for treatment of liquid tumors. We expect to continue lead optimization of this program through the end of the first quarter of 2023, with advancement to support entry into preclinical development later in the year. HTG Therapeutics has a second oncology directed small molecule program for the treatment of a solid tumor type that is nearing completion in the hit-to-lead discovery phase, with lead optimization efforts planned through the second quarter of 2023 and subsequent preparation for potential preclinical development expected by the end of 2023. In our neuroscience pipeline, we hadhave completed early discovery stage efforts and chemical library generation for candidate small molecules for application to neurodegenerative conditions which are expected to enter the hit-to-lead phase in the second half of 2023.
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We expect to initiate several early discovery-stage programs evaluating small molecule candidates against a variety of different cancers, from which we plan to select candidates for additional indications to continually expand our drug discovery pipeline. As additional candidates are identified, we may choose to retain certain candidates internally to be advanced through early development, with the intention to increase the value of these pipeline assets before moving to license or partner for further development. In parallel to these therapy-area specific programs, we continue to enrich the proprietary dataset that supports our transcriptome-informed drug discovery platform and to evolve and refine the complementary AI and machine learning portions of our drug discovery engine throughout these discovery processes. Finally, we would expect to maintain the exclusive rights and the opportunity to solely develop new CDx assays relating to these drug candidates as they move through the increasingly advanced stages of development with our future collaboration partners, further growing our existing gene expression profiling business.
Our Competitive Advantages
We believe that our proprietary technologies provide us with a number of competitive advantages that set us apart from others in our industry and that will continue to drive new customers toward our solutions.
In drug discovery, we intend to use our captive transcriptomic profiling capabilities combined with our captive medicinal chemistry capabilities to create an installed baseAI driven drug candidate optimization process. Differentiation begins with our profiling capability. Our HTG EdgeSeq technology uses very little sample, has a high sample pass rate and high sensitivity, uses an automated workflow and produces high quality data in under three days for hundreds of 61 instruments (consistingsamples at a time. This enables us to use high quality primary transcriptomic data as an input to analyze the biological response of 44 systems sold, four coveredcells to individual molecules in candidate chemical libraries. We believe competing profiling technologies are not as robust, are more variable and take significantly longer to generate data.
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A further point of differentiation is our chemistry platform. A combination of cheminformatics, molecular docking and machine learning algorithms allow for building and refinement of compound libraries in silico, rapidly generating highly focused compound libraries for specific targets. These small molecule-focused libraries are screened using traditional methods and via molecular profiling, allowing for rapid feedback into the compound design system for optimization of lead compounds. All compound molecules, along with their attendant data, are added to HTG's proprietary compound library.
The key element of our drug discovery engine is a machine learning ‘conversation’ between several data sources, including our proprietary transcriptomic data and the chemical structures of the compound used to generate the data. Additional data sources include pre-trained data from multiple databases for RNA and protein biology, pathway analysis, compound properties and compound structures. Data that we are generating are continually being added and experimental data from our compound libraries will be used in an effort to optimize the design and selection of potential drug candidates for considerations based on transcriptomic indicators related to efficacy and safety. Our drug discovery engine is designed and built to be a modular and highly scalable set of machine learning algorithms, with the flexibility to incorporate cutting-edge techniques in this rapidly-changing area.
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In molecular profiling, our products and services are designed to work with many different biological sample types, can generate robust results from very small samples, and obviate the need for many of the sample-preparation steps associated with traditional molecular techniques. Our platform and assays enable the simultaneous detection and quantitation of tens, hundreds or thousands of molecular targets and are capable of profiling multiple parameters such as RNA expression levels, RNA-expressed gene fusions and RNA modifications in a single testing workflow that can use NGS detection for quantitative measurement.
We believe we are well positioned with the following key product benefits:
•Optimize sample utilization. Our platform can analyze several thousand genes from extremely small sample volumes such as a single five-micron section of tissue or 15 microliters of plasma or serum. With the launch of our transcriptome panel, the analysis plex increases 10 times, while maintaining minimal sample input requirements. Our technology allows customers to do more with less, which meets the needs of clinical or pre-clinical laboratories where there is often not enough patient sample to do all the testing desired. We believe providing customers the ability to work with extremely small sample volumes will be a driver of adoption of our technology and systems.
•Compatibility with multiple sample types. Our proprietary technology allows customers to profile and unlock molecular information from a wide variety of biological samples such as FFPE tissue, cultured cells, and blood-based sample types such as PAXgene, serum and plasma. We have successfully demonstrated the ability to profile these and other sample types and believe we ultimately can profile most clinically relevant sample types, including cell-free circulating nucleic acids from tumors, a rapidly developing area of investigation which is referred to as a liquid biopsy. We believe that the capabilities of our technology will allow us to efficiently expand applications, regardless of sample type.
•Flexible and adaptable chemistry allows for use in multiple applications. We believe our proprietary chemistry provides the ability to measure a variety of molecular targets in many necessary applications, including RNA expression levels and expressed RNA gene rearrangements (such as gene fusions and insertions), and offers the ability to quantify these applications on a variety of NGS platforms. This flexibility provides customers the ability to optimize their use of our technologies based on their specific throughput, workflow and application needs. Our proprietary chemistry is comparatively simple, with fewer steps than competing technologies. For example, compared to RT-qPCR, our chemistry does not require cDNA synthesis. Compared to traditional RNA sequencing, our chemistry does not require extraction, cDNA synthesis, shearing, rRNA depletion, among other library preparation steps. We believe that the elimination of these steps helps prevent biases associated with these steps, sample degradation and opportunities for operator error.
•Robust data. Molecular profiling produces large amounts of information that is used, among other things, to make important decisions, such as identifying potential drug targets or selecting a patient for a therapeutic treatment. This information is valuable only to the extent it accurately represents the true biology of the test sample and can be replicated under reagent rental agreements, six evaluation unitsmany different conditions. Our chemistry is highly specific and seven systemssensitive, meaning it can detect the right target even when very little is present in the sample. Our system produces consistent results on a replicate-to-replicate, day-to-day and instrument-to-instrument basis.
•Automation provides superior workflow and ease of use. Our technology is designed with key opinion leaders)fewer workflow steps in part due to the elimination of the need for complex sample-preparation processes such as extraction, cDNA synthesis, selection, depletion and an additional three instruments installed at third-party sitesshearing. This enables customers to limit hands-on time and the need for specialized skills, resulting in supportturnaround times of approximately 36 hours. Additionally, our HTG EdgeSeq platform further integrates sample preparation for targeted sequencing and greatly simplifies the data bioinformatics, so customers looking to leverage their NGS instrument can seamlessly add this capability to their current workflows.
•Simplified bioinformatics. Our HTG EdgeSeq Reveal software provides data in a simple and easy to use format through a simple graphical user interface that is flexible for researchers and can be used to deliver patient reports. The HTG EdgeSeq parser software, which processes the data generated from the NGS platform, is modular so that new panels can be added without changes to the underlying software or hardware. We believe the simplicity of our bioinformatics solution will help drive the adoption of our platform.
Revenue and Commercialization of our Products
Commercialization of our Drug Discovery Assets
We have recently begun partnering conversations regarding our drug discovery assets. These portfolio discussions are being addressed in two ways. First, we will seek to identify biopharmaceutical companies who want to partner with us to further develop individual drug candidates. These partnerships could be molecule, target or indication specific, or a combination of all three. We expect to have drug candidates for the first two indications available for potential partnership opportunities in 2023.
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Second, we expect to begin partnering conversations with biopharmaceutical companies around the potential licensing of our drug discovery technology. These partnerships could use all of the platform technologies or only certain elements. We expect the supporting data associated with our discovery efforts to serve as tangible and objective proof of our ability to develop differentiated molecules, which would further enable partnership discussions.
Revenue and Commercialization of our Profiling Products
We currently market proprietary molecular profiling panels targeting early and late-stage drug development programs with potential breakthrough therapies. We market these panels to biopharmaceutical companies, with which we may collaborate in biomarker development programs. We believe these programs could facilitate our commercialization of companion diagnostic tests. In addition, our panels are used in pre-clinical and clinical research areas, which we believe will facilitate our commercialization of diagnostic tests, including tumor classifiers and prognostic tests.
Our product and product-related services revenue is generated primarily through the sale of our profiling instruments and consumables and sample processing services to biopharmaceutical companies, academic research centers and molecular testing laboratories.
Customers can purchase our HTG EdgeSeq instrument and related consumables, which consist primarily of our proprietary molecular profiling panels and other assay components. We currently market a number of proprietary profiling panels including, but not limited to, the following panels which profile the full human mRNA and miRNA transcripts, respectively:
•HTG Transcriptome Panel. HTP is expertly designed to provide extensive coverage of most human mRNA transcripts. The panel can simultaneously interrogate 19,398 gene targets using FFPE, PAXgene and extracted RNA samples, generating data for up to 96 samples in less than three days. HTP uses our proprietary workflow and leverages the sensitivity and dynamic range of NGS, allowing researchers to generate reliable results using limited sample amount.
•HTG EdgeSeq miRNA Whole-Transcriptome Assay. Human microRNAs (“miRNA”) are short non-coding strands of RNA that are used by the cell for gene expression regulation. The HTG EdgeSeq miRNA Whole-Transcriptome Assay enables the simultaneous profiling of 2,083 miRNAs, allowing new, potentially clinically relevant miRNA profiles to be discovered. Our ability to efficiently profile small FFPE samples or as little as 15 µL of plasma or serum is a significant differentiator in the rapidly growing miRNA market.
Customers can also access our technology through contracted services. Pre-clinical services, including custom assay design and sample processing services provided by our VERI/O laboratory, allow our customers to identify and validate biomarker signatures across their drug portfolios or patient cohorts more efficiently. Our VERI/O laboratory is a high-volume molecular laboratory focused solely on providing high-quality data from our proprietary molecular profiling technology. These services provide our customers expedited access to our technology at a competitive price. For our biopharmaceutical company customers, we offer an end-to-end solution leveraging a single technology from discovery to diagnostics.
Through collaboration projects.
Opportunities for Comprehensive Molecular Profiling in Diagnostics
Wewith biopharmaceutical company customers, we believe we are planninguniquely positioned to provide comprehensive services to design, develop a portfolio ofand manufacture custom targeted assays with complex molecular diagnostic products using our proprietary technology to provide a single, efficient testing system for sample profiling that integrates seamlessly into a customer’s NGS testing workflow.
We are initially focused on areas where the diagnostic testing paradigm has significant inefficiencies. For example, many leading medical institutions are shifting from a single-drug / single-test approach to a broader tumor profiling strategy for their oncology practices. Rather than testing for single mutational analyses, suchsignatures as KRAS mutations in colorectal cancer, these institutions use their NGS platforms to assess the mutational status of 50 or more genes. In addition, the information a physician needs to make clinical decisions often comes from tests conducted using various testing modalities such as IHC, FISH and NGS. These complexities lead to a growing and unmet demand in clinical diagnostics for more comprehensive molecular profiles that can include RNA expression, RNA fusions and rearrangements, DNA mutations and protein expression.
We completed the CE marking of the HTG EdgeSeq ALKPlus Assay EU in Europe in March 2017 as a companion diagnostic for ALK positive therapies in NSCLC lung cancer cases. Information on the ROS1, RET, NTRK1 and HER2 gene rearrangements included in the ALKPlus Assay panel is provided with RUO status. After obtaining the appropriate exemption(s), we believe the ROS1, RET, NTRK1 and HER2 gene rearrangements detected with the ALKPlus Assay could also be used for investigational use only (“IUO”) assays for certain late stage drug development trials,use in global prospective or retrospective clinical trials. Our expertise in medical device design control and global regulatory submissions, coupled with our ISO 13485:2016 certified quality system, enable us to support potential CDx programs. Although our initial focus primarily has been in oncology, we offer customers a full solution from biomarker discovery to deployment of CDx assays across numerous disease states. Utilizing NGS as appropriate, receive FDA approval inour method of detection provides our customers with the future. Our Premarket Approval (“PMA”) application forbenefits of our highly multiplexed and extraction-free chemistry and the HTG EdgeSeq AlkPlus Assay insensitivity and dynamic range of the U.S. market, which we initiated in 2016, is currently on hold as we evaluate additional medical content for this assay. sequencers, providing a powerful value proposition and complete workflow.
Research and Development
We also CE/IVD markedare committed to the continued evolution of our HTG EdgeSeq DLBCL COO EU test in October 2015, which is utilized to differentiate the two main subtypes of DLBCL, ABC and GCB.
We have also initiated early development on a comprehensive whole transcriptome assay intended to allow for breast cancer prognosis and prediction. Over the past decade, significant molecular information and understanding of breast cancer biology has emerged, which we believe has created a substantial opportunity to develop a broader and more comprehensive set of markers and signatures to support clinical decision making using a single panel. We estimate that this type of panel could serve a target market of nearly 1,000,000 patients in Europe and North America, alone; an available market of $1.5 billion assuming current reimbursement rates and a potential for up to 50% market capture for us.
We are leveragingtechnology platforms, including our platform to develop comprehensive moleculartranscriptomic profiling, panels across an increasing set of molecular applications, with initial focus in immuno-oncology and the identification of pathologies through molecular profiling (“next-generation pathology”). In conjunction with our biopharmaceutical collaborators, we plan to develop novel RNA-based gene panels and possibly classifiers that can provide information about inflammation signatures and the molecular classification of tumors. Separately, we also plan to develop novel RNA-based gene panels designed for expanded applications in immune health monitoring and prescreening, detection of hyper-progression and predicting patient response to combination therapies. We believe that we will need to develop, refine and implement new panel protocols and make changes or adjustments to ourmachine learning chemistry and software to optimize these planned applications and panels for use with our HTG EdgeSeq system. We expect this to require substantial effort from our research scientists and the use of various laboratory equipment, supplies and materials, which all together represent the most significant costs that we expect to incur in connection with the development of these applications and profiling panels.
Research and Development
We have committed, and expect to commit, significant resources to developing new technologies and products, improving product performance and reliability and reducing costs.AI drug discovery technology. We have assembled an experienced research and development team with the scientific, drug design and development, engineering and software and process talentdevelopment experience that we believe is requirednecessary to successfully grow our business.business and allow us to reach our strategic objectives.
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For the year ended December 31, 2022, the largest portion of our research and development efforts were focused on achievement of our drug discovery milestones. We expect to continue to invest in this area as we expand our pipeline and take candidates into development. Upon commercial release of our HTP in August 2021, primary focus of development efforts related to our profiling business has shifted from development of new products to expansion of sample types and improvement of processes associated with our existing product portfolio. As of December 31, 2019,2022, our research and development team consisted of 3515 employees across the disciplines of research and development, scientist, platform development and bioinformatics. As a resultchemistry, therapeutics and bioinformatics, of fewer collaborative development programs in 2019 and into early 2020, our research and development team was reduced to 28 employees in January 2020.which 10 held PhDs.
Our development team is responsible for clinical assay development services being performed for biopharmaceutical company customers. We believe these programs have the potential to generate future revenue through the sale of HTG EdgeSeq instruments and test kit annuities associated with a successfully approved companion diagnostic test as the related drug gains adoption. Our research efforts are currently focused on the expansion of our technology into new immune-oncology applications as well as other applications in solid and liquid biopsies, while working to continuously improve assay performance and probe design.
Sales and Marketing
We distribute our instruments and consumables via direct sales in the United States and Europe and through distributors in parts of Europe and other countries.
As of December 31, 2019,2022, our U.S. sales and marketing organization consisted of 18seven employees including seventhree in direct sales or sales management, seventwo in sales support and fourtwo in marketing. In addition to our U.S. sales team, as of December 31, 2019,2022, we had 11six direct sales and support employees in Europe and distribution agreements in several additional countries. This sales model provides us with direct sales coverage in Austria, Belgium, France, Germany, Luxembourg, the Netherlands, the United Kingdom France, Germany,and Switzerland, Belgium and the Nordic countries, with distributors in Bulgaria, Croatia, Czech Republic, Denmark, Estonia, Finland, Hungary, Ireland, Israel, Italy, Kosovo, Leetonia, Lithuania, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain Portugal, Italy and Israel.Sweden.
Our sales and marketing efforts target biopharmaceutical companies, clinical research centers and clinical diagnostic labs focused on sample profiling for translational research, biomarker/companion assay development and lab-developed diagnostic testing. We intend to promote adoption of our HTG EdgeSeq system,platform, sample profiling panels and future molecular diagnostic assays upon marketing clearance or approval by the FDA, by expanding our U.S. sales force, building a greater direct sales presence in Europe, expanding international distribution and continuing to collaborate with key opinion leaders to validate our platform and to influence utilization of our products.
We expect that our drug discovery assets will be monetized through internal and third-party corporate development resources, and expect initial partnering conversations to be primarily in the United States. We will conduct business development activities internally and with third parties with the objective of partnering our assets as they progress through the preclinical and clinical development pathway.
Manufacturing and Suppliers
We primarily manufacture our products within our facility in Tucson, AZ. External resources are leveraged for their specific expertise in either producing components for our HTG EdgeSeq instrument and raw materials for our consumables in accordance with our designs or based on their catalog products which are utilized as is within our designs. We manufacture HTG EdgeSeq instruments and reagent kits at our Tucson, Arizona facility, which has been certified to ISO 13485:2016 standards. We believe that our existing manufacturing capacity is sufficient to meet our needs for at least the next several years.
InstrumentsWe require a wide variety of raw materials, electronic and mechanical components, chemical and biochemical materials and other supplies to manufacture our products. While multiple commercial sources provide the majority of these required components and supplies, we currently rely on a single supplier to manufacture a subcomponent used in our HTG EdgeSeq instrument. As part of our standard supply management process, we continuously monitor material availability, vendor status and supply chain disruptions to identify and mitigate potential risks by expanding material and source alternatives. Although there are a limited number of manufacturers for components of this type, we believe that other suppliers could provide similar products on comparable terms if additional or alternative supply sources should be necessary in the future. In addition, while we attempt to keep our inventory at minimal levels, we closely monitor inventory of this subcomponent and purchase incremental inventory in this area as circumstances warrant to protect our supply chain.
Instruments
We assemble and test our HTG EdgeSeq instruments at our Tucson, Arizona facility. Instrument component vendors are qualified under our quality system and reviewed regularly to ensure that manufacturing standards are met and maintained. We award contracts for estimated annual quantities of components and, considering the replenishment lead times of our vendors, take delivery of batches covering approximately one month of demand at a time.
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Consumables
We manufacture and test our HTG EdgeSeq consumables at our Tucson, Arizona facility. Raw material vendors are selected using precise standards and are reviewed regularly for compliance with our specific quality requirements. We purchase raw material stock in quantities that often exceed projected annual demand.demand in order to take advantage of bulk pricing discounts and manufacturing efficiencies. We completeproduce batches of finished goods approximating quarterly demand and supervise inventory on a minimum/maximum basis to ensure that we are replenishing our finished goods and raw material ahead of demand.
Competition
Competition
We have categorized known competition into:
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| Other molecular platform offerings, such as PCR-based technologies, microarrays and next-generation sequencers from companies such as Agilent Technologies, Inc., ArcherDx, Inc., BioRad Laboratories, Fluidigm Corporation, Illumina, Inc., Abbott Molecular, Luminex Corporation, Affymetrix, Inc., NanoString Technologies, Inc., entities owned and controlled by QIAGEN N.V., Roche Diagnostics, a division of the Roche Group of companies, Personal Genome Diagnostics and Thermo Fisher Scientific, Inc.;
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•In drug discovery, companies such as Accent Therapeutics, Arrakis Therapeutics, Storm Therapeutics and other discovery-stage biotechnology companies are focused on similar therapeutic areas;
•In profiling, other molecular platform offerings, such as PCR-based technologies, microarrays and next-generation sequencers from companies such as Abbott Molecular, Affymetrix, Inc., Agilent Technologies, Inc., BioRad Laboratories, Invitae, Fluidigm Corporation, Illumina, Inc., Luminex Corporation, NanoString Technologies, Inc., Personal Genome Diagnostics (acquired by Labcorp), entities owned and controlled by QIAGEN N.V., Roche Diagnostics, a division of the Roche Group of companies, and Thermo Fisher Scientific, Inc.;
•Centralized CLIA certified labs offering molecular profiling and gene expression tests as laboratory-developed tests (“LDTs”) such as Caris, Inc., Exact Sciences, Inc., Guardant Health, Inc., Foundation Medicine, Inc., Caris, Inc., NeoGenomics, Inc., Trovagene, Inc., Guardant Health, Inc. Exact Sciences,Personalis, Inc. and Personalis,Trovagene, Inc.; and
•Decentralized CLIA certified labs developing LDTs locally such as major cancer centers.
We believe that the principal competitive factors in all of our target markets include:
•accuracy and reproducibility of results;
•flexibility and ease-of-use;
•compatibility with existing laboratory processes, tools and methods;
•reputation among customers;
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| reputation among customers;
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cost of capital equipment;
•cost of consumables and supplies; and
•innovation in product offerings.
We believe that additional competitive factors specific to the diagnostics market include:
breadth of clinical decisions that can be influenced by information generated by tests;
volume, quality, and strength of clinical and analytical validation data;
availability of coverage and adequate reimbursement for testing services; and
economic benefit accrued to customers based on testing services enabled by product.
We believe the automation afforded by our HTG EdgeSeq systemplatform coupled with fast turnaround time, high multiplexing capability, lysis only/no extraction protocol and low sample requirement gives us numerous competitive advantages in our target markets, as discussed in more detail elsewhere in this report.
While we believe that we compete favorably based on the factors described above, many of our competitors are more highly capitalized and/or have been in existence for a longer period, and enjoy several competitive advantages over us, including:
•Greatergreater name and brand recognition, financial and human resources;
•Broaderbroader product lines;
•Largerlarger sales forces and more established distributor networks;
•Substantialsubstantial intellectual property portfolios;
•Largerlarger and more established customer bases and relationships; and
•Betterbetter established, larger scale and lower cost manufacturing capabilities.
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The biopharmaceutical sector is populated with companies advancing new or differentiated approaches to discovery and experimental therapeutics by way of different platform technologies or modalities with intent for application to specific disease areas through focus on pharmacologic targets or through phenotypic approaches. Each approach has inherent scientific risks that are intrinsic to the discovery sciences for molecule selection, as these efforts provide the early pipeline assets that progress into the more established and regulated stages of drug development. We believe that our approach, which is grounded in our exceptional RNA profiling capabilities now being applied to experimental systems used in conjunction with an advanced medicinal chemistry technology, can result in more well-informed design and selection of small molecule drug candidates very early on in the drug discovery process, thereby allowing for greater chances for success of these molecules. As such, we believe our approach differentiates us from the competition as the early risk reduction of small molecule design and selection is at the core of our strategy, with the flexibility for application across multiple therapy areas.
Intellectual Property
Our success depends in large part on our ability to develop and maintain intellectual property rights relating to key aspects of the technology employed in our HTG EdgeSeq platform and assays, maintain any strategic licenses to use intellectual property owned by third parties, preserve the confidentiality of our trade secrets and operate without infringing the valid and enforceable patents and other proprietary rights of third parties. We rely upon certain patents, registered and common law trademarks, trade secrets, know-how, invention and patent assignment agreements and continuing technological innovation to develop and maintain our competitive position. We intend to aggressively protect, defend and extend the intellectual property rights in our technology.
Patents and Patent Applications
As of December 31, 2019,2022, our patent portfolio included 13 patent families that, collectively, consisted of seven issued U.S. patents, 4958 granted foreign patents (variously in Australia, Canada, China, Japan, France, Germany, Italy, Spain, and United Kingdom), and 1922 patent applications pending in the United States and foreign jurisdictions (including one allowed in Canada).jurisdictions. This portfolio is directed to,inter alia, our nuclease-protection-based technologies, other nucleic-acid detection methods, and to methods for DLBCL andsubtyping diffuse large B-cell lymphoma ("DLBCL"), distinguishing indeterminate nevi from melanoma.melanoma and methods of therapeutics treatments using novel pharmaceutical compounds. Our patent portfolio will help us maintain an exclusive position in key areas of our business, including in the areas of targeted nuclease-protection based sequencing, and DLBCL cell-of-origindrug discovery applications of our technology. In addition, this portfolio may provide out‑licensing opportunities, such as, for methods of detecting melanoma or detection of single-nucleotide changes.opportunities. There were at least 10 granted patents, including one U.S. patent, directed to our novel HTG EdgeSeq methodsproduct in the portfolio as of December 31, 2019. The2022. Our HTG EdgeSeq method patents will begin to expire in April 2032. Our patent portfolio also included 19includes at least four applications as of December 31, 2019, including six forand five patents directed towards our direct-target sequencing (V2) HTG EdgeSeq methods, at least three applications and eight patents directed towards our methods of subtyping DLBCL, and at least six forapplications directed towards our DLBCL subtyping methods and a provisional application directed toof detecting DNA and RNA in the same sample.
Trade Secrets
We also rely on trade secrets, including unpatented know-how, technology and other proprietary information to maintain our competitive position. We seek to protect these trade secrets, in part, by entering into nondisclosure and confidentiality agreements with parties who have access to them, such as our employees, corporate collaborators, outside scientific collaborators, contract manufacturers, consultants, advisors and other third parties. We also enter into invention or patent assignment agreements with our employees and consultants that obligate them to assign to us any inventions developed in the course of their work for us. We cannot provide any assurance, however, that we have entered into such agreements with all relevant parties, or that these parties will abide by the terms of these agreements. Despite measures taken to protect our intellectual property, unauthorized parties might copy or commercially exploit aspects of our technology or obtain and use information that we regard as proprietary.
For additional information relating to the risks associated with our intellectual property position see “Risk Factors – Risks Related to our Intellectual Property.”
Agreements with Third Parties
Asset Purchase Agreement with NuvoGen Research, LLC
We entered into an asset purchase agreement dated January 9, 2001, as amended in November 2003, September 2004, November 2012 and February 2014, with NuvoGen Research, LLC (“NuvoGen”) to acquire certain intellectual property from NuvoGen.NuvoGen (“NuvoGen obligation”). The acquired technology generally relates to our former array-based nuclease protection panels. Pursuant to the terms of the agreement, in exchange for the acquired technology, we initially paid NuvoGen 5,587 shares of our common stock, fixed payments of $740,000 over the first two years of the agreement and, thereafter, agreed to pay NuvoGen the greater of $400,000 per year or 6% of our annual revenue, until the total aggregate cash compensation paid to NuvoGen under the agreement equals $15,000,000. Beginning in 2018, onof $15.0 million. On an annual basis, we becameare currently obligated to pay the greater of $400,000$0.4 million or 6% of our annual revenue, until the total aggregate cash compensation paid to NuvoGen under the agreement totals $15,000,000. As of January 1, 2019, and continuing until the remaining obligation has been paid in full, interest$15.0 million. Interest on the remaining unpaid obligation has been accrued since January 1, 2019 and compounds annually at a rate of 2.5% per year. Accrued interest on this unpaid obligation is payable on the date that the remaining obligation is paid in full.
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SVB Term Loan
In a transaction related to the foregoing acquisition, NuvoGen also received a non-exclusive, royalty free license under the acquired technology pursuant to an agreement dated September 15, 2004. The license is limited to NuvoGen’s own internal service-oriented efforts and activities to accelerate the development of targeted drugs and other pharmaceutical compounds and agents as part of NuvoGen’s grant funded or other basic research and development of drugs intended for the treatment of cancer. Pursuant to the agreement, if NuvoGen produces revenue through the sale of cancer drugs developed through use of the license for entities other than for-profit and other commercial drug-research and development service ventures, NuvoGen will pay us a royalty in the mid-single digit range percentage of such revenue for the quarter. This agreement may be terminated by either party in case of a breach by the other party, and we may terminate the agreement by giving written notice if NuvoGen files for bankruptcy or performs other similar actions.
MidCap Credit Facility
On March 26, 2018 (“MidCap Closing Date”)June 2020, we entered into a Credit and Security Agreement (Term Loan) (the “MidCap Term Loan”) and a Credit and Security Agreement (Revolving Loan) (the “MidCap Revolving Loan” and together with the MidCap Term Loan (the “MidCap Credit Facility”) with MidCap Financial Trust, as agent. MidCap Financial Trust subsequently assigned its rights and obligations as agent to MidCap Funding IV Trust.
The MidCap Term Loan provides a secured term loan facility in an aggregate principal amount of up to $20.0 million. We borrowed the first advance of $7.0 million (“MidCap Tranche 1”) on the closing date. Under the terms of the MidCap Term Loan, the second advance of $13.0 million (“MidCap Tranche 2”) was to be available to us on or before September 30, 2019, subject to our satisfaction of certain conditions described in the MidCap Term Loan. As we did not satisfy these conditions, MidCap Tranche 2 was not made available to us for borrowing.
MidCap Tranche 1 was used to repay in full all outstanding amounts and fees due under our Loan and Security Agreement dated August 2014(the "Loan Agreement") for an asset-secured loan in the principal amount of $10.0 million with Oxford Finance LLC and Silicon Valley Bank (currently named Silicon Valley Bridge Bank, N.A. following the closure of Silicon Valley Bank on March 10, 2023 by the California Department of Financial Protection and Innovation, which appointed the Federal Deposit Insurance Corporation as receiver) ("SVB"), as lender (the “Growth"SVB Term Loan”Loan"). The proceeds remaining from MidCap Tranche 1the SVB Term Loan were fully funded on the June 25, 2020. Our obligations under the SVB Term Loan are being used for working capital and general corporate purposes.secured by a security interest in substantially all of our assets, excluding intellectual property (which is subject to a negative pledge).
MidCap Tranche 1The SVB Term Loan bears interest at a floating rate equal to 7.25% per annum, plus the greater of (i) 1.25% or (ii)2.5% above the one-month LIBOR.Prime Rate (as defined in the Loan Agreement) and 5.75%. Interest on MidCap Tranche 1the SVB Term Loan is due and payable monthly in arrearsarrears. The SVB Term Loan originally required interest-only payments through June 30, 2021. As a result of achieving an equity milestone defined in the Loan Agreement during the quarter ended June 30, 2021, the interest only period was extended for six months through December 31, 2021. Following the extended interest-only period, the Loan Agreement required equal monthly payments of principal and was calculated at a rate of 8.9% for interest accrued asthrough the maturity date of December 31, 2019. Principal on this term loan advance was payable in 36 equal monthly installments beginning April 1, 2020 until paid in full on March 1, 2023 prior to the Amendment (described below). 2023.
Prepayments of the term loan under the MidCapremaining SVB Term Loan, in whole or in part, will be subject to early termination fees in an amount equal to 2.0% of principal prepaid if prepayment occurs after the first anniversary of the MidCap Closing Date but on or prior to the second anniversary of the MidCap Closing Date,1% and 1.0% of principal prepaid if prepayment occurs after the second anniversary of the MidCap Closing Date and prior to or on the third anniversary of the MidCap Closing Date. In connection with execution of the MidCap Term Loan, we paid MidCap a $100,000 origination fee. Upon termination of the MidCap Term Loan, we arewill be required to pay an exita final fee premium equal to 4.50%8% of the principal amount of all term loans advanced to us under the MidCap Term Loan.
The MidCapSVB Term Loan also required that we deliver subordination documents with respect to the QNAH Convertible Note, or that the QNAH Convertible Note otherwise be converted or prepaid, on or before June 30, 2018, and required us to deposit approximately $3.3 million into an escrow account by July 15, 2018 if neither event occurred by such date. As neither event occurred prior to June 30, 2018, we deposited approximately $3.3 million into an escrow account on July 11, 2018. Such escrowed funds will be released to us upon subsequent deliverytermination of the requisite subordination documents or conversion of the QNAH Convertible Note, or as permitted under the terms of the Amendment (described below). If neither delivery of the subordination documents or conversion of the QNAH Convertible Note occurs or the escrowed funds are not provided to us in accordance with the terms of the Amendment, such funds will be applied by the escrow agent to repay in full the QNAH Convertible Note at maturity (or in connection with a prepayment at the direction of the Company after September 1, 2020), subject to (i) our having at least $18.0 million of unrestricted cash and cash equivalents and (ii) there being no default under the MidCap Credit Facility.Loan Agreement.
The MidCap Revolving Loan provides a secured revolving credit facility in an aggregate principal amount of up to $2.0 million. We may request an increase in the total commitments under the MidCap Revolving Loan by up to an additional $8.0 million, subject to agent and lender approval and the satisfaction of certain conditions. Availability of the revolving credit facility under the MidCap Revolving Loan will be based upon a borrowing base formula and periodic borrowing base certifications valuing certain of our accounts receivable and inventory, as reduced by certain reserves, if any. The proceeds of any loans under the MidCap Revolving Loan may be used for working capital and general corporate purposes.
Loans under the MidCap Revolving Loan accrue interest at a floating rate equal to 4.25% per annum, plus the greater of (i) 1.25% or (ii) the one-month LIBOR. Accrued interest on the revolving loans will be paid monthly and revolving loans may be borrowed, repaid and re-borrowed until March 1, 2023, when all outstanding amounts must be repaid. Subject to certain exceptions, termination or permanent reductions of the revolving loan commitment under the MidCap Revolving Loan will be subject to termination fees in an amount equal to 2.0% of the commitment amount terminated or reduced if such termination or reduction occurs after the first anniversary of the MidCap Closing Date but on or prior to the second anniversary of the MidCap Closing Date, and 1.0% of the commitment amount terminated or reduced if such termination or reduction occurs after the second anniversary of the MidCap Closing Date and prior to or on the third anniversary of the MidCap Closing Date.
In connection with the MidCap Revolving Loan, we are required to pay customary fees, including an origination fee of 0.50% of the original commitment amount at closing (and an equivalent origination fee with respect to any increased commitments at the time of the applicable increase), a monthly unused line fee of 0.50% per annum based upon the average daily unused portion of the revolving credit facility and a monthly collateral management fee of 0.50% per annum based upon the average daily used portion of the revolving credit facility. We are also required to maintain a minimum drawn balance of not less 20% of availability under the revolving line. If we do not maintain such minimum drawn balance, it is required to pay monthly interest and fees as if an amount equal to 20% of availability had been drawn down under the revolving line.
Our obligations under the MidCap Credit Facility are secured by a security interest in substantially all of our assets, including intellectual property. Additionally, our future subsidiaries may be required to become co-borrowers or guarantors under the MidCap Credit Facility.
The MidCap Credit FacilityAgreement contains customary affirmative covenants and customary negative covenants limiting our ability and the ability of our subsidiaries, if any, to, among other things, dispose of assets, undergo a change in control, merge or consolidate, make acquisitions, incur debt, incur liens, pay dividends, repurchase stock and make investments, in each case subject to certain exceptions.
The MidCap Credit Facility also contains customary events of default relating to, among other things, payment defaults, breaches of covenants, a material adverse change, delisting of our common stock, bankruptcy and insolvency, cross defaults with certain material indebtedness and certain material contracts, judgments, and inaccuracies of representations and warranties. Upon an event of default, agent andIn July 2022, the lenders may declare all or a portion of our outstanding obligations to be immediately due and payable and exercise other rights and remedies provided for under the agreement. During the existence of an event of default, interest on the obligations could be increased by 3.0%.
In March 2018, we granted the lender ten-year warrants to purchase 18,123 shares of our common stock at $7.73 per share as a result of Tranche 1. The fair value of the warrants on the date of issuance was approximately $74,000, determined using the Black-Scholes option-pricing model, and was recorded as a discount to the MidCap Term Loan.
In February 2020, weCompany entered into an amendment to the MidCap Credit FacilitySVB Term Loan (the “Amendment”"Term Loan Amendment"). Under the Term Loan Amendment, SVB agreed to remove a financial covenant under the Loan Agreement that had required the Company to maintain a minimum unrestricted cash balance. In exchange for this accommodation, the Company prepaid $2.5 million of outstanding principal under the SVB Term Loan (the "Prepayment"). SVB waived the prepayment fee that otherwise would have applied to the Prepayment. The Amendment extendedremaining outstanding principal amount due under the interest-only payments on the term loan advances by an additional 11 months, with principal on each term loan advance payableTerm Loan will continue to be paid in 25 equal monthly installments beginning March 1, 2021, until paid in full on March 1, 2023. The Amendment also allows forpayments of principal and interest through the extension of the interest-only period by an additional four months, with principal on each term loan advance then payable in 21 equal monthly installments beginning July 1, 2021, if certain revenue milestones are achieved for the 12-month period ending on December 31, 2020.
In addition to the extension of the interest-only period, the Amendment (i) permits the use of the $3.3 million of escrowed funds previously deposited for repayment of the QNAH Convertible Note, subject to such repayment not being made before September 1, 2020, us having at least $18.0 million of unrestricted cash and cash equivalents and there being no default under the MidCap Term Loan or the MidCap Revolving Loan and (ii) includes a grant of a security interest in our intellectual property, effective as of thematurity date of the Amendment.
The London interbank offered rate (“LIBOR”), which is the basic rate of interest used in lending between banks on the London interbank market and is widely used as a reference for setting the interest rate on loans globally, is currently scheduled to be phased out in 2021. Before LIBOR is phased out, we will need to amend the MidCap Credit Facility to replace LIBOR with a new reference rate, which has yet to be established. The consequences of this amendment cannot be entirely predicted but could result in higher interest rates on our borrowings under the MidCap Credit Facility.
Development and Component Supply Agreement with Illumina, Inc.
In June 2017, we entered into an Amended and Restated Development and Component Supply Agreement with Illumina, Inc. (“Illumina”), effective May 31, 2017 (the “Restated Agreement”), which amended and restated our IVD Test Development and Component Supply Agreement originally entered into with Illumina in October 2014 (the “Original Agreement”). The Restated Agreement provides for the development and worldwide commercialization by the Company of nuclease-protection-based RNA or DNA profiling tests (“IVD test kits”) for use with Illumina’s MiSeqDx sequencer in the field of diagnostic oncology testing in humans (the “Field”). In addition, we have agreed to pay Illumina a single digit percentage royalty on net sales of any IVD test kits that we commercialize pursuant to the Restated Agreement.
In April 2019, we entered into the First Amendment to the Restated Agreement (the “First Amendment”) with Illumina, effective April 3, 2019. The First Amendment expands the scope of the Field defined in the Restated Agreement to include diagnostic testing in humans for (i) autoimmune disorders and diseases, (ii) cardiovascular disorders and diseases, and (iii) fibrosis disorders and diseases ((i)-(iii) together, the “Other Fields”). We have continued the development plans that have been previously entered into under the Restated Agreement, and we may, at our discretion, submit additional development plans for IVD test kits in the Field to Illumina for its approval, not to be unreasonably withheld. In addition, Illumina will consider requests for additional development plans for IVD test kits in the Other Fields in good faith, but Illumina may accept or reject such requests in its sole and absolute discretion.
Absent earlier termination, the Restated Agreement will expire in May 2027; however, Illumina is no longer obligated to notify us of changes in its products that may affect our IVD test kits after May 31, 2023. We may terminate the Restated Agreement at any time upon 90 days’ written notice and may terminate any development plan under the Restated Agreement upon 30 days’ prior written notice. Illumina may terminate the Restated Agreement upon 30 days’ prior written notice if we undergo certain changes of control, subject to a transition period of up to 12 months for then-ongoing development plans. Either party may terminate the Restated Agreement upon the other party’s material breach of the Restated Agreement that remains uncured for 30 days, or upon the other party’s bankruptcy.
QIAGEN Agreements
Governing Agreement
In November 2016, we entered the Governing Agreement with QML. The Governing Agreement created a framework for the companies to combine their technological and commercial strengths to offer biopharmaceutical companies a complete NGS-based solution for the development, manufacture and commercialization of companion diagnostic assays. Under the Governing Agreement, the parties jointly sought companion diagnostic programs with biopharmaceutical companies, whereby QML entered into sponsor project agreements with interested biopharmaceutical companies for specified projects, and we and QML entered into statements of work, that set forth the rights and obligations of each party with respect to each project. We entered into three statements of work under the Governing Agreement since its initiation, of which two remained active as of December 31, 2019.2023.
In November 2019, we terminated the Governing Agreement, effective immediately, as a result of QML’s material breach of the Governing Agreement. Our termination of the Governing Agreement did not terminate active statements of work under the Governing Agreement. For additional information relating to the statements of work associated with our Governing Agreement, see Item 8, “Notes to Consolidated Financial Statements.”
QNAH Convertible Note Agreement
In October 2017, we issued a subordinated convertible promissory note (the “QNAH Convertible Note”) to QNAH in the principal amount of $3.0 million against receipt of cash proceeds equal to such principal amount. The QNAH Convertible Note bears simple interest at the rate of 3.0% per annum and matures on October 26, 2020. QNAH may elect to convert all or any portion of the outstanding principal balance of the QNAH Convertible Note and all unpaid accrued interest thereon at any time prior to the maturity date into shares of our common stock at a conversion price of $3.984 per share.
Third-Party Coverage and Reimbursement
Clinical laboratories acquire our instrumentation through a capital purchase, capital lease or reagent purchasing agreement. These laboratories offer their customers a menu of testing services using our IVD test kits or their LDTs,laboratory-developed tests ("LDTs"), which they may develop using componentsconsumables they purchase from us, or a combination of both.us. Our customers generate revenue for these testing services by collecting payments from third-party payors, including public and private payors, as well as patient co-payments.
United States
In the United States, molecular testing laboratories have multiple options for reimbursement coding, but we expect that the primary codes used will be the Genomic Sequencing Procedure codes. We are also monitoring the Protecting Access to Medicare Act implementation as well as the recent National Coverage Determination for NGS testing by the Centers for Medicare & Medicaid Services (“CMS”).
Genomic Sequencing Procedures.
The American Medical Association (“AMA”) created codes for Genomic Sequencing Procedures (“GSPs”) and other Molecular Multianalyte Assays as part of its calendar year 2015 update to the clinical laboratory fee schedule. AMA has since modified the GSP codes to clarify the definition to include DNA and RNA. Our customers may use these codes to seek reimbursement for diagnostic multi-analyte test offerings, such as:
Gene expression classifiers for hematolymphoid neoplasms, such as the determination of ABC or GCB subtypes of diffuse large B-cell lymphomas;
Gene rearrangements in solid tumors and hematolymphoid neoplasms; and
Mutations in solid tumors and hematolymphoid neoplasms.
Payments for Tier 1 and Tier 2 Molecular Pathology Procedures and GSPs may be sought from both public and private payors. Claimsclaims for Medicare coverage are processed by private Medicare Administrative Contractors (“MACs”) such as Novitas and Cahaba on behalf of the Centers for Medicare & Medicaid Services (“CMS”), and coverage for specific test codes are specified in Local Coverage Determinations (“LCDs”) issued by individual MACs or National Coverage Determinations (“NCDs”) which apply to all MACs. Private payors issue their own coverage determinations that are largely reflective of the CMS LCDs and NCDs. HTG closely monitors trends in coverage through interactions with customers, industry associations such as the College of American Pathologists (“CAP”) and the Association for Molecular Pathology (“AMP”) and industry consultants; these trends are key considerations in our product development plans.
Our customers may use our products, if approved, and subject to regulatory limitations, to offer testing services that provide an analysis of 5‑50 genes as well as 51 or more genes. In October 2014, CMS released its preliminary determinations regarding the method for determining 2015 payment rates for new codes under the clinical laboratory fee schedule. CMS recommended that payment rates for GSPs be determined through a process known as gapfill rather than by crosswalking to allow CMS and its contractors to gather information about the manner in which the tests are performed and the resources necessary to provide them, so that ultimately CMS can set an appropriate payment rate for these tests. In the gapfill process, the local MACs determine the appropriate fee schedule amounts in the first year, and CMS calculates a national payment rate based on the median of these local fee schedule amounts in the second year. Gapfill pricing for CPTs 81445 and 81450 for the assessment of 5-50 genes in solid and liquid tumors, respectively, is set at $598 and $692, respectively, as of December 31, 2019. CPT 81455 for the assessment of 51 or more genes in solid and liquid tumors is $2,920.
In 2018, CMS released its NCD for reimbursement of CDx tests in oncology. We believe this was a very important event as many of the diagnostic assays that we are in the process of developing are expected to be oncology CDx tests which would be addressed in this NCD.
We believe that establishment of the aforementioned reimbursement codes specific to genomic sequencing procedures such as our CDx tests currently in development is an important factor in expanding access to our products. In addition, coverage and reimbursement of our tests by government and private payors is essential to our commercial success. Accordingly, our strategy includes efforts to encourage third-party payors to establish coverage, coding and payment that will facilitate access to our tests as we seek FDA approval for these tests and expand our commercialization efforts in the United States. Our success in these efforts depends in part on the extent to which governmental authorities, private health insurers and other third-party payors provide coverage for and establish adequate reimbursement levels for tests using our technology. Failure by our customers who use our tests to obtain coverage and sufficient reimbursement from healthcare payors or adverse changes in government and private third-party payors’ policies would have a material adverse effect on our business, financial condition, results of operations and future growth prospects.
Outside the United States
Our target markets outside of the United States are Europe and Asia/Pacific. Our diagnostic product menu plans for Europe and Asia/Pacific consist primarily of NGS‑based test kits that will satisfy existing or emerging testing demand, and we expect to be competing based on testing efficiency, quality and price.
In Europe, coverage for molecular diagnostic testing is varied. Countries with statutory health insurance (e.g., Germany, France, Thethe Netherlands) tend to be more progressive in technology adoption with favorable reimbursement for molecular diagnostic testing. In countries such as the United Kingdom with tax-based insurance, adoption and reimbursement for molecular diagnostic testing is not uniform and is influenced by local budgets.
Failure by our U.S. and ex-U.S. customers who use our tests to obtain sufficient coverage and sufficient reimbursement for our diagnostic products from healthcare payors or adverse changes in government and private third-party payors’ policies wouldcould have a material adverse effect on our ex-U.S. growth prospects and our overall business, financial condition, and results of operations.operations and future growth prospects.
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Government Regulation – Medical Device Regulations
United States
Our products and operations are subject to extensive and rigorous regulation by the FDA and other federal, state, local and foreign authorities. Currently we are limited to marketing our products in the United States for research use only, which means that we cannot make any diagnostic or clinical claims. However, we intend to seek regulatory clearances or approvals in the United States and other jurisdictions to market certain assays for diagnostic purposes. The companion diagnostic tests under development by HTG are classified as “medical devices” under the United States Food, Drug and Cosmetic Act (“FDCA”). The FDA regulates, among other things, the research, development, testing, manufacturing, approval, labeling, storage, recordkeeping, advertising, promotion and marketing, distribution, post approval monitoring and reporting and import and export of medical devices in the United States to assure the safety and effectiveness of such products for their intended use.
Unless an exemption applies, each new or significantly modified medical device we seek to commercially distribute in the United States will require either a premarket notification to the FDA requesting permission for commercial distribution under Section 510(k) of the FDCA, also referred to as a 510(k) clearance, or approval from the FDA of a PMApremarket approval (“PMA”) application. Both the 510(k) clearance and PMA submission can be expensive, and lengthy, and require payment of significant user fees, unless an exemption is available. We believe that our companion diagnostic tests under development would be eligible for the less burdensome 510(k) regulatory pathway.
Device Classification
Under the FDCA, medical devices are classified into one of three classes – Class I, Class II or Class III – depending on the degree of risk associated with each medical device and the extent of control needed to provide reasonable assurances with respect to safety and effectiveness.
Class I devices are those for which safety and effectiveness can be reasonably assured by adherence to a set of regulations, referred to as General Controls, which require compliance with the applicable portions of the FDA’s Quality System Regulation (“QSR”) facility registration and product listing, reporting of adverse events and malfunctions, and appropriate, truthful and non-misleading labeling and promotional materials. Most Class I products are exempt from the premarket notification requirements.
Class II devices are those that are subject to the General Controls, as well as Special Controls, which can include performance standards, guidelines and post market surveillance. Most Class II devices are subject to premarket review and clearance by the FDA. Premarket review and clearance by the FDA for Class II devices is accomplished through the 510(k) premarket notification process. Under the 510(k) process, the manufacturer must submit to the FDA a premarket notification, demonstrating that the device is “substantially equivalent,” to either:
•a device that was legally marketed prior to May 28, 1976, the date upon which the Medical Device Amendments of 1976 were enacted; or
•another commercially available, similar device that was cleared through the 510(k) process.
To be “substantially equivalent,” the proposed device must have the same intended use as the predicate device, and either have the same technological characteristics as the predicate device or have different technological characteristics and not raise different questions of safety or effectiveness than the predicate device. Clinical data are sometimes required to support substantial equivalence.
After a 510(k) notice is submitted, the FDA determines whether to accept it for substantive review. If it lacks necessary information for substantive review, the FDA will refuse to accept the 510(k) notification. If it is accepted for filing, the FDA begins a substantive review. By statute, the FDA is required to complete its review of a 510(k) notification within 90 days of receiving the 510(k) notification. As a practical matter, clearance often takes longer, and clearance is never assured. Although many 510(k) premarket notifications are cleared without clinical data, the FDA may require further information, including clinical data, to make a determination regarding substantial equivalence, which may significantly prolong the review process. If the FDA agrees that the device is substantially equivalent, it will grant clearance to commercially market the device.
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After a device receives 510(k) clearance, any modification that could significantly affect its safety or effectiveness, or that would constitute a new or major change in its intended use, will require a new 510(k) clearance or, depending on the modification, could require a PMA application. The FDA requires each manufacturer to make this determination initially, but the FDA can review any such decision and can disagree with a manufacturer’s determination. If the FDA disagrees with a manufacturer’s determination regarding whether a new premarket submission is required for the modification of an existing device, the FDA can require the manufacturer to cease marketing and/or recall the modified device until 510(k) clearance or approval of a PMA application is obtained. If the FDA requires us to seek 510(k) clearance or approval of a PMA application for any modifications to a previously cleared product, we may be required to cease marketing or recall the modified device until we obtain this clearance or approval. In addition, in these circumstances, we may be subject to significant regulatory fines or penalties for failure to submit the requisite PMA application(s). In addition, the FDA is currently evaluating the 510(k) process and may make substantial changes to industry requirements.
The PMA Process
If the FDA determines that the device is not “substantially equivalent” to a predicate device, or if the device is classified into Class III, the device sponsor must then fulfill the much more rigorous premarketing requirements of the PMA process, or seek reclassification of the device through the de novo process. A manufacturer can also submit a petition for direct de novo review if the manufacturer is unable to identify an appropriate predicate device and the new device or new use of the device presents a moderate or low risk.
Class III devices include devices deemed by the FDA to pose the greatest risk such as life-supporting or life-sustaining devices, or implantable devices, in addition to those deemed not substantially equivalent following the 510(k) process. The safety and effectiveness of Class III devices cannot be reasonably assured solely by the General Controls and Special Controls described above. Therefore, these devices are subject to the PMA application process, which is generally costlier and more time consuming than the 510(k) process. Through the PMA application process, the applicant must submit data and information demonstrating reasonable assurance of the safety and effectiveness of the device for its intended use to the FDA’s satisfaction. Accordingly, aA PMA application typically includes, but is not limited to, extensive technical information regarding device design and development, pre-clinical and clinical study data, manufacturing information, labeling and financial disclosure information for the clinical investigators in device studies. The PMA application must provide valid scientific evidence that demonstrates to the FDA’s satisfaction reasonable assurance of the safety and effectiveness of the device for its intended use.studies.
In the United States, absent certain limited exceptions, human clinical studies intended to support medical device clearance or approval require an Investigational Device Exemption (“IDE”) application. Some types of studies deemed to present “non-significant risk” are deemed to have an approved IDE once certain requirements are addressed and Institutional Review Board approval is obtained. If the device presents a “significant risk” to human health, as defined by the FDA, the sponsor must submit an IDE application to the FDA and obtain IDE approval prior to commencing the human clinical studies. The IDE application must be supported by appropriate data, such as animal and laboratory testing results, showing that it is safe to test the device in humans and that the testing protocol is scientifically sound. The IDE application must be approved in advance by the FDA for a specified number of subjects. Generally, clinical studies for a significant risk device may begin once the IDE application is approved by the FDA and the study protocol and informed consent are approved by appropriate institutional review boards at the clinical study sites. There can be no assurance that submission of an IDE will result in the ability to commence clinical studies, and although the FDA’s approval of an IDE allows clinical testing to go forward for a specified number of subjects, it does not bind the FDA to accept the results of the trial as sufficient to prove the product’s safety and efficacy, even if the trial meets its intended success criteria.
Following receipt of a PMA application, the FDA conducts an administrative review to determine whether the application is sufficiently complete to permit a substantive review. If it is not, the agency will refuse to file the PMA. If the PMA application is determined to be sufficiently complete, the FDA will accept the application for filing and begin the review. The FDA, by statute and by regulation, has 180 days to review a filed PMA application, although the review of an application more often occurs over a significantly longer period. During this review period, the FDA may request additional information or clarification of information already provided, and the FDA may issue a major deficiency letter to the applicant, requesting the applicant’s response to deficiencies communicated by the FDA. The FDA considers a PMA or PMA supplement to have been voluntarily withdrawn if an applicant fails to respond to an FDA request for information (e.g. major deficiency letter) within a total of 360 days. Before approving or denying a PMA, an FDA advisory panel may be convened to review the PMA and provide the FDA with the committee’s recommendation on whether the FDA should approve the submission, approve it with specific conditions, or not approve it. This advisory panel may also involve a public meeting if FDA determines public input is required. Prior to approval of a PMA, the FDA may conduct a bioresearch monitoring inspection of the clinical study data and clinical study sites, and a QSR inspection of the manufacturing facility and processes. Overall, the FDA review of a PMA application generally takes between one and three years, but may take significantly longer.
If the FDA evaluation of a PMA is favorable, the FDA will issue either an approval letter, or an approvable letter, which usually contains several conditions that must be met in order to secure final approval of the PMA. When and if those conditions have been fulfilled to the satisfaction of the FDA, the agency will issue a PMA letter authorizing commercial marketing of the device, subject to the conditions of approval and the limitations established in the approval letter. If the FDA’s evaluation of a PMA application or manufacturing facilities is not favorable, the FDA will deny approval of the PMA or issue a not approvable letter. The FDA also may determine that additional analytical studies or clinical studies are necessary, in which case approval of the PMA submission may be delayed for several months or years while the analytical studies and/or trials are conducted and data are submitted in an amendment to the PMA.
New PMA applications or PMA supplements may be required for modification to the manufacturing process, labeling, device specifications, materials or design of a device that has been approved through the PMA process. PMA supplements often require submission of the same type of information as an initial PMA application, except that the supplement is limited to information needed to support any changes from the device covered by the approved PMA application and may or may not require as extensive technical or clinical data or the convening of an advisory panel, depending on the nature of the proposed change.
In approving a PMA application, the FDA may also require some form of post market studies or post market surveillance, whereby the applicant follows certain patient groups for several years and makes periodic reports to the FDA on the clinical status of those patients when necessary to protect the public health or to provide additional safety and effectiveness data for the device. FDA may also require post market surveillance for certain devices cleared under a 510(k) notification, such as implants or life-supporting or life-sustaining devices used outside a device user facility. The FDA may also approve a PMA application with other post-approval conditions intended to ensure the safety and effectiveness of the device, such as, among other things, restrictions on labeling, promotion, sale, distribution and use.
Post-Approval Requirements
After the FDA permits a device to enter commercial distribution, numerous regulatory requirements apply. These include, but are not limited to:
•the registration and listing regulation, which requires manufacturers to register all manufacturing facilities and list all medical devices placed into commercial distribution;
•the QSR, which requires manufacturers, including third-party manufacturers, to follow elaborate design, testing, production, control, supplier/contractor selection, complaint handling, documentation and other quality assurance procedures during the manufacturing process;
•labeling regulations and unique device identification requirements;
•advertising and promotion requirements;
•restrictions on sale, distribution or use of a device;
•PMA annual reporting requirements;
the FDA’s general prohibition against promoting products for unapproved or “off-label” uses;
•the Medical Device Reporting (“MDR”) regulation, which requires that manufacturers report to the FDA if their device may have caused or contributed to a death or serious injury or malfunctioned in a way that would likely cause or contribute to a death or serious injury if it were to reoccur;
•medical device correction and removal reporting regulations, which require that manufacturers report to the FDA field corrections and product recalls or removals if undertaken to reduce a risk to health posed by the device or to remedy a violation of the FDCA that may present a risk to health;
•recall requirements, including a mandatory recall if there is a reasonable probability that the device would cause serious adverse health consequences or death;
an order of repair, replacement or refund;
•device tracking requirements; and
•post-approval study and post market surveillance requirements.
Our facilities, records and manufacturing processes are subject to periodic unscheduled inspections by the FDA. Failure to comply with the applicable United States medical device regulatory requirements could result in, among other things, warning letters, untitled letters, fines, injunctions, consent decrees, civil penalties, unanticipated expenditures, repairs, replacements, refunds, recalls or seizures of products, operating restrictions, total or partial suspension of production, the FDA’s refusal to issue certificates to foreign governments needed to export products for sale in other countries, the FDA’s refusal to grant future premarket clearances or approvals, withdrawals or suspensions of current product clearances or approvals and criminal prosecution.
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Research Use Only
An RUO product is one that is not intended for clinical diagnostic use and must be labeled “For Research Use Only.Only”. Not for use in diagnostic procedures.” Products that are intended for research use only and are properly labeled as RUO are exempt from compliance with the FDA requirements discussed above, including the approval or clearance and most QSR requirements. A product labeled RUO but intended to be used diagnostically may be viewed by the FDA as adulterated and misbranded under the FDC Act and is subject to FDA enforcement activities. The FDA may consider the totality of the circumstances surrounding distribution and use of an RUO product, including how the product is marketed, when determining its intended use. In November 2013 the FDA issued a guidance document entitled “Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only” (the “RUO Guidance”) which highlights the FDA’s interpretation that distribution of RUO products with any labeling, advertising or promotion that suggests that clinical laboratories can validate the test through their own procedures and subsequently offer it for clinical diagnostic use as a laboratory developed test is in conflict with RUO status. The RUO Guidance further articulates the FDA’s position that any assistance offered in performing clinical validation or verification, or similar specialized technical support, to clinical laboratories, conflicts with RUO status.
European Union
The European Union (“EU”) has also adopted requirements that affect our products. These requirements include establishing standards that address creating a certified quality system as well as several directives that address specific product areas. The most significant of these currently effective directives is the In Vitro Diagnostic Medical Device Directive (“IVDD”) which includes:
•Essential Requirements. The IVDD specifies “essential requirements” that all medical devices must meet. The requirements are similar to those adopted by the FDA relating to quality systems and product labeling.
•Conformity Assessment. Unlike United States regulations, which require virtually all devices to undergo some level of premarket review by the FDA, the IVDD currently allows manufacturers to bring many devices to market using a process in which the manufacturer certifies that the device conforms to the essential requirements of the IVDD for that device. A small number of products must go through a more formal premarket review process. Devices that comply with the requirements of a relevant directive will be entitled to bear the CE conformity marking, indicating that the device conforms to the essential requirements of the applicable directives and, accordingly, can be marketed throughout the EU and European Economic Area.
•Vigilance. The IVDD also specifies requirements for post market reporting similar to those adopted by the FDA.
On May 26, 2017, the EU released a new regulatory framework, the In Vitro Diagnostic Medical Device Regulation (“IVDR”) which is expected to replace IVDD. Our products in the EU will have to comply with the IVDR requirements after May 26, 2022. Until that time, our CE/IVD marked products must continuecontinued to meet the requirements of IVDD for commercialization in the EU.EU until the requirements of IVDR took effect on May 26, 2022. At this time we do not anticipate moving to the requirements of IVDR for our existing CE/IVD marked products. As such, these products are no longer available other than for research use only.
Other International
Several other countries, including Australia, Canada, China and Japan, have adopted or are in the process of adopting standards for medical devices sold in those countries. Many of these standards are loosely patterned after those adopted by the EU, but with elements unique to each country. Although there is a trend towards harmonization of quality system standards, regulations in each country may vary substantially, which can affect timelines of introduction. We routinely monitor these developments and address compliance with the various country requirements as new standards are adopted.
Government Regulation – Fraud and Abuse and Other Healthcare Regulation
We may be subject to various federal and state healthcare laws, including, but not limited to, anti-kickback, false claims, data privacy and security, and transparency laws. Penalties for violations of these healthcare laws include, but are not limited to, significant criminal, civil and administrative penalties, damages, fines, disgorgement, imprisonment, possible exclusion from Medicare, Medicaid and other federal healthcare programs, additional reporting requirements and/or oversight if we become subject to a corporate integrity agreement or similar agreement to resolve allegations of non-compliance with these laws and the curtailment or restructuring of operations. These laws include the following:
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Federal•the federal Anti-Kickback Statute,
The Federal Anti-Kickback Statute prohibits persons or entities from which makes it illegal for any person, including a prescription drug manufacturer (or a party acting on its behalf), to knowingly and willfully soliciting, offering, receivingsolicit, receive, offer or payingpay any remuneration directly or indirectly, overtly or covertly, in cash or in-kind, in exchange for orthat is intended to induce eitheror reward referrals, including the referralpurchase, recommendation, order or prescription of an individual, or the furnishing, arranging for or recommending a good or service, or for the purchasing, leasing, ordering, or arranging for or recommending, any good, facility, service or itemparticular drug, for which payment may be made in whole or in part under a federal healthcare programs,program, such as Medicare or Medicaid. Moreover, the Medicare and Medicaid programs. The Federal Anti-Kickback Statute is broad and prohibits many arrangements and practices that are lawful in businesses outside of the healthcare industry. The term “remuneration” expressly includes kickbacks, bribes, or rebates and has been broadly interpreted to include anything of value, including for example, gifts, discounts, the furnishing of supplies or equipment, credit arrangements, payments of cash, waivers of payments, ownership interests and providing anything at less than its fair market value.
There are several statutory exceptions and regulatory safe harbors protecting certain business arrangements from prosecution under the Federal Anti-Kickback Statute. These statutory exceptions and regulatory safe harbors set forth provisions that, if all their applicable requirements are met, will assure healthcare providers and other parties that they may not be prosecuted under the Federal Anti-Kickback Statute. Such statutory exceptions and regulatory safe harbors are drawn narrowly. The failure of a transaction or arrangement to fit precisely within one or more applicable statutory exceptions or regulatory safe harbors does not necessarily mean that it is illegal or that prosecution will be pursued. However, conduct and business arrangements that do not fully satisfy all requirements of an applicable safe harbor may result in increased scrutiny by government enforcement authorities and will be evaluated on a case-by-case basis based on a cumulative review of all of its facts and circumstances. Additionally, the intent standard under the Federal Anti-Kickback Statute was amended under the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010 (collectively, the “ACA”) to a stricter standard such that a person or entity no longer needs to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation. Further, the intent to induce referrals need only be “one purpose” of the remuneration for violations of the Federal Anti-Kickback Statute. The ACAACA) provides that the government may assert that a claim including items or services resulting from a violation of the Federalfederal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal civil False Claims Act which is discussed below.
Federal Civil False Claims Act
TheAct;
•the federal
civil and criminal false claims laws, including the civil False Claims Act
prohibits,that can be enforced by private citizens through civil whistleblower or qui tam actions, and civil monetary penalties laws prohibit individuals or entities from, among other things,
persons or entities from knowingly presenting, or causing to be presented,
ato the federal government, claims for payment that are false or fraudulent
claimor making a false statement to
avoid, decrease or
the knowing use of false statements to obtain payment from or approval by the Federal Government. Suits filed under the federal civil False Claims Act, known as “qui tam” actions, can be brought by any individual on behalf of the government. These individuals, sometimes known as “relators” or, more commonly, as “whistleblowers,” may share in any amounts paid by the entity to the government in fines or settlement. Ifconceal an
entity is determined to have violated the federal civil False Claims Act, it may be requiredobligation to pay
up to three times the actual damages sustained by the government, plus significant civil penalties for each separate false claim. Many comparable state laws are broader in scope and apply to all payors, and therefore, are not limited to only those claims submitted to the Federal Government.Federal Physician Self-Referral Prohibition
We are also subjectmoney to the federal government;
•the federal Health Insurance Portability and Accountability Act of 1996 (HIPAA) which prohibits, among other things, executing or attempting to execute a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters;
•federal physician self-referral
prohibitions,statute, commonly known as the Stark Law, which prohibits, among other things, physicians who have a financial relationship, including an investment, ownership or compensation relationship with an entity, from referring Medicare and Medicaid patients to the entity for designated health services, which include clinical laboratory services, unless an exception applies. Similarly, entities may not bill Medicare, Medicaid or any other party for services furnished pursuant to a prohibited
referral. Many states have their own self-referral laws as well, which in some cases apply to all third-party payors, not just Medicare and Medicaid.Federal Civil Monetary Penalties Statute
The Federal Civil Monetary Penalties Statute, among other things, imposes fines against any person or entity who is determined to have presented, or caused to be presented, claims to a federal healthcare program that the person knows, or should know, is for an item or service that was not provided as claimed or is false or fraudulent.
Health Insurance Portability and Accountability Act of 1996
The Federal Health Insurance Portability and Accountability Act (“HIPAA”) created several additional federal crimes, including healthcare fraud and false statements relating to healthcare matters. The healthcare fraud statute prohibits knowingly and willfully executing a scheme to defraud any healthcare benefit program, including private third-party payors. The false statements statute prohibits knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services.
referral;
In addition, •HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (“HITECH”) and their implementing regulations, established uniform standards for coveredwhich imposes obligations, including mandatory contractual terms, on “covered entities, which are” including certain healthcare providers, health plans, and healthcare clearinghouses, and their respective “business associates” that create, receive, maintain or transmit individually identifiable health information for or on behalf of a covered entity as well as their business associates that perform services for them that involvecovered subcontractors, with respect to safeguarding the creation, use, maintenance or disclosureprivacy, security and transmission of individually identifiable health information, governing information;
•the
conduct of specified electronic healthcare transactions and protecting the security and privacy of protected health information. Among other things, HITECH also created four new tiers of civil monetary penalties and gave state attorneys general new authority to file civil actions for damages or injunctions in federal
courts to enforce federal HIPAA laws and seek attorneys’ fees and costs associated with pursuing federal civil actions. The EU has established its own data security and privacy legal framework, including but not limited to Directive 95/46/EC (“Data Protection Directive”). The Data Protection Directive was replaced in May 2018 with the recently adopted European General Data Protection Regulation (“GDPR”), which contains new provisions specifically directed at the processing of health information, higher sanctions and extra-territoriality measures intended to bring non-EU companies under the regulation. Over time we may expand our business operations to include additional operations in the EU. With such expansion, we would be subject to increased governmental regulation, including the GDPR, in the EU countries in which we operate.The Federal Physician Payments Sunshine Act,
The Federal Physician Payments Sunshine Act which requires certainapplicable manufacturers of covered drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program, with certainspecific exceptions, to annually report annually to CMS information related to “payments orregarding payments and other transfers of value” providedvalue to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), other healthcare professionals (such as physicians assistants and nurse practitioners) and teaching hospitals and applicable manufacturers and group purchasing organizations to report annually to CMSas well as information regarding ownership and investment interests held by physicians as defined above, and their immediate family members. Beginning in 2022, applicable manufacturers also will be required to reportmembers; and
•analogous state and foreign laws and regulations, such
information regarding payments and transfers of value provided, as
well as ownership and investment interests held, during the previous year to physician assistants, nurse practitioners, clinical nurse specialists, certified nurse anesthetists and certified nurse-midwives. Failure to submit timely, accurately and completely the required information for all payments, transfers of value and ownership or investment interests may result in significant civil monetary penalties.State Law Equivalents
Many states have also adopted laws similar to each of the above federal laws, such asstate anti-kickback and false claims laws which may be broader in scopeapply to sales or marketing arrangements and apply toclaims involving healthcare items or services reimbursed by anynon-governmental third-party payor,payors, including commercialprivate insurers, as well asstate laws that restrict our marketing activitiesrequire biotechnology companies to comply with health care professionalsthe biotechnology industry’s voluntary compliance guidelines and entities,the relevant compliance guidance promulgated by the federal government and may require usdrug manufacturers to track and report information related to payments and other transfers of value including consulting fees, provided to physicians and other healthcare professionalsproviders or marketing expenditures, state laws that require biotechnology companies to report information on the pricing of certain drug products, state and entities. Some states mandate implementationlocal laws that require the registration of compliance programs to ensure compliance with these laws. We also are subject to foreign fraudpharmaceutical sales representatives, and abuse laws, which vary by country. We may be subject to certain statestate and foreign laws governingthat govern the privacy and security of health information in some circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts.
California recently enacted legislation that has been dubbed For example, the first “GDPR-like” lawEU and the United Kingdom have established their own data security and privacy legal framework, including the European General Data Protection Regulation (“EU GDPR”) and the United Kingdom General Data Protection Regulation ("UK GDPR"), which contain provisions specifically directed at the processing of health information, higher sanctions and extra-territoriality measures intended to bring non-EU or non-UK based companies under the regulation. Over time we may expand our business operations to include additional operations in the United States. Known asEU or UK. With such expansion, we would be subject to increased governmental regulation, including the EU GDPR, in the EU countries in which we operate, and the UK GDPR. In addition, California has enacted the California Consumer Privacy Act (“CCPA”), it creates new individualwhich provides certain privacy rights for consumers (as that word is broadly defined in the law)California residents and places increased privacy and security obligations on entities handling personal data of consumerssuch individuals or households. The CCPA became effective January 1, 2020,applies to the personal data of California consumers, business representatives and employees, requires covered companies to provide newcertain disclosures to California consumers, provide such consumers new ways to opt-out of certain sales of personal information,data, and allows for a new cause of action for certain data breaches. In addition, the California Privacy Rights Act of 2020 ("CPRA") amends the CCPA and expands its requirements, including by adding a new right for individuals to correct their personal data and establishing a new regulatory agency to implement and enforce the law.
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Healthcare Reform
In March 2010, President Obama enactedThere have been and we anticipate that there will be healthcare reform measures that may be adopted in the future that may result in more rigorous coverage criteria and additional downward pressure on the reimbursement for healthcare products and services. For example, the ACA, which is substantially changingchanged healthcare financing and delivery by both governmental and private insurers, and is significantly impactingremains subject to challenge. On June 17, 2021, the medical device industry. The ACA’s provisions of importance to our business include, but are not limited to,U.S. Supreme Court dismissed a deductible 2.3% excise taxchallenge on any entityprocedural grounds that manufactures or imports medical devices offered for sale inargued the United States, with limited exceptions, which since has been permanently eliminated by the 2020 federal spending package.
There remain judicial and Congressional challenges to certain aspects of the ACA, as well as efforts by the Trump administration to repeal or replace certain aspects of the ACA. Since January 2017, President Trump has signed two Executive Orders and other directives designed to delay the implementation of certain provision of the ACA and otherwise circumvent some of the requirements for health insurance mandated by the ACA. Concurrently, Congress has considered legislation that would repeal or repeal and replace all or part of the ACA. While Congress has not passed comprehensive repeal legislation, two bills affecting the implementation of certain taxes under the ACA have been signed into law. The Tax Cuts and Jobs Act of 2017 (the “Tax Act”) includes a provision repealing, effective January 1, 2019, the tax-based shared responsibility payment imposed by the ACA on certain individuals who fail to maintain qualifying health coverage for all or part of a year that is commonly referred to as the “individual mandate”. Additionally, the 2020 federal spending package permanently eliminated, effective January 1, 2020, the ACA-mandated medical device tax and “Cadillac” tax on high-cost employer-sponsored health coverage and, effective January 1, 2021, also eliminates the health insurer tax.On December 14, 2018, a Texas U.S. District Court Judge ruled that ACA is unconstitutional in its entirety because the “individual mandate” was repealed by Congress as part ofCongress. Further, on August 16, 2022, President Biden signed the Tax Act. Additionally, on December 18, 2019, the U.S. Court of Appeals for the 5th Circuit upheld the District Court ruling that the individual mandate was unconstitutional and remanded the case back to the District Court to determine whether the remaining provisions of the ACA are invalid as well. It is unclear how this decision, future decisions, subsequent appeals, and other efforts to repeal and replace ACA will impact ACA.
In addition, other legislative changes have been proposed and adopted since the ACA was enacted. On August 2, 2011, President Obama signed into law the Budget ControlInflation Reduction Act of 2011,2022, or IRA, into law, which, among other things, createdextends enhanced subsidies for individuals purchasing health insurance coverage in ACA marketplaces through plan year 2025. The IRA also eliminates the Joint Select Committee on Deficit Reduction to recommend to Congress proposals in spending reductions. The Joint Select Committee did not achieve a targeted deficit reduction of at least $1.2 trillion for the years 2013 through 2021, triggering the legislation’s automatic reduction to several government programs. This includes reductions to Medicare payments to providers of 2% per fiscal year, which went into effect on April 1, 2013, and, following the passage of other legislative amendments, including the Bipartisan Budget Act of 2018, will stay in effect through 2029 unless additional Congressional action is taken. On January 2, 2013, President Obama signed into law the American Taxpayer Relief Act of 2012, which, among other things, further reduced Medicare payments to several providers, including hospitals, imaging centers and cancer treatment centers and increased the statute of limitations period for the government to recover overpayments to providers from three to five years.
The full impact of the ACA, its possible repeal, and any legislation passed to replace the ACA, as well as other laws and reform measures that may be proposed and adopted in the future, remains uncertain, but may continue the downward pressure on medical device pricing, especially“donut hole” under the Medicare Part D program beginning in 2025 by significantly lowering the beneficiary maximum out-of-pocket cost and creating a new manufacturer discount program. The IRA also includes measures designed to lower the cost of certain pharmaceutical products under the Medicare program. It is possible that the ACA will be subject to judicial or Congressional challenges in the future. Congress and the Biden administration are considering various health reform measures. Moreover, payment methodologies may also increase ourbe subject to changes in healthcare legislation and regulatory burdens and operating costs, which could have a material adverse effect on our business operations.initiatives.
The Foreign Corrupt Practices Act
The Foreign Corrupt Practices Act (“FCPA”) prohibits any U.S. individual or business from paying, offering, or authorizing payment or offering of anything of value, directly or indirectly, to any foreign official, political party or candidate for the purpose of influencing any act or decision of the foreign entity to assist the individual or business in obtaining or retaining business. The FCPA also obligates companies whose securities are listed in the United States to comply with accounting provisions requiring the company to maintain books and records that accurately and fairly reflect all transactions of the corporation, including international subsidiaries, and to devise and maintain an adequate system of internal accounting controls for international operations.
EmployeesHuman Capital
Our ability to identify and recruit strong candidates into our company and to retain and develop current talent and recruit new employees intowithin our Companyorganization is a critical factor in our continued growth and performance improvement. We continue to initiate programs to promote our organizational culture and to identify the best possible new talent as the organization grows and new positions are made available. We believe our culture and commitment to our employees result in the attraction and retention of qualified talent, while providing significant value to our company and its stockholders. As of December 31, 2019,2022, we had 10853 full-time and fourone part-time employees,employee, of which 1811 are employed in administration, 2513 in manufacturing and operations, 3515 in research and development, fivetwo in regulatory and quality affairs, and 2913 in direct sales and marketing. Of these employees, 11six were located in Europe and all others were located in the United States. We believe that our success will depend, in part, on our ability to attract and retain qualified personnel. We have never experienced a work stoppage due to labor difficulties and believe that our relations with our employees are good. None of our U.S. employees are represented by labor unions. Collective bargaining is established by law in France. We and our French employees have agreed to the terms of the applicable collective bargaining agreements.
Corporate Information
We were originally incorporated in Arizona in October 1997 as “High Throughput Genomics, Inc.” In December 2000, we reincorporated in Delaware as “HTG, Inc.” and in March 2011 we changed our name to “HTG Molecular Diagnostics, Inc.” Our principal executive offices are located at 3430 E. Global Loop, Tucson, AZ 85706, and our telephone number is (877) 289-2615. Our corporate website address is www.htgmolecular.com. Information contained on or accessible through our website is not a part of this report, and the inclusion of our website address in this report is an inactive textual reference only.
This report contains references to our trademarks, including VERI/O and HTG EdgeSeq, and to trademarks belonging to other entities. Solely for convenience, trademarks and trade names referred to in this report, including logos, artwork and other visual displays, may appear without the ® or TM symbols, but such references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights or the rights of the applicable licensor to these trademarks and trade names. We do not intend our use or display of other companies’ trade names or trademarks to imply a relationship with, or endorsement or sponsorship of us by, any other companies.
We are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act of 2012. We will remain an emerging growth company until December 31, 2020. We refer to the Jumpstart Our Business Startups Act of 2012 in this Annual Report on Form 10-K as the “JOBS Act,” and references to “emerging growth company” have the meaning associated with it in the JOBS Act.
We are also a “smaller reporting company” as defined in the Securities Exchange Act of 1934 (the “Exchange Act”) and have elected to take advantage of certain of the scaled disclosures available to smaller reporting companies.
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Where You Can Find Additional Information
We make available free of charge through our investor relations website, www.htgmolecular.com, our annual reports, quarterly reports, current reports, proxy statements and all amendments to those reports as soon as reasonably practicable after such material is electronically filed or furnished with the SEC. These reports may also be obtained without charge by contacting Investor Relations, HTG Molecular Diagnostics, Inc., 3430 E. Global Loop, Tucson, Arizona 85706, e-mail: info@htgmolecular.com. Our Internet website and the information contained therein or incorporated therein are not intended to be incorporated into this Annual Report on Form 10-K. In addition, the SEC maintains an Internet site that contains reports, proxy and information statements and other information regarding reports that we file or furnish electronically with them at www.sec.gov.
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Item 1A. Risk Factors.
RISK FACTORS
An investment in shares of our common stock involves a high degree of risk. You should carefully consider the following risk factors, as well as the other information in this report, and in our other public filings, before deciding to purchase, hold or sell shares of our common stock. The occurrence of any of the following risks could have a material adverse effect on our business, financial condition, results of operations and future growth prospects or cause our actual results to differ materially from those contained in forward-looking statements we have made in this report and those we may make from time to time. In these circumstances, the market price of our common stock could decline, and you may lose all or part of your investment. You should consider all of the risk factors described when evaluating our business.
Risks Related to our Business and Strategy
There is substantial doubt about our ability to continue as a going concern. We will need to raise additional capital to fund our operations in the future. If we are unsuccessful in attracting new capital, we may be forced to delay, reduce or eliminate at least some of our product development programs or business development plans, may not be able to continue operations or may be forced to sell assets to do so. Alternatively, capital may not be available to us on favorable terms, or if at all. If available, financing terms may lead to significant dilution of our stockholders’ equity.
We are not profitable and have had negative cash flow from operations since our inception. To fund our operations and develop and commercialize our products, we have relied primarily on equity and debt financings and revenue generated from the sale of our HTG EdgeSeq products and related services. We currently expect that our existing resources will only be sufficient to fund our planned operations and expenditures until at least July 2023. In addition, potentially changing circumstances may also result in the depletion of our capital resources more rapidly than we currently anticipate. These circumstances raise substantial doubt about our ability to continue as a going concern.
Our efforts to use our transcriptome-based drug discovery engine to deliver new drug candidates in areas of significant unmet medical need are broad, expensive to achieve and will require substantial additional capital in the future. Our existing programs span early and late-stage discovery, with some approaching entrance into preclinical development. We expect our expenses to increase in connection with our ongoing activities as we continue research and development and add to our pipeline that we believe will be an accelerating number of additional programs. Preclinical testing is expensive and can take many years, which may make equity and debt financing more difficult to obtain.
We will need to obtain additional funds to finance our operations. Additional capital may not be available at such times or in amounts needed by us. Historically we have financed our business in part by access to the capital markets. However, the current volatility in the equity markets creates additional challenges to raising a sufficient amount of capital through an equity financing in the near term. Even if capital is available, it might be available only on unfavorable terms. Any additional equity or convertible debt financing into which we enter could be dilutive to our existing stockholders. Any future debt financing into which we enter may impose covenants upon us that restrict our operations, including limitations on our ability to incur liens or additional debt, pay dividends, repurchase our stock, make certain investments and engage in certain merger, consolidation or asset sale transactions. Any debt financing or additional equity that we raise may contain terms that are not favorable to us or our stockholders. If we raise additional funds through strategic collaborations, partnerships or licensing arrangements with third parties, we may need to relinquish rights to our technologies, our products or our drug candidates or grant licenses on terms that are not favorable to us. If access to sufficient capital is not available as and when needed, our business will be materially impaired, and we may be required to cease operations, curtail one or more product development or commercialization programs, or significantly reduce expenses, sell assets, seek a merger or joint venture partner, file for protection from creditors or liquidate all of our assets. Any of these factors could harm our operating results.
We have incurred losses since our inception and expect to incur losses for the foreseeable future. We cannot be certain that we will achieve or sustain profitability.
We have incurred losses since our inception and expect to incur losses in the future. We incurred net losses of $19.3$21.6 million and $16.5$17.1 million for the years ended December 31, 20192022 and 2018,2021, respectively. As of December 31, 2019,2022, we had an accumulated deficit of $170.3$229.9 million. We expect that our losses will continue for the foreseeable future as we will be required to invest significant additional funds to support product development, including development of new proprietary HTG EdgeSeq panels and products, and the commercialization of our HTG EdgeSeq systemplatform and proprietary consumables. We also expect thatconsumables and advancement of our selling, general and administrative expenses will continue to increase due to the additional costs associated with market development activities and expanding our staff to sell and support our products and services.HTG Therapeutics business unit. Our ability to achieve or, if achieved, sustain profitability is based on numerous factors, many of which are beyond our control, including the market acceptance of our products and services, competitive product development and our market penetration and margins. We may never be able to generate sufficient revenue to achieve or, if achieved, sustain profitability.
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Payments under the instruments governing our indebtedness may reduce our working capital. In addition, a default under our SVB Term Loan could cause a material adverse effect on our financial position.
Pursuant to the terms of the NuvoGen obligation, we have paid NuvoGen $11.1 million, and are required to annually pay NuvoGen the greater of $400,000 or 6% of our yearly revenue until the total aggregate cash compensation paid to NuvoGen under the agreement equals $15.0 million. Payments to NuvoGen will result in a reduction in our working capital as we continue to make payments on this obligation.
The SVB Term Loan requires us, and any debt arrangements we may enter into in the future may require us, to comply with various covenants that limit our ability to, among other things:
•complete mergers or acquisitions;
•incur indebtedness or modify existing debt agreements;
•amend or modify certain material agreements;
•engage in additional lines of business;
•pay dividends or make other distributions to holders of our capital stock;
•make specified investments; and
•engage in transactions with our affiliates.
These restrictions could inhibit our ability to pursue our business strategies. If we default under our obligations under the SVB Term Loan, including as a result of a “material adverse change,” the lender could proceed against the collateral granted to them to secure our indebtedness or declare all obligations under the SVB Term Loan to be due and payable. The definition of “material adverse change” is broad and includes a material impairment in the value of the collateral securing the SVB Term Loan, a material adverse change in our business, operations, or condition (financial or otherwise), and a material impairment of the prospect of repayment of any portion of the SVB Term Loan. Moreover, the determination by the lender as to whether a “material adverse change” has occurred is not within our control. This risk may be exacerbated by the recent closure of SVB. On March 10, 2023, the FDIC took control and was appointed receiver of SVB. The SVB Term Loan remains intact and we will continue to make required payments through the end of the current year, at which time the SVB Term Loan will be repaid in full. However, it is unclear how the current managers of SVB will view the SVB Term Loan from a risk standpoint and what actions they may elect to take under the SVB Term Loan to protect the financial interests of SVB.
In certain circumstances, procedures by the lender could result in a loss by us of all of our equipment and inventory, which are included in the collateral granted to the lender. Our intellectual property is not included in the collateral granted to the lender but is subject to a negative pledge. In addition, upon any distribution of assets pursuant to any liquidation, insolvency, dissolution, reorganization or similar proceeding, the holders of secured indebtedness will be entitled to receive payment in full from the proceeds of the collateral securing our secured indebtedness before the holders of other indebtedness or our common stock will be entitled to receive any distribution with respect thereto.
Unstable market and economic conditions may have serious adverse consequences on our business, financial condition and share price.
The global economy, including credit and financial markets particularly in the emerging biotech sector, has experienced extreme volatility and disruptions, including severely diminished liquidity and credit availability, declines in consumer confidence, declines in economic growth, record inflation and uncertainty about economic stability. For example, the COVID-19 pandemic resulted in widespread unemployment, economic slowdown and extreme volatility in the capital markets. Similarly, the current Russia-Ukraine conflict has resulted and may result in the future in volatility in the global capital markets and has disrupted the global supply chain and energy markets. Any such volatility and disruptions may have adverse consequences on us or the third parties on whom we rely. If the equity and credit markets deteriorate, including as a result of bank failures, political unrest or war, it may make any necessary debt or equity financing more difficult to obtain in a timely manner or on favorable terms, more costly or more dilutive.
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Our HTG Therapeutics business strategy is unique, may not lead to successful drug products for various reasons, may require significant investments in working capital and may not generate any revenue.
In July 2021, we formed a new drug discovery business unit, HTG Therapeutics. This business unit uses our HTP and our epitranscriptomic profiling technologies to more thoroughly understand at the cellular level how cells respond to pharmacologic perturbation. By leveraging these profiling technologies earlier in the drug discovery process, our objective is for HTG Therapeutics to generate lead compounds faster, and with potentially more favorable efficacy and toxicity profiles, with the ultimate goal of generating interest from pharmaceutical companies that results in research or licensing collaborations for, or acquisitions of, these compounds. While we have hired experienced employees and added drug development depth to our Board of Directors, as a company we have no prior experience with drug discovery and development and may not be successful in this endeavor. If studying the transcriptomic profile does not prove to be a more insightful approach to understand diseases and the effects of molecules or does not lead to the biological insights for selection and design of drug candidates that we anticipate, our drug discovery platform may not be as useful or may not lead to as successful drug products, or we may have to move to a new business strategy, any of which could have an adverse effect on our reputation and results of operations.
Moreover, drug discovery and development is expensive and will require investments in working capital by us that may be significant. Our current drug candidates are discovery stage and are approaching entrance to preclinical development. Before we or a partner can bring any drug candidate to market, we must, among other things, complete preclinical studies, have the candidate manufactured to appropriate specifications, conduct extensive clinical trials to demonstrate safety and efficacy in humans, prepare regulatory registration packages and ultimately obtain marketing approval from global regulatory authorities, which, based on our early stage, we have not yet demonstrated our ability to do. Even if we are successful in partnering for one or more early-stage drug discovery programs with a pharmaceutical company, we will need to expend potentially significant capital resources on these programs prior to any such partnering, and potentially after, and there can be no assurance that we will generate meaningful revenue from these programs. Preclinical and clinical development are expensive, difficult to design and implement, can take many years to complete and are uncertain as to outcome. A failure of a clinical trial can occur at any stage of testing. The outcome of preclinical development testing and early clinical trials may not be predictive of success in later clinical trials, and interim results of a clinical trial do not necessarily predict final results.
We have a limited experiencehistory of operations for our preclinical-stage platform-based drug discovery business and no products approved by regulators for commercial sale, which may make it difficult to evaluate our current and future business prospects.
Since the creation of our drug discovery business in marketingJuly 2021, we have focused substantial efforts and sellingfinancial resources on building our drug discovery platform and developing our initial target compounds. All of our compounds are in the discovery stages and/or approaching preclinical development. We may never establish an out-licensing or collaboration arrangement for any compounds we develop, or if we do, the terms may not be favorable to us. Until we successfully partner, out-license develop and/or commercialize drug candidates for these targets, which may never occur, we expect to finance our operations through a combination of equity offerings, debt financings and strategic collaborations or similar arrangements. Biopharmaceutical product development is a highly speculative undertaking and involves a substantial degree of risk. For these and other reasons discussed elsewhere in this Risk Factors section, it may be difficult to evaluate our current business and our future prospects.
As part of our current business model, we intend to seek to enter into strategic collaborations and licensing arrangements with third parties.
We have relied, and expect to continue to rely, on strategic development collaborations and licensing agreements with third parties to develop or in-license technologies based on which products or services we may develop or offer.
We have entered into agreements with third parties to facilitate or enable our development of assays, and ifultimately diagnostic tests, to aid in the diagnosis of oncology diseases, such as breast cancer and melanoma, and other diseases. We intend to enter into additional similar agreements with life sciences companies, biopharmaceutical companies and other researchers for future diagnostic products.
In addition, we intend to seek strategic collaborations, partnerships and licensing arrangements with pharmaceutical and biotechnology companies related to preclinical or clinical development or commercialization to fund expenses associated with development, registration and commercialization of our potential drug candidates. In the near term, the value of our company will depend in part on the number and quality of the collaborations and similar arrangements that we create. Whether we reach a definitive agreement for a collaboration will depend, among other things, on our assessment of the collaborator's resources and expertise, the terms and conditions of the proposed collaboration and the potential collaborator's evaluation of our technologies and capabilities.
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We cannot guarantee that we will enter into any additional agreements or collaborations. For example, our life sciences research or biopharmaceutical customers are not obligated to collaborate with us or license technology to us, and they may choose to develop diagnostic products themselves or collaborate with our competitors. Establishing strategic collaborations and licensing arrangements is difficult and time-consuming. Discussions may not lead to development collaborations or licenses on favorable terms, or at all. Potential collaborators or licensors may elect not to work with us based upon their assessment of our financial, regulatory or intellectual property position. To the extent that we enter new collaborative development or licensing agreements, they may never result in the successful development or commercialization offuture drug candidates or other products or the generation of future sales revenue for a variety of reasons. The success of these arrangements will depend heavily on the efforts and activities of our collaborators. We cannot control the amount and timing of our collaborators’ resources that will be devoted to performing their responsibilities under our agreements with them. Moreover, to the extent we agree to work exclusively with a party in a given area, our opportunities to collaborate with others would be limited. Disputes with our collaborators could also impair our reputation or result in development delays, could consume time and divert management resources away from operations, impact our ability to enter into future collaboration agreements, decrease future revenue and or result litigation expenses or payments to settle disputes.
If we are unable to successfully commercialize our products, our business may be adverselyaffected.
We have limited experience marketing and selling our products. Our HTG Edge system was introduced for sale in the life sciences research market in the third quarter of 2013. Our HTG EdgeSeq chemistry was introduced for sale in the life sciences research market in the third quarter of 2014. Our dedicated HTG EdgeSeq system was introduced for sale in the life sciences research market in the fourth quarter of 2015 and has been our primary product focus since 2016. Our VERI/O service laboratory was announced in June 2016. Our first diagnostic assay, based on our HTG EdgeSeq chemistry and automated in our HTG EdgeSeq system, was introduced for sale in Europe in July 2016. We currently market our products through our own sales force in the United States and Europe and have distributors in parts of Europe and the Middle East. We intend to expand our sales and support teams in the United States and in Europe and to establish additional distributor and/or third-party contract sales team relationships in other parts of the world. However, we may not be able to market and sell our products effectively. Our sales of life science research products, profiling and diagnostic products, and potential future products will depend in large part on our ability to successfully increase the scope of our marketing efforts and establish and maintain a sales force commensurate with our then applicable markets. BecauseWe currently market our products through our own sales force in the United States and Europe and have distributors in parts of Europe, though we have limited experience inmay choose to expand our marketing and sellingsales efforts into other parts of the world. However, we may not be able to market and sell our products in the life science research market and in marketing and selling our products in the diagnostic market, our ability to forecast demand, the infrastructure required to support such demand and the sales cycle to customers is unproven.effectively. If we do not build and maintain an efficient and effective sales force and distributor relationships targeting thesenew markets, our business and operating results will be adversely affected. Further, if our products fail to achieve and sustain sufficient market acceptance, or we are not able to continue to expand our service relationships with third parties, we may not generate the expected revenues and our prospects could be harmed.
If our HTG EdgeSeq systemplatform and proprietary profiling panels fail to achieve and sustain sufficient market acceptance, or we are not able to continue to expand our service or collaborative relationships with biopharmaceutical customers, either directly or through a collaboration partner, we will not generate expected revenue, and our prospects may be harmed.
We are currently focused on selling If the utility of our HTG EdgeSeq systemplatform, proprietary profiling panels, services and solutions in development is not supported by studies published in peer-reviewed medical publications, the rate of adoption of our current and future products and the rate of reimbursement of our future products by third-party payors may be negatively affected. We may provide our HTG EdgeSeq instrument and profiling panels within the life sciences research marketfree of charge or through other arrangements to customers or key opinion leaders through evaluation agreements or reagent rental programs, and where approved,these programs may not be successful in the diagnostic market. We plan to develop panels for many different disease states including companion diagnostics to determine the proper course of treatment for those diseases. We may experience reluctance, or refusal, on the part of physicians to order, and third-party payors to cover and provide adequate reimbursement for, our panels if the resultsgenerating recurring revenue from sales of our researchsystems and clinical studies, and our sales and marketing activities relating to communication of these results, do not convey to physicians, third-party payors and patients that the HTG EdgeSeq system and related profiling panels provide equivalent or better diagnostic information than other available technologies and methodologies. We believe our panels represent an emerging methodology in diagnosing disease states, and we may have to overcome resistance among physicians to adopting it for the marketing of our products to be successful. Even if we are able to obtain regulatory approval from the U.S. Food and Drug Administration (“FDA”) or other applicable regulatory authorities, the use of our panels may not become the standard diagnostic tool for those diseases on which we plan to focus our efforts.proprietary panels.
In addition, a key component of our strategy is to develop diagnostic tools in conjunction with biopharmaceutical companies’ drug development programs, to help assess the proper course of treatment for specific diseases. Even if we are successful in developing those diagnostic tools and receive regulatory approval, we still may not be successful in marketing those diagnostic tests. Furthermore, the decision to advance an underlying drug candidate through clinical trials and ultimately to commercialization is at the discretion of biopharmaceutical companies with which we collaborate. Our biopharmaceutical partners may take certain actions that could negatively impact the utility and marketability of our diagnostic tests. For example, our biopharmaceutical partners could:
•determine not to actively pursue the development or commercialization of an applicable drug candidate, including due to the failure to demonstrate sufficient efficacy, the occurrence of safety or tolerability issues, or any number of other reasons;
•fail to obtain necessary regulatory approval of an applicable drug candidate;
•obtain regulatory approval for a drug candidate in a manner that neither requires nor recommends the use of a companion diagnostic test prior to its use; or
•choose alternative diagnostic tests to market with their products instead of ours.
To the extent that we develop diagnostic assays for a biopharmaceutical company in collaboration with a collaboration partner, we may not have responsibility for some or all aspects of developing, marketing or commercializing any resulting diagnostic tests. In addition to this biopharmaceutical partner risk, a collaboration partner may take certain actions that could negatively impact the development, utility and marketability of the applicable diagnostic tests. For example, a collaboration partner could fail to satisfy or fall behind in its obligations to us or to the biopharmaceutical company for which we develop a companion diagnostic test, which may delay development, regulatory approvals, market development and/or commercialization of the applicable companion diagnostic test.
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COVID-19 has adversely affected our business and a resultresurgence of our termination of the Governing Agreement in November 2019, we no longerCOVID-19 or another health epidemic or pandemic may have a commercialization partner for the development, manufacture and commercialization of companion diagnostics for biopharmaceutical companies. Although the termination of the Governing Agreement does not preclude us from working with QML in the future, either party may be unwilling to partner with the other, and we may be unable to establish a partnering relationship with another suitable company for the development, manufacture, marketing and/or commercialization of companion diagnostic assays on acceptable terms, or at all. If we are unable to establish such a relationship with another company, our efforts to develop, manufacture and commercialize companion diagnostic assays may be significantly delayed and limited in scale, or may not occur at all. In addition, we do not know whether we will be able to enter into new collaborative arrangements with biopharmaceutical company customers on an independent basis. Any of these events could limit our diagnostic test sales and revenues and have a material adverse effectimpact on our business operating resultsin the future.
Our business, including our workforce, supply chain and financial condition.
Our financial results may vary significantly from quarter to quartercustomer base, has been adversely affected by COVID‑19 in the past and a resurgence of COVID-19 or may fall below the expectations of investorsanother health epidemic or securities analysts, each of whichpandemic may adversely affect our stock price.
Investors should consider our business and prospects considering the risks and difficulties we expect to encounterus in the new, uncertain and rapidly evolving markets in which we compete. Because these markets are new and evolving, predicting their future growth and size is difficult. We expect that our visibility into future sales of our products, including volumes, prices and product mix between instruments, consumables and services, will continue to be limited and could result in unexpected fluctuations in our quarterly and annual operating results.future.
Numerous other factors, many of which are outside our control, may cause or contribute to significant fluctuations in our quarterly and annual operating results. For example, three customers accounted for 24%, 22% and 19% of our revenue, respectively, for the year ended December 31, 2019, and three customers accounted for 29%, 26% and 10% of our accounts receivable balance as of December 31, 2019. If orders from our top customers are discontinued and we are unable to establish new collaboration projects with biopharmaceutical companies, our revenue in future periods may materially decrease. Fluctuations in our operating results may make financial planning and forecasting difficult. In addition, these fluctuations may result in unanticipated decreases in our available cash, which could negatively affect our business and prospects. Factors that may contribute to fluctuations in our operating results include many of the risks described under the caption “Risk Factors – Risks Related to Our Business and Strategy” of this report. In addition, one or more of such factors may cause our revenue or operating expenses in one period to be disproportionately higher or lower relative to the others. Our products involveCOVID-19 had a significant capital commitment from our customers or may dependnegative impact on customer studies that have variable or indefinite timelines and accordingly, involve a lengthy sales cycle. We may expend significant effort in attempting to make a particular sale, which may be deferred by the customer or never occur. Accordingly, comparing our operating results on a period-to-period basis may not be meaningful, and investors should not rely on our past results as an indication of our future performance. If such fluctuations occur or if our operating results deviate from our expectations or the expectations of investors or securities analysts, our stock price may be adversely affected.
Our sales cycle is lengthy and variable, which makes it difficult for us to forecast revenue and other operating results.
Our sales process involves numerous interactions with multiple individuals within any given organization, and often includes in-depth analysis by potential customers of our products (where in some instances we will provide a demonstration unit for their use and evaluation), performance of proof-of-principle studies, preparation of extensive documentation and a lengthy review process. As a result of these factors, the capital investment required in purchasing our instrument and the budget cycles of our customers, the time from initial contact with a customer to our receipt of a purchase order can vary significantly and be up to 12 months or longer. Given the length and uncertainty of our sales cycle, we have in the past experienced, and likely will in the future experience, fluctuations in our product and product-related services revenue on a period-to-period basis. In addition, any failure to meet customer expectations could resultin 2020, 2021 and 2022. While we saw some recovery in customers choosingreturning to retainwork in 2022, the period of reduced revenue continued in 2022 as many customers did not return to historical operating levels, did not allow visitors on site at their existing systemsfacilities for some portion of the year or service providershave not resumed previously planned studies. The extent of this impact has varied from customer to customer depending upon how they have been directly or indirectly impacted by local stay-at-home orders and other social distancing measures, priorities for the customers when the immediate impacts of the pandemic had passed, and the workforce and supplier impacts that each customer experienced during the pandemic.
It is also possible that COVID-19 or another epidemic or pandemic will impact our workforce, supply chains or distribution networks or otherwise impact our ability to conduct sample processing services in our laboratory or to purchase systemstravel to customer facilities for commercial or services other than ours. The revenue that we expect to earn from our collaborative development services are also subject to an extended, variable timeline based on each project agreement, which will likely resultsupport functions in fluctuations in our collaborative development services revenue on a period-to-period basis as well.
Wethe future. Governmental mandates may not be able to develop new products or enhance the capabilitiesrequire forced shutdowns of our systemsfacilities for extended or indefinite periods. A public health crisis could also substantially interfere with general commercial activity related to keep pace with rapidly changing technologyour supply chain and customer requirements,base, which could have a material adverse effect on our financial condition, results of operations, business and operating results.
Our success depends onor prospects. Restrictions resulting from a public health crisis may disrupt our supply chains or distribution networks or limit our ability to develop new products and applicationsobtain sufficient materials for our technology in existingconsumables or instruments and new markets, while improving the performance and cost-effectiveness of our systems. New technologies, techniques or products could emerge that might offer better combinations of price and performance than our current or future products and systems. Existing or future markets for our products, including gene expression analysis, liquid-based specimen analysis (e.g., plasma, blood and urine) and single-cell analysis, as well as potential markets for our diagnostic product candidates, are characterized by rapid technological change and innovation. It is critical to our success that we anticipate changes in technology and customer requirements and successfully introduce new, enhanced and competitive technologies to meet our customers’ and prospective customers’ needs on a timely and cost-effective basis. At the same time, however, we must carefully manage the introduction of new products. If customers believe that such products will offer enhanced features or be sold for a more attractive price, they may delay purchases until such products are available. We may also have excess or obsolete inventory of older products as we transition to new products and our experience in managing product transitions is very limited. If we do not successfully innovate and introduce new technology into our product lines or effectively manage the transitions to new product offerings, our revenues and results of operations will be adversely impacted.
Competitors may respond more quickly and effectively than we do to new or changing opportunities, technologies, standards or customer requirements. We anticipate that we will face increased competition in the future as existing companies and competitors develop new or improved products and as new companies enter the market with new technologies.
If we do not successfully manage the development and launch of new products, our financial results could be adversely affected.
We face risks associated with launching new products and with undertaking to comply with regulatory requirements for certain types of our products (i.e. IVDs). If we encounter development or manufacturing challenges, adjust our product development priorities, or discover deficiencies during our product development cycle, the product launch date(s) may be delayed or certain product development projects may be terminated. The expenses or losses associated with unsuccessful product development or launch activities or lack of market acceptance of our new products could adversely affect our business or financial condition.
Our future success is dependent upondisrupt our ability to expand ourprocess customer base and introduce new applications.
Our current customer base is primarily composed of biopharmaceutical companies (including those contracted by QML pursuantsamples or, to the Governing Agreement), academic institutions and molecular labs that perform analyses using or directly or indirectly obtain services based on our HTG EdgeSeq system and consumables for research use only, which means that the products or data from services may not be used for clinical diagnostic purposes. In July 2016,extent we obtained CE marking in Europe for our HTG EdgeSeq system and HTG EdgeSeq DLBCL Cell of Origin Assay EU. In March 2017, we obtained CE marking in Europe for our HTG EdgeSeq ALKPlus Assay EU. These products may be used by customers for diagnostic purposes in Europe. Currently, we do not intend to and, where applicable, do not have appropriate licenses or permits to conduct diagnostic testing services. Our success will depend, in part, upon our ability to increase our market penetration among our customer bases and to expand our market by developing and marketing new companion diagnostic tests and RUO applications (whether product or service). We may not be able to successfully complete development of or commercialize any of our planned future tests and applications. To achieve these goals, we will need to conduct substantial research and development, conduct clinical validation studies, expend significant funds, expand and scale-up our research, development, service and manufacturing processes and facilities, enter into service and collaborative development services arrangements with biopharmaceutical company customers, expand and train our sales force; and seek and obtain regulatory clearance or approvals of our new tests and applications, as required by applicable regulations. Additionally, we must demonstrate to laboratory directors, physicians and third-party payors that our current and any future diagnostic products are effective in obtaining clinically relevant information that can inform treatment decisions, and that our HTG EdgeSeq system and related panels can enable an equivalent or superior approach than other available technology. Furthermore, we expect that a combination of increasing the installed base of our HTG EdgeSeq systems and entering into additional service and custom RUO assay design agreements with biopharmaceutical customers, will drive increased demand forperform collaborative development services. Further, to the extent our relatively high margin panels. If wecustomers’ businesses are not able to successfully increase our installed base and biopharmaceutical customer relationships, then sales of our products and services, and our margins for these revenue items may not meet expectations. Attracting new customers and introducing new products and services requires substantial time and expense. Any failure to expand our existing customer base, or launch new products, including diagnostic products or services, would adversely affect our ability to improve our operating results.
The development of future products is dependent on new methods and/or technologies that we may not be successful in developing.
We have initiated early development of a comprehensive whole transcriptome assay, which we are building for clinical use and which we believe will serve as our anchor product not only for RUO profiling but also for our proprietary breast diagnostic products. In addition, we believe this product will serve as a universal CDx platform for gene expression profiling for our biopharmaceutical company customers. Moreover, we believe this product will allow us to expand our product offerings outside of oncology and autoimmune into markets such as transplant and diabetes. We cannot guarantee that we will be able to successfully develop a comprehensive whole transcriptome assay or that it will have the benefits that we anticipate. If we are unsuccessful at developing this assay or it does not provide the benefits that we anticipate, we may be limited in the breadth of additional products we can offer in the future, which could impact our future revenue and profits.
Our HTG EdgeSeq product portfolio requires the use of NGS instrumentation and reagents and could be adversely affected by actions of third-party NGS product manufacturers over whom we have no control.
A key element of our strategy is to establish our HTG EdgeSeq system as the best sample and library preparation method for clinical applications of next-generation sequencers. We depend at least in part on the availability of NGS instrumentation and reagents, and the ability of our HTG EdgeSeq products to operate seamlessly with NGS instrumentation. Any significant interruptionpandemic, they might delay or delay in the ability of our HTG EdgeSeq products to operate on or with NGS instrumentation could reduce demand for our products and result in a loss of customers.
Our reputation, and our ability to continue to establish or develop our technology for clinical applications of next-generation sequencers, are dependent upon the availability of NGS instrumentation and the reliable performance of our products with NGS instrumentation. We are not able to control the providers of NGS instrumentation, which increases our vulnerability to interoperability problems with the products that they provide. For example, providers of NGS instruments may discontinue existing products, or introduce new NGS instrumentation products with little or no notice to us. This may cause some of our products not to be operable with one or more NGS instruments or may adversely affect regulatory approvals of our future IVD HTG EdgeSeq products, potentially for extended periods of time. Any interruption in the ability of our products to operate on NGS instruments could harm our reputation or decrease market acceptance of our products, and our business, financial condition and operating results may be materially and adversely affected. We also could experience additional expense in developing new products or changes to existing products to meet developments in NGS instrumentation, including fees charged by our development partners to access new technology, and our business, financial condition and operating results may be materially and adversely affected.
Current medical device regulation in the United States and other jurisdictions requires manufacturers of IVD molecular profiling tests that use NGS detection, referred to as NGS IVD tests, to include in regulatory submissions, technical information about the NGS products that are required for performance of, but are not supplied with, the NGS IVD test. These regulatory agencies also require that the NGS instrumentation have “locked” software for the detection of the NGS IVD test results. Thus, to obtain regulatory approval for NGS IVD tests, manufacturers like us, currently must have arrangements with NGS product manufacturers to gain access to technical information and NGS instrument software. We currently have agreements with two NGS product manufacturers that grant us rights to develop, manufacture and sell future HTG EdgeSeq NGS IVD tests in specified fields, subject to, among other things, the NGS product manufacturers’ rights to terminate such agreements and discontinue products or implement product design changes that could adversely affect our HTG EdgeSeq NGS IVD tests. There can be no assurance that our agreements with these NGS product manufacturers, or any future NGS product manufacturers that we contract with, will not be terminated earlier than we currently expect, that a NGS product manufacturer will perform its contractual duties topurchases from us or that we will otherwise receive the benefits we anticipate receiving under those agreements. In addition, if regulatory agencies do not change their requirements for NGS IVD test approval or clearance and the NGS instrument manufacturers close their systems to third-party NGS IVD test development (in general orprojects with specific NGS IVD test manufacturers) and we are not able to maintain or enforce our agreements with such manufacturers, we may not be able to meet our commercial goals and our business, financial condition and operating results may be materially and adversely affected.
If we do not achieve, sustain or successfully manage our anticipated growth, our business and growth prospects will be harmed.
Our current personnel, systems and facilities may not be adequate to support our business plan and future growth. Our need to effectively manage our operations, growth and various projects requires that we, among other things:
continue to improve our operational, financial, management and regulatory compliance controls and reporting systems and procedures;
attract and retain sufficient numbers of talented employees;
manage our commercialization activities effectively and in a cost-effective manner;
manage our relationship with third parties related to the commercialization of our products; and
manage our development efforts effectively while carrying out our contractual obligations to contractors and other third parties.
Moreover, growth will place significant strains on our management and our operational and financial systems and processes. For example, expanded market penetration of our HTG EdgeSeq system and related proprietary panels, and future development and approval of diagnostic products, are key elements of our growth strategy that will require us, to hire and retain additional sales and marketing, regulatory, manufacturing and quality assurance personnel. If we do not successfully forecast the timing and cost of the development of new panels and diagnostic products, the regulatory clearance or approval for product marketing of any future diagnostic products or the demand and commercialization costs of such products, or manage our anticipated expenses accordingly, our operating results will be harmed.
If regulatory limitations are placed on our diagnostic products our business and growth will be harmed.
In many jurisdictions, including the United States, we are currently limited to marketing our HTG EdgeSeq system and proprietary profiling panels for research use only, which means that we cannot make any diagnostic or clinical claims for those products in those jurisdictions.
We obtained the right to CE mark the HTG EdgeSeq DLBCL Cell of Origin Assay EU and the HTG EdgeSeq ALKPlus Assay EU for sale as IVDs in Europe, in July 2016 and March 2017, respectively. If we are unable to maintain CE marking or achieve appropriate ex-U.S. approvals on any of our products for their intended commercial uses on a timely basis or at all, or if clinical diagnostic laboratories or other customers outside the United States do not accept our tests, our ability to grow our business outside of the United States could be compromised.
Clinical studies of any product candidate that we intend to market as an IVD kit may not be successful. If we are unable to successfully complete non-clinical and clinical studies of our product candidates or experience significant delays in doing so, our business will be materially harmed.
Our clinical diagnostic business prospects in the United States and other applicable jurisdictions will depend on our ability to successfully complete clinical studies for product candidates that we intend to market as IVD kits. A failure of one or more clinical studies can occur at any stage of testing. The outcome of non-clinical studies may not be predictive of the success of clinical studies, and interim results, if any, of a clinical study do not necessarily predict final results. Moreover, non-clinical and clinical data are often susceptible to varying interpretations and analyses, and many companies that have believed their product candidates performed satisfactorily in non-clinical and clinical studies have nonetheless failed to obtain premarketing clearance or approval for their products. Completion of clinical studies, announcement of results of the studies and our ability to obtain regulatory approvals could be delayed for a variety of reasons, including:
unsatisfactory results of any clinical study, including failure to meet study objectives;
the failure of our principal third-party investigators to perform our clinical studies on our anticipated schedules;
imposition of a clinical hold following an inspection of our clinical study operations or trial sites by the FDA or other regulatory authorities;
our inability to adhere to clinical study requirements directly or with third parties, such as contract research organizations;
different interpretations of our non-clinical and clinical data, which could initially lead to inconclusive results; and
delays in obtaining suitable patient samples for use in a clinical study.
Our development costs will increase if we have material delays in any clinical study or if we need to perform more or larger clinical studies than planned. If the delays are significant, or if any of our products do not prove to be equivalent to a predicate device or safe or effective, as applicable, or do not receive required regulatory approvals, our financial results and the commercial prospects for our product candidates will be harmed. Furthermore, our inability to complete our clinical studies in a timely manner could jeopardize our ability to obtain regulatory approval.
Our strategy of developing companion diagnostic products may require large investments in working capital and may not generate any revenues.
A key component of our strategy is the development of companion diagnostic products designed to determine the appropriate patient population for administration of a particular therapeutic to more successfully treat a variety of illnesses. Prior to the termination of the Governing Agreement in November 2019, we had an exclusive arrangement with QML to develop certain companion diagnostic products for biopharmaceutical companies under the Governing Agreement. We may now choose to develop companion diagnostic products independently or with a collaboration partner. Successfully developing a companion diagnostic product depends both on regulatory approval for administration of the therapeutic, as well as regulatory approval of the associated diagnostic product. Even if we are successful in developing products that would be useful as companion diagnostic products, and potentially receive regulatory approval for such products, the biopharmaceutical companies that develop the corresponding therapeutics may ultimately be unsuccessful in obtaining regulatory approval for any such therapeutic, or, even if successful, select a competing technology to use in their regulatory submission instead of ours. The development, especially the independent development, of companion diagnostic products requires a significant investment of working capital which may not result in any future income. This could require us to raise additional funds which could dilute our current investors or could impact our ability to continue our operations in the future.
We expect to generate a portion of our revenue internationally and are subject to various risks relating to our international activities which could adversely affect our operating results.
For the year ended December 31, 2019, approximately 34% of our revenue was generated from sales originated by customers located outside of the United States, compared to 69% for year ended December 31, 2018. We expect that a percentage of our future revenue will continue to come from international sources, and we expect to expand our overseas operations and develop opportunities in additional areas. Engaging in international business involves a number of difficulties and risks, including:
required compliance with existing and changing foreign regulatory requirements and laws;
required compliance with anti-bribery laws, such as the U.S. Foreign Corrupt Practices Act and U.K. Bribery Act, data privacy requirements, labor laws and anti-competition regulations;
export and import restrictions;
various reimbursement, pricing and insurance regimes;
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longer payment cycles and difficulties in enforcing agreements and collecting receivables through certain foreign legal systems;
political and economic instability;
potentially adverse tax consequences, tariffs, customs charges, bureaucratic requirements and other trade barriers, including transfer pricing, value added and other tax systems, double taxation and restrictions and/or taxation on repatriation of earnings;
tariffs, customs charges, bureaucratic requirements and other trade barriers;
difficulties and costs of staffing and managing foreign operations, including difficulties and costs associated with foreign employment laws;
increased financial accounting and reporting burdens and complexities; and
difficulties protecting, procuring, or enforcing intellectual property rights, including from reduced or varied protection for intellectual property rights in some countries.
As we expand internationally our results of operationsoperations. The effects of ongoing or future health epidemics on our business remain uncertain and cash flows will become increasingly subject to fluctuations due to changes in foreign currency exchange rates. Historically, mostchange. While we do not know the full extent of our revenue has been denominated in U.S. dollars, although wepotential delays or impacts on the global economy, these effects could have sold our products and services in local currency outside of the United States, principally the Euro. Our expenses are generally denominated in the currencies in whicha material adverse impact on our operations, are located, which is primarily in the United States. As our operations in countries outside of the United States grows, our results of operationsfinancial position and cash flows will increasingly be subject to fluctuations due to changes in foreign currency exchange rates, which could negatively impact our results of operations in the future. For example, if the value of the U.S. dollar increases relative to foreign currencies, in the absence of an offsetting change in local currency prices, our revenue could be adversely affected as we convert revenue from local currencies to U.S. dollars.liquidity.
If we dedicate significant resources to our international operations and are unable to manage these risks effectively, our business, operating results and prospects will suffer. Moreover, we cannot be certain that the investment and additional resources required in establishing operations in other countries will produce desired levels of revenue or profitability.
In addition, any failure to comply with applicable legal and regulatory obligations could negatively impact us in a variety of ways that include, but are not limited to, significant criminal, civil and administrative penalties, including imprisonment of individuals, fines and penalties, denial of export privileges, seizure of shipments and restrictions on certain business activities.
If the utility of our HTG EdgeSeq system, proprietary profiling panels, services and solutions in development is not supported by studies published in peer-reviewed medical publications, the rate of adoption of our current and future products and the rate of reimbursement of our future products by third-party payors may be negatively affected.
We anticipate that we will need to maintain a continuing presence in peer-reviewed publications to promote adoption of our products by biopharmaceutical companies, academic institutions and molecular labs and to promote favorable coverage and reimbursement decisions. We believe that peer-reviewed journal articles that provide evidence of the utility of our current and future products or the technology underlying the HTG EdgeSeq system, consumables and services are important to our commercial success. It is critical to the success of our sales efforts that we educate a sufficient number of clinicians and administrators about our HTG EdgeSeq system, our current panels and services and our future solutions, and demonstrate the research and clinical benefits of these solutions. Our customers may not adopt our current and future solutions, and third-party payors may not cover or adequately reimburse our future products, unless they determine, based on published peer-reviewed journal articles and the experience of other researchers and clinicians, that our products provide accurate, reliable, useful and cost-effective information. Peer-reviewed publications regarding our products and solutions may be limited by many factors, including delays in the completion of, poor design of, or lack of compelling data from studies that would be the subject of the article. If our current and future product and product-related service solutions or the technology underlying such products and services do not receive sufficient favorable exposure in peer-reviewed publications, the rate of research and clinical adoption and positive coverage and reimbursement decisions could be negatively affected.
We provide our HTG EdgeSeq system and profiling panels free of charge or through other arrangements to customers or key opinion leaders through evaluation agreements or reagent rental programs, and these programs may not be successful in generating recurring revenue from sales of our systems and proprietary panels.
We sell our HTG EdgeSeq system and profiling panels under different arrangements to expand our installed base and facilitate the adoption of our platform.
In some instances, we provide equipment free of charge under evaluation agreements for a limited period of time to permit the user to evaluate the system for their purposes in anticipation of a decision to purchase the system. We retain title to the equipment under such arrangements unless the evaluator purchases the equipment, and in most cases, require evaluation customers to purchase a minimum quantity of consumables during the evaluation period.
When we place a system under a reagent rental agreement, we install equipment in the customer’s facility without a fee and the customer agrees to purchase consumable products at a stated price over the term of the agreement. While some of these agreements did not historically contain a minimum purchase requirement, we have included a minimum purchase requirement in all current reagent rental agreements and will continue to do so in the future. We retain title to the equipment and such title is transferred to the customer at no additional charge at the end of the initial arrangement. The cost of the instrument under the agreement is expected to be recovered in the fees charged for consumables, to the extent sold, over the term of the agreement.
Other arrangements might include a research agreement whereby an academic collaborator agrees to provide biological samples in exchange for the use of an HTG EdgeSeq system at no cost in furtherance of the collaborator’s professional goals and/or the educational or research objectives of an applicable institution.
Any of the foregoing arrangements could result in lost revenues and profit and potentially harm our long-term goal of achieving profitable operations. In addition, we require customers who receive systems that we continue to own to carry insurance sufficient to protect us against any equipment losses, we cannot guarantee that they will maintain such coverage, which may expose us to a loss of the value of the equipment in the event of any loss or damage.
There are instances where we provide our systems to key opinion leaders free of charge, to gather data and publish the results of their research to assist our marketing efforts. We have no control over some of the work being performed by these key opinion leaders, or whether the results will be satisfactory. It is possible that the key opinion leader may generate data that is unsatisfactory and could potentially harm our marketing efforts. In addition, customers may from time to time create negative publicity about their experience with our systems, which could harm our reputation and negatively affect market perception and adoption of our platform.
Placing our HTG EdgeSeq systems under evaluation agreements, under reagent rental agreements or with our key opinion leaders without receiving payment for the instruments could require substantial additional working capital to provide additional units for sale to our customers.
The life sciences research and diagnostic markets are highly competitive. We face competition from enhanced or alternative technologies and products, which could render our products and/or technologies obsolete. If we fail to compete effectively, our business and operating results will suffer.
We face significant competition in the life sciences research and diagnostics markets. We currently compete with both established and early stage life sciences research companies that design, manufacture and market instruments and consumables for gene expression analysis, liquid-based specimen analysis (e.g., plasma, blood and urine), single-cell analysis, PCR, digital PCR, other nucleic acid detection and additional applications. These companies use well-established laboratory techniques such as microarrays or qPCR as well as newer technologies such as next-generation sequencing. We believe our principal competitors in the life sciences research market are Agilent Technologies, Inc., ArcherDx, Inc., BioRad Laboratories, Fluidigm Corporation, Illumina, Inc., Abbott Molecular, Luminex Corporation, Affymetrix, Inc., NanoString Technologies, Inc., entities owned and controlled by QIAGEN N.V., Roche Diagnostics, a division of the Roche Group of companies, Personal Genome Diagnostics and Thermo Fisher Scientific, Inc. In addition, there are several other market entrants in the process of developing novel technologies for the life sciences market. One or more of our competitors could develop a product that is superior to a product we offer or intend to offer, or our technology and products may be rendered obsolete or uneconomical by advances in existing technologies.
Within the diagnostic market, there are competitors that manufacture systems for sales to hospitals and laboratories and other competitors that offer tests conducted through CLIA laboratories. We will also compete with commercial diagnostics companies. Most of our current competitors are either publicly traded, or are divisions of publicly traded companies, and enjoy a number of competitive advantages over us, including:
greater name and brand recognition, financial and human resources;
larger sales forces and more established distributor networks;
substantial intellectual property portfolios;
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better established, larger scale, and lower cost manufacturing capabilities.
We believe that the principal competitive factors in all of our target markets include:
cost of capital equipment;
cost of consumables and supplies;
reputation among customers;
innovation in product offerings;
flexibility and ease-of-use;
accuracy and reproducibility of results; and
compatibility with existing laboratory processes, tools and methods.
We believe that additional competitive factors specific to the diagnostics market include:
breadth of clinical decisions that can be influenced by information generated by tests;
volume, quality, and strength of clinical and analytical validation data;
availability of coverage and adequate reimbursement for testing services; and
economic benefit accrued to customers based on testing services enabled by products.
Our products may not compete favorably, and we may not be successful in the face of increasing competition from new products and technologies introduced by our existing competitors or new companies entering our markets. In addition, our competitors may have or may develop products or technologies that currently or in the future will enable them to produce competitive products with greater capabilities or at lower costs than ours. Any failure to compete effectively could materially and adversely affect our business, financial condition and operating results.
Our current business depends on levels of research and development spending by academic and governmental research institutions and biopharmaceutical companies, a reduction in which could limit demand for our products and adversely affect our business and operating results.
Our revenue is currently derived from sales of our HTG EdgeSeq system and related proprietary panels, the design of custom RUO assays and sample processing for research applications to biopharmaceutical companies, academic institutions and molecular labs, predominantly in the United States and Europe, and collaborative development services. The demand for our products and services will depend in part upon the research and development budgets of these customers, which are impacted by factors beyond our control, such as:
changes in government programs that provide funding to research institutions and companies;
macroeconomic conditions and the political climate;
changes in the regulatory environment;
differences in budgetary cycles;
market-driven pressures to consolidate operations and reduce costs; and
market acceptance of relatively new technologies, such as ours.
We believe that any uncertainty regarding the availability of research funding may adversely affect our operating results and may adversely affect sales to customers or potential customers that rely on government funding. In addition, academic, governmental and other research institutions that fund research and development activities may be subject to stringent budgetary constraints that could result in spending reductions, reduced allocations or budget cutbacks, which could jeopardize the ability of these customers to purchase our products or services. Our operating results may fluctuate substantially due to reductions and delays in research and development expenditures by these customers. Any decrease in our customers’ budgets or expenditures, or in the size, scope or frequency of capital or operating expenditures, could materially and adversely affect our business, operating results and financial condition.
As part of our current business model, we intend to seek to enter into strategic development collaborations and licensing arrangements with third parties to develop diagnostic tests.
We have relied, and expect to continue to rely, on strategic development collaborations and licensing agreements with third parties to develop or in-license technologies based on which products or services we may develop or offer. We have entered into agreements with third parties to facilitate or enable our development of assays, and ultimately diagnostic tests, to aid in the diagnosis of oncology diseases, such as breast cancer and melanoma, and other diseases. We intend to enter into additional similar agreements with life sciences companies, biopharmaceutical companies and other researchers for future diagnostic products. However, we cannot guarantee that we will enter into any additional agreements. In particular, our life sciences research or biopharmaceutical customers are not obligated to collaborate with us or license technology to us, and they may choose to develop diagnostic products themselves or collaborate with our competitors. Establishing development collaborations and licensing arrangements is difficult and time-consuming. Discussions may not lead to development collaborations or licenses on favorable terms, or at all. Potential collaborators or licensors may elect not to work with us based upon their assessment of our financial, regulatory or intellectual property position. To the extent that we enter new collaborative development or licensing agreements, they may never result in the successful development or commercialization of future tests or other products for a variety of reasons, including because our collaborators may not succeed in performing their obligations or may choose not to cooperate with us. We cannot control the amount and timing of our collaborators’ resources that will be devoted to performing their responsibilities under our agreements with them. Moreover, to the extent we agree to work exclusively with a party in a given area, our opportunities to collaborate with others would be limited. Even if we establish new relationships, they may never result in the successful development or commercialization of future tests or other products. Disputes with our collaborators could also impair our reputation or result in development delays, decreased revenues and litigation expenses.
Our research and development efforts will be hindered if we are not able to contract with third parties for access to archival patient samples.
Our future development of products for clinical indications will require access to archival patient samples for which data relevant to the clinical indication of interest is known. We rely on our ability to secure access to these archived patient samples, including FFPE tissue, plasma, serum, whole blood preserved in PAXgene, or various cytology preparations, together with the information pertaining to the clinical outcomes of the patients from which the samples were taken. Owners or custodians of relevant samples may be difficult to identify and/or identified samples may be of poor quality or limited in number or amount. Additionally, others compete with us for access to these samples for both research and commercial purposes. Even when an appropriate cohort of samples is identified, the process of negotiating access to these samples can be lengthy because it typically involves numerous parties and approval levels to resolve complex issues such as usage rights, institutional review board approval, privacy rights, publication rights, and intellectual property ownership. In addition, in some instances the cost to acquire samples can be prohibitively expensive. If we are not able to negotiate access to archived patient samples on a timely basis and on acceptable terms, or at all, or if our competitors or others secure access to these samples before us, our ability to research, develop and commercialize future products will be limited or delayed.
We are dependent on a single third-party supplier for a certain subcomponent of our systems and the loss of this supplier could harm our business.
We currently rely on a single supplier to supply a subcomponent used in our HTG EdgeSeq processors. While we periodically forecast our needs for this subcomponent, our contract with this supplier, which may be a standard purchase order, does not commit them to carry inventory or make available any particular quantities, and the supplier may give other customers’ needs higher priority than ours and we may not be able to obtain adequate supplies in a timely manner or on commercially reasonable terms. If we were to lose this supplier, we may not be able to identify or enter into agreements with alternative suppliers on a timely basis on acceptable terms, or at all. If we should encounter delays or difficulties in securing the quality and quantity of subcomponent we require for our processors, our supply chain would be interrupted which would adversely affect our sales. A loss of this supplier could significantly delay the delivery of our HTG EdgeSeq processor, which in turn would materially affect our ability to generate revenue. If any of these events occur, our business and operating results could be materially harmed.
We may encounter manufacturing difficulties that could impede or delay production of our HTG EdgeSeq systems.
We began manufacturing our HTG EdgeSeq system internally in 2016. We have limited experience with manufacturing the system and our internal manufacturing operations may encounter difficulties involving, among other things, scale-up of manufacturing processes, production efficiency and output, regulatory compliance, quality control and quality assurance, and shortages of qualified personnel. Any failure in our planned internal manufacturing operations could cause us to be unable to meet demand for these systems, delay the delivery of the system to customers, and harm our business relationships and reputation.
If we encounter difficulties in our planned internal manufacturing operations, we may need to engage a third-party supplier, provided we cannot be sure we will be able to do so in a timely manner, or at all, or on favorable terms.
Any of these factors could cause us to delay or suspend production of our HTG EdgeSeq system, entail unplanned additional costs and materially harm our business, results of operations and financial condition.
Our business operations might be disrupted or adversely affected by catastrophic events.
We manufacture our consumable products and our HTG EdgeSeq systeminstrument and consumable products and perform our RUO profiling and collaborative developmentcustom RUO assay design services in our Tucson, Arizona facilities. In addition, our Tucson facilities are the center for order processing, receipt of critical components of our HTG EdgeSeq instrument and shipping products to customers. We do not have redundant facilities. Damage or the inability to utilize our Tucson facilities and the equipment we use to perform research, development or services and manufacture our products could be costly, and we would require substantial lead-time to repair or replace this facility and equipment. The Tucson facilities may be harmed or rendered inoperable by natural or man-made disasters, including flooding, wind damage, power spikes and power outages, which may render it difficult or impossible for us to perform these critical functions for some period of time. The inability to manufacture consumables or instruments, process customer samples, perform development services or ship products to customers for even a short period of time may result in the loss of customers or harm our reputation, and we may be unable to regain those customers in the future. Although we possess insurance for damage to our property and the disruption of our business, this insurance may not be sufficient to cover all of our potential losses and may not continue to be available to us on acceptable terms, or at all. In addition, natural disasters or other catastrophic events in various parts of the world, including interruptions in the supply of natural resources, political and governmental changes, disruption in transportation networks or delivery services, severe weather conditions, wildfires and other fires, explosions, actions of animal rights activists, terrorist attacks, earthquakes, wars, conflicts (including the current Russia-Ukraine conflict), and public health issues could disrupt our operations or those of our collaborators, contractors and vendors or contribute to unfavorable economic or other conditions that could adversely impact us.
Public health epidemics, pandemicsOur financial results may vary significantly from quarter to quarter or outbreaks, includingmay fall below the recent coronavirus pandemic, couldexpectations of investors or securities analysts, each of which may adversely affect our business.stock price.
OurInvestors should consider our business and prospects considering the risks and difficulties we expect to encounter in the new, uncertain and rapidly evolving markets in which we compete. Because these markets are new and evolving, predicting their future growth and size is difficult. We expect that our visibility into future sales of our products, including volumes, prices and product mix between instruments, consumables and services, will continue to be limited and could result in unexpected fluctuations in our workforce, supply chainquarterly and annual operating results.
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Numerous other factors, many of which are outside our control, may cause or contribute to significant fluctuations in our quarterly and annual operating results. For example, two customers accounted for 16% and 14% of our revenue for the year ended December 31, 2022. The three largest customers accounted for 37%, 24%, and 13% of our accounts receivable balance as of December 31, 2022. If orders from our top customers are discontinued and we are unable to establish new projects or continue to expand our customer base, our revenue in future periods may materially decrease. In addition, we experienced a significant slowing of product and product-related services revenue generation beginning in March 2020 as a result of COVID-19. This period of reduced revenue continued through the remainder of 2020, 2021 and into 2022 due to disruptions to our customers’ businesses as a result of the pandemic. The extent of this impact on our ongoing business is likely to vary from customer to customer depending upon how they are directly or indirectly impacted by local stay-at-home orders and other social distancing measures, priorities for the customers when the immediate impacts of the pandemic have passed, and the workforce and supplier impacts that each customer has experienced during the pandemic. Fluctuations in our operating results may make financial planning and forecasting difficult. In addition, these fluctuations may result in unanticipated decreases in our available cash, which could negatively affect our business and prospects. Factors that may contribute to fluctuations in our operating results include many of the risks described under the caption “Risk Factors – Risks Related to Our Business and Strategy” of this report. In addition, one or more of such factors may cause our revenue or operating expenses in one period to be disproportionately higher or lower relative to the others. Our products involve a significant capital commitment from our customers or may depend on customer studies that have variable or indefinite timelines and accordingly, involve a lengthy sales cycle. We may expend significant effort in attempting to make a particular sale, which may be deferred by the customer or never occur. Accordingly, comparing our operating results on a period-to-period basis may not be meaningful, and investors should not rely on our past results as an indication of our future performance. If such fluctuations occur or if our operating results deviate from our expectations or the expectations of investors or securities analysts, our stock price may be adversely affectedaffected.
Our sales cycle is lengthy and variable, which makes it difficult for us to forecast revenue and other operating results.
Our sales process involves numerous interactions with multiple individuals within any given organization, and often includes in-depth analysis by the effectspotential customers of health epidemics, including the recent outbreakour products (where in some instances we will provide a demonstration unit for their use and evaluation), performance of the novel strainproof-of-principle studies, preparation of coronavirus (COVID-19) which has been declaredextensive documentation and a pandemic.lengthy review process. As a result of health epidemics, including COVID-19, businesses maythese factors, the capital investment required in purchasing our instrument and the budget cycles of our customers, the time from initial contact with a customer to our receipt of a purchase order can vary significantly and be shut down, supply chains can be interrupted, slowed,up to 12 months or rendered inoperable,longer. Given the length and individuals can become ill, quarantined, or otherwise unable to work and/or travel due to health reasons or governmental restrictions.
The outbreakuncertainty of COVID-19 has caused several countries to implement quarantines and/or significant restrictionsour sales cycle, we have in the past experienced, and likely will in the future experience, fluctuations in our product and product-related services revenue on travel.a period-to-period basis. In addition, certain affected regions, including several states withinany failure to meet customer expectations could result in customers choosing to retain their existing systems or service providers or to purchase systems or services other than ours. To the United States, have implemented work restrictionsextent we enter into collaborative services agreements with biopharmaceutical customers, the revenue that prohibit many employeeswe expect to earn from goingour collaborative development services are also subject to work. Moreover,an extended, variable timeline based on each project agreement, which will likely result in fluctuations in our collaborative development services revenue on a period-to-period basis as well.
We may not be able to develop new products or enhance the COVID-19 pandemic has resulted in business closures and a substantial reduction in economic activity in the United States and worldwide.
Governmental mandates may require forced shutdownscapabilities of our facilities for extended or indefinite periods. In addition, these widespread outbreaks of illness could adversely affect our workforce resulting in serious health issues and absenteeism. Pandemic outbreaks, including the coronavirus, could also substantially interferesystems to keep pace with general commercial activity related to our supply chainrapidly changing technology and customer base,requirements, which could have a material adverse effect on our business and operating results.
Our success depends on our ability to develop new products and applications for our technology in existing and new markets, while improving the performance and cost-effectiveness of our systems. If we do not successfully manage the development and launch of new products, our products or our financial condition,results could be adversely affected. Developing new products and applications may require large investments in working capital and/or the development of new methods or technologies.
Although we believe that our HTG Transcriptome Panel will be a foundational product for RUO profiling, future companion diagnostics and potential proprietary diagnostic products, and will allow us to further expand our product offerings outside of oncology and autoimmune, we have only recently initiated commercial sales of this panel and it may not have the commercial success that we anticipate or hope for, and we may not be able to continue to expand our product offerings.
In July 2021, we formed a new drug discovery business unit, HTG Therapeutics, which uses our HTP and epitranscriptomic profiling technologies in RNA profiling, and we expect that, by leveraging these profiling technologies earlier in the drug discovery process, HTG Therapeutics will generate lead compounds faster, and with potentially more favorable efficacy and toxicity profiles. However, there can be no assurance that HTG Therapeutics will be able to accomplish these goals or will otherwise be successful. In addition, we have built a machine learning-based chemical library design platform, which is expected to better predict the binding properties of a drug candidate to its target. If we are unsuccessful at developing this full machine learning-based chemical library design platform, or it, HTG Therapeutics or our HTP do not provide the benefits that we anticipate, our future revenue opportunities will be limited.
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New technologies, techniques or products could emerge that might offer better combinations of price and performance than our current or future products and systems. Existing or future markets for our products, including gene expression analysis, liquid-based specimen analysis (e.g., plasma, blood and urine) and single-cell analysis, as well as potential markets for our diagnostic product candidates, are characterized by rapid technological change and innovation. It is critical to our success that we anticipate changes in technology and customer requirements and successfully introduce new, enhanced and competitive technologies to meet our customers’ and prospective customers’ needs on a timely and cost-effective basis. At the same time, however, we must carefully manage the introduction of new products. If customers believe that such products will offer enhanced features or be sold for a more attractive price, they may delay purchases until such products are available. We may also have excess or obsolete inventory of older products as we transition to new products and our experience in managing product transitions is very limited. If we do not successfully innovate and introduce new technology into our product lines or effectively manage the transitions to new product offerings, our revenue and results of operations will be adversely impacted.
Competitors may respond more quickly and effectively than we do to new or changing opportunities, technologies, standards or customer requirements. We anticipate that we will face increased competition in the future as existing companies and competitors develop new or improved products and as new companies enter the market with new technologies.
If we do not successfully manage the development and launch of new products, our financial results could be adversely affected.
We face risks associated with launching new products and with undertaking to comply with regulatory requirements for certain types of our products. If we encounter development or manufacturing challenges, adjust our product development priorities, or discover deficiencies during our product development cycle, the product launch date(s) may be delayed, or certain product development projects may be terminated. The expenses or losses associated with unsuccessful product development or launch activities or lack of market acceptance of our new products could adversely affect our business or prospects. Restrictions resultingfinancial condition.
We may not be successful in expanding our customer base and introducing new applications for our profiling business.
Our current customer base is primarily composed of biopharmaceutical companies, academic institutions and molecular labs that perform analyses using or directly or indirectly obtain services based on our HTG EdgeSeq platform and consumables for research use only, which means that the products or data from the COVID-19 pandemicservices may disruptnot be used for clinical diagnostic purposes. The success of our supply chain or limitprofiling business will depend, in part, upon our ability to obtain sufficient materialsincrease our market penetration among our customer bases, to continue to introduce new applications for our consumablesexisting technology and to expand existing customer adoption of our RUO applications (whether product or service). To achieve these goals, we will need to enter into service arrangements with biopharmaceutical company customers, expand and adjust our sales strategy, continue to train our sales force and support publication of scientific publications that reflect the application of our technology in various areas. Additionally, we must demonstrate to laboratory directors, physicians and third-party payors that our products are effective in obtaining relevant information, and that our HTG EdgeSeq platform and related panels can enable an equivalent or superior approach than other available technology. Furthermore, we expect that a combination of increasing the installed base of our HTG EdgeSeq instruments and entering into additional service agreements with biopharmaceutical customers will drive increased demand for our relatively high margin panels. If we are not able to successfully increase our installed base and biopharmaceutical customer relationships,then sales of our products and services, and our margins for these revenue items may disruptnot meet expectations. Attracting new customers and introducing new applications for our products and services requires time and expense. Any failure to expand adoption of our technology would adversely affect our ability to process customer samplesimprove our operating results.
Our HTG EdgeSeq product portfolio requires the use of NGS instrumentation and reagents and could be adversely affected by actions of third-party NGS product manufacturers over whom we have no control.
We depend at least in part on the availability of NGS instrumentation and reagents, and the ability of our HTG EdgeSeq products to operate seamlessly with NGS instrumentation. Any significant interruption or perform collaborativedelay in the ability of our HTG EdgeSeq products to operate on or with NGS instrumentation could reduce demand for our products and result in a loss of customers.
Our reputation, and our ability to continue to establish or develop our technology for clinical applications of next-generation sequencers, are dependent upon the availability of NGS instrumentation and the reliable performance of our products with NGS instrumentation. We are not able to control the providers of NGS instrumentation, which increases our vulnerability to interoperability problems with the products that they provide. For example, providers of NGS instruments may discontinue existing products, or introduce new NGS instrumentation products with little or no notice to us.
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If we do not achieve, sustain or successfully manage our anticipated growth, our business and growth prospects will be harmed.
Our current personnel, systems and facilities may not be adequate to support our business plan and future growth. Our need to effectively manage our operations, growth and various projects requires that we, among other things:
•continue to improve our operational, financial, management and regulatory compliance controls and reporting systems and procedures;
•attract and retain sufficient numbers of talented employees;
•manage our commercialization activities effectively and in a cost-effective manner;
•manage our relationship with third parties related to the development services. Further, ifand commercialization of our customers’ businessesproducts; and
•manage our development efforts effectively while carrying out our contractual obligations to contractors and other third parties.
Moreover, growth will place significant strains on our management and our operational and financial systems and processes. For example, expanded market penetration of our HTG EdgeSeq platform and related proprietary panels, and future development and approval of diagnostic products, are similarly affected, they might delaykey elements of our growth strategy that will require us to hire and retain additional sales and marketing, regulatory, manufacturing and quality assurance personnel. If we do not successfully forecast the timing and cost of the development of new panels and diagnostic products, the regulatory clearance or reduce purchases from usapproval for product marketing of any future diagnostic products or collaborative development projects with us,the demand and commercialization costs of such products, or manage our anticipated expenses accordingly, our operating results will be harmed.
We expect to generate a portion of our revenue internationally and are subject to various risks relating to our international activities, which could adversely affect our operating results.
For the year ended December 31, 2022, approximately 35% of our revenue was generated from sales originated by customers located outside of the United States, respectively, compared with 31% for the year ended December 31, 2021. We expect that a percentage of our future revenue will continue to come from international sources, and we expect to expand our overseas operations and develop opportunities in additional areas. Engaging in international business involves a number of difficulties and risks, including:
•required compliance with existing and changing foreign regulatory requirements and laws;
•required compliance with anti-bribery laws, such as the U.S. Foreign Corrupt Practices Act and U.K. Bribery Act, data privacy requirements, labor laws and anti-competition regulations;
•export and import restrictions;
•various reimbursement, pricing and insurance regimes;
•laws and business practices favoring local companies;
•longer payment cycles and difficulties in enforcing agreements and collecting receivables through certain foreign legal systems;
•political and economic instability, including due to the current Russia-Ukraine conflict;
•potentially adverse tax consequences, tariffs, customs charges, bureaucratic requirements and other trade barriers, including transfer pricing, value added and other tax systems, double taxation and restrictions and/or taxation on repatriation of earnings;
•tariffs, customs charges, bureaucratic requirements and other trade barriers;
•difficulties and costs of staffing and managing foreign operations, including difficulties and costs associated with foreign employment laws;
•increased financial accounting and reporting burdens and complexities; and
•difficulties protecting, procuring, or enforcing intellectual property rights, including from reduced or varied protection for intellectual property rights in some countries.
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As we expand internationally our results of operations.operations and cash flows will become increasingly subject to fluctuations due to changes in foreign currency exchange rates. Historically, most of our revenue has been denominated in U.S. dollars, although we have sold our products and services in local currency outside of the United States, principally the Euro. Our expenses are generally denominated in the currencies in which our operations are located, which is primarily in the United States. As our operations in countries outside of the United States grows, our results of operations and cash flows will increasingly be subject to fluctuations due to changes in foreign currency exchange rates, which could negatively impact our results of operations in the future. For example, if the value of the U.S. dollar increases relative to foreign currencies, in the absence of an offsetting change in local currency prices, our revenue could be adversely affected as we convert revenue from local currencies to U.S. dollars.
If we dedicate significant resources to our international operations and are unable to manage these risks effectively, our business, operating results and prospects will suffer. Moreover, we cannot be certain that the investment and additional resources required in establishing operations in other countries will produce desired levels of revenue or profitability.
WhileIn addition, any failure to comply with applicable legal and regulatory obligations could negatively impact us in a variety of ways that include, but are not limited to, significant uncertainty remains ascriminal, civil and administrative penalties, including imprisonment of individuals, fines and penalties, denial of export privileges, seizure of products and restrictions on certain business activities.
If the utility of our HTG EdgeSeq platform, proprietary profiling panels, services and solutions in development is not supported by studies published in peer-reviewed medical publications, the rate of adoption of our current and future products and the rate of reimbursement of our future products by third-party payors may be negatively affected.
We anticipate that we will need to maintain a continuing presence in peer-reviewed publications to promote adoption of our products by biopharmaceutical companies, academic institutions and molecular labs and to promote favorable coverage and reimbursement decisions. We believe that peer-reviewed journal articles that provide evidence of the utility of our current and future products or the technology underlying the HTG EdgeSeq platform, consumables and services are important to our commercial success. It is critical to the potential impactsuccess of our sales efforts that we educate a sufficient number of clinicians and administrators about our HTG EdgeSeq technology, including our epitranscriptomic profiling technology, our current panels and services and our future solutions, and demonstrate the research and clinical benefits of these solutions. Our customers may not adopt our current and future solutions, and third-party payors may not cover or adequately reimburse our future products, unless they determine, based on published peer-reviewed journal articles and the experience of other researchers and clinicians, that our products provide accurate, reliable, useful and cost-effective information. Peer-reviewed publications regarding our products and solutions may be limited by many factors, including delays in the completion of, poor design of, or lack of compelling data from studies that would be the subject of the COVID-19 pandemic onarticle. If our operations,current and on the global economy as a whole, we believe it is likely that the COVID-19 outbreak will have a negative impact on our future product and product‑relatedproduct-related service solutions or the technology underlying such products and services do not receive sufficient favorable exposure in peer-reviewed publications, the rate of research and clinical adoption and positive coverage and reimbursement decisions could be negatively affected.
We may provide our HTG EdgeSeq instrument and profiling panels free of charge or through other arrangements to customers or key opinion leaders through evaluation agreements or reagent rental programs, and these programs may not be successful in generating recurring revenue from sales of our systems and proprietary panels.
We sell our HTG EdgeSeq instrument and profiling panels under different arrangements to expand our installed base and facilitate the adoption of our platform.
In some instances, we provide equipment free of charge under evaluation agreements for a limited period of time to permit the user to evaluate the system for their purposes in anticipation of a decision to purchase the system. We retain title to the equipment under such arrangements unless the evaluator purchases the equipment, and in most cases, require evaluation customers to purchase a minimum quantity of consumables during the evaluation period.
When we place a system under a reagent rental agreement, we install equipment in the customer’s facility without a fee and the customer agrees to purchase consumable products at a stated price over the term of the agreement. While some of these agreements did not historically contain a minimum purchase requirement, we have included a minimum purchase requirement in all current reagent rental agreements and will continue to do so in the future. We retain title to the equipment and such title is transferred to the customer at no additional charge at the end of the initial arrangement. The cost of the instrument under the agreement is expected to be recovered in the fees charged for consumables, to the extent sold, over the term of the agreement.
Other arrangements might include a research agreement whereby an academic collaborator agrees to provide biological samples in exchange for the use of an HTG EdgeSeq instrument at no cost in furtherance of the collaborator’s professional goals and/or the educational or research objectives of an applicable institution.
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Any of the foregoing arrangements could result in lost revenue and collaborative development services revenueprofit and potentially harm our long-term goal of achieving profitable operations. In addition, we require customers who receive systems that we continue to own to carry insurance sufficient to protect us against any equipment losses, we cannot guarantee that they will maintain such coverage, which may expose us to a loss of the value of the equipment in 2020.the event of any loss or damage.
There are instances where we provide our systems to key opinion leaders free of charge, to gather data and publish the results of their research to assist our marketing efforts. We believe this negative impacthave no control over some of the work being performed by these key opinion leaders, or whether the results will be primarily demand-side driven as our customers experience disruptions in their own businesses from the pandemic. However, itsatisfactory. It is possible that the COVID-19 pandemickey opinion leader may generate data that is unsatisfactory and could potentially harm our marketing efforts. In addition, customers may from time to time create negative publicity about their experience with our systems, which could harm our reputation and negatively affect market perception and adoption of our platform.
Placing our HTG EdgeSeq instruments under evaluation agreements, under reagent rental agreements or with our key opinion leaders without receiving payment for the instruments could require substantial additional working capital to provide additional units for sale to our customers.
We face risks related to handling of hazardous materials and other regulations governing environmental safety.
Our operations are subject to complex and stringent environmental, health, safety and other governmental laws and regulations that both public officials and private individuals may seek to enforce. Our activities that are subject to these regulations include, among other things, our use of hazardous materials and the generation, transportation and storage of waste. We could discover that we or an acquired business is not in material compliance with these regulations. Existing laws and regulations may also be revised or reinterpreted, or new laws and regulations may become applicable to us, whether retroactively or prospectively, that may have a negative effect on our business and results of operations. It is also impossible to eliminate completely the risk of accidental environmental contamination or injury to individuals. In such an event, we could be liable for any damages that result, and any liability could exceed our resources or any applicable insurance coverage we may have, which events could adversely affect our business.
The life sciences research and diagnostic markets are highly competitive. We face competition from enhanced or alternative technologies and products, which could render our products and/or technologies obsolete. If we fail to compete effectively, our business and operating results will suffer.
We face significant competition in the drug discovery, life sciences research and diagnostics markets.
The biopharmaceutical sector is populated with companies seeking to advance new and differentiated approaches to discovery and experimental therapeutics by way of different platform technologies or modalities with the intent for application to specific disease areas through focus on pharmacologic targets or through phenotypic approaches. In drug discovery, companies such as Accent Therapeutics, Arrakis Therapeutics, Storm Therapeutics and other discovery-stage biotechnology companies are focused in similar therapeutic areas.
We currently compete with both established and early-stage life sciences research companies that design, manufacture and market instruments and consumables for gene expression analysis, liquid-based specimen analysis (e.g., plasma, blood and urine), single-cell analysis, PCR, digital PCR, other nucleic acid detection and additional applications. These companies use well-established laboratory techniques such as microarrays or qPCR as well as newer technologies such as next-generation sequencing. We believe our principal competitors in the life sciences research market are Abbott Molecular, Affymetrix, Inc., Agilent Technologies, Inc., BioRad Laboratories, Invitae, Fluidigm Corporation, Illumina, Inc., Luminex Corporation, NanoString Technologies, Inc., Personal Genome Diagnostics (acquired by Labcorp), entities owned and controlled by QIAGEN N.V., Roche Diagnostics, a division of the Roche Group of companies, and Thermo Fisher Scientific, Inc. In addition, there are several other market entrants in the process of developing novel technologies for the life sciences market. One or more of our competitors could develop a product that is superior to a product we offer or intend to offer, or our technology and products may be rendered obsolete or uneconomical by advances in existing technologies.
Within the diagnostic market, there are competitors that manufacture systems for sales to hospitals and laboratories and other competitors that offer tests conducted through CLIA certified laboratories. We will also impactcompete with commercial diagnostics companies. Most of our workforce, supply chainscurrent competitors are either publicly traded, or distribution networksare divisions of publicly traded companies, and enjoy a number of competitive advantages over us, including:
•greater name and brand recognition, financial and human resources;
•larger sales forces and more established distributor networks;
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•substantial intellectual property portfolios;
•larger and more established customer bases and relationships; and
•better established, larger scale, and lower cost manufacturing capabilities.
We believe that the principal competitive factors in all of our target markets include:
•cost of capital equipment;
•cost of consumables and supplies;
•reputation among customers;
•innovation in product offerings;
•flexibility and ease-of-use;
•accuracy and reproducibility of results; and
•compatibility with existing laboratory processes, tools and methods.
We believe that additional competitive factors specific to the diagnostics market include:
•breadth of clinical decisions that can be influenced by information generated by tests;
•volume, quality, and strength of clinical and analytical validation data;
•availability of coverage and adequate reimbursement for testing services; and
•economic benefit accrued to customers based on testing services enabled by products.
Our products may not compete favorably, and we may not be successful in the face of increasing competition from new products and technologies introduced by our existing competitors or otherwise impactnew companies entering our markets. In addition, our competitors may have or may develop products or technologies that currently or in the future will enable them to produce competitive products with greater capabilities or at lower costs than ours. Any failure to compete effectively could materially and adversely affect our business, financial condition and operating results.
Our revenue currently depends in part on research and development spending by academic and governmental research institutions and biopharmaceutical companies, a reduction in which could limit demand for our products and adversely affect our business and operating results.
Our revenue is currently derived from sales of our HTG EdgeSeq instrument and related proprietary panels, the design of custom RUO assays and sample processing for research applications to biopharmaceutical companies, academic institutions and molecular labs, predominantly in the United States and Europe. The demand for our products and services will depend in part upon the research and development budgets of these customers, which are impacted by factors beyond our control, such as:
•changes in government programs that provide funding to research institutions and companies;
•macroeconomic conditions and the political climate;
•changes in the regulatory environment;
•differences in budgetary cycles;
•market-driven pressures to consolidate operations and reduce costs; and
•market acceptance of relatively new technologies, such as ours.
We believe that any uncertainty regarding the availability of research funding may adversely affect our operating results and may adversely affect sales to customers or potential customers that rely on government funding. In addition, academic, governmental and other research institutions that fund research and development activities may be subject to stringent budgetary constraints that could result in spending reductions, reduced allocations or budget cutbacks, which could jeopardize the ability of these customers to purchase our products or services. Our operating results may fluctuate substantially due to reductions and delays in research and development expenditures by these customers. Any decrease in our customers’ budgets or expenditures, or in the size, scope or frequency of capital or operating expenditures, could materially and adversely affect our business, operating results and financial condition.
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Our research and development efforts will be hindered if we are not able to contract with third parties for access to archival patient samples.
Our future development of products for clinical indications will require access to archival patient samples for which data relevant to the clinical indication of interest is known. We rely on our ability to conduct sample processing servicessecure access to these archived patient samples, including FFPE tissue, plasma, serum, whole blood preserved in PAXgene, or various cytology preparations, together with the information pertaining to the clinical outcomes of the patients from which the samples were taken. Owners or custodians of relevant samples may be difficult to identify and/or identified samples may be of poor quality or limited in number or amount. Additionally, others compete with us for access to these samples for both research and custom assay development servicescommercial purposes. Even when an appropriate cohort of samples is identified, the process of negotiating access to these samples can be lengthy because it typically involves numerous parties and approval levels to resolve complex issues such as usage rights, institutional review board approval, privacy rights, publication rights, and intellectual property ownership. In addition, in some instances the cost to acquire samples can be prohibitively expensive. If we are not able to negotiate access to archived patient samples on a timely basis and on acceptable terms, or at all, or if our competitors or others secure access to these samples before us, our ability to provide collaborative development servicesresearch, develop and commercialize future products will be limited or delayed.
We are dependent on third-party suppliers for companion diagnostic development programs.
certain subcomponents of our products, including a single supplier for one subcomponent of our HTG EdgeSeq instruments.
The ultimate impact of the COVID-19 pandemic orWe rely on third-party suppliers to supply certain subcomponents used in our HTG EdgeSeq instruments and consumables, including a similar health epidemic is highly uncertain and subjectsingle supplier, In Position Technologies, to change. Weproduce a certain subcomponent used in our HTG EdgeSeq instruments. While we periodically forecast our needs for these subcomponents, our contracts with these suppliers do not yet knowcommit them to carry inventory or make available any particular quantities, and the full extentsuppliers may give other customers’ needs higher priority than ours and we may not be able to obtain adequate supplies in a timely manner or on commercially reasonable terms. If we were to lose any of potentialthese suppliers, we may not be able to identify or enter into agreements with alternative suppliers on a timely basis on acceptable terms, or at all. In addition, we have in the past experienced supply issues, as well as quality control problems such as shipment errors, with certain of our suppliers, and may experience problems in the future. If we should encounter delays or impacts ondifficulties in securing the quality and quantity of subcomponents we require for our products, our supply chain would be interrupted or our products may not perform as expected, which would adversely affect our sales. A loss or performance failure of any of these suppliers could significantly delay the delivery or impact the performance of our products, which in turn would materially affect our ability to generate revenue. If any of these events occur, our business our customers’ businesses, healthcare systems or the global economy as a whole. However, these effectsand operating results could have a material adverse impact on our operations, financial position and liquidity.be materially harmed.
We rely on distributors for sales of our products in several markets outside of the United States.
We have established exclusive and non-exclusive distribution agreements for our HTG EdgeSeq platform and related profiling panels within parts of Europe and the Middle East. We intend to continue to grow our business internationally, and to do so, in addition to expanding our own direct sales and support team, we plan to attract additional distributors and sales partners to maximize the commercial opportunity for our products. We cannot guarantee that we will be successful in attracting desirable distribution and sales partners or that we will be able to enter into such arrangements on favorable terms. Distributors and sales partners may not commit the necessary resources to market and sell our products to the level of our expectations or may favor marketing the products of our competitors. If current or future distributors or sales partners do not perform adequately, or we are unable to enter into effective arrangements with distributors or sales partners in particular geographic areas, we may not realize long-term international revenue growth.
Limitations in the use of our products could harm our reputation or decrease market acceptance of our products; undetected errors or defects in our products could harm our reputation, decrease market acceptance of our products or expose us to product liability claims.
Our products are subject to the limitations set forth in the product labeling, which may not satisfy the needs of all customers. For example, in the past we have introduced new panels that initially were intended to be used with specific sample types. Because our customers desire that our panels be broadly applicable to many biological sample types, these initial limitations could harm our reputation or decrease market acceptance of our products. If that occurs, we may incur significant costs, the attention of our key personnel could be diverted, or other significant customer relations problems may arise, which could harm our business and operating results.
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Similarly, our products may contain undetected errors or defects when first introduced or as new versions are released. Since our current customers use our products for research and, if cleared or approved for diagnostic applications, disruptions or other performance problems with our products may damage our customers’ businesses and could harm our reputation. If that occurs, we may incur significant costs, the attention of our key personnel could be diverted, or other significant customer relations problems may arise. We may also be subject to warranty and liability claims for damages related to errors or defects in our products. A material liability claim or other occurrence that harms our reputation or decreases market acceptance of our products could harm our business and operating results.
The sale and use of products or services based on our technologies, or activities related to our research and clinical studies, could lead to the filing of product liability claims if someone were to allege that one of our products contained a design or manufacturing defect which resulted in the failure to adequately perform the analysis for which it was designed. A product liability claim could result in substantial damages and be costly and time consuming to defend, either of which could materially harm our business or financial condition. We cannot assure investors that our product liability insurance could adequately protect our assets from the financial impact of defending a product liability claim. Any product liability claim brought against us, with or without merit, could increase our product liability insurance rates or prevent us from securing insurance coverage in the future.
We may need to raise additional capital to fund our operationsUncertainties in the future. Ifinterpretation and application of existing, new and proposed tax laws and regulations could materially affect our tax obligations and effective tax rate.
The tax regimes to which we are unsuccessful in attracting new capital,subject or under which we may not be able to continue operations oroperate are unsettled and may be forced to sell assets to do so. Alternatively, capital may not be available to us on favorable terms, or if at all. If available, financing terms may leadsubject to significant dilutionchange. The issuance of our stockholders’ equity.
We are not profitable and have had negative cash flow from operations since our inception. To fund our operations and develop and commercialize our products, we have relied primarily on equity and debt financings and revenue generated from the sale of our HTG EdgeSeq systems, proprietary consumables,additional guidance related services and collaborative development service arrangements with biopharmaceutical company customers (directlyto existing or indirectly via the Governing Agreement). We currently anticipate that our cash and cash equivalents will be sufficientfuture tax laws, or changes to enable us to fund our operations for at least the next 12 months. We may need to obtain additional funds to finance our operations in the future if our estimates of the amount of cash necessary to fund our operations and development and commercialization activities prove to be wrong, and we could spend our available financial resources much faster than we currently expect. Additional capital may not be available at such times or amounts as needed by us. Even if capital is available, it might be available only on unfavorable terms. Any additional equity or convertible debt financing into which we enter could be dilutive to our existing stockholders. Any future debt financing into which we enter may impose covenants upon us that restrict our operations, including limitations on our ability to incur liens or additional debt, pay dividends, repurchase our stock, make certain investments and engage in certain merger, consolidation or asset sale transactions. Any debt financing or additional equity that we raise may contain terms that are not favorable to us or our stockholders. If we raise additional funds through collaboration and licensing arrangements with third parties, we may need to relinquish rights to our technologies or our products, or grant licenses on terms that are not favorable to us. If access to sufficient capital is not available as and when needed, our business will be materially impaired, and we may be required to cease operations, curtail one or more product development or commercialization programs, or significantly reduce expenses, sell assets, seek a merger or joint venture partner, file for protection from creditors or liquidate all of our assets. Any of these factors could harm our operating results.
Payments under the instruments governing our indebtedness may reduce our working capital. In addition, a default under our MidCap Credit Facility could cause a material adverse effect on our financial position.
Pursuant to the terms of an asset purchase agreement with NuvoGen, we agreed to annually pay NuvoGen the greater of $400,000 or 6% of our yearly revenue until the total aggregate cash compensation paid to NuvoGen under the agreement equals $15.0 million. To date, we have paid NuvoGen approximately $9.4 million. Payments to NuvoGen will result in a reduction in our working capital as we continue to make payments on this obligation
Pursuant to the terms of the $3.0 million QNAH Convertible Note that we issued in October 2017, we will be required to repay the entire outstanding principal amount of the QNAH Convertible Note and unpaid accrued interest thereon in October 2020, subject potentially to the terms of a future subordination agreement between QNAH and our senior lenders, provided QNAH may, at its election, convert all or any portion of the outstanding principal balance of the QNAH Convertible Note and unpaid accrued interest at any time prior to the maturity date into shares of our common stock at a conversion price of $3.984 per share. Repayment of this note and unpaid accrued interest thereon at maturity would result in a reduction in our working capital, which could be significant depending on our cash position on the maturity date.
Under the MidCap Credit Facility, our interest rate on borrowed amounts is dependent on LIBOR. LIBOR, which is the basic rate of interest used in lending between banks on the London interbank market and is widely used as a reference for setting the interest rate on loans globally, is currently scheduled to be phased out in 2021. Before LIBOR is phased out, we may need to renegotiate the MidCap Credit Facility to replace LIBOR with a new reference rate, which has yet to be established. The consequences of these developments cannot be entirely predicted, but could result in higher interest rates on our loans under the MidCap Credit Facility. We cannot provide assurance that future interest rate changes will not have a material negative impact on our business, financial position, or operating results.
Further, the MidCap Credit Facility requires us, and any debt arrangements we may enter into in the future may require us, to comply with various covenants that limit our ability to, among other things:
complete mergers or acquisitions;
incur indebtedness or modify existing debt agreements;
amend or modify certain material agreements;
engage in additional lines of business;
pay dividends or make other distributions to holders of our capital stock;
make specified investments;
change certain key management personnel or organizational documents; and
engage in transactions with our affiliates.
These restrictions could inhibit our ability to pursue our business strategies. If we default under our obligations under the MidCap Term Loan, the lender could proceed against the collateral granted to them to secure our indebtedness or declare all obligation under the MidCap Term Loan to be due and payable. In certain circumstances, procedures by the lender could result in a loss by us of all of our equipment, inventory and intellectual property, which are included in the collateral granted to the lender. In addition, upon any distribution of assets pursuant to any liquidation, insolvency, dissolution, reorganization or similar proceeding, the holders of secured indebtedness will be entitled to receive payment in full from the proceeds of the collateral securing our secured indebtedness before the holders of other indebtedness or our common stock will be entitled to receive any distribution with respect thereto.
Changes in tax laws or regulations proposed or implemented by the current or a future U.S. presidential administration, Congress, or taxing authorities in other jurisdictions, including jurisdictions outside of the United States, could materially affect our tax obligations and effective tax rate. To the extent that are applied adversely to us or our customers maysuch changes have a material adverse effectnegative impact on us, including as a result of related uncertainty, these changes may adversely impact our business, cash flow, financial condition, or results of operations.operations, and cash flows.
New income, sales, use or otherThe amount of taxes we pay in different jurisdictions depends on the application of the tax laws statutes, rules, regulationsof various jurisdictions, including the United States, to our international business activities, tax rates, new or ordinancesrevised tax laws, or interpretations of tax laws and policies, and our ability to operate our business in a manner consistent with our corporate structure and intercompany arrangements. The taxing authorities of the jurisdictions in which we operate may challenge our methodologies for pricing intercompany transactions pursuant to our intercompany arrangements or disagree with our determinations as to the income and expenses attributable to specific jurisdictions. If such a challenge or disagreement were to occur, and our position was not sustained, we could be enacted at any time,required to pay additional taxes, interest, and penalties, which could adversely affectresult in one-time tax charges, higher effective tax rates, reduced cash flows, and lower overall profitability of our business operationsoperations. Our financial statements could fail to reflect adequate reserves to cover such a contingency. Similarly, a taxing authority could assert that we are subject to tax in a jurisdiction where we believe we have not established a taxable connection, often referred to as a “permanent establishment” under international tax treaties, and financial performance. Further, existingsuch an assertion, if successful, could increase our expected tax laws, statutes, rules, regulationsliability in one or ordinances could be interpreted, changed, modified or applied adversely to us. For example,more jurisdictions.
Effective January 1, 2022, legislation enacted in 2017, informally titled the Tax Cuts and Jobs Act enacted many significant changes(the “Tax Act”) eliminated the option to deduct research and development expenses for tax purposes in the U.S. tax laws.year incurred and requires taxpayers to capitalize and subsequently amortize such expenses over five years for research activities conducted in the United States and over 15 years for research activities conducted outside the United States. Although there have been legislative proposals to repeal or defer the capitalization requirement to later years, there can be no assurance that the provision will be repealed or otherwise modified. Future guidance from the Internal Revenue Service and other tax authorities with respect to the Tax Actsuch legislation may affect us, and certain aspects of the Tax Actsuch legislation could be repealed or modified in future legislation. In addition, it is uncertain if and to what extent various states will conform to the Tax Act or any newly enacted federal tax legislation. Changes in corporate tax rates, the realization of net deferred tax assets relating to our operations, the taxation of foreign earnings, and the deductibility of expenses under the Tax Act or future reform legislation could have a material impact on the value of our deferred tax assets, could result in significant one-time charges, and could increase our future U.S. tax expense.
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Our ability to use net operating loss carryforwards and certain other tax attributedattributes may be limited.
As of December 31, 2019,2022, we had federal net operating loss carryforwards (“NOLs”) to offset future taxable income of approximately $158.2$203.0 million, of which $121.8$121.6 million will begin to expire in 2021after 2023 if not utilized, while the remainder can be carried forward indefinitely. A lack of future taxable income would adversely affect our ability to utilize these NOLs. Under the Tax Act,current law, our federal NOLs incurred in taxabletax years endingbeginning after December 31, 2017 may be carried forward indefinitely but the deductibility of these federal NOLs generated in tax years beginning before January 1, 2018, is limited. It is uncertain if andlimited to what extent various states will conform to the Tax Act.80% of taxable income. In addition, under Sections 382 and 383 of the Internal Revenue Code of 1986, as amended, (the “IRC”), and corresponding provisions of state law, a corporation that undergoes an “ownership change” (generally defined as a greater than 50% change, by value, in its equity ownership over a three-year period) is subject to limitations on its ability to utilize its pre-ownership change NOL carryforwards and certain other pre-ownership change tax attributes to offset post-ownership change income or taxes. We believe we may have already experienced one or more ownership changes and may in the future experience one or more additional ownership changes, and thus, our ability to utilize pre-ownership change NOL carryforwards and other pre-ownership change tax attributes to offset post-ownership change income or taxes may be limited. Such limitations may cause a portion of our NOL and credit carryforwards to expire before we are able to utilize them. In addition, at the state level, there may be periods during which the use of NOL carryforwards is suspended or otherwise limited, which could accelerate or permanently increase state taxes owed. We have recorded a full valuation allowance related to our NOLs and other deferred tax assets due to the uncertainty of the ultimate realization of the future benefits of those assets.assets.
Acquisitions or joint ventures could disrupt our business, cause dilution to our stockholders and otherwise harm our business.
We may acquire other businesses, products or technologies as well as pursue strategic alliances, partnerships, joint ventures, technology licenses or investments in complementary businesses. We have limited experience with respect to business, product or technology acquisitions or the formation of collaborations, strategic alliances and joint ventures or investing in complementary businesses. Any of these transactions could be material to our financial condition and operating results and expose us to many risks, including:
•disruption in our relationships with customers, distributors or suppliers as a result of such a transaction;
•unanticipated liabilities related to acquired companies;
•difficulties integrating acquired personnel, intellectual property, products, technologies and operationsor drug candidates of an acquired company into our existing business;
•diversion of management time and focus from operating our business to acquisition integration challenges;
•increases in our expenses and reductions in our cash available for operations and other uses; and
•possible write-offs or impairment charges relating to acquired businesses.
Foreign acquisitions involve unique risks in addition to those mentioned above, including those related to integration of operations across different cultures and languages, currency risks and the particular economic, political and regulatory risks associated with specific countries. Also, the anticipated benefit of any acquisition may not materialize. Future acquisitions or dispositions could result in potentially dilutive issuances of our equity securities, the incurrence of debt, contingent liabilities or amortization expenses or write-offs of goodwill, any of which could harm our financial condition. We cannot predict the number, timing or size of future joint ventures or acquisitions, or the effect that any such transactions might have on our operating results.
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If any members of our management team were to leave us or we are unable to recruit, train and retain key personnel, we may not achieve our goals.
Our future success depends on our ability to recruit, train, retain and motivate key personnel, including our senior management, research and development, manufacturing, service and sales and marketing personnel. If we were to lose one or more of our key employees, we may experience difficulties in competing effectively, developing our technologies and implementing our business strategies. Competition for qualified personnel is intense, and we may not be able to attract talent. Our growth depends, in part, on attracting, retaining and motivating highly trained sales personnel with the necessary scientific background and ability to understand our systems at a technical level to effectively identify and sell to potential new customers, including new biopharmaceutical company customers. In particular, our HTG Therapeutics business division requires us to continue to establish and maintain scientific expertise in drug discovery and early development and may require in the future additional support in the areas of expertise that contribute to our transcriptome-informed drug discovery and design platforms and well as to our therapeutics pipeline. In addition, the commercialization of our HTG EdgeSeq systemplatform and related panels requires us to continue to establish and maintain sales and support teams to optimize the markets for research tools and, where approved, diagnostic assays, and to fully optimize a broad array of diagnostic market opportunities as we receive approval for any future diagnostic products. We do not maintain fixed term employment contracts or key man life insurance relating to any of our employees. Because of the complex and technical nature of our products and the dynamic market in which we compete, any failure to retain our management team or to attract, train, retain and motivate other qualified personnel could materially harm our operating results and growth prospects.
Our operating results may be harmed if we are required to collect sales, services or other related taxes for our products and services in jurisdictions where we have not historically done so.
We do not believe that we are required to collect sales, use, services or other similar taxes from our customers in certain jurisdictions. However, one or more countries or states may seek to impose sales, use, services, or other tax collection obligations on us, including for past sales. A successful assertion by one or more jurisdictions that we should collect sales or other taxes on the sale of our products and services could result in substantial tax liabilities for past sales and decrease our ability to compete for future sales. Each country and each state has different rules and regulations governing sales and use taxes and these rules and regulations are subject to varying interpretations that may change over time. We review these rules and regulations periodically and, when we believe sales and use taxes apply in a particular jurisdiction, voluntarily engage tax authorities in order to determine how to comply with their rules and regulations. WeHowever, we cannot assure youguarantee that we will not be subject to sales and use taxes or related penalties for past sales in jurisdictions where we presently believe sales and use taxes are not due.
Providers of goods or services are typically held responsible by taxing authorities for the collection and payment of any applicable sales and similar taxes. If one or more taxing authorities determines that taxes should have, but have not, been paid with respect to our products and services, we may be liable for past taxes in addition to being required to collect sales or similar taxes in respect of our products and services going forward. Liability for past taxes may also include substantial interest and penalty charges. Our customer contracts provide that our customers must pay all applicable sales and similar taxes. Nevertheless, customers may be reluctant to pay back taxes and may refuse responsibility for interest or penalties associated with those taxes or we may determine that it would not be feasible to seek reimbursement. If we are required to collect and pay back taxes and the associated interest and penalties and if our customers do not reimburse us for all or a portion of these amounts, we will have incurred unplanned expenses that may be substantial. Moreover, imposition of such taxes on our products and services going forward will effectively increase the cost of such products and services to our customers.
Many states are also pursuing legislative expansion of the scope of goods and services that are subject to sales and similar taxes as well as the circumstances in which a vendor of goods and services must collect such taxes. Following the U.S. Supreme Court decision in South Dakota v. Wayfair, Inc., states are now free to levy taxes on sales of goods and services based on an “economic nexus,” regardless of whether the seller has a physical presence in the state. Furthermore, legislative proposals have been introduced in Congress that would provide states with additional authority to impose such taxes. Accordingly, it is possible that either federal or state legislative changes may require us to collect additional sales and similar taxes from our customers in the future.
Our insurance policies are expensive and protect us only from some business risks, which may leave us exposed to significant uninsured liabilities.
We do not carry insurance for all categories of risk that our business may encounter. Some of the policies we currently maintain include general liability, foreign liability, employee benefits liability, property, automobile, umbrella, workers’ compensation, crime (including cybercrime), fiduciary, products liability, pollution, errors and omissions and directors’directors and officers’officers insurance. We do not know, however, if we will be able to maintain existing insurance with adequate levels of coverage. Any significant uninsured liability may require us to pay substantial amounts, which would adversely affect our cash position and results of operations.
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Performance issues, service interruptions or price increases by our shipping carriers could adversely affect our business and harm our reputation and ability to provide our services on a timely basis.
Expedited, reliable shipping is essential to our operations. We rely heavily on providers of transport services for reliable and secure point-to-point transport of our HTG EdgeSeq systemsinstrument and consumables to our customers and, as applicable, customers’ samples to our laboratory, and for enhanced tracking of these shipments. Should a carrier encounter delivery performance issues such as loss, damage or destruction of any instrumentation, consumables or samples, it would be costly to replace such instrumentation or consumables in a timely manner and may be difficult to replace customers’ samples lost or damaged in shipping, and such occurrences may damage our reputation and lead to decreased demand for our products and increased cost and expense to our business. In addition, any significant increase in shipping rates could adversely affect our operating margins and results of operations. Similarly, strikes, severe weather, natural disasters or other service interruptions affecting delivery services we use would adversely affect our ability to process orders for our products or receive recipient samples on a timely basis.
Changes in funding for the FDA, the SEC and other government agencies could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developedIf our information technology systems or commercialized in a timely mannerthose of third parties upon which we rely are or otherwise prevent those agencies from performing normal functions on which the operation of our business may rely, which could negatively impact our business.
The ability of the FDA to review and approve new products can be affected by a variety of factors, including government budget and funding levels, ability to hire and retain key personnel and accept payment of user fees, and statutory, regulatory, and policy changes. Average review times at the agency have fluctuated in recent years as a result. In addition, government funding of the SEC
and other government agencies on which our operations may rely, including those that fund research and development activities is subject to the political process, which is inherently fluid and unpredictable.
Disruptions at the FDA and other agencies may also slow the time necessary for new drugs to be reviewed and/or approved by necessary government agencies, which would adversely affect our business. For example, over the last several years, the U.S. government has shut down several times and certain regulatory agencies, such as the FDA and the SEC, have had to furlough critical FDA, SEC and other government employees and stop critical activities. If a prolonged government shutdown occurs, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions, which could have a material adverse effect on our business. Further, future government shutdowns could impact our ability to access the public markets and obtain necessary capital in order to properly capitalize and continue our operations.
The withdrawal of the United Kingdom, from the European Union, commonly referred to as “Brexit,” may adversely impact our ability to obtain regulatory approvals of our product candidates in the European Union, result in restrictions or imposition of taxes and duties for importing our product candidates into the European Union, and may require us to incur additional expenses in order to develop, manufacture and commercialize our product candidates in the European Union.
Following the result of a referendum in 2016, the United Kingdom left the European Union on January 31, 2020, commonly referred to as Brexit. Pursuant to the formal withdrawal arrangements agreed between the United Kingdom and the European Union, the United Kingdom will be subject to a transition period until December 31, 2020, or the Transition Period, during which EU rules will continue to apply. Negotiations between the United Kingdom and the European Union are expected to continue in relation to the customs and trading relationship between the United Kingdom and the European Union following the expiry of the Transition Period.
Since a significant proportion of the regulatory framework in the United Kingdom applicable to our business and our product candidates is derived from EU directives and regulations, Brexit, following the Transition Period, could materially impact the regulatory regime with respect to the development, manufacture, importation, approval and commercialization of our product candidates in the United Kingdom or the European Union. For example, as a result of the uncertainty surrounding Brexit, the EMA relocated to Amsterdam from London. Following the Transition Period, the United Kingdom will no longer be covered by the centralized procedures for obtaining EU-wide marketing authorization from the EMA and, unless a specific agreement is entered into, a separate process for authorization of drug products, including our product candidates, will be required in the United Kingdom, the potential process for which is currently unclear. Any delay in obtaining, or an inability to obtain, any marketing approvals, as a result of Brexit or otherwise, would prevent us from commercializing our product candidates in the United Kingdom or the European Union and restrict our ability to generate revenue and achieve and sustain profitability. In addition, we may be required to pay taxes or duties or be subjected to other hurdles in connection with the importation of our product candidates into the European Union, or we may incur expenses in establishing a manufacturing facility in the European Union in order to circumvent such hurdles. If any of these outcomes occur, we may be forced to restrict or delay efforts to seek regulatory approval in the United Kingdom or the European Union for our product candidates, or incur significant additional expenses to operate our business, which could significantly and materially harm or delay our ability to generate revenues or achieve profitability of our business. Any further changes in international trade, tariff and import/export regulations as a result of Brexit or otherwise may impose unexpected duty costs or other non-tariff barriers on us. These developments, or the perception that any of them could occur, may significantly reduce global trade and, in particular, trade between the impacted nations and the United Kingdom.
We face risks related to handling of hazardous materials and other regulations governing environmental safety.
Our operations are subject to complex and stringent environmental, health, safety and other governmental laws and regulations that both public officials and private individuals may seek to enforce. Our activities that are subject to these regulations include, among other things, our use of hazardous materials and the generation, transportation and storage of waste. We could discover that we or an acquired business is not in material compliance with these regulations. Existing laws and regulations may also be revised or reinterpreted, or new laws and regulations may become applicable to us, whether retroactively or prospectively, that may have a negative effect on our business and results of operations. It is also impossible to eliminate completely the risk of accidental environmental contamination or injury to individuals. In such an event,were compromised, we could be liable for any damages that result, and any liability could exceed our resources or any applicable insurance coverage we may have, which events could adversely affect our business.
Cyber security risks and the failureexperience adverse consequences resulting from such consequences including but not limited to maintain the confidentiality, integrity and availability of our computer hardware, software, internet applications and related tools and functions could result in damage to our reputation and/or subject us to costs, fines, penalties, lawsuits, business interruption or lawsuits.otherwise adversely affect our business.
Our business requires collecting, receiving, processing, generating, transferring, disposing of, transmitting, sharing, manipulating, analyzing, disclosing, storing, making accessible and storingotherwise using (collectively, processing) large amounts of data. In addition, we rely on an enterprise software system to operateproprietary, confidential and manage our business. We also maintain personally identifiable informationsensitive data, including personal data about our employees.employees and others, information we collect from samples we process, intellectual property, trade secrets, and proprietary business information owned or controlled by ourselves or other third parties (collectively, sensitive data).
The confidentiality, availability, integrity and protection of our data and information technology systems is critical to our business and relevant stakeholders have a high expectation that we will adequately protect sensitive data. Our business therefore depends on the continuous, effective, reliable and secure operation of our computer hardware, software, networks, Internet serversdata and related infrastructure. information technology systems.
To the extent that our hardware and softwareinformation technology systems malfunction or access to our data by internal personnel is interrupted or otherwise compromised, our business could suffer. TheIf we or the third parties upon which we rely have experienced or in the future experience any security incident(s) or other interruption(s) that result in any data loss, deletion or destruction, unauthorized, unlawful or accidental access to, loss of, acquisition of or disclosure of, alteration, encryption or exposure of sensitive data, or compromise related to the security, confidentiality, integrity and protectionor availability of our employee(or their) information technology systems or data, it may result in material adverse impacts.
We and company data is critical to our business and employees have a high expectation thatthird parties upon which we will adequately protect their personal information. The regulatory environment governing information, security and privacy laws is increasingly demanding and continues to evolve. Maintaining compliance with applicable
security and privacy regulations may increase our operating costs. Although our computer and communications softwarerely are protected through physical and software safeguards, it is still vulnerable to natural or man-made hazards,cyberattacks, malicious internet-based activity and online and offline fraud and other similar activities, such as fire, storm, flood, power loss, wind damage,social-engineering attacks, credential harvesting, supply-chain attacks, software bugs, malicious code (such as viruses and worms), employee theft or misuse, denial-of-service attacks (such as credential stuffing), ransomware attacks, phishing attacks, viruses, malware installation, server malfunction, software or hardware failures, telecommunications failures, physical or software break-ins, loss of data and other computer assets, adware or other similar issues. Such threats are prevalent and continue to increase and come from a variety of sources, including traditional computer “hackers”, threat actors, “hacktivists”, organized criminal threat actors, personnel (such as through theft or misuse), sophisticated nation states, and nation-state-supported actors. Some actors now engage and are expected to continue to engage in cyber-attacks, including without limitation nation-state actors for geopolitical reasons and in conjunction with military conflicts and defense activities. During times of war and other major conflicts, we and the third parties upon which we rely may be vulnerable to a heightened risk of these attacks, including retaliatory cyber-attacks, that could materially disrupt our systems and operations, supply chain, and ability to produce, sell and distribute our services. For example, some third parties upon which we rely to support our business are located in unstable regions and regions experiencing (or expected to experience) geopolitical or other conflicts, including Ukraine which was attacked by Russia in February 2022 through various means, including cyberattacks.
In particular, severe ransomware attacks, including those from organized criminal threat actors, nation-states and nation-state supported actors, are becoming increasingly prevalent and severe and can lead to significant interruptions, delays, or outages in our operations, loss of data (including sensitive data) and income, significant extra expenses to restore data or systems, reputational loss and the diversion of funds. To alleviate the financial, operational and reputational impact of a ransomware attack, it may be preferable to make extortion payments, but we may be unwilling or unable to do so (including, for example, if applicable laws or regulations prohibit such payments).
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Additionally, as remote work has become more common, there is an increased risk to our information technology systems and data, as more of our employees utilize network connections, computers and devices outside our premises or network, including working at home, while in transit and in public locations. Moreover, future or past business transactions (such as acquisitions or integrations) could expose us to additional cybersecurity risks and vulnerabilities, as our systems could be negatively affected by vulnerabilities present in acquired or integrated entities’ systems and technologies. Furthermore, we may discover security issues that were not found during due diligence of such acquired or integrated entities, and it may be difficult to integrate companies into our information technology environment and security program.
In addition, we rely on enterprise software virusessystems and similar events.third-party service providers and sub-processors to operate and manage our business, and to process sensitive data in a variety of contexts, including, without limitation, cloud-based infrastructure, data center facilities, encryption and authentication technology, employee email, content delivery to customers, and other functions. Our ability to monitor these third parties’ information security practices is limited, and these third parties may not have adequate information security measures in place. If our third-party service providers experience a security incident or other interruption, we could experience adverse consequences. While we may be entitled to damages if our third-party service providers fail to satisfy their privacy or security-related obligations to us, any award may be insufficient to cover our damages, or we may be unable to recover such award. Additionally, supply chain attacks have increased in frequency and severity, and we cannot guarantee that third parties and infrastructure in our supply chain have not been compromised or that they do not contain exploitable defects or bugs that could result in a breach of or disruption to our systems and networks or the systems and networks of third parties that support us and our services.
While we have implemented security measures designed to protect against security incidents, and take steps to detect and remediate vulnerabilities, we may not be able to detect and remediate all vulnerabilities because the threats and techniques used to exploit the vulnerability change frequently and are often sophisticated in nature. Therefore, such vulnerabilities could be exploited but may not be detected until after a security incident has occurred. Further, we may experience delays in developing and deploying remedial measures designed to address any such identified vulnerabilities. We could be required to expend significant resources, fundamentally change our business activities and practices or modify our services, software, operations or information technology in an effort to protect against security incidents and to mitigate, detect and remediate actual and potential vulnerabilities and security incidents. There can be no assurances that our security measures or those of the third parties upon which we rely will be effective in protecting against all security incidents and the material adverse impacts that may arise from such incidents.
Despite the security controls we have in place, security incidents are very difficult to avoid. We have experienced specific instances of cyber breachesevents, including attempted compromises, in the past, and there could be unauthorized access, acquisition, disclosure and use of non-public information (including personal data) in the future. The techniques used by criminal elements to attack computerinformation technology systems are sophisticated change frequently and may originate from less regulated and remote areas of the world.change. As a result, we or the third parties upon which we rely may not be able to address these techniques proactively or implement adequate preventative measures. If our computerdata or information technology systems (or those of third parties upon which we rely) are compromised, we could be subject to restrictions on processing sensitive data (including personal data), negative publicity, monetary fund diversions, interruptions in our operations (including availability of data), financial loss, reputational damage, fines, penalties, damages, litigation (including class claims) and enforcement actions (for example, investigations, audits and inspections), and we could lose trade secrets, the occurrence of which could harm our business. In addition, any sustained disruptiona security incident may require notification to governmental agencies, supervisory bodies, credit reporting agencies, the media or individuals pursuant to various obligations. Such disclosures are costly, and the disclosures or the failure to comply with such requirements, could lead to material adverse impacts, including without limitation, negative publicity, a loss of customer confidence in internet access provided by other companiesour services or security measures or breach of contract claims.
There can be no assurance that the limitations of liability in our contracts would be enforceable or adequate or would otherwise protect us from liabilities or damages if we fail to comply with obligations related to security incidents. We cannot be sure that our insurance coverage will be adequate or sufficient to protect us from or adequately mitigate liabilities or damages with respect to claims, costs, expenses, litigation, fines, penalties, business loss, data loss, regulatory actions or material adverse impacts arising out of our privacy and security practices, processing or security incidents we may experience, or that such coverage will continue to be available on commercially reasonable terms or at all. The successful assertion of one or more large claims against us that exceeds our available insurance coverage, or results in changes to our insurance policies (including premium increases or the imposition of large deductible or co-insurance requirements) could harmhave an adverse effect on our business. In addition, we cannot be sure that our existing insurance coverage and coverage for errors and omissions will continue to be available on acceptable terms or that our insurers will not deny coverage as to any future claim.
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We are subject to stringent and evolving U.S. and foreign laws, regulations, rules, contractual obligations, policies, self-regulatory schemes, government regulation, and other obligations or standards related to data privacy and security. The actual or perceived failure by us, our customers, partners or vendors to comply with such obligations could lead to regulatory investigations or actions; litigation; fines and penalties; disruptions of our business operations; reputational harm; loss of revenue or profits; and other adverse business consequences.
In the ordinary course of business, we process sensitive data. We are subject to numerous federal, state, local and foreign laws and regulations, as well as regulatory guidance, industry standards, and other obligations relating to data privacy and security, governing the processing of personal data, such as information that we collect about employees and patients in the United States and abroad. Our data processing activities may subject us to numerous data privacy and security obligations, such as various laws, regulations, guidance, industry standards, external and internal privacy and security policies, contractual requirements, and other obligations relating to data privacy and security.
In the United States, federal, state, and local governments have enacted numerous data privacy and security laws, including data breach notification laws, personal data privacy laws, consumer protection laws (e.g., Section 5 of the Federal Trade Commission Act), and other similar laws (e.g., wiretapping laws). For example, HIPAA, as amended by HITECH, imposes specific requirements relating to the privacy, security, and transmission of individually identifiable health information. Additionally, the California Consumer Privacy Act, as amended by the California Privacy Rights Act (“CPRA”) (collectively, “CCPA”), applies to personal data of California-resident consumers, business representatives, and employees, and establishes a privacy framework for covered businesses. The CCPA provides for administrative fines of up to $7,500 per violation and allows private rights of action for certain data breaches. Although the CCPA exempts some data processed in the context of clinical trials, as we expand our operations, the CCPA may increase our compliance costs and potential liability. Additionally, the CPRA expanded the CCPA’s requirements, including by expanding consumers’ rights with respect to certain sensitive personal data and creating a new state agency to implement and enforce the law. We may be subject to additional U.S. privacy regulations in the future, including the Virginia Consumer Data Protection Act, and the Colorado Privacy Act, both of which either took or take effect in 2023. While these states, like the CCPA, also exempt some data processed in the context of clinical trials, these developments further complicate compliance efforts, and increase legal risk and compliance costs for us and the third parties upon which we rely.
Our operations abroad may also be subject to increased scrutiny or attention from data protection authorities. Many countries in the regions in which we operate or may operate have established or are in the process of establishing privacy and data security legal frameworks with which we and the third parties upon which we rely must comply. For example, the EU has adopted the General Data Protection Regulation (EU) 2016/679 (“EU GDPR”), which went into effect in May 2018, and the United Kingdom has adopted the United Kingdom’s GDPR (“UK GDPR”). These regulations introduce strict requirements for processing the personal data of individuals in the EU and UK. The EU and UK GDPR have and will continue to increase compliance burdens on us, including by mandating potentially burdensome documentation requirements and granting certain rights to individuals to control how we collect, use, disclose, retain and process information about them. Processing sensitive personal data, such as health information, may impose heightened compliance burdens under the EU and UK GDPR and is a topic of active interest among foreign regulators. In addition, the EU and UK GDPR provide for more robust regulatory enforcement and fines of up to €20 million under the EU GDPR (or £17.5 million under the UK GDPR) or 4% of the annual global revenue of the noncompliant company, whichever is greater. Under the EU GDPR, companies may face private litigation related to processing of personal data brought by classes of data subjects or consumer protection organizations authorized at law to represent their interests. As we expand into other foreign countries and jurisdictions, we may be subject to additional laws and regulations that may affect how we conduct business.
Certain data protection laws, including the EU GDPR, restrict the transfer of personal data from Europe, including the European Economic Area (“EEA”), UK and Switzerland, and other jurisdictions to the United States or other countries unless the parties to the transfer have implemented specific safeguards to protect the transferred personal data. In particular, the EEA and UK have significantly restricted the transfer of personal data to the United States and other countries whose privacy laws it believes are inadequate. Other jurisdictions may adopt similarly stringent interpretations of their data localization and cross-border data transfer laws. Although there are currently various mechanisms that may be used to transfer personal data from the EEA and UK to the United States in compliance with law, such as the EEA and UK’s standard contractual clauses, these mechanisms are subject to legal challenges, and there is no assurance that we can satisfy or rely on these measures to lawfully transfer personal data to the United States. As such, if there is no lawful manner for us to transfer personal data from the EEA, the UK or other jurisdictions to the United States, or if the requirements for a legally-compliant transfer are too onerous, we could face significant adverse consequences, including the interruption or degradation of our operations, the need to relocate part of or all of our business or data processing activities to other jurisdictions at significant expense, increased exposure to regulatory actions, substantial fines and penalties and injunctions against our processing or transferring of personal data necessary to operate our business. Companies that transfer personal data out of the EEA and UK to other jurisdictions, particularly to the United States, are subject to increased scrutiny from regulators, individual litigants, and activist groups. Some European regulators have ordered certain companies to suspend or permanently cease certain transfers out of Europe for allegedly violating the EU GDPR’s cross-border data transfer limitations.
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In addition to data privacy and security laws, we may be contractually subject to industry standards adopted by industry groups and may become subject to such obligations in the future. We are also bound by contractual obligations related to data privacy and security, and our efforts to comply with such obligations may not be successful. We publish privacy policies, marketing materials and other statements regarding data privacy and security. If these policies, materials or statements are found to be deficient, lacking in transparency, deceptive, unfair, or misrepresentative of our practices, we may be subject to investigation, enforcement actions by regulators or other adverse consequences.
The global data protection landscape is rapidly evolving, and implementation standards and enforcement practices are likely to remain uncertain for the foreseeable future. Furthermore, the obligations are not consistent and may conflict with each other. This evolution may create uncertainty in our business, affect our or the third parties upon which we rely ability to operate in certain jurisdictions or to process personal data, necessitate the acceptance of more onerous obligations in our contracts, or result in liability or impose additional costs on us. The cost of compliance with these obligations is high and is likely to increase in the future. Compliance with these obligations is a rigorous and time-intensive process, and we may be required to put in place additional mechanisms, potentially at significant expense, to ensure compliance with such obligations.
Although we endeavor to comply with our obligations, we may at times fail to do so or may be perceived to have failed to do so. Any failure or perceived failure by us or the third parties upon which we rely to comply with data privacy and security obligations could result in negative publicity, disruptions or interruptions in our operations, fines, penalties (including changes to our data processing practices), lawsuits, liability, an inability to process personal data, diversion of management time and effort and proceedings against us by governmental entities or others, any of which could interrupt or stop our business operations (including our clinical trials) and adversely affect our business, financial condition, results of operations and growth prospects. In many jurisdictions, enforcement actions and consequences for noncompliance are rising.
Risks Related to Government Regulation and Diagnostic Product Reimbursement
Changes in laws or regulations may have a material adverse effect on our business, cash flow, financial conditions or results of operations.
Approval and/New laws, statutes, rules, regulations or clearanceordinances could be enacted at any time which could adversely affect our business operations and financial performance. Further, existing laws, statutes, rules, regulations or ordinances could be interpreted, changed, modified or applied in ways that are detrimental to us or our customers. For example, if regulatory limitations are placed on our products or if tax laws are changed or reinterpreted, our business and growth could be harmed.
New income, sales, use or other tax laws, statutes, rules, regulations or ordinances could be enacted at any time, which could adversely affect our business operations and financial performance. Further, existing tax laws, statutes, rules, regulations or ordinances could be interpreted, changed, modified or applied adversely to us. For example, the Biden administration and Congress have proposed various U.S. federal tax law changes, which if enacted could have a material impact on our business, cash flow, financial condition or results of operations. In addition, it is uncertain if and to what extent various states will conform to federal tax laws. Future tax reform legislation could have a material impact on the value of our deferred tax assets, could result in significant one-time charges, and could increase our future U.S. tax expense.
We do not believe that we are required to collect sales, use, services or other similar taxes from our customers in certain jurisdictions. However, one or more countries or states may seek to impose sales, use, services, or other tax collection obligations on us, including for past sales. A successful assertion by one or more jurisdictions that we should collect sales or other taxes on the FDAsale of our products and foreign regulatoryservices could result in substantial tax liabilities for past sales and decrease our ability to compete for future sales. Each country and each state has different rules and regulations governing sales and use taxes and these rules and regulations are subject to varying interpretations that may change over time. We review these rules and regulations periodically and, when we believe sales and use taxes apply in a particular jurisdiction, voluntarily engage tax authorities in order to determine how to comply with their rules and regulations. However, we cannot guarantee that we will not be subject to sales and use taxes or related penalties for past sales in jurisdictions where we presently believe sales and use taxes are not due.
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Providers of goods or services are typically held responsible by taxing authorities for the collection and payment of any diagnostic tests will take significant timeapplicable sales and require significant research, development and clinical study expenditures and ultimately maysimilar taxes. If one or more taxing authorities determines that taxes should have, but have not, succeed.
Before we beginbeen paid with respect to label and market our products for use as clinical diagnostics in the United States, including as companion diagnostics, unless an exemption applies, we will be required to obtain either 510(k) clearance or PMA from the FDA. In addition,and services, we may be liable for past taxes in addition to being required to seek FDA clearance for any changescollect sales or modifications tosimilar taxes in respect of our products and services going forward. Liability for past taxes may also include substantial interest and penalty charges. Our customer contracts provide that could significantly affect their safety or effectiveness or would constitute a change in intended use. The 510(k) clearance processes can be expensive, time-consumingour customers must pay all applicable sales and uncertain. In addition to the time required to conduct clinical studies, if necessary, it generally takes from four to twelve months from submission of an application to obtain 510(k) clearance; however, it may take longer and 510(k) clearance may never be obtained. Even if the FDA accepts a 510(k) submission for filing, the FDA may request additional information or clinical studies during its review. Our ability to obtain additional regulatory clearances for new products and indicationssimilar taxes. Nevertheless, customers may be significantly delayedreluctant to pay back taxes and may refuse responsibility for interest or may never be obtained. In addition,penalties associated with those taxes or we may be required to obtain PMAs for new products or product modifications. The requirements of the more rigorous PMA process could delay product introductions and increase the costs associated with FDA compliance. As with all IVD products, the FDA reserves the right to redefine the regulatory path at the time of submission or during the review process and could require a more burdensome approach. Even if we were to obtain regulatory approval or clearance,determine that it may not be for the uses we believe are important or commercially attractive, in which case we would not be permittedfeasible to marketseek reimbursement. If we are required to collect and pay back taxes and the associated interest and penalties and if our productcustomers do not reimburse us for those uses.
A 510(k) clearanceall or PMA submission for any future medical device product would likely place substantial restrictions on how the device is marketed or sold, anda portion of these amounts, we will have incurred unplanned expenses that may be requiredsubstantial. Moreover, imposition of such taxes on our products and services going forward will effectively increase the cost of such products and services to continueour customers.
Many states are also pursuing legislative expansion of the scope of goods and services that are subject to comply with extensive regulatory requirements, including, but not limitedsales and similar taxes as well as the circumstances in which a vendor of goods and services must collect such taxes. Following the U.S. Supreme Court decision in South Dakota v. Wayfair, Inc., states are now free to Quality System Regulations (“QSRs”), registering manufacturing facilities, listinglevy taxes on sales of goods and services based on an “economic nexus,” regardless of whether the products with the FDA, and complying with labeling, marketing, complaint handling, adverse event and medical device reporting requirements and corrections and removals. We cannot assure you that we will successfully maintain the clearances or approvals we may receiveseller has a physical presence in the future. In addition, any clearancesstate. Furthermore, legislative proposals have been introduced in Congress that would provide states with additional authority to impose such taxes. Accordingly, it is possible that either federal or approvals we obtainstate legislative changes may be revoked if any issues arise that bring into questionrequire us to collect additional sales and similar taxes from our products’ safety or effectiveness. Any failure to maintain compliance with FDA regulatory requirements could harm our business, financial condition and results of operations.customers in the future.
Sales of our diagnostic products outside the United States will be subject to foreign regulatory requirements governing clinical studies, vigilance reporting, marketing approval, manufacturing, product licensing, pricing and reimbursement. These regulatory requirements vary greatly from country to country. As a result, the time required to obtain approvals outside the United States may differ from that required to obtain FDA approval and we may not be able to obtain foreign regulatory approvals on a timely basis or at all. Approval by the FDA does not ensure approval by regulatory authorities in other countries, and approval by one foreign regulatory authority does not ensure approval by regulatory authorities in other countries or by the FDA and foreign regulatory authorities could require additional testing. In addition, the FDA regulates exports of medical devices. Failure to comply with these regulatory requirements or obtain required approvals could impair our ability to commercialize our diagnostic products outside of the United States.
Our research use only products for the life sciences market could become subject to regulation as medical devices by the FDA or other regulatory agencies in the future, which could increase our costs and delay our commercialization efforts, thereby materially and adversely affecting our life sciences business and results of operations.
In the United States, our products are currently labeled and sold for research use only, and not for the diagnosis or treatment of disease, and are sold to a variety of parties, including biopharmaceutical companies, academic institutions and molecular labs. Because such products are not intended for use in clinical practice in diagnostics, and the products cannot include clinical or diagnostic claims, they are exempt from many regulatory requirements otherwise applicable to medical devices. In particular, while the FDA regulations require that RUO products be labeled, “For Research Use Only. Not for use in diagnostic procedures,” the regulations do not otherwise subject such products to the FDA’s pre- and post-market controls for medical devices.
A significant change in the laws governing RUO products or how they are enforced may require us to change our business model in order to maintain compliance. For instance, in November 2013 the FDA issued a guidance document entitled “Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only” (the “RUO Guidance”) which highlights
the FDA’s interpretation that distribution of RUO products with any labeling, advertising or promotion that suggests that clinical laboratories can validate the test through their own procedures and subsequently offer it for clinical diagnostic use as a laboratory developed test is in conflict with RUO status. The RUO Guidance further articulates the FDA’s position that any assistance offered in performing clinical validation or verification, or similar specialized technical support, to clinical laboratories, conflicts with RUO status. If we engage in any activities that the FDA deems to be in conflict with the RUO status held by the products that we sell, we may be subject to immediate, severe and broad FDA enforcement action that would adversely affect our ability to continue operations. Accordingly, if the FDA finds that we are distributing our RUO products in a manner that is inconsistent with its regulations or guidance, we may be forced to stop distribution of our RUO tests until we are in compliance, which would reduce our revenues,revenue, increase our costs and adversely affect our business, prospects, results of operations and financial condition. In addition, the FDA’s proposed implementation for a new framework for the regulation of laboratory developed tests (“LDTs”)LDTs may negatively impact the LDT market and thereby reduce demand for RUO products.
If the FDA requires marketing authorization of our RUO products in the future, there can be no assurance that the FDA will ultimately grant any clearance or approval requested by us in a timely manner, or at all.
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We expect to rely on third parties to conduct any future studies of our diagnostic products that may be required by the FDA or other regulatory authorities, and those third parties may not perform satisfactorily.
We do not have the ability to independently conduct the clinical studies or other studies that may be required to obtain FDA and other regulatory clearance or approval for our diagnostic products, including the HTG EdgeSeq systeminstrument and related proprietary panels. Accordingly, we expect to rely on third parties, such as medical institutions, contract research organizations and clinical investigators, and providers of NGS instrumentation, to conduct such studies and/or to provide information necessary for our submissions to regulatory authorities. Our reliance on these third parties for clinical development activities or information will reduce our control over these activities. These third-partiesthird parties may not complete activities on schedule or conduct studies in accordance with regulatory requirements or our study design. Similarly, providers of NGS instrumentation may not place the same importance on our regulatory submissions as we do. Our reliance on third parties that we do not control will not relieve us of any applicable requirement to prepare, and ensure compliance with, the various procedures requiresrequired under good clinical practices, or the submission of all information required in connection with requested regulatory approvals. If these third parties do not successfully carry out their contractual duties or regulatory obligations or meet expected deadlines if the third parties need to be replaced or if the quality or accuracy of the data they obtain is compromised due to their failure to adhere to our clinical protocols or regulatory requirements or for other reasons, our studies may be extended, delayed, suspended or terminated, and we may not be able to obtain regulatory approval for our diagnostic products.
Even if we are able to obtain regulatory approval or clearance for our diagnostic products, we will continue to be subject to ongoing and extensive regulatory requirements, and our failure to comply with these requirements could substantially harm our business.
If we receive regulatory approval or clearance for our diagnostic products, we will be subject to ongoing FDA obligations and continued regulatory oversight and review, such as compliance with QSRs, inspections by the FDA, continued adverse event and malfunction reporting, corrections and removals reporting, registration and listing, and promotional restrictions, and we may also be subject to additional FDA post-marketing obligations. If we are not able to maintain regulatory compliance, we may not be permitted to market our diagnostic products and/or may be subject to fines, injunctions, and civil penalties; recall or seizure of products; operating restrictions; and criminal prosecution. In addition, we may be subject to similar regulatory compliance actions of foreign jurisdictions.
If Medicare and other third-party payors in the United States and foreign countries do not approve coverage and adequate reimbursement for our future clinical diagnostic tests enabled by our technology, the commercial success of our diagnostic products would be compromised.
We plan to develop, obtain regulatory approval for and sell clinical diagnostics products for a number of different indications. Successful commercialization of our clinical diagnostic products depends, in large part, on the availability of coverage and adequate reimbursement for testing services using our diagnostic products from third-party payors, including government insurance plans, managed care organizations and private insurance plans. There is significant uncertainty surrounding third-party coverage and reimbursement for the use of tests that incorporate new technology, such as the HTG EdgeSeq systemplatform and related applications and assays. Reimbursement rates have the potential to fluctuate depending on the region in which the testing is provided, the type of facility or treatment center at which the testing is done, and the third-party payor responsible for payment. If our customers are unable to obtain positive coverage decisions from third-party payors approving reimbursement for our tests at adequate levels, the commercial success of our products would be compromised, and our revenue would be significantly limited. Even if we do obtain favorable reimbursement for our tests, third-party payors may withdraw their coverage policies, review and adjust the rate of
reimbursement, require co-payments from patients or stop paying for our tests, which would reduce revenue for testing services based on our technology and demand for our diagnostic products.
The American Medical Association Current Procedural Terminology (“CPT”) Editorial Panel created new CPT codes that could be used by our customers to report testing for certain large-scale multianalyte genomic sequencing procedures (“GSPs”), including our diagnostic products, if approved. Effective January 1, 2015, these codes allow for uniform reporting of broad genomic testing panels using technology similar to ours. While these codes standardize reporting for these tests, coverage and payment rates for GSPs remain uncertain and we cannot guarantee that coverage and reimbursement for these tests will be provided in the amounts we expect, or at all. Initially, industry associations recommended that payment rates for GSPs be cross-walked to existing codes on the clinical laboratory fee schedule. On October 27, 2014, Centers for Medicare and Medicaid Services (“CMS”) issued preliminary determinations for 29 new molecular pathology codes, including the GSPs, of gapfill rather than crosswalking as recommended by the Association for Molecular Pathology. This means that local private Medicare Administrative Contractors, such as Palmetto, Novidian, Novitas and Cahaba, were instructed to determine the appropriate fee schedule amounts in the first year, and CMS calculated a national payment rate based on the median of those local fee schedule amounts in the second year. This process may make it more difficult for our customers to obtain coverage and adequate reimbursement for testing services using our diagnostic products. We cannot assure that CMS and other third-party payors will establish reimbursement rates sufficient to cover the costs incurred by our customers in using our clinical diagnostic products, if approved. On September 22, 2017, gapfill pricing was set for three CPT codes which our customers may potentially utilize to obtain reimbursement, subject to regulatory limitations, for the use of our products. CPTs 81445 and 81450, for the assessment of 5-50 genes in solid and liquid tumors, respectively, were set at $602 and $760, respectively, and remains the same as of December 31, 2019. Additionally, CPT 81455 for the assessment of 51 or more genes in solid and liquid tumors was set at $2,920.
Even if we are able to establish coverage and reimbursement codes for our clinical diagnostic products in development, we will continue to be subject to significant pricing pressure, which could harm our business, results of operations, financial condition and prospects.
Third-party payors, including managed care organizations as well as government payors such as Medicare and Medicaid, have increased their efforts to control the cost, utilization and delivery of healthcare services, which may include decreased coverage or reduced reimbursement. From time to time, Congress has considered and implemented changes to the Medicare fee schedules in conjunction with budgetary legislation, and pricing and payment terms, including the possible requirement of a patient co-payment for Medicare beneficiaries for laboratory tests covered by Medicare, and are subject to change at any time. Reductions in the reimbursement rate of third-party payors have occurred and may occur in the future. Reductions in the prices at which testing services based on our technology are reimbursed in the future could result in pricing pressures and have a negative impact on our revenue. In many countries outside of the United States, various coverage, pricing and reimbursement approvals are required. We expect that it will take several years to establish broad coverage and reimbursement for testing services based on our products with payors in countries outside of the United States, and our efforts may not be successful.
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We may be subject, directly or indirectly, to federal and state healthcare fraud and abuse laws and other federal and state healthcare laws applicable to our business and marketing practices. If we are unable to comply, or have not complied, with such laws, we could face substantial penalties.
Our operations may be, and may continue to be, directly, or indirectly through our customers, subject to various federal and state fraud and abuse laws, including, without limitation, the federal and state anti-kickback statutes, false claims statutes, civil monetary penalties laws, patient data privacy and security laws, physician transparency laws and marketing compliance laws. These laws may impact, among other things, our proposed sales and marketing and education programs.
The laws that may affect our ability to operate include, but are not limited to:
•The Federal Anti-kickback Statute, which prohibits, among other things, knowingly and willfully soliciting, receiving, offering or paying any remuneration (including any kickback, bribe, or rebate), directly or indirectly, overtly or covertly, in cash or in-kind, to induce, or in return for, either the referral of an individual, or the purchase, lease, order or recommendation of any good, facility, item or service for which payment may be made, in whole or in part, under a federal healthcare program, such as the Medicare and Medicaid programs; a person or entity does not need to have actual knowledge of the statute or specific intent to violate it to have committed a violation, rather, if one purpose of the remuneration is to induce referrals, the Federal Anti-Kickback Statute is violated.
•The federal physician self-referral prohibition, commonly known as the Stark Law, which prohibits, among other things, physicians who have a financial relationship, including an investment, ownership or compensation relationship with an entity, from referring Medicare and Medicaid patients to that entity for designated health services, which include clinical laboratory services, unless an exception applies. Similarly, entities may not bill Medicare, Medicaid or any other party for services furnished pursuant to a prohibited referral. Unlike the Federal Anti-Kickback Statute, the Stark Law is a strict liability statute, meaning that all of the requirements of a Stark Law exception must be met in order to be compliant with the law.
•Federal civil and criminal false claims laws, including the federal civil False Claims Act, and civil monetary penalties laws, which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment or approval from Medicare, Medicaid or other governmental third-party payors that are false or fraudulent, knowingly making a false statement material to an obligation to pay or transmit money to the Federal Government or knowingly concealing or knowingly and improperly avoiding or decreasing an obligation to pay money to the Federal Government, which may apply to entities that provide coding and billing advice to customers; the Federal Government may assert that a claim including items or services resulting from a violation of the Federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal civil False Claims Act.
•HIPAA,The Federal Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), which created additional federal civil and criminal statutes that prohibit knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program or obtain, by means of false or fraudulent pretenses, representations, or promises, any of the money or property owned by, or under the custody or control of, any healthcare benefit program, regardless of the payor (e.g., public or private) and knowingly and willfully falsifying, concealing, or covering up by any trick or device a material fact or making any materially false statements in connection with the delivery of, or payment for, healthcare benefits, items or services relating to healthcare matters; similar to the Federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the healthcare fraud statute or specific intent to violate it to have committed a violation.
•HIPAA, as amended by HITECH,the Health Information Technology for Economic and Clinical Health Act of 2009 (“HITECH”), and their respective implementing regulations, which impose requirements on covered entities, which include certain healthcare providers, health plans, and healthcare clearinghouses as well as their respective business associates and their contractors that perform services for them that involve the use, maintenance, or disclosure of individually identifiable health information, relating to the privacy, security and transmission of individually identifiable health information.In addition,
•The Federal Physician Payments Sunshine Act, which require certain manufacturers of drugs, devices, biologicals and medical supplies for which payment is available under Medicare, Medicaid or the EU has established its own data security and privacy legal framework, including but not limitedChildren’s Health Insurance Program (with certain exceptions) to the recently adopted General Data Protection Regulation (EU) 2016/679 (“GDPR”), which contains new provisions specifically directed at the processingreport annually to CMS information related to payments or other transfers of health information, higher sanctions and extra-territoriality measures intendedvalue made to bring non-EU companies under the regulation. Over time we may expand our business operationsphysicians, defined to include additional operations in the EU. With such expansion, we would be subjectphysicians, dentists, optometrists, podiatrists and chiropractors, other healthcare practitioners (such as physicians assistants and nurse practitioners), and teaching hospitals, as well as applicable manufacturers and group purchasing organizations to increased governmental regulation, including the GDPR, in the EU countries in which we operate.report annually to CMS certain ownership and investment interests held by physicians and their immediate family members.
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•California recently enacted legislation that has been dubbed the first “GDPR-like” law in the United States. Known as the California Consumer Privacy Act (“CCPA”), it creates new individual privacy rights for consumers (as that word is broadly defined in the law) and places increased privacy and security obligations on entities handling personal data of consumers or households. The CCPA requires covered companies to provide new disclosures to California consumers, provides such consumers new ways to opt-out of certain sales of personal information, and allows for a new cause of action for data breaches.
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| The Federal Physician Payments Sunshine Act, which require certain manufacturers of drugs, devices, biologicals and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report annually to CMS information related to payments or other transfers of value made to physicians, as defined by such law, and teaching hospitals, as well as applicable manufacturers and group purchasing organizations to report annually to CMS certain ownership and investment interests held by physicians and their immediate family members.
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State law equivalents of each of the above federal laws, such as anti-kickback, self-referral, and false claims laws which may apply to our business practices, including but not limited to, research, distribution, sales and marketing arrangements as well as submitting claims involving healthcare items or services reimbursed by any third-party payor, including commercial insurers; state laws that require device companies to comply with the industry’s voluntary compliance guidelines and the applicable compliance guidance promulgated by the Federal Government that otherwise restricts payments that may be made to healthcare providers; state laws that require device manufacturers to file reports with states regarding marketing information, such as the tracking and reporting of gifts, compensations and other remuneration and items of value provided to healthcare professionals and entities (compliance with such requirements may require investment in infrastructure to ensure that tracking is performed properly, and some of these laws result in the public disclosure of various types of payments and relationships, which could potentially have a negative effect on our business and/or increase enforcement scrutiny of our activities); and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways, with differing effects.
Promotional activities for FDA-regulated products have been the subject of significant enforcement actions brought under healthcare reimbursement laws, fraud and abuse laws, and consumer protection statutes, among other theories. Advertising and promotion of medical devices are also regulated by the Federal Trade Commission and by state regulatory and enforcement authorities. In addition, under the Federal Lanham Act and similar state laws, competitors and others can initiate litigation relating to advertising claims.
In addition, the approval and commercialization of any of our product candidates outside the United States will also likely subject us to foreign equivalents of the healthcare laws mentioned above, among other foreign laws.
Because of the breadth of these laws and the narrowness of the statutory exceptions and regulatory safe harbors available under such laws, it is possible that some of our business activities, including our relationships with physicians and other health care providers, and our evaluation, reagent rental and collaborative development agreements with customers, and sales and marketing efforts could be subject to challenge under one or more of such laws.
If our operations are found to be in violation of any of the laws described above or any other governmental regulations that apply to us, we may be subject to significant penalties, including administrative, civil and criminal penalties, damages, fines, imprisonment, disgorgement, exclusion from participation in federal healthcare programs, such as Medicare and Medicaid, contractual damages, reputational harm, additional reporting requirements and/or oversight if we become subject to a corporate integrity agreement or similar agreement to resolve allegations of non-compliance with these laws, and the curtailment or restructuring of our operations, any of which could adversely affect our ability to operate our business and our results of operations.
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Our employees, independent contractors, principal investigators, consultants, commercial partners and vendors may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements.
We are exposed to the risk of fraud or other misconduct by our employees, independent contractors, principal investigators, consultants, commercial partners and vendors. Misconduct by these parties could include intentional, reckless or negligent failures to, among other things: (i) comply with the regulations of the FDA, CMS, the Department of Health and Human Services Office of Inspector General (“OIG”) and other similar foreign regulatory bodies; (ii) provide true, complete and accurate information to the FDA and other similar regulatory bodies; (iii) comply with manufacturing standards we have established; (iv) comply with healthcare fraud and abuse laws and regulations in the United States and similar foreign fraudulent misconduct laws; or (v) report financial information or data accurately, or disclose unauthorized activities to us. These laws may impact, among other things, our activities with collaborators and key opinion leaders, as well as our sales, marketing and education programs. In particular, the promotion, sales, marketing and business arrangements in the healthcare industry are subject to extensive laws and regulations intended to prevent fraud, misconduct, kickbacks, self-dealing and other abusive practices. These laws may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, sales commission, customer incentive programs and other business arrangements. Such misconduct could also involve the improper use of information obtained in the course of clinical studies, which could result in regulatory sanctions and cause serious harm to our reputation. We currently have a code of conduct applicable to all of our employees, but it is not always possible to identify and deter employee misconduct, and our code of conduct and the other precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses, or in protecting us from
governmental investigations or other actions or lawsuits stemming from a failure to comply with these laws or regulations. If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business, including the imposition of significant civil, criminal and administrative penalties, damages, monetary fines, disgorgement, imprisonment, possible exclusion from participation in Medicare, Medicaid and other federal healthcare programs, contractual damages, reputational harm, diminished profits and future earnings, additional reporting requirements and/or oversight if we become subject to a corporate integrity agreement or similar agreement to resolve allegations of non-compliance with these laws, and curtailment of our operations. Any of these actions or investigations could result in substantial costs to us, including legal fees, and divert the attention of management from operating our business.
Healthcare policy changes, including recently enacted legislation reforming the United States healthcare system, may have a material adverse effect on our financial condition and results of operations.
On April 1, 2014, the Protecting Access to Medicare Act of 2014 (“PAMA”) was signed into law, which, among other things, significantly altered the current payment methodology under the Medicare Clinical Laboratory Fee Schedule (“CLFS”). Effective January 1, 2018, the CLFS is based on weighted median private payor rates as required by PAMA. Under the law, starting January 1, 2016 and every three years thereafter (or annually in the case of advanced diagnostic lab tests), applicable clinical laboratories must report laboratory test payment data for each Medicare-covered clinical diagnostic lab test that it furnishes. The most recent data collection period was from January 1, 2019, through June 30, 2019 and was followed by a six-month validation period from July 1, 2019 through December 31, 2019. Thereafter, applicable laboratories will report their data between January 1, 2020 and March 31, 2020. The reported data must include the payment rate (reflecting all discounts, rebates, coupons and other price concessions) and the volume of each test that was paid by each private payor (including health insurance issuers, group health plans, Medicare Advantage plans and Medicaid managed care organizations). Reporting of payment data under PAMA for clinical diagnostic laboratory tests has been delayed on numerous occasions. Based on current law, between January 1, 2023 and March 31, 2023, applicable laboratories will be required to report on data collected during January 1, 2019 and June 30, 2019. This data collection and data reporting cycle will be usedutilized to determine the CLFS payment rates for 2021 through 2023.2024 to 2026 clinical diagnostic laboratory test rates. The payment rate applies to laboratory tests furnished by a hospital laboratory if the test is separately paid under the hospital outpatient prospective payment system. In addition, CMS updated the statutory phase-in provisions such that the rates for clinical diagnostic laboratory tests in 2020 could not be reduced by more than 10% of the rates for 2019. Pursuant to the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”), as updated by the Consolidated Appropriations Act, 2023, the statutory phase-in of the payment reductions has been extended through 2026, with a 0% reduction cap for 2021-2023, and a 15% reduction cap for 2024 through 2026. It is still too early to predict the full impact on reimbursement for our products in development.
Also, under PAMA, CMS is required to adopt temporary billing codes to identify new tests and new advanced diagnostic laboratory tests that have been cleared or approved by the FDA. For an existing test that is cleared or approved by the FDA and for which Medicare payment is made as of April 1, 2014, CMS is required to assign a unique billing code if one has not already been assigned by the agency. In addition to assigning the code, CMS was required to publicly report payment for the tests. We cannot determine at this time the full impact of the law, including its implementing regulations, on our business, financial condition and results of operations.
The ACAPatient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010 (collectively, the “ACA”), made changes that significantly impacted the biopharmaceutical and medical device industries and clinical laboratories. For example, the ACA imposes a multifactor productivity adjustment to the reimbursement rate paid under Medicare for certain clinical diagnostic laboratory tests, which may reduce payment rates. These or any future proposed or mandated reductions in payments may apply to some or all of the clinical laboratory tests that our diagnostics customers use our technology to deliver to Medicare beneficiaries and may reduce demand for our diagnostic products.
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Other significant measures contained in the ACA include, for example, coordination and promotion of research on comparative clinical effectiveness of different technologies and procedures, initiatives to revise Medicare payment methodologies, such as bundling of payments across the continuum of care by providers and physicians, and initiatives to promote quality indicators in payment methodologies. The ACA also includes significant new fraud and abuse measures, including required disclosures of financial arrangements with physician customers, lower thresholds for violations and increasing potential penalties for such violations. However, the future of the ACA is uncertain. There remainhave been executive, judicial and Congressional challenges to certain aspects of the ACA, as well as efforts byACA. On June 17, 2021, the Trump administration to repeal or replace certain aspects of the ACA. AsU.S. Supreme Court dismissed a result, there have been delays in the implementation of, and action taken to repeal or replace, certain aspects of the ACA. Since January 2017, President Trump has signed two Executive Orders and other directives designed to delay the implementation of certain provisions of the ACA or otherwise circumvent some of the requirements for health insurance mandated by the ACA. Concurrently, Congress has considered legislationchallenge on procedural grounds that would repeal or repeal and replace all or part of the ACA. While Congress has not passed comprehensive repeal legislation, it has enacted laws that modify certain provisions of the ACA. For example, the Tax Act includes a provision repealing, effective January 1, 2019, the tax-based shared responsibility payment imposed by the ACA on certain individuals who fail to maintain qualifying health coverage for all or part of a year that is commonly referred to as the “individual mandate”. In addition, the 2020 federal spending package permanently eliminated, effective January 1, 2020, the ACA-mandated medical device tax and “Cadillac” tax on high-cost employer-sponsored health coverage and, effective January 1, 2021, also eliminates the health insurer tax. On December 14, 2018, a Texas U.S. District Court Judge ruled thatargued the ACA is unconstitutional in its entirety because the “individual mandate” was repealed by Congress as part of the Tax Act. Additionally, on December 18, 2019,Congress. Further, prior to the U.S. Court of Appeals for the 5th Circuit upheld the DistrictSupreme Court ruling, on January 28, 2021, President Biden issued an executive order that initiated a special enrollment period for purposes of obtaining health insurance coverage through the ACA marketplace. The executive order also instructed certain governmental agencies to review and reconsider their existing policies and rules that limit access to healthcare, including among others, reexamining Medicaid demonstration projects and waiver programs that include work requirements, and policies that create unnecessary barriers to obtaining access to health insurance coverage through Medicaid or the ACA. On August 16, 2022, President Biden signed the Inflation Reduction Act of 2022 (“IRA”) into law, which, among other things, extends enhanced subsidies for individuals purchasing health insurance coverage in ACA marketplaces through plan year 2025. The IRA also eliminates the “donut hole” under the Medicare Part D program beginning in 2025 by significantly lowering the beneficiary maximum out-of-pocket cost and creating a new manufacturer discount program. The IRA also includes measures designed to lower the cost of certain pharmaceutical products under the Medicare program. It is currently unclear how the IRA will be implemented but is likely to have a significant impact on the pharmaceutical industry. It is possible that the individual mandate was unconstitutional and remandedACA will be subject to judicial or Congressional challenges in the case back to the District Court to determine whether the remaining provisions of the ACA are invalid as well.future. It is unclear how this decision, future decisions, subsequent appeals,
and other efforts to repeal and replace ACAany additional healthcare reform measures of the Biden administration will impact the ACA and our business. We continue to evaluate the effect that the ACA and its possible repeal and replacement has on our business.
In addition, other legislative changes have been proposed and adopted since the ACA was enacted. On August 2, 2011, then-President Obama signed into law the Budget Control Act of 2011, which, among other things, created the Joint Select Committee on Deficit Reduction to recommend to Congress proposals in spending reductions. The Joint Select Committee did not achieve a targeted deficit reduction of at least $1.2 trillion for the years 2013 through 2021, triggering the legislation’s automatic reduction to several government programs. This includes reductions to Medicare payments to providers of 2% per fiscal year, which went into effect on April 1, 2013, and, following the passage of other legislative amendments, including the Bipartisan Budget Act of 2018, will stay in effect through 2029until 2031 unless additional Congressional action is taken. Under current legislation, the actual reduction in Medicare payments will vary from 1% in 2022 to up to 4% in the final fiscal year of this sequester. Further, Congress and the Biden administration are considering additional health reform measures. On January 2, 2013, then-President Obama signed into law the American Taxpayer Relief Act of 2012, which, among other things, further reduced Medicare payments to several providers, including hospitals, imaging centers and cancer treatment centers and increased the statute of limitations period for the government to recover overpayments to providers from three to five years.
Various healthcare reform proposals have also emerged from federal and state governments. Changes in healthcare law or policy, such as the creation of broad test utilization limits for diagnostic products in general or requirements that Medicare patients pay for portions of clinical laboratory tests or services received, could substantially impact the sales of our tests, increase costs and divert management’s attention from our business. In addition, sales of our tests outside of the United States will subject us to foreign regulatory requirements, which may also change over time.
We cannot predict whether future healthcare initiatives will be implemented at the federal or state level or in countries outside of the United States in which we may do business, or the effect any future legislation or regulation will have on us. The full impact of the ACA, as well as other laws and reform measures that may be proposed and adopted in the future, remains uncertain, but may continue the downward pressure on medical device pricing, especially under the Medicare program, and may also increase our regulatory burdens and operating costs, which could have a material adverse effect on our business operations.
Changes in funding for the FDA, the SEC and other government agencies could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal functions on which the operation of our business may rely, which could negatively impact our business.
The ability of the FDA to review and approve new products can be affected by a variety of factors, including government budget and funding levels, ability to hire and retain key personnel and accept payment of user fees, and statutory, regulatory, and policy changes. Average review times at the agency have fluctuated in recent years as a result. In addition, government funding of the SEC and other government agencies on which our operations may rely, including those that fund research and development activities is subject to the political process, which is inherently fluid and unpredictable.
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Disruptions at the FDA and other agencies may also slow the time necessary for new drugs or diagnostic products to be reviewed and/or approved by necessary government agencies, which would adversely affect our business. For example, over the last several years, the U.S. government has shut down several times and certain regulatory agencies, such as the FDA and the SEC, have had to furlough critical FDA, SEC and other government employees and stop critical activities. If a prolonged government shutdown occurs, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions, which could have a material adverse effect on our business. Further, future government shutdowns could impact our ability to access the public markets and obtain necessary capital in order to properly capitalize and continue our operations.
Risks Related to Intellectual Property
If we are unable to protect our intellectual property effectively, our business will be harmed.
We rely on patent protection as well as trademark, copyright, trade secret and other intellectual property rights protection and contractual restrictions to protect our proprietary technologies, all of which provide limited protection and may not adequately protect our rights or permit us to gain or keep any competitive advantage. Our U.S. and foreign patent and patent application portfolio relates to our nuclease-protection-based technologies as well as to lung cancer and melanoma and DLBCL biomarker panels discovered using our nuclease-protection-based technology. We have exclusive or non-exclusive licenses to multiple U.S. and foreign patents and patent applications covering technologies that we may elect to utilize in developing diagnostic tests for use on our HTG EdgeSeq system.platform. Those licensed patents and patent applications cover technologies related to the diagnosis of breast cancer and melanoma.
If we fail to protect our intellectual property, third parties may be able to compete more effectively against us and we may incur substantial litigation costs in our attempts to recover or restrict use of our intellectual property.
We cannot assure investors that any of our currently pending or future patent applications will result in issued patents, and we cannot predict how long it will take for such patents to be issued. Further, we cannot assure investors that other parties will not challenge any patents issued to us or that courts or regulatory agencies will hold our patents to be valid or enforceable. We cannot guarantee investors that we will be successful in defending challenges made against our patents. Any successful third-party challenge to our patents could result in the unenforceability or invalidity of such patents.
The patent positions of life sciences companies can be highly uncertain and involve complex legal and factual questions for which important legal principles remain unresolved. No consistent policy regarding the breadth of claims allowed in such companies’ patents has emerged to date in the United States. Furthermore, in the biotechnology field, courts frequently render opinions that may adversely affect the patentability of certain inventions or discoveries, including opinions that may adversely affect the patentability of methods for analyzing or comparing nucleic acids molecules, such as RNA or DNA.
The patent positions of companies engaged in development and commercialization of molecular diagnostic tests are particularly uncertain. Various courts, including the U.S. Supreme Court, have recently rendered decisions that impact the scope of patentability of certain inventions or discoveries relating to molecular diagnostics. Specifically, these decisions stand for the proposition that patent claims that recite laws of nature (for example, the relationships between gene expression levels and the likelihood of risk of recurrence of cancer) are not themselves patentable unless those patent claims have sufficient additional features that provide practical assurance that the processes are genuine inventive applications of those laws rather than patent drafting efforts designed to monopolize the law of nature itself. What constitutes a “sufficient” additional feature is uncertain. Accordingly, this evolving case law in the United States may adversely impact our ability to obtain new patents and may facilitate third-party challenges to our existing owned and licensed patents.
The laws of some non-U.S. countries do not protect intellectual property rights to the same extent as the laws of the United States, and many companies have encountered significant problems in protecting and defending such rights in foreign jurisdictions. The legal systems of certain countries, particularly certain developing countries, do not favor the enforcement of patents and other intellectual property protection, particularly those relating to biotechnology, which could make it difficult for us to stop the infringement of our patents. Proceedings to enforce our patent rights in foreign jurisdictions could result in substantial cost and divert our efforts and attention from other aspects of our business.
Changes in either the patent laws or in interpretations of patent laws in the United States or other countries may diminish the value of our intellectual property. We cannot predict the breadth of claims that may be allowed or enforced in our patents or in third-party patents. For example:
•We might not have been the first to make the inventions covered by each of our patents and pending patent applications.
•We might not have been the first to file patent applications for these inventions.
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•Others may independently develop similar or alternative products and technologies or duplicate any of our products and technologies.
•It is possible that none of our pending patent applications will result in issued patents, and even if they issue as patents, they may not provide a basis for commercially viable products, may not provide us with any competitive advantages, or may be challenged and invalidated by third parties.
•We may not develop additional proprietary products and technologies that are patentable.
•The patents of others may have an adverse effect on our business.
•We apply for patents covering our products and technologies and uses thereof, as we deem appropriate. However, we may fail to apply for patents on important products and technologies in a timely fashion or at all.
In addition to pursuing patents on our technology, we take steps to protect our intellectual property and proprietary technology by entering into confidentiality agreements and intellectual property assignment agreements with our employees, consultants, corporate partners and, when needed, our advisors. Such agreements may not be enforceable or may not provide meaningful protection for our trade secrets or other proprietary information in the event of unauthorized use or disclosure or other breaches of the agreements, and we may not be able to prevent such unauthorized disclosure. Monitoring unauthorized disclosure is difficult, and we do not know whether the steps we have taken to prevent such disclosure are, or will be, adequate. If we were to enforce a claim that a third-party had illegally obtained and was using our trade secrets, it would be expensive and time consuming, and the outcome would be unpredictable. In addition, courts outside the United States may be less willing to protect trade secrets.
In addition, competitors could purchase our products and attempt to replicate some or all of the competitive advantages we derive from our development efforts, willfully infringe our intellectual property rights, design around our protected technology or develop their own competitive technologies that fall outside of our intellectual property rights. If our intellectual property is not adequately protected so as to protect our market against competitors’ products and methods, our competitive position could be adversely affected, as could our business.
We have not yet registered certain of our trademarks, including “HTG Edge,” “HTG EdgeSeq,” “VERI/O,” “qNPA,” and “qNPA,”“HTG Transcriptome Panel” in all of our potential markets. If we apply to register these trademarks, our applications may not be allowed for registration, and our registered trademarks may not be maintained or enforced. In addition, opposition or cancellation proceedings may be filed against our trademark applications and registrations, and our trademarks may not survive such proceedings. If we do not secure registrations for our trademarks, we may encounter more difficulty in enforcing them against third parties than we otherwise would.
To the extent our intellectual property, including licensed intellectual property, offers inadequate protection, or is found to be invalid or unenforceable, we would be exposed to a greater risk of direct competition. If our intellectual property does not provide adequate protection against our competitors’ products, our competitive position could be adversely affected, as could our business. Both the patent application process and the process of managing patent disputes can be time consuming and expensive.
We may need to depend on certain technologies that are licensed to us. We do not control these technologies and any loss of our rights to them could prevent us from selling some of our products.
We have entered into several license agreements with third parties for certain licensed technologies that are, or may become relevant to the products we market, or plan to market. In addition, we may in the future elect to license third-party intellectual property to further our business objectives and/or as needed for freedom to operate for our products. We do not and will not own the patents, patent applications or other intellectual property rights that are a subject of these licenses. Our rights to use these technologies and employ the inventions claimed in the licensed patents, patent applications and other intellectual property rights are or will be subject to the continuation of and compliance with the terms of those licenses.
We might not be able to obtain licenses to technology or other intellectual property rights that we require. Even if such licenses are obtainable, they may not be available at a reasonable cost or multiple licenses may be needed for the same product (e.g., stacked royalties). We could therefore incur substantial costs related to royalty payments for licenses obtained from third parties, which could negatively affect our margins. Further, we could encounter delays in product introductions, or interruptions in product sales, as we develop alternative methods or products.
In some cases, we do not or may not control the prosecution, maintenance, or filing of the patents or patent applications to which we hold licenses, or the enforcement of these patents against third parties. As a result, we cannot be certain that drafting or prosecution of the licensed patents and patent applications by the licensors have been or will be conducted in compliance with applicable laws and regulations or will result in valid and enforceable patents and other intellectual property rights.
Certain of the U.S. patent rights we own, have licensed or may license relate to technology that was developed with U.S. government grants, in which case the U.S. government has certain rights in those inventions, including, among others, march-in license rights. In addition, federal regulations impose certain domestic manufacturing requirements with respect to any products within the scope of those U.S. patent claims.
We may be involved in lawsuits to protect or enforce our patent or other proprietary rights, to determine the scope, coverage and validity of others’ patent or other proprietary rights, or to defend against third-party claims of intellectual property infringement, any of which could be time-intensive and costly and may adversely impact our business or stock price.
We may from time to time receive notices of claims of infringement and misappropriation or misuse of other parties’ proprietary rights, including with respect to third-party trade secrets, infringement by us of third-party patents and trademarks or other rights, or challenges to the validity or enforceability of our patents, trademarks or other rights. Some of these claims may lead to litigation. We cannot assure investors that such actions will not be asserted or prosecuted against us or that we will prevail in any or all such actions.
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Litigation may be necessary for us to enforce our patent and other proprietary rights or to determine the scope, coverage and validity of the proprietary rights of others. The outcome of any litigation or other proceeding is inherently uncertain and might not be favorable to us. In addition, any litigation that may be necessary in the future could result in substantial costs, even if we were to prevail, and diversion of resources and could have a material adverse effect on our business, operating results or financial condition.
As we move into new markets and applications for our products, incumbent participants in such markets may assert their patents and other proprietary rights against us as a means of slowing our entry into such markets or as a means to extract substantial license and royalty payments from us. Our competitors and others may now and in the future have significantly larger and more mature patent portfolios than we currently have. In addition, future litigation may involve patent holding companies or other adverse patent owners who have no relevant product revenue and against whom our own patents may provide little or no deterrence or protection. Therefore, our commercial success may depend in part on our non-infringement of the patents or proprietary rights of third parties. Numerous significant intellectual property issues have been litigated, and will likely continue to be litigated, between existing and new participants in our existing and targeted markets and competitors may assert that our products infringe their intellectual property rights as part of a business strategy to impede our successful entry into those markets. We have not conducted comprehensive freedom-to-operate searches to determine whether the commercialization of our products or other business activities would infringe patents issued to third parties. Third parties may assert that we are employing their proprietary technology without authorization. In addition, our competitors and others may have patents or may in the future obtain patents and claim that use of our products infringes these patents. We could incur substantial costs and divert the attention of our management and technical personnel in defending against any of these claims. Parties making claims against us may be able to obtain injunctive or other relief, which could block our ability to develop, commercialize and sell products, and could result in the award of substantial damages against us. In the event of a successful claim of
infringement against us, we may be required to pay damages and obtain one or more licenses from third parties or be prohibited from selling certain products. We may not be able to obtain these licenses at a reasonable cost, if at all. We could therefore incur substantial costs related to royalty payments for licenses obtained from third parties, which could negatively affect our margins. In addition, we could encounter delays in product introductions while we attempt to develop alternative methods or products to avoid infringing third-party patents or proprietary rights. Defense of any lawsuit or failure to obtain any of these licenses on favorable terms could prevent us from commercializing products, and the prohibition of sale of any of our products could materially affect our ability to grow and gain market acceptance for our products.
Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation. In addition, during the course of this kind of litigation, there could be public announcements of the results of hearings, motions or other interim proceedings or developments. If securities analysts or investors perceive these results to be negative, it could have a substantial adverse effect on the price of our common stock.
In addition, our agreements with some of our suppliers, distributors, customers and other entities with whom we do business require us to defend or indemnify these parties to the extent they become involved in infringement claims against us, including the claims described above. We could also voluntarily agree to defend or indemnify third parties in instances where we are not obligated to do so if we determine it would be important to our business relationships. If we are required or agree to defend or indemnify any of these third parties in connection with any infringement claims, we could incur significant costs and expenses that could adversely affect our business, operating results, or financial condition.
We may need to depend on certain technologies that are licensed to us. We do not control these technologies and any loss of our rights to them could prevent us from selling some of our products.
We have entered into several license agreements with third parties for certain licensed technologies that are, or may become relevant to the products we market, or plan to market. In addition, we may in the future elect to license third-party intellectual property to further our business objectives and/or as needed for freedom to operate for our products. We do not and will not own the patents, patent applications or other intellectual property rights that are a subject of these licenses. Our rights to use these technologies and employ the inventions claimed in the licensed patents, patent applications and other intellectual property rights are or will be subject to the continuation of and compliance with the terms of those licenses.
We might not be able to obtain licenses to technology or other intellectual property rights that we require. Even if such licenses are obtainable, they may not be available at a reasonable cost or multiple licenses may be needed for the same product (e.g., stacked royalties). We could therefore incur substantial costs related to royalty payments for licenses obtained from third parties, which could negatively affect our margins. Further, we could encounter delays in product introductions, or interruptions in product sales, as we develop alternative methods or products.
In some cases, we do not or may not control the prosecution, maintenance, or filing of the patents or patent applications to which we hold licenses, or the enforcement of these patents against third parties. As a result, we cannot be certain that drafting or prosecution of the licensed patents and patent applications by the licensors have been or will be conducted in compliance with applicable laws and regulations or will result in valid and enforceable patents and other intellectual property rights.
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Certain of the U.S. patent rights we own, have licensed or may license relate to technology that was developed with U.S. government grants, in which case the U.S. government has certain rights in those inventions, including, among others, march-in license rights. In addition, federal regulations impose certain domestic manufacturing requirements with respect to any products within the scope of those U.S. patent claims.
We may be subject to damages resulting from claims that we or our employees have wrongfully used or disclosed alleged trade secrets of our employees’ former employers.
Many of our employees were previously employed at other medical diagnostic companies, including our competitors or potential competitors. Although no claims against us are currently pending, we may be subject to claims that these employees or we have inadvertently or otherwise used or disclosed trade secrets or other proprietary information of their former employers. Litigation may be necessary to defend against these claims. If we fail in defending such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights. A loss of key research personnel work product could hamper or prevent our ability to commercialize certain potential products, which could severely harm our business. Even if we are successful in defending against these claims, litigation could result in substantial costs and be a distraction to management.
Our products contain third-party open sourceopen-source software components, and failure to comply with the terms of the underlying open sourceopen-source software licenses could restrict our ability to sell our products.
Our products contain software tools licensed by third-party authors under “open source”“open-source” licenses. Use and distribution of open sourceopen-source software may entail greater risks than use of third-party commercial software, as open sourceopen-source licensors generally do not provide warranties or other contractual protections regarding infringement claims or the quality of the code. Some open sourceopen-source licenses contain requirements that we make available source code for modifications or derivative works we create based upon the type of open sourceopen-source software we use. If we combine our proprietary software with open sourceopen-source software in a certain manner, we could, under certain open sourceopen-source licenses, be required to release the source code of our proprietary software to the public. This would allow our competitors to create similar products with less development effort and time and ultimately could result in a loss of product sales.
Although we monitor our use of open sourceopen-source software to avoid subjecting our products to conditions we do not intend, the terms of many open sourceopen-source licenses have not been interpreted by U.S. courts, and there is a risk that these licenses could be construed in a way that could impose unanticipated conditions or restrictions on our ability to commercialize our products. Moreover, we cannot assure investors that our processes for controlling our use of open sourceopen-source software in our products will be effective. If we are held to have breached the terms of an open sourceopen-source software license, we could be required to seek licenses from third parties to continue offering our products on terms that are not economically feasible, to re-engineer our products, to discontinue the sale of our products if re-engineering could not be accomplished on a timely basis, or to make generally available, in source code form, our proprietary code, any of which could adversely affect our business, operating results, and financial condition.
We use third-party software that may be difficult to replace or cause errors or failures of our products that could lead to lost customers or harm to our reputation.
We use software licensed from third parties in our products. In the future, this software may not be available to us on commercially reasonable terms, or at all. Any loss of the right to use any of this software could result in delays in the production of our products until equivalent technology is either developed by us, or, if available, is identified, obtained and integrated, which could harm our business. In addition, any errors or defects in third-party software, or other third-party software failures could result in errors, defects or cause our products to fail, which could harm our business and be costly to correct. Many of these providers attempt to impose limitations on their liability for such errors, defects or failures, and if enforceable, we may have additional liability to our customers or third-party providers that could harm our reputation and increase our operating costs.
We will need to maintain our relationships with third-party software providers and to obtain software from such providers that do not contain any errors or defects. Any failure to do so could adversely impact our ability to deliver reliable products to our customers and could harm our results of operations.
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Risks Related to Being a Public Company
If we fail to maintain proper and effective internal controls, our ability to produce accurate consolidated financial statements on a timely basis could be impaired.
We are subject to the reporting requirements of the Exchange Act, the Sarbanes-Oxley Act and the rules and regulations of The Nasdaq Stock Market (“Nasdaq”). The Sarbanes-Oxley Act requires, among other things, that we maintain effective disclosure controls and procedures. Internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of consolidated financial statements in accordance with US GAAP. We have performed system and process evaluation and testing of our internal controls over financial reporting to allow management to report annually on the effectiveness of our internal controls over financial reporting, as required by Section 404 of the Sarbanes-Oxley Act. This has required and will require that we incur substantial professional fees and internal costs to augment our accounting and finance functions and that we expend significant management efforts as we continue to make this assessment and ensure maintenance of proper internal controls on an ongoing basis.
If we are not able to comply with the requirements of Section 404 of the Sarbanes-Oxley Act in a timely manner, or if we fail to establish and maintain proper and effective internal control over financial reporting, we may not be able to produce timely and accurate consolidated financial statements, and our ability to accurately report our financial results could be adversely affected. If that were to happen, the market price of our stock could decline, and we could be subject to sanctions or investigations by Nasdaq, the SEC or other regulatory authorities.
Changes or modifications in financial accounting standards, including those related to revenue recognition, may harm our results of operations.
From time to time, the FASB, either alone or jointly with other organizations, promulgates new accounting principles that could have an adverse impact on our financial position, results of operations or reported cash flows. For example, in May 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers, and subsequently issued implementation guides (collectively, the “New Revenue Standard”). The New Revenue Standard superseded nearly all previous revenue recognition guidance under US GAAP and became effective for us beginning January 1, 2018. Our inability to adopt or implement any new accounting standard correctly, or to update or modify our internal controls as needed, by the mandated adoption dates could adversely affect our financial reporting obligations, corresponding regulatory compliance and/or investors’ confidence in us. Also, if we were to change our critical accounting estimates, including those related to the recognition of collaboration revenue and other revenue sources, our operating results could be significantly affected.
Complying with the laws and regulations affecting public companies increases our costs and the demands on management and could harm our operating results.
As a public company, we will continue to incur significant legal, accounting and other expenses. The Exchange Act requires, among other things, that we file annual, quarterly and current reports with respect to our business and operating results. In addition, the Sarbanes-Oxley Act and rules subsequently implemented by the SEC and Nasdaq, impose numerous requirements on public companies, including corporate governance requirements. Our management and other personnel will need to continue to devote a substantial amount of time to compliance with these laws and regulations. These requirements have resulted and will continue to result in significant legal, accounting, and financial compliance costs and have made and will continue to make some activities more time consuming and costly.
As an “emerging growth company,”a “non-accelerated filer” we have availed ourselves of the exemption from the requirement that our independent registered public accounting firm attest to the effectiveness of our internal control over financial reporting under Section 404. However, we may no longer avail ourselves of this exemption when we cease to be an “emerging growth company.” When our independent registered public accounting firm is required to undertake an assessment of our internal control over financial reporting, the cost of our compliance with Section 404 will correspondingly increase. Our compliance with applicable provisions of Section 404 will require that we incur substantial accounting expense and expend significant management time on compliance-related issues as we implement additional corporate governance practices and comply with reporting requirements. Moreover, if we are not able to comply with the requirements of Section 404 applicable to us in a timely manner, or if we or our independent registered public accounting firm identifies deficiencies in our internal control over financial reporting that are deemed to be material weaknesses, the market price of our stock could decline and we could be subject to sanctions or investigations by the SEC or other regulatory authorities, which would require additional financial and management resources.
Furthermore, investor perceptions of our company may suffer if deficiencies are found, and this could cause a decline in the market price of our stock. Irrespective of compliance with Section 404, any failure of our internal control over financial reporting could have a material adverse effect on our stated operating results and harm our reputation. If we are unable to implement these requirements effectively or efficiently, it could harm our operations, financial reporting, or financial results and could result in an adverse opinion on our internal controls from our independent registered public accounting firm.
We are an “emerging growth company,” and a “smaller reporting company” and a “non-accelerated filer” and any decision on our part to comply only with certain reduced reporting and disclosure requirements applicable to emerging growthsmaller reporting companies or smaller reporting companiesnon-accelerated filers could make our common stock less attractive to investors.
We are an “emerging growth company,” as defined in the JOBS Act, enacted in April 2012, and a “smaller reporting company,”company” and a “non-accelerated filer” as defined in the Exchange Act, and for as long as we continue to be an “emerging growtha “smaller reporting company” or a “smaller reporting company,“non-accelerated filer,” we may choose to take advantage of exemptions from various reporting requirements applicable to other public companies but not to “emerging growth“smaller reporting companies” or “smaller reporting companies,“non-accelerated filers,” including, but not limited to, not being required to have our independent registered public accounting firm audit our internal control over financial reporting under Section 404 (for so long as we are an “emerging growth company”a “non-accelerated filer”), and reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements (for so long as we are an “emerging growth company” or a “smaller reporting company”), and exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved (for so long as we are an “emerging growth company”). We will be an “emerging growth company” until December 31, 2020. We will be a “smaller reporting company” until the market value of our common stock that is held by non-affiliates exceeds $250.0 million as of the last business day of our most recently completed second fiscal quarter. We cannot predict if investors will find our common stock less attractive if we choose to rely on these exemptions. If some investors find our common stock less attractive as a result of any choices to reduce future disclosure, there may be a less active trading market for our common stock and our stock price may be more volatile.
Risks Related to Our Common Stock
We expect that our stock price will fluctuate significantly.
The trading price of our common stock may be highly volatile and could be subject to wide fluctuations in response to various factors, some of which are beyond our control. These factors include:
•actual or anticipated quarterly variation in our results of operations or the results of our competitors;
•announcements by us or our competitors of new products, significant contracts, commercial relationships or capital commitments;
•failure to obtain or delays in obtaining product approvals or clearances from the FDA or foreign regulators;
•adverse regulatory or coverage and reimbursement announcements;
•issuance of new or changed securities analysts’ reports or recommendations for our stock;
•developments or disputes concerning our intellectual property or other proprietary rights;
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•commencement of, or our involvement in, litigation;
•market conditions in the life sciences and molecular diagnostics markets;
•manufacturing disruptions;
•any future sales of our common stock or other securities;
•any change to the composition of our Board of Directors, executive officers or key personnel;
•our failure to meet applicable Nasdaq listing standards and the possible delisting of our common stock from Nasdaq;
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| our failure to meet applicable Nasdaq listing standards and the possible delisting of our common stock from Nasdaq;
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announcements by us or our competitors of significant acquisitions, strategic partnerships, joint ventures or capital commitments;
•general economic conditions and slow or negative growth of our markets; and
markets •other events or factors, including those resulting from such events, or the prospect of such events, including war, terrorism and other international conflicts, such as the recent Russian invasion of Ukraine as well as continued and any new sanctions against Russia by, among others, the United States and the European Union, which restrict a wide range of trade and financial dealings with Russia and Russia parties, public health issues including health epidemics or pandemics, such as COVID-19, and natural disasters such as fire, hurricanes, earthquakes, tornados or other adverse weather and climate conditions, whether occurring in the United States or elsewhere, any of which could disrupt our operations, disrupt the operations of our suppliers or result in political or economic instability; and
•the other factors described in this report under the caption “Risk Factors – Risks Related to Our Common Stock.”
The stock market in general, and market prices for the securities of health technology companies like ours in particular, have from time to timetime-to-time experienced volatility that often has been unrelated to the operating performance of the underlying companies. COVID-19, for example, has resulted in significant volatility in the stock market over the last several months. These broad market and industry fluctuations may adversely affect the market price of our common stock, regardless of our operating performance. In several recent situations where the market price of a stock has been volatile, holders of that stock have instituted securities class action litigation against the company that issued the stock. If any of our stockholders were to bring a lawsuit against us, the defense and disposition of the lawsuit could be costly and divert the time and attention of our management and harm our operating results.
In addition, to date our common stock has generally been sporadically and thinly traded. As a consequence, the trading of relatively small quantities of our shares may disproportionately influence the price of our common stock in either direction. The price for our common stock could decline precipitously if even a moderate amount of our common stock is sold on the market without commensurate demand.
Future sales and issuances of our common stock or rights to purchase common stock, including pursuant to our equity incentive plans, could result in additional dilution of the percentage ownership of our stockholders and could cause our stock price to fall.
We expect that significant additional capital will be needed in the future to continue our planned operations. We may sell common stock, convertible securities or other equity securities in one or more transactions at prices and in a manner we determine from time to time. If we sell common stock, convertible securities or other equity securities in more than one transaction, investors may be materially diluted by these and subsequent sales. New investors could also gain rights superior to our existing stockholders.
Pursuant to our 2014 Equity Incentive Plan (“2014 Plan”) our Board of Directors is authorized to grant stock options and other equity-based awards to our employees, directors and consultants. The number of shares available for future grant under the 2014 Plan will automatically increase on January 1 of each year by 4% of the total number of shares of our common stock outstanding on December 31 of the preceding calendar year, subject to the ability of our board of directors to take action to reduce the size of the increase in any given year. In addition, our Board of Directors approved the granting of rights to eligible employees to purchase shares of our common stock pursuant to our 2014 Employee Stock Purchase Plan (“ESPP”) beginning January 1, 2016. The number of shares of our common stock reserved for issuance under the ESPP will automatically increase on January 1 of each calendar year by the lesser of 1% of the total number of shares of our common stock outstanding on December 31 of the preceding calendar year and 195,000 shares, subject to the ability of our Board of Directors to take action to reduce the size of the increase in any given year. Currently, we plan to register the increased number of shares available for issuance under the 2014 Plan and ESPP each year. Increases in the number of shares available for future grant or purchase may result in additional dilution, which could cause our stock price to decline.
Sales of a substantial number of shares of our common stock in the public market could cause our stock price to fall.
Sales of a substantial number of shares of our common stock in the public market or the perception that these sales might occur, could depress the market price of our common stock and could impair our ability to raise capital through the sale of additional equity securities. We are unable to predict the effect that sales may have on the prevailing market price of our common stock.
If securities or industry analysts do not publish research reports about our business, or if they issue an adverse opinion about our business, our stock price and trading volume could decline.
The trading market for our common stock will be influenced by the research and reports that industry or securities analysts publish about us or our business. If one or more of the analysts who cover us issues an adverse opinion about our company, our stock price would likely decline. If one or more of these analysts ceases coverage of us or fails to regularly publish reports on us, we could lose visibility in the financial markets, which in turn could cause our stock price or trading volume to decline.
If we are unable to continue to satisfy the applicable continued listing requirements of Nasdaq, our common stock could be delisted.
Our common stock is currently listed on The Nasdaq Capital Market under the symbol “HTGM.” In order to maintain this listing, we must continue to satisfy minimum financial and other continued listing requirements and standards. There can be no assurance that we will be able to continue to comply with the applicable listing standards. If we were not able to comply with applicable listing standards, our shares of common stock would be subject to delisting. The delisting of our common stock from trading on Nasdaq may have a material adverse effect on the market for, and liquidity and price of, our common stock and impair our ability to raise capital. Delisting from Nasdaq could also have other negative results, including, without limitation, the potential loss of confidence by customers and employees, the loss of institutional investor interest and fewer business development opportunities. In the event that our common stock is delisted from Nasdaq and is not eligible for quotation or listing on another market or exchange, trading of our common stock could be conducted only in the over-the-counter market or on an electronic bulletin board established for unlisted securities such as the Pink Sheets or the OTC Bulletin Board. In such event, it could become more difficult to dispose of, or obtain accurate price quotations for, our common stock, and there would likely also be a reduction in our coverage by securities analysts and the news media, which could cause the price of our common stock to decline further.
Future sales and issuances of our common stock or rights to purchase common stock, including pursuant to our equity incentive plans, could result in additional dilution of the percentage ownership of our stockholders and could cause our stock price to fall.
We expect that significant additional capital will be needed in the future to continue our planned operations. We may sell common stock, convertible securities or other equity securities in one or more transactions at prices and in a manner we determine from time to time. If we sell common stock, convertible securities or other equity securities in more than one transaction, investors may be materially diluted by these and subsequent sales. New investors could also gain rights superior to our existing stockholders.
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Pursuant to our 2020 Equity Incentive Plan (“2020 Plan”), we are authorized to grant stock options and other equity-based awards to our employees, directors and consultants. Pursuant to our 2021 Inducement Plan (“Inducement Plan”), we are authorized to grant up to 300,000 shares to new employees as inducements material to such new employees entering into employment with us. The number of shares which may be granted under the Inducement Plan may be increased in the future by our board of directors without stockholder approval. In addition, our amended and restated 2014 Employee Stock Purchase Plan (“ESPP”) authorizes us to offer, sell and issue shares to our employees. Increases in the number of shares available for future grant or purchase may result in additional dilution, which could cause our stock price to decline.
We do not intend to pay dividends on our common stock in the foreseeable future.
We have never declared or paid any cash dividend on our common stock. We currently anticipate that we will retain future earnings for the development, operation and expansion of our business and do not anticipate declaring or paying any cash dividends for the foreseeable future. In addition, our ability to pay cash dividends is currently prohibited by the terms of our debt facility, and any future debt financing arrangement may contain terms prohibiting or limiting the amount of dividends that may be declared or paid on our common stock. Any return to stockholders will therefore be limited to the appreciation of their stock.
Provisions in our amended and restated certificate of incorporation and bylaws, as well as provisions of Delaware law, could make it more difficult for a third-party to acquire us or increase the cost of acquiring us, even if doing so would benefit our stockholders or remove our current management.
Some provisions of our charter documents and Delaware law may have anti-takeover effects that could discourage an acquisition of us by others, even if an acquisition would be beneficial to our stockholders and may prevent attempts by our stockholders to replace or remove our current management. These provisions include:
•authorizing the issuance of “blank check” preferred stock, the terms of which may be established and shares of which may be issued without stockholder approval;
•limiting the removal of directors by the stockholders;
•creating a staggered board of directors;
•prohibiting stockholder action by written consent, thereby requiring all stockholder actions to be taken at a meeting of our stockholders;
•eliminating the ability of stockholders to call a special meeting of stockholders; and
•establishing advance notice requirements for nominations for election to the board of directors or for proposing matters that can be acted upon at stockholder meetings.
These provisions may frustrate or prevent any attempts by our stockholders to replace or remove our current management by making it more difficult for stockholders to replace members of our Board of Directors, which is responsible for appointing the members of our management. In addition, we are subject to Section 203 of the Delaware General Corporation Law, which generally prohibits a Delaware corporation from engaging in any of a broad range of business combinations with an interested stockholder for a period of three years following the date on which the stockholder became an interested stockholder, unless such transactions are approved by our Board of Directors. This provision could have the effect of delaying or preventing a change of control, whether or not it is desired by or beneficial to our stockholders. Further, other provisions of Delaware law may also discourage, delay or prevent someone from acquiring us or merging with us.
Our amended and restated certificate of incorporation and amended and restated bylaws provide that the Court of Chancery of the State of Delaware is the exclusive forum for certain disputes between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers, or employees.
Our amended and restated certificate of incorporation and our amended and restated bylaws provide that, unless we consent in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware shall, to the fullest extent permitted by law, be the sole and exclusive forum for (1) any derivative action or proceeding brought on our behalf; (2) any action asserting a claim of breach of a fiduciary duty owed by any of our directors, officers or other employees to us or our stockholders; (3) any action asserting a claim against us or any of our directors or officers or other employees arising pursuant to any provision of the Delaware General Corporation Law, our amended and restated certificate or our amended and restated bylaws; and/or (4) any action asserting a claim against us or any of our directors or officers or other employees governed by the internal affairs doctrine. The foregoing provisions do not apply to actions brought to enforce a duty or liability created by the Securities Act or the Exchange Act, or any other claim for which the federal courts have exclusive jurisdiction.
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These exclusive forum provisions may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with us or our directors, officers, or other employees, which may discourage lawsuits against us and our directors, officers and other employees. If a court were to find the exclusive forum provision in our governing documents to be inapplicable or unenforceable in an action, we may incur further significant additional costs associated with resolving the dispute in other jurisdictions, all of which could seriously harm our business.
General Risk Factors
Sales of a substantial number of shares of our common stock in the public market could cause our stock price to fall.
Sales of a substantial number of shares of our common stock in the public market or the perception that these sales might occur, could depress the market price of our common stock and could impair our ability to raise capital through the sale of additional equity securities. We are unable to predict the effect that sales may have on the prevailing market price of our common stock.
If we fail to maintain proper and effective internal controls, our ability to produce accurate consolidated financial statements on a timely basis could be impaired.
We are subject to the reporting requirements of the Exchange Act, the Sarbanes-Oxley Act and the rules and regulations of The Nasdaq Stock Market (“Nasdaq”). The Sarbanes-Oxley Act requires, among other things, that we maintain effective disclosure controls and procedures. Internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of consolidated financial statements in accordance with accounting principles generally accepted in the United States of America (“GAAP”). We have performed system and process evaluation and testing of our internal control over financial reporting to allow management to report annually on the effectiveness of our internal control over financial reporting, as required by Section 404 of the Sarbanes-Oxley Act. This has required and will require that we incur substantial professional fees and internal costs to augment our accounting and finance functions and that we expend significant management efforts as we continue to make this assessment and ensure maintenance of proper internal controls on an ongoing basis.
If we are not able to comply with the requirements of Section 404 of the Sarbanes-Oxley Act in a timely manner, or if we fail to establish and maintain proper and effective internal control over financial reporting, we may not be able to produce timely and accurate consolidated financial statements, and our ability to accurately report our financial results could be adversely affected. If that were to happen, the market price of our stock could decline, and we could be subject to sanctions or investigations by Nasdaq, the SEC or other regulatory authorities.
In addition, for so long as we remain a non-accelerated filer, our independent registered public accounting firm will not be required to attest to the effectiveness of our internal control over financial reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act. An independent assessment of the effectiveness of our internal controls could detect problems that our management’s assessment might not. Undetected material weaknesses in our internal controls could lead to financial statement restatements and require us to incur the expense of remediation.
If securities or industry analysts do not publish research reports about our business, or if they issue an adverse opinion about our business, our stock price and trading volume could decline.
The trading market for our common stock will be influenced by the research and reports that industry or securities analysts publish about us or our business. If one or more of the analysts who cover us issues an adverse opinion about our company, our stock price would likely decline. If one or more of these analysts ceases coverage of us or fails to regularly publish reports on us, we could lose visibility in the financial markets, which in turn could cause our stock price or trading volume to decline.
None.
Item 2. Properties.Properties.
Our corporate facilities are comprised of 30,10037,100 square feet of administrative, laboratory and manufacturing spaces located in Tucson, Arizona. We occupy these facilities pursuant to two separate leases. TheFollowing its amendment in January 2019, which amended the lease to add approximately 7,000 square feet of additional administrative, manufacturing and laboratory space effective August 2019, the first lease concerns 17,50024,500 square feet housing our administrative, manufacturing, and lab services facilities. The second lease concerns 12,600 square feet of space used for our research and development facilities.
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We first amended these leases in August 2015 to, among other things, align and extend the lease terms to expire in January 2021. In connection withUpon amendment of the first lease termin 2019, the lease for the additional space was aligned to this January 2021 expiration. In December 2020, the leases were again amended to extend their terms for one additional year, through January 2022 and again in September 2021 to extend the terms of the leases for three years, through January 31, 2025. The lease extension allows for an additional extension of two years upon the landlord agreed to perform certain capital improvements to expandsame terms and improveconditions of the existing manufacturing facilities. In addition,amended lease agreements, except that lease rates would be adjusted to rates applicable to like-kind buildings within the market at the time we completedelect to exercise the expansion and improvement of our administrative and research and development facilities, resultingextension option, but in no event to less than the capitalization of additional leasehold improvements in 2016, which will be amortized over the remaining life of the lease.last applicable rental rate. Base rent payable is currently approximately $24,000 per month and $16,000 per month, respectively, under the first lease is approximately $27,000 per month, and base rent payable under the second lease is approximately $16,000 per month,leases, in each case for the remaining terms of the respective leases. The aggregate rents payable over the renewal term of the amended first lease represent an increase of $804,000, over the prior term rental rates for a five-year period. The amended second lease specified no rent increase over the prior term and the annual rent increases for the applicable space were eliminated.
In January 2019, we further amended the first lease to add approximately 7,000 square feet of additional administrative, manufacturing and laboratory space, effective August 15, 2019, and continuing through expiration of the lease in January 2021. In connection with this lease amendment, the landlord has agreed to fund certain leasehold improvements, of which approximately $22,000 was incurred through December 31, 2019, which will be amortized over the shorter of the useful life of the leasehold improvements or the remaining lease term. Base rent for the additional leased space will be approximately $6,800 per month, excluding reimbursement of landlord funded improvements, commencing on the date of occupancy and extending through the remaining term of the lease. Our landlord holds security deposits equal to a total of approximately $30,000. We expect to renew our Tucson leases on or before their expiration on terms similar to the expiring leases.
We also lease 4,800 square feet of administrative and development laboratory space in San Carlos, California, which we took occupancy on in April 2019. The initial term of this lease is 48 months, to expire in March 2023, with the option to extend the term for an additional 12 months. Base rent payable under this lease increases approximately 3% per year over the term of the lease from $21,600 per month in the first year to $23,616 per month in the final year of the lease, plus reimbursement of operating expenses to the landlord. Our landlord also holds a security deposit of $50,000 for this facility.
We believe that our existing facilities are adequate to meet our business requirements for the reasonably foreseeable future and that additional space will be available on commercially reasonable terms, if required.
Item 3. Legal Proceedings.
We are not engaged in any material legal proceedings. However, in the normal course of business, we may from time to time be named as a party to legal claims, actions and complaints, including matters involving employment, intellectual property others. Although we anticipate that we will continue to incur legal fees in the coming periods to defend our intellectual property rights, we do not believe that there are any claims or actions pending against us currently, the ultimate disposition of which could have a material adverse effect on our consolidated results of operation, financial condition or cash flows.
Item 4. Mine Safety Disclosures.
Not applicable.
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PART II
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities.
Market Information
Our common stock is traded on The Nasdaq Capital Market under the symbol “HTGM.” Trading of our common stock on The Nasdaq Stock Market commenced on May 6, 2015 in connection with our initial public offering.
On March 2, 2020,15, 2023, the last reported sale price of our common stock was $0.55$3.10 per share.
Holders
As of March 2, 2020,15, 2023, there were approximately 15157 registered holders of record of our common stock. The actual number of stockholders is greater than this number of record holders and includes stockholders who are beneficial owners but whose shares are held in street name by brokers and other nominees.
Dividends
We have never declared or paid any cash dividends on our common stock. We anticipate that we will retain all available funds and any future earnings, if any, for use in the operation of our business and do not anticipate paying cash dividends in the foreseeable future. In addition, our term loan agreementthe Loan Agreement materially restricts, and future debt instruments we issue may materially restrict, our ability to pay dividends on our common stock. Payment of future cash dividends, if any, will be at the discretion of the board of directors after considering various factors, including our financial condition, operating results, current and anticipated cash needs, the requirements of current or then-existing debt instruments and other factors the board of directors deems relevant.
Item 6. Selected Financial Data.Reserved.
We are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and are not required to provide the information otherwise required under this item.
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Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
You should read the following discussion and analysis together with our consolidated financial statements and related notes included elsewhere in this Annual Report. The following discussion contains forward-lookingstatements that involve risks and uncertainties. Our actual results could differ materially from those expressed or implied in any forward-looking statements due to various factors, including those set forth under the caption “Item 1A. Risk Factors.” All forward-looking statements included in this Annual Report are based on information available to us as of the time we file this Annual Report and, except as required by law, we undertake no obligation to update publicly or revise any forward-looking statements. In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this Annual Report, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain.
OverviewIn December 2022, we completed a reverse stock split of our outstanding shares of common stock pursuant to which every 12 shares of issued and outstanding common stock were exchanged for one share of common stock. All share and per share amounts within this Annual Report have been adjusted to reflect the reverse stock split for all periods and dates presented.
Overview
We are a commercial stage RNA platform-based life sciences company focused on advancing the promiseprecision medicine and drug discovery through our innovative transcriptome-wide profiling and advanced drug discovery platform technologies. Building on more than a decade of precision medicine. Our product and service solutions are based onpioneering innovation, our proprietary next-generation HTG EdgeSeq technology is the basis for our tech-driven hybrid business model allowing our RNA molecular profiling applications to be more effective, efficient and relevant and also serving as a key component of the engine behind our platform-based drug discovery process. Central to our business strategy is our drug discovery engine, which uses our captive transcriptomic profiling capabilities combined with a proprietary medicinal chemistry machine learning platform to render an AI-driven drug candidate optimization platform. We are using this platform to innovate drug discovery with the goal of building best-in-class molecules for known pharmacologic targets across multiple disease areas, better, faster and in a more cost-effective manner.
The training data sets for our machine learning platform utilize our own primary data generated specifically for this purpose. This high quality, standardized data provides a clear advantage over other platform approaches which are typically dependent upon publicly available data. The medicinal chemistry portion of our platform allows for rapid design and in silico evaluation of large chemical libraries in order to prioritize and select compounds for synthesis and advancement into early testing. These data are then integrated and processed into an iterative loop using a series of proprietary machine learning algorithms prior to further advancing the molecules to more traditional drug discovery studies. We expect that enables fullthis will allow for rapid identification, selection and optimization of drug candidates for entrance into development. Further, we believe that our ability to rapidly iterate between primary data and computational analyses gives us valuable information and insights for candidate molecule design and selection.
To date, we have used our transcriptome-informed drug discovery engine to develop an early pipeline of drug candidate molecules for two known pharmacologic targets, both of which can target several potential therapeutic indications, but with a current focus on oncology and neurodegenerative diseases. We believe that our technology provides a differentiated and potentially disruptive approach to drug discovery, that may allow ourselves and our partners to potentially improve upon key attrition factors, namely efficacy and toxicity, early in the discovery process, thereby allowing for better chances for candidate success when entering development.
Our business strategy is to build our drug discovery pipeline in order to out-license certain drug candidates and carry other candidates into preclinical and early development ourselves. In addition, we would expect to retain and potentially capitalize upon CDx rights through the clinical development and commercialization of these assets where appropriate.
We also operate a profiling business in life science tools. Our profiling product and service solutions enable targeted RNA profiling using a small amount of biological sample, in liquid or solid forms. Our menu of HTG EdgeSeq assays, including our HTP, which has been designed to measure approximately 20,000 mRNA targets using our HTG EdgeSeq technology, is automated on our HTG EdgeSeq platform,system, which applies genomic sequencingNGS tools, that generateenabling the generation of gene expression data in a timely manner utilizing aour simplified workflow for customers.workflow. We seek to leverage key business drivers in molecular profiling for biomarker analysis and diagnostics, including the acceleration of precision medicine, the migration of molecular testing to NGS-based applications, the movement to smaller and less invasive biopsies, the need for greater diagnostic sensitivity, the need to conform to challenging healthcare economics and the need for automation and an easily deployable workflow, including simplified bioinformatics. For example, theseThese capabilities enable customers to extend the use of limited biological samples for retrospective or prospective analysis, gaining further understanding of the molecular drivers of disease with the goal of developing biomarker-driven targeted therapies. We also believe our HTG EdgeSeq technology can be used as a platform technology in clinical applications that will simplify, consolidate and reduce the cost of NGS-based diagnostic workflows and in commercialized CDx tests.
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Our existing products include instrumentation,instruments, consumables including assay kits, and software that, as an integrated system,platform, automate sample processing and can quickly, robustly and simultaneously profile hundreds, thousands or tens hundreds orof thousands of molecular targets from samples which are a fraction of the size required by many prevailing technologies. Our objective is to establish our solutions as the standard in molecular profiling, companion diagnostic development and molecular diagnostics, and to make their benefits accessible to all molecular labs from research to the clinic. We believe that our target customers desire high quality molecular profiling information in a multiplexed panel format from increasingly smaller and less invasive samples, with the ability to test and analyze such information locally to minimize turnaround time and cost.
In 2014, we launched our HTG EdgeSeq technology, which generates a molecular profiling library for gene expression profiling using NGS. Our HTG EdgeSeq assays are automated on our HTG EdgeSeq platform. Our innovative platform and menu of molecular profiling panels are being utilized in two complimentary ways in advancing precision health. Biopharmaceutical companies and other translational research centers utilize our technology to discover and validate biomarkers and develop molecular subtypes, which can identify patient populations most likely to respond to certain therapies. In addition to purchasing our technology for use in customer facilities, customers can also obtain the advantages of our proprietary technology through our service offerings. Pre-clinical services, including custom assay development and sample processing services provided by our Tucson-based VERI/O laboratory, allow customers the ability to more efficiently identify and validate biomarker signatures across their drug portfolios or patient cohorts. Our ISO 13485 2016 quality system and diagnostic development teams also partner with biopharmaceutical company customers to develop, manufacture and commercialize companion diagnostics. Although our initial focus is oncology, we offer customers a full solution from biomarker discovery to deployment of CDx tests across all disease states. Utilizing NGS as our method of detection provides our customers with the benefits of our highly multiplexed and extraction-free chemistry and the sensitivity and dynamic range of the sequencers, providing a powerful value proposition and complete workflow.
We have two primary sources of revenue: product and product-related services revenue from the sale of research use only (“RUO”) and CE/IVD marked profiling products, sample processing services and custom assay development services to biopharmaceutical companies, academic research centers and molecular testing laboratories; and revenue from collaborative development services for companion diagnostic development programs for biopharmaceutical companies.
Profiling product and product-related services revenue includes customer purchases of our HTG EdgeSeq instrument and related assay kits, development of custom RUO assay kits for customers and the use of our HTG EdgeSeq instrument and RUO assay kits to process samples on the customer’s behalf in our VERI/O laboratory. In addition, as of December 31, 2019, we sell two internally developed proprietary CE/IVD marked assays, including our HTG EdgeSeq DLBCL Cell of Origin Assay EU and HTG EdgeSeq ALKPlus Assay EU.
Collaborative development revenue relates to services performed using our HTG EdgeSeq proprietary technology to develop, seek regulatory approval for and commercialize companion diagnostic assays for biopharmaceutical drug candidates and corresponding therapeutics. Collaborative development services revenue generated to date has primarily related to three statements of work entered into under our Governing Agreement with QML. In November 2019, we terminated the Governing Agreement, effective immediately, as a result of QML’s material breach of the Governing Agreement, including QML’s failure to develop an IVD version of its GeneReader. Our termination of the Governing Agreement did not terminate active statements of work under the Governing Agreement. On future agreements, we may choose to develop companion diagnostic products independently or with a collaboration partner.
Our business currently reflects a laboratory services and collaborative development services-oriented revenue model. However, we anticipate that this will be a catalyst toward an emerging product-based strategy in the long-term as additions to our diagnostic panel menu are expected to increase the demand for our instrument and consumables products in individual laboratories and customer locations.
We have incurred significant losses since our inception, and we have never been profitable. We incurred net losses of $19.3 million and $16.5 million for the years ended December 31, 2019 and 2018, respectively, and had an accumulated deficit of $170.3 million as of December 31, 2019. As of December 31, 2019, we had available cash and cash equivalents totaling approximately $7.6 million, investments in short-term available-for-sale securities totaling $25.4 million and had current liabilities of approximately $8.9 million and long-term liabilities of approximately $12.3 million, primarily attributable to our MidCap Term Loan and NuvoGen obligations. We believe that our existing resources will be sufficient to fund our planned operations for at least the next 12 months from the issuance of these consolidated financial statements included elsewhere in this report. However, we cannot provide assurances that our plans will not change or that changed circumstances will not result in the depletion of our capital resources more rapidly than we currently anticipate.
Recent Developments
In January 2020, we received a European patent grant notification for our methods for subtyping diffuse large B-cell lymphoma, effective October 2019. We were previously granted a patent for this technology in the United States in 2018. We also appeared in two significant peer-reviewed publications, Cell and Nature. The total number of publications referencing our HTG EdgeSeq technology, including these peer-reviewed publications is now over 140 as of December 31, 2019.
From January 1, 2020 through March 15, 2020, we sold 4,399,062 shares of our common stock under the 2019 ATM Offering (see Note 14 with Cantor Fitzgerald at then-market prices for total gross proceeds of approximately $2.6 million. After deferred offering costs and sales commissions owed in connection with the 2019 ATM Offering, our aggregate net proceeds through March 15, 2020 were approximately $2.5 million.
In February 2020, we entered into an Exchange and Purchase Agreement with certain accredited investors (the “Investors”) pursuant to which we agreed to (i) issue to the Investors an aggregate of 41,100 shares of its newly designated Series A Convertible Preferred Stock, par value $0.001 per share (“Series A Preferred”), in exchange for the Investors surrendering for cancellation an aggregate of 4,110,000 shares of its common stock (the “Exchange”) and (ii) sell and issue to the Investors an aggregate of 10,170 shares of Series A Preferred for an aggregate purchase price of $600,030, or $59.00 per share (the “Private Placement”), both of which were completed prior to the end of February 2020.
In February 2020, we amended our MidCap Term Loan and MidCap Revolving Loan agreements to (i) extend the interest only payments on the term loan advances by an additional 11 months, with principal on each term loan advance payable in 25 equal monthly installments beginning March 1, 2021 until paid in full on March 1, 2023, with the ability to further extend the interest-only period by an additional four months if we achieve a stated revenue milestone for the 12-month period ending on December 31, 2020; (ii) permit the use of the $3.3 million of escrowed funds previously deposited by us for repayment of the QNAH Convertible Note, subject to certain limitations; and (iii) to include a grant of a security interest in our intellectual property, effective as of the date of the amendments.
In March 2020, we entered into a purchase agreement ("LP Purchase Agreement") with Lincoln Park Capital Fund, LLC ("Lincoln Park") pursuant to which, upon the terms and subject to the conditions and limitations set forth therein, we have the right to sell to Lincoln Park up to $20,000,000 of shares of our common stock (“Purchase Shares”) from time to time over the 36-month term of the LP Purchase Agreement. The purchase price of the Purchase Shares will be based on recent closing prices of our common stock at the time of sale. We issued Lincoln Park an aggregate of 615,384 shares of our common stock as consideration for their purchase commitment pursuant to the LP Purchase Agreement.
Factors Affecting our Performance
We believe that our future results of operations are dependent on several additional factors discussed below. While each of these areas present significant opportunities for us, they also pose significant risks and challenges that we must successfully address. See the section entitled “Risk Factors” for further discussion of these risks.
Biopharmaceutical Biomarker and Companion Diagnostic Solutions
Biopharmaceutical companies are continually working to improve the efficacy of their drug development process and the safety and efficacy of their drugs. We believe that our technology can support these initiatives by providing a seamless solution from biomarker discovery to a commercialized companion diagnostic test that can be used to assist clinicians in confidently prescribing these drugs to their patients. Our products and service solutions allow us to partner with our biopharmaceutical company customers to identify molecular biomarkers that can help determine which patients are most likely to benefit from a particular drug, validate these biomarkers in clinical trials and partner to commercialize the validated CDx assay. Customers can access our technology by purchasing our platformHTG EdgeSeq system and assays for their internal use or by engaging us to perform certain services,through our Tucson, Arizona-based VERI/O service laboratory, including molecular profiling of respective cohorts in our VERI/O laboratory and development of custom RUO panels to support early stageearly-stage clinical programs IUOand investigational-use-only assays for clinical trials or companion diagnostic assays for approved drugs.trials. However, with the release of our HTP, revenue from our RUO assay design services is expected to be lower than historical levels, as our RUO assay design services revenue is replaced by HTP consumables purchases and sample processing laboratory services using our HTP. Our product and service solutions have providedenabled us withto access a growing number of early stageearly-stage biomarker discovery programs andprograms. We believe this approach will enable new opportunities to collaboratecollaborating with biopharmaceutical companies in their future drug development programs.
Our Drug Discovery Approach
In June 2021, we announced the formation of HTG Therapeutics, with the addition of several highly experienced drug development professionals to our leadership team. Throughout 2021, we strengthened our HTG EdgeSeq technology platform and added new profiling capabilities, including epitranscriptomic profiling, which currently provides the capability to generate over 40,000 biological data points from each experimental sample. By leveraging these profiling technologies in the drug discovery process, integrated with an advanced AI and machine learning-based medicinal chemistry approach, we have established a novel transcriptome-informed small molecule discovery engine at the core of our HTG Therapeutics business modelunit which we believe will generate drug candidate molecules that are intrinsically lower risk and will have greater potential for clinical development success when compared to currently existing early-stage drug discovery methods in the biopharmaceutical industry. We further expect that this approach to small molecule discovery can be applied agnostically across therapeutic areas and is structured to allowscalable and flexible, allowing us to captureadapt our strategic and therapeutic focus rapidly as new information emerges on the pathogenesis of diseases.
We believe that our approach will potentially provide multiple revenue at each stageopportunities, including collaboration or out-licensing arrangements for small molecule drug candidates we generate from as early as lead optimization through early preclinical development, the out-licensing of our technology to pharmaceutical companies to enable them to implement our advanced drug discovery approach into their own internal discovery efforts, and potentially new companion diagnostic opportunities to support the related clinical development programs for molecules that are brought forward through this novel discovery approach.
In the first half of 2022, we released a series of white papers after demonstrating the utility of our proprietary technologies as a key component of our novel transcriptome-informed drug discovery and design approach and applying the approach to our initial therapeutic target. As anticipated, the results of our studies summarized in these white papers supported our approach and its ability to reveal indication-specific effects and potential undesirable effects in our first target through analysis of transcriptomic profiles from compound-treated human cell line test systems.
Throughout the second half of 2022, we continued to work to strengthen our drug discovery core platform technology, including advancing the machine learning component of our platform with the refinement of key proprietary algorithms while continuing to generate our own internal data supporting training sets. In addition, we made capital investments to establish internal cell culture capabilities to support the expansion of our cell-based test system models. Our medicinal chemistry effort has produced a series of chemical libraries for our first target, and our most advanced library for this target has entered preclinical characterization, with a series of data generated including early efficacy in two different disease states.
As a result of the progress made throughout 2022, we filed a patent application in December 2022, which included claims directed toward specific compounds, pharmaceutical compositions and methods of treating or preventing disease by administration of the compounds. Our initial therapeutic pipeline is focused on oncology and degenerative neuroscience, emphasizing pharmacologic targets with understood roles in the progression of diseases in these areas.
The most advanced discovery program in oncology is a small molecule program for treatment of liquid tumors. We expect to continue lead optimization of this program through the end of the first quarter of 2023, with advancement to support entry into preclinical development later in the year. HTG Therapeutics has a second oncology directed small molecule program for the treatment of a solid tumor type that is nearing completion in the hit-to-lead discovery phase, with lead optimization efforts planned through the second quarter of 2023 and subsequent preparation for potential preclinical development expected by the end of 2023. In our neuroscience pipeline, we have completed early discovery stage efforts and chemical library generation for candidate small molecules for application to neurodegenerative conditions which are expected to enter the hit-to-lead phase in the second half of 2023.
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We expect to initiate several early discovery-stage programs evaluating small molecule candidates against a variety of different cancers, from which we plan to select candidates for additional indications to continually expand our drug discovery pipeline. As additional candidates are identified, we may choose to retain certain candidates internally to be advanced through early development, lifecycle with the highestintention to increase the value of these pipeline assets before moving to license or partner for further development. In parallel to these therapy-area specific programs, we continue to enrich the proprietary dataset that supports our transcriptome-informed drug discovery platform and to evolve and refine the complementary AI and machine learning portions of our drug discovery engine throughout these discovery processes. Finally, we would expect to maintain the exclusive rights and the opportunity to solely develop new CDx assays relating to these drug candidates as they move through the increasingly advanced stages of development with our future collaboration partners, further growing our existing gene expression profiling business.
Revenue and Commercialization of our Profiling Products
We believe the future financial performance of our profiling business will continue to be driven by adoption and utilization of our HTG EdgeSeq instruments and consumables, and an overall increase in the formnumber and type of a drug linked companion diagnostic as the ultimate objective.
Customer Adoption of HTG Technology
Todaycustomers using our technology. As such, we believe the primary measures of adoption for our profiling technology are the number of total active customers, the number of active programs in our biopharmaceutical company customer pipeline, the number of total active customersinstruments actively producing revenue in our installed base and revenue growth relating to new and existing customers. InTotal active customers and active installed base reflect customers and instruments that have generated revenue for the future,Company within the last 12 months. To be included in our active programs metric, a program needs to be associated with a pharma sponsored clinical trial, be traceable to a program on clinicaltrials.gov and have generated revenue for the Company within the last 12 months. As of December 31, 2022, we expect increased saleshad 78 active customers, 73 active programs and 42 instruments actively producing revenue in our installed base, compared with 82 active customers, 62 active programs and 51 instruments actively producing revenue in our installed base as of December 31, 2021.
Our profiling business continues to experience the ripple effects of the COVID-19 pandemic and has not yet recovered to pre-pandemic revenue levels, as seen in a year over year decrease in two out of three of the metrics discussed above, active customer base and active instruments. This trend reflects the continued challenge of the significant reduction of and delay in clinical trial activities during the pandemic generating lower quantities of retrospective samples for testing, budget reductions, labor shortages and supply chain issues being faced by a number of our productscustomers. In response to these trends, our focus has shifted to the quality and services as we add new proprietary panels tosustainability of future revenue, including higher revenue per sample, larger cohorts and minimum batch sizes for service in our product menu and as additional European customers adopt our existing assays or custom assays for use in clinical diagnostic testing. While our current customer mix is dominated by biopharmaceutical company customers, we expect to see growth in clinical diagnostic labs as we commercialize companion diagnostic assays from the collaborative development services programs and as biomarker strategies are validated through our partnerships with key opinion leaders in Europe.
Our ability to increase instrument and consumable revenue depends on several factors, including (i) adoption of our HTG EdgeSeq platforms by our customer base, including increasing market share for our proprietary panels for the research market; (ii) the efforts of our sales and marketing teams to demonstrate the utility of our products and technology; (iii) our ability to develop and market novel molecular profiling panels designed to meet customer needs, including unmet medical needs; (iv) our ability to demonstrate the benefits of our products to key opinion leaders so they publish information supporting those benefits; (v) pricing and reimbursement; (vi) our ability to expand the addressable market of our HTG EdgeSeq platform through the development of new applications; (vii) our product capabilities compared with competition; and (viii) successful outcomes to our companion diagnostic collaborations.VERI/O laboratory. Given the length of our profiling business sales cycle we have experienced historically,and ongoing concerns regarding the economy throughout our industry, we expect to continue to see fluctuations in our instrument and consumables salesprofiling revenue on a period-to-period basis.basis despite our ongoing focus on continuing to identify new opportunities to effectively commercialize our profiling technology and seek expanded commercial partnering channels. As a result of these profiling revenue trends, we have taken actions to reduce operating expenses and minimize the impact of reduced revenue on our operating loss and cash utilization, including a significant reduction in force late in the second quarter of 2022. We will continue to make appropriate operating adjustments in support of what we believe will be a quickly evolving, best-in-class drug discovery company and our existing gene expression profiling business.
A key element of increasing adoption of our technology is our assay and panel menu available for use by our customers on the HTG EdgeSeq. To sell additional instruments, grow our installed base and drive larger consumable annuities2022 Equity Financings
In March 2022, we must develop and commercialize new assays and addentered into a Securities Purchase Agreement (the “March 2022 Securities Purchase Agreement”) with a single investor pursuant to which we agreed to issue to the utilityinvestor 270,415 units at a price of existing panels by expanding applications$27.744 per unit (less $0.012 for each pre-funded warrant purchased in lieu of a share of common stock) for net proceeds, after deducting the placement agent fees and other fees and expenses, of approximately $7.0 million. Each unit consisted of one share of common stock (or one pre-funded warrant in lieu thereof), a common warrant to purchase one share of common stock with a term of 24 months from the issuance date, and a common warrant to purchase one share of common stock with a term of 66 months from the issuance date. Each of the common warrants became exercisable commencing on our REVEAL software. Our arrangementsSeptember 21, 2022 and has an exercise price of $24.744 per share. Each pre-funded warrant had an exercise price of $0.012 per share. May 2022, the 200,911 pre-funded warrants were exercised for proceeds of $2,411.
In December 2022, in connection with biopharmaceutical companies are expecteda best-efforts public offering, we entered into a Securities Purchase Agreement (the "December 2022 Securities Purchase Agreement") with a certain institutional investor, pursuant to generate new menu items in addition to our diagnostic development strategies in immuno-oncologywhich we issued and next-generation pathology. We will remain focused on high quality instrument placements and consumable pull through as the primary indicators of future commercial adoption and success in our business.
Timing and effectiveness of research and development expenses
Our spending on collaboration-based research and development may vary substantially from period to period duesold to the natureinvestor 1,290,322 units at a combined public offering price of $7.75 per share (less $0.001 for each pre-funded warrant purchased in lieu of a share of common stock) for net proceeds, after deducting the placement agent fees and timingexpenses and other fees and expenses, of biopharmaceutical company drug development processes and the development effort involvedapproximately $8.7 million. Each unit consisted of one share of common stock (or one pre-funded warrant in reaching key milestones under our companion diagnostic development agreements. Costs from our collaborative development services programs, including but not limitedlieu thereof), a common warrant to the quantitypurchase one share of HTG EdgeSeq assay kits and instruments, third-party sequencing equipment and third-party or internal labor required to complete development milestones, allcommon stock with a term of which are expensed to research and development expense in our consolidated statements of operations, can vary significantly from one development stage to the next. Expenses associated with our ongoing proprietary product research and development efforts are carefully managed and are standardized under our stage-gate-based new product development methodology. Program progress and priorities are assessed by time, quality and adherence to budgetary metrics at each phase of the product development.
Potential Impact of the COVID-19 Pandemic
Significant uncertainty remains as to the potential impact of the COVID-19 pandemic on our operations, and on the global economy as a whole. However, we believe it is likely that the COVID-19 pandemic will have a negative impact on our product and product-related services revenue and collaborative development services revenue in 2020. We believe this negative impact will be primarily demand-side driven as our customers experience disruptions in their own businesses24 months from the pandemic. However, it is possible thatissuance date, and a common warrant to purchase one share of common stock with a term of 60 months from the COVID-19 pandemic will also impact our workforce, supply chains or distribution networks or otherwise impact our ability to conduct sample processing services and custom assay development services and our ability to provide collaborative development servicesissuance date. Each of these common warrants has an exercise price of $7.50 per share. In December 2022, the 1,188,322 pre-funded warrants were exercised for companion diagnostic development programs. proceeds of $1,188.
61
Financial Operations Overview and Consolidated Results of Operations
Comparison of the Years Ended December 31, 20192022 and 20182021
| | | Years Ended December 31, | | | Change | | | | | | | | | | | | | | | | | |
| | | 2019 | | | 2018 | | | $ | | | % | | | | Years Ended December 31, | | | Change | |
Revenue: | | | | | | | | | | | | | | | | | | |
Product and product-related services | | | $ | 14,632,204 | | | $ | 9,121,390 | | | $ | 5,510,814 | | | | 60 | % | |
Collaborative development services | | | | 4,571,684 | | | | 12,382,504 | | | | (7,810,820 | ) | | | (63 | %) | |
Total revenue | | | | 19,203,888 | | | | 21,503,894 | | | | (2,300,006 | ) | | | (11 | %) | |
| | | 2022 | | | 2021 | | | $ | | | % | |
Product and product-related services revenue | | | $ | 6,366,220 | | | $ | 8,906,828 | | | $ | (2,540,608 | ) | | | (29 | %) |
Operating expenses: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Cost of product and product-related services revenue | | | | 8,911,372 | | | | 5,090,475 | | | | 3,820,897 | | | | 75 | % | | | 4,572,134 | | | | 4,094,980 | | | | 477,154 | | | | 12 | % |
Selling, general and administrative | | | | 18,682,396 | | | | 19,974,616 | | | | (1,292,220 | ) | | | (6 | %) | | | 15,841,790 | | | | 16,546,740 | | | | (704,950 | ) | | | (4 | %) |
Research and development | | | | 10,570,225 | | | | 12,598,034 | | | | (2,027,809 | ) | | | (16 | %) | | | 6,781,892 | | | | 6,088,934 | | | | 692,958 | | | | 11 | % |
Total operating expenses | | | | 38,163,993 | | | | 37,663,125 | | | | 500,868 | | | | 1 | % | | | 27,195,816 | | | | 26,730,654 | | | | 465,162 | | | | 2 | % |
Operating loss | | | | (18,960,105 | ) | | | (16,159,231 | ) | | | (2,800,874 | ) | | | 17 | % | | | (20,829,596 | ) | | | (17,823,826 | ) | | | (3,005,770 | ) | | | 17 | % |
Loss on extinguishment of Growth Term Loan | | | | — | | | | (105,064 | ) | | | 105,064 | | | | (100 | %) | |
Interest income (expense) | | | | (334,180 | ) | | | (186,097 | ) | | | (148,083 | ) | | | 80 | % | |
Gain on forgiveness of PPP Loan | | | | — | | | | 1,735,792 | | | | (1,735,792 | ) | | | (100 | %) |
Other income (expense), net | | | | (754,043 | ) | | | (1,034,661 | ) | | | 280,618 | | | | (27 | %) |
Net loss before income taxes | | | $ | (19,294,285 | ) | | $ | (16,450,392 | ) | | $ | (2,843,893 | ) | | | 17 | % | | $ | (21,583,639 | ) | | $ | (17,122,695 | ) | | $ | (4,460,944 | ) | | | 26 | % |
RevenueProduct and product-related services revenue
We generate revenue from two primary sources:Our product and product-related services revenue fromis generated primarily through the sale of RUOour profiling instruments and CE/IVD marked profiling products,consumables and sample processing services and custom assay development services to biopharmaceuticalperformed on behalf of pharmaceutical companies, academic research centers and molecular testing laboratories; and revenue from collaborative development services for biopharmaceutical companies under our companion diagnostic development programs. laboratories.
RUO profiling is currently made available to our customers through product sales and service offerings. Customers can purchase our HTG EdgeSeq instrument and related consumables, which consist primarily of our proprietary molecular profiling panels and other assay components. Customerscomponents, for use in their own facilities. They can also access our technology through contracted services. We perform theseRUO profiling services using our HTG EdgeSeq instruments and RUO consumables to process their samples in our VERI/O laboratory. Our proprietary technology is also used to developlaboratory and through the development of custom RUO panels which are expected to generate future sample processing or RUO consumables revenue.
Collaborative development services revenue generated to date has primarily related to three statements of work entered into under our Governing Agreement with QML. Under these agreements, we and QML combined our technological and commercial strengths to offer biopharmaceutical companies a complete NGS-based solution for the development, manufacture and commercialization of companion diagnostic assays in support of and in conjunction with, biopharmaceutical companies’ drug development programs.
Total revenue decreased by 11% to $19.2 million for the year ended December 31, 2019 compared with total revenue of $21.5 million for the year ended December 31, 2018. The decrease in total revenue was driven by the decrease of revenue generated from collaborative development services relating to our Governing Agreement, as existing programs reached biopharmaceutical company partner decision points and no new collaborative development programs were entered into in 2019. This decrease was substantially offset by increased product and product-related services profiling revenue compared with 2018, driven by the demand for our RUO service offerings as a result of the expansion of our RUO assay menu and the continued strengthening of relationships with key biopharmaceutical company customers.
Product and product-related services revenue
Product and product-related services revenue, which includes biomarker profiling revenue generated through the sale of our HTG EdgeSeq instruments and consumables and from services performed for customers in our VERI/O laboratory using our proprietary RUO technology, increased $5.5 milliondecreased by 29% to $14.6$6.4 million for the year ended December 31, 20192022 compared with $9.1$8.9 million for the year ended December 31, 2018,2021, and was comprised of the following:
| | | | | | | | |
| | Years Ended December 31, | |
| | 2022 | | | 2021 | |
Product revenue: | | | | | | |
Instrument | | $ | 609,627 | | | $ | 1,385,665 | |
Consumables | | | 3,140,420 | | | | 3,786,923 | |
Total product revenue | | | 3,750,047 | | | | 5,172,588 | |
Product-related services revenue: | | | | | | |
Custom RUO assay design | | | 20,000 | | | | 48,350 | |
RUO sample processing | | | 2,596,173 | | | | 3,685,890 | |
Total product-related services revenue | | | 2,616,173 | | | | 3,734,240 | |
Total product and product-related services revenue | | $ | 6,366,220 | | | $ | 8,906,828 | |
| | Years Ended December 31, | | | Change | |
| | 2019 | | | 2018 | | | $ | | | % | |
Product revenue: | | | | | | | | | | | | | | | | |
Instruments | | $ | 1,436,730 | | | $ | 351,885 | | | $ | 1,084,845 | | | | 308 | % |
Consumables | | | 3,010,094 | | | | 1,964,499 | | | | 1,045,595 | | | | 53 | % |
Total product revenue | | $ | 4,446,824 | | | $ | 2,316,384 | | | $ | 2,130,440 | | | | 92 | % |
Product-related services revenue: | | | | | | | | | | | | | | | �� | |
Custom RUO assay design | | | 4,498,088 | | | | 964,241 | | | | 3,533,847 | | | | 366 | % |
RUO sample processing | | | 5,687,292 | | | | 5,840,765 | | | | (153,473 | ) | | | (3 | %) |
Total product-related services revenue | | | 10,185,380 | | | | 6,805,006 | | | | 3,380,374 | | | | 50 | % |
Total product and product-related services revenue | | $ | 14,632,204 | | | $ | 9,121,390 | | | $ | 5,510,814 | | | | 60 | % |
Product revenue, which includes gene expression profiling revenue generated fromthrough the sale of our HTG EdgeSeq instruments and RUO and CE/IVD assay kits increased 92%consumables, decreased by 28% to $4.4$3.8 million for the year ended December 31, 20192022, compared with $2.3$5.2 million for the year ended December 31, 2018,2021. The decrease in new instrument placements when compared with the prior year is consistent with the decrease in new customers added in 2022 compared with 2021. As we have worked to right size our business to profiling revenue trends experienced since the beginning of the COVID-19 pandemic in March 2020, our commercial team has prioritized its efforts on expanding business with existing customers and represented 23%seeking out new customers with larger studies and 11%those with expectations of more extensive future profiling needs. This resulted in the need to place fewer new instruments in 2022, as many of our totalcustomers purchased instruments in prior years or have opted to use our laboratory or a certified reference laboratory who previously purchased our instruments to run their samples. Consumables revenue reflected the slower than anticipated recovery of our business to pre-COVID-19 levels. Consumables revenue generated from the sale of our HTP, commercially launched in August 2021, was $1.8 million and $1.3 million for the years ended December 31, 20192022 and 2018,2021, respectively. The increase inHTP consumables revenue represented 47% of our product revenue in 2019for the year ended December 31, 2022, compared with 2018 is attributable to increased sale25% of our instrumentsproduct revenue for the year ended December 31, 2021 reflecting expanding adoption of that product by new and consumables as a result of the expansion of the menu of profiling assays that is available for purchase by the increasing number ofexisting customers who have adopted our technology in the United States and Europe.since its launch.
Service62
Product-related services revenue, consisting of RUO sample processing using our HTG EdgeSeq instruments and consumables in our VERI/O laboratory and custom RUO assay development, increaseddesign, decreased by $3.4 million30% to $10.2$2.6 million for the year ended December 31, 20192022, compared with $6.8$3.7 million for the year ended December 31, 2018,2021. RUO sample processing revenue decreased primarily due to the timing of several biopharma programs pending decisions from data generated in previous studies using our technology, continued delays in our ability to obtain customer samples for planned sample processing programs, and our customers' reprioritizing their programs due to continuing impacts of COVID-19 on their operations. Revenue generated from sample processing services using our HTP was $0.9 million and $0.1 million for the years ended December 31, 2022 and 2021, respectively, and represented 53%34% and 32%3% of our totalproduct-related services revenue for the years ended December 31, 20192022 and 2018,2021, respectively. The increase in service revenue for the year ended December 31, 2019 compared with 2018 primarily reflects an increase in the development of custom RUO panels which are expected to generate future sample processing, collaborative development services or RUO consumables revenue.
Collaborative development services revenue
Collaborative development services revenue includes services performed on biopharmaceutical company companion diagnostic development programs using our HTG EdgeSeq proprietary technology to develop, validate in clinical trials, seek regulatory approvals for and commercialize CDx assays for biopharmaceutical company therapeutics. Collaborative development services revenue, consisting of precision diagnostic program services performed for biopharmaceutical companies pursuant to our Governing Agreement with QML, decreased $7.8 million to approximately $4.6 million for the year ended December 31, 2019 compared with approximately $12.4 million for the year ended December 31, 2018, and represented 24% and 58% of our total revenue for the years ended December 31, 2019 and 2018, respectively. Collaborative development services revenue for the year ended December 31, 2019 included approximately $3.2 million of monthly development fees and $1.4 million of profit-sharing payments. Collaborative development services revenue for the year ended December 31, 2018 included approximately $10.2 million of monthly development fees and $2.2 million of profit-sharing payments. This variability is reflective of the number of active programs in each of these periods, the amount and timing of work to be performed under each program, the timing and number of development deliverables and the timing and amount of any profit-sharing payments under these agreements. Given these factors, we expect there to continue to be significant variability in the timing and amount of collaborative development services revenue recognized from one fiscal period to the next. No new collaborative development services programs were entered into in 2019 and our existing programs are awaiting additional activity based on customer decision points. As a result, we currently do not anticipate significant revenue from collaborative development services programs in 2020.
Cost of product and product-related services revenue
Cost of product and product-related services revenue includes both product-related and services-related costs. Product-related costs include the aggregate costs incurred in manufacturing, delivering, installing and servicing instruments and consumables. The components of our product-related costs of revenue include consumables and lab supplies, subcomponent and servicing costs, manufacturing costs incurred internally (which include direct labor costs), and equipment and infrastructure expenses associated with the manufacturing and distribution of our products. Due to the fixed nature of certain of these expenses, such as overhead, equipment and infrastructure, associated with our regulated industry and our expectations for further growth in customer demand, we expect our cost of product and product-related services revenue as a percentage to decrease over time as we increaseour product and product-related services revenue increases, further absorbing these fixed costs.
Cost of product and product-related services revenue increased by 75%12% to $8.9$4.6 million for the year ended December 31, 20192022 compared with $5.1$4.1 million for the year ended December 31, 2018.2021. This overall increase primarily reflects thean increase in productexcess inventory allowance of $1.1 million in the fourth quarter of 2022, reflecting our estimation of inventory in excess of our projections of future demand for certain of our products and product‑related services revenue$0.5 million of Employee Retention Credit ("ERC") benefits that served to partially offset compensation expense in 2019 compared2021 but did not recur in 2022. This increase was partially offset by a decrease in direct and indirect costs incurred consistent with 2018. The increase in cost oflower year over year product and product-related services revenue as a percentage of product and product-related services revenue is primarily the result of low margin subcontracted laboratory services relating to two large ongoing biopharmaceutical company customer programs for which the related revenue is in product-related services revenue for the year ended December 31, 2019. While we do not anticipate recurrence of these significant levels of subcontracted laboratory services in future periods, we expect we might need to contract these services for biopharmaceutical company programs from time to time in support of the overall development of custom assays.revenue.
Selling, general and administrative expenses
Selling, general and administrative expenses consist primarily of personnel costs for our sales and marketing, regulatory, legal, executive management and finance and accounting functions. The expenses also include third-party professional and consulting fees incurred by these functions, promotional expenses and facility and overhead costs forrelating to our administrative offices. Selling, general and administrative expenses decreased by $1.3 million4% to $18.7$15.8 million for the year ended December 31, 20192022 compared with $20.0$16.5 million for the year ended December 31, 2018. The2021. This decrease primarily reflects a decrease in legal fees incurred to protect our selling, generalintellectual property and administrativedecreased compensation and stock-based compensation expenses are primarily due to executive officers’ restricted stock grants that resultedfollowing a reduction in approximately $1.0force completed in the second quarter of 2022. This decrease was partially offset by $0.8 million of additional non-cash, stock-basedERC benefits that served to offset a portion of compensation expense in 2021 but did not recur in 2022.
Research and development expenses
Research and development expenses increased by 11% to $6.8 million for the year ended December 31, 2022, compared with $6.1 million for the year ended December 31, 2021. This increase in research and development expense for the year ended December 31, 2018.
Research and development expenses
Research and development expenses represent amounts incurred to perform collaborative development services, costs to develop new proprietary panels and corresponding assays and costs to continue to develop and improve our HTG EdgeSeq platform. These expenses include payroll and related expenses, consulting expenses, laboratory supplies, facilities and equipment. Research and development costs are expensed as incurred. Research and development expenses decreased by $2.0 million to $10.6 million for the year ended December 31, 20192022 compared with $12.6the same period in 2021 reflects $0.4 million for the year ended December 31, 2018. This decrease is primarily dueof ERC benefits that served to the decreaseoffset a portion of compensation expense in collaborative development costs associated with biopharmaceutical customer companion diagnostic development programs, which costs are included2021, and an increase in research and development expensespending associated with efforts to build and strengthen our drug discovery engine in our consolidated statements of operations2021. This increase was partially offset by a decrease in profiling product development as the contracts are accounted for under the FASB’s guidance for collaborative arrangements. Research and development costs relatingwe shifted focus to our collaborative development services revenue were approximately $2.8 million for the year ended December 31, 2019 compared with $8.0 million for the year ended December 31, 2018. We expect researchtherapeutics efforts and development costs to continue to increase in 2020 as we progress toward key milestones in the development of our whole transcriptome assay being developed in our California laboratorymaintenance and continue to build new applications to add to the utilitymarketing of our existing proprietary panels.product portfolio following commercial release of our HTP in August 2021.
InterestGain on forgiveness of PPP Loan
In May 2021, upon receipt of the notification that the PPP Loan and related accrued interest had been forgiven by the U.S. Small Business Administration and that the note associated with the PPP Loan had been cancelled, we reversed the liabilities related to the PPP Loan and recorded a gain on forgiveness of PPP Loan of approximately $1.7 million.
Other income (expense)
As of both December 31, 2019,2022 and 2021, we had an obligationoutstanding obligations due to NuvoGen in the amount of $5.7 million under an asset purchase agreement a MidCapand to SVB under the SVB Term Loan obligation of $6.9 million, net of discount and deferred financing costs and a $3.0 million convertible debt liability to QNAH.Loan. Interest expense related to these obligations and non-cash interest expense recognized forto the discount, deferred financing fee amortization and final fee premium amortization of amounts relating toassociated with these obligations increased to $1.0was $0.9 million and $1.1 for the yearyears ended December 31, 2019 as compared with $0.9 million for the year ended December 31, 2018. Interest income included2022 and 2021, respectively. This decrease in interest income (expense) decreased by $92,368 to $623,355 forexpense was primarily the year ended December 31, 2019 as compared with $715,723 for the year ended December 31, 2018 primarily as a result of available-for-sale securities investmentsa $2.5 million payment made withto SVB as part of the net proceeds from our January 2018 underwritten public offering with Leerink Partners LLCTerm Loan Amendment which, in addition to regularly scheduled SVB Term Loan and Cantor Fitzgerald & Co. (“Cantor”) used to fund operations throughout 2019.NuvoGen obligation payments, resulted in a decreased balance on which interest is being accrued and/or paid.
63
Cash Flows for the Years Ended December 31, 20192022 and 20182021
The following table summarizes the primary sources and uses of cash for each of the periods presented:
| | | Years Ended December 31, | | | Change | | | Years Ended December 31, | | | Change | |
| | 2019 | | | 2018 | | | $ | | | % | | | 2022 | | | 2021 | | | $ | | | % | |
Net cash provided by (used in): | | | | | | | | | | | | | | | | | | | | | | | | | | |
Operating activities | | $ | (16,695,936 | ) | | $ | (13,173,918 | ) | | | (3,522,018 | ) | | | 27 | % | | $ | (18,407,791 | ) | | $ | (16,508,554 | ) | | $ | (1,899,237 | ) | | | 12 | % |
Investing activities | | | (3,504,384 | ) | | | (23,220,435 | ) | | | 19,716,051 | | | | (85 | %) | | | 12,420,233 | | | | (6,664,744 | ) | | | 19,084,977 | | | | (286 | %) |
Financing activities | | | 19,391,804 | | | | 38,129,745 | | | | (18,737,941 | ) | | | (49 | %) | | | 8,604,820 | | | | 10,391,622 | | | | (1,786,802 | ) | | | (17 | %) |
Effect of exchange rate on cash | | | (4,336 | ) | | | (1,145 | ) | | | (3,191 | ) | | | 279 | % | | | (6,355 | ) | | | (16,186 | ) | | | 9,831 | | | | (61 | %) |
(Decrease) increase in cash, cash equivalents and restricted cash | | $ | (812,852 | ) | | $ | 1,734,247 | | | | (2,547,099 | ) | | | (147 | %) | |
Increase (decrease) in cash and cash equivalents | | | $ | 2,610,907 | | | $ | (12,797,862 | ) | | $ | 15,408,769 | | | | (120 | %) |
Operating Activities
Net cash used in operating activities for the year ended December 31, 20192022 increased by $3.5 million12% to $16.7$18.4 million compared with $13.2$16.5 million for the year ended December 31, 2018.2021. This increase for the year ended December 31, 20192022 reflected (i) the net loss of $19.3$21.6 million and (ii) net non-cash items of $3.1$3.3 million consisting primarily of stock-based compensationprovision for excess inventory of $1.2 million, andstock-based compensation expense of $0.8 million, depreciation and amortization expense of $1.3$0.6 million, amortization of loan discount and issuance costs of $0.4 million, non-cash operating lease expense of $0.4 million and gain on abandonment and disposal of assets of $0.1 million; and (iii) a net cash outflow from changes in balances of operating assets and liabilities of $0.1 million.
Net cash used in operating activities for the year ended December 31, 20182021 was $13.2$16.5 million and reflected (i) the net loss of $16.5$17.1 million and (ii) net non-cash items of $3.3$1.6 million consisting primarily of the gain on the forgiveness of our PPP loan of $1.7 million, stock-based compensation expense of $1.9$1.3 million, and depreciation and amortization expense of $1.5$0.7 million, amortization of loan discount and issuance costs of $0.5 million, non-cash operating lease expense of $0.5 million and loss on abandonment and disposal of assets of $0.2 million; and (iii) a net cash outflow from changes in balances of operating assets and liabilities of $1.0 million.
Investing Activities
Net cash provided by investing activities for the year ended December 31, 2022 increased by 286% to $12.4 million compared with net cash used in investing activities of $6.7 million for the year ended December 31, 2021. Net cash provided by investing activities for the year ended December 31, 2022 consisted primarily of the maturity of $20.0 million of the available-for-sale securities and the proceeds from the sale of property and equipment of $0.1 million, partially offset by the purchases of available-for-sale securities of $7.6 million.
Net cash used in investing activities for the year ended December 31, 2019 decreased by $19.7 million to $3.5 million compared with $23.2 million for the year ended December 31, 2018. Net cash used in investing activities for the year ended December 31, 2019 consisted primarily of purchases of available-for-sale securities of $34.6 million, partially offset by the maturity of $32.2 million of the available-for-sale securities and the purchase of $1.1 million of laboratory equipment for our California-based technology center and other fixed assets during the year.
Net cash used in investing activities for the year ended December 31, 20182021 was $23.2$6.7 million and consisted primarily of purchases of available-for-sale securities of $54.0$18.6 million with proceeds received from our underwritten public offering in January 2018,and purchases of laboratory equipment and other fixed assets during the year of $0.6 million, partially offset by the maturity of $31.7$12.6 million of the available-for-sale securities and the purchase of $0.9 million of tooling used in manufacturing, furniture and equipment for our new applications laboratory in France and other fixed assets during the year.securities.
Financing Activities
Net cash provided by financing activities for the year ended December 31, 20192022 decreased by $18.7 million17% to $19.4$8.6 million compared with $38.1$10.4 million for the year ended December 31, 2018.2021. This activity for the year ended December 31, 20192022 consisted primarily of $20.8$9.1 million of proceeds net of commissions and issuance costs from the December 2022 Securities Purchase Agreement (see Note 14 of the accompanying consolidated financial statements), $7.0 million in net proceeds from our 2019 underwritten publicthe March 2022 Securities Purchase Agreement (see Note 14 to the accompanying consolidated financial statements) and private offerings with Cantor and $1.3$0.8 million in proceeds from our 2022 Insurance Note, partially offset by $6.8 million of payments on our SVB Term Loan, $0.5 million of payments made on our outstanding NuvoGen obligation.obligation, and $1.0 million of payments made on our 2021 and 2022 Insurance Notes.
Net cash provided by financing activities for the year ended December 31, 20182021 was $38.1$10.4 million and consisted primarily of $37.7$10.7 million in net proceeds from our underwritten public offering in January 2018, $6.6 million in net proceeds from our MidCap Term Loan in March 2018, and $0.6 million in net proceeds from an at-the-market offeringsales of our common stock throughin an “at the market offering” and $0.9 million in proceeds from our 2017 Controlled Equity Offering Sales Agreementstock purchase agreement (the “LP Purchase Agreement”) with Cantor,Lincoln Park Capital Fund, LLC (“Lincoln Park”), $0.1 million in proceeds from shares purchased under stock purchase plans, partially offset by $6.0$0.5 million inof payments made on our Growth Term Loan balanceoutstanding NuvoGen obligation, and $1.0$0.7 million inof payments made on our NuvoGen obligation.2020 and 2021 Insurance Notes.
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Liquidity and Capital Resources
Since our inception, our operations have primarily been financed through the issuance of our common stock, redeemable convertible preferred stock, the incurrence of debt and cash received from product sales, services revenue and other income. As of December 31, 2019,2022, we had $33.0$12.2 million in cash and cash equivalents, current liabilities of $8.3 million and investments in short-term available-for-sale securities, and $17.0$4.1 million of long-term liabilities outstandingprimarily relating to our MidCap Term Loan, NuvoGen and QNAH Convertible Note obligations and our financingobligation and operating leases.
In March 2018,June 2020, we entered into the MidCapSVB Term Loan andwith SVB. The proceeds from the Midcap Revolving Loan with MidCap Financial Trust, as agent. The MidCapSVB Term Loan, provides a secured term loan facilitytogether with cash on hand, were used to repay in an aggregate principal amount of up to $20.0 million. We borrowed the first advance of $7.0 million in March 2018. Under the terms of the MidCap Term Loan, the second advance of $13.0 million was to be available to us on or before September 30, 2019, subject to the Company’s satisfaction of certain conditions described in the MidCap Term Loan. As the Company did not satisfy these conditions, MidCap Tranche 2 was not made available to the Company for borrowing. All obligations under the Growth Term Loan were terminated andfull all outstanding amounts and fees due under the Growthour prior MidCap Credit Facility and a subordinated convertible note that has since been repaid. Our SVB Term Loan were repaid with proceeds from the MidCap Term Loan in March 2018. Amounts outstanding under the MidCap Term Loan bearbears interest at a floating rate equal to 7.25% per annum, plus the greater of (i) 1.25% or (ii)2.50% above the one-month LIBOR. WithPrime Rate (as defined in the amendment ofLoan Agreement) and 5.75%. In July 2022, we entered into the MidCap Revolving Loan and the MidCap Term Loan in February 2020,Amendment with SVB. Under the Term Loan Amendment, SVB agreed to remove the financial covenant under the Loan Agreement. In exchange for this accommodation, we prepaid $2.5 million of outstanding principal on each term loan advance is payableunder the SVB Term Loan. The remaining outstanding principal amount due under the SVB Term Loan will continue to be paid in 25 equal monthly installments beginningpayments of principal and interest through the maturity date of December 1, 2023.
In March 1, 2021 until paid in full on March 1, 2023. If2022, we achieveentered into a stated revenue milestone for the 12-month period ending on December 31, 2020, the interest-only period will be further extended by an additional four months, with principal on each term loan advance then payable in 21 equal monthly installments beginning July 1, 2021 until paid in full on March 1, 2023. The proceeds remaining from the March 2018 MidCap Term Loan funding are expected to be used for working capital and general corporate purposes.
LIBOR is currently scheduled to be phased out in 2021. Before LIBOR is phased out, we expect to modify the MidCap Credit Facility to replace LIBORSecurities Purchase Agreement with a new reference rate, which has yetsingle investor pursuant to be established. The consequences of these developments cannot be entirely predicted but might result in higher interest rates on our borrowings under the MidCap Credit Facility.
The MidCap Revolving Loan provides a secured revolving credit facility in an aggregate principal amount of up to $2.0 million. We may request an increase in the total commitments under the MidCap Revolving Loan by up to an additional $8.0 million, subject to agent and lender approval and the satisfaction of certain conditions. Availability of the revolving credit facility under the MidCap Revolving Loan will be based upon a borrowing base formula and periodic borrowing base certifications valuing certain of our accounts receivable and inventory, as reduced by certain reserves, if any. Though the MidCap Revolving Loan was made available upon our establishment of certain lockbox arrangements in June 2018, there were no amounts outstanding under the MidCap Revolving Loan as of December 31, 2019. The proceeds of any loans under the MidCap Revolving Loan may be used for working capital and general corporate purposes.
In September 2019, we completed an underwritten public offering in which we issued and sold 29,298,537 sharesto the investor 270,415 units at a price of $27.744 per unit (less $0.012 for each pre-funded warrant purchased in lieu of a share of common stock) for net proceeds, after deducting the placement agent fees and other fees and expenses, of approximately $7.0 million. Each unit consisted of one share of common stock (or one pre-funded warrant in lieu thereof), a common warrant to purchase one share of our common stock atwith a term of 24 months from the issuance date, and a common warrant to purchase one share of our common stock with a term of 66 months from the issuance date. Each of these common warrants became exercisable commencing on September 21, 2022 and has an exercise price of $0.65$24.744 per share. Each pre-funded warrant had an exercise price of $0.012 per share including 3,821,548 shares sold pursuant to the exercise in fulland had no expiration date. In May 2022, all of the underwriter’s option to purchase additional shares. The shares of common stock described above were offered pursuant to a Registration Statement on Form S-3 (File No. 333-229045) previously filed with the SEC and declared effective by the SEC on February 11, 2019, and a prospectus supplement thereafter. In addition, we concurrently entered into a securities purchase agreement with certain institutional accredited investors for the sale of 5,411,687200,911 pre-funded warrants exercisablewere exercised for an aggregateproceeds of 5,411,687 shares of common stock, at$2,411.
In December 2022, in connection with a purchase price of $0.64 per pre-funded warrant. The aggregate net proceeds from these offerings were approximately $20.8 million, after deducting the underwriting discounts and commissions andbest-efforts public offering, expenses.
In March 2020, we entered into a purchase agreement ("LPSecurities Purchase Agreement (the "December 2022 Securities Purchase Agreement") with Lincoln Park Capital Fund, LLC ("Lincoln Park")a certain institutional investor, pursuant to which uponwe issued and sold to the investor 1,290,322 units at a combined public offering price of $7.75 per share (less $0.001 for each pre-funded warrant purchased in lieu of a share of common stock) for net proceeds, after deducting the Placement Agent fees and expenses and other estimated fees and expenses of approximately $8.7 million. Each unit consisted of one share of common stock (or one pre-funded warrant in lieu thereof), a common warrant to purchase one share of common stock with a term of 24 months from the issuance date, and a common warrant to purchase one share of common stock with a term of 60 months from the issuance date. Each of these common warrants has an exercise price of $7.50 per share. In December 2022, all of the 1,188,322 pre-funded warrants were exercised for proceeds of $1,188.
The current volatility in the equity markets may create additional challenges to raising a sufficient amount of capital through an equity financing in the near term. If sufficient additional capital is not available as and when needed, we may have to delay, scale back or discontinue one or more product development programs, curtail our commercial activities, significantly reduce expenses, sell assets (potentially at a discount to their fair value or carrying value), enter into relationships with third parties to develop or commercialize products or technologies that we otherwise would have sought to develop or commercialize independently, pursue a sale of the Company at a price that may result in a significant loss on investment for our stockholders, file for bankruptcy or seek other protection from creditors, or liquidate all assets. In addition, if we default under any of the terms and subject to the conditions and limitations set forth therein, we have the right to sell to Lincoln Park up to $20,000,000 of shares of our common stock (“Purchase Shares”) from time to time over the 36-month term of the LP Purchase Agreement. The purchase priceLoan Agreement, including as a result of a material adverse change, Silicon Valley Bridge Bank could accelerate the payment of the Purchase Shares will be basedSVB Term Loan and ultimately foreclose on recent closing prices of our common stock at the time of sale. We issued Lincoln Park an aggregate of 615,384 shares of our common stock as consideration for their purchase commitment pursuant to the LP Purchase Agreement.assets.
FundingContractual Obligations, Commitments and Material Cash Requirements
We have had recurring operating losses and negative cash flows from operations since our inception and have an accumulated deficit of approximately $170.3$229.9 million as of December 31, 2019.2022. As of December 31, 2019,2022, we had cash and cash equivalents and investments in short-term available-for-sale securities of approximately $33.0$12.2 million and had current liabilities of approximately $8.9$8.3 million. As of December 31, 2019,2022, we also had $12.3approximately $4.1 million inof long-term liabilities primarily attributableoutstanding, relating to our MidCap Term LoanNuvoGen obligation, and NuvoGen obligations. our financing and operating leases.
We believecurrently expect that our existing resources will only be sufficient to fund our planned operations and expenditures foruntil at least the next 12 months from the issuanceJuly 2023. In addition, potentially changing circumstances, including those related to a resurgence of these consolidated financial statements. However, we cannot provide assurances that our plans will not change or that changed circumstances will notCOVID-19, inflation and high interest rates, may also result in the depletion of our capital resources more rapidly than we currently anticipate. These circumstances raise substantial doubt about our ability to continue as a going concern.
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Our primary capital needs, including contractual obligations and commitments, which are subject to change, include:
•Debt Obligations – As of December 31, 2022, our outstanding debt balance was $3.8 million. See Note 8, “Debt Obligations” within our consolidated financial statements for further detail of our SVB Term Loan, the remaining balance of which is included in current liabilities in the accompanying consolidated balance sheets as of December 31, 2022, as the remaining payments are due within the next twelve months.
•NuvoGen Obligation – As of December 31, 2022, our NuvoGen obligation balance was $4.0 million. See Note 10, “Other Agreements” within our consolidated financial statements for further detail and the timing of expected future payments.
•Operating Leases – As of December 31, 2022, our contractual commitment for operating leases was $1.0 million. See Note 11, “Leases” within our consolidated financial statements for further detail of our lease obligations and the timing of expected future payments, including a three-year maturity schedule.
•Planned costs to operating our business, including amounts required to fund working capital and capital expenditures.
•Support of commercialization efforts related to our current and future products.
•Continued advancement of research and development efforts, including those related to our HTG Therapeutics business unit.
Until our revenue reaches a level sufficient to support self-sustaining cash flows, if ever, we expect to finance our cash needs through public or private equity offerings, debt financings, or other capital sources which may needinclude strategic collaborations, licensing arrangements or other arrangements with third parties. The current volatility in the equity markets may create additional challenges to raise additionalraising a sufficient amount of capital to fund our continued operations, including our product development and commercialization activities related to our current and future products.through an equity financing in the near term. Future funding requirements will depend on a number of factors, including our ability to generate significant revenue, our ability to repay our debt obligations as they become due, the cost and timing of establishing additional sales, marketing and distribution capabilities, the ongoing cost of research and development activities, the cost and timing of regulatory clearances and approvals, the effect of competing technology and market developments, the nature and timing of companion diagnostic development collaborations we may establish and the successful commercialization of clinical diagnostic products developed and approved as a result of such collaborations and the extent to which we acquire or invest in businesses, products and technologies.
Additional capital may not be available at such times or in amounts needed by us. Even if sufficient capital is available to us, it might be available only on unfavorable terms. If we are unable to raise additional capital in the future when required and insufficientin sufficient amounts or on terms acceptable to us, we may have to delay, scale back or discontinue one or more product development programs, curtail our commercialization activities, significantly reduce expenses, sell assets (potentially at a discount to their fair value or carrying value), enter into relationships with third parties to develop or commercialize products or technologies that we otherwise would have sought to develop or commercialize independently, cease operations altogether, pursue an acquisition of our company at a price that may result in a significant loss on investment to our stockholders, file for bankruptcy, seek other protection from creditors, or liquidate all of our assets. In addition, if we default under our MidCapSVB Term Loan agreement, including as a result of a “material adverse change,” our lenderslender could foreclose on our assets, including someassets. The definition of our cash“material adverse change” is broad and cash equivalents which are heldincludes a material impairment in accounts with other financial institutions.
Contractual Obligations
We are a “smaller reporting company” as defined by Rule 12b-2the value of the Exchange Actcollateral securing the SVB Term Loan, a material adverse change in our business, operations, or condition (financial or otherwise), and a material impairment of the prospect of repayment of any portion of the SVB Term Loan. As the remaining payments under the SVB Term Loan are not requireddue within twelve months of December 31, 2022, the impact of a material adverse change would be to provideaccelerate the information otherwise required underpayment of this item.short-term debt further.
Off-Balance Sheet Arrangements
We have not entered into any off-balance sheet arrangements as defined by applicable SEC regulations.
Recent Accounting Pronouncements
For a summary of recent accounting pronouncements applicable to our consolidated financial statements, see “Note 2. Basis of Presentation and Summary of Significant Accounting Policies” in Part II, Item 8, Notes to Consolidated Financial Statements.
Critical Accounting Policies and Significant Judgments and Critical Accounting Estimates
Our management’sManagement’s discussion and analysis of our financial condition and results of operations is based on our consolidated financial statements, which have been prepared in accordance with GAAP. The preparation of consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenue and expenses during the reporting period. Items subjectCritical accounting policies and estimates are those that we consider most important to the portrayal of our financial condition and results of operations because they require our most difficult, subjective or complex judgments, often as a result of the need to make estimates based on judgmentsabout the effect of matters that are inherently uncertain. Our critical accounting policies and estimates include but are not limited to:those related to revenue recognition, fair value measurements stock-based compensation expense, the value of our lease and warrant liabilities, the resolution of uncertain tax positions, income tax valuation allowances and reserves, recovery of long-lived assets and provisions for doubtful accounts, inventory obsolescence and inventory valuation. Actual results could materially differ from these estimates and such differences could affect the results of operations in future periods.
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Revenue from Contracts with Customers
Revenue from contracts with customers is recognized when, or as, we satisfy our performance obligations by delivering the promised goods or service deliverables to our customers. A good or service deliverable is transferred to a customer when, or as, the customer obtains control of that good or service deliverable. A performance obligation may be satisfied over time or at a point in time. Revenue from a performance obligation satisfied over time is recognized by measuring our progress in satisfying the performance obligation in a manner that depicts the transfer of the goods or services to the customer. Revenue from a performance obligation satisfied at a point in time is recognized at the point in time that we determine the customer obtains control over the promised good or service deliverable. The amount of revenue recognized reflects the consideration we expect to be entitled to in exchange for those promised goods or services (i.e., the “transaction price”). In determining the transaction price, we consider multiple factors, including the effects of variable consideration. Variable consideration is included in the transaction price only to the extent it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainties with respect to the amount are resolved. In determining when to include variable consideration in the transaction price, we consider the range of possible outcomes, the predictive value of itsour past experiences, the time period of when uncertainties expect to be resolved and the amount of consideration that is susceptible to factors outside of our influence, such as the judgment and actions of third parties.
For contracts where the period between when we transfer a promised good or service to the customer and when the customer pays is one year or less, we have elected the practical expedient to not adjust the promised amount of consideration for the effects of a significant financing component.
We have made a policy election to exclude from the measurement of the transaction price all taxes assessed by a government authority that are both imposed on and concurrent with a specific revenue producing transaction and collected from a customer. Such taxes may include but are not limited to sales, use, value added and certain excise taxes.
Product and Product-related Services Revenue
Sale of instruments and consumables
The delivery of each instrument and related installation and calibration are considered to be a single performance obligation, as the HTG EdgeSeq instrument must be professionally installed and calibrated prior to use. Instrument product revenue is generally recognized upon installation and calibration of the instrument by field service engineers, which represents the point at which the customer has the ability to use the instrument and has accepted the asset. Installation generally occurs within one month of instrument shipment.
The delivery of each consumable is a separate performance obligation. Consumables revenue is recognized upon transfer of control, which represents the point when the customer has legal title and the significant risks of ownership of the asset. Our standard terms and conditions provide that no right of return exists for instruments and consumables, unless replacement is necessary due to delivery of defective or damaged product. Customer payment terms vary but are typically between 30 and 90 days of revenue being earned from shipment or delivery, as applicable.
Shipping and handling fees charged to customers for instruments shipped are included in the accompanying consolidated statements of operations as part of product and product-related services revenue. Shipping and handling costs for products shipped to customers are included in the accompanying consolidated statements of operations as part of cost of product and product-related services revenue.
For sales of consumables in the United States, standard delivery terms are FOB shipping point, unless otherwise specified in the customer contract, reflecting transfer of control to the customer upon shipment. Standard delivery terms for sales to customers outside of the United States are FOB delivery point, unless otherwise specified in the customer contract. We have elected the practical expedient to account for shipping and handling as activities to fulfill the promise to transfer the consumables.
We provide instruments to certain customers under reagent rental agreements. Under these agreements, an instrument is installed in the customer’s facility without a fee and the customer agrees to purchase consumable products at a stated price over the term of the agreement; in some instances, the agreements do not contain a minimum purchase requirement. Terms range from several months to multiple years and may automatically renew in several month or multiple year increments unless either party notifies the other in advance that the agreement will not renew. We measure progress toward complete satisfaction of this performance obligation to provide the instrument and deliver the consumables using an output method based on the number of consumables delivered in relation to the total consumables to be provided under the reagent rental agreement. This is considered to be representative of the delivery of outputs under the arrangement and the best measure of progress because the customer benefits from the instrument only in conjunction with the consumables. We expect to recover the cost of the instrument under the agreement through the fees charged for consumables, to the extent sold, over the term of the agreement.
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In reagent rental agreements, we retain title to the instrument and title is transferred to the customer at no additional charge at the conclusion of the initial arrangement. The cost of the instrument is amortized on a straight-line basis over the term of the arrangement, unless there is no minimum consumable product purchase, in which case the instrument would be expensed as cost of product and product-related services revenue upon installation. Cost to maintain the instrument while we hold title is charged to selling, general and administrative expense as incurred.
Service revenue
Sample Processing Services
We also provide sample preparation and processing services and molecular profiling of retrospective cohorts for itsour customers through itsour VERI/O laboratory, whereby the customer provides samples to be processed using HTG EdgeSeq technology specified in the order. Customers are charged a per sample fee for sample processing services which is recognized as revenue upon delivery of a data file to the customer showing the results of testing and completing delivery of the agreed upon service. This is when the customer can use and benefit from the results of testing and we have the present right to payment.
Custom RUO Assay Development
We enter into custom RUO assay design agreements that may generate up-front fees and subsequent payments that might be earned upon completion of design process phases. Progress is measured toward complete satisfaction of the performance obligation to perform custom RUO assay design using an output method based on the costs incurred to date compared to total expected costs, as this is representative of the delivery of outputs under the arrangements and the best measure of progress. However, because in most instances the assay development fees are contingent upon completion of each phase of the design project and the decision of the customer to proceed to the next phase, the amount to be included in the transaction price and recognized as revenue is limited to that which the customer is contractually obligated to pay upon completion of that phase, which is when it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur. Changes in estimates of total expected costs are accounted for prospectively as a change in estimate. From period to period, custom RUO assay design service revenue can fluctuate substantially based on the completion of design-related phases.
Collaborative Development Services
We follow ASC 606, Revenue from Contracts with Customers and ASC 808, Collaborative Arrangements to determine the appropriate recognition of revenue under our collaborative research, development and commercialization agreements that contain multiple elements. For the years ended December 31, 2019 and 2018, collaborative development services revenue was generated from our Governing Agreement with QML. We have determined that SOW One, SOW Two and SOW Three under the Governing Agreement are collaborative arrangements and that QML meets the definition of a customer under ASC 606. Additionally, each SOW is a separate contract with a single performance obligation to provide development services. Under each SOW, QML pays a monthly fee for development work performed by us and our subcontractors. The monthly fee is based on the employee and materials costs incurred during the month, which is subject to significant variability from period to period and unknown until the costs are incurred. Therefore, the monthly fee, which is based on use of hours and costs as a measure of progress, is included in the transaction price and recognized as revenue over time when the costs are incurred and the monthly fee is billed to QML. As we have the right to consideration from the customer in an amount that corresponds directly to the value to the customer of our performance completed to date, we recognize revenue in the amount to which we have the right to invoice. It is at this time that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur. We also share any net profits resulting from performance of the development work with QML as determined pursuant to the Governing Agreement. Such profit-sharing payment(s) is deemed to be variable consideration using the expected value method and is included in the transaction price upon completion of the respective SOW deliverables, acceptance of corresponding deliverables, and the mutual agreement by both parties on the calculation of net profit, which is when it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur.
Because each SOW has an expected duration of one year or less, we have elected the practical expedient in ASC 606-10-50-14(a) to not disclose information about its remaining performance obligations for each SOW.
Fair Value Measurements
We establish the fair value of all of our financial assets and liabilities, which are recognized and disclosed at fair value in the consolidated financial statements, using the price that would be received to sell an asset or paid to transfer a financial liability in an orderly transaction between market participants at the measurement date. A fair value hierarchy is used to measure fair value. The three levels of the fair value hierarchy are as follows:
Level 1 – Quoted prices in active markets for identical assets and liabilities.
Level 2 – Pricing inputs are based on quoted prices for similar instruments in active markets, quoted prices for identical or similar instruments in markets that are not active; and model-derived valuations in which all significant inputs and significant value drivers are observable in active markets.
Level 3 – Valuations derived from valuation techniques in which one or more significant inputs or significant value drivers are unobservable and include situations where there is little, if any, market activity for the investment.
Our portfolio of securities comprises U.S. Treasuries and high credit quality corporate debt securities classified as available-for-sale securities.
Inventory Valuation
Inventory consists of raw materials and finished goods which are stated at the lower of cost (first-in, first-out) or net realizable value. We reserve or write downassess the valuation of our inventory on a periodic basis and make adjustments to the value for estimated obsolescence, inventory in excess of reasonably expected near term sales or unmarketable inventory, in an amount equal to the difference between the cost of inventory and the estimated market value, based upon assumption about future demand and market conditions. Such estimates are difficult to make under most economic conditions. Our excess inventory review process includes analysis of sales forecasts and expected customer demand, careful management of product utilization and future purchasing and coordinating with manufacturing to maximize recovery of excess inventory. If actual market conditions are less favorable than those projected, additional inventory adjustmentswrite-downs may be required. Inventory impairment charges establish a new cost basis for inventory and charges are not reversed subsequently to income, even if circumstances later suggest that increased carrying amounts are recoverable.
Leases
Effective January 1, 2019, we account for our leases under ASC 842, Leases (“ASC 842”). Under this guidance, arrangements meeting the definition of a lease If actual market conditions are classified as operating or financing leases and are recorded on the consolidated balance sheets as both a right-of-use asset and lease liability, calculated by discounting fixed lease payments over the lease term at the rate implicitmore favorable than anticipated, inventory previously written down may be sold to customers, resulting in the lease or our incremental borrowing rate. Lease liabilities are increased by interest and reduced by payments each period, and the right-of-use asset is amortized over the lease term. For operating leases, interest on the lease liability and the amortization of the right-of-use asset result in straight-line rent expense over the lease term. For financing leases, interest on the lease liability and the amortization of the right-of-use asset results in front-loaded expense over the lease term. Variable lease expenses are recorded to rent expense as incurred.
Certain leasehold improvements constructed by the landlord of our Tucson, AZ facilities as an incentive for us to extend our leases are included in leasehold improvements in the consolidated balance sheets as of December 31, 2018. The totallower cost of the improvements constructed by the landlord of $710,000 was capitalized when construction was completedsales and lower operating loss than expected in February 2016 and is being amortized over the remaining term of the lease agreement. The incentive of $710,000 was also recognized as deferred rent and was being amortized over the lease term as a reduction of lease expense. As of December 31, 2018, the remaining unamortized incentive of $295,833 was recognized as deferred rent within other current liabilities and other liabilities, in accordance with ASC Topic 840, Leases (“ASC 840”). Upon implementation of ASC 842, the $295,833 remaining unamortized incentive of was recognized as an offset to operating lease right-of-use asset in the consolidated balance sheets.
In calculating the right-of-use asset and lease liability, we have elected to combine lease and non-lease components for all classes of assets currently under lease, including facilities and computer equipment. We have also excluded short-term leases having initial terms of 12 months or less from the new guidance as an accounting policy election and recognizes rent expense on a straight-line basis over the lease term for these leases.
Stock-Based Compensation
We recognize compensation costs related to stock-based payments to employees, including grants under our equity incentive plans of stock options and restricted stock units (“RSUs”) and stock purchase rights granted under our ESPP, based on the estimated fair value of the awards on the date of grant. The fair value of RSUs is based on the quoted market price of our common stock on the date of grant. We do not estimate the number of awards expected to be forfeited but instead we account for them as they occur. The fair value of ESPP rights and stock options granted pursuant to our equity incentive plans is estimated on the date of grant using the Black-Scholes option pricing model. The determination of the fair value using the Black-Scholes option pricing model is affected by the fair value of our common stock and several assumptions, including volatility, expected term, risk-free interest rate and dividend yield. Generally, these assumptions are based on historical information and judgment is required to determine if historical trends may be indicators of future outcomes. These estimates involve inherent uncertainties. Changes to the assumptions that we have used in the Black-Sholes option pricing model could significantly impact the compensation expense that has been recognized in our consolidated statements of operations. If we had made different assumptions, our stock-based compensation expense, net loss and net loss per share of common stock could have been significantly different.period.
Foreign Currency Translation and Foreign Currency Transactions
We have assets and liabilities, including accounts receivable and accounts payable, which are denominated in currencies other than our functional currency. These balance sheet items are subject to re-measurement, the impact of which is recorded in selling, general and administrative expense within the consolidated statements of operations.
Adjustments resulting from translating foreign functional currency financial statements of our wholly owned subsidiary into U.S. Dollars are included in the foreign currency translation adjustment, a component of accumulated other comprehensive loss in the accompanying consolidated statements of stockholder’s equity (deficit).
Income Taxes
We account for income taxes under the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to the differences between the financial statement carrying amounts and tax base of assets and liabilities using enacted tax rates and laws that will be in effect when the differences are expected to reverse. A valuation allowance is established against net deferred tax assets for the uncertainty it presents of our ability to use the net deferred tax assets, in this case, primarily carryforwards of net operating tax losses and research and development tax credits. In assessing the realizability of net deferred tax assets we have assessed the likelihood that net deferred tax assets will be recovered from future taxable income, and to the extent that recovery is not “more likely than not” or there is an insufficient history of operating profits, a valuation allowance is established. We record the valuation allowance in the period we determine that it is more likely than not that net deferred tax assets will not be realized. For the years ended December 31, 2019 and 2018, we have provided a full valuation allowance for all net deferred tax assets due to their current realization being considered remote. Uncertain tax positions taken or expected to be taken in a tax return are accounted for using the more likely than not threshold for financial statement recognition and measurement. The Tax Act, which was signed into law on December 22, 2017, significantly revised the IRC. For further information as to its impact on our financial statements see “Note 16. Income Taxes” in Part II, Item 8, Notes to Financial Statements.
Emerging Growth Company Status
We are an “emerging growth company” as defined in the JOBS Act. Under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards issued subsequent to the enactment of the JOBS Act until such time as those standards apply to private companies. We have irrevocably elected not to avail ourselves of this exemption from new or revised accounting standards and, therefore, will be subject to the same new or revised accounting standards as other public companies that are not emerging growth companies.
Item 7A. Quantitative and Qualitative Disclosures About Market Risk.
We are a “smaller reporting company” as defined by Rule 12b-2 of the Exchange Act and are not required to provide the information otherwise required under this item.
Item 8. Consolidated Financial Statements and Supplementary Data.
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INDEX TO FINANCIAL STATEMENTS
F-1
Report of Independent RegisteredRegistered Public Accounting Firm
Stockholders and Board of Directors
HTG Molecular Diagnostics, Inc.
Tucson, Arizona
Opinion on the Consolidated Financial Statements
We have audited the accompanying consolidated balance sheets of HTG Molecular Diagnostics, Inc. (the “Company”) and subsidiary as of December 31, 20192022 and 2018,2021, the related consolidated statements of operations, comprehensive loss, changes in stockholders’ equity, (deficit), and cash flows for the years then ended, and the related notes (collectively referred to as the “consolidated financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company and subsidiary at December 31, 20192022 and 2018,2021, and the results of theirits operations and theirits cash flows for the years then ended, in conformity with accounting principles generally accepted in the United States of America.
Going Concern Uncertainty
Change in Accounting Method Related to Leases
The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Notes 2 and 11Note 1 to the consolidated financial statements, the Company has changedsuffered recurring losses from operations and negative operating cash flows that raise substantial doubt about its methodability to continue as a going concern. Management’s plans in regard to these matters are also described in Note 1. The consolidated financial statements do not include any adjustments that might result from the outcome of accounting for leases during the year ended December 31, 2019 due to the adoption of Accounting Standards Codification (“ASC”) 842, Leases.this uncertainty.
Basis for Opinion
These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s consolidated financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audits provide a reasonable basis for our opinion.
Critical Audit Matter
The critical audit matter communicated below is a matter arising from the current period audit of the consolidated financial statements that was communicated or required to be communicated to the audit committee and that: (1) relates to accounts or disclosures that are material to the consolidated financial statements and (2) involved our especially challenging, subjective, or complex judgments. The communication of the critical audit matter does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing separate opinions on the critical audit matter or on the accounts or disclosures to which it relates.
Reserve for Excess and Obsolete Inventory
As more fully described in Notes 2 and 3 to the consolidated financial statements, the Company’s consolidated inventory balance was approximately $1.3 million at December 31, 2022. Inventory, consisting of raw materials, work in process and finished goods, is stated at the lower of cost (first-in, first-out) or net realizable value. The Company reserves its inventory for estimated obsolescence or inventory in excess of expected sales or unmarketable inventory, based upon assumptions about future demand and market conditions.
F-2
We identified the valuation of inventories with respect to excess and obsolete inventory as a critical audit matter. Specifically, the determination of the reserve for excess and obsolete inventory requires management to make judgments and assumptions about the future usage and sales of inventory. Auditing these elements involved especially challenging auditor judgment due to the nature and extent of audit effort required to address this matter.
The primary procedures we performed to address this critical audit matter included:
•Evaluating management’s process for establishing a reserve for excess and obsolete inventory by understanding inventory management practices and assessing the appropriateness of management’s estimation.
•Testing the existence of inventory items through the attendance of a physical inventory observation at the selected location.
•Assessing whether any known or knowable factors occurred subsequent to year end that impact management's forecast of future inventory usage by comparing actual sales to forecasted sales for the subsequent period and assessing changes in macroeconomic conditions and scientific receptivity to the technology.
/s/ BDO USA, LLP
We have served as the Company's auditor since 2014.
Los Angeles, California
March 25, 202030, 2023
F-3
HTG Molecular Diagnostics, Inc.
Consolidated Balance Sheets
| | | December 31, | | | December 31, | |
| | 2019 | | | 2018 | | | 2022 | | | 2021 | |
Assets | | | | | | | | | | | | | | |
Current assets: | | | | | | | | | | | | | | |
Cash and cash equivalents | | $ | 7,619,748 | | | $ | 8,432,600 | | | $ | 12,210,857 | | | $ | 9,599,950 | |
Short-term investments available-for-sale, at fair value | | | 25,410,222 | | | | 22,681,049 | | |
Accounts receivable | | | 3,164,176 | | | | 5,012,678 | | |
Inventory, net of allowance of $39,403 at both December 31, 2019 and December 31, 2018 | | | 1,269,667 | | | | 1,306,609 | | |
Restricted cash, current | | | 3,270,247 | | | | — | | |
Investments available-for-sale, at fair value | | | | — | | | | 12,343,456 | |
Accounts receivable, net of allowance of $0 at December 31, 2022
and $20,315 at December 31, 2021 | | | | 1,421,695 | | | | 2,092,466 | |
Inventory, net | | | | 909,328 | | | | 1,987,753 | |
Prepaid expenses and other | | | 633,522 | | | | 519,002 | | | | 1,109,571 | | | | 1,163,339 | |
Total current assets | | | 41,367,582 | | | | 37,951,938 | | | | 15,651,451 | | | | 27,186,964 | |
| | | | | | | | | |
Restricted cash, non-current | | | — | | | | 3,270,247 | | |
Operating lease right-of-use assets | | | 1,209,145 | | | | — | | | | 1,007,202 | | | | 1,345,361 | |
Property and equipment, net | | | 2,240,133 | | | | 2,373,790 | | | | 598,006 | | | | 1,118,886 | |
Other non-current assets | | | 302,409 | | | | 175,305 | | | | 520,996 | | | | 809,476 | |
Total assets | | $ | 45,119,269 | | | $ | 43,771,280 | | | $ | 17,777,655 | | | $ | 30,460,687 | |
| Liabilities and stockholders’ equity | | | | | | | | | | | | | | |
Current liabilities: | | | | | | | | | | | | | | |
Accounts payable | | $ | 1,662,583 | | | $ | 1,849,921 | | | $ | 1,157,449 | | | $ | 1,649,440 | |
Accrued liabilities | | | 1,870,296 | | | | 3,358,465 | | | | 2,209,606 | | | | 2,022,569 | |
Contract liabilities - current | | | 426,014 | | | | 332,711 | | |
Current portion of long-term debt, net of discount and debt issuance costs | | | | 3,812,498 | | | | 5,167,586 | |
NuvoGen obligation - current | | | 1,152,233 | | | | 1,290,234 | | | | 446,031 | | | | 548,301 | |
Convertible note - current, net of debt issuance costs | | | 2,987,667 | | | | — | | |
Operating lease liabilities - current | | | 758,932 | | | | — | | | | 475,126 | | | | 413,865 | |
Other current liabilities | | | 41,134 | | | | 186,043 | | | | 170,047 | | | | 141,749 | |
Total current liabilities | | | 8,898,859 | | | | 7,017,374 | | | | 8,270,757 | | | | 9,943,510 | |
NuvoGen obligation - non-current, net of discount | | | 4,498,777 | | | | 5,702,519 | | | | 3,519,058 | | | | 3,900,880 | |
Convertible note - non-current, net of debt issuance costs | | | — | | | | 2,974,213 | | |
MidCap Term Loan payable - net of discount and debt issuance costs | | | 6,871,545 | | | | 6,704,641 | | |
Operating lease liabilities - non-current | | | 636,340 | | | | — | | |
Long-term debt, net of current portion, discount and debt issuance costs | | | | — | | | | 5,178,629 | |
Operating lease liabilities - non-current, net of discount | | | | 546,324 | | | | 949,461 | |
Other non-current liabilities | | | 244,114 | | | | 280,471 | | | | 49,819 | | | | 88,383 | |
Total liabilities | | | 21,149,635 | | | | 22,679,218 | | | | 12,385,958 | | | | 20,060,863 | |
Commitments and Contingencies (Note 15) | | | | | | | | | | | | | |
Stockholders’ equity: | | | | | | | | | | | | | |
Common stock, $0.001 par value; 200,000,000 shares authorized at December 31, 2019 and December 31, 2018, 58,090,233 shares issued and outstanding at December 31, 2019 and 28,585,449 shares issued and outstanding at December 31, 2018 | | | 58,090 | | | | 28,585 | | |
Series A convertible preferred stock, $0.001 par value; no shares authorized,
issued and outstanding at December 31, 2022; 23,770 shares authorized,
issued and outstanding at December 31, 2021 | | | | — | | | | 24 | |
Common stock, $0.001 par value; 26,666,667 shares authorized at
December 31, 2022 and December 31, 2021; 2,213,897 shares issued
and outstanding at December 31, 2022 and 632,340 shares issued
and outstanding at December 31, 2021 | | | | 2,214 | | | | 632 | |
Additional paid-in-capital | | | 194,234,151 | | | | 172,086,909 | | | | 235,314,311 | | | | 218,730,305 | |
Accumulated other comprehensive loss | | | (4,964 | ) | | | (3,453 | ) | |
Accumulated other comprehensive income | | | | 2,679 | | | | 1,894 | |
Accumulated deficit | | | (170,317,643 | ) | | | (151,019,979 | ) | | | (229,927,507 | ) | | | (208,333,031 | ) |
Total stockholders’ equity | | | 23,969,634 | | | | 21,092,062 | | | | 5,391,697 | | | | 10,399,824 | |
Total liabilities and stockholders' equity | | $ | 45,119,269 | | | $ | 43,771,280 | | | $ | 17,777,655 | | | $ | 30,460,687 | |
The accompanying notes are an integral part of these consolidated financial statements.
F-4
HTG Molecular Diagnostics, Inc.
Consolidated Statements of Operations
| | Years Ended December 31, | | | | | | | | | |
| | 2019 | | | 2018 | | | Years Ended December 31, | |
Revenue: | | | | | | | | | |
Product and product-related services | | $ | 14,632,204 | | | $ | 9,121,390 | | |
Collaborative development services | | | 4,571,684 | | | | 12,382,504 | | |
Total revenue | | | 19,203,888 | | | | 21,503,894 | | |
| | | 2022 | | | 2021 | |
Product and product-related services revenue | | | $ | 6,366,220 | | | $ | 8,906,828 | |
| | | | | | | | | | | | | |
Operating expenses: | | | | | | | | | | | | | |
Cost of product and product-related services revenue | | | 8,911,372 | | | | 5,090,475 | | | | 4,572,134 | | | | 4,094,980 | |
Selling, general and administrative | | | 18,682,396 | | | | 19,974,616 | | | | 15,841,790 | | | | 16,546,740 | |
Research and development | | | 10,570,225 | | | | 12,598,034 | | | | 6,781,892 | | | | 6,088,934 | |
Total operating expenses | | | 38,163,993 | | | | 37,663,125 | | | | 27,195,816 | | | | 26,730,654 | |
Operating loss | | | (18,960,105 | ) | | | (16,159,231 | ) | | | (20,829,596 | ) | | | (17,823,826 | ) |
| | | | | | | | | | | | | |
Other income (expense): | | | | | | | | | | | | | |
Interest expense | | | (957,535 | ) | | | (901,820 | ) | | | (856,731 | ) | | | (1,064,545 | ) |
Interest income | | | 623,355 | | | | 715,723 | | | | 94,355 | | | | 29,884 | |
Loss on extinguishment of Growth Term Loan | | | — | | | | (105,064 | ) | |
Other income | | | | 8,333 | | | | — | |
Gain on forgiveness of PPP Loan | | | | — | | | | 1,735,792 | |
Total other income (expense) | | | (334,180 | ) | | | (291,161 | ) | | | (754,043 | ) | | | 701,131 | |
Net loss before income taxes | | | (19,294,285 | ) | | | (16,450,392 | ) | | | (21,583,639 | ) | | | (17,122,695 | ) |
Provision for income taxes | | | (3,379 | ) | | | (3,526 | ) | | | (10,837 | ) | | | (22,475 | ) |
Net loss | | $ | (19,297,664 | ) | | $ | (16,453,918 | ) | | $ | (21,594,476 | ) | | $ | (17,145,170 | ) |
Net loss per share, basic and diluted | | $ | (0.51 | ) | | $ | (0.60 | ) | | $ | (24.28 | ) | | $ | (29.66 | ) |
Shares used in computing net loss per share, basic and diluted | | | 38,099,687 | | | | 27,523,463 | | | | 889,284 | | | | 578,011 | |
The accompanying notes are an integral part of these consolidated financial statements.
F-5
HTG Molecular Diagnostics, Inc.
Consolidated Statements of Comprehensive Loss
| | | Years Ended December 31, | | | Years Ended December 31, | |
| | 2019 | | | 2018 | | | 2022 | | | 2021 | |
Net loss | | $ | (19,297,664 | ) | | $ | (16,453,918 | ) | | $ | (21,594,476 | ) | | $ | (17,145,170 | ) |
Other comprehensive income (loss), net of tax effect: | | | | | | | | | |
Unrealized gain (loss) on short-term investments | | | 2,299 | | | | (2,308 | ) | |
Other comprehensive loss, net of tax effect: | | | | | | | |
Foreign currency translation adjustment | | | (3,810 | ) | | | (1,145 | ) | | | 785 | | | | (3,404 | ) |
Total other comprehensive loss | | | (1,511 | ) | | | (3,453 | ) | |
Comprehensive loss | | $ | (19,299,175 | ) | | $ | (16,457,371 | ) | | $ | (21,593,691 | ) | | $ | (17,148,574 | ) |
The accompanying notes are an integral part of these consolidated financial statements.
F-5F-6
HTG Molecular Diagnostics, Inc.
Consolidated Statements of Changes in Stockholders’ Equity (Deficit)
| | Common Stock | | | Additional Paid-In | | | Accumulated Other Comprehensive | | | Accumulated | | | Total Stockholders' | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Shares | | | Amount | | | Capital | | | Loss | | | Deficit | | | Equity (Deficit) | | | | Series A Convertible
Preferred Stock | | | Common Stock | | | Additional
Paid-In | | | Accumulated
Other
Comprehensive | | | Accumulated | | | Total
Stockholders' | |
Balance at January 1, 2018 | | | 13,929,763 | | | $ | 13,929 | | | $ | 131,492,595 | | | $ | — | | | $ | (134,566,061 | ) | | $ | (3,059,537 | ) | |
Exercise of stock options | | | 144,645 | | | | 145 | | | | 316,622 | | | | — | | | | — | | | | 316,767 | | |
| | | Shares | | | Amount | | | Shares | | | Amount | | | Capital | | | Income (Loss) | | | Deficit | | | Equity | |
| | | | | | | | | | | | | | | | | | | | | | | | | |
Balance at January 1, 2021 | | | | 23,770 | | | $ | 24 | | | | 433,333 | | | $ | 433 | | | $ | 205,666,766 | | | $ | 5,298 | | | $ | (191,187,861 | ) | | $ | 14,484,660 | |
Stock-based compensation expense | | | — | | | | — | | | | 1,887,764 | | | | — | | | | — | | | | 1,887,764 | | | | — | | | | — | | | | — | | | | — | | | | 1,317,351 | | | | — | | | | — | | | | 1,317,351 | |
Release of restricted stock awards | | | 291,010 | | | | 291 | | | | — | | | | — | | | | — | | | | 291 | | | | — | | | | — | | | | 377 | | | | 1 | | | | 3 | | | | — | | | | — | | | | 4 | |
Net share settlement of restricted stock award | | | (38,582 | ) | | | (39 | ) | | | (150,709 | ) | | | — | | | | — | | | | (150,748 | ) | |
Net share settlement of restricted stock awards | | | | — | | | | — | | | | (50 | ) | | | — | | | | (3,239 | ) | | | — | | | | — | | | | (3,239 | ) |
Employee stock purchase plan expense | | | | — | | | | — | | | | — | | | | — | | | | 57,669 | | | | — | | | | — | | | | 57,669 | |
Stock issued under stock purchase plans | | | 82,261 | | | | 82 | | | | 199,792 | | | | — | | | | — | | | | 199,874 | | | | — | | | | — | | | | 2,830 | | | | 3 | | | | 125,825 | | | | — | | | | — | | | | 125,828 | |
Issuance of common stock from ATM Offering, net of issuance costs of $17,000 | | | 261,352 | | | | 262 | | | | 556,444 | | | | — | | | | — | | | | 556,706 | | |
Issuance of common stock from underwritten public offering, net of underwriting discounts, commissions and issuance costs of $2.6 million | | | 13,915,000 | | | | 13,915 | | | | 37,710,401 | | | | — | | | | — | | | | 37,724,316 | | |
Issuance of common stock warrants in connection with MidCap Term Loan | | | — | | | | — | | | | 74,000 | | | | — | | | | — | | | | 74,000 | | |
Issuance of common stock from ATM Offering, net of commissions of approximately $0.3 million | | | | — | | | | — | | | | 170,907 | | | | 171 | | | | 10,665,648 | | | | — | | | | — | | | | 10,665,819 | |
Issuance of common stock in connection with LP Purchase Agreement | | | | — | | | | — | | | | 12,864 | | | | 12 | | | | 899,968 | | | | — | | | | — | | | | 899,980 | |
Exercise of September 2019 Securities Purchase Agreement pre-funded warrants | | | | — | | | | — | | | | 12,073 | | | | 12 | | | | (12 | ) | | | — | | | | — | | | | — | |
Exercise of stock options | | | | — | | | | — | | | | 6 | | | | — | | | | 326 | | | | — | | | | — | | | | 326 | |
Net loss | | | — | | | | — | | | | — | | | | — | | | | (16,453,918 | ) | | | (16,453,918 | ) | | | — | | | | — | | | | — | | | | — | | | | — | | | | — | | | | (17,145,170 | ) | | | (17,145,170 | ) |
Unrealized loss on short-term investments | | | — | | | | — | | | | — | | | | (2,308 | ) | | | — | | | | (2,308 | ) | |
Foreign currency translation adjustment | | | — | | | | — | | | | — | | | | (1,145 | ) | | | — | | | | (1,145 | ) | | | — | | | | — | | | | — | | | | — | | | | — | | | | (3,404 | ) | | | — | | | | (3,404 | ) |
Balance at December 31, 2018 | | | 28,585,449 | | | $ | 28,585 | | | $ | 172,086,909 | | | $ | (3,453 | ) | | $ | (151,019,979 | ) | | $ | 21,092,062 | | |
Exercise of stock options | | | 54,256 | | | | 54 | | | | 120,900 | | | | — | | | | — | | | | 120,954 | | |
Balance at December 31, 2021 | | | | 23,770 | | | $ | 24 | | | | 632,340 | | | $ | 632 | | | $ | 218,730,305 | | | $ | 1,894 | | | $ | (208,333,031 | ) | | $ | 10,399,824 | |
Stock-based compensation expense | | | — | | | | — | | | | 1,156,486 | | | | — | | | | — | | | | 1,156,486 | | | | — | | | | — | | | | — | | | | — | | | | 774,160 | | | | — | | | | — | | | | 774,160 | |
Release of restricted stock awards | | | 81,462 | | | | 81 | | | | — | | | | — | | | | — | | | | 81 | | | | — | | | | — | | | | 1,139 | | | | 1 | | | | (1 | ) | | | — | | | | — | | | | — | |
Net share settlement of restricted stock award | | | (16,927 | ) | | | (17 | ) | | | (30,887 | ) | | | — | | | | — | | | | (30,904 | ) | |
Net share settlement of restricted stock awards | | | | — | | | | — | | | | (355 | ) | | | — | | | | (11,190 | ) | | | — | | | | — | | | | (11,190 | ) |
Employee stock purchase plan expense | | | | — | | | | — | | | | — | | | | — | | | | 40,347 | | | | — | | | | — | | | | 40,347 | |
Stock issued under stock purchase plans | | | 87,456 | | | | 88 | | | | 171,102 | | | | — | | | | — | | | | 171,190 | | | | — | | | | — | | | | 6,876 | | | | 7 | | | | 37,560 | | | | — | | | | — | | | | 37,567 | |
Issuance of common stock from underwritten public and private offerings, net of underwriting discounts, commissions and issuance costs of $1.7 million | | | 29,298,537 | | | | 29,299 | | | | 20,729,641 | | | | — | | | | — | | | | 20,758,940 | | |
Conversion of Series A convertible preferred stock for common stock | | | | (23,770 | ) | | | (24 | ) | | | 13,206 | | | | 13 | | | | 11 | | | | — | | | | — | | | | — | |
Issuance of common stock and pre-funded warrants from March 2022 Securities Purchase Agreement, net of issuance costs of approximately $0.5 million | | | | — | | | | — | | | | 69,505 | | | | 70 | | | | 7,033,979 | | | | — | | | | — | | | | 7,034,049 | |
Issuance of common stock and pre-funded warrants from December 2022 Securities Purchase Agreement, net of commissions and issuance costs of approximately $1.3 million | | | | — | | | | — | | | | 102,000 | | | | 102 | | | | 8,707,297 | | | | — | | | | — | | | | 8,707,399 | |
Exercise of March 2022 Securities Purchase Agreement pre-funded warrants | | | | — | | | | — | | | | 200,911 | | | | 201 | | | | 2,210 | | | | — | | | | — | | | | 2,411 | |
Exercise of December 2022 Securities Purchase Agreement pre-funded warrants | | | | — | | | | — | | | | 1,188,322 | | | | 1,188 | | | | — | | | | — | | | | — | | | | 1,188 | |
Cash in lieu of fractional shares related to reverse stock split | | | | — | | | | — | | | | (47 | ) | | | — | | | | (367 | ) | | | — | | | | — | | | | (367 | ) |
Net loss | | | — | | | | — | | | | — | | | | — | | | | (19,297,664 | ) | | | (19,297,664 | ) | | | — | | | | — | | | | — | | | | — | | | | — | | | | — | | | | (21,594,476 | ) | | | (21,594,476 | ) |
Unrealized gain on short-term investments | | | — | | | | — | | | | — | | | | 2,299 | | | | — | | | | 2,299 | | |
Foreign currency translation adjustment | | | — | | | | — | | | | — | | | | (3,810 | ) | | | — | | | | (3,810 | ) | | | — | | | | | | | — | | | | — | | | | — | | | | 785 | | | | — | | | | 785 | |
Balance at December 31, 2019 | | | 58,090,233 | | | $ | 58,090 | | | $ | 194,234,151 | | | $ | (4,964 | ) | | $ | (170,317,643 | ) | | $ | 23,969,634 | | |
Balance at December 31, 2022 | | | | - | | | $ | - | | | | 2,213,897 | | | $ | 2,214 | | | $ | 235,314,311 | | | $ | 2,679 | | | $ | (229,927,507 | ) | | $ | 5,391,697 | |
The accompanying notes are an integral part of these consolidated financial statements.
F-7
HTG Molecular Diagnostics, Inc.
Consolidated Statements of Cash Flows
| | | | | | | | |
| | Years Ended December 31, | |
| | 2022 | | | 2021 | |
Operating activities | | | | | | |
Net loss | | $ | (21,594,476 | ) | | $ | (17,145,170 | ) |
Adjustments to reconcile net loss to net cash used in operating activities: | | | | | | |
Depreciation and amortization | | | 587,138 | | | | 721,246 | |
Accretion of interest on NuvoGen obligation | | | (11,467 | ) | | | (12,288 | ) |
Provision for excess inventory | | | 1,211,114 | | | | 174,589 | |
Amortization of SVB Term Loan discount and issuance costs | | | 412,857 | | | | 470,281 | |
Stock-based compensation expense | | | 774,160 | | | | 1,317,355 | |
Employee stock purchase plan expense | | | 40,347 | | | | 57,669 | |
Bad debt expense | | | — | | | | 20,315 | |
Non-cash operating lease expense | | | 415,544 | | | | 458,001 | |
Accrued interest on available-for-sale securities investments | | | 4,179 | | | | (25,018 | ) |
Gain on forgiveness of PPP Loan | | | — | | | | (1,735,792 | ) |
(Gain) loss on abandonment and disposal of assets, net | | | (104,000 | ) | | | 180,008 | |
Changes in operating assets and liabilities: | | | | | | |
Accounts receivable | | | 670,771 | | | | (805,736 | ) |
Inventory | | | 140,828 | | | | (1,365,384 | ) |
Prepaid expenses and other | | | 110,976 | | | | 619,226 | |
Accounts payable | | | (525,175 | ) | | | 453,337 | |
Accrued liabilities | | | (135,890 | ) | | | 616,447 | |
Contract liabilities | | | 14,564 | | | | (38,314 | ) |
Operating lease liabilities | | | (419,261 | ) | | | (469,326 | ) |
Net cash used in operating activities | | | (18,407,791 | ) | | | (16,508,554 | ) |
Investing activities | | | | | | |
Purchase of property and equipment | | | (23,044 | ) | | | (644,381 | ) |
Proceeds from the sale of property and equipment | | | 104,000 | | | | — | |
Maturities of available-for-sale securities | | | 19,950,000 | | | | 12,600,000 | |
Purchase of available-for-sale securities | | | (7,610,723 | ) | | | (18,620,363 | ) |
Net cash (used in) provided by investing activities | | | 12,420,233 | | | | (6,664,744 | ) |
Financing activities | | | | | | |
Proceeds from ATM Offering, net of commissions of approximately $0.3 million | | | — | | | | 10,665,819 | |
Proceeds from March 2022 Securities Purchase Agreement, net of issuance costs of approximately $0.5 million | | | 7,034,049 | | | | — | |
Proceeds from LP Purchase Agreement | | | — | | | | 899,980 | |
Payments on NuvoGen obligation | | | (472,625 | ) | | | (530,656 | ) |
Payments on SVB Term Loan | | | (6,764,706 | ) | | | — | |
Payments on SVB Term Loan Amendment issuance costs | | | (14,282 | ) | | | — | |
Payments on deferred offering costs | | | (80,692 | ) | | | — | |
Payments on financing leases | | | (16,804 | ) | | | (22,563 | ) |
Proceeds from exercise of stock options | | | — | | | | 326 | |
Taxes paid for net share settlement of restricted stock awards | | | (11,190 | ) | | | (3,239 | ) |
Proceeds from shares purchased under stock purchase plans | | | 37,567 | | | | 125,828 | |
Proceeds from exercise of March 2022 Securities Purchase Agreement pre-funded warrants | | | 2,411 | | | | — | |
Proceeds from December 2022 Securities Purchase Agreement, net of commissions and issuance costs of approximately $0.9 million | | | 9,057,857 | | | | — | |
Proceeds from exercise of December 2022 Securities Purchase Agreement pre-funded warrants | | | 1,188 | | | | — | |
Cash in lieu of fractional shares related to reverse stock split | | | (367 | ) | | | — | |
Proceeds from insurance note | | | 822,889 | | | | — | |
Payments on insurance notes | | | (990,475 | ) | | | (743,873 | ) |
Net cash provided by financing activities | | | 8,604,820 | | | | 10,391,622 | |
Effect of exchange rates on cash | | | (6,355 | ) | | | (16,186 | ) |
Increase (decrease) in cash and cash equivalents | | | 2,610,907 | | | | (12,797,862 | ) |
Cash and cash equivalents at beginning of year | | | 9,599,950 | | | | 22,397,812 | |
Cash and cash equivalents at end of year | | $ | 12,210,857 | | | $ | 9,599,950 | |
Supplemental disclosure of noncash investing and financing activities | | | | | | |
Fixed asset purchases payable at year end | | $ | 6,238 | | | $ | — | |
Issuance costs payable and accrued at year end | | | 350,458 | | | | — | |
Issuance of common stock upon conversion of Series A convertible preferred stock | | | 1,402,430 | | | | — | |
Issuance of common stock from cashless exercise of pre-funded warrants | | | — | | | | 12 | |
2021 Insurance Note issued for insurance premiums | | | — | | | | 746,360 | |
Gain on forgiveness of PPP Loan | | | — | | | | 1,735,792 | |
Operating lease right-of-use assets obtained in exchange for operating lease liabilities | | | 77,385 | | | | 1,302,457 | |
Carrying value of demonstration units transferred from property and equipment to inventory | | | — | | | | 16,128 | |
Disposal of fully depreciated assets | | | 1,075,715 | | | | 635,870 | |
Reclassification of instrument from inventory to property and equipment | | | 36,976 | | | | — | |
Supplemental cash flow information | | | | | | |
Cash paid for interest | | $ | 477,625 | | | $ | 599,922 | |
Cash paid for taxes | | | 8,973 | | | | 12,665 | |
| | Years Ended December 31, | |
| | 2019 | | | 2018 | |
Operating activities | | | | | | | | |
Net loss | | $ | (19,297,664 | ) | | $ | (16,453,918 | ) |
Adjustments to reconcile net loss to net cash used in operating activities: | | | | | | | | |
Depreciation and amortization | | | 1,259,015 | | | | 1,468,121 | |
Accretion of discount on NuvoGen obligation | | | (13,821 | ) | | | (12,480 | ) |
Provision for excess inventory | | | 153,729 | | | | 83,218 | |
Amortization of Growth Term Loan discount and issuance costs | | | — | | | | 62,951 | |
Loss on extinguishment of Growth Term Loan | | | — | | | | 105,064 | |
Write-off of ATM offering costs | | | 108,883 | | | | — | |
Amortization of QNAH Convertible Note issuance costs | | | 13,454 | | | | 13,453 | |
Amortization of MidCap Credit Facility discount and issuance costs | | | 183,002 | | | | 133,963 | |
Stock-based compensation expense | | | 1,156,567 | | | | 1,888,055 | |
Employee stock purchase plan expense | | | 66,238 | | | | 58,959 | |
Amortization of operating lease right-of-use assets | | | 476,789 | | | | — | |
Amortization of incentive from landlord | | | — | | | | (142,000 | ) |
Accrued interest on available-for-sale securities investments | | | (325,666 | ) | | | (412,436 | ) |
Loss on disposal of assets | | | 9,051 | | | | 8,104 | |
Changes in operating assets and liabilities: | | | | | | | | |
Accounts receivable | | | 1,848,502 | | | | 1,332,030 | |
Inventory | | | (116,787 | ) | | | (171,909 | ) |
Prepaid expenses and other | | | (177,307 | ) | | | (113,581 | ) |
Deferred offering costs | | | — | | | | 2,953 | |
Accounts payable | | | (155,974 | ) | | | (150,176 | ) |
Accrued liabilities | | | (1,440,065 | ) | | | (447,351 | ) |
Contract liabilities | | | 188,507 | | | | (426,938 | ) |
Operating lease liabilities | | | (632,389 | ) | | | — | |
Net cash used in operating activities | | | (16,695,936 | ) | | | (13,173,918 | ) |
Investing activities | | | | | | | | |
Purchase of property and equipment | | | (1,103,176 | ) | | | (949,514 | ) |
Sales, redemptions and maturities of available-for-sale securities | | | 32,200,000 | | | | 31,700,000 | |
Purchase of available-for-sale securities | | | (34,601,208 | ) | | | (53,970,921 | ) |
Net cash used in investing activities | | | (3,504,384 | ) | | | (23,220,435 | ) |
Financing activities | | | | | | | | |
Proceeds from MidCap Credit Facility | | | — | | | | 7,000,000 | |
MidCap Credit Facility lender fees | | | — | | | | (422,390 | ) |
Payments on Growth Term Loan | | | — | | | | (1,684,626 | ) |
Payments for extinguishment of Growth Term Loan | | | — | | | | (4,276,988 | ) |
Proceeds from 2018 underwritten public offering, net of underwriting discounts, commissions and issuance costs of $2.6 million | | | — | | | | 37,724,316 | |
Proceeds from 2019 underwritten public and private offerings, net of underwriting discounts, commissions and issuance costs of $1.7 million | | | 20,758,940 | | | | — | |
Proceeds from ATM Offering, net | | | — | | | | 556,706 | |
Payments on NuvoGen obligation | | | (1,327,922 | ) | | | (1,012,122 | ) |
Payments on financing leases | | | (44,043 | ) | | | (62,085 | ) |
Proceeds from exercise of stock options | | | 120,954 | | | | 316,767 | |
Taxes paid for net share settlement of restricted stock awards | | | (30,904 | ) | | | (150,748 | ) |
Proceeds from shares purchased under stock purchase plans | | | 104,952 | | | | 140,915 | |
Payment of deferred offering costs | | | (190,173 | ) | | | — | |
Net cash provided by financing activities | | | 19,391,804 | | | | 38,129,745 | |
| | | | | | | | |
Effect of exchange rates on cash | | | (4,336 | ) | | | (1,145 | ) |
| | | | | | | | |
(Decrease) increase in cash, cash equivalents and restricted cash | | | (812,852 | ) | | | 1,734,247 | |
Cash, cash equivalents and restricted cash at beginning of year | | | 11,702,847 | | | | 9,968,600 | |
Cash, cash equivalents and restricted cash at end of year | | $ | 10,889,995 | | | $ | 11,702,847 | |
| | | | | | | | |
Supplemental disclosure of noncash investing and financing activities | | | | | | | | |
Fixed asset purchases payable and accrued at period end | | $ | 8,299 | | | $ | 39,265 | |
Adoption of ASC 842, Leases | | | 694,352 | | | | — | |
Operating lease right-of-use assets obtained in exchange for operating lease liabilities | | | 1,005,085 | | | | — | |
Financing lease right-of-use assets obtained in exchange for financing lease liabilities | | | 63,406 | | | | — | |
Equipment purchased through capital leases | | | — | | | | 71,709 | |
Carrying value of demonstration units transferred from property and equipment to inventory | | | — | | | | 49,245 | |
Debt issuance costs payable and accrued at period end | | | — | | | | 59,030 | |
MidCap Term Loan fees and warrant discount | | | — | | | | 389,000 | |
Supplemental cash flow information | | | | | | | | |
Cash paid for interest | | $ | 686,042 | | | $ | 553,070 | |
Cash paid for taxes | | | 3,379 | | | | 3,545 | |
The accompanying notes are an integral part of these consolidated financial statements.
F-8
HTG Molecular Diagnostics, Inc.
Notes to Consolidated Financial Statements
Note 1. Description of Business and Basis of Presentation and Principles of Consolidation
HTG Molecular Diagnostics, Inc. (the “Company”) is a provider of instruments, reagentslife science company whose mission is to advance precision medicine through its innovative transcriptome-wide profiling technology and services for molecular profiling applications.advanced medicinal chemistry technology. The Company derives revenue primarily from sales of its HTG EdgeSeq automation system and integrated next-generation sequencing-based (“NGS-based”) HTG EdgeSeq assays, from services including sample processing and custom research use only (“RUO”) assay developmentassays and from collaborative development services.sample processing services performed in its VERI/O laboratory.
The Company operates in one segment and its customers and distributors are located primarily in the United States and Europe. Revenue is reported based upon the geographic locations of the customers or distributors who purchase the Company's products and services. For sales to distributors, their locations may be different from the locations of the end customers. For the year ended December 31, 2019,2022, approximately 34%35% of the Company’s revenue was generated from sales originated by customers located outside of the United States, compared with 69%31% for the year ended December 31, 2018. Approximately 69% and 84% of the sales to customers located outside of the United States resulted from collaborative development services revenue generated through the Master Assay Development, Commercialization and Manufacturing Agreement (the “Governing Agreement”), with QIAGEN Manchester Limited (“QML”), a wholly owned subsidiary of QIAGEN N.V. (see Note 9), for the years ended December 31, 2019 and 2018, respectively.2021.
Basis of Presentation
The consolidated financial statements and accompanying notes were prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”).In December 2022, the Company completed a reverse stock split of its outstanding shares of common stock pursuant to which every twelve shares of issued and outstanding common stock were exchanged for one share of common stock. All share and per share amounts within the consolidated financial statements and notes thereto have been adjusted to reflect the reverse stock split for all periods and dates presented. See Note 14 for more information about the Company’s reverse stock split.
Principles of Consolidation
The Company formed a French subsidiary, HTG Molecular Diagnostics France SARL, (“HTG France”), in November 2018. The consolidated financial statements include the accounts of the Company and this wholly owned subsidiary after elimination of intercompany transactions and balances as of December 31, 20192022 and 2018.2021.
Going Concern andLiquidity
Reclassifications
Certain priorManagement has assessed the Company’s ability to continue as a going concern within one year amountsof issuance of these consolidated financial statements. The accompanying consolidated financial statements have been reclassified for consistencyprepared assuming that the Company will continue as a going concern, which contemplates the realization of the assets and satisfaction of liabilities in the normal course of business. However, the Company has had recurring operating losses and negative operating cash flows since its inception and has an accumulated deficit of approximately $229.9 million as of December 31, 2022. As of December 31, 2022, the Company had working capital of approximately $7.4 million and long-term liabilities of approximately $4.1 million. The Company’s liability balances consist primarily of its debt obligations, including an asset-secured loan with Silicon Valley Bank (currently named Silicon Valley Bridge Bank, N.A. following the current period presentation. These reclassifications had no effectclosure of Silicon Valley Bank on March 10, 2023 by the reported resultsCalifornia Department of operations.
Liquidity
Financial Protection and Innovation, which appointed the Federal Deposit Insurance Corporation ("FDIC") as receiver) (“SVB”), as lender, (the “SVB Term Loan”) (see Note 8), as well as an obligation to NuvoGen Research, LLC (the “NuvoGen obligation”) (see Note 10). The Company currently expects that its existing resources will be sufficient to fund its planned operations and expenditures until at least July 2023. In addition, potentially changing circumstances, including those related to a resurgence of COVID-19, inflation and high interest rates, may result in the depletion of the Company’s capital resources more rapidly than it currently anticipates. These circumstances raise substantial doubt about the Company’s ability to continue as a going concern. The accompanying consolidated financial statements do not include any adjustments that may result from the outcome of these uncertainties.
F-9
The Company will need to raise additional capital to fund its operations and service its near and long-term debt obligations until its revenue reaches a level sufficient to provide for self-sustaining cash flows. There can be no assurance that additional capital will be available on acceptable terms, or at all, or that the Company’s revenue will reach a level sufficient to provide for self-sustaining cash flows. If sufficientthe Company is not able to generate additional capital, is not available as and when needed, the Company may have to delay, scale back or discontinue one or more productof its therapeutics development programs, curtail its commercializationcommercial activities, significantly reduce expenses, sell assets (potentially at a discount to their fair value or carrying value), enter into relationships with third parties to develop or commercialize products or technologies that the Company otherwise would have sought to develop or commercialize independently, cease operations altogether, pursue a sale of the Company at a price that may result in a significant loss on investment for its stockholders, file for bankruptcy or seek other protection from creditors, or liquidate all assets.creditors. In addition, if the Company defaults under its term loan agreement, its lendersany of the provisions of the Loan and Security Agreement for the SVB Term Loan (the "Loan Agreement"), SVB could charge an interest rate of 5% above the otherwise applicable floating rate, accelerate the payment of the SVB Term Loan and ultimately foreclose on the Company’s assets.
COVID-19 Pandemic and Relief
The Company experienced a significant slowing of product and product-related services revenue generation beginning in March 2020 as a result of COVID-19. The extent of this impact has varied from customer to customer depending upon how they have been directly or indirectly impacted by local stay-at-home orders and other social distancing measures, how they have prioritized studies and previously planned trials as the immediate impacts of the pandemic have passed, and how significantly their workforces and supplier networks have been impacted by the pandemic. The Company has not experienced delays in development even with its assets, including someefforts to prioritize the safety of its cashemployees during the pandemic. In addition, the impact of COVID-19 on the Company’s ability to source raw materials and cash equivalents, whichother supplies has not been significant to date. However, a change in or loss of suppliers or other supply chain or distribution network partners due to the ongoing impacts of the pandemic or a resurgence of COVID-19 on the global economy could adversely affect the Company’s business and the business of its vendors, partners and customers, and could result in future reductions in sales and operating results.
While there remains uncertainty as to the future impact of COVID-19, the Company has considered the known impacts on its business as of the date these consolidated financial statements were issued and has reflected any known or expected impacts in its consolidated financial statements, including consideration of potential impairment risks to its long-lived assets, potential accounts receivable collection risks and potential impacts to its overall liquidity position.
As a result of various government programs enacted to address the ongoing impacts of COVID-19, the Company was able to qualify for and receive Employee Retention Credits (“ERC”) during the year ended December 31, 2021. ERC benefits of approximately $0.5 million, $0.8 million, and $0.4 million were included in cost of product and product-related services revenue, selling, general and administrative and research and development, respectively, as an offset to the related compensation costs in the accompanying consolidated statements of operations for the year ended December 31, 2021. In November 2021, the Infrastructure Investment and Jobs Act was signed into law, making wages paid after September 30, 2021 ineligible for these credits. As such, no further ERC benefits were received for the year ended December 31, 2022.ERC benefits receivable of approximately $0.4 million were included in prepaid expenses and other in the accompanying consolidated balance sheets as of both December 31, 2022 and 2021.
In April 2020, the Company received proceeds from a loan pursuant to the Paycheck Protection Program (“PPP”) of the CARES Act (the “PPP Loan”) in the amount of approximately $1.7 million from SVB, as lender. The Company applied for full forgiveness of the PPP Loan in October 2020. In May 2021, the Company received notification that the PPP Loan and related interest, totaling approximately $1.7 million, were forgiven by the U.S. Small Business Administration (“SBA”), and that the PPP Loan had been canceled. Accordingly, the Company recorded a gain on forgiveness of the PPP Loan for the year ended December 31, 2021, included in other income (expense) in the accompanying consolidated statements of operations.
Laws and regulations concerning government programs, including the ERC and PPP Loan, are heldcomplex and subject to varying interpretations. Claims made under these programs may also be subject to retroactive audit and review. While the Company does not believe there is a basis for estimation of an audit or recapture risk at this time, there can be no assurance that regulatory authorities will not challenge the Company’s claim to the ERC or PPP Loan in accounts with other financial institutions. a future period.
F-10
Note 2. Summary of Significant Accounting Policies
Use of Estimates
The preparation of the consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, and disclosures of contingent assets and liabilities at the date of the consolidated financial statements, and the reported amounts of revenues and expenses during the reporting period. The Company’s significant estimates include revenue recognition, stock-based compensation expense, bonus and warranty accrual, income tax valuation allowances and reserves, recovery of long‑lived assets, lease liability, inventory obsolescencevaluation, allowance for doubtful accounts and inventory valuation.available-for-sale securities. Actual results could materially differ from those estimates.
Cash and Cash Equivalents
The Company considers all highly liquid investments with an original maturity of three months or less to be cash equivalents. Cash and cash equivalents consist of cash on deposit with financial institutions, commercial paper, money market instruments and high credit quality corporate debt securities purchased with a term of three months or less.
Accounts Receivable
Accounts receivable represent valid claims against debtors. Management reviews accounts receivable regularly to determine, using the specific identification method, if any receivable amounts will potentially be uncollectible and to estimate the amount of allowance for doubtful accounts necessary to reduce accounts receivable to its estimated net realizable value.
Investments in Available-for-Sale Securities
Investments
The Company classifies its debt securities, as available-for-sale, which are reported at estimated fair value with unrealized gains and losses included in accumulated other comprehensive loss,income, net of tax.tax, as available-for-sale securities. Investments in securities with maturities of less than one year, or where management’s intent is to use the investments to fund current operations, or to make them available for current operations, are classified as short-term investments. Realized gains, realized losses and declines in value of securities judged to be other-than-temporary, are included in other income (expense) within the accompanying consolidated statements of operations. The cost of investments for purposes of computing realized and unrealized gains and losses is based on the specific identification method. Interest earned on all securities is also included in other income (expense) within the accompanying consolidated statements of operations. Investments
The Company recognizes other-than-temporary impairment (“OTTI”) of a debt security for which there has been a decline in securities with maturities of less than one year, or where management’s intent is to use the investments to fund current operations, or to make them available for current operations, are classified as short-term investments.
If the estimated fair value of abelow amortized cost if (i) management intends to sell the security, is below its carrying value, the Company evaluates whether(ii) it is more likely than not that itthe Company will be required to sell the security before recovery of its anticipated recovery in market value and whether evidence indicating that theamortized cost of the investment is recoverable within a reasonable period of time outweighs evidence to the contrary. The Company also evaluates whetherbasis, or not it intends to sell the investment. If the impairment is considered to be other-than-temporary, the security is written down to its estimated fair value. In addition,(iii) the Company considers whether credit losses exist for any securities. A credit loss exists ifdoes not expect to recover the present value of cash flows expected to be collected is less than theentire amortized cost basis of the security. Other-than-temporary declines in estimatedThe amount by which amortized cost exceeds the fair value of a debt security that is considered to have OTTI is separated into a component representing the credit loss, which is recognized in earnings, and a component related to all other factors, which is recognized in other comprehensive loss. The measurement of the credit losses are charged against other income (expense).
Restricted Cash
The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the accompanying consolidated balance sheets that sumloss component is equal to the totaldifference between the debt security’s amortized cost basis and the present value of its expected future cash flows discounted at the security’s effective yield. If the Company intends to sell the security, or if it is more likely than not it will be required to sell the security before recovery, an OTTI write-down is recognized in earnings equal to the entire difference between the amortized cost basis and fair value of the same such amounts shown in the accompanying consolidated statements of cash flows.
| | December 31, | |
| | 2019 | | | 2018 | |
Cash and cash equivalents | | $ | 7,619,748 | | | $ | 8,432,600 | |
Restricted cash, current | | | 3,270,247 | | | | — | |
Restricted cash, non-current | | | — | | | | 3,270,247 | |
Total cash, cash equivalents and restricted cash shown in the consolidated statements of cash flows | | $ | 10,889,995 | | | $ | 11,702,847 | |
In October 2017,security. As the Company received $3.0 million in gross proceeds from,did not have available-for-sale securities as of December 31, 2022 and issued a subordinated convertible promissory note (the “QNAH Convertible Note”) in that principal amount to, QIAGEN North American Holdings, Inc. (“QNAH”). Amounts included in restricted cash represent those required to be set aside in escrow under the termsdid not have any unrealized losses as of the MidCap Term Loan to collateralize the payment that will be due upon maturityDecember 31, 2021, there was no OTTI of the QNAH Convertible Note (see Note 8). The amounts will be released to the Company upon subsequent deliveryits available-for-sale securities as of subordination documents for the QNAH Convertible Note to MidCap or conversion of the QNAH Convertible Note. If neither occurs, the amounts will be applied by the escrow agent to repay in full the QNAH Convertible Note at maturity (or in connection with a prepayment at the direction of the Company after September 1, 2020) subject to the terms of the MidCap Term Loan including (i) having at least $18.0 million of unrestricted cash and cash equivalents and (ii) there being no default under the MidCap Credit Facility.either balance sheet date.
F-11
Fair Value of Financial Instruments
Fair value measurements are based on the premise that fair value is an exit price representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions, the following three-tier fair value hierarchy has been used in determining the inputs used in measuring fair value:
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Level 1 |
| – |
| Quoted prices in active markets for identical assets or liabilities on the reporting date. |
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Level 2 |
| – |
| Pricing inputs are based on quoted prices for similar instruments in active markets, quoted prices for identical or similar instruments in markets that are not active and model-based valuation techniques for which all significant assumptions are observable in the market or can be corroborated by observable market data for substantially the full term of the assets or liabilities. |
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Level 3 |
| – |
| Pricing inputs are generally unobservable and include situations where there is little, if any, market activity for the investment. The inputs into the determination of fair value require management’s judgment or estimation of assumptions that market participants would use in pricing the assets or liabilities. The fair values are therefore determined using factors that involve considerable judgment and interpretations, including but not limited to private and public comparables, third-party appraisals, discounted cash flow models, and fund manager estimates. |
The carrying value of financial instruments classified as current assets and current liabilities approximate fair value due to their liquidity and short-term nature. Investments that are classified as available-for-sale are recorded at fair value, which wasis determined using quoted market prices, broker or dealer quotations or alternative pricing sources with reasonable levels of price transparency. The carrying value of the MidCapSVB Term Loan (see Note 8) is estimated to approximate its fair value as the interest rate approximates the market rate for debt securities with similar terms and risk characteristics.
As of December 31, 2019, the estimated aggregate fair value of the QNAH Convertible Note with QNAH is approximately $3.0 million, based on a discounted cash flow approach and utilizing an option pricing model to value the conversion feature, with key assumptions including expected volatility, discount rates, term and risk-free rates.
The NuvoGen obligation is an obligation relatingrelates to an asset purchase transaction with a then-common stockholder of the Company.Company (see Note 10). As of December 31, 2019,2022, the estimated aggregate fair value of the NuvoGen obligation is approximately $5.1$3.9 million, determined using a Monte Carlo simulation with key assumptions including future revenue, volatility, discount and risk-free rates.
The estimated fair valuesvalue of the QNAH Convertible Note and the NuvoGen obligation representrepresents a Level 3 measurements.measurement.
Inventory
Inventory net
Inventory, consisting of raw materials, work in process and finished goods, is stated at the lower of cost (first-in, first-out) or net realizable value. Cost is determined using a standard cost system, whereby the standard costs are updated periodically to reflect current costs and net realizable value represents the lower of replacement cost or estimated net realizable value. The Company reserves or writes down its inventory for estimated obsolescence or inventory in excess of reasonably expected near term sales or unmarketable inventory, in an amount equal to the difference betweendetermines the cost of inventory using the first-in, first out method. The Company estimates the recoverability of inventory by reference to internal estimates of future demands and product life cycles, including expiration. The Company periodically analyzes its inventory levels to identify inventory that may expire prior to expected sale or has a cost basis in excess of its estimated realizable value and records a charge to expense for such inventory as appropriate. The Company classifies inventory as long-term when it expects to utilize the estimated marketinventory beyond its normal operating cycle.
The Company charges cost of sales for inventory provisions to write-down our inventory to the lower of cost or net realizable value or for obsolete or excess inventory. Most of its inventory provisions relate to excess quantities of products, based uponon our inventory levels and future product purchase commitments compared to assumptions about future demand and market conditions. If actual market conditions are less favorable than those projected by the Company, additionalOnce inventory write-downs may be required. Inventory impairment charges establishhas been written-off or written-down, it creates a new cost basis for the inventory and charges arethat is not reversed subsequently to income, even if circumstances later suggest that increased carrying amounts are recoverable.written-up, any increase in demand forecasted or inventory value of such inventory is not realized until such inventory is sold.
Equipment that is under evaluation for purchase remains in inventory as the Company maintains title to the equipment throughout the evaluation period. The period of time customers use to evaluate the Company’s equipment generally ranges from 90 to 180 days, and in certain circumstances the evaluation period may need to be extended beyond that period. However, in no case will the evaluation period exceed one year. If the customer has not purchased the equipment or entered into a reagent rental agreement with the Company after evaluating the product for one year, the equipment is returned to the Company or the customer is allowed to continue use of the equipment, in which case the equipment is written off to selling, general and administrative expense in the accompanying consolidated statements of operations. HTG EdgeSeq instruments at customer locations under evaluation agreements are included in finished goods inventory. Finished goods inventory under evaluation was approximately $0.1 million and $0.2 million as of December 31, 2019 was $79,338 compared to $143,271 as of December 31, 2018.2022 and 2021, respectively.
F-12
Property and Equipment net
Property and equipment are stated at historical cost and depreciated over their useful lives, which range from three to five years, using the straight-line method. Equipment used in the field is amortized using the straight-line method over the lesser of the period of the related reagent rental or collaborative development services agreement where applicable or the estimated useful life. Leasehold improvements are amortized using the straight-line method over the lesser of the remaining lease term or the estimated useful life.
Costs incurred in the development and installation of software for internal use and in the development of the Company’s website are expensed or capitalized, depending on whether they are incurred in the preliminary project stage (expensed), application development stage (capitalized), or post-implementation stage (expensed). Amounts capitalized following project completion are amortized on a straight-line basis over the useful life of the developed asset, which is generally three years.years.
Long-lived assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of the asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset group to the estimated undiscounted future cash flows expected to be generated by the asset group. If the carrying amount of an asset group exceeds its estimated future cash flow, an impairment charge is recognized in the amount by which the carrying amount of the asset group exceeds the fair value of the asset group. Although the Company has accumulated losses since inception, the Company believes the future cash flows will be sufficient to exceed the carrying value of the Company’s long-lived assets. There were no impairments of long-lived assets during the years ended December 31, 20192022 and 2018.2021.
Leases
Leases
Effective January 1, 2019, the Company accounts for its leases under Financial Accounting Standards Board (“FASB”), Accounting Standards Codification (“ASC”) 842. Under this guidance, arrangementsArrangements meeting the definition of a lease are classified as operating or financing leases and are recorded on the consolidated balance sheets as both a right-of-use asset and a lease liability for each type of lease, calculated by discounting fixed lease payments over the lease term at the rate implicit in the lease or the Company’s incremental borrowing rate. Lease liabilities are increased by interest and reduced by payments each period, and the right-of-use asset is amortized over the lease term. For operating leases, interest on the lease liability and the amortization of the right-of-use asset result in straight-line rent expense over the lease term. For financing leases, interest on the lease liability and the amortization of the right-of-use asset results in front-loaded expense over the lease term. Variable lease expenses are recorded to rent expense as incurred.
Certain leasehold improvements constructed by the landlord of the Company’s Tucson, AZ facilities as an incentive for the Company to extend its leases are included in leasehold improvements in the consolidated balance sheets as of December 31, 2018. The total cost of the improvements constructed by the landlord of $710,000 was capitalized when construction was completed in February 2016 and is being amortized over the remaining term of the lease agreement. The incentive of $710,000 was also recognized as deferred rent and was being amortized over the lease term as a reduction of lease expense. As of December 31, 2018, the remaining unamortized incentive of $295,833 was recognized as deferred rent within other current liabilities and other liabilities, in accordance with ASC Topic 840, Leases (“ASC 840”). Upon implementation of ASC 842 on January 1, 2019, the Company recognized the $295,833 unamortized incentive as an offset to operating lease right-of-use asset in the accompanying consolidated balance sheets.
In calculating the right-of-use asset and lease liability, the Company elects to combine lease and non-lease components for all classes of assets currently under lease, including facilities and computer equipment. The Company excludes short-term leases having initial terms of 12 months or less from the new guidance as an accounting policy election and recognizes rent expense on short-term leases on a straight-line basis over the lease term for these leases.
The comparative information in these consolidated financial statements has not been restated and continues to be reported under ASC 840.
Debt Issuance Costs and Debt Discounts
Costs incurred to issue non-revolving debt instruments are recognized as a reduction to the related debt balance in the accompanying consolidated balance sheets and amortized to interest expense over the contractual term of the related debt using the effective interest method. Costs incurred to issue revolving debt instruments arethe Loan Agreement with SVB were deferred as an asset in the accompanying consolidated balance sheets and are being amortized on a straight-line basis to interest expense over the term of the revolving commitment.
Deferred Offering Costs
Deferred offering costs represent legal and other direct costs related to planned future stock offering transactions. Deferred offering costs of $140,320 included as non-current assets in the accompanying consolidated balance sheets represent legal costs incurred, $81,290 of which were incurred during the year ended December 31, 2019 and $59,030 of which were incurred during the year ended December 31, 2018, by the Company in contemplation of the issuance of additional shares in a future financing transaction. In January 2020, these deferred offering costs were recorded to additional paid in capital, as an offset to proceeds received from the 2019 ATM Offeringloan (see Note 17)8).
Contract Liabilities
Contract liabilitiesrepresent cash receipts for products or services to be delivered in future periods, including up-front fees received relating to custom RUO assay design and collaborative development services.periods. When products or services are delivered to customers, contract liabilities are recognized as earned. Up-front fees received for custom RUO assay design or collaborative development services are recognized over time based on the costs incurred to date compared towith total expected costs as design or development procedures are completed and outputs are produced.
F-13
Revenue Recognition
The Company adopted ASC 606, Revenue from Contractscontracts with Customers (“ASC 606”), on January 1, 2018 using the full retrospective approach. The adoption of this standard did not have a material impact on 2017 revenue recognitioncustomers is recognized when, or on opening equity, as, the timing and measurementCompany satisfies its performance obligations by delivering the promised goods or service deliverables to the customers. A good or service deliverable is transferred to a customer when, or as, the customer obtains control of that good or service deliverable. A performance obligation may be satisfied over time or at a point in time. Revenue from a performance obligation satisfied over time is recognized by measuring the Company’s progress in satisfying the performance obligation in a manner that depicts the transfer of the goods or services to the customer. Revenue from a performance obligation satisfied at a point in time is recognized at the point in time that the Company determines the customer obtains control over the promised good or service deliverable. The amount of revenue recognition forrecognized reflects the consideration the Company expects to be entitled to in exchange for those promised goods or services (i.e., the “transaction price”). In determining the transaction price, the Company considers multiple factors, including the effects of variable consideration. Variable consideration is materiallyincluded in the same under ASC 606transaction price only to the extent it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainties with respect to the amount are resolved. In determining when to include variable consideration in the transaction price, the Company considers the range of possible outcomes, the predictive value of its past experiences, the time period of when uncertainties expect to be resolved and the amount of consideration that is susceptible to factors outside of the Company’s influence, such as it was under the prior relevant guidance.judgment and actions of third parties.
For contracts where the period between when the Company transfers a promised good or service to the customer and when the customer pays is one year or less, the Company has elected the practical expedient to not adjust the promised amount of consideration for the effects of a significant financing component.
As the Company’s agreements for product and product-related services revenue have an expected duration of one year or less, the Company has elected the practical expedient to not disclose information about its remaining performance obligations.
The Company has also made a policy election to exclude from the measurement of the transaction price all taxes assessed by a government authority that are both imposed on and concurrent with a specific revenue producing transaction and collected by the Company from a customer. Such taxes may include but are not limited to sales, use, value added and certain excise taxes.
See Note 9 for additional discussion of the Company’s revenue recognition policies.
Product Warranty
The Company generally provides a one-year warranty on its HTG EdgeSeq systemsplatform covering the performance of system hardware and software in conformance with customer specifications under normal use and protecting against defects in materials and workmanship. The Company may, at its option, replace, repair or exchange products covered under valid warranty claims. A provision for estimated warranty costs is recognized at the time of sale, through cost of product and product-related services revenue, based upon recent historical experience and other relevant information as it becomes available. Customers have the option to purchase an extended warranty after the one-year warranty period expires. The Company continuously assesses the adequacy of its product warranty accrual by reviewing actual claims and adjusts the provision as needed. Warranty accrual is included in accrued liabilities and other non-current liabilities in the accompanying consolidated balance sheets.
Research and Development Expenses
Research and development expenses represent costs incurred internally for and externally in support of research and development activities and costs incurred externally to fund research activities. These costs include those generated through research and development efforts for the improvement and expansion of the Company’s proprietary profiling technology and product offerings, as well as thoseand payroll, related expenses, consulting expenses, laboratory supplies, facilities and equipment costs incurred to third-party collaborativecomplete development agreements, for which related revenue is included in collaborative development services revenue in the accompanying consolidated statements of operations. See Note 9 for further discussion of the development costsmilestones associated with collaborative development services agreements included in research and development expense as compared to cost of product and product-related services revenue in the accompanying consolidated statements of operations.Company's transcriptome-informed drug discovery business, HTG Therapeutics.
Advertising
All costs associated with advertising and promotions are expensed as incurred. Advertising expense was $4,595 and $110,591 for the years ended December 31, 2019 and 2018, respectively, and is included as a component of selling, general and administrative expenses on the accompanying consolidated statements of operations.
Stock-based Compensation
The Company incurs stock-based compensation expense relating to grants under its equity incentive plans of restricted stock units (“RSUs”) and stock options to employees, consultants and non-employee directors under its equity incentive plans, and stock purchase rights granted under the 2014 Employee Stock Purchase Plan (“ESPP”).
its employee stock purchase plans. The Company recognizes expense for stock-based awards based on the fair value of awards on the date of grant. The fair value of RSUs is based on the quoted market price of the Company’s common stock on the date of grant. The fair value of ESPPstock purchase rights and stock options granted pursuant to the Company’s equity incentive plans is estimated on the date of grant using the Black-Scholes option pricing model. The determination of the fair value utilizing the Black-Scholes option pricing model is affected by the fair value of the Company’s stock price and several assumptions, including volatility, expected term, risk-free interest rate, and dividend yield. Generally, these assumptions are based on historical information and judgment is required to determine if historical trends may be indicators of future outcomes.
The Company does not estimate the number of awards expected to be forfeited, but instead accounts for such forfeitures as they occur.
F-14
Income Taxes
The Company accounts for income taxes under the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to the differences between the financial statement carrying amounts and tax base of assets and liabilities using enacted tax rates and laws that will be in effect when the differences are expected to reverse. A valuation allowance is established against net deferred tax assets for the uncertainty it presents of our ability to use the net deferred tax assets, in this case, primarily carryforwards of net operating tax losses and research and development tax credits. In assessing the realizability of net deferred tax assets we havethe Company has assessed the likelihood that net deferred tax assets will be recovered from future taxable income, and to the extent that it is “more likely than not” that the assets will not be recovered or there is an insufficient history of operating profits, a valuation allowance is established. We recordThe Company records the valuation allowance in the period we determineit determines that it is more likely than not that net deferred tax assets will not be realized. For the years ended December 31, 20192022 and 2018, we have2021, the Company has provided a full valuation allowance for all net deferred tax assets due to their current realization being considered remote in the near term. Uncertain tax positions taken or expected to be taken in a tax return are accounted for using the more likely than not threshold for financial statement recognition and measurement. Therefore, for income tax positions where it is not more likely than not that a tax benefit will be sustained in a court of last resort, the Company does not recognize a tax benefit in its financial statements.
Foreign Currency Translation and Foreign Currency Transactions
The Company has assets and liabilities, including accounts receivable and accounts payable, which are denominated in currencies other than its functional currency. These assets and liabilities are subject to re-measurement, the impact of which is recorded in selling, general and administrative expense within the consolidated statements of operations.
Adjustments resulting from translating foreign functional currency financial statements of the Company’s wholly owned subsidiary into U.S. Dollars are included in the foreign currency translation adjustment, a component of accumulated other comprehensive lossincome in the accompanying consolidated statements of stockholder’s equity (deficit).changes in stockholders' equity.
Comprehensive Loss
Comprehensive loss includes certain changes in equity that are excluded from net loss. Specifically, unrealized gains and losses on short-term available-for-sale investments and adjustments resulting from translating foreign functional currency financial statements into U.S. Dollars are included in comprehensive loss.
Concentration Risks
Financial instruments that potentially subject the Company to credit risk consist principally of cash and cash equivalents and accounts receivable. The Company maintains the majority of its cash balances in the form of cash deposits in bank checking and money market accounts in amounts in excess of federally insured limits. In accordance with the Loan Agreement, as of December 31, 2022, the Company's cash balances were held in operating accounts at and in a custodial account at U.S. Bank subject to a control agreement with Silicon Valley Bank. On March 12, 2023, the U.S. Treasury, Federal Reserve and FDIC announced that SVB depositors will have access to all of their money beginning on March 13, 2023. Management believes based upon the quality of the financial institutions, that the credit risk with regard to these deposits is not significant.significant based on the quality of the financial institution or, with respect to deposits with SVB, as a result of the guarantee provided by the U.S. Treasury, Federal Reserve and FDIC.
The Company sells its instruments, consumables, sample processing services, custom RUO assay design and collaborative development services primarily to biopharmaceutical companies, academic institutions and molecular labs. The Company routinely assesses the financial strength of its customers and credit losses have been minimal to date.
The Company’s top threetwo customers accounted for 24%, 22%16% and 19%14% of the Company’s total revenue for the year ended December 31, 2019,2022, compared with 58%, 10%the top two customers accounting for 20% and 9%10% of the Company’s total revenue for the year ended December 31, 2018.2021. The largest twothree customers accounted for approximately 29%37%, 24% and 25%13% of the Company’s net accounts receivable as of December 31, 2019. These accounts receivable primarily relate to sample processing services performed for a biopharmaceutical company customer and work performed under the Company’s Governing Agreement with QML.2022. The largest threetwo customers accounted for approximately 44%, 27%,18% and 11%17% of the Company’s net accounts receivable atas of December 31, 2018.
Three vendors2021. The third and fourth largest customers accounted for 36%, 10% and 10%approximately 10% each of the Company’s accounts receivable as of December 31, 2021.
One vendor accounted for 13% of the Company’s accounts payable as of December 31, 2019 primarily related to a strategic marketing study2022, compared to 24%, 14%with two vendors who accounted for 28% and 11%16% of the Company’s accounts payable atas of December 31, 2018.2021.
F-15
The Company currently reliesis also subject to supply chain risks related to the reliance on a single supplier to supplymanufacture a subcomponent used in its HTG EdgeSeq processors. Ainstruments. Although there are a limited number of manufacturers for components of this type, the Company believes that other suppliers could provide similar products on comparable terms. However, a change in or loss of this supplier could significantly delay the delivery of products, which in turn would materially affect the Company’s ability to generate revenue.
Recently AdoptedRecent Accounting Pronouncements
In February 2016, the FASB issued ASU No. 2016-02, Leases, which was subsequently amended by ASU No. 2018-01, ASU No. 2018-10 and ASU No. 2018-11, collectively ASC 842. Under this standard, which applies to both lessors and lessees, lessees will be required to recognize all leases (except for short-term leases) as a lease liability, which is a lessee’s obligation to make lease payments arising from a lease measured on a discounted basis, and as a right-of-use asset, which is an asset that represents the lessee’s right to use, or control the use of, a specified asset for the lease term. Leases will be classified as either financing or operating, with classification affecting the pattern of expense recognition in the statements of operations. The Company adopted ASC 842 on January 1, 2019 using the additional (optional) approach, with certain available practical expedients. The adoption of ASC 842 resulted in the recording of a right-of-use asset of $694,352 and a lease liability of $1,033,107, and there was no effect on opening retained earnings. The difference between the operating lease asset and the operating lease liability primarily represents our straight-line rent liability of $0.3 million recorded under previous accounting guidance. Under ASC 842, this liability is considered a reduction of the operating lease asset. The Company continues to account for leases in the prior period consolidated financial statements under ASC 840. The Company has presented additional qualitative and quantitative disclosures regarding the Company’s lease obligations as required upon implementation of ASC 842 and has identified and implemented changes to its business processes and internal controls relating to implementation of the new standard. In adopting the new standard, the Company elected to apply the practical expedients regarding the identification of leases, lease classification, indirect costs, and the combination of lease and non-lease components.
In June 2018, the FASB issued ASU No. 2018-07, Compensation – Stock Compensation (Topic 718): Improvements to Nonemployee Share-based Payment Accounting. The standard expanded the scope of Topic 718 to include share-based payments issued to nonemployees for goods or services, simplifying the accounting for share-based payments to nonemployees by aligning it with the accounting for share-based payments to employees, with certain exceptions and was effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years with early adoption permitted, including adoption in an interim period. The Company’s adoption of this standard on January 1, 2019 did not have a material impact on its consolidated financial statements given the limited number of nonemployee stock-based awards outstanding.
In July 2017, the FASB issued ASU 2017-11, Accounting for Certain Financial Instruments with Down Round Features. This new standard makes limited changes to previous guidance on classifying certain financial instruments as either liabilities or equity. The new standard was effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years with early adoption permitted, including adoption in an interim period. Adoption of this standard as of January 1, 2019 did not have an effect on the Company’s consolidated financial statements as the Company’s existing financial instruments did not have down round features.
New Accounting Pronouncements
The following are new FASB ASUsAccounting Standard Updates ("ASU") that had not been adopted by the Company as of December 31, 2019, and are grouped by their respective2022. The Company's management does not believe that any other recently issued, but not yet effective, dates:accounting standards updates, if currently adopted, would have a material effect on the accompanying consolidated financial statements.
January 1, 2020
In August 2018,June 2022, the FASB issued ASU No. 2018-13, 2022-03, Fair Value Measurement – Disclosure Framework – Changesof Equity Securities Subject to the Disclosure Requirements for Fair Value MeasurementContractual Sale Restrictions ("ASU 2022-03"), which makesamends ASC 820 to clarify that a number of changes meantcontractual sales restriction is not considered in measuring an equity security at fair value and to add, modify or remove certainintroduce new disclosure requirements associated withfor equity securities subject to contractual sale restrictions that are measured at fair value. ASU 2022-03 applies to both holders and issuers of equity and equity-linked securities measured at fair value. The amendments in this ASU are effective for the movement against or hierarchy associated with Level 1, Level 2 and Level 3 fair value measurements. The standard is effective forCompany in fiscal years and interim periods within those fiscal years, beginning after December 15, 2019.2023. Early adoption is permitted upon issuance of the update.for both interim and annual financial statements that have not yet been issued or made available for issuance. The Company does not expectis still evaluating the adoptionimpact of this guidance to have a material impactpronouncement on its consolidatedthe financial statements.
In November 2018,August 2020, the FASB issued ASU No. 2018-18,2020-06, Debt – Debt with Conversion and other Options (Subtopic 470-20) and Derivatives and Hedging – Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity (“ASU 2020-06”), which amended ASC 808, Collaborative Arrangementssimplifies accounting for convertible instruments by removing major separation models required under current GAAP. ASU 2020-06 removes certain settlement conditions that are required for equity contracts to qualify for the derivative scope exception and ASC 606, Revenue from Contracts with Customers (“ASU 2018-18”), to require that transactionsalso simplifies the diluted earnings per share calculation in collaborative arrangements be accounted for under ASC 606 if the counterparty is a customer for a good or service (or bundle of goods and services) that is a distinct unit of account. The amendments also preclude entities from presenting consideration from transactions with a collaborator that is not a customer together with revenue recognized from contracts with customers.certain areas. The standard is effective for fiscal years and interim periods within thosethe Company effective for fiscal years beginning after December 15, 2019.2023. Early adoption is permitted, including in any interim period, provided an entity has already adopted ASC 606 or does so concurrently with theand adoption of this guidance. The Company does not believe the adoption of this standard will have an effect on its consolidated financial statements as it will not change the way collaborative development services and the related costs of these services are reflected in the Company’s consolidated financial statements.
In March 2020, the FASB issued ASU No. 2020-04, Reference Rate Reform (Topic 848): Facilitation of the Effects of Reference Rate Reform on Financial Reporting (“ASU 2020-04”), which provides temporary optional guidance to ease the potential burden in accounting for reference rate reform. The new guidance provides optional expedients and exceptions for applying generally accepted accounting principles to transactions affected by reference rate reform if certain criteria are met. These transactions include: contract modifications, hedging relationships, and sale or transfer of debt securities classified as held-to-maturity. Entities may apply the provisions of the new standardmust be as of the beginning of the reporting period when the election is made (i.e. as early as the first quarter 2020). Unlike other topics, the provisions of this update are only available until December 31, 2022, when the reference rate replacement activity is expected to have completed.Company’s annual fiscal year. The Company is currently evaluating the impact of this standard on its consolidated financial statements and related disclosures and has yet to elect an adoption date.disclosures.
January 1, 2021
In December 2019, the FASB issued ASU No. 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes (“ASU 2019-12”), which is intended to simplify various aspects of the accounting for income taxes. ASU 2019-12 removes certain exceptions to the general principles in Topic 740 and also clarifies and amends existing guidance to improve consistent application. This standard is effective for fiscal years and interim periods within those fiscal years, beginning after December 15, 2020. Early adoption is permitted. The Company is currently evaluating the impact of this standard on its consolidated financial statements and related disclosures.
January 1, 2023
In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments - Credit Losses, which was subsequently amended by ASU 2018-19, ASU 2019-10 and ASU 2019-10,2020-02, and requires the measurement of expected credit losses for financial instruments carried at amortized cost held at the reporting date based on historical experience, current conditions and reasonable forecasts. The updated guidance also amends the current other-than-temporary impairment model for available-for-sale debt securities by requiring the recognition of impairments relating to credit losses through an allowance account and limits the amount of credit loss to the difference between a security’s amortized cost basis and its fair value. In addition, the length of time a security has been in an unrealized loss position will no longer impact the determination of whether a credit loss exists. The main objective of this ASU is to provide financial statement users with more decision-useful information about the expected credit losses on financial instruments and other commitments to extend credit held by a reporting entity at each reporting date. With the issuance of ASU 2019-10 in November 2019, the standard iswill be effective for the Company for fiscal years and interim periods within those fiscal years beginning after December 15, 2022. The Company will continue to assess the possible impact of this standard, but currently does not expect theCompany's adoption of this standard willon January 1, 2023 is not expected to have a significantmaterial impact on its consolidated financial statements or related footnote disclosures, given the high credit quality of the obligors to its available-for-sale debt securities and its limited history of minimal bad debt expense relating to trade accounts receivable.
Note 3. Inventory
Inventory - current, net of allowance, consisted of the following as of the datedates indicated:
| | | | | | | | |
| | December 31, | |
| | 2022 | | | 2021 | |
Raw materials | | $ | 426,516 | | | $ | 1,253,111 | |
Work in process | | | 113,063 | | | | 312,803 | |
Finished goods | | | 394,016 | | | | 447,145 | |
Total gross inventory - current | | | 933,595 | | | | 2,013,059 | |
Less general inventory allowance | | | (24,267 | ) | | | (25,306 | ) |
| | $ | 909,328 | | | $ | 1,987,753 | |
F-16
| | December 31, | |
| | 2019 | | | 2018 | |
Raw materials | | $ | 872,947 | | | $ | 892,631 | |
Work in process | | | 151,351 | | | | 168,937 | |
Finished goods | | | 284,772 | | | | 284,444 | |
Total gross inventory | | | 1,309,070 | | | | 1,346,012 | |
Less inventory allowance | | $ | (39,403 | ) | | | (39,403 | ) |
| | $ | 1,269,667 | | | $ | 1,306,609 | |
The reserve for shrinkage andInventory - non-current, net of excess inventory was $39,403allowance, included in other non-current assets on the consolidated balance sheets, consisted of the following as of both December 31, 2019 and 2018. the dates indicated:
| | | | | | | | |
| | December 31, | |
| | 2022 | | | 2021 | |
Raw materials - non-current, net | | $ | 244,915 | | | $ | 711,296 | |
Work in process - non-current, net | | | 81,958 | | | | — | |
Finished goods - non-current | | | 73,930 | | | | — | |
| | $ | 400,803 | | | $ | 711,296 | |
For the year ended December 31, 2019,2022, the Company recorded $0 in adjustments to theits specific inventory reserve comparedof $49,249, to reflect the projected obsolescence of a net decreasespecific inventory item, and to the general inventory allowance for estimated shrinkage, obsolescence and cycle count adjustments of $22,739$44,762. In addition, the Company recorded a provision for excess inventory of approximately $1.1 million, primarily related to the write-down of estimated excess quantities of raw materials, whose inventory levels are higher than our updated forecasts of future demand for those products.
For the year ended December 31, 2018, to adjust for estimated shrinkage and obsolescence. For the years ended December 31, 2019 and 2018,2021, the Company recorded adjustments to the provision for excessgeneral inventory allowance of $153,729 and $83,218, respectively.approximately $0.2 million. Adjustments in these periods to the allowance for estimated shrinkage, obsolescencegeneral, specific and excess inventory allowances have been included in cost of product and product-related services revenue in the accompanying consolidated statements of operations.
Note 4. Fair Value
Financial assets and liabilities measured at fair value are classified in their entirety in the fair value hierarchy, based on the lowest level input significant to the fair value measurement. The following table classifies the Company’s financial assets and liabilities measured at fair value on a recurring basis atas of December 31, 20192022 and 2018,2021, respectively, in the fair value hierarchy:
| | | December 31, 2019 | | | December 31, 2022 | |
| | Level 1 | | | Level 2 | | | Level 3 | | | Total | | | Level 1 | | | Level 2 | | | Level 3 | | | Total | |
Asset included in: | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Cash and cash equivalents | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Money market securities | | $ | 7,217,096 | | | $ | — | | | $ | — | | | $ | 7,217,096 | | | $ | 10,753,684 | | | $ | — | | | $ | — | | | $ | 10,753,684 | |
Investments available-for-sale at fair value | | | | | | | | | | | | | | | | | |
U.S. Treasury securities | | | 5,961,983 | | | | — | | | | — | | | | 5,961,983 | | |
Corporate debt securities | | | — | | | | 19,448,239 | | | | — | | | | 19,448,239 | | |
Total | | $ | 13,179,079 | | | $ | 19,448,239 | | | $ | — | | | $ | 32,627,318 | | | $ | 10,753,684 | | | $ | — | | | $ | — | | | $ | 10,753,684 | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | December 31, 2018 | | | December 31, 2021 | |
| | Level 1 | | | Level 2 | | | Level 3 | | | Total | | | Level 1 | | | Level 2 | | | Level 3 | | | Total | |
Asset included in: | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Cash and cash equivalents | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Money market securities | | $ | 6,923,255 | | | $ | 998,400 | | | $ | — | | | $ | 7,921,655 | | | $ | 9,083,302 | | | $ | — | | | $ | — | | | $ | 9,083,302 | |
Investments available-for-sale at fair value | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
U.S. Treasury securities | | | 6,031,515 | | | | — | | | | — | | | | 6,031,515 | | |
Corporate debt securities | | | — | | | | 16,649,534 | | | | — | | | | 16,649,534 | | | | — | | | | 12,343,456 | | | | — | | | | 12,343,456 | |
Total | | $ | 12,954,770 | | | $ | 17,647,934 | | | $ | — | | | $ | 30,602,704 | | | $ | 9,083,302 | | | $ | 12,343,456 | | | $ | — | | | $ | 21,426,758 | |
There were no other financial instruments subject to fair value measurement on a recurring basis. Transfers to and from Levels 1, 2 and 3 are recognized at the end of the reporting period. There were no transfers between levels for the years ended December 31, 20192022 and 2018.2021.
Level 1 instruments include investments in money market funds, U.S. Treasuries and U.S. government agency obligations.securities. These instruments are valued using quoted market prices for identical unrestricted instruments in active markets. The Company defines active markets for debt instruments based on both the average daily trading volume and the number of days with trading activity. Level 2 instruments includeas of December 31, 2021 included corporate debt securities, including commercial paper and commercial paper.corporate bonds. Valuations of Level 2 instruments can be verified to quoted prices, recent trading activity for identical or similar instruments, broker or dealer quotations or alternative pricing sources with reasonable levels of price transparency. Consideration is given to the nature of the quotations (e.g. indicative or firm) and the relationship of recent market activity to the prices provided from alternative pricing sources.
F-17
Fair values of these assets and liabilities are based on prices provided by independent market participants that are based on observable inputs using market-based valuation techniques. These valuation models and analytical tools use market pricing or similar instruments that are both objective and publicly available, including matrix pricing or reported trades, benchmark yields, broker/dealer quotes, issuer spreads, two-sided markets, benchmark securities, bids and/or offers. The Company did not adjust any of the valuations received from these third parties with respect to any of its Level 1 or 2 securities for either of the years ended December 31, 20192022 or 20182021 and did not have any Level 3 financial assets or liabilities during either of these periods.
Note 5. Available-for-Sale Securities
The Company’sCompany did not have any investments in available-for-sale securities as of December 31, 2022. The Company's portfolio of available-for-sale securities consistsas of U.S. Treasuries andDecember 31, 2021 consisted of high credit quality corporate debt securities. The following is a summary of the Company’ssecurities as of that date:
| | | | | | | | | | | | | | | |
| December 31, 2021 | |
| | | | Gross | | | Gross | | | Fair Value | |
| Amortized | | | Unrealized | | | Unrealized | | | (Net Carrying | |
| Cost | | | Gains | | | Losses | | | Amount) | |
Corporate debt securities | $ | 12,343,456 | | | $ | — | | | $ | — | | | $ | 12,343,456 | |
Total available-for-sale securities | $ | 12,343,456 | | | $ | — | | | $ | — | | | $ | 12,343,456 | |
There were no gross unrealized gains or losses related to the Company's available-for-sale securities atinvestments as of December 31, 2019 and 2018:
| December 31, 2019 | | | |
| | | | | Gross | | | Gross | | | Fair Value | | |
| Amortized | | | Unrealized | | | Unrealized | | | (Net Carrying | |
| Cost | | | Gains | | | Losses | | | Amount) | |
| | | | | | | | | | | | | | | | | |
U.S. Treasury securities | $ | 5,962,224 | | | $ | 394 | | | $ | (635 | ) | | $ | 5,961,983 | | | |
Corporate debt securities | | 19,448,239 | | | | — | | | | — | | | | 19,448,239 | | | |
Total available-for-sale securities | $ | 25,410,463 | | | $ | 394 | | | $ | (635 | ) | | $ | 25,410,222 | | | |
| December 31, 2018 | |
| | | | | Gross | | | Gross | | | Fair Value | |
| Amortized | | | Unrealized | | | Unrealized | | | (Net Carrying | |
| Cost | | | Gains | | | Losses | | | Amount) | |
U.S. Treasury securities | $ | 6,032,844 | | | $ | — | | | $ | (1,329 | ) | | $ | 6,031,515 | |
Corporate debt securities | | 16,650,513 | | | | — | | | | (979 | ) | | | 16,649,534 | |
Total available-for-sale securities | $ | 22,683,357 | | | $ | — | | | $ | (2,308 | ) | | $ | 22,681,049 | |
The2022 or 2021. There were no net adjustmentadjustments to unrealized holding gains (losses) on short-term investments, net of tax in other comprehensive income totaled $2,299 and $(2,308) for the years ended December 31, 20192022 and 2018, respectively.2021.
Contractual maturities of debt investment securities at December 31, 2019 are shown below. Expected maturities will differ from contractual maturities because the issuers of the securities may have the right to prepay obligations without prepayment penalties.
| Under | | | | | | | | | |
| 1 Year | | | 1 to 2 Years | | | Total | |
U.S. Treasury securities | $ | 5,961,983 | | | $ | — | | | $ | 5,961,983 | |
Corporate debt securities | | 19,448,239 | | | | — | | | | 19,448,239 | |
Total available-for-sale securities | $ | 25,410,222 | | | $ | — | | | $ | 25,410,222 | |
The following table shows the gross unrealized losses and fair values of the Company’s investments that have unrealized losses, aggregated by investment category and length of time that individual securities have been in a continuous unrealized loss position as of December 31, 2019:
| Under 1 Year | | | 1 to 2 Years | | | Total | |
| | | | | Gross | | | | | | | Gross | | | | | | | Gross | |
| Fair | | | Unrealized | | | Fair | | | Unrealized | | | Fair | | | Unrealized | |
| Value | | | Losses | | | Value | | | Losses | | | Value | | | Losses | |
U.S. Treasury securities | $ | 3,956,401 | | | $ | (635 | ) | | $ | — | | | $ | — | | | $ | 3,956,401 | | | $ | (635 | ) |
Corporate debt securities | | — | | | | — | | | | — | | | | — | | | | — | | | | — | |
Total available-for-sale securities with unrealized losses | $ | 3,956,401 | | | $ | (635 | ) | | $ | — | | | $ | — | | | $ | 3,956,401 | | | $ | (635 | ) |
For debt securities, the Company determines whether it intends to sell or if it is more likely than not that it will be required to sell impaired securities. This determination considers current and forecasted liquidity requirements, regulatory and capital requirements and securities portfolio management. For all impaired debt securities for which there was no intent or expected requirement to sell, the evaluation considers all available evidence to assess whether it is likely the amortized cost value will be recovered. The Company conducts a regular assessment of its debt securities with unrealized losses to determine whether securities have other-than-temporary impairment considering, among other factors, the nature of the securities, credit rating or financial condition of the issuer, the extent and duration of the unrealized loss, expected cash flows of underlying collateral, market conditions and whether the Company intends to sell or it is more likely than not that the Company will be required to sell the debt securities. The Company did not have any other-than-temporary impairment in its available-for-sale securities at December 31, 2019.
Note 6. Property and Equipment
Property and equipment, net consistsconsisted of the following:following as of the dates indicated:
| | | December 31, | | | December 31, | |
| | 2019 | | | 2018 | | | 2022 | | | 2021 | |
Furniture & fixtures | | $ | 1,089,371 | | | $ | 791,973 | | | $ | 756,065 | | | $ | 872,877 | |
Leasehold improvements | | | 1,987,997 | | | | 1,930,300 | | | | 1,938,981 | | | | 1,931,762 | |
Equipment used in manufacturing | | | 2,305,340 | | | | 2,297,797 | | | | 1,863,976 | | | | 2,432,242 | |
Equipment used in research & development | | | 2,134,019 | | | | 1,456,954 | | | | 2,080,319 | | | | 2,343,930 | |
Equipment used in the field | | | 182,762 | | | | 125,253 | | | | 159,563 | | | | 216,218 | |
Software | | | 374,812 | | | | 373,683 | | | | 469,408 | | | | 480,740 | |
Construction in progress | | | — | | | | 19,246 | | |
| | | 8,074,301 | | | | 6,995,206 | | |
Property and equipment | | | | 7,268,312 | | | | 8,277,769 | |
Less: accumulated depreciation and amortization | | | (5,834,168 | ) | | | (4,621,416 | ) | | | (6,670,306 | ) | | | (7,158,883 | ) |
| | $ | 2,240,133 | | | $ | 2,373,790 | | | $ | 598,006 | | | $ | 1,118,886 | |
Depreciation and leasehold improvement amortization expense was $1,259,015approximately $0.6 million and $1,468,121$0.7 million for the years ended December 31, 20192022 and 2018,2021, respectively.
Note 7. Accrued Liabilities
Accrued liabilities consistconsisted of the following:following as of the dates indicated:
| | | | | | | | |
| | December 31, | |
| | 2022 | | | 2021 | |
Accrued employee bonuses | | $ | 1,252,622 | | | $ | 1,254,355 | |
Payroll and employee benefit accruals | | | 416,070 | | | | 389,385 | |
Accrued professional fees | | | 355,377 | | | | 47,594 | |
Other accrued liabilities | | | 185,537 | | | | 331,235 | |
| | $ | 2,209,606 | | | $ | 2,022,569 | |
F-18
| | December 31, | |
| | 2019 | | | 2018 | |
Accrued employee bonuses | | $ | 900,740 | | | $ | 2,150,418 | |
Payroll and employee benefit accruals | | | 469,530 | | | | 698,969 | |
Accrued professional fees | | | 43,850 | | | | 60,400 | |
Accrued interest | | | 245,350 | | | | 156,492 | |
Other accrued liabilities | | | 210,826 | | | | 292,186 | |
| | $ | 1,870,296 | | | $ | 3,358,465 | |
Note 8. Debt Obligations.Obligations
GrowthCurrent portion of long-term debt consisted of the following as of the dates indicated:
| | | | | | | | |
| | December 31, | |
| | 2022 | | | 2021 | |
SVB Term Loan, net of discount and debt issuance costs | | $ | 3,812,498 | | | $ | 5,000,000 | |
2021 Insurance Note | | | — | | | | 167,586 | |
| | $ | 3,812,498 | | | $ | 5,167,586 | |
Long-term debt, net of current portion, discount and debt issuance costs, consisted of the following as of the dates indicated:
| | | | | | | | |
| | December 31, | |
| | 2022 | | | 2021 | |
SVB Term Loan, net of discount and debt issuance costs | | $ | - | | | $ | 5,178,629 | |
SVB Term Loan
In August 2014, the Company entered into a Loan and Security AgreementOn June 24, 2020 (the “Growth Term Loan”) with a syndicate of two lending institutions, Oxford Finance LLC and Silicon Valley Bank, which was amended in August 2015 and June 2016. The first tranche of the Growth Term Loan (“Growth Term Loan A”) of $11.0 million was funded in August 2014. The second tranche of $5.0 million (“Growth Term Loan B”) was funded in March 2016. With the August 2015 amendment, the interest-only payment period for the Growth Term Loan was extended until April 1, 2016. Following the interest-only payment period, the Company became obligated to make equal monthly payments of principal and interest amortized over the remaining term of the loan for all funds drawn under the Growth Term Loan. Growth Term Loan A and B bore interest at fixed rates of 8.5% and 8.75% per annum, respectively, and were scheduled to mature in September 2018. The amended agreement also included a prepayment fee of 1% of the principal amount repaid if the Growth Term Loan was repaid after the second anniversary of the August 2015 amendment and prior to maturity.
The debt discount was being amortized to interest expense using the effective interest method, over the term of the related Growth Term Loan tranche. The aggregate amortization of debt discount associated with the Growth Term Loan was approximately $0 and $62,951 for the years ended December 31, 2019 and 2018, respectively.
Extinguishment of Growth Term Loan upon MidCap Credit Facility Closing
In March 2018, the Company repaid all principal and interest amounts outstanding under the Growth Term Loan in an aggregate amount equal to approximately $4.3 million, including collateral agent legal fees and prepayment fees. The repayment was funded with net proceeds from the MidCap Credit Facility (see description of the MidCap Credit Facility below). As a result of the repayment, the Company recorded a loss on extinguishment of the Growth Term Loan of $105,064, including remaining unamortized discounts of $67,272 and prepayment and other Growth Term Loan lender fees in the accompanying consolidated statements of operations for the year ended December 31, 2018. All obligations under the Growth Term Loan were terminated upon extinguishment of the Growth Term Loan.
MidCap Credit Facility
On March 26, 2018 (the “MidCap Closing“Closing Date”), the Company entered into a Credit and Security Agreement (Term Loan) (the “MidCap Term Loan”) and a Credit and Security Agreement (Revolving Loan) (the “MidCap Revolving Loan” and together with the MidCapSVB Term Loan the “MidCap Credit Facility”) with MidCap Financial Trust, as agent. MidCap Financial Trust subsequently assigned its rights and obligations as agent to MidCap Funding IV Trust.
The MidCap Term LoanSVB, which provided a secured term loan facility in an aggregatethe principal amount of up to $20.0$10.0 million. The Company borrowedproceeds from the first advance of $7.0 million (“MidCap Tranche 1”) on the MidCap Closing Date. Under the terms of the MidCapSVB Term Loan the second advance of $13.0 million (“MidCap Tranche 2”) was to be available to the Companywere fully funded on or before September 30, 2019, subject to the Company’s satisfaction of certain conditions described in the MidCapJune 25, 2020.
The SVB Term Loan including (a) the Company achieving the first commercial sale of an FDA-approved diagnostic assay utilizing next-generation sequencing under its Governing Agreement with QML, and (b) delivery of subordination documents with respect to the QNAH Convertible Note (or the satisfaction of alternative arrangements as provided in the MidCap Term Loan, as described below). As the Company did not satisfy these conditions, MidCap Tranche 2 was not made available to the Company for borrowing.
MidCap Tranche 1 was used to repay in full all outstanding amounts and fees due under the Growth Term Loan. The proceeds remaining from MidCap Tranche 1 are being used for working capital and general corporate purposes.
MidCap Tranche 1 bears interest at a floating rate equal to 7.25% per annum, plus the greater of (i) 1.25% or (ii)2.50% above the one-month LIBOR. As LIBOR is currently scheduled to be phased outPrime Rate (as defined in 2021, the Company expects to modify the MidCap Credit Facility to replace LIBOR with a new reference rate, which has yet to be established. The consequences of these developments cannot be entirely predicted but might result in higher interest rates on our borrowings under the MidCap Credit Facility.
Loan Agreement) and 5.75%. Interest on MidCap Tranche 1the SVB Term Loan is due and payable monthly in arrears andarrears. The SVB Term Loan originally required interest-only payments through June 30, 2021. As a result of the Company’s achievement of an equity milestone defined in the Loan Agreement during the quarter ended June 30, 2021, the interest-only period was calculated at a rate of 8.9%extended for interest accrued as ofsix months through December 31, 2019. Principal on this term loan advance was payable in 362021. Following the extended interest-only period, the Loan Agreement required equal monthly installments beginning Aprilpayments of principal and interest through the maturity date of December 1, 2020 until paid in full on March 1, 2023 prior to amendment of the MidCap Credit Facility in February 2020. .
Prepayments of the term loan under the MidCapSVB Term Loan, in whole or in part, will beare subject to early termination fees in an amount equal to 2.0% of principal prepaid if prepayment occurs after the first anniversary of the MidCap Closing Date but on or prior to the second anniversary of the MidCap Closing Date, and 1.0%1.0% of principal prepaid if prepayment occurs after the second anniversary of the MidCap Closing Date and prior to or on the third anniversary of the MidCap Closing Date. In connection with execution of the MidCap Term Loan, the Company paid MidCap a $100,000 origination fee.
The MidCap Credit Facility was amended to, amongst other things, extend the interest-only payments on the term loan advances by an additional 11 months, with principal on each term loan advance payable in 25 equal monthly installments beginning March 1, 2021 until paid in full on March 1, 2023 (see Note 17). As such, the principal repayments remaining due under the MidCap Term Loan as of December 31, 2019 have been classified as long-term debt within MidCap Term Loan payable, net of discount and debt issuance costs in the accompanying consolidated balance sheet as of December 31, 2019. The remaining principal repayments due under the MidCap Term Loan, following amendment of this agreement in February 2020, are as follows:
2020 | | | — | |
2021 | | | 2,800,000 | |
2022 | | | 3,360,000 | |
2023 | | | 840,000 | |
Total MidCap Term Loan payments | | | 7,000,000 | |
Less discount and deferred financing costs | | | (443,455 | ) |
Plus final fee premium | | | 315,000 | |
Total MidCap Term Loan, net | | $ | 6,871,545 | |
maturity date. Upon termination of the MidCap Term Loan Agreement, the Company is required to pay an exita final fee premium equal to 4.50%8.00% of the principal amount of all term loans advancedthe SVB Term Loan.
In July 2022, the Company and SVB entered into an amendment to the SVB Term Loan (the "Term Loan Amendment"). Under the Term Loan Amendment, the Company and SVB agreed to remove the financial covenant under the MidCap Term Loan.
The MidCap Term Loan also requiredAgreement that the Company deliver subordination documents with respect to the QNAH Convertible Note, or that the QNAH Convertible Note otherwise be converted or prepaid, on or before June 30, 2018, andhad required the Company to deposit approximately $3.3 million into an escrow account by July 15, 2018 if neither event occurred by such date. As neither event occurred prior to June 30, 2018, the Company deposited approximately $3.3 million into an escrow account on July 11, 2018. Such escrowed funds will be released to the Company upon subsequent delivery of the requisite subordination documents or conversion of the QNAH Convertible Note. If neither delivery of the subordination documents or conversion of the QNAH Convertible Note occurs, such funds will be applied by the escrow agent to repay in full the QNAH Convertible Note at maturity (or in connection with a prepayment at the direction of the Company after September 1, 2020), subject to (i) our having at least $18.0 million ofmaintain unrestricted cash, and cash equivalents and (ii) there being no default under the MidCap Credit Facility.
The MidCap Revolving Loan provides a secured revolving credit facility in an aggregate principal amountincluding short term investments available-for-sale, of up to $2.0 million. The Company may request an increase in the total commitments under the MidCap Revolving Loan by up to an additional $8.0 million, subject to agent and lender approval and the satisfaction of certain conditions. Availability of the revolving credit facility under the MidCap Revolving Loan will be based upon a borrowing base formula and periodic borrowing base certifications valuing certain of the Company’s accounts receivable and inventory, as reduced by certain reserves, if any. Further, although the revolving credit facility was made available following establishment of required lockbox arrangements by the Company in June 2018, there were no amounts outstanding under the MidCap Revolving Loan as of either December 31, 2019 or 2018. The proceeds of any loans under the MidCap Revolving Loan may be used for working capital and general corporate purposes.
Loans under the MidCap Revolving Loan accrue interest at a floating rate equal to 4.25% per annum, plusnot less than the greater of (i) 1.25% or$12.5 million and (ii) the one-month LIBOR. Accrued interest on the revolving loans will be paid monthly and revolving loans may be borrowed, repaid and re-borrowed until March 1, 2023, when all outstanding amounts must be repaid. Subject to certain exceptions, termination or permanent reductions of the revolving loan commitment under the MidCap Revolving Loan will be subject to termination fees in an amount equal to 2.0%six times the amount of the commitment amount terminated or reduced if such termination or reduction occurs afterCompany's average monthly Cash Burn (as defined in the first anniversaryLoan Agreement) over the trailing three months. In exchange for this accommodation, the Company prepaid $2.5 million of outstanding principal under the MidCap Closing Date but on or priorTerm Loan (the "Prepayment"). SVB waived the prepayment fee that otherwise would have applied to the second anniversaryPrepayment. The remaining outstanding principal amount due under the Term Loan will continue to be paid in equal monthly payments of principal and interest through the MidCap Closing Date, and 1.0%maturity date of the commitment amount terminated or reduced if such termination or reduction occurs after the second anniversary of the MidCap Closing Date and prior to or on the third anniversary of the MidCap Closing Date.
In connection with the MidCap RevolvingDecember 1, 2023. The Term Loan the Company is required to pay customary fees, including an origination fee of 0.50%Amendment was accounted for as a modification of the original commitment amount at closing (and an equivalent origination fee with respectSVB Term Loan.
On March 10, 2023, the FDIC took control and was appointed receiver of SVB. The SVB Term Loan remains intact and the Company will continue to any increased commitments atmake required payments through the timeend of the applicable increase), a monthly unused line fee of 0.50% per annum based uponcurrent year, at which time the average daily unused portion of the revolving credit facility and a monthly collateral management fee of 0.50% per annum based upon the average daily used portion of the revolving credit facility. The Company is also required to maintain a minimum drawn balance of not less 20% of availability under the revolving line. If the Company does not maintain such minimum drawn balance, it is required to pay monthly interest and fees as if an amount equal to 20% of availability had been drawn down under the revolving line.SVB Term Loan will be repaid in full.
The Company’s obligations under the MidCap Credit FacilityLoan Agreement are secured by a security interest in substantially all of its assets, includingexcluding intellectual property. Additionally,property (which is subject to a negative pledge), and the Company’s future subsidiaries, if any, may be required to become co-borrowers or guarantors under the MidCap Credit Facility.
Loan Agreement. If we default under our obligations under the SVB Term Loan, including as a result of a material adverse change, as defined in the SVB Term Loan, the lender could proceed against the collateral granted to them to secure our indebtedness or declare all obligations under the SVB Term Loan to be due and payable. The MidCap Credit Facility contains customary affirmative covenantsdetermination as to whether a material adverse change has occurred is not within the Company's control and customary negative covenants limitingit is unclear how the Company’s abilitycurrent managers of Silicon Valley Bridge Bank will view the SVB Term Loan from a risk standpoint and what actions they may elect to take under the abilitySVB Term Loan to protect the financial interests of the Company’s subsidiaries, if any,lender.
F-19
The remaining principal repayments due under the SVB Term Loan as of December 31, 2022 are as follows:
| | | | |
2023 | | $ | 3,235,294 | |
Less discount and deferred financing costs | | | (222,796 | ) |
Plus final fee premium | | | 800,000 | |
Total SVB Term Loan, net | | $ | 3,812,498 | |
The Company included $0.2 million and $0.6 million of debt discount associated with the SVB Term Loan, resulting from fees and debt issuance costs, inclusive of the fair value of warrants issued, in current portion of long-term debt, net of discount and debt issuance costs and long-term debt, net of current portion, discount and debt issuance costs, respectively, in the accompanying consolidated balance sheets as of December 31, 2022 and 2021, respectively. Amortization of the debt discount associated with the SVB Term Loan was $0.4 million and $0.5 million for the years ended December 31, 2022 and 2021, respectively, and was included in interest expense in the consolidated statements of operations. The effective interest rates for the years ended December 31, 2022 and 2021 were 16.15% and 10.47%, respectively.
Insurance Note
In May 2021, the Company entered into a new commercial financing agreement to among other things, disposeextend the payment period related to its directors and officers insurance policy (the “2021 Insurance Note”). The 2021 Insurance Note required a down payment to be made upon signing the agreement equal to approximately $0.4 million. The remaining unpaid premium balance of assets, undergoapproximately $0.7 million was financed at an annual rate of 3.57% and was repaid in nine equal monthly payments of principal and interest through February 2022.
In May 2022, the Company entered into a changenew commercial financing agreement to extend the payment period related to its directors and officers insurance policy (the "2022 Insurance Note"). The 2022 Insurance Note required a down payment to be made upon signing the agreement equal to approximately $0.3 million. The remaining unpaid premium balance of approximately $0.8 million was financed at an annual rate of 3.32% and was to be repaid in control, merge or consolidate, make acquisitions, incur debt, incur liens, pay dividends, repurchase stocknine equal monthly payments of principal and make investments,interest beginning in each case subject to certain exceptions.
June 2022. The MidCap Credit Facility also contains2022 Insurance Note contained customary events of default relating to, among other things, payment defaults and breaches of covenants, a material adverse change, delistingrepresentations, warranties or terms of the Company’s common stock, bankruptcy2022 Insurance Note documents, and insolvency, cross defaults with certain material indebtedness and certain material contracts, judgments, and inaccuracies of representations and warranties. Upon an event of default, agent andmay be prepaid by the lenders may declare all or a portion of the Company’s outstanding obligations to be immediately due and payable and exercise other rights and remedies provided for under the agreement. During the existence of an event of default, interest on the obligations could be increased by 3.0%.
In March 2018, the Company granted the lender ten-year warrants to purchase 18,123 shares of the Company’s common stock at $7.73 per share as a result of Tranche 1. The fair value of the warrants on the date of issuance was approximately $74,000, determined using the Black-Scholes option-pricing model, and was recorded as a discount to the MidCap Term Loan.
The Company has recognized approximately $443,455 and $610,359 of unamortized debt discount associated with the MidCap Term Loan, resulting from fees and debt issuance costs, in the accompanying consolidated balance sheets as of December 31, 2019 and 2018, respectively. Amortization of the debt discount associated with the MidCap Term Loan was approximately $166,904 and $121,611 for the years ended December 31, 2019 and 2018, respectively, and was included in interest expense in the accompanying consolidated statements of operations. Unamortized costs incurred in connection with the issuance of the Midcap Revolving Loan of $50,970 and $67,068 as of December 31, 2019 and 2018, respectively, are presented in other non-current assets in the accompanying consolidated balance sheets. Amortization of deferred MidCap revolving loan costs was $16,098 and $12,352 for the years ended December 31, 2019 and 2018, respectively, and is included in interest expense in the accompanying consolidated statements of operations.
See Note 17 for further information regarding the MidCap Credit Facility.
QNAH Convertible Note Agreement
In October 2017, the Company issued a subordinated convertible promissory note to QNAH in the principal amount of $3.0 million against receipt of cash proceeds equal to such principal amount. The QNAH Convertible Note bears simple interest at the rate of 3.0% per annum and matures on October 26, 2020 (the “Maturity Date”). Neither interest nor principal payment are due until the Maturity Date, subject to earlier conversion. QNAH may elect to convert all or any portion of the outstanding principal balance of the QNAH Convertible Note and all unpaid accrued interest thereon at any time prior to maturity with no prepayment penalties. In November 2022, the Maturity Date into sharesCompany prepaid the remainder of the Company’s common stock at a conversion price of $3.984 per share.2022 Insurance Note.
Debt issuance costs of $12,333 and $25,787 relating to the QNAH Convertible Note are being presented as a direct reduction of Convertible Note – net of debt issuance costs - current as of December 31, 2019 and of Convertible note – net of debt issuance costs – non-current as of December 31, 2018, respectively. Amortization of the QNAH Convertible Note deferred financing costs was $13,454 and $13,453 for the years ended December 31, 2019 and 2018, respectively. Interest accrued on the QNAH Convertible Note for the years ended December 31, 2019 and 2018 was $188,630 and $98,630, respectively. Both amounts were included in interest expense in the accompanying consolidated statements of operations.
Note 9. Revenue from Contracts with Customers
Revenue from contracts with customers is recognized when, or as, the Company satisfies its performance obligations by delivering the promised goods or service deliverables to the customers. A good or service deliverable is transferred to a customer when, or as, the customer obtains control of that good or service deliverable. A performance obligation may be satisfied over time or at a point in time. Revenue from a performance obligation satisfied over time is recognized by measuring the Company’s progress in satisfying the performance obligation in a manner that depicts the transfer of the goods or services to the customer. Revenue from a performance obligation satisfied at a point in time is recognized at the point in time that the Company determines the customer obtains control over the promised good or service deliverable. The amount of revenue recognized reflects the consideration the Company expects to be entitled to in exchange for those promised goods or services (i.e., the “transaction price”). In determining the transaction price, the Company considers multiple factors, including the effects of variable consideration. Variable consideration is included in the transaction price only to the extent it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainties with respect to the amount are resolved. In determining when to include variable consideration in the transaction price, the Company considers the range of possible outcomes, the predictive value of its past experiences, the time period of when uncertainties expect to be resolved and the amount of consideration that is susceptible to factors outside of the Company’s influence, such as the judgment and actions of third parties.
Product and Product-related Services Revenue
The Company had product and product-related services revenue consisting of revenue from the sale of instruments and consumables and the use of the HTG EdgeSeq proprietary technology to process samples and design custom RUO assays for the years ended December 31, 20192022 and 20182021 as follows:
| | | | | | | | |
| | Years Ended December 31, | |
| | 2022 | | | 2021 | |
Product revenue: | | | | | | |
Instrument | | $ | 609,627 | | | $ | 1,385,665 | |
Consumables | | | 3,140,420 | | | | 3,786,923 | |
Total product revenue | | | 3,750,047 | | | | 5,172,588 | |
Product-related services revenue: | | | | | | |
Custom RUO assay design | | | 20,000 | | | | 48,350 | |
RUO sample processing | | | 2,596,173 | | | | 3,685,890 | |
Total product-related services revenue | | | 2,616,173 | | | | 3,734,240 | |
Total product and product-related services revenue | | $ | 6,366,220 | | | $ | 8,906,828 | |
Revenue by primary geographic market for the years ended December 31, 2022 and 2021 was as follows:
| | | | | | | | | | | | |
| | December 31, 2022 | |
| | United States | | | Europe | | | Other | |
Product revenue | | | 1,904,025 | | | | 1,839,445 | | | | 6,577 | |
Product-related services revenue | | | 2,237,691 | | | | 358,905 | | | | 19,577 | |
Total product and product-related services revenue | | $ | 4,141,716 | | | $ | 2,198,350 | | | $ | 26,154 | |
F-20
| | Years Ended December 31, | |
| | 2019 | | | 2018 | |
Product revenue: | | | | | | | | |
Instruments | | $ | 1,436,730 | | | $ | 351,885 | |
Consumables | | | 3,010,094 | | | | 1,964,499 | |
Total product revenue | | $ | 4,446,824 | | | $ | 2,316,384 | |
Product-related services revenue: | | | | | | | | |
Custom RUO assay design | | | 4,498,088 | | | | 964,241 | |
RUO sample processing | | | 5,687,292 | | | | 5,840,765 | |
Total product-related services revenue | | | 10,185,380 | | | | 6,805,006 | |
Total product and product-related services revenue | | $ | 14,632,204 | | | $ | 9,121,390 | |
| | | | | | | | | | | | |
| | December 31, 2021 | |
| | United States | | | Europe | | | Other | |
Product revenue | | | 3,114,818 | | | | 2,026,728 | | | | 31,042 | |
Product-related services revenue | | | 3,063,381 | | | | 198,336 | | | | 472,523 | |
Total product and product-related services revenue | | $ | 6,178,199 | | | $ | 2,225,064 | | | $ | 503,565 | |
Because the Company’s agreements for product and product-related services revenue have an expected duration of one year or less, the Company has elected the practical expedient in ASC 606-10-50-14(a) to not disclose information about its remaining performance obligations.
Sale of instruments and consumables
The delivery of each instrument and the related installation and calibration are considered to be a single performance obligation, as the HTG EdgeSeq instrument must be professionally installed and calibrated prior to use. Instrument product revenue is generally recognized upon installation and calibration of the instrument by field service engineers, which represents the point at which the customer has the ability to use the instrument and has accepted the asset. Installation generally occurs within one month of instrument shipment.
The delivery of each consumable is a separate performance obligation. Consumables revenue is recognized upon transfer of control, which represents the point when the customer has legal title and the significant risks of ownership of the asset. The Company’s standard terms and conditions provide that no right of return exists for instruments and consumables, unless replacement is necessary due to delivery of defective or damaged product. Customer payment terms vary but are typically between 30 and 90 days of revenue being earned from shipment or delivery, as applicable.
Shipping and handling fees charged to the Company’s customers for instruments and consumables shipped are included in the accompanying consolidated statements of operations as part of product and product-related services revenue. Shipping and handling costs for sold products shipped to the Company’s customers are included in the accompanying consolidated statements of operations as part of cost of product and product-related services revenue.
For sales of consumables in the United States, standard delivery terms are FOB shipping point, unless otherwise specified in the customer contract, reflecting transfer of control to the customer upon shipment. Standard delivery terms for sales to customers outside of the United States are FOB delivery point, unless otherwise specified in the customer contract. The Company has We have elected the practical expedient to account for shipping and handling as activities to fulfill the promise to transfer the consumables.
The Company provides instruments to certain customers under reagent rental agreements. Under these agreements, the Company installs instrumentsan instrument in the customer’s facility without a fee and the customer agrees to purchase consumable products at a stated price over the term of the agreement; in some instances, the agreements do not contain a minimum purchase requirement. Terms range from several months to multiple years and may automatically renew in several month or multiple year increments unless either party notifies the other in advance that the agreement will not renew. The Company measures progress toward complete satisfaction of itsthis performance obligation to provide the instrument and deliver the consumables using an output method based on the number of consumables delivered in relation to the total consumables to be provided under the reagent rental agreement. This is considered to be representative of the delivery of outputs under the arrangement and the best measure of progress because the customer benefits from the instrument only in conjunction with the consumables. The Company expects to recover the cost of the instrument under the agreement through the fees charged for consumables, to the extent sold, over the term of the agreement.
In reagent rental agreements, the Company retains title to the instrument and title is transferred to the customer at no additional charge at the conclusion of the initial arrangement. The cost of the instrument is amortized on a straight-line basis over the term of the arrangement, unless there is no minimum consumable product purchase, in which case the instrument would be expensed as cost of product and product-related services revenue upon installation. Cost to maintain the instrument while title remains with the Company is charged to selling, general and administrative expense as incurred.
Service Revenue
RUO Sample Processing
The Company also provides sample preparation and processing services and molecular profiling of retrospective cohorts for its customers through its VERI/O laboratory, whereby the customer provides samples to be processed using HTG EdgeSeq technology specified in the order. Customers are charged a per sample fee for sample processing services which is recognized as revenue upon delivery of a data file to the customer showing the results of testing and completing delivery of the agreed upon service. This is when the customer can use and benefit from the results of testing and the Company has the present right to payment.
Custom RUO Assay Design and Related Agreements
The Company enters into custom RUO assay design agreements that may generate up-front fees and subsequent payments that mightmay be earned upon completion of design process phases. The Company measures progress toward complete satisfaction of its performance obligation to perform custom RUO assay design procedures using an output method based on the costs incurred to date compared towith total expected costs, as this is representative of the delivery of outputs under the arrangements and the best measure of progress. However, because in most instances the assay development fees are contingent upon completion of each phase of the design project and the decision of the customer to proceed to the next phase, the amount to be included in the transaction price and recognized as revenue is limited to that which the customer is contractually obligated to pay upon completion of that phase, which is when it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur. Changes in estimates of total expected costs are accounted for prospectively as a change in estimate. From period to period, custom RUO assay design serviceservices revenue can fluctuate substantially based on the completion of design-related phases.
Collaborative Development Services Revenue
The Company enters into collaborative development services agreements with biopharmaceutical companies for the development of NGS-based companion diagnostic assaysdid not recognize any custom RUO assay design revenue from performance obligations that were satisfied in support of and in conjunction with, biopharmaceutical companies’ drug development programs. These collaborative development services agreements may generate upfront fees, and in some cases subsequent milestone payments that may be earned upon completion of certain product development milestones or activities. Collaborative development services revenue forprevious periods during the years ended December 31, 2019 and 2018 was generated through statements of work entered into under the Governing Agreement with QML as discussed below.2022 or 2021.
F-21
| | Years Ended December 31, | |
| | 2019 | | | 2018 | |
Collaborative development services | | $ | 4,571,684 | | | $ | 12,382,504 | |
Master Assay Development, Commercialization and Manufacturing AgreementContract Liabilities
In November 2016, the Company entered into the Governing Agreement, which created the framework for QML and the Company to combine their technological and commercial strengths to offer biopharmaceutical companies a complete NGS-based solution for the development, manufacture and commercialization of companion diagnostic assays. Under the Governing Agreement, the parties jointly sought companion diagnostic programs with biopharmaceutical companies, with QML entering into sponsor project agreements with interested biopharmaceutical companies for specified projects, and QML and the Company entering into statements of work which set forth the rights and obligations of QML and the Company with respect to each project. In November 2019, the Company elected to terminate the Governing Agreement with QML, effective immediately, as a result of QML’s material breach of the Governing Agreement, including QML’s failure to develop an in vitro diagnostic (“IVD”) version of its GeneReader sequencing platform for development of PDP Assays. The Company’s termination of the Governing Agreement did not terminate active statements of work under the Governing Agreement.
The Company has determined that SOW One, SOW Two and SOW Three (each defined below) are collaborative arrangements and that QML meets the definition of a customer under ASC 606. Additionally, each SOW is a separate contract with a single performance obligation to provide development services. Under each SOW, QML pays the Company a monthly fee for development work performed by the Company and its subcontractors (collectively, the “Monthly Fee”). The Monthly Fee is based on the employee and materials costs incurred during the month, which is subject to significant variability from period to period and unknown until the costs are incurred. Therefore, the Monthly Fee, which is based on use of hours and costs as a measure of progress, is included in the transaction price and recognized as revenue over time when the costs are incurred, and the Monthly Fee is billed to QML. It is at this time that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur. The Company and QML also share any net profits resulting from performance of the development work as determined pursuant to the Governing Agreement. Such profit-sharing payment(s) are deemed to be variable consideration using the expected value method and are included in the transaction price upon completion of the respective SOW deliverables, acceptance of corresponding deliverables, and the mutual agreement by QML and the Company on the calculation of net profit, which is when it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur.
Because each SOW has an expected duration of one year or less, the Company has elected the practical expedient in ASC 606-10-50-14(a) to not disclose information about its remaining performance obligations for each SOW.
Statement of Work No. One
In June 2017, the Company and QML entered into the first statement of work under the Governing Agreement, which has been twice amended in December 2017 and March 2018 (collectively, “SOW One”). SOW One addressed the activities of the Company and QML in support of the development and potential commercialization of a NGS-based companion diagnostic assay that was the subject of a sponsor project agreement between QML and a biopharmaceutical company (“Pharma One”). In May 2018, SOW One was terminated by QML as a result of Pharma One’s termination of the development project. The Company discontinued development activities related to the project following wind down activities completed in the second quarter of 2018.
Revenue of $2,397,136, inclusive of SOW One Monthly Fees and $99,394 of SOW One profit-sharing payments was included in the accompanying consolidated statements of operations for the year ended December 31, 2018. Costs relating to development activities conducted by the Company pursuant to SOW One of $1,716,115 have been included in research and development expense in the accompanying consolidated statements of operations for the year ended December 31, 2018. There was no revenue or costs relating to SOW One during the year ended December 31, 2019, and there were no accounts receivable relating to SOW One as of December 31, 2019 or 2018.
Statement of Work No. Two
In October 2017, the Company and QML entered into the second statement of work under the Governing Agreement (“SOW Two”), which was made effective as of June 2, 2017 (“Onset Date”). The Company and QML amended SOW Two twice in August 2018 and two additional times, in September 2018 and in February 2019. SOW Two addresses development activities conducted by the Company and QML since the Onset Date and those expected to be further conducted by the parties in connection with what is expected to be a multi-stage project leading to the potential development and commercialization of an NGS-based companion diagnostic assay in support of one or more therapeutic development and commercialization programs for a third-party biopharmaceutical company.
The initial-phase investigational-use-only (“IUO”) development activities under SOW Two and the first three amendments related to next phases, which include the use of the IUO assay developed in the initial-phase in a retrospective clinical trial and in additional disease indications, have been completed. The fourth amendment of SOW Two, effective as of February 5, 2019, contemplates the use of the IUO assay in multiple biopharmaceutical company clinical trials and additional development activities which could potentially be included in a future companion diagnostic regulatory submission. As of December 31, 2019, development activities agreed upon in the fourth amendment are ongoing and expected to continue into the first half of 2020.
Revenue of $2,685,634, inclusive of SOW Two Monthly Fees and $657,000 of SOW Two profit-sharing payments has been included in collaborative development services revenue in the accompanying consolidated statements of operations for the year ended December 31, 2019. Revenue of $5,988,021, inclusive of SOW Two Monthly Fees and $1,779,827 of SOW Two profit-sharing payments has been included in collaborative development services revenue in the accompanying consolidated statements of operations for the year ended December 31, 2018. Accounts receivable relating to SOW Two of $171,298 and $1,007,950 remained in the accompanying consolidated balance sheets as of December 31, 2019 and 2018, respectively. Costs relating to development activities conducted by the Company pursuant to SOW Two of $1,849,088 have been included in research and development expense in the accompanying consolidated statements of operations for the year ended December 31, 2019, compared to $3,625,332 for the year ended December 31, 2018.
Statement of Work No. Three
In January 2018, the Company and QML entered into a third statement of work under the Governing Agreement (“SOW Three”) and amended SOW Three in September 2018. SOW Three relates to development activities for an NGS-based clinical-trial assay (“SOW Three Project”) in connection with a sponsor project agreement between QML and a pharmaceutical company (“Pharma Three”). Initial assay development activities under SOW Three have been completed, and the first amendment to SOW Three provides for the development of an IUO assay, subsequent retrospective testing of clinical trial samples, design verification and, subject to satisfactory achievement of relevant performance and regulatory milestones, regulatory submissions in the United States and European Union necessary for the commercialization of a companion diagnostic for a corresponding Pharma Three drug. As of December 31, 2019, the Company and QML are on hold pending customer decision as to whether to proceed with next phase contract activities.
Revenue of $1,886,050, inclusive of SOW Three Monthly Fees and $720,270 of SOW Three profit-sharing payment has been included in collaborative development services revenue in the accompanying consolidated statements of operations for the year ended December 31, 2019. Revenue of $3,997,346 inclusive of SOW Three Monthly Fees and $355,631 of SOW Three profit-sharing payments has been included in collaborative development services revenue in the accompanying consolidated statements of operations for the year ended December 31, 2018. Accounts receivable relating to SOW Three of $760,274 and $363,869 remained in the accompanying consolidated balance sheets as of December 31, 2019 and 2018, respectively. Costs relating to development activities conducted by the Company pursuant to SOW Three of $983,603 have been included in research and development expense in the accompanying consolidated statements of operations for the year ended December 31, 2019, compared to $2,667,030 for the year ended December 31, 2018.
Contract Liabilities
The Company receivesmay receive up-front payments from customers for custom RUO assay design services, and occasionally for sample processing services. PaymentsIn addition, payments for instrument extended warranty contracts are required to be made in advance as are payments for certain agreed-upon capital purchases required for collaborative development service projects.advance. The Company recognizes such up-front payments as a contract liability.liabilities. The contract liability isliabilities are subsequently reduced at the point in time that the data fileas revenue is delivered for sample processing services or as the Company satisfies its performance obligations over time for RUO assay design, collaborative development and extended warranty services.recognized. Contract liabilities of $599,454approximately $0.2 million and $410,947$0.1 million were included in contractother current liabilities – current and other non-current liabilities in the accompanying consolidated balance sheets as of December 31, 20192022 and 2018, respectively.2021, respectively, and an additional immaterial amount of contract liabilities were included in other non-current liabilities as of each date in the consolidated balance sheets reflecting the period in which the Company expects to realize the deferred revenue.
Changes in the Company’s contract liabilities were as follows as of the dates indicated:
| | | | | | | | | | | | |
| | Product
Revenue | | | Sample
Processing | | | Total Contract
Liability | |
Balance at January 1, 2022 | | $ | 128,529 | | | $ | 30,621 | | | $ | 159,150 | |
Deferral of revenue | | | 293,158 | | | | 197,904 | | | | 491,062 | |
Recognition of deferred revenue | | | (274,973 | ) | | | (201,525 | ) | | | (476,498 | ) |
Balance at December 31, 2022 | | $ | 146,714 | | | $ | 27,000 | | | $ | 173,714 | |
| | | | | | | | | | | | |
| | Product
Revenue | | | Sample
Processing | | | Total Contract
Liability | |
Balance at January 1, 2021 | | $ | 103,580 | | | $ | 93,884 | | | $ | 197,464 | |
Deferral of revenue | | | 286,349 | | | | 587,091 | | | | 873,440 | |
Recognition of deferred revenue | | | (261,400 | ) | | | (650,354 | ) | | | (911,754 | ) |
Balance at December 31, 2021 | | $ | 128,529 | | | $ | 30,621 | | | $ | 159,150 | |
| | Product Revenue | | | Custom RUO Assay Design | | | Sample Processing | | | Total Contract Liability | |
Balance at January 1, 2019 | | $ | 116,547 | | | $ | 50,000 | | | $ | 244,400 | | | $ | 410,947 | |
Deferral of revenue | | | 218,802 | | | | 972,267 | | | | 529,913 | | | | 1,720,982 | |
Recognition of deferred revenue | | | (240,201 | ) | | | (956,051 | ) | | | (336,223 | ) | | | (1,532,475 | ) |
Balance at December 31, 2019 | | $ | 95,148 | | | $ | 66,216 | | | $ | 438,090 | | | $ | 599,454 | |
| | Product Revenue | | | Custom RUO Assay Design | | | Sample Processing | | | Collaborative Development Services | | | Total Contract Liability | |
Balance at January 1, 2018 | | $ | 39,426 | | | $ | 197,606 | | | $ | 490,536 | | | $ | 110,317 | | | $ | 837,885 | |
Deferral of revenue | | | 190,703 | | | | 448,580 | | | | 197,541 | | | | 70,918 | | | | 907,742 | |
Customer deposits | | | 131,864 | | | | - | | | | - | | | | — | | | | 131,864 | |
Recognition of deferred revenue | | | (245,446 | ) | | | (596,186 | ) | | | (443,677 | ) | | | (181,235 | ) | | | (1,466,544 | ) |
Balance at December 31, 2018 | | $ | 116,547 | | | $ | 50,000 | | | $ | 244,400 | | | $ | — | | | $ | 410,947 | |
Note 10. Other Agreements
NuvoGen Obligation
The Company entered into an asset purchase agreement in 2001, as amended, with NuvoGen Research, LLC (“NuvoGen”) to acquire certain intellectual property from NuvoGen. The Company accounted for the transaction as an asset acquisition. However, as the intellectual property was determined to not have an alternative future use, the upfront consideration was expensed. In exchange for the intellectual property, the Company initially paid NuvoGen 5,587 shares of the Company’s common stock, fixed payments of $740,000 over the first two years of the agreement and agreed to make quarterly installment payments to NuvoGen until thepay total aggregate cash compensation paid to NuvoGen under the agreement equaled $15,000,000.of $15.0 million. Certain terms of the agreement were amended in November 2003, September 2004, November 2012 and February 2014.
Pursuant to the latest amendment to the agreement, the Company is obligated to pay the greater of $400,000$0.4 million or 6%6% of annual revenue until the obligation is paid in full. The Company paid yearly fixed fees, in quarterly installments, to NuvoGen of $400,000$0.4 million as well as revenue-based payments of $927,922 and $612,122approximately $0.1 million during the years ended December 31, 20192022 and 2018,2021, respectively, for the amount by which 6% of revenue exceeded the applicable fixed fee. Additional revenue-based payments of $187,997 and $363,686 were payable as of December 31, 2019 and 2018, respectively. Beginning on January 1, 2019 and continuing until the remaining obligation has been paid in full, interest on the remaining unpaid obligation is being accrued and will accrue and compound annually at a rate of 2.5%2.5% per year. Accrued interest onrelated to this unpaid obligation is payable on the date that the remaining obligation is paid in full.
Minimum payments to be made in 20202023 include $187,997$46,031 of revenue-based payments payable as of December 31, 20192022 and an estimate of additional revenue-based payments to be made throughout the remainder of 20202023 relating to revenue generated in the first, second and third quarters of 20202023 using actual revenue generated in the same quarters in 2019.2022. Minimum payments for the remaining years include only the minimum payments for each year. Actual payments could be significantly more than provided in the table, to the extent that 6% of the Company’s annual revenue in 2020 and beyondthose years exceeds $400,000:$0.4 million:
| | | | |
2023 | | $ | 446,031 | |
2024 | | | 400,000 | |
2025 | | | 400,000 | |
2026 | | | 400,000 | |
2027 | | | 400,000 | |
2028 and beyond | | | 1,863,438 | |
Total NuvoGen obligation payments | | | 3,909,469 | |
Plus interest accretion | | | 55,620 | |
Total NuvoGen obligation, net | | $ | 3,965,089 | |
F-22
2020 | | | 1,152,233 | |
2021 | | | 400,000 | |
2022 | | | 400,000 | |
2023 | | | 400,000 | |
2024 | | | 400,000 | |
2025 and beyond | | | 2,806,466 | |
Total NuvoGen obligation payments | | | 5,558,699 | |
Plus interest accretion | | | 92,311 | |
Total NuvoGen obligation, net | | $ | 5,651,010 | |
The Company has recorded the obligation at the estimated present value of the future payments using a discount rate of 2.5%2.5%, which represented the Company’s estimate of its effective borrowing rate for similar obligations. The unamortized debt discountinterest accretion was $(92,311)$(55,620) and $(106,132) at$(67,088) as of December 31, 20192022 and 2018,2021, respectively. Discount accreted during the years ended December 31, 20192022 and 20182021 was $(13,821)$(11,467), and $(12,480), respectively.
Illumina, Inc. Agreement
In June 2017, the Company entered into an Amended and Restated Development and Component Supply Agreement with Illumina, Inc. (“Illumina”$(12,288), effective May 31, 2017 (“Restated Agreement”), which amendedrespectively, and restated the parties’ IVD Test Development and Component Supply Agreement entered intowas included in October 2014 (“Original Agreement”). The Restated Agreement provided for the development and worldwide commercialization by the Company of nuclease-protection-based RNA or DNA profiling tests (“IVD test kits”) for use with Illumina’s MiSeqDx sequencer in the field of diagnostic oncology testing in humans (“Field”). In addition, the Company agreed to pay Illumina a single digit percentage royalty on net sales of any IVD test kits that the Company commercializes pursuant to the Restated Agreement.
On April 23, 2019, the Company and Illumina entered into the First Amendment to the Restated Agreement, effective as of April 3, 2019 (the “First Amendment”). The First Amendment expanded the scope of the Field defined in the Restated Agreement to include diagnostic testing in humans for (i) autoimmune disorders and diseases, (ii) cardiovascular disorders and diseases, and (iii) fibrosis disorders and diseases ((i)-(iii) together, the “Other Fields”). The Company and Illumina have continued the development plans that were previously entered into under the Restated Agreement, and the Company may, at its discretion, submit additional development plans for IVD test kits in the Field to Illumina for its approval, not to be unreasonably withheld. In addition, Illumina will consider requests for additional development plans for IVD test kits in the Other Fields in good faith, but Illumina may accept or reject such requests in its sole and absolute discretion.
Under each development plan, Illumina will provide specified regulatory support and rights, and develop and deliver to the Company an executable version of custom software, which, when deployed on Illumina’s MiSeqDx sequencer, would enable sequencing by the end-user of the subject IVD test kit probe library. Illumina retains ownership of the custom software, subject to the Company’s right to use the custom software in connection with the commercialization of IVD test kits. The Company is required to pay Illumina up to $0.6 million in the aggregate upon achievement of specified regulatory milestones relating to the IVD test kits, though none of these regulatory milestones have been reached through December 31, 2019.
As a result of IVD test kit development plans submitted by the Company to Illumina in accordance with the Restated Agreement, the Company paid Illumina $0 and $12,500 for the years ended December 31, 2019 and 2018, respectively. Costs incurred for development plans under the Restated Agreement have been expensed as incurred to research and developmentinterest expense in the accompanying consolidated statements of operations.
Absent earlier termination, the Restated Agreement will expire in May 2027; however, Illumina is no longer obligated to notify the Company of changes in its products that may affect the Company’s IVD test kits after May 31, 2023. The Company may terminate the Restated Agreement at any time upon 90 days’ written notice and may terminate any development plan under the Restated Agreement upon 30 days’ prior written notice. Illumina may terminate the Restated Agreement upon 30 days’ prior written notice if the Company undergoes certain changes of control, subject to a transition period of up to 12 months for then-ongoing development plans. Either party may terminate the Restated Agreement upon the other party’s material breach of the Restated Agreement that remains uncured for 30 days, or upon the other party’s bankruptcy.
Note 11. Leases
Operating Leases
TheThe Company leases office space and equipment under agreements classified as operating leases that expire on various dates through 2023. leases. The Company’s most significant active leases as of December 31, 2019 are for2022 relate to the Company’s office and manufacturing space in Tucson, Arizona, whichand expire in 2021. The Company also leases a development laboratory space in San Carlos, California, for which the lease term expires in 2023.2025. The Company’s leases do not include any contingent rental payments, impose any financial restrictions, or contain any residual value guarantees. Certain
The Company amended its Tucson facility leases in September 2021 to extend the terms of the Company’s leases includefor three years through January 31, 2025. The lease extension was treated as a lease modification for accounting purposes, and allows for an additional extension of two years on the same terms and conditions of the existing amended lease agreement, except that the lease rates would be adjusted to reflect lease rates applicable to like-kind buildings within the market at the time that the Company elects to exercise the extension options, but in no event less than the last applicable rental rate. The Company has not accounted for these renewal options and escalation clauses; renewal options have not been included in the calculation of the lease liabilities and right-of-use assets as the Company is not reasonably certain to exercise the options. Annual rent increases are included
In the fourth quarter of 2022, the Company recorded an increase to its operating lease liability as the result of leasehold improvements financed by the landlord, to be repaid in equal installments over the calculationremaining term of the lease.
In the first quarter of 2021, the Company closed its development laboratory in San Carlos, California and, as a result, $0.2 million of operating lease right-of-use assets. assets related to the abandonment of the laboratory were written off to research and development expense for the year ended December 31, 2021.
Variable expenses generally represent the Company’s share of the landlord’s operating expenses and are recorded when incurred. Incremental borrowing rates used to discount future lease payments in calculating lease liabilities were estimated by reference to the rate onrates for similar length secured lines of credit to the Company’s MidCap Term Loan,lease agreements provided by the Company’s lenders at the time that the lease liabilities were recorded, as this representsthese rates represented the cost of borrowing for secured loans of similar duration. The Company does not have any operating lease arrangements where it acts as a lessor.
The components of lease cost for operating leases were as follows:
| | | | | | | | |
| | Years Ended December 31, | |
| | 2022 | | | 2021 | |
Operating leases | | | | | | |
Operating lease cost | | $ | 483,956 | | | $ | 503,130 | |
Variable lease cost | | | 99,989 | | | | 88,708 | |
Total rent expense | | $ | 583,945 | | | $ | 591,838 | |
| | Year Ended | |
| | December 31, 2019 | |
Operating leases | | | | |
Operating lease cost | | $ | 618,463 | |
Variable lease cost | | | 131,387 | |
Operating lease expense | | | 749,850 | |
Short-term lease rent expense | | | 1,497 | |
Total rent expense | | $ | 751,347 | |
The table below summarizes other information related to the Company’s operating leases:
| | | | | | | | |
| | Years Ended December 31, | |
| | 2022 | | | 2021 | |
Cash paid for amounts included in measurement of operating lease liabilities | | $ | 487,673 | | | $ | 514,453 | |
Establishment of operating lease liabilities arising from obtaining right-of-use- assets | | | 77,385 | | | | 1,302,457 | |
Weighted-average remaining lease term – operating leases | | | 2.1 | | | | 3.1 | |
Weighted-average discount rate – operating leases | | | 5.8 | % | | | 5.8 | % |
F-23
| | Year Ended or As of December 31, 2019 | |
Operating cash flows for operating leases | | $ | 770,658 | |
Establishment of operating lease liabilities arising from obtaining right-of-use assets | | $ | 2,038,193 | |
Weighted-average remaining lease term – operating leases | | | 2.3 | |
Weighted-average discount rate – operating leases | | | 9.6 | % |
As of December 31, 2019, remainingRemaining maturities of ourthe Company’s operating leases, excluding short-term leases, are as follows:
2020 | | $ | 881,300 | |
2021 | | | 352,243 | |
2022 | | | 281,232 | |
2023 | | | 70,848 | |
Total | | | 1,585,623 | |
Less present value discount | | | (190,351 | ) |
Operating lease liabilities, net | | $ | 1,395,272 | |
Prior toincluded in operating lease liabilities – current and operating lease liabilities - non-current, net of discount, in the Company’s adoption of ASC 842, rent expense was $583,182 for the year ended December 31, 2018, recorded on a straight-line basis. Lease commitments as presented under ASC 840consolidated balance sheets as of December 31, 2018 were2022, are as follows:
2019 | | | 525,745 | |
2020 | | | 528,225 | |
2021 | | | 53,907 | |
2022 | | | 10,768 | |
2023 | | | 10,768 | |
2024 and beyond | | | 43,073 | |
| | $ | 1,172,486 | |
| | | | | | |
2023 | | | | $ | 521,467 | |
2024 | | | | | 521,379 | |
2025 | | | | | 43,444 | |
Total | | | | | 1,086,290 | |
Less present value discount | | | | | (64,840 | ) |
Total operating lease liabilities | | | | | 1,021,450 | |
Less operating lease liabilities - current | | | | | (475,126 | ) |
Operating lease liabilities - non-current | | | | $ | 546,324 | |
Financing Leases
The Company has a small number of computer and copier equipment leases that are classified as financing leases. Incremental borrowing rates used to discount future lease payments in calculating lease liabilities were estimated by reference to information received by the Company from bankers regarding estimated current borrowing rates for collateralized loans with similar amount and duration as the leases. The Company doesdid not have any material financing leases where it acts as a lessor. The components of lease cost for financing leases were as follows:
| Year Ended | |
| December 31, 2019 | |
Financing leases | | | |
Amortization of right-of-use assets | $ | 46,255 | |
Interest on lease liability | | 6,859 | |
Total financing lease cost | $ | 53,114 | |
The table below summarizes other information related toeither the Company’s financing leases:
| December 31,
| |
| 2019
| |
Weighted-average remaining lease term – financing leases
| | 3.7
| |
Weighted-average discount rate – financing leases
| | 9.77
| %
|
As ofyear ended December 31, 2019, remaining maturities of our financing leases are as follows:2022 or 2021.
2020 | $ | 50,072 | |
2021 | | 28,355 | |
2022 | | 20,716 | |
2023 | | 18,396 | |
2024 | | 16,080 | |
Total | | 133,619 | |
Less present value discount | | (21,811 | ) |
Financing lease liabilities, net | $ | 111,808 | |
At December 31, 2019 the Company had financing lease liabilities net of discount of $111,808, of which $41,134 was included in other current liabilities and $70,674 was included in other non-current liabilities, and financing right-of-use assets of $108,253, which were included in property and equipment, net, in the accompanying consolidated balance sheet.
Note 12. Net Loss Per Share
Basic loss per common share is computed by dividing the net loss allocable to common stockholders by the weighted-average number of shares of common stock or common stock equivalents outstanding. Diluted loss per common share is computed similar to basic loss per common share except that it reflects the potential dilution that could occur if dilutive securities or other obligations to issue common stock were exercised or converted into common stock.
The following table provides a reconciliation of the numerator and denominator used in computing basic and diluted net loss per share for the periods presented:
| | | | Years Ended December 31, | | | Years Ended December 31, | |
| | | 2019 | | | 2018 | | | 2022 | | | 2021 | |
Numerator: | | | | | | | | | | | | | | | |
Net loss | | | $ | (19,297,664 | ) | | $ | (16,453,918 | ) | | $ | (21,594,476 | ) | | $ | (17,145,170 | ) |
Denominator: | | | | | | | | | | | | | | | |
Weighted-average shares outstanding-basic and diluted | | | | 38,099,687 | | | | 27,523,463 | | |
Weighted-average shares outstanding-basic and diluted * | | | | 889,284 | | | | 578,011 | |
Net loss per share, basic and diluted | | | $ | (0.51 | ) | | $ | (0.60 | ) | | $ | (24.28 | ) | | $ | (29.66 | ) |
In connection with*Reflects the Securities Purchase Agreement (see Note 14), the Company issued and sold an aggregate of 5,411,687 pre-funded warrants exercisable for an aggregate of 5,411,687 shares of common stock. The total exercise price of the pre-funded warrants is $0.65 per share, $0.64 of which was pre-funded and paidretrospective adjustment related to the Company upon issuance of the pre-funded warrants. The remaining exercise price of the pre-funded warrants is $0.01 per share. The pre-funded warrants are immediately exercisable and do not expire. As the shares underlying the pre-funded warrants are issuable for nominal consideration of $0.01 per share, they are considered outstanding for purposes of the calculation of loss per share.reverse stock split completed on December 20, 2022.
The following outstanding options, warrants, restrictedcommon stock units and debt conversion optionequivalents were excluded from the computation of diluted net loss per share for the periods presented because their effect would have been anti-dilutive:
| | | | | | | | |
| | Years Ended December 31, | |
| | 2022 | | | 2021 | |
Options to purchase common stock | | | 76,099 | | | | 46,611 | |
Series A Preferred | | | — | | | | 13,212 | |
Common stock warrants | | | 3,164,267 | | | | 4,890 | |
Unvested restricted stock units | | | 1,041 | | | | 2,598 | |
| | Years Ended December 31, | |
| | 2019 | | | 2018 | |
Options to purchase common stock | | | 2,904,898 | | | | 2,047,237 | |
Common stock warrants | | | 236,915 | | | | 237,846 | |
Restricted stock units | | | 223,745 | | | | 227,707 | |
QNAH convertible note | | | 800,359 | | | | 777,769 | |
Note 13. Warrants
In connection with certain of its redeemable convertible preferred stock issuances, debt agreements, convertible debt financings and other financing arrangements, the Company has issued warrants for shares of its common stock and various issues of its redeemable convertible preferred stock which have since been converted to common stock warrants.
On August 22, 2014, in connection with the Company’s entry into the Growth Term Loan (see Note 8), the Company issued to the two-lender syndicate warrants exercisable for an aggregate of 2,512,562 shares of Series E stock at a price of $0.2189 per share. The warrants provide for cashless exercise at the option of the holders, and contain provisions for the adjustment of the number of shares issuable upon the exercise of the warrant in the event of stock splits, recapitalizations, reclassifications, consolidations or dilutive issuances. F-24
In connection with the closing of the IPO in May 2015, the warrants became exercisable for an aggregate of 23,396 shares of common stock at an exercise price of $23.51 per share. The warrants expire by their terms on August 22, 2024, provided that the warrants will be automatically exercised on a cashless basis upon expiration if not previously exercised if the fair market value of a share of the common stock exceeds the per share exercise price. In connection with the funding of Growth Term Loan B, in March 2016 the Company issued Oxford Finance LLC a common stock warrant exercisable for 45,307 shares of common stock at an exercise price of $2.759 per share, and the warrant originally issued to Silicon Valley Bank automatically became exercisable for an additional 5,317 shares of common stock at an exercise price of $23.51 per share in accordance with the terms of the Growth Term Loan.
On December 30, 2014, in connection with the Company’s entry into convertible note agreements, the Company agreed to issue warrants (“Convertible Note Warrants”) to the holders exercisable for an aggregate of 9,311,586 shares of Series E Stock at a price of $0.2189 per share, for aggregate consideration of $1,354 on January 15, 2015. The warrants provide for cashless exercise at the option of the holders, and contain provisions for the adjustment of the number of shares issuable upon the exercise of the warrant in the event of stock splits, recapitalizations, reclassifications, consolidations or dilutive issuances. In connection with the closing of the IPO in May 2015, the Convertible Note Warrants became exercisable for an aggregate of 144,772 shares of common stock at the IPO price of $14.00 per share. The Convertible Note Warrants expire by their terms on January 15, 2022.
In March 2018, in connection with the entry into the MidCap Term Loan (see Note 8), the Company granted the lender ten-year warrants to purchase 18,123 shares of the Company’s common stock at $7.73 per share as a result of the Company borrowing $7.0 million under MidCap Tranche 1 on the MidCap Closing Date.
In September 2019, in connection with the2022 Securities Purchase Agreement (see Note 14), the Company issued and sold an aggregate of 5,411,687 pre-funded warrants exercisable for an aggregate of 5,411,687200,911 shares of common stock. The totalpre-funded warrants had an exercise price of the pre-funded warrants is $0.65$0.012 per share $0.64and were exercised in full in May 2022 for proceeds of which was pre-funded$2,411. The Company also issued and paidsold to the Company upon issuanceinvestor common warrants to purchase 270,415 shares of the pre-funded warrants. The remainingcommon stock that will expire on March 17, 2024 and common warrants to purchase an additional 270,415 shares of common stock that will expire on September 17, 2027. Each of these common warrants became exercisable commencing September 21, 2022 and has an exercise price of $24.744 per share.
In connection with the December 2022 Securities Purchase Agreement (see Note 14), the Company issued and sold pre-funded warrants is $0.01 per share.exercisable for an aggregate of 1,188,322 shares of common stock. The pre-funded warrants are immediatelyhad an exercise price of $0.001 per share and were exercised in full in December 2022 for proceeds of $1,188. The Company also issued and sold to the investor warrants to purchase 1,290,322 shares of common stock that will expire on December 23, 2027 and warrants to purchase an additional 1,290,322 shares of common stock that will expire on December 23, 2024. Each of these common warrants became exercisable commencing December 23, 2022 and do not expire.has an exercise price of $7.50 per share.
Also in connection with the December 2022 Securities Purchase Agreement, the Company issued warrants to purchase up to an aggregate of 38,709 shares of common stock to designees of the placement agent for the transaction. The warrants issued to the placement agent have substantially the same terms as the warrants above, except the placement agent warrants have an exercise price of $9.6875 per share and expire on December 21, 2027.
The following table shows the common stock warrants outstanding as of December 31, 2019:2022:
| | | | | | | | | | |
Warrant Issuance Date | | Shares of
Common Stock
Underlying
Warrants | | | Exercise
Price/Share | | | Expiration Date |
August 2014 | | | 159 | | | $ | 4,231.80 | | | 2024 |
March 2016 | | | 251 | | | | 496.80 | | | 2026 |
March 2018 | | | 100 | | | | 1,391.40 | | | 2028 |
June 2020 | | | 3,574 | | | | 139.878 | | | 2030 |
March 2022 | | | 270,415 | | | | 24.74 | | | 2024 |
March 2022 | | | 270,415 | | | | 24.74 | | | 2027 |
December 2022 | | | 1,290,322 | | | | 7.50 | | | 2024 |
December 2022 | | | 1,290,322 | | | | 7.50 | | | 2027 |
December 2022 | | | 38,709 | | | | 9.6875 | | | 2027 |
Warrant Issuance Date | | Shares of Common Stock Underlying Warrants | | | Exercise Price/Share | | | Expiration Date |
August 2014 | | | 28,713 | | | $ | 23.51 | | | 2024 |
December 2014 | | | 144,772 | | | | 14.00 | | | 2022 |
March 2016 | | | 45,307 | | | | 2.76 | | | 2026 |
March 2018 | | | 18,123 | | | | 7.73 | | | 2028 |
September 2019 | | | 5,411,687 | | | | 0.01 | | | N/A |
Note 14. Stockholders’ Equity
Public OfferingsReverse Stock Split
ATM Offering
In April 2017,On December 20, 2022, the Company entered intocompleted a Controlled Equity Offering Sales Agreement (the “Sales Agreement”) with Cantor Fitzgerald & Co. (“Cantor”), as sales agent, pursuant to which the Company had the right to offer and sell, from time to time, through Cantor, sharesreverse stock split of the Company’s common stock, par value $0.001 per share, by any method deemed to be an “at the market offering” as defined in Rule 415(a)(4) under the Securities Act of 1933, as amended (the “Securities Act”), (the “ATM Offering”). In April 2017, the Company also filed a prospectus supplement (File No. 333-216977) with the SEC relating to the offer and sale of up to $20.0 million of common stock in the ATM Offering. In June 2017, the Company filed a first amendment to the prospectus supplement with the SEC to increase the amount of common stock that could be offered and sold in the ATM Offering under the Sales Agreement to $40.0 million in the aggregate, inclusive of the common stock previously sold in the ATM Offering prior to the date of the first amendment. In January 2018, the Company filed a second amendment to the prospectus supplement with the SEC to decrease the amount of common stock that could be offered and sold in the ATM Offering under the Sales Agreement to $23.0 million in the aggregate, inclusive of the common stock sold in the ATM Offering prior to the date of the second amendment. In February 2018, the Company and Cantor mutually agreed to terminate the Sales Agreement.
Prior to termination of the Sales Agreement, the Company sold 5,733,314its outstanding shares of common stock under the ATM Offering at then-market prices for total gross proceeds of approximately $21.1 million, including 0.3 million shares of common stock sold for gross proceeds of $0.6 million during the first quarter ended March 31, 2018. After $0.6 million of sales commissions and $0.2 million of other offering expenses paid by the Company in connection with the ATM Offering, the Company’s aggregate net proceeds from the ATM Offering were approximately $20.2 million. Sales commissions and offering expenses have been recorded as a reduction of proceeds received in arriving at the amounts recorded in additional paid-in capital in the accompanying consolidated balance sheets as of December 31, 2018.
2018 Underwritten Public Offering
In January 2018, the Company completed an underwritten public offering of 13,915,000 shares of its common stock at a price of $2.90 per share, including 1,815,000 shares sold pursuant to the exercise in full of the underwriters’ option to purchase additional shares. The Company sold its common stock through an underwriting agreement with Leerink Partners LLC and Cantor as representatives of the underwriters for the offering. The aggregate net proceeds to the Company from the offering were approximately $37.7 million, after deducting the underwriting discounts and commissions and offering expenses.
Cowen ATM Offering
In March 2019, the Company entered into a Controlled Equity Offering Sales Agreement (“Cowen Sales Agreement”) with Cowen and Company (“Cowen”), as sales agent, pursuant to which the Company has the right to offer and sell, from time to time, through Cowen,every 12 shares of the Company’sissued and outstanding common stock having an aggregate offering pricewere exchanged for one share of up to $40.0 million, by any method deemed to be an “at the market offering” as defined in Rule 415(a)(4) under the Securities Act (the “Cowen ATM Offering”) under the Company’s shelf registration statement on Form S-3 (File No. 333-229045). Approximately $0.2 million of costs incurred in connection with the offeringcommon stock.No fractional shares were capitalized as deferred offering costsissued in the Company’sreverse stock split. Instead, fractional shares that would have otherwise resulted from the stock split were purchased by us at the applicable percentage of $8.20 per share. All share and per share amounts included within these consolidated financial statements have been retrospectively adjusted to reflect the reverse stock split.
Equity Offerings
September 2019 consolidated balance sheet upon entry into this agreement.Securities Purchase Agreement
As of December 31, 2019, no shares were sold under the Cowen ATM Offering and no shares will be sold under the Cowen ATM Offering as the Company terminated the Cowen Sales Agreement in November 2019. As a result of this termination, the Company wrote off approximately $0.1 million of the previously capitalized deferred offering costs as the Company will not utilize these costs in the sale of shares through the Cowen ATM Offering. The remaining approximately $60,000 of costs capitalized as deferred offering costs in the consolidated balance sheets related to the filing of the Form S-3 were able to be utilized for the 2019 ATM Offering discussed below.
2019 Underwritten Public and Private Offerings
Public Offering
In September 2019, the Company entered into an underwriting agreement with Cantor (the “2019 Underwriting Agreement”), relating to the issuance and sale in a public offering of 29,298,537 shares of its common stock, including 3,821,548 shares sold pursuant to the full exercise of the underwriter’s option to purchase additional shares. The price to the public in the offering was $0.65 per share and the underwriter agreed to purchase the shares from the Company pursuant to the 2019 Underwriting Agreement at a price of $0.611 per share. The net proceeds to the Company were approximately $17.7 million, after deducting the underwriting discounts and commissions and offering expenses.
The offering was made pursuant to the Company’s registration statement on Form S-3 (Registration Statement No. 333‑229045), previously filed with the Securities and Exchange Commission (“SEC”) and declared effective by the SEC on February 11, 2019, and a prospectus supplement and accompanying prospectus thereunder.
Securities Purchase Agreement
In September 2019, concurrentconcurrently with the closing of the September 2019an underwritten public offering, the Company entered into a Securities Purchase Agreement (the “Securities"September 2019 Securities Purchase Agreement”Agreement") with certain institutional accredited investors (the “Purchasers”"Purchasers"), pursuant to which the Company sold to the Purchasers, in a private placement transaction, an aggregate of 5,411,687 pre-funded warrants to purchase up to an aggregate of 5,411,68730,064 shares of ourits common stock (“("Warrant Shares”Shares"), at a price of $0.64$115.20 per warrant (which $0.64$115.20 price relatesrelated to the pre-funded portion of the total $0.65$117.00 exercise price per share). Each pre-funded warrant hashad a remaining exercise price of $0.01$1.80 per share and became immediately exercisable upon issuance, subject to certain beneficial ownership limitations.
The exercise price of In June 2021, the remaining 12,416 pre-funded warrants will be subject to adjustmentwere exercised on a cashless, net exercise basis, resulting in the eventissuance of any stock dividends and splits, recapitalization, reorganization or similar transaction, as described in the pre-funded warrants. The pre-funded warrants are exercisable on a “cashless” basis in certain circumstances.
The pre-funded warrants and the Warrant Shares were not registered under the Securities Act and were offered pursuant to the exemption provided in Section 4(a)(2) under the Securities Act and Rule 506(b) promulgated thereunder. The Company agreed to file a registration statement to register the resale12,073 shares of the Warrant Shares within 30 days following the date of the Closing and to obtain effectiveness of such registration statement within 90 days following the Closing, subject to certain exceptions. Each Purchaser was an “accredited investor” as defined in Rule 501(a) under the Securities Act.common stock.
Cantor (the “Placement Agent”) acted as the sole placement agent in connection with the private placement of the warrants. Pursuant to a Placement Agency Agreement between us and the Placement Agent, we agreed to pay the Placement Agent a cash fee equal to 6% of the gross proceeds to us from the sale of the pre-funded warrants, and to provide reimbursement for certain out-of-pocket expenses. Upon closing, the Company received approximately $3.1 million in net proceeds from the sale of the pre-funded warrants in the private placement, which does not include proceeds that may be received upon exercise of the pre-funded warrants, after deducting the Placement Agent fee and other expenses.F-25
2019 ATM Offering
In November 2019, the Company entered into a Controlled Equity Offering Sales Agreement (the “Cantor Sales Agreement”) with Cantor Fitzgerald & Co. ("Cantor") as sales agent, pursuant to which the Company maywas able to offer and sell, from time to time, through Cantor, shares of the Company’sits common stock, par value $0.001$0.001 per share, having an aggregate offering price of up to $20.0 million, by any method deemed to be an “at"at the market offering”offering" as defined by rule 415(a)(4) under the Securities Act (the “2019"ATM Offering").
During the year ended December 31, 2021, the Company sold 170,907 shares of common stock under the ATM Offering”Offering at then-market prices for net proceeds of approximately $10.7 million after paying sales commissions of approximately $0.3 million.
LP Purchase Agreement
In March 2020, the Company entered into a purchase agreement ("LP Purchase Agreement"). The shares will be offered and sold with Lincoln Park Capital Fund, LLC ("Lincoln Park"), pursuant to which, upon the Company’s shelf registration statement on Form S-3 (File No. 333-229045).
Theterms and subject to the conditions and limitations set forth therein, the Company is not obligatedhad the right to sell anyto Lincoln Park up to $20.0 million of shares of its common stock ("Purchase Shares") from time to time over the 36-month term of the LP Purchase Agreement. During the year ended December 31, 2021, the Company sold 12,864 shares of common stock under the LP Purchase Agreement at a weighted average price of $69.96 per share for total gross proceeds of approximately $0.9 million. The LP Purchase Agreement is no longer in effect.
Exchange and Private Placement
In February 2020, the Company entered into an Exchange and Purchase Agreement with certain accredited investors pursuant to which the Company agreed to (i) issue the investors an aggregate of 41,100 shares of its newly designated Series A Convertible Preferred Stock, par value $0.001 per share ("Series A Preferred"), in exchange for the investors surrendering to the Company for cancellation an aggregate of 22,833 shares of its common stock and (ii) sell and issue to the investors an aggregate of 10,170 shares of Series A Preferred for an aggregate purchase price of $0.6 million, or $59.00 per share.
In March 2022, the remaining 23,770 shares of Series A Preferred were converted by the investors into an aggregate of 13,206 shares of common stock. Accordingly, no shares of Series A Preferred are outstanding as of December 31, 2022. All of the previously designated Series A Preferred have resumed the status of authorized, unissued and undesignated preferred stock, which may be designated from time to time by the Company's Board of Directors.
March 2022 Securities Purchase Agreement
In March 2022, the Company entered into a Securities Purchase Agreement (the “March 2022 Securities Purchase Agreement”) with a single investor pursuant to which it agreed to issue to the investor 270,415 units at a price of $27.744 per unit (less $0.012 for each pre-funded warrant purchased in lieu of a share of common stock) for net proceeds, after deducting the placement agent fees and other estimated fees and expenses, of approximately $7.0 million. Each unit consists of one share of common stock (or one pre-funded warrant in lieu thereof), a common warrant to purchase one share of common stock with a term of 24 months from the issuance date, and a common warrant to purchase one share of common stock with a term of 66 months from the issuance date. Each of the common warrants became exercisable commencing on September 21, 2022 and has an exercise price of $24.744 per share. Each pre-funded warrant has an exercise price of $0.012 per share and does not expire until exercised in full. The pre-funded warrants may not be exercised if the aggregate number of shares of common stock beneficially owned by the holder thereof would exceed 9.99% immediately after exercise thereof. In May 2022, the 200,911 pre-funded warrants were exercised for proceeds of $2,411.
The common warrants issued in this transaction may not be exercised if the aggregate number of shares of common stock beneficially owned by the holder thereof would exceed 4.99% immediately after exercise thereof, which ownership cap may be increased by the holder up to 9.99% upon 61 days’ prior notice.
Cantor Sales Agreement. Approximately $81,000 of costs incurredserved as the placement agent in connection with the offering were capitalized as deferred offering costs in the Company’s consolidated balance sheets upon entry into this agreement in addition to the Form S-3 costs capitalized previously, as discussed in Cowen ATM Offering above, of which $45,000 are reimbursable by Cantor through reduction of commissions earned on shares sold under the Cantor SalesMarch 2022 Securities Purchase Agreement. The Company is not obligated to sell any shares under the Cantor Sales Agreement and will paypaid Cantor a commissionfee of approximately $0.3 million plus reimbursement for certain out-of-pocket expenses for its role as placement agent and has incurred approximately $0.2 million of additional transaction costs.
December 2022 Securities Purchase Agreement
In December 2022, in connection with a best-efforts public offering, the Company entered into a Securities Purchase Agreement (the "December 2022 Securities Purchase Agreement") with a certain institutional investor, pursuant to which the Company sold the investor 1,290,322 units at a combined public offering price of $7.75 per share (less $0.001 for each pre-funded warrant purchased in lieu of a share of common stock) for net proceeds, after deducting the Placement Agent fees and expenses and other estimated fees and expenses, of approximately $8.7 million. Each unit consisted of one share of common stock (or one pre-funded warrant in lieu thereof), a common warrant to purchase one share of common stock with a term of 24 months from the issuance date, and a common warrant to purchase one share of common stock with a term of 60 months from the issuance date.
F-26
The common warrants issued in this transaction may not be exercised if the aggregate number of shares of common stock beneficially owned by the holder thereof would exceed 4.99% immediately after exercise thereof, which ownership cap may be increased by the holder up to 3.0%9.99% upon 61 days’ prior notice.
Each pre-funded warrant had an exercise price of $0.001 per share and did not expire until exercised in full. In December 2022, the 1,188,322 pre-funded warrants were exercised for proceeds of $1,188. Each of the common warrants became immediately exercisable upon issuance and has an exercise price of $7.50 per share. The exercise price of the warrants issued in this agreement is subject to adjustment for stock split, reverse splits and similar capital transactions as described in the warrants.
H.C. Wainwright & Co., LLC (the "Placement Agent") served as the exclusive placement agent in connection with the December 2022 Securities Purchase Agreement. The Company paid the Placement Agent a cash fee of 6.5% of the aggregate gross proceeds from each saleraised at the closing of shares, reimbursethe December 2022 Securities Purchase Agreement, plus a management fee equal to 0.5% of the gross proceeds raised at the closing, and reimbursement of certain expenses and legal fees and disbursements and provide Cantor with customary indemnification and contribution rights. The Sales Agreement may be terminated by Cantor or the Company at any time upon notice to the other party, or by Cantor at any time in certain circumstances, including the occurrence of a material and adverse change in the Company’s business or financial condition that makes it impractical or inadvisableamount of $125,000. The Company also issued to market the shares or to enforce contracts for the saledesignees of the shares. There were noPlacement Agent warrants to purchase up to an aggregate of 38,709 shares soldof common stock (the “Placement Agent warrants”). The Placement Agent warrants have substantially the same terms as the warrants issued under the Cantor SalesDecember 2022 Securities Purchase Agreement, throughexcept the Placement Agent warrants have an exercise price of $9.6875 per share and expire on December 31, 2019. See Note 17 for further information regarding the 2019 ATM Offering.21, 2027.
Common Stock
Pursuant to the Company Amendedits amended and Restated Certificaterestated certificate of Incorporation,incorporation, the Company is authorized to issue 200,000,00026,666,667 shares of common stock at a par value of $0.001$0.001 per share.
Each share of common stock is entitled to one vote. The shares of common stock have no preemptive or conversion rights, no redemption or sinking fund provisions, no liability for further call or assessment, and are not entitled to cumulative voting rights.
Preferred Stock
Pursuant to the Company’sits amended and restated certificate of incorporation, the Company has been authorized to issue 10,000,000 shares of preferred stock, each having a par value of $0.001.$0.001. The preferred stock may be issued from time to time in one or more series with the authorization of the Company’s Board of Directors. The Board of Directors can determine voting power for each series issued, as well as designation, preferences, and relative, participating, optional or other rights and such qualifications, limitations or restrictions thereof.
Series A Preferred Stock
In October 2022, the Company entered into a Purchase Agreement (the "Purchase Agreement" with Ann Hanham, Ph.D., the Chair of the Company's Board of Directors (the "Purchaser"), pursuant to which the Company agreed to issue and sell one share of the Company's newly designated Series A Preferred Stock, par value $0.001 per share (the "Series A Preferred Stock"), to the Purchaser for a purchase price of $100.00. The Series A Preferred Stock was non-convertible, generally had voting rights only with respect to a proposal to authorize a reverse split of our common stock, and was automatically redeemed in an event certain to occur. On November 29, 2022, the one share of Series A Preferred Stock was redeemed for $100.00 upon stockholder approval of a reverse stock split.
Stock-based Compensation
The Company incurs stock-based compensation expense relating to the grants under its equity incentive plans of RSUs and stock options to employees, non-employee directors and consultants of the Company andunder its affiliatesequity incentive plans and through stock purchase rights granted under the ESPP.
Equity Incentive Plans
The Company initially establishedIn August 2020, the Company’s stockholders, upon the recommendation of the Company’s Board of Directors, approved the 2020 Equity Incentive Plan (the “2020 Plan”) as a successor to and continuation of the previous 2001 Stock Option Plan, (the “2001 Plan”), which included incentive and nonqualified stock options and restricted stock to be granted to directors, officers, employees, consultants and others. The 2001 Plan terminated, and no further awards were granted under the 2001 Plan upon the effective date of the Company’s 2011 Equity Incentive Plan (the “2011 Plan”).
In February 2014, the number of shares reserved under the 2011 Plan was increased to 20% of the total outstanding shares of the Company calculated on a fully diluted basis. The shares reserved under the 2011 Plan were required to be kept at that percentage with each subsequent equity financing. No new equity awards may be granted under the 2011 Plan.
In May 2015, 940,112 shares were reserved for issuance under the Company’sand 2014 Equity Incentive Plan (the “2014 Plan”"2014 Plan"), including 14,006 remaining shares reserved under the 2011 Plan. No shares. Upon approval of the Company’s stock available for issuance under the 20142020 Plan, as of December 31, 2019, other than those reserved for inducement awards, as outlined below. On January 1, 2020, an additional 2,323,60962,057 shares, were registered for issuance under the 2014 Plan pursuant to an evergreen provision contained in the 2014 Plan.
In May 2019, 200,000including 5,712 remaining shares were reserved for issuance under the 2014 Plan pursuant(excluding shares available for the granting of inducement awards under the 2014 Plan’s inducement share pool), were reserved for issuance under the 2020 Plan. No new awards may be granted under the 2001, 2011 or 2014 equity plans.
F-27
There were 16,668 shares of the Company’s common stock available for issuance under the 2020 Plan as of December 31, 2022 in addition to shares that may become available from time to time as shares of our common stock subject to outstanding awards granted under the 2014 Plan (excluding Inducement Awards) or the 2011 Plan that, following the effective date of the 2020 Plan (i) are not issued because such award or any portion thereof expires or otherwise terminates without all of the shares covered by such award having been issued; (ii) are not issued because such award or any portion thereof is settled in cash; or (iii) are forfeited back to or repurchased by the Company because of the failure to meet a contingency or condition required for the vesting of such shares. The 2020 Plan does not contain an amendment approved byevergreen provision.
In July 2021, the Company’s Board of Directors adopted the Company’s 2021 Inducement Plan (the “2021 Inducement Plan”), pursuant to Rule 5635(c)(4) of the Nasdaq Listing Rules, to be usedwhich 25,000 shares were initially authorized and reserved for issuance exclusively for the grant of awards to individuals who were not previously employees or non-employee directors of the Company, as inducement material to the individuals’ entering into employment with the Company (“Inducement Awards”). AsThere were 13,961 shares of December 31, 2019, there were 120,000 Inducement Awardsthe Company’s stock available for issuance under the 2014 Plan.2021 Inducement Plan as of December 31, 2022, in addition to shares that may become available from time to time as shares of the Company’s common stock subject to outstanding awards granted under the 2021 Inducement Plan are forfeited back to or repurchased by the Company because of the failure to meet a contingency or condition required for the vesting of such shares.
The Company’s Board of Directors determines the grant date for all awards granted under the 2014 Plan. equity plans. The option exercise price of stock options and Inducement Awards granted is generally equal to the closing price of the Company’s common stock on the date of grant or on the employee’s hire date for new hire grants.grant. All stock options granted have a ten-year term. The vesting period of stock options Inducement Awards and RSUs is established by the Company’s Board of Directors but typically ranges between one and four years.years.
Amounts recognized in the accompanying consolidated statements of operations with respect to the Company’s equity incentive plans were as follows:
| | | | | | | | |
| | Years Ended December 31, | |
| | 2022 | | | 2021 | |
Selling, general and administrative | | $ | 559,226 | | | $ | 1,154,000 | |
Research and development | | | 197,705 | | | | 141,281 | |
Cost of product and product-related services revenue | | | 17,229 | | | | 22,074 | |
| | $ | 774,160 | | | $ | 1,317,355 | |
| | | Years Ended December 31, | |
| | | 2019 | | | 2018 | |
Selling, general and administrative | | | $ | 859,653 | | | $ | 1,668,227 | |
Research and development | | | | 243,804 | | | | 159,450 | |
Cost of product and product-related services revenue | | | | 53,110 | | | | 60,378 | |
| | | $ | 1,156,567 | | | $ | 1,888,055 | |
The following table summarizes stock option activity (including Inducement Award activity) during the two-year period ended December 31, 2019:2022:
| | Number of Shares | | | Weighted- Average Exercise Price Per Share | | | Weighted- Average Remaining Contractual Life (Years) | | | Aggregate Intrinsic Value | | | | | | | | | | | | | | | | | |
Balance at January 1, 2018 | | | 1,517,771 | | | $ | 2.97 | | | | 7.5 | | | $ | 67,242 | | |
| | | Number of
Shares | | | Weighted-
Average
Exercise Price
Per Share | | | Weighted-
Average
Remaining
Contractual
Life (Years) | | | Aggregate
Intrinsic Value | |
Balance at January 1, 2021 | | | | 40,602 | | | $ | 201.36 | | | | 8.6 | | | $ | 1,536 | |
Granted | | | 802,500 | | | | 3.39 | | | | | | | | | | | | 12,819 | | | | 65.40 | | | | | | | |
Exercised | | | (144,645 | ) | | | 2.19 | | | | | | | $ | 243,531 | | | | (6 | ) | | | 52.20 | | | | | | $ | 107 | |
Forfeited | | | (66,428 | ) | | | 3.24 | | | | | | | | | | | | (4,406 | ) | | | 143.76 | | | | | | | |
Expired/Cancelled | | | (61,961 | ) | | | 6.52 | | | | | | | | | | | | (2,398 | ) | | | 244.68 | | | | | | | |
Balance at December 31, 2018 | | | 2,047,237 | | | $ | 3.07 | | | | 7.6 | | | $ | 366,007 | | |
Balance at December 31, 2021 | | | | 46,611 | | | $ | 167.16 | | | | 8.2 | | | $ | 30,267 | |
Granted | | | 1,270,000 | | | | 1.48 | | | | | | | | | | | | 39,667 | | | | 12.91 | | | | | | | |
Exercised | | | (54,256 | ) | | | 2.23 | | | | | | | $ | 21,380 | | | | — | | | | — | | | | | | | |
Forfeited | | | (161,571 | ) | | | 3.29 | | | | | | | | | | | | (4,944 | ) | | | 66.58 | | | | | | | |
Expired/Cancelled | | | (196,512 | ) | | | 3.23 | | | | | | | | | | | | (5,235 | ) | | | 292.56 | | | | | | | |
Balance at December 31, 2019 | | | 2,904,898 | | | $ | 2.37 | | | | 8.0 | | | $ | 781 | | |
Vested and expected to vest at December 31, 2019 | | | 2,904,898 | | | | 2.37 | | | | 8.0 | | | $ | 781 | | |
Exercisable at December 31, 2018 | | | 1,256,352 | | | | 2.91 | | | | 6.5 | | | $ | 346,595 | | |
Exercisable at December 31, 2019 | | | 1,380,865 | | | | 2.84 | | | | 6.6 | | | $ | 96 | | |
Balance at December 31, 2022 | | | | 76,099 | | | $ | 84.73 | | | | 8.3 | | | $ | - | |
Exercisable at December 31, 2021 | | | | 24,915 | | | $ | 241.68 | | | | 7.4 | | | $ | 6,269 | |
Exercisable at December 31, 2022 | | | | 38,096 | | | $ | 142.34 | | | | 7.6 | | | $ | - | |
The weighted-average fair value of stock options granted was $0.97$10.50 and $2.29$52.56 for the years ended December 31, 20192022 and 2018,2021, respectively. ThisStock option activity includes 80,0008,748 Inducement Awards outstanding as of December 31, 2022, including 3,332 Inducement Awards granted and 3,750 Inducement Awards cancelled or forfeited during the year ended December 31, 2022 and 9,166 Inducement Awards granted during the year ended December 31, 2019. No Inducement Awards were granted during the year ended December 31, 2018.2021. As of December 31, 2019,2022, total unrecognized compensation cost related to non-vested stock option awardsoptions was approximately $1,833,329,$0.8 million, which is expected to be recognized over approximately 2.311.87 years.
In June 2018, in connection with the retirement of two employees, the vesting of stock options covering 46,613 shares of common stock was accelerated and the post-termination exercise period for the employees’ options was extended to a one-year period from the termination date. As a result of this modification, the Company recorded incremental stock-based compensation expense of approximately $79,400 for the year ended December 31, 2018.F-28
The fair value of each stock option granted has been determined using the Black-Scholes option pricing model. The material factors incorporated in the Black-Scholes model in estimating the fair value of the stock options granted for the periods presented were as follows:
| | | 2019 | | | 2018 | | | 2022 | | 2021 |
Fair value of common stock on grant date | | $0.68 - 2.26 | | | $3.26 - 5.06 | | | $8.28 - 49.27 | | $48.84 - 75.00 |
Risk-free interest rate | | 1.43% - 2.21% | | | 2.59% - 2.82% | | | 1.53% - 3.64% | | 0.85% - 1.20% |
Expected volatility | | 63.9% - 97.1% | | | 79.5% - 85.8% | | | 89.6% - 110.7% | | 104.2% - 107.3% |
Expected term | | 5.5 to 6.1 years | | | 5.3 to 5.5 years | | | 5.5 to 5.8 years | | 5.2 to 6.1 years |
Expected dividend yield | | 0% | | | 0% | | | 0% | | 0% |
•Expected stock price volatility. The expected volatility assumption is derived from the volatility of the Company’s common stock in recent periods, as well as that of publicly traded industry competitors, over a period approximately equal toduring the expected term.
years ended December 31, 2022 and 2021. •Risk-free interest rate. The risk-free interest rate assumption is based on observed interest rates on the date of grant with maturities approximately equal to the expected term.
•Expected term. The expected term represents the period that the stock-based awards are expected to be outstanding. The Company’s historical share option exercise experience does not provide a reasonable basis upon which to estimate an expected term because of a lack of sufficient data. Therefore, the Company estimates the expected term by using the simplified method provided by the SEC. The simplified method calculates the expected term as the average of the time-to-vesting and the contractual life of the stock options.
•Expected dividend yield. The expected dividend is assumed to be zero as the Company has never paid dividends and does not anticipate paying any dividends on its common stock.
In preparing its Black-Scholes option-pricing model fair value calculations, the Company does not estimate a forfeiture rate to calculate stock-based compensation. The Company uses judgment in evaluating the expected volatility and expected terms utilized for the Company’s stock-based compensation calculations on a prospective basis.
The following table summarizes RSU award activity (including Inducement Award activity) during the two-year period ended December 31, 2019:2022:
| | Number of Shares | | | Weighted- Average Grant Date Fair Value Per Share | | | | | | | | | |
Balance at January 1, 2018 | | | 26,666 | | | $ | 2.78 | | |
| | | Number of
Shares | | | Weighted-
Average
Grant Date
Fair Value
Per Share | |
Balance at January 1, 2021 | | | | 1,017 | | | $ | 343.32 | |
Granted | | | 492,051 | | | | 3.63 | | | | 2,500 | | | | 62.40 | |
Released | | | (291,010 | ) | | | 3.72 | | | | (377 | ) | | | 349.56 | |
Balance at December 31, 2018 | | | 227,707 | | | $ | 3.30 | | |
Forfeited | | | | (542 | ) | | | 290.16 | |
Balance at December 31, 2021 | | | | 2,598 | | | $ | 83.16 | |
Granted | | | 77,500 | | | | 1.93 | | | | 416 | | | | 8.29 | |
Released | | | (81,462 | ) | | | 3.31 | | | | (1,139 | ) | | | 110.47 | |
Balance at December 31, 2019 | | | 223,745 | | | $ | 2.91 | | |
Vested and unissued at December 31, 2019 | | | 15,942 | | | $ | 3.14 | | |
Forfeited | | | | (626 | ) | | | 62.50 | |
Balance at December 31, 2022 | | | | 1,249 | | | $ | 44.40 | |
Vested and unissued at December 31, 2022 | | | | 208 | | | $ | 62.42 | |
The weighted-average fair value of RSUs granted was $1.93$8.29 and $3.63$62.40 for the years ended December 31, 20192022 and 2018,2021, respectively. As of December 31, 2019,2022, total unrecognized compensation cost related to RSU awardsnon-vested RSUs was approximately $555,439,$41,600, which is expected to be recognized over approximately 2.260.91 years.
RSU activity includes 1,249 Inducement Awards outstanding as of December 31, 2022, including 416 Inducement Awards granted, 1,041 Inducement Awards released and 626 Inducement Awards forfeited during the year ended December 31, 2022 and 2,500 Inducement Awards granted in the year ended December 31, 2021.
Vested and unissued awards at December 31, 20192022 represents RSU awards granted on August 16, 2018, January 21, 2019 and September 12, 2019in November 2021 for which a portion of the awards vested on December 31, 2019,2022, but for which issuance of awardsshares occurred on the next business day,in January 2, 2020.2023.
F-29
2014 Employee Stock Purchase Plan
In April 2015, the Company’s stockholders approved the 2014 Employee Stock Purchase Plan (the “2014 ESPP"), which became effective in May 2015. Initially,Under the 2014 ESPP, authorized the issuance of up to 110,820 shares of common stock pursuant to purchase rights granted to the Company’s employees or to employees of any of the Company’s designated affiliates. The number of shares of common stock reserved for issuance automatically increasesincreased on January 1 of each calendar year, from January 1, 2016 to January 1, 20242021 by the leastlesser of (i) 1% of the total number of shares of the Company’s common stock outstanding on December 31 of the preceding calendar year, (ii) 195,0001,083 shares, or (iii) a number determined by the Company’s boardBoard of directorsDirectors that is less than (i) and (ii). The 2014 ESPP enables participants to contribute up to 15%15% of such participant’s eligible compensation during a defined period (not to exceed 27 months) to purchase common stock of the Company. The purchase price of common stock under the 2014 ESPP is the lesser of: (i) 85%85% of the fair market value of a share of the Company’s common stock on the first day of an offering or (ii) 85%85% of the fair market value of the Company’s common stock at the applicable purchase date.
In August 2021, the Company’s stockholders, upon the recommendation of the Company’s Board of Directors, approved the Amended and Restated 2014 Employee Stock Purchase Plan (the “Amended 2014 ESPP”). Upon approval of the Amended 2014 ESPP, 41,666 shares of the Company’s common stock were reserved for issuance under the Amended 2014 ESPP in addition to 2,023 shares of the Company’s common stock reserved for issuance under the original 2014 ESPP. The Amended 2014 ESPP does not contain an evergreen provision; all other provisions of the 2014 ESPP remained unchanged.
Amounts recognized in the accompanying consolidated statements of operations with respect to the Amended 2014 ESPP were as follows:
| | | | | | | | |
| | Years Ended December 31, | |
| | 2022 | | | 2021 | |
Selling, general and administrative | | $ | 22,187 | | | $ | 34,219 | |
Research and development | | | 11,046 | | | | 11,643 | |
Cost of product and product-related services revenue | | | 7,114 | | | | 11,807 | |
| | $ | 40,347 | | | $ | 57,669 | |
| | | Years Ended December 31, | |
| | | 2019 | | | 2018 | |
Selling, general and administrative | | | $ | 43,615 | | | $ | 41,716 | |
Research and development | | | | 18,454 | | | | 12,556 | |
Cost of product and product-related services revenue | | | | 4,169 | | | | 4,687 | |
| | | $ | 66,238 | | | $ | 58,959 | |
During the year ended December 31, 2019,2022, employees entering the plan at various times throughout the year purchased the following shares at the end of each of the ESPP’s six-month purchase periods:
| | | | | | | | | | | | | | | | |
| | June 2022 | | | December 2022 | |
| | Number of
Shares | | | Price
per Share | | | Number of
Shares | | | Price
per Share | |
Total number of shares purchased | | | 4,083 | | | $ | 5.71 | | | | 2,792 | | | $ | 5.10 | |
| | June 2019 | | | December 2019 | |
| | Number of Shares | | | Price per Share | | | Number of Shares | | | Price per Share | |
ESPP Group: | | | | | | | | | | | | | | | | |
Group A | | | 29,580 | | | $ | 1.57 | | | | 27,449 | | | $ | 0.57 | |
Group B | | | 5,828 | | | | 1.79 | | | | 5,240 | | | | 0.57 | |
Group C | | | 4,581 | | | | 1.79 | | | | 4,804 | | | | 0.57 | |
Group D | | | — | | | N/A | | | | 2,474 | | | | 0.57 | |
Total number of shares purchased | | | 39,989 | | | | | | | | 39,967 | | | | | |
During the year ended December 31, 2018,2021, employees entering the plan at various times throughout the yearoffering period purchased the following shares at the end of each of the ESPP’s six-month purchase periods:
| | June 2018 | | | December 2018 | |
| | Number of Shares | | | Price per Share | | | Number of Shares | | | Price per Share | |
ESPP Group: | | | | | | | | | | | | | | | | |
Group A | | | 39,976 | | | $ | 1.57 | | | | 35,805 | | | $ | 1.57 | |
Group B | | | — | | | N/A | | | | 4,176 | | | | 2.81 | |
Total number of shares purchased | | | 39,976 | | | | | | | | 39,981 | | | | | |
| | | | | | | | | | | | | | | | |
| | June 2021 | | | December 2021 | |
| | Number of
Shares | | | Price
per Share | | | Number of
Shares | | | Price
per Share | |
Total number of shares purchased | | | 1,136 | | | $ | 47.04 | | | | 1,693 | | | $ | 42.72 | |
| | | | | | | | | | | | |
As of December 31, 2019,2022, approximately 273,11135,120 shares of the Company’s common stock were reserved for future issuance under the Amended 2014 ESPP. On January 1, 2020, an additional 195,000 shares were registered for issuance pursuant to an evergreen provision contained in the ESPP.
The Company recognizes ESPPemployee stock purchase plan expense based on the fair value of the ESPP stock purchase rights, estimated for each six-month purchase period using the Black-Scholes option pricing model. The model requires the Company to make subjective assumptions, including expected stock price volatility, risk free rate of return and estimated life. The fair value of equity-based awards is amortized straight-line over the vesting period of the award.
The material factors incorporated in the Black-Scholes model in estimating the fair value of the ESPP awardsemployee stock purchase plan stock purchase rights for the periods presented were as follows:
| | | | |
| | 2022 | | 2021 |
Fair value of common stock | | $6.00 - 49.80 | | $56.04 - 70.20 |
Risk-free interest rate | | 0.11% - 2.25% | | 0.04% - 0.08% |
F-30
| | | | |
Expected volatility | | 64.9% - 96.7% | | 71.9% - 89.2% |
Expected term | | 0.5 years | | 0.5 years |
Expected dividend yield | | 0% | | 0% |
| | 2019 | | | 2018 | |
Fair value of common stock | | $1.85 - 4.00 | | | $1.85 - 4.00 | |
Risk-free interest rate | | 1.88% - 2.37% | | | 1.88% - 2.07% | |
Expected volatility | | 79.5% - 85.8% | | | 83.2% - 85.8% | |
Expected term | | 0.5 years | | | 0.5 years | |
Expected dividend yield | | 0% | | | 0% | |
Fair value of common stock. Estimated as the price of the Company’s common stock on the first day of each offering period.
•Expected stock price volatility. The expected volatility assumption is derived from the average volatility of the Company’s common stock in recent periods as well as that of publicly traded industry competitors, over a period approximately equal tofor the expected term.
years ended December 31, 2022 and 2021. •Risk-free interest rate. The risk-free interest rate assumption is based on observed interest rates on the first day of the purchase period with maturities approximately equal to the expected term.
•Expected term. The expected term represents the length of a purchase period under the Amended 2014 ESPP.
•Expected dividend yield. The expected dividend is assumed to be zero as the Company has never paid dividends and does not anticipate paying any dividends on its common stock.
Stock Purchase Plan
In December 2015, the Board of Directors adopted a Stock Purchase Plan (the “Purchase Plan”) which allows directors, any individual deemed by the Board of Directors to be an officer for purposes of Section 16 of the Exchange Act, and anyone designated by the Board of Directors as eligible to participate in the Purchase Plan to purchase shares of the Company’s common stock from the Company at fair market value. The aggregate number of shares of common stock that may be issued under the Purchase Plan shall not exceed 250,000 shares of common stock, and a maximum of 7,500 shares of common stock may be purchased by any one participant on any one purchase date. The Board of Directors or an authorized committee must review and approve each individual request to purchase common stock under the Purchase Plan. Cash received from the sale of common stock by the Company to eligible participants for the year ended December 31, 2019 was $17,250, which resulted in the sale of 7,500 shares of the Company’s common stock at fair market value. Cash received from the sale of common stock by the Company to eligible participants for the year ended December 31, 2018 was $9,997 which resulted in the sale of 2,304 shares of the Company’s common stock at fair market value. As of December 31, 2019, there were 174,871 shares available for issuance under the Purchase Plan.
Note 15. Commitments and Contingencies
Legal Matters
The Company’s industry is characterized by frequent claims and litigation, including claims regarding intellectual property and product liability. As a result, the Company may be subject to various legal proceedings from time to time. The results of any current or future litigation cannot be predicted with certainty, and regardless of the outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources, and other factors. Any current litigation is considered immaterial and counter claims have been assessed as remote.
EmploymentEmployee Agreements
The Company has entered into employmentSeverance and Change in Control Plan agreements or other arrangements with certain named executive officers and various other members of management, which provide salary continuation payments, bonuses and, in certain instances, the acceleration of the vesting of certain equity awards to individuals in the event that the individual is terminated other than for cause, as defined in the applicable agreement.
Indemnification Agreements
In the course of operating its business, the Company has entered into, and continues to enter into, separate indemnification agreements with the Company’s directors and executive officers, in addition to the indemnification provided for in the Company’s amended and restated bylaws. These agreements may require the Company to indemnify its directors and executive officers for certain expenses incurred in any action or proceeding arising out of their services as one of the Company’s directors or executive officers.
Product Warranty
The following is a summary of the Company’s general product warranty liability, which isliability. Product warranty liabilities of approximately $73,000 and $15,000 were included in accrued liabilities and other non-current liabilities, respectively, in the accompanying consolidated balance sheets for the years endedas of December 31, 20192022. Expense relating to the recording of this reserve is recorded in cost of product and 2018:product-related services revenue within the accompanying consolidated statements of operations.
F-31
| | Years Ended December 31, | |
| | 2019 | | | 2018 | |
Beginning balance | | $ | 63,461 | | | $ | 37,156 | |
Cost of warranty claims | | | (40,055 | ) | | | (2,596 | ) |
Increase in warranty reserve | | | 71,076 | | | | 28,901 | |
Ending balance | | $ | 94,482 | | | $ | 63,461 | |
| | | | | | | | |
Beginning balance | | $ | 120,385 | | | $ | 92,696 | |
Cost of warranty claims | | | (147,192 | ) | | | (166,641 | ) |
Increase in warranty reserve | | | 115,089 | | | | 194,330 | |
Ending balance | | $ | 88,282 | | | $ | 120,385 | |
Defined Contribution Plan
In January 2003, the Company established a defined contribution plan (“401(k) Plan”) under section 401(k) of the Internal Revenue Code of 1986, as amended (the “IRC”).amended. All employees who are over the age of 21 and who are expected to work at least 1,000 hours in a calendar year are eligible for participation in the 401(k) Plan upon commencement of employment with the Company. The Company may make discretionary contributions to the 401(k) Plan but has notnot done so during the years ended December 31, 20192022 and 2018.2021.
Note 16. Income Taxes
The Company provides for income taxes based upon management’s estimate of taxable income or loss for each respective period. The Company recognizes an asset or liability for the deferred tax consequences of temporary differences between the tax bases of assets and liabilities and their reported amounts in the financial statements. These temporary differences would result in deductible or taxable amounts in future years, when the reported amounts of the assets are recovered or liabilities are settled, respectively.
In each period since inception, the Company has recorded a valuation allowance for the full amount of its net deferred tax assets, as the realization of the net deferred tax assets is uncertain. As a result, the Company has not recorded any federal or state income tax benefit in the accompanying consolidated statements of operations; however, state income tax expense has been recorded for state minimum and foreign income taxes.
The Company periodically reviews its filing positions for all open tax years in all U.S. federal, state and international jurisdictions where the Company is or might be required to file tax returns or other required reports.
The Company applies a two-step approach to recognizing and measuring uncertain tax positions. The Company evaluates the tax position for recognition by determining if the weight of available evidence indicates that it is “more likely than not” that the position will be sustained on audit, including resolution of related appeals or litigation process, if any. The term “more likely than not” means a likelihood of more than 50 percent. If the tax position is not more likely than not to be sustained in a court of last resort, the Company may not recognize any of the potential tax benefit associated with the position. The Company recognizes a benefit for a tax position that meets the more likely than not criterion at the largest amount of tax benefit that is greater than 50 percent likely of being realized upon its effective resolution. Unrecognized tax benefits involve management’s judgment regarding the likelihood of the benefit being sustained. The final resolution of uncertain tax positions could result in adjustments to recorded amounts and may affect the Company’s results of operations, financial position and cash flows. As discussed below, the Company has estimated $2,731,015$3.4 million and $1,538,220$3.2 million of uncertain tax positions as of December 31, 20192022 and 2018,2021, respectively, related to certain tax credit carryforwards.
The Company’s policy is to recognize interest and/or penalties related to income tax matters in income tax expense. The Company had no accrual for interest or penalties at December 31, 20192022 or 2018,2021, and has not recognized interest or penalties during the years ended December 31, 20192022 and 2018,2021, since there was no reduction in income taxes paid due to uncertain tax positions. Management of the Company believes no significant change to the amount of unrecognized tax benefits will occur within the next 12 months.
The following table summarizes loss before income taxes:
| | | | | | | | |
| | Years Ended December 31, | |
| | 2022 | | | 2021 | |
U.S. pre-tax loss | | $ | (21,611,254 | ) | | $ | (17,156,070 | ) |
Foreign pre-tax gain (loss) | | | 27,615 | | | | 33,375 | |
Loss before income taxes | | $ | (21,583,639 | ) | | $ | (17,122,695 | ) |
| | Years Ended December 31, | |
| | 2019 | | | 2018 | |
U.S. pre-tax loss | | $ | (19,332,809 | ) | | $ | (16,406,443 | ) |
Foreign pre-tax gain (loss) | | | 38,524 | | | | (43,949 | ) |
Loss before income taxes | | $ | (19,294,285 | ) | | $ | (16,450,392 | ) |
The components of income tax expense are as follows:
| | | | | | | | |
| | Years Ended December 31, | |
| | 2022 | | | 2021 | |
Current: | | | | | | |
Federal | | $ | — | | | $ | — | |
State | | | 3,270 | | | | 13,769 | |
Foreign | | | 7,567 | | | | 8,706 | |
F-32
| | | | | | | | |
Total current income tax expense | | $ | 10,837 | | | $ | 22,475 | |
| | | | | | |
Deferred: | | | | | | |
Federal | | $ | — | | | $ | — | |
State | | | — | | | | — | |
Foreign | | | — | | | | — | |
Total deferred income tax expense | | $ | — | | | $ | — | |
Total income tax expense | | $ | 10,837 | | | $ | 22,475 | |
| | Years Ended December 31, | |
| | 2019 | | | 2018 | |
Current: | | | | | | | | |
Federal | | $ | — | | | $ | — | |
State | | | 3,379 | | | | 3,526 | |
Total current income tax expense | | $ | 3,379 | | | $ | 3,526 | |
| | | | | | | | |
Deferred: | | | | | | | | |
Federal | | $ | — | | | $ | — | |
State | | | — | | | | — | |
Total deferred income tax expense | | $ | — | | | $ | — | |
Total income tax expense | | $ | 3,379 | | | $ | 3,526 | |
The Company’s actual income tax expense for the years ended December 31, 20192022 and 20182021 differ from the expected amount computed by applying the statutory federal income tax rate to loss before income taxes as follows:
| | | | | | | | |
| | Years Ended December 31, | |
| | 2022 | | | 2021 | |
Computed tax (benefit) at 21% | | $ | (4,532,565 | ) | | $ | (3,586,925 | ) |
State taxes, net of federal benefit | | | (989,018 | ) | | | (1,177,951 | ) |
Stock-based compensation | | | 128,789 | | | | 240,177 | |
Foreign tax rate differential | | | 5,635 | | | | (2,171 | ) |
Return to provision | | | 13,047 | | | | 53,340 | |
Nontaxable loan forgiveness | | | — | | | | (360,570 | ) |
Other | | | 17,615 | | | | 9,048 | |
Research and development tax credit - state | | | (234,971 | ) | | | (265,362 | ) |
Research and development tax credit - federal | | | (235,910 | ) | | | (212,408 | ) |
Uncertain tax position adjustment for prior periods | | | (8,856 | ) | | | (6,395 | ) |
Increase in valuation allowance | | | 5,847,071 | | | | 5,331,692 | |
| | $ | 10,837 | | | $ | 22,475 | |
| | Years Ended December 31, | |
| | 2019 | | | 2018 | |
Computed tax (benefit) at 21% | | $ | (4,051,800 | ) | | $ | (3,454,582 | ) |
State taxes, net of federal benefit | | | (881,670 | ) | | | (384,035 | ) |
Stock-based compensation | | | 183,167 | | | | 82,024 | |
Foreign tax rate differential | | | 4,298 | | | | (3,158 | ) |
Return to provision | | | 80,668 | | | | (31,111 | ) |
Other | | | 51,737 | | | | 51,598 | |
Research and development tax credit - state | | | (342,320 | ) | | | (511,845 | ) |
Research and development tax credit - federal | | | (301,878 | ) | | | (506,364 | ) |
Uncertain tax position adjustment for prior periods | | | 650,687 | | | | 1,029,115 | |
Increase in valuation allowance | | | 4,610,490 | | | | 3,731,884 | |
| | $ | 3,379 | | | $ | 3,526 | |
Deferred tax assets and liabilities comprise the following:
| | | | | | | | |
| | Years Ended December 31, | |
| | 2022 | | | 2021 | |
Deferred tax assets: | | | | | | |
Net operating loss carryforwards | | $ | 50,968,402 | | | $ | 47,752,053 | |
Research and development credits | | | 4,393,368 | | | | 3,940,199 | |
R&D expenditures capitalization | | | 2,001,908 | | | | — | |
Deferred revenue | | | 45,373 | | | | 42,802 | |
Inventory reserve | | | 310,983 | | | | 6,806 | |
Fixed assets and intangibles | | | 291,244 | | | | 304,019 | |
Accrued NuvoGen liability | | | 1,035,659 | | | | 1,196,563 | |
Lease liability | | | 266,797 | | | | 366,653 | |
Other | | | 755,029 | | | | 711,343 | |
Gross deferred tax assets | | | 60,068,763 | | | | 54,320,438 | |
Valuation allowance | | | (59,805,688 | ) | | | (53,958,617 | ) |
Deferred tax assets, net | | | 263,075 | | | | 361,821 | |
Deferred tax liabilities: | | | | | | |
Right of use asset | | | 263,075 | | | | 361,821 | |
Total deferred tax liabilities | | | 263,075 | | | | 361,821 | |
Net deferred tax assets (liabilities) | | $ | - | | | $ | - | |
| | Years Ended December 31, | |
| | 2019 | | | 2018 | |
Deferred tax assets: | | | | | | | | |
Net operating loss carryforwards | | $ | 38,357,970 | | | $ | 33,431,082 | |
Research and development credits | | | 3,061,981 | | | | 3,076,441 | |
Deferred revenue | | | 154,497 | | | | 86,567 | |
Inventory reserve | | | 10,155 | | | | 9,645 | |
Fixed assets and intangibles | | | 217,332 | | | | 223,767 | |
Accrued NuvoGen liability | | | 1,456,435 | | | | 1,720,335 | |
Accrued expense | | | — | | | | 86,034 | |
Lease liability | | | 359,603 | | | | — | |
Other | | | 150,134 | | | | 106,913 | |
Gross deferred tax assets | | | 43,768,107 | | | | 38,740,784 | |
Valuation allowance | | | (43,350,682 | ) | | | (38,740,784 | ) |
Deferred tax assets, net | | | 417,425 | | | | — | |
Deferred tax liabilities: | | | | | | | | |
Right of use asset | | | 311,633 | | | | — | |
Other | | | 105,792 | | | | — | |
Total deferred tax liabilities | | | 417,425 | | | | — | |
Net deferred tax assets (liabilities) | | $ | — | | | $ | — | |
As of December 31, 2019,2022, the Company has estimated federal and state net operating loss (“NOL”) carryforwards of approximately $158,175,977$206.2 million and $106,182,477 for federal and state income tax purposes,$155.2 million, respectively. $121,776,595$121.6 million of the Company’s federal NOLs are scheduled to expire from 20212023 through 2037, while the remaining federal NOLs of $36,399,382 do not expire. The Company’s$154.2 million of the state NOLs are scheduled to expire from 20272024 through 2039.2042, while the remaining NOLs do not expire. The Company’s federal and state tax credit carryforwards begin expiring in 2021 and 2020, respectively.2023.
F-33
For financial reporting purposes, valuation allowances of $43,350,682$59.8 million and $38,740,784$54.0 million at December 31, 20192022 and 2018,2021, respectively, have been established to offset deferred tax assets relating primarily to NOLs and research and development credits. The increase in the valuation allowance of $4,609,898$5.8 million for the year ended December 31, 20192022 was primarily due to increased operating losses. The Company has established a valuation allowance against its entire net deferred tax asset. As a result, the Company does not recognize any tax benefit until it is in a taxpaying position or there is no longer negative evidence leading to the conclusion that it is more likely than not that the benefits will not be realized.
Pursuant to Sections 382 and 383 of the IRC, annual use of the Company’s NOLs and research and development credit carryforwards may be limited if there is a cumulative change in ownership of greater than 50% within a three-year period. The amount of the annual limitation is determined based on the value of the Company immediately prior to the ownership change. Subsequent ownership changes may further affect the limitation in future years. If limited, the related tax asset would be removed from the deferred tax asset schedule with a corresponding reduction in the valuation allowance. A preliminary analysis of past and subsequent equity offerings by the Company, and other transactions that have an impact on the Company’s ownership structure, concluded that the Company may have experienced one or more ownership changes under Sections 382 and 383 of the IRC. Sections 382 and 383As such, the Company has established a valuation allowance as the realization of its deferred tax assets has not met the more likely than not threshold requirement. Due to the existence of the IRC place limitations onvaluation allowance, further changes in the usage of NOLs and credit carryforwards following an ownership change. Such limitations may limit or eliminateCompany’s unrecognized tax benefits will not impact the potential futureCompany’s effective tax benefit to be realized by the Company from its accumulated NOLs and research and development credits.rate.
A reconciliation of the Company’s gross unrecognized tax benefits is as follows:
| | | | | | | | |
| | Years Ended December 31, | |
| | 2022 | | | 2021 | |
Balance at beginning of year | | $ | 3,193,331 | | | $ | 2,960,842 | |
Increases to prior positions | | | — | | | | — | |
Decreases to prior positions | | | (8,856 | ) | | | (6,395 | ) |
Increases for current year positions | | | 235,441 | | | | 238,884 | |
Balance at end of year | | $ | 3,419,916 | | | $ | 3,193,331 | |
| | Years Ended December 31, | |
| | 2019 | | | 2018 | |
Balance at beginning of year | | $ | 1,538,220 | | | $ | — | |
Increases to prior positions | | | 650,687 | | | $ | 1,029,115 | |
Increases for current year positions | | | 542,108 | | | | 509,105 | |
Balance at end of year | | $ | 2,731,015 | | | $ | 1,538,220 | |
As of December 31, 2019,2022, the Company had $2,731,015$3.4 million of gross unrecognized tax benefits, related to research and experimental tax credits. The Company had no unrecognized tax benefits as of December 31, 2019,2022, which, if recognized, would affect the annual effective tax rate, due to the full valuation allowance on the deferred tax assets. Although it is possible that the amount of unrecognized benefits with respect to our uncertain tax positions will increase or decrease in the next twelve months, the Company does not expect material changes.
On August 16, 2022, the President signed into law the Inflation Reduction Act of 2022 which contained provisions effective January 1, 2023, including a 15% corporate minimum tax and a 1% excise tax on stock buybacks, both of which we expect to be immaterial to our financial results, financial position and cash flows.
The Company files income tax returns in the United States, Arizona, California, Texas, various other state jurisdictions, and France,, with varying statutes of limitations. As of December 31, 2019,2022, the earliest year subject to examination is 20162019 for U.S. federal tax
purposes. The earliest year subject to examination is 20152018 for Arizona, California and Texas, 2016 for the remaining state jurisdictions, and 2019 for France. However, the Company’s federal and state NOLs and tax credit carryforwards for periods ending December 31, 20012003 and thereafter remain subject to examination by the United States and certain states.
F-34
Note 17. Subsequent Events
2019 ATM Offering
From January 1, 2020 through March 15, 2020, the Company has sold 4,399,062 shares of common stock under the 2019 ATM Offering at then-market prices for total gross proceeds of approximately $2.6 million. After deferred offering costs included as non-current assets in the condensed balance sheets as of December 31, 2019 of approximately $0.1 million and sales commissions owed in connection with the 2019 ATM Offering, the Company’s aggregate net proceeds through March 15, 2020 were approximately $2.5 million.
Private Placement Agreement
On February 25, 2020, the Company entered into an Exchange and Purchase Agreement (the “Exchange Agreement”) with certain accredited investors (the “Investors”) pursuant to which the Company agreed to (i) issue to the Investors an aggregate of 41,100 shares of its newly designated Series A Convertible Preferred Stock, par value $0.001 per share (“Series A Preferred”), in exchange for the Investors surrendering to the Company for cancellation an aggregate of 4,110,000 shares of its common stock (the “Exchange”) and (ii) sell and issue to the Investors an aggregate of 10,170 shares of Series A Preferred for an aggregate purchase price of $600,030, or $59.00 per share (the “Private Placement”), both of which were completed prior to the end of February 2020.
The Series A Preferred have not been registered under the Securities Act or any state securities laws. The Company relied on exemptions from the registration requirements of the Securities Act by virtue of Section 3(a)(9) and Section 4(a)(2) thereof. Each Investor represented that it was acquiring the securities for investment only and not with a view towards, or for resale in connection with, the public sale or distribution thereof.
In February 2020, in connection with the Exchange Agreement and the planned issuance of shares of Series A Preferred pursuant to the Exchange and Private Placement, the Company filed a Certificate of Designation of Preferences, Rights and Limitations of Series A Convertible Preferred Stock (the “Series A Certificate of Designation”). The Series A Certificate of Designation establishes and designates the Series A Preferred and the rights, preferences and privileges thereof.
Each share of Series A Preferred is convertible into 100 shares of the Company’s common stock, subject to proportional adjustment and beneficial ownership limitations as provided in the Series A Certificate of Designation. In the event of the Company’s liquidation, dissolution or winding up, holders of Series A Preferred will participate pari passu with any distribution of proceeds to holders of the Company’s common stock. Holders of Series A Preferred are entitled to receive dividends on shares of Series A Preferred equal (on an as converted to common stock basis) to and in the same form as dividends actually paid on the Company’s common stock. Shares of Series A Preferred generally have no voting rights, except as required by law.
MidCap Credit Facility
On February 26, 2020 (the “Amendment Effective Date”), the Company entered into (i) Amendment No. 2 to its MidCap Term Loan (the “MidCap Term Loan Amendment”), and (ii) Amendment No. 3 to its MidCap Revolving Loan, (the “MidCap Revolving Loan Amendment,” and together with the MidCap Term Loan Amendment, the “Amendments”).
The MidCap Term Loan Amendment extends the interest only payments on the term loan advances by an additional 11 months, with principal on each term loan advance payable in 25 equal monthly installments beginning March 1, 2021 until paid in full on March 1, 2023. If the Company achieves a stated revenue milestone for the 12-month period ending on December 31, 2020, the interest-only period will be further extended by an additional four months, with principal on each term loan advance then payable in 21 equal monthly installments beginning July 1, 2021.
In addition, both Amendments (i) permit the use of the $3.3 million of escrowed funds previously deposited by the Company for repayment of the QNAH Convertible Note, subject to such repayment not being made before September 1, 2020, the Company having at least $18.0 million of unrestricted cash and cash equivalents and there being no default under the MidCap Term Loan or the MidCap Revolving Loan and (ii) include a grant by the Company of a security interest in its intellectual property, effective as of the Amendment Effective Date.
LP Purchase Agreement
On March 24, 2020, we entered into a purchase agreement ("LP Purchase Agreement") with Lincoln Park Capital Fund, LLC ("Lincoln Park"), pursuant to which, upon the terms and subject to the conditions and limitations set forth therein, we have the right to sell to Lincoln Park up to $20,000,000 of shares of our common stock (“Purchase Shares”) from time to time over the 36-month term of the LP Purchase Agreement. The purchase price of the Purchase Shares will be based on recent closing prices of our common stock at the time of sale. We issued Lincoln Park an aggregate of 615,384 shares of our common stock as consideration for their purchase commitment pursuant to the LP Purchase Agreement.
COVID-19 Pandemic
On January 30, 2020, the World Health Organization (“WHO”) announced a global health emergency because of a new strain of coronavirus originating in Wuhan, China (the “COVID-19 outbreak”) and the risks to the international community as the virus spreads globally. In March 2020, the WHO classified the COVID-19 outbreak as a pandemic.
The full impact of the COVID-19 outbreak continues to evolve as of the date of this report and likewise the full impact of the pandemic on the Company’s financial condition, liquidity, and future results of operations is uncertain. Management is actively monitoring the global situation on its financial condition, liquidity, operations, suppliers, industry and workforce. Given the daily evolution of the COVID-19 outbreak and the global responses to curb its spread, the Company is not able to estimate the effects of the COVID-19 outbreak on its results of operations, financial condition or liquidity for fiscal year 2020.
While significant uncertainty remains as to the potential impact of the COVID-19 outbreak on the Company’s operations, and on the global economy as a whole, the Company believes it is likely that the COVID-19 outbreak will have a negative impact on the Company’s product and product-related services revenue and collaborative development services revenue in 2020. The Company believes this negative impact will be primarily demand-side driven as its customers experience disruptions in their own businesses from the pandemic. However, it is possible that the COVID-19 pandemic will also impact the Company’s workforce, supply chains or distribution networks or otherwise impact the Company’s ability to conduct sample processing services and custom assay development services and its ability to provide collaborative development services for companion diagnostic development programs.
Although the Company cannot estimate the length or gravity of the impact of the COVID-19 outbreak at this time, if the pandemic continues, it may have a material adverse effect on the Company’s results of operations, financial position and liquidity in fiscal year 2020.
Item 9. Changes in and Disagreements with AccountantsAccountants on Accounting and Financial Disclosure.
None.
Item 9A. Controls and Procedures.
Evaluation of Disclosure Controls and Procedures.
We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in our periodic and current reports that we file with the SEC is recorded, processed, summarized and reported with the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure.
In designing and evaluating the disclosure controls and procedures, management recognized that any controls and procedures, no matter how well designed and operated, can provide only reasonable and not absolute assurance of achieving the desired control objectives. In reaching a reasonable level of assurance, management is required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures. In addition, the design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions; over time, control may become inadequate because of changes in conditions, or the degree of compliance with policies or procedures may deteriorate. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.
As of December 31, 2019,2022, we carried out an evaluation, under the supervision and with the participation of our management, including our Chief Executive Officer and our Chief Financial Officer, of the effectiveness of the design and operation of our disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended. Based on that evaluation, our Chief Executive Officer and our Chief Financial Officer have concluded that, as of December 31, 2019,2022, our disclosure controls and procedures were effective at the reasonable assurance level.
Management’s Report on Internal Control over Financial Reporting.
Our management is responsible for establishing and maintaining adequate internal control over financial reporting, as such term is defined in Exchange Act Rules 13a-15(f). Internal control over financial reporting is a process designed under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of consolidated financial statements for external purposes in accordance with accounting principles generally accepted in the United States of America.The effectiveness of any system of internal control over financial reporting, including ours, is subject to inherent limitations, including the exercise of judgment in designing, implementing, operating and evaluating the controls and procedures, and the inability to eliminate misconduct completely. Accordingly, any system of internal control over financial reporting, including ours, no matter how well designed and operated, can only provide reasonable, not absolute assurances. In addition, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate. Therefore, even those systems determined to be effective can provide only reasonable assurance with respect to financial statement preparation and presentation.
We conducted an evaluation of the effectiveness of our internal control over financial reporting based on the framework in Internal Control – Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework). Based on our evaluation of the framework in Internal Control – Integrated Framework, our management concluded that our internal control over financial reporting was effective at the reasonable assurance level as of December 31, 2019.2022.
Changes in Internal Control Over Financial Reporting
An evaluation was performed under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, of any change in our internal control over financial reporting that occurred during our last fiscal quarter and that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting. That evaluation did not identify any change in our internal control over financial reporting that occurred during the quarter ended December 31, 20192022 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
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Item 9B. Other Information.
None.
Item 9C. Disclosure Regarding Foreign Jurisdictions That Prevent Inspections.
Not applicable.
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PART III
Item 10. Directors, Executive Officers and Corporate Governance.
Executive Officers and Directors
The following table sets forth certain information regarding our current executive officers and directors:
| | | | | | |
Name |
| Age |
|
| Position(s) |
Executive Officers |
|
|
|
| |
|
John L. Lubniewski |
|
| 5659
|
|
| President, Chief Executive Officer and Director |
Shaun D. McMeans |
|
| 5861
|
|
| Senior Vice President, Chief Financial Officer, Treasurer and Secretary |
Timothy B. JohnsonByron T. Lawson
|
|
| 5848
|
|
| Executive ChairmanSenior Vice President, Chief Commercial Officer
|
Byron T. LawsonStephen A. Barat
|
|
| 4553
|
|
| Senior Vice President, and Chief Commercial OfficerTherapeutics |
|
|
|
|
| |
|
Non-Employee Directors |
|
|
|
| |
|
Ann F. Hanham, Ph.D. (3) |
|
| 6770
|
|
| Lead Independent DirectorChair of Board of Directors
|
Thomas W. Dubensky Jr.(2)(4) |
|
| 65 |
|
| Director |
Michelle R. Griffin (1)(2) |
|
| 5457
|
|
| Director |
Harry A. George (1)
| | | 71
| | | Director
|
Donnie M. Hardison (2) |
|
| 6972
|
|
| Director |
James T. LaFranceChristopher P. Kiritsy (1)(3)
|
|
| 6158
|
|
| Director |
Lee R. McCracken (1)(2)(3) |
|
| 6265
|
|
| Director |
(1)Member of the audit committee.
(2)Member of the compensation committee.
(3)Member of the nominating and governance committee.
(4)Appointed to the Board of Directors in August 2022.
(1)
| Member of the audit committee.
|
(2)
| Member of the compensation committee.
|
(3)
| Member of the nominating and governance committee.
|
Executive Officers
John L. Lubniewski.Mr. Lubniewski has served as our President and Chief Executive Officer and as a member of our Board of Directors since April 2019 and previously served as our President and Chief Operating Officer since April 2018. Prior to this, he served as our Senior Vice President and Chief Business Officer since April 2011. Mr. Lubniewski joined us from Ventana Medical Systems, Inc. (“Ventana”), a medical diagnostics company and member of the Roche Group, and the global headquarters of Roche Tissue Diagnostics (“RTD”) where he served in leadership roles for nine years both before and after the acquisition of Ventana by Roche Holdings, Inc. (“Roche”) in March 2008. From August 2010 to April 2011, Mr. Lubniewski was Senior Vice President and Lifecycle Leader, Advanced Staining Platforms at Ventana. From January 2008 to August 2010, Mr. Lubniewski served as Senior Vice President and Lifecycle Leader, Clinical Assays at RTD, with responsibility for three lifecycle teams, technical marketing and medical marketing and global accountability for all RTD clinical assay products. Prior to the Roche acquisition of Ventana, Mr. Lubniewski served at Ventana as Senior Vice President, Advanced Staining Business Unit, Vice President Worldwide Marketing and Translational Diagnostic Business Unit, and General Manager, Research Products. In these roles, Mr. Lubniewski was responsible for a variety of assay and platform development and commercialization efforts. Prior to Ventana, Mr. Lubniewski worked for over ten years at Corning, Inc., a manufacturing company, in a variety of divisional, sector and corporate salesleadership roles at Corning, Incorporated, a multinational technology company that specializes in specialty glass, ceramics and marketing roles.related materials and technologies including advanced optics, primarily for industrial and scientific applications. Mr. Lubniewski earned a B.S. in Chemical Engineering from Clarkson University. Our Board of Directors believes that Mr. Lubniewski’s extensive executive management experience in commercialization, marketing, and strategic planning and management of operations, as well as his service as our Chief Executive Officer, qualify him to serve on our Board of Directors.
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Shaun D. McMeans. Mr. McMeans has served as our Senior Vice President and Chief Financial Officer since February 2018 and as our Vice President and Chief Financial Officer since February 2012. He previously was our Vice President of Finance & Administration from February 2012 until February 2018. Prior to joining us, Mr. McMeans was Vice President – Finance of Securaplane Technologies, Inc., a product supply company and division of Meggitt PLC, an aerospace, defense and energy conglomerate, from May 2011 to February 2012. Mr. McMeans was a financial consultant from February 2008 to April 2011, working both in an individual capacity and as a partner for Tatum LLC, a consulting company. Prior to February 2008, Mr. McMeans was Chief Financial Officer for The Long Companies, a full service residential and commercial real estate division of Berkshire Hathaway, Inc. Mr. McMeans also worked for over five years at LXU Healthcare, Inc., a manufacturer and distributor of specialty surgical equipment, as Controller and then Chief Financial and Operating Officer. In his early career, Mr. McMeans worked in roles of increasing responsibility, including Director of Finance, for Burnham Holdings, Inc., formerly Burnham Corporation, a manufacturer and distributor of residential and commercial hydronic heating equipment. Mr. McMeans received his B.S. in Accounting from The Pennsylvania State University.
Timothy (TJ) B. Johnson. Mr. Johnson has served as the Executive Chairman of our Board of Directors since March 2019 and as a member of our Board of Directors since January 2008. Mr. Johnson previously served as our Chief Executive Officer from January 2008 until March 2019. He also served as our President from January 2008 until April 2018. Mr. Johnson joined us from LVC Consulting, a consulting company, where he was a partner from April 2007 to January 2008. Prior to April 2007, Mr. Johnson spent five years in leadership roles at Ventana prior to its acquisition by Roche. At Ventana, Mr. Johnson held the positions of Senior Vice President, Global Business Services, Senior Vice President, Corporate Development and Operations, and Vice President/General Manager, Operations and Lean Systems. In these roles, Mr. Johnson’s responsibilities included product technical support, worldwide marketing, corporate development, strategic planning and manufacturing. Prior to working at Ventana, Mr. Johnson had a 12-year career at Hillenbrand Industries, Inc., a global diversified industrial company, where he held several leadership roles in the corporate offices and in the Hill-Rom Division, including Vice President, Global Marketing, Vice President/General Manager, Hill-Rom AirShields, Vice President, Operations, and Vice President, Continuous Improvement and Strategic Planning. Mr. Johnson spent part of his early career at PricewaterhouseCoopers LLP, a public accounting firm. Mr. Johnson previously served on the board of directors of Kalypto Medical, Inc. and was the Industry co-chair for the Biosciences Leadership Council of Southern Arizona. He earned a B.S. in Business from Indiana University. Our Board of Directors believes that Mr. Johnson’s extensive executive background in general management, strategic planning and managing operations of a diagnostic company and past service as our Chief Executive Officer qualify him to serve on our Board of Directors.
Byron T. Lawson. Lawson. Mr. Lawson has served as our Senior Vice President and Chief Commercial Officer insince January 2020 and previously served as our Senior Vice President, Pharma Business Unit since January 2018. Prior to this, he served as our Vice President, Commercial Operations since April 2016 and Senior Director, Commercial Options since October 2012. Mr. Lawson joined us from Ventana, where he worked for nearly 15 years and served in a variety of roles with increasinglyincreasing responsibility in the North American commercial organization. He also served in the United States Air Force for nearly 10 years between Active and Reserve Duty as a certified Histology Technician.
Stephen A. Barat, Ph.D. Dr. Barat has served as our Senior Vice President of Therapeutics since joining our company in October 2021. Our Board of Directors designated him an executive officer in February 2023. Prior to joining us, Dr. Barat was the U.S.-head of the non-clinical safety leaders at Janssen Pharmaceutical Companies of Johnson and Johnson ("Janssen"), the world's largest healthcare company, from March 2020 to October 2021. Prior to Janssen, from January 2017 to March 2020, he was vice president of research and early development at Scynexis, a biotechnology company focused on discovering and developing novel anti-fungal agents. Prior to January 2017, Dr. Barat served in a variety of leadership positions through a series of mergers and acquisitions with Forest Laboratories/Actavis/Allergan, having joined from Merck (Schering-Plough). Professionally, Dr. Barat is an internationally recognized speaker having delivered numerous talks on subjects related to global drug development, having served as a course creator and continuing education faculty member and having been active with industry expert working groups including U.S. Pharmacopeia and Product Quality Research Institute. A pharmacologist by training, Dr. Barat received his B.S. in Clinical Laboratory Sciences (Toxicology) from Rutgers University and his Ph.D. degree in Biomedical Sciences (Pharmacology and Toxicology) from New Jersey Medical School.
Non-Employee Directors
Ann F. Hanham Ph.D. Dr. Hanham has served on our Board of Directors since August 2016 and has served as chair of our Lead Independent DirectorBoard of Directors since April 2019.January 2021. Prior to her appointmentthis, Dr. Hanham served as Lead Independent Director Dr. Hanham servedfrom April 2019 to December 2020 and as the chair of our Board of Directors from March 2017 to March 2019. Since March 2017, Dr. Hanham has provided independent management consulting as a sole proprietor. Previously, she was the founding and managing partner of BAR Capital LLC, an investment company, a position she has held from December 2013 to March 2017. From February 2000 to November 2013, Dr. Hanham was the Managing Director and General Partner of Burrill and Company, a life science investment company. Prior to that, Dr. Hanham held positions of increasing responsibility in product development, medical affairs, and clinical and regulatory affairs at various companies, including InterMune Inc., Otsuka America Pharmaceuticals, Inc. (“Otsuka”), Celtrix Pharmaceuticals, Inc. (“Celtrix”), and Becton Dickinson and Company (“BD”). InterMune, Inc., Otsuka and Celtrix are, or prior to respective acquisitions, were clinical-stage biopharmaceutical companies, and BD is a life sciences discovery and diagnostics company. Dr. Hanham also currently serves on the board of directors of SCYNEXIS (Nasdaq: SCYX). Dr. Hanham received her B.Sc. degree from the University of Toronto, Canada; her M.Sc. degree, in biology, from Simon Fraser University, Canada; and her Ph.D. degree, in biology, from the University of British Columbia, Canada. Our Board of Directors believes that Dr. Hanham’s extensive industry and executive experience, and her experience serving on the board of directors of other public companies qualifies her to serve on our Board of Directors.
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Thomas W. Dubensky Jr., Ph.D. Dr. Dubensky joined our Board of Directors in August 2022. Dr. Dubensky was the Chief Executive Officer and a director of Tempest Therapeutics, Inc. (“Legacy Tempest”) since 2017 until its merger with Millendo Therapeutics, Inc. in June 2021, which combined company is now called Tempest Therapeutics, Inc. (Nasdaq: TPST) ("Tempest"), and has served as the President and a member of the Board of Tempest since June 2021. Prior to Legacy Tempest, Dr. Dubensky was the Chief Scientific Officer of Aduro Biotech, where he led the development of STRING agonists. Additionally, Dr. Dubensky served in executive and principal roles in leading discovery biology, development and clinical translation of multiple first-in-class agents in cancer immunotherapy and infectious disease indications at several biotech companies, including Viagene Biotech, Inc., Chiron Corporation, Onyx Pharmaceuticals, Inc., Cerus Corporation and Immune Design, Inc. Dr. Dubensky has served on the scientific advisory boards of Turnstone Biologics, Oncorus, Inc., Remedy Plan, Inc., Vaccitech PLC-ADR and Tyligand Bioscience. Dr. Dubensky has an extensive publication and patent record. Dr. Dubensky received his B.A. in Bacteriology and Immunology from the University of California, Berkeley, his Ph.D. from the University of Colorado Health Sciences Center, conducted his post-doctoral studies at Harvard Medical School in the Department of Pathology, and received executive training at the University of California, San Diego, in the Executive Program for Scientists and Engineers. Our Board of Directors believes that Dr. Dubensky's extensive industry and executive experience, especially in the areas of drug discovery and development, qualifies him to serve on our Board of Directors.
Michelle R. Griffin.Ms. Griffin has served on our Board of Directors since August 2018. Ms. Griffin currently serves as a member of the board of directors and chair of the auditcompensation committee for Acer Therapeutics, Inc.Inc (Nasdaq: ACER) and, Adaptive Biotechnologies Corp (Nasdaq: ADPT) and Chinook Therapeutics, Inc. (Nasdaq KDNY). She has also served on the board of directors and as audit committee chair for PhaseRx, Inc. (Nasdaq:PZRX) from 2016 to 2018, OncoGenex Pharmaceuticals Inc. (Nasdaq: OGXI) from 2008 to 2011, and Sonus Pharmaceuticals, Inc. (Nasdaq: SNUS) from 2004 to 2008; as chair of the board of directors for Universal Cells, Inc. from 2017 until its acquisition by Astellas Pharma Inc. in 2018; as a member of the board of directors of Virginia Mason Health System and Virginia Mason Medical Center from 2014 to 2018; and as a member of the board of directors for Polynoma LLC from 2012 to 2014.2008. Ms. Griffin served as executive vice president, operations,Executive Vice President, Operations, and chief financial officerChief Financial Officer at OncoGenex from 2011 to 2013; served as acting chief executive, senior vice presidentChief Executive, Senior Vice President and chief operating officerChief Operating Officer at Trubion Pharmaceuticals, Inc. (Nasdaq: TRBN) from 2009 until its acquisition in 2010 and as its chief financial officerChief Financial Officer from 2006 to 2009; and served as senior vice presidentSenior Vice President and chief financial officerChief Financial Officer of Dendreon Corp. (Nasdaq: DNRN) from 2005 to 2006. Ms. Griffin began her career in the biopharmaceuticals industry in 1994 at Corixa Corp. (Nasdaq: CRXA) and served as its chief financial officerChief Financial Officer from its IPO in 1997 until 2005 when Corixa was acquired by GlaxoSmithKline plc. She received a post‐graduate certificate in accounting and an MBA from Seattle University, a B.S. in statistics and marketing from George Mason University and has passed the certified public accountant exam. Our Board of Directors believes that Ms. Griffin’s financial and accounting expertise and extensive executive experience qualifies her to serve on our Board of Directors.
Harry A. George. Mr. George has served on our Board of Directors since 2002 and served as the chair of our Board of Directors from December 2007 until September 2013. Mr. George co-founded Solstice Capital, a venture capital firm, in 1995 and serves as its Managing General Partner. Mr. George serves as President and CFO of Radiance Therapeutics where he also serves on the board of directors. Mr. George has served as a member of the board of directors of a number of private and public companies and is currently serving on the boards of directors of Medipacs, Inc., Post.Bid.Ship, Inc., AdiCyte, Inc., RxActuator, Inc. and Splash Pharmaceuticals, Inc. Mr. George is also a member of the boards of directors of several non-profit organizations, including Southern Arizona Leadership Council, Desert Angels and Start-up Tucson, a member of the Board of Visitors of the McGuire Center for Entrepreneurship, and an advisor to Tech Launch Arizona. Prior to 1995, Mr. George was co-founder, Director, and Vice-President of Finance for Interleaf Inc., a software products company. Prior to his time at Interleaf, Mr. George was co-founder, Director and Vice President of Finance of Kurzweil Computer Products, Inc., a computer products company, which subsequently was purchased by Xerox Imaging Systems. Mr. George received an A.B. from Bowdoin College and, in 2012, received an Honorary Doctorate of Science from the University of Arizona. Also in 2012, the Arizona BioIndustry Association conferred upon Mr. George the John McGarrity Bioscience Leader of the Year Award. Our Board of Directors believes Mr. George’s detailed knowledge of our company and long tenure with us, together with his more than 40 years of experience serving as founder, operating officer, or investor with successful rapid growth technology-related companies qualify him to serve on our Board of Directors.
Donnie M. Hardison.Mr. Hardison has served on our Board of Directors since May 2016. Since February 2021, he has been working as an independent consultant. He currently iswas most recently the President and Chief Executive Officer, and servesserved on the board of directors, of Biotheranostics, Inc., a molecular diagnostic company focused on oncology, positions he has held sincefrom February 2017.2017 until it was acquired by Hologic, Inc. in February 2021. From April 20162010 to January 2017, Mr. Hardison served as the sole proprietor of DMH Consulting, a management consulting firm, which he founded. Between April 2010 and March 2016, Mr. Hardison was the President and Chief Executive Officer of Good Start Genetics, a medical devicemolecular genetic testing and information company. For more than 20 years prior to that, Mr. Hardison held a number ofvarious executive and senior management positions at companies including Laboratory Corporation of America (“LabCorp”) a clinical laboratory company, Exact Sciences Corporation, a molecular diagnostics company, OnTarget, Inc., a sales and marketing consulting company, Quest Diagnostics Inc., a clinical laboratory company, SmithKline Beecham Corporation, a pharmaceutical company, and others. He currently serves on the board of directors of Cytek Biosciences (Nasdaq: CTKB), MDxHealth (Nasdaq: MDXH) and BioPorto, Inc. (BIOPOR.CO) and as an independent director on the boards of directors ofor advisor for several private companies, including Seventh Sense Biosystems, Boston MicrofluidicsStemina Biomarker Discovery, Inc., YourBio Health, Breath BioMedical and IQuity, Inc. He also previously served on the board of directors of Exact Sciences Corporation (Nasdaq: EXAS) from May 2000, through its initial public offering in February 2001, until August 2007. Mr. Hardison received his Bachelor of Arts degree, in political science, from the University of North Carolina, Chapel Hill. OurOur Board of Directors believes that Mr. Hardison’s broad private and public company background, his extensive executive and industry experience, his experience with newly emerging and well-established companies, and his extensive commercial and operational experience qualify him to serve on our Board of Directors.
James (Jim) T. LaFrance. Christopher P. Kiritsy.Mr. LaFranceKiritsy has served on our Board of Directors since December 2015.January 2022. Mr. LaFranceKiritsy currently serves as audit and compensation committee chairs and on the board of directors of Pieris Pharmaceuticals, Inc. (Nasdaq: PIRS). Since 2018, Mr. Kiritsy has almost thirty yearsbeen the managing member of diagnostic industry experience, and has worked since January 2015 as a sales, marketing, strategy development and commercial operational management consultant for LaFrance ConsultingPrecision Kapital, LLC, a private investment and advisory firm that he founded. He currently serves on three additional boards, Vermillion, Inc (Nasdaq: VRML) as Chairman; BioArray Genetics,Prior to forming Precision Kapital, Mr. Kiritsy co-founded Arisaph Pharmaceuticals, Inc., a private company, as Chairman, (“Arisaph”) and as an independent director of privately held Personal Genome Diagnostics. He served as interimArisaph’s President and Chief Executive Officer until its exit in 2018. At Arisaph, Mr. Kiritsy evolved the drug discovery organization from an academic orientation to a clinical development enterprise, taking several cardiometabolic products into clinical development. Prior to Arisaph, Mr. Kiritsy served as Executive Vice President, Corporate Development and Chief Financial Officer of Vermillion,Kos Pharmaceuticals, Inc. (Nasdaq: VRML)KOSP). Mr. Kiritsy is a seasoned entrepreneur, who possesses more than 25 years of business and technical experience in 2014the biopharmaceutical industry. He received his A.B. in Biology from Bowdoin College and as a CEO for Omnyx, LLC, a UPMC/GE Healthcare joint venturean MBA from 2012 to 2013. Mr. LaFrance held a series of senior management roles at Ventana Medical Systems (now Roche Tissue Diagnostics), including general management of the North American and international commercial operations. Prior to working for Ventana, Mr. LaFrance served in leadership roles in strategic marketing and business development at Bayer Diagnostics. He earned a Bachelor of Arts degree in Economics from the University of Connecticut and holds a Master’s in Business Administration from the University of Notre Dame. Boston University. Our Board of Directors believes that Mr. LaFrance’sKiritsy’s extensive industry and executive experience, and his experience serving on the board of directors of another public company qualify him to serve on our Board of Directors.
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Lee R. McCracken. Mr. McCracken has served on our Board of Directors since October 2015. Since 2022, Mr. McCracken currently ishas served as the Chief Executive Officer of NephroSant, a diagnostics company developing innovative tests focused on early detection of kidney disease and injury. From May 2021 to October 2022, Mr. McCracken was an Entrepreneur in Residence at Thorne HealthTech, a memberleader in the development of innovative solutions for personalized approaches to health and wellbeing, following its acquisition of Drawbridge Health, where he served as Chief Executive Officer from June 2018 to April 2021 and became the Chair of the board of directors of Drawbridge Health, Inc., a company focused on enabling personal diagnostic testing, positions he has held since June 2017.in May 2021. From May 2016 to May 2017 and from April 2013 to March 2014, he served asMr. McCracken was a strategic and restructuring consultant in the regenerative medicine and diagnostic sectors fordiagnostics industries through his firm, McCracken Consulting, a consulting firmConsulting. In addition, he founded. Between April 2014 and May 2016, Mr. McCracken wasserved as Chief Executive Officer of Gensignia Life Sciences, Inc., a molecular diagnostics company. Earlier in his career,company, from April 2014 through May 2016. Mr. McCracken previously held a number of executive positions or roles with significant responsibility at several biotechnology and therapeutics companies, including Pathwork Diagnostics, Inc., Prometheus Laboratories Inc., GenStar Therapeutics Corporation, CombiChem Inc., and Allergan Inc., as well as at the investment companies, 3i Capital and Union Venture. Mr. McCracken received his M.B.A. from the Anderson School of Management at the University of California, Los Angeles, his Master of Computer Science (MCS) from the University of Dayton, and his B.S. in Commerce from Santa Clara University. Our Board of Directors believes Mr. McCracken’s extensive executive and industry experience and his broad knowledge of molecular diagnostics qualify him to serve on our Board of Directors.
Board Composition
Our business and affairs are organized under the direction of our boardBoard of directors,Directors, which currently consists of eightsix members. The primary responsibilities of our Board of Directors are to provide oversight, strategic guidance, counseling and direction to our management. Our Board of Directors meets on a regular basis and additionally as required.
Our Board of Directors has determined that all of our directors other than Mr. Lubniewski and Mr. Johnson are independent directors, as defined by Rule 5605(a)(2) of the Nasdaq Listing Rules. The Nasdaq independence definition includes a series of objective tests, including that the director is not, and has not been for at least three years, one of our employees and that neither the director nor any of his family members has engaged in various types of business dealings with us. In addition, as required by Nasdaq rules, our Board of Directors has made a subjective determination as to each independent director that no relationships exist, which, in the opinion of our Board of Directors, would interfere with the exercise of independent judgment in carrying out the responsibilities of a director. In making these determinations, our Board of Directors reviewed and discussed information provided by the directors and us with regard toregarding each director’s business and personal activities and relationships as they may relate to us and our management. There are no family relationships among any of our directors or executive officers.
In accordance with the terms of our amended and restated certificate of incorporation, our Board of Directors is divided into three classes, as follows:
•Class I, which consists of Mr. Lubniewski,McCracken, Mr. GeorgeKiritsy and Dr. Dubensky, whose terms will expire at our annual meeting of stockholders to be held in 2025;
•Class II, which consists of Mr. Lubniewski and Mr. Hardison, whose terms will expire at our annual meeting of stockholders to be held in 2020;2023; and
•Class II,III, which consists of Mr. Johnson, Dr. Hanham and Ms. Griffin, whose terms will expire at our annual meeting of stockholders to be held in 2021: and
Class III, which consists of Mr. McCracken and Mr. LaFrance, whose terms will expire at our annual meeting of stockholders to be held in 2022.
2024.At each annual meeting of stockholders, the successors to directors whose terms then expire will serve until the third annual meeting following their election and until their successors are duly elected and qualified. The authorized number of directors may be changed only by resolution of our Board of Directors. Any additional directorships resulting from an increase in the number of directors will be distributed between the three classes so that, as nearly as possible, each class will consist of one-third of the directors. This classification of the board of directors may have the effect of delaying or preventing changes in our control or management. Our directors may be removed for cause by the affirmative vote of the holders of at least 66 2/3% of our voting stock.
Board Leadership Structure
As a general policy, our Board of Directors believes that separation of the positions of chairChair and Chief Executive Officer reinforces the independence of the Board from management, creates an environment that encourages objective oversight of management’s performance and enhances the effectiveness of the Board as a whole.
Mr. Johnson77
Dr. Hanham serves as Chair of our Executive ChairmanBoard of Directors and Mr. Lubniewski serves as our Chief Executive Officer. As our Executive Chairman, Mr. Johnson advises our management, including our Chief Executive Officer, on various strategic matters. We believe that separation of the positions of Executive Chairman and Chief Executive Officer reinforces the independence of the Board of Directors in its oversight of our business and affairs.
In addition, Dr. Hanham serves as our Lead Independent Director. As Lead Independent Director, Dr. Hanham presides over Board of Directors meetings,, sets meeting agendas, ensures the duties, responsibilities and roles of members of our Board of Directors are clearly understood, ensures that our Board of Directors receives appropriate and timely information, material and reports from management regarding our business, provides input to the Board regarding candidates for nomination or appointment to the Board and Board committees, and performs such additional duties as set forth in our bylaws and as our Board of Directors may otherwise determine and delegate.delegate.
We also have a separate chair for each committee of our Board of Directors. The chair of each committee is expected to report at least annually to our Board of Directors on the activities of their respective committee in fulfilling their responsibilities as detailed in their respective charters or specify any shortcomings should that be the case.
Role of the Board in Risk Oversight
One of the key functions of our Board of Directors is informed oversight of our risk management process. The Board does not have a standing risk management committee, but rather administers this oversight function directly through theour Board of Directors as a whole, as well as through various standing Board committees that address risks inherent in their respective areas of oversight. The risk oversight process includes receiving regular reports from Board committees and members of senior management to enable our Board of Directors to understand our risk identification, risk management and risk mitigation strategies with respect to areas of potential material risk, including operations, finance, legal, regulatory, strategic and reputational risk. In particular, our Board of Directors is responsible for monitoring and assessing strategic risk exposure and our Audit Committee has the responsibility to consider and discuss our major financial risk exposures and the steps our management has taken to monitor and control these exposures, including guidelines and policies to govern the process by which risk assessment and management is undertaken. The Audit Committee also monitors compliance with legal and regulatory requirements. Oversight by the Audit Committee includes direct communication with our external auditors. Our Nominating and Governance Committee monitors the effectiveness of our corporate governance practices, including whether they are successful in preventing illegal or improper liability-creating conduct. Our Compensation Committee assesses and monitors whether any of our compensation policies and programs has the potential to encourage excessive risk-taking.
Board Committees
Our Board of Directors has established an audit committee, a compensation committee and a nominating and governance committee.
Audit Committee
Our Audit Committee consists of Ms. Griffin, Mr. GeorgeKiritsy and Mr. LaFrance. Ms. GriffinMcCracken. Mr. Kiritsy serves as the chair of our Audit Committee. Our Board of Directors has determined that each of the members of our Audit Committee satisfies the Nasdaq Stock Market and SEC independence requirements. The functions of this committee include, among other things:
•evaluating the performance, independence and qualifications of our independent auditors and determining whether to retain our existing independent auditors or engage new independent auditors;
•reviewing and approving the engagement of our independent auditors to perform audit services and any permissible non-audit services;
•monitoring the rotation of partners of our independent auditors on our engagement team as required by law;
•prior to engagement of any independent auditor, and at least annually thereafter, reviewing relationships that may reasonably be thought to bear on their independence, and assessing and otherwise taking the appropriate action to oversee the independence of our independent auditor;
•reviewing our annual and quarterly financial statements and reports, including the disclosures contained under the caption “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” and discussing the statements and reports with our independent auditors and management;
•reviewing with our independent auditors and management significant issues that arise regarding accounting principles and financial statement presentation and matters concerning the scope, adequacy and effectiveness of our financial controls;
•reviewing with management and our auditors any earnings announcements and other public announcements regarding material developments;
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•establishing procedures for the receipt, retention and treatment of complaints received by us regarding financial and cybersecurity-related controls, accounting or auditing matters and other matters;
•preparing the report that the SEC requires in our annual proxy statement;
•reviewing and providing oversight of any related-person transactions in accordance with our related-person transaction policy and reviewing and monitoring compliance with legal and regulatory responsibilities, including our code of business conduct and ethics;
•reviewing our major financial and cybersecurity risk exposures, including the guidelines and policies to govern the process by which risk assessment and risk management is implemented;
•reviewing on a periodic basis our investment policy; and
•reviewing and evaluating on an annual basis the performance of the Audit Committee, including compliance of the Audit Committee with its charter.
Our Board of Directors has determined that each member of the audit committee meets the requirements for financial literacy under the applicable rules and regulations of the SEC and the Nasdaq Stock Market. It has also determined that Ms. GriffinMr. Kiritsy qualifies as an audit committee financial expert within the meaning of SEC regulations and meets the financial sophistication requirements of the Nasdaq Listing Rules. In making this determination, our Board of Directors has considered Ms. Griffin’sMr. Kiritsy’s formal education and experience in financial and executive roles. Both our independent registered public accounting firm and management periodically meet privately with our Audit Committee. The audit committee operates under a written charter that satisfies the applicable standards of the SEC and the Nasdaq Stock Market.
Compensation Committee
Our Compensation Committee consists of Dr. Dubensky, Ms. Griffin, Mr. Hardison, and Mr. McCracken. Mr. Hardison serves as the chair of our Compensation Committee. Our Board of Directors has determined that each of the members of our Compensation Committee is a non-employee director, as defined in Rule 16b-3 promulgated under the Securities Exchange Act of 1934, as amended (the “Exchange Act”) and satisfies the Nasdaq Stock Market independence requirements. None of these individuals has ever been an executive officer or employee of ours. The functions of this committee include, among other things:
•reviewing, modifying and approving (or if it deems appropriate, making recommendations to the full Board of Directors regarding) our overall compensation strategy and policies;
•reviewing and recommending to our Board of Directors the compensation and other terms of employment of our executive officers;
•reviewing and recommending to our Board of Directors the performance goals and objectives relevant to the compensation of our executive officers and assessing their performance against these goals and objectives;
•reviewing and approving (or if it deems it appropriate, making recommendations to the full Board of Directors regarding) the equity incentive plans, compensation plans and similar programs advisable for us, as well as modifying, amending or terminating existing plans and programs;
•evaluating risks associated with our compensation policies and practices and assessing whether risks arising from our compensation policies and practices for our employees are reasonably likely to have a material adverse effect on us;
•reviewing and approving (or if it deems it appropriate, making recommendations to the full Board of Directors regarding) the type and amount of compensation to be paid or awarded to our non-employee board members;
•establishing policies for allocating between long-term and currently paid out compensation, between cash and non-cash compensation and the factors used in deciding between the various forms of compensation;
•establishing policies with respect to votes by our stockholders to approve executive compensation as required by Section 14A of the Exchange Act and determining our recommendations regarding the frequency of advisory votes on executive compensation;
•reviewing and assessing the independence of compensation consultants, legal counsel and other advisors as required by Section 10C of the Exchange Act;
•establishing elements of corporate performance for purposes of increasing or decreasing compensation;
•administering our equity incentive plans;
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•establishing policies with respect to equity compensation arrangements;
•reviewing regional and industry-wide compensation practices and trends to assess the competitiveness of our executive compensation programs and evaluating the effectiveness of our compensation policy and strategy in achieving expected benefits to us;
•reviewing the adequacy of its charter on a periodic basis;
•reviewing with management and approving our disclosures under the caption “Compensation Discussion and Analysis” in our periodic reports or proxy statements to be filed with the SEC, if applicable;
•preparing the report that the SEC requires in our annual proxy statement, if applicable; and
•reviewing and assessing on an annual basis the performance of the Compensation Committee.
The compensation committee operates under a written charter that satisfies the applicable standards of the SEC and the Nasdaq Stock Market.
In 2019,2022, our Compensation Committee retained Radford, an Aon Hewitt company and a provider of compensation market intelligence to the technology and life sciences industries, to provide a report summarizing relevant benchmark data relating to industry-appropriate peers and make recommendations regarding base salary, target total cash (base salary plus target cash incentives) and the amounts and terms of long-term equity incentive awards for our executives as well as to benchmark and make recommendations regarding the initial and annual cash retainer amounts for directors and chairpersons of our Board of Directors and the various committees and the amounts and terms of initial and annual long-term equity incentive awards for directors. No work performed by Radford during fiscal year 20192022 raised a conflict of interest.
None of our executive officers currently serves, or has served during the last completed fiscal year, on the compensation committee or board of directors of any other entity that has one or more executive officers serving as a member of our Board of Directors or Compensation Committee.
Nominating and Governance Committee
Our Nominating and Governance Committee consists of Dr. Hanham, Mr. McCracken and Mr. LaFrance.McCracken. Dr. Hanham serves as the chair of our Nominating and Governance Committee. Our Board of Directors has determined that each of the members of this committee satisfies the Nasdaq Stock Market independence requirements. The functions of this committee include, among other things:
•identifying, reviewing and evaluating candidates to serve on our Board of Directors consistent with criteria approved by our Board of Directors;
•determining the minimum qualifications for service on our Board of Directors;
•evaluating director performance on the board and applicable committees of the board and determining whether continued service on our Board is appropriate;
•evaluating, nominating and recommending individuals for membership on our Board of Directors;
•evaluating nominations by stockholders of candidates for election to our Board of Directors;
•considering and assessing the independence of members of our Board of Directors;
•developing a set of corporate governance policies and principles, including a code of business conduct and ethics, periodically reviewing and assessing these policies and principles and their application and recommending to our Board of Directors any changes to such policies and principles;
•assist the chair of our Board of Directors or lead independent director in developing effective board of directors meeting practices and procedures;
•oversee and review the processes and procedures used by us to provide information to our Board of Directors and its committees;
•assist the members of our Compensation Committee, as requested, in determining the compensation paid to non-employee directors for their service on our Board of Directors and its committees and recommend any changes considered appropriate to our full board of directors for approval;
•periodically review with our Chief Executive Officer the plans for succession to the offices of our Chief Executive Officer and other key executive officers and make recommendations to our Board of Directors with respect to the selection of appropriate individuals to succeed those positions;
•reviewing the adequacy of its charter on an annual basis; and
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•annually evaluating the performance of the Nominating and Governance Committee.
The nominating and governance committee operates under a written charter, which the nominating and governance committee reviews and evaluates at least annually.
The nominating and governance committee will consider qualified director candidates recommended by stockholders in compliance with our procedures and subject to applicable inquiries. The nominating and governance committee’s evaluation of candidates recommended by stockholders does not differ materially from its evaluation of candidates recommended from other sources. Any stockholder may recommend nominees for director by writing to Dr. Ann F. Hanham, Ph.D., Chair of the Nominating and Governance Committee of the Board of Directors, HTG Molecular Diagnostics, Inc., 3430 E. Global Loop, Tucson, Arizona 85706,, giving the name and address of the stockholder on whose behalf the submission is made, the number of Company shares that are owned beneficially by such stockholder as of the date of the submission, the full name of the proposed candidate, a description of the proposed candidate’s business experience for at least the previous five years, complete biographical information for the proposed candidate and a description of the proposed candidate’s qualifications as a director. All of these communications will be reviewed by our Nominating and Governance Committee, for further review and consideration in accordance with this policy.
Delinquent Section 16(a) Reports
Under Section 16(a) of the Exchange Act, directors, officers and beneficial owners of 10% or more of our common stock are required to file with the SEC on a timely basis initial reports of beneficial ownership and reports of changes regarding their beneficial ownership of our common stock. Officers, directors and 10% beneficial owners are required by SEC regulations to furnish us with copies of all Section 16(a) forms that they file.
Based solely on our review of the copies of such forms received and the written representations from certain reporting persons, we have determined that no officer, director or 10% beneficial owner known to us was delinquent with respect to their reporting obligations as set forth in Section 16(a) of the Exchange Act during the fiscal year ended December 31, 2019, with the exception of Timothy B. Johnson, our Executive Chairman, who sold shares of our common stock on December 26, 2019 and filed a Form 4 late on January 2, 2020.
Limitation on Liability and Indemnification of Directors and Officers
Our amended and restated certificate of incorporation and bylaws limits our directors’ and officers’ liability to the fullest extent permitted under Delaware corporate law. Delaware corporate law provides that directors of a corporation will not be personally liable for monetary damages for breach of their fiduciary duties as directors, except for liability:
•for any transaction from which the director derives an improper personal benefit;
•for any act or omission not in good faith or that involves intentional misconduct or a knowing violation of law;
•under Section 174 of the Delaware General Corporation Law (unlawful payment of dividends or redemption of shares); or
•for any breach of a director’s duty of loyalty to the corporation or its stockholders.
If the Delaware General Corporation Law is amended to authorize corporate action further eliminating or limiting the personal liability of directors or officers, then the liability of our directors or officers shall be eliminated or limited to the fullest extent permitted by the Delaware General Corporation Law, as so amended.
Delaware law and our amended and restated bylaws provide that we will, in certain situations, indemnify any person made or threatened to be made a party to a proceeding by reason of that person’s former or present official capacity with us against judgments, penalties, fines, settlements and reasonable expenses. Any person is also entitled, subject to certain limitations, to payment or reimbursement of reasonable expenses (including attorneys’ fees and disbursements) in advance of the final disposition of the proceeding.
In addition, we have entered, and intend to continue to enter, into separate indemnification agreements with our directors and executive officers. These agreements, among other things, require us to indemnify our directors and executive officers for certain expenses, including attorneys’ fees, judgments, fines and settlement amounts incurred by a director or executive officer in any action or proceeding arising out of their services as one of our directors or executive officers or as a director or executive officer of any other company or enterprise to which the person provides services at our request.
We believe that these provisions in our amended and restated certificate of incorporation and amended bylaws and these indemnification agreements are necessary to attract and retain qualified persons as directors and officers. We also maintain a directors’ and officers’ insurance policy pursuant to which our directors and officers are insured against liability for actions taken in their capacities as directors and officers.
Insofar as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers or control persons, in the opinion of the SEC, such indemnification is against public policy as expressed in the Securities Act and is therefore unenforceable.
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Stockholder Communications with the Board of Directors
We have adopted a formal process by which stockholders may communicate with the Board or any of its directors. Stockholders who wish to communicate with the Board may do so by sending written communications addressed to: Attn: Corporate Secretary, 3430 E. Global Loop, Tucson, Arizona, 85706. These communications will be reviewed by the Secretary, who will determine whether the communication is appropriate for presentation to the Board or the relevant director. The purpose of this screening is to allow the Board to avoid having to consider irrelevant or inappropriate communications (such as advertisements, solicitations and hostile communications).
Code of Ethics
We have adopted a Code of Business Conduct and Ethics that applies to all officers, directors and employees. The Code of Business Conduct and Ethics is available on our website at www.htgmolecular.com. If we make any substantive amendments to the Code of Business Conduct and Ethics or grants any waiver from a provision of the Code to any executive officer or director, we will promptly disclose the nature of the amendment or waiver on our website.
Item 11. Executive Compensation.
Our named executive officers for the year ended December 31, 2019,2022, which consist of our principal executive officer and our two other most highly compensated executive officers as of December 31, 2019,2022, are as follows:
•John L. Lubniewski, our President and Chief Executive Officer;
•Shaun D. McMeans, Senior Vice President Finance and Chief Financial Officer; and
•Timothy B. Johnson, Executive ChairmanByron T. Lawson, Senior Vice President and former Chief ExecutiveCommercial Officer.
Summary Compensation Table
| | | | | | | | | | | | | | | | | | | | | | | | |
Name and principal position | | Year | | Salary
($) | | | Option
awards
($) (1) | | | Non-equity
incentive
plan
compensation
($) (2) | | | | All other
compensation
($) (3) | | | Total
($) | |
John L. Lubniewski | | 2022 | | | 538,000 | | | | 92,700 | | | | 282,450 | | | (4 | ) | | 741 | | | | 913,891 | |
President and Chief Executive Officer | | 2021 | | | 460,000 | | | | — | | | | 276,000 | | | | | 741 | | | | 736,741 | |
Shaun D. McMeans | | 2022 | | | 385,000 | | | | 46,350 | | | | 148,225 | | | (4 | ) | | 741 | | | | 580,316 | |
Senior Vice President and Chief Financial Officer | | 2021 | | | 370,000 | | | | — | | | | 139,860 | | | | | 741 | | | | 510,601 | |
Byron T. Lawson | | 2022 | | | 345,000 | | | | 15,444 | | | | 60,375 | | | | | 741 | | | | 421,560 | |
Chief Commercial Officer | | 2021 | | | 333,000 | | | | — | | | | 106,560 | | | | | 741 | | | | 440,301 | |
(1)The dollar amounts in this column represent the aggregate grant date fair value of stock option awards granted in 2022 and 2021, as applicable. These amounts have been computed in accordance with FASB ASC Topic 718, using the Black-Scholes option pricing model. For a discussion of valuation assumptions, see Note 14 “Stockholders’ Equity” to our consolidated financial statements included elsewhere in this Annual Report on Form 10-K.
(2)Amounts shown represent annual performance-based bonuses earned for 2022 and 2021. A description of our annual bonus program for 2022 is set forth below under "Annual Performance-Based Bonus Opportunity."
(3)Amount shown represents premiums for life, disability and accidental death and dismemberment insurance paid by us on behalf of the named executive officer.
(4)Each of Mr. Lubniewski and Mr. McMeans have elected to defer receipt of their annual performance-based bonus earned for 2022 until the earliest to occur of: (i) our company’s completion of a significant financing transaction or business development transaction with a significant upfront payment, as determined by the Board; (ii) the determination by the Board that we have cash on hand that is estimated to be sufficient for at least nine months following the determination; (iii) the occurrence of a liquidation, bankruptcy, or similar events; (iv) the consummation of a transaction that rules in a change in control of our company, as that term is defined in our 2020 equity incentive plan; and (v) December 31, 2023.
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Name and principal position | | Year | | Salary ($) | | | Bonus ($) (1) | | | Stock awards ($) (2) | | | Option awards ($) (3) | | | Non-equity incentive plan compensation ($) (4) | | All other compensation ($) (5) | | Total ($) | |
John L. Lubniewski | | 2019 | | | 384,125 | | | | — | | | | — | | | | 772,875 | | | | — | | | 741 | | | 1,157,741 | |
President and Chief Executive Officer | | 2018 | | | 327,230 | | | | 100,000 | | | | 413,775 | | | | 340,000 | | | | 116,007 | | | 741 | | | 1,297,753 | |
Shaun D. McMeans | | 2019 | | | 320,625 | | | | — | | | | — | | | | 45,125 | | | | — | | | 741 | | | 366,491 | |
Senior Vice President and Chief Financial Officer | | 2018 | | | 288,608 | | | | 50,000 | | | | 270,437 | | | | 340,000 | | | | 91,438 | | | 741 | | | 1,041,224 | |
Timothy B. Johnson | | 2019 | | | 187,500 | | | | — | | | | — | | | | 35,500 | | | | 24,411 | | | 437 | | | 247,848 | |
Executive Chairman | | 2018 | | | 426,250 | | | | 200,000 | | | | 708,343 | | | | 510,000 | | | | 166,183 | | | 741 | | | 2,011,517 | |
(1)
| The dollar amounts in this column represent the aggregate grant date fair value of RSU awards granted in 2018, as applicable. For further discussion of valuation assumptions, see Note 14 “Stockholders’ Equity” to our consolidated financial statements included elsewhere in this Annual Report on Form 10-K.
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(2)
| The dollar amounts in this column represent the aggregate grant date fair value of stock option awards granted in 2019 and 2018, as applicable. These amounts have been computed in accordance with FASB ASC Topic 718, using the Black-Scholes option pricing model. For a discussion of valuation assumptions, see Note 14 “Stockholders’ Equity” to our consolidated financial statements included elsewhere in this Annual Report on Form 10-K.
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(3)
| Amounts shown represent annual performance-based bonuses earned for 2019 and 2018. The 2019 performance-based bonus for Mr. Johnson was pro-rated for the period for which he served as the Company’s Chief Executive Officer. The Board of Directors determined that Mr. Lubniewski and Mr. McMeans would forgo a 2019 performance-based bonus.
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(4)
| Amount shown represents premiums for life, disability and accidental death and dismemberment insurance paid by us on behalf of the named executive officer.
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(5)
| Mr. Johnson transitioned from the role of Chief Executive Officer to Executive Chairman effective March 31, 2019.
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Annual Base Salary
The base salary of our named executive officers is generally set forth in each officer’s employment letter agreement with us and periodically reviewed and adjusted by our Board of Directors, based on the recommendation of our Compensation Committee and following analyses conducted by independent third-party consultants. At the beginning of 2019, theThe 2022 base salaries for our named executive officers were $385,000, $315,000 and $450,000 for Mr. Lubniewski, Mr. McMeans and Mr. Johnson,Lawson were $538,000, $385,000 and $345,000, respectively. In August 2019, the base salaries for Mr. Lubniewski and Mr. McMeans were increased to $416,000 and $330,000, respectively.
In January 2019, our Board of Directors designated Mr. Johnson as the Executive Chairman effective March 31, 2019. The base salary for Mr. Johnson was decreased to $100,000 in connection with his appointment to the Executive Chairman position.
Annual Performance-Based Bonus Opportunity
In addition to base salaries, our named executive officers are eligible to receive annual performance-based bonuses, which are designed to provide appropriate incentives to our executives to achieve defined annual corporate goals and to reward our executives for individual achievement towards these goals. As with annual base salary, the target annual performance-based bonus percentage for each of our named executive officers is determined by our Board of Directors, based uponon the recommendation of our Compensation Committee and input from independent third-party consultants. The annualperformance-based bonus each named executive officer is awarded is generally based on the extent to which we achieve the corporate goals that our Board of Directors establishes each year. At the end of the year, our Board of Directors reviews our performance against each corporate goal and approves the extent to which we achieved each of our corporate goals.
Our Board of Directors will generally consider each named executive officer’s individual contributions towards reaching our annual corporate goals but does not typically establish specific individual goals for our named executive officers. There is no minimum bonus percentage or amount established for the named executive officers and, thus, the bonus amounts vary from year to year based on corporate and individual performance. For 2019,2022, Mr. Lubniewski was eligible to receive a target bonus of up to 75% of his base salary pursuant to the terms of his employment letter agreement described below. For 2022, Mr. McMeans was eligible to receive a target bonus of up to 55% of his base salary pursuant to the terms of his employment letter agreement described below. For 2019,2022, Mr. McMeansLawson was eligible to receive a target bonus of up to 45%50% of his base salary pursuant to the terms of his employment letter agreement described below. For 2019, Mr. Johnson was eligible to receive a target bonus of up to 55% of his base salary pursuant to the terms of his employment letter agreement described below through March 31, 2019 and 0% of his base salary thereafter, following his appointment by our Board of Directors to Executive Chairman.
The corporate goals established by our Board of Directors for 20192022 were based upon strategic commercialfinancial and financialstrategic goals. Specific goals included financial performancedirect revenue and cash, management, market and commercializationcustomer metrics and progress with companion diagnostic collaborations.strategic metrics related to technology development and Therapeutics. The financial and strategic goals were weighted at 70% towards overall corporate goal achievement20%, 15% and the commercial goals were weighted at 30%65%, respectively, towards overall corporate goal achievement. There was no minimum percentage of corporate goals that was required to be achieved to earn a bonus. No specific individual goals were established for any of our named executive officers for 2019.2022.
In January 2020,February 2023, our Board of Directors determined that the 20192022 corporate goals related to direct revenue and cash, customer metrics and strategic metrics related to technology development and Therapeutics had been achieved at an aggregate level of 40%.70%, to be allocated based on individual performance objectives. As a result, our Board of Directors awarded a bonusbonuses of $24,411$282,450, $148,225 and $60,375 to Mr. Johnson,Lubniewski, Mr. McMeans and Mr. Lawson, respectively, representing 40%the performance-adjusted percentage of hiseach executive’s target bonus of 55% of his base salary for the period over which he served as the Company’s Chief Executive Officer in 2019. It was further determined that Mr. Lubniewski and Mr. McMeans would forgo a 2019 performance-based bonus. In addition, it was determined that Mr. Lubniewski would be eligible to receive a target bonus of up to 75% of his base salary pursuant to the terms of his employment letter agreement for 2020.period.
Equity-Based Incentive Awards
Our equity-based incentive awards are designed to align our interests with those of our employees and consultants, including our named executive officers. Our Board of Directors or any authorized committee thereof is responsible for approving equity grants, which include to date, stock options and RSUs. Vesting of the stock option and RSU awards is tied to continuous service with us and serves as an additional retention measure. Our executives generally are awarded an initial stock option grant upon commencement of employment. Additional equity awards may occur periodically to specifically incentivize executives to achieve certain corporate goals or to reward executives for exceptional performance. As of December 31, 2019,2022, our named executive officers have been granted both stock option awards and RSUs.
Prior to the initial public offering, we granted all equity awards pursuant to the 2011 Plan and the 2001 Plan. All equity awards granted since our initial public offering have been granted pursuant to the 2014 Plan, the 2020 Plan and the 2021 Inducement Plan, the terms of which are described below under “—Equity Benefit Plans.” All stock options are granted with a per share exercise price equal to no less than the fair market value of a share of our common stock on the date of the grant and a term of such award.up to 10 years from the date of grant.
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Generally, our stock option and RSU awards vest over a one to four-year period subject to the holder’s continuous service to us andus. Should the Board of Directors deem it appropriate, stock option awards may be granted with an early exercise feature. Such early exercise feature allowswhich would allow the holder to exercise and receive unvested shares of our stock, so that the holder may have a greater opportunity for gains on the shares to be taxed at long-term capital gains rates rather than ordinary income rates. From time to time as our Board of Directors considers appropriate, we may grant stock options or RSUs that vest upon achievement of performance goals.
In 2022, Mr. Lubniewski, Mr. McMeans and Mr. Lawson received grants of options to purchase 10,000, 5,000, and 1,666 shares, respectively, of our common stock, vesting in equal quarterly installments over a two-year period, subject to each individual’s continued service with us through each vesting date.
401(k) Plan
We maintain a tax-qualified retirement plan that provides eligible employees with an opportunity to save for retirement on a tax advantaged basis. All participants’ interests in their deferrals are 100% vested when contributed. We made no matching contributions into the 401(k) plan for either of the years ended December 31, 2022 or 2021. Pre-tax contributions are allocated to each participant’s individual account and are then invested in selected investment alternatives according to the participants’ directions. The 401(k) plan is intended to qualify under Sections 401(a) and 501(a) of the Code. As a tax-qualified retirement plan, contributions to the 401(k) plan and earnings on those contributions are not taxable to the employees until distributed from the 401(k) plan, and all contributions are deductible by us when made.
Agreements with Named Executive Officers
We have entered into letter agreements with each of our named executive officers. The letter agreements generally provide for at-will employment and set forth the named executive officer’s initial base salary, eligibility for employee benefits, in some cases, and severance benefits upon a qualifying termination of employment. In addition, each of our named executive officers has executed a form of our standard confidential information and invention assignment agreement. The key terms of the letter agreements with our named executive officers are described below. Any potential payments and benefits due upon a qualifying termination of employment or a change in control are further described below under “– Potential Payments and Benefits upon Termination or Change in Control.”
Employment Letter Agreement with Mr. Lubniewski. We entered into an amended and restated letter agreement with Mr. Lubniewski in December 2014March 2019 that replaced his previous December 2014 letter agreement and became effective in May 2015.agreement. The agreement sets forth certain agreed upon terms and conditions of employment. Mr. Lubniewski was initially entitled to receive an annual base salary of $293,500,$460,000 (which has been increased, most recently in January 2022 to $538,000), an annual target performance bonus of up to 40%75% of his base salary as determined by the boardBoard of directors,Directors following analysis conducted by independent third-party consultants, and certain severance benefits, which were superseded and replaced by the terms of which areour Severance Plan, as further described below under “—Potential Payments and Benefits upon Termination or Change of Control.” Mr. Lubniewski’s base salary and target bonus percentage are subject to modification from time to time in the discretion of our Board of Directors or any authorized committee thereof.
Effective March 31, 2019, Mr. Lubniewski was appointed by our Board of Directors as our President and Chief Executive Officer. In connection with his appointment, we entered into an amended and restated employment agreement with Mr. Lubniewski. Pursuant to the agreement, Mr. Lubniewski’s salary was increased to $385,000 (which has been increased, most recently in August 2019 to $416,000), and he became eligible to receive an annual target performance bonus of up to 55% of his base salary (increased in January 2020 to 75% of base salary) as determined by our Board of Directors following analysis conducted by independent third-party consultants.
Employment Letter Agreement with Mr. McMeans. We entered into an amended and restated letter agreement with Mr. McMeans in July 2019 that replaced his previous December 2014 letter agreement. The agreement sets forth certain agreed upon terms and conditions of employment. Mr. McMeans was initially entitled to an annual base salary of $246,000$370,000 (which has been increased, most recently in August 2019January 2022 to $330,000)$385,000), an annual target performance bonus of up to 40%55% of his base salary (increased in August 2018 to 45% of base salary) as determined by the board of directors, and certain severance benefits, which were superseded and replaced by the terms of which areour Severance Plan, as further described below under “—Potential Payments and Benefits upon Termination or Change of Control.” Mr. McMeans’ and target bonus percentage are subject to modification from time to time in the discretion of our Board of Directors or any authorized committee thereof.
Employment Letter Agreement with Mr. Johnson. We entered into an amended and restated letter agreement with Mr. Johnson in December 2014 that replaced his previous letter agreement and became effective in May 2015. The agreement sets forth certain agreed upon terms and conditions of employment. Mr. Johnson was initially entitled to receive an annual base salary of $400,000 (increased in August 2018 to $450,000), an annual target performance bonus of up to 50% of his base salary (increased in August 2018 to 55% of base salary) as determined by our Board of Directors, and certain severance benefits. Mr. Johnson’s base salary and target bonus percentage are subject to modification from time to time in the discretion of our Board of Directors or any authorized committee thereof.
Effective March 31, 2019,Employment Letter Agreement with Mr. Johnson transitioned from the role of Chief Executive Officer to Executive Chairman. In connection with this transition, weLawson. We entered into an amended and restated employmentletter agreement with Mr. Johnson. Pursuant to theLawson in July 2019 that replaced his previous letter agreement that became effective in June 2017. The agreement sets forth certain agreed upon terms and conditions of employment. Mr. Johnson’s annual base salaryLawson was reduced to $100,000, he will no longer be eligibleinitially entitled to receive an annual base salary of $333,000 (which has been increased, most recently in January 2022 to $345,000), an annual target performance bonus of up to 50% of his base salary as determined by our Board of Directors, and certain severance benefits, which were superseded and replaced by the terms of our Severance Plan, as further described below under “—Potential Payments and Benefits upon Termination or Change of Control.” Mr. Lawson's base salary and target bonus percentage are subject to modification from time to time in the discretion of our Board of Directors or severance benefits.any authorized committee thereof.
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Potential Payments and Benefits upon Termination or Change of Control
UnderIn October 2020, our Compensation Committee adopted our Severance and Change in Control Plan, or the terms Mr. Lubniewski and Mr. McMeans’ amended and restated letter agreementsSeverance Plan, which provides for severance and/or change in control benefits to our named executive officers upon the executive’s termination without “cause,”(i) a “change in control termination” or resignation for “good reason,” each(ii) a “regular termination” (each as defined below, including any such termination that occurs in connection withdescribed below). Upon a change ofin control termination, each of our named executive officers is eligibleentitled to receive continued payment of his base salary paymentsfor a specified period of time (18 months for Mr. Lubniewski, 15 months for Mr. McMeans and 12 months for Mr. Lawson), payment of COBRA premium payments (together “severance benefits”)premiums for a period of time (up to 18 months for Mr. Lubniewski, 15 months for Mr. McMeans and 12 months for Mr. Lawson) and accelerated vesting of outstanding time-vesting equity awards. Upon a regular termination, each of our named executive officers is entitled to receive continued payment of his base salary for a specified period of time (12 months for Mr. Lubniewski, 12 months for Mr. McMeans and 9 months for Mr. Lawson) and payment of COBRA premiums for a period of time (up to 12 months for Mr. Lubniewski, 12 months for Mr. McMeans and 9 months for Mr. Lawson). Under hisAll severance benefits under the Severance Plan are subject to the executive’s execution of an effective release of claims against the Company. The Severance Plan superseded and replaced any change in control or severance benefit plans previously provided to our named executive officers, including any such benefits in their amended and restated letter agreement, Mr. Lubniewski is eligible to receive 12 months of severance benefits due to involuntary termination other than in connectionagreements with a change of control and 18 months for a change of control. Mr. McMeans is eligible to receive nine months of severance benefits due to involuntary termination other than in connection with a change in control and 12 months for a change of control. Upon amendment of his letter agreement upon transition to Executive Chairman in March 2019, Mr. Johnson is no longer eligible to receive ongoing benefits upon termination or change of control.us.
For purposes of the amendedSeverance Plan, a “regular termination” is an involuntary termination (i.e., a termination other than for cause (and not as a result of death or disability) or a resignation for good reason, as defined in the Severance Plan) that does not occur during the period of time beginning three months prior to, and restated letter agreements,ending 12 months following, a “change in control” (as defined in the 2020 Plan), or the “change in control period.” A “change in control termination” is a regular termination that occurs during the change in control period.
For purposes of the Severance Plan, “cause” generally means the occurrence of any of the following events, conditions or actions with respect to the executive: (1) conviction of any felony or crime involving fraud or dishonesty; (2) participation in any material fraud, material act of dishonesty or other material act of misconduct against us; (3) willful and habitual neglect of the executive’s duties after written notice and opportunity to cure; (4) material violation of any fiduciary duty or duty of loyalty owed to us; (5) breach of any material term of any material contract with us which has a material adverse effect on us; (6) knowing violation of any material company policy which has a material adverse effect on us; or (7) knowing violation of state or federal law in connection with the performance of the executive’s job which has a material adverse effect on us.
For purposes of each of the named executive officer’s amended and restated letter agreements,Severance Plan, “good reason” generally means the following events, conditions or actions takenundertaken by us with respect to the executive without cause and without the executive’s expressprior written consent: (1) a material reduction in base salary; (2) a material reduction in the executive’s authority, duties or responsibilities; (3) a material reduction in the authority, duties or responsibilities of the supervisor to whom the executive is required to report;report (which, with respect to Mr. Lubniewski, includes a change requiring him to report to a corporate officer or employee rather than directly to the Board of Directors); (4) a material breach by the Company of any provision of the Severance Plan or any other material agreement between the executive and the Company concerning the terms and conditions of the executive’s employment; or (5) a relocation of the executive’s principal place of employment to a place that increases the executive’s one-way commute by more than 50 miles.
Each of our named executive officers holds stock options and RSUs under our equity incentive plans that were granted subject to our form of stock option and RSU agreements. A description of the termination and change of control provisions in such equity incentive plans and stock options and RSUs granted thereunder is provided below under “– Equity Benefit Plans” and the specific vesting terms of each named executive officer’s stock options and RSUs are described below under “– Outstanding Equity Awards at Fiscal Year-End.”
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Outstanding Equity Awards at Fiscal Year-End
The following table presents information concerning equity awards held by our named executive officers as of December 31, 2019, granted under2022.
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| | | | | Option Awards | | Stock Awards | |
Name | | | Grant Date/Vesting Commencement Date | | Number of Securities Underlying Unexercised Options (#) Exercisable | | Number of Securities Underlying Unexercised Options (#) Unexercisable | | | | Option Exercise Price ($) | | | Option Expiration Date | | Number of Shares or Units of Stock That Have Not Vested (#) | | | Market Value of Shares or Units of Stock That Have Not Vested ($) | |
John L. Lubniewski | | | 2/01/2013 | | | 19 | | | — | | | | | 387.00 | | | 2/01/2023 | | | — | | | | — | |
| | | 8/06/2013 | | | 72 | | | — | | | | | 387.00 | | | 8/06/2023 | | | — | | | | — | |
| | | 3/20/2014 | | | 165 | | | — | | | | | 387.00 | | | 3/20/2024 | | | — | | | | — | |
| | | 12/29/2014 | | | 20 | | | — | | | | | 2,320.20 | | | 12/29/2024 | | | — | | | | — | |
| | | 2/16/2016 | | | 194 | | | — | | | | | 424.80 | | | 2/16/2026 | | | — | | | | — | |
| | | 2/13/2017 | | | 111 | | | — | | | | | 345.60 | | | 2/13/2027 | | | — | | | | — | |
| | | 8/16/2018 | | | 555 | | | — | | | | | 612.00 | | | 8/16/2028 | | | — | | | | — | |
| | | 5/23/2019 | | | 1,666 | | | — | | | | | 399.60 | | | 5/23/2029 | | | — | | | | — | |
| | | 8/15/2019 | | | 625 | | | — | | | | | 171.00 | | | 8/15/2029 | | | — | | | | — | |
| | | 1/23/2020 | | | 2,986 | | | — | | | | | 118.80 | | | 1/23/2030 | | | — | | | | — | |
| | (1) | 8/20/2020 | | | 4,028 | | | 2,638 | | | | | 86.40 | | | 8/20/2030 | | | — | | | | — | |
| | (2) | 8/18/2022 | | | 2,500 | | | 7,500 | | | | | 11.28 | | | 8/18/2032 | | | — | | | | — | |
Shaun D. McMeans | | | 2/01/2013 | | | 10 | | | — | | | | | 387.00 | | | 2/01/2023 | | | — | | | | — | |
| | | 8/06/2013 | | | 72 | | | — | | | | | 387.00 | | | 8/06/2023 | | | — | | | | — | |
| | | 3/20/2014 | | | 168 | | | — | | | | | 387.00 | | | 3/20/2024 | | | — | | | | — | |
| | | 12/29/2014 | | | 12 | | | — | | | | | 2,320.20 | | | 12/29/2024 | | | — | | | | — | |
| | | 2/16/2016 | | | 111 | | | — | | | | | 424.80 | | | 2/16/2026 | | | — | | | | — | |
| | | 2/13/2017 | | | 102 | | | — | | | | | 345.60 | | | 2/13/2027 | | | — | | | | — | |
| | | 8/16/2018 | | | 555 | | | — | | | | | 612.00 | | | 8/16/2028 | | | — | | | | — | |
| | | 8/15/2019 | | | 263 | | | — | | | | | 171.00 | | | 8/15/2029 | | | — | | | | — | |
| | | 1/23/2020 | | | 1,319 | | | — | | | | | 118.80 | | | 1/23/2030 | | | — | | | | — | |
| | (1) | 8/20/2020 | | | 1,678 | | | 1,099 | | | | | 86.40 | | | 8/20/2030 | | | — | | | | — | |
| | (2) | 8/18/2022 | | | 1,250 | | | 3,750 | | | | | 11.28 | | | 8/18/2032 | | | — | | | | — | |
Byron T. Lawson | | | 2/1/2013 | | | 1 | | | — | | | | | 387.00 | | | 2/1/2023 | | | — | | | | — | |
| | | 8/6/2013 | | | 10 | | | — | | | | | 387.00 | | | 8/6/2023 | | | — | | | | — | |
| | | 3/20/2014 | | | 29 | | | — | | | | | 387.00 | | | 3/20/2024 | | | — | | | | — | |
| | | 12/29/2014 | | | 10 | | | — | | | | | 2,320.20 | | | 12/29/2024 | | | — | | | | — | |
| | | 11/25/2015 | | | 55 | | | — | | | | | 914.40 | | | 11/25/2025 | | | — | | | | — | |
| | | 5/25/2016 | | | 27 | | | — | | | | | 509.40 | | | 5/25/2026 | | | — | | | | — | |
| | | 1/31/2017 | | | 55 | | | — | | | | | 315.00 | | | 1/31/2027 | | | — | | | | — | |
| | | 5/31/2017 | | | 27 | | | — | | | | | 622.80 | | | 5/31/2027 | | | — | | | | — | |
| | | 7/25/2017 | | | 41 | | | — | | | | | 430.20 | | | 7/25/2027 | | | — | | | | — | |
| | | 8/16/2018 | | | 166 | | | — | | | | | 612.00 | | | 8/16/2028 | | | — | | | | — | |
| | | 8/6/2019 | | | 361 | | | — | | | | | 248.40 | | | 8/6/2029 | | | — | | | | — | |
| | | 9/12/2019 | | | 194 | | | — | | | | | 144.00 | | | 9/12/2029 | | | — | | | | — | |
| | | 1/7/2020 | | | 388 | | | — | | | | | 135.00 | | | 1/7/2030 | | | — | | | | — | |
| | (1) | 8/20/2020 | | | 907 | | | 593 | | | | | 86.40 | | | 8/20/2030 | | | — | | | | — | |
| | (2) | 8/18/2022 | | | 416 | | | 1,250 | | | | | 11.28 | | | 8/18/2032 | | | — | | | | — | |
(1)Stock options vest over four years as follows: 1/48th of the 2001 Plan,outstanding shares vest at the 2011 Plan andend of each calendar month over a period of approximately four years, subject to the 2014 Plan.individual’s continued service with us through each vesting date.
(2)Stock options vest in equal quarterly installments over a two-year period, subject to the individual’s continued service with us through each vesting date.
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| | | | | Option Awards | | Stock Awards | |
Name | | | Grant Date/Vesting Commencement Date | | Number of Securities Underlying Unexercised Options (#) Exercisable | | | Number of Securities Underlying Unexercised Options (#) Unexercisable | | | Option Exercise Price ($) | | | Option Expiration Date | | Number of Shares or Units of Stock That Have Not Vested (#) | | | Market Value of Shares or Units of Stock That Have Not Vested ($) | |
John L. Lubniewski | | | 4/26/2011 | | | 13,036 | | | | — | | | | 2.15 | | | 4/26/2021 | | | — | | | | — | |
| | | 3/08/2012 | | | 2,793 | | | | — | | | | 2.15 | | | 3/08/2022 | | | — | | | | — | |
| | | 2/01/2013 | | | 3,503 | | | | — | | | | 2.15 | | | 2/01/2023 | | | — | | | | — | |
| | | 8/06/2013 | | | 13,036 | | | | — | | | | 2.15 | | | 8/06/2023 | | | — | | | | — | |
| | | 3/20/2014 | | | 29,818 | | | | — | | | | 2.15 | | | 3/20/2024 | | | — | | | | — | |
| | | 12/29/2014 | | | 3,724 | | | | — | | | | 12.89 | | | 12/29/2024 | | | — | | | | — | |
| | | 2/16/2016 | | | 35,000 | | | | — | | | | 2.36 | | | 2/15/2026 | | | — | | | | — | |
| | | 2/13/17 | | | 20,000 | | | | — | | | | 1.92 | | | 2/13/2027 | | | — | | | | — | |
| | (1) | 8/16/18 | | | 37,500 | | | | 62,500 | | | | 3.40 | | | 8/16/28 | | | — | | | | — | |
| | (2) | 5/23/19 | | | 87,500 | | | | 212,500 | | | | 2.22 | | | 5/23/29 | | | — | | | | — | |
| | (3) | 8/15/19 | | | 18,760 | | | | 93,740 | | | | 0.95 | | | 8/15/29 | | | — | | | | — | |
| | (4) | 8/16/18 | | | — | | | | — | | | | | | | | | | 31,250 | | | | 106,250 | |
Shaun D. McMeans | | | 3/08/2012 | | | 8,380 | | | | — | | | | 2.15 | | | 3/08/2022 | | | — | | | | — | |
| | | 2/01/2013 | | | 1,854 | | | | — | | | | 2.15 | | | 2/01/2023 | | | — | | | | — | |
| | | 8/06/2013 | | | 13,036 | | | | — | | | | 2.15 | | | 8/06/2023 | | | — | | | | — | |
| | | 3/20/2014 | | | 30,308 | | | | — | | | | 2.15 | | | 3/20/2024 | | | — | | | | — | |
| | | 12/29/2014 | | | 2,327 | | | | — | | | | 12.89 | | | 12/29/2024 | | | — | | | | — | |
| | | 2/16/2016 | | | 20,000 | | | | — | | | | 2.36 | | | 2/15/2026 | | | — | | | | — | |
| | | 2/13/2017 | | | 18,500 | | | | — | | | | 1.92 | | | 2/13/2027 | | | — | | | | — | |
| | (1) | 8/16/18 | | | 37,500 | | | | 62,500 | | | | 3.40 | | | 8/16/28 | | | — | | | | — | |
| | (3) | 8/15/19 | | | 7,920 | | | | 39,580 | | | | 0.95 | | | 8/15/29 | | | — | | | | — | |
| | (4) | 8/16/18 | | | — | | | | — | | | | | | | | | | 15,622 | | | | 53,115 | |
Timothy B. Johnson | | | 3/01/2010 | | | 6,983 | | | | — | | | | 4.30 | | | 3/01/2020 | | | — | | | | — | |
| | | 4/13/2010 | | | 675 | | | | — | | | | 4.30 | | | 4/13/2020 | | | — | | | | — | |
| | | 10/21/2010 | | | 581 | | | | — | | | | 4.30 | | | 10/21/2020 | | | — | | | | — | |
| | | 1/20/2011 | | | 675 | | | | — | | | | 4.30 | | | 1/20/2021 | | | — | | | | — | |
| | | 4/26/2011 | | | 29,797 | | | | — | | | | 2.15 | | | 4/26/2021 | | | — | | | | — | |
| | | 2/01/2013 | | | 18,328 | | | | — | | | | 2.15 | | | 2/01/2023 | | | — | | | | — | |
| | | 8/06/2013 | | | 9,311 | | | | — | | | | 2.15 | | | 8/06/2023 | | | — | | | | — | |
| | | 3/20/2014 | | | 43,267 | | | | — | | | | 2.15 | | | 3/20/2024 | | | — | | | | — | |
| | | 12/29/2014 | | | 9,311 | | | | — | | | | 12.89 | | | 12/29/2024 | | | — | | | | — | |
| | | 2/16/2016 | | | 105,000 | | | | — | | | | 2.36 | | | 2/15/2026 | | | — | | | | — | |
| | | 2/13/2017 | | | 19,000 | | | | — | | | | 1.92 | | | 2/13/2027 | | | — | | | | — | |
| | (1) | 8/16/18 | | | 56,250 | | | | 93,750 | | | | 3.40 | | | 8/16/28 | | | — | | | | — | |
| | (5) | 9/13/19 | | | — | | | | 15,000 | | | | 0.78 | | | 9/13/29 | | | — | | | | — | |
| | (1) | 11/14/19 | | | 4,376 | | | | 30,624 | | | | 0.68 | | | 11/14/29 | | | — | | | | — | |
| | (4) | 8/16/18 | | | — | | | | — | | | | | | | | | | 46,872 | | | | 159,365 | |
(1)
| Stock options vest over four years as follows: 1/16th of the outstanding shares vest at the end of each calendar quarter over a period of approximately four years, subject to the individual’s continued service with us through each vesting date.
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(2)
| Stock options vest at the end of each month beginning June 30, 2019, with 50% vesting in the first year and 25% vesting in each of years 2 and 3, subject to the individual’s continued service with us through each vesting date.
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(3)
| Stock options vest in equal monthly installments over a two-year period, subject to the individual’s continued service with us through each vesting date.
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(4)
| RSUs vest over four years as follows: 1/16th of the award vests at the end of each calendar quarter over a period of approximately four years, subject to the individual’s continued service with us through each vesting date.
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(5)
| Stock options vest on the earliest to occur of (i) August 14, 2020 and (ii) the 2020 annual stockholder meeting, subject to the individual’s continued service with us through this vesting date.
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Equity Benefit Plans
2014 Equity Incentive2021 Inducement Plan
OurIn July 2021, the Company’s Board of Directors adopted the 2014Company’s 2021 Inducement Plan in December 2014 and our stockholders approved the 2014 Plan in April 2015. The 2014 Plan became effective on May 5, 2015 in connection with our initial public offering.
Stock Awards. The 2014 Plan provides for the grant of incentive stock options (“ISOs”(the “2021 Inducement Plan”), nonstatutory stock options (“NSOs”), stock appreciation rights, restricted stock awards, restricted stock unit awards, performance-based stock awards, and other forms of equity compensation (collectively “stock awards”), all of which may be granted to employees, including officers, non-employee directors and consultants of us and our affiliates. Additionally, the 2014 Plan provides for the grant of performance cash awards. ISOs may be granted only to employees. All other awards may be granted to employees, including officers, and to non-employee directors and consultants.
Share Reserve. Initially, the aggregate number of shares of our common stock that may be issued pursuant to stock awards under the 2014 Plan was the sum of (1) 925,616which 25,000 shares plus (2) the number of shares (not to exceed 608,819 shares) (i)were initially authorized and reserved for issuance under our 2011 Plan at the time the 2014 Plan became effective, and (ii) any shares subject to outstanding stock options or other stock awards that were granted under our 2011 Plan or 2001 Plan that, on or after the effective date of the 2014 Plan, are forfeited, terminate, expire or are otherwise not issued. Additionally, the number of shares of our common stock reserved for issuance under the 2014 Plan automatically increases on January 1 of each year, beginning on January 1, 2016 and continuing through and including January 1, 2024, by 4% of the total number of shares of our capital stock outstanding on December 31 of the preceding calendar year, or a lesser number of shares determined by our Board of Directors. The maximum number of shares of our common stock that may be issued upon the exercise of ISOs under the 2014 Plan is 1,800,000 shares.
No person may be granted stock awards covering more than 200,000 shares of our common stock under the 2014 Plan during any calendar year pursuant to stock options, stock appreciation rights and other stock awards whose value is determined by reference to an increase over an exercise or strike price of at least 100% of the fair market value on the date the stock award is granted. Additionally, no person may be granted in a calendar year a performance stock award covering more than 200,000 shares of our common stock or a performance cash award having a maximum value in excess of $2,000,000. Such limitations were designed to help assure that any deductions to which we would otherwise be entitled with respect to such awards would not be subject to the $1,000,000 limitation on the income tax deductibility of compensation paid to any covered executive officer imposed by Section 162(m) of the Code. The exemption from the deduction limit under Section 162(m) of the Code for “performance-based compensation” has been repealed, effective for taxable years beginning after December 31, 2017.
If a stock award granted under the 2014 Plan expires or otherwise terminates without being exercised in full, or is settled in cash, the shares of our common stock not acquired pursuant to the stock award again will become available for subsequent issuance under the 2014 Plan. In addition, the following types of shares of our common stock under the 2014 Plan may become available for the grant of new stock awards under the 2014 Plan: (1) shares that are forfeited to or repurchased by us prior to becoming fully vested; (2) shares withheld to satisfy income or employment withholding taxes; or (3) shares used to pay the exercise or purchase price of a stock award. Shares issued under the 2014 Plan may be previously unissued shares or reacquired shares bought by us on the open market.
In March 2019, 200,000 shares were reserved for issuance under the 2014 Plan pursuant to an amendment approved by our Board of Directors pursuant to Rule 5635(c)(4) of the Nasdaq Listing Rules, to be used exclusively for the grant of awards to individuals who were not previously employees or non-employee directors of the Company, as inducement material to the individuals’ entering into employment with the Company (“Inducement Awards”). There were 13,961 shares of the Company’s stock available for issuance under the 2021 Inducement Plan as of December 31, 2022, in addition to shares that may become available from time to time as shares of the Company’s common stock subject to outstanding awards granted under the 2021 Inducement Plan are forfeited back to or repurchased by the Company because of the failure to meet a contingency or condition required for the vesting of such shares.
Stock Awards. The 2021 Inducement Plan provides for the grant of nonstatutory stock options (“NSOs”), stock appreciation rights, restricted stock awards, restricted stock unit awards, performance awards and other awards.
Share Reserve. Subject to adjustment for certain changes in our capitalization, the aggregate number of shares of our common stock that may be issued under the 2021 Inducement Plan will not exceed 25,000 shares.
If any shares of our common stock issued pursuant to an award granted under the 2021 Inducement Plan are forfeited back to or redeemed or repurchased by us because of the failure to meet a contingency or condition required for the vesting of such shares, then such shares will become available again for issuance under the 2021 Inducement Plan.
The following shares of our common stock will not become available again for issuance under the 2021 Inducement Plan: (i) any shares repurchased by us on the open market with the proceeds of the exercise or strike price of an award granted under the 2021 Inducement Plan or a Prior Plan Award; and (ii) in the event that a stock appreciation right granted under the 2021 Inducement Plan or a stock appreciation right that is a Prior Plan Award is settled in shares, the gross number of shares subject to such award.
Eligibility.Awards may only be granted to persons who are Eligible Employees described in Section 1(a) of the Plan, where the Award is an inducement material to the individual’s entering into employment with the Company or an Affiliate within the meaning of Rule 5635(c)(4) of the Nasdaq Marketplace Rules or is otherwise permitted pursuant to Rule 5635(c) of the Nasdaq Marketplace Rules.
Administration. The 2021 Inducement Plan will be administered by our Board of Directors, which may in turn delegate some or all of the administration of the 2021 Inducement Plan to a committee or committees composed of members of the board of directors. Our Board of Directors has delegated concurrent authority to administer the 2021 Inducement Plan to our Compensation Committee, but may, at any time, revest in itself some or all of the power delegated to our Compensation Committee. We refer to the plan administrator as the “Plan Administrator” herein.
2020 Equity Incentive Plan
In August 2020, the Company’s stockholders, upon the recommendation of the Company’s Board of Directors, approved the 2020 Equity Incentive Plan (the “2020 Plan”) as a successor to and continuation of the 2014 Plan. As of December 31, 2019,2022, option awards covering an aggregate of 2,904,89854,042 shares of our common stock including 80,000under the 2020 Plan were outstanding.
Stock Awards. The 2020 Plan provides for the grant of incentive stock options (“ISOs”), nonstatutory stock options (“NSOs”), stock appreciation rights, restricted stock awards, restricted stock unit awards, performance awards and other awards.
Share Reserve. Subject to adjustment for certain changes in our capitalization, the aggregate number of shares of our common stock that may be issued under the 2020 Plan will not exceed 62,057 shares, which number is the sum of (i) the number of shares remaining available for the grant of new awards under the 2014 Plan (excluding shares available for the grant of inducement awards under the 2014 Plan’s inducement share pool) as of immediately prior to the effective date of the 2020 Plan; (ii) 56,344 new shares; and an additional 223,745 RSU(iii) the number of the Prior Plan Returning Shares (as defined below), if any, as such shares become available from time to time.
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The “Prior Plan Returning Shares” are shares of our common stock subject to outstanding awards have been granted under the 2014 Plan and were outstanding.
Administration. Our Board(excluding shares available for the granting of Directors, or a duly authorized committee thereof, has the authority to administerinducement awards under the 2014 Plan. Our BoardPlan), the 2011 Plan or 2001 Plan (together, the “Prior Plans,” and each such award, a “Prior Plan Award”) that, following the effective date of Directors may also delegatethe 2020 Plan: (i) are not issued because such award or any portion thereof expires or otherwise terminates without all of the shares covered by such award having been issued; (ii) are not issued because such award or any portion thereof is settled in cash; or (iii) are forfeited back to one or morerepurchased by us because of the failure to meet a contingency or condition required for the vesting of such shares. The number of shares of our officerscommon stock available for issuance under the authority2020 Plan will be reduced or increased by (i) one share for each share of common stock issued pursuant to (1) designate employees (other than other officers)an Appreciation Award (as defined in the 2020 Plan), and (ii) 1.5 shares for each share of common stock issued pursuant to be recipientsa Full Value Award (as defined in the 2020 Plan). The following actions will not result in an issuance of certainshares of our common stock awards,under the 2020 Plan and (2) determineaccordingly will not reduce the number of shares of our common stock available for issuance under the 2020 Plan: (i) the expiration or termination of any portion of an award granted under the 2020 Plan without the shares covered by such portion of the award having been issued; or (ii) the settlement of any portion of an award granted under the 2020 Plan in cash.
If any shares of our common stock issued pursuant to bean award granted under the 2020 Plan are forfeited back to or redeemed or repurchased by us because of the failure to meet a contingency or condition required for the vesting of such shares, then such shares will become available again for issuance under the 2020 Plan.
The following shares of our common stock will not become available again for issuance under the 2020 Plan: (i) any shares that are reacquired or withheld (or not issued) by us to satisfy the exercise or strike price of an award granted under the 2020 Plan or a Prior Plan Award (including any shares subject to such award that are not delivered because such award is exercised through a reduction of shares subject to such award); (ii) any shares that are reacquired or withheld (or not issued) by us to satisfy a tax withholding obligation in connection with an award granted under the 2020 Plan or a Prior Plan Award; (iii) any shares repurchased by us on the open market with the proceeds of the exercise or strike price of an award granted under the 2020 Plan or a Prior Plan Award; and (iv) in the event that a stock awards. appreciation right granted under the 2020 Plan or a stock appreciation right that is a Prior Plan Award is settled in shares, the gross number of shares subject to such award.
Eligibility. All of our (including our affiliates’) employees, non-employee directors and consultants are eligible to participate in the 2020 Plan and may receive all types of awards other than incentive stock options. Incentive stock options may be granted under the 2020 Plan only to our (including our affiliates’) employees.
Administration. The 2020 Plan will be administered by our Board of Directors, which may in turn delegate some or all of the administration of the 2020 Plan to a committee or committees composed of members of the board of directors. Our Board of Directors has delegated concurrent authority to administer the 2020 Plan to our Compensation Committee, but may, at any time, revest in itself some or all of the power delegated to our Compensation Committee. We refer to the plan administrator as the “Plan Administrator” herein.
Subject to the terms of the 20142020 Plan, our Board of Directors or the authorized committee, referred to herein asPlan Administrator may determine the plan administrator, determines recipients, dates of grant, the numbers and types of stock awards to be granted, the number of shares of our common stock subject to or the cash value of awards, and the terms and conditions of awards granted under the stock awards,2020 Plan, including the period of their exercisability and vesting. The Plan Administrator has the authority to provide for accelerated exercisability and vesting schedule and change of control provision applicable to a stock award, if any.awards. Subject to the limitations set forth below, the plan administrator willPlan Administrator also determinedetermines the fair market value applicable to an award and the exercise price,or strike price of stock options and stock appreciation rights granted under the 2020 Plan.
In addition, the Plan Administrator may delegate to one or purchasemore executive officers the authority to designate employees who are not executive officers to be recipients of certain awards and the number of shares of our common stock subject to such awards. Under any such delegation, the Plan Administrator will specify the total number of shares of our common stock that may be subject to the awards granted by such executive officer. The executive officer may not grant an award to himself or herself.
Repricing; Cancellation and Re-Grant of Stock Options or Stock Appreciation Rights. Under the 2020 Plan, unless our stockholders have approved such an action within 12 months prior to such an event, the Plan Administrator does not have the authority to reprice any outstanding stock option or stock appreciation right by (1) reducing the exercise or strike price of the stock option or stock appreciation right, or (2) canceling any outstanding stock option or stock appreciation right that has an exercise or strike price greater than the then-current fair market value of our common stock in exchange for cash or other awards.
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Limit on Non-Employee Director Compensation. Pursuant to the 2020 Plan, the aggregate value of all compensation granted or paid, as applicable, by the Company to any individual for service as a non-employee director with respect to any period commencing on the date of the annual meeting of stockholders for a particular year and ending on the day immediately prior to the date of the annual meeting of stockholders for the next subsequent year (the “Annual Period”), including awards granted and cash fees paid by the typesCompany to such non-employee director, will not exceed (i) $400,000 in total value or (ii) in the event such non-employee director is first appointed or elected to the Board of consideration toDirectors during such Annual Period, $600,000 in total value, in each case calculating the value of any equity awards based on the grant date fair value of such equity awards for financial reporting purposes.
Dividends and Dividend Equivalents. The 2020 Plan provides that dividends or dividend equivalents may be paid foror credited with respect to any shares of our common stock subject to an award other than an option or stock appreciation right, as determined by the award.
The plan administrator hasPlan Administrator and contained in the authorityapplicable award agreement; provided, however, that (i) no dividends or dividend equivalents may be paid with respect to modify outstanding awardsany such shares before the date such shares have vested, (ii) any dividends or dividend equivalents that are credited with respect to any such shares will be subject to all of the terms and conditions applicable to such shares under the 2014 Plan. Subject to the terms of the 2014applicable award agreement (including any vesting conditions), and (iii) any dividends or dividend equivalents that are credited with respect to any such shares will be forfeited to us on the date such shares are forfeited to or repurchased by us due to a failure to vest.
Stock Options. Stock options may be granted under the 2020 Plan the plan administrator has the authority to reduce the exercise, purchase or strike price of any outstanding stock award, cancel any outstanding stock award in exchange for new stock awards, cash or other consideration, or take any other action that is treated as a repricing under generally accepted accounting principles, with the consent of any adversely affected participant.
Stock Options. ISOs and NSOs are granted pursuant to stock option agreements adopted byagreements. The 2020 Plan permits the plan administrator. The plan administrator determines the exercise price for agrant of stock option, within the termsoptions that are intended to qualify as ISOs and conditions of the 2014 Plan, provided that theNSOs.
The exercise price of a stock option generally cannotgranted under the 2020 Plan may not be less than 100% of the fair market value of ourthe common stock subject to the stock option on the date of grant.grant and, in some cases (see “-Limitations on Incentive Stock options granted under the 2014 Plan vest at the rate specified by the plan administrator.Options” below), may not be less than 110% of such fair market value.
The plan administrator determines the term of stock options granted under the 20142020 Plan up tomay not exceed ten years from the date of grant and, in some cases (see “-Limitations on Incentive Stock Options” below), may not exceed five years from the date of grant. Except as otherwise provided in a maximum of ten years. Unless the terms of an optionholder’sparticipant’s stock option agreement provide otherwise,or other written agreement with us or one of our affiliates, if an optionholder’sa participant’s service relationship with us or any of our affiliates ceases(“continuous service” as defined in the 2020 Plan) terminates (other than for any reason other than disability,cause (as defined in the 2020 Plan) or the participant’s death or cause, the optionholder may generally exercise any vested options for a period of three months following the cessation of service. The option term may be extendeddisability (as defined in the event that exercise of2020 Plan)), the option following such a termination of service is prohibited by applicable securities laws or our insider trading policy. If an optionholder’s service relationship with us or any of our affiliates ceases due to disability or death, or an optionholder dies within a certain period following cessation of service, the optionholder or a beneficiaryparticipant may generally exercise any vested stock options for up to three months following the participant’s termination of continuous service. Except as otherwise provided in a periodparticipant’s stock option agreement or other written agreement with us or one of our affiliates, if a participant’s continuous service terminates due to the participant’s disability, the participant may exercise any vested stock options for up to 12 months following the participant’s termination due to the participant’s disability. Except as otherwise provided in a participant’s stock option agreement or other written agreement with us or one of our affiliates, if a participant’s continuous service terminates due to the eventparticipant’s death (or the participant dies within a specified period following termination of disability andcontinuous service), the participant’s beneficiary may exercise any vested stock options for up to 18 months following the participant’s death. Except as explicitly provided otherwise in a participant’s stock option agreement or other written agreement with us or one of our affiliates, if a participant’s continuous service is terminated for cause, all stock options held by the eventparticipant will terminate upon the participant’s termination of death. Incontinuous service and the eventparticipant will be prohibited from exercising any stock option from and after such termination date. Except as otherwise provided in a participant’s stock option agreement or other written agreement with us or one of our affiliates, the term of a terminationstock option may be extended if a participant’s continuous service terminates for any reason other than for cause stock options generally terminate immediately uponand, at any time during the terminationapplicable post-termination exercise period, the exercise of the individual for cause.stock option would be prohibited by applicable laws or the sale of any common stock received upon such exercise would violate our insider trading policy. In no event, however, may ana stock option be exercised beyond theafter its original expiration of its term.date.
Acceptable forms of consideration for the purchase of our common stock issued uponpursuant to the exercise of a stock option under the 2020 Plan will be determined by the plan administratorPlan Administrator and may include (1)payment: (i) by cash, check, bank draft or money order (2)payable to us; (ii) pursuant to a broker-assisted cashless exercise, (3)program developed under Regulation T as promulgated by the tenderFederal Reserve Board; (iii) by delivery to us of shares of our common stock previously owned(either by the optionholder, (4)actual delivery or attestation); (iv) by a net exercise of the option if it is an NSO, and (5)arrangement (for NSOs only); or (v) in other legal consideration approved by the plan administrator.Plan Administrator.
UnlessStock options granted under the plan administrator provides otherwise,2020 Plan may become exercisable in cumulative increments, or “vest,” as determined by the Plan Administrator at the rate specified in the stock option agreement. Shares covered by different stock options generally aregranted under the 2020 Plan may be subject to different vesting schedules as the Plan Administrator may determine.
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The Plan Administrator may impose limitations on the transferability of stock options granted under the 2020 Plan in its discretion. Generally, a participant may not transferable excepttransfer a stock option granted under the 2020 Plan other than by will or the laws of descent and distribution or, subject to approval by the Plan Administrator, pursuant to a domestic relations order. An optionholderHowever, the Plan Administrator may designatepermit transfer of a beneficiary, however, whostock option in a manner that is not prohibited by applicable tax and securities laws. Options may exercise the option following the optionholder’s death.not be transferred to a third-party financial institution for value.
Tax Limitations on Incentive Stock Options. TheOptions. In accordance with current federal tax laws, the aggregate fair market value, determined at the time of grant, of shares of our common stock with respect to ISOs that are exercisable for the first time by an optionholdera participant during any calendar year under all of our stock plans may not exceed $100,000. StockThe stock options or portions thereofof stock options that exceed suchthis limit will generally beor otherwise fail to qualify as ISOs are treated as NSOs. No ISO may be granted to any person who, at the time of the grant, owns or is deemed to own stock possessing more than 10% of our total combined voting power or that of any of our affiliates unless (1) the optionfollowing conditions are satisfied:
•the exercise price isof the ISO must be at least 110% of the fair market value of the common stock subject to the optionISO on the date of grant,grant; and (2)
•the term of the ISO doesmust not exceed five years from the date of grant.
Subject to adjustment for certain changes in our capitalization, the aggregate maximum number of shares of our common stock that may be issued pursuant to the exercise of ISOs under the 2020 Plan is 124,591 shares.
Stock Appreciation Rights. Stock appreciation rights may be granted under the 2020 Plan pursuant to stock appreciation right agreements. Each stock appreciation right is denominated in common stock share equivalents. The strike price of each stock appreciation right will be determined by the Plan Administrator but will in no event be less than 100% of the fair market value of the common stock subject to the stock appreciation right on the date of grant. The term of stock appreciation rights granted under the 2020 Plan may not exceed ten years from the date of grant. The Plan Administrator may also impose restrictions or conditions upon the vesting of stock appreciation rights that it deems appropriate. The appreciation distribution payable upon exercise of a stock appreciation right may be paid in shares of our common stock, in cash, in a combination of cash and stock, or in any other form of consideration determined by the Plan Administrator and set forth in the stock appreciation right agreement. Stock appreciation rights will be subject to the same conditions upon termination of continuous service and restrictions on transfer as stock options under the 2020 Plan.
Restricted Stock Awards. Awards. Restricted stock awards may be granted under the 2020 Plan pursuant to restricted stock award agreements adopted by the plan administrator. Restrictedagreements. A restricted stock awardsaward may be granted in consideration for (1) cash, check, bank draft or money order (2) services renderedpayable to us, the participant’s services performed for us, or our affiliates, or (3) any other form of legal consideration. Commonconsideration acceptable to the Plan Administrator. Shares of our common stock acquired under a restricted stock award may but need not, be subject to a shareforfeiture to or repurchase option in our favorby us in accordance with a vesting schedule to be determined by the plan administrator. APlan Administrator. Rights to acquire shares of our common stock under a restricted stock award may be transferred only upon such terms and conditions as are set by the plan administrator. Except as otherwise providedforth in the applicable award agreement, restricted stock awards that have not vested may be forfeited or repurchased by us upon theaward agreement. Upon a participant’s cessationtermination of continuous service for any reason.reason, any shares subject to restricted stock awards held by the participant that have not vested as of such termination date may be forfeited to or repurchased by us.
Restricted Stock Unit Awards. Awards. Restricted stock unit awards aremay be granted under the 2020 Plan pursuant to restricted stock unit award agreements adopted by the plan administrator. RSUsagreements. Payment of any purchase price may be grantedmade in consideration for any form of legal consideration. An RSUconsideration acceptable to the Plan Administrator. A restricted stock unit award may be settled by cash,the delivery of shares of our common stock, in cash, in a combination of cash and stock, as deemed appropriate by the plan administrator, or in any other form of consideration determined by the Plan Administrator and set forth in the restricted stock unit award agreement. RSUs typically vest and underlying shares of commonRestricted stock are delivered as outlined in the applicable RSU agreements following the grantee’s satisfaction of minimum statutory employee tax withholding requirements, where applicable. Employee RSU agreements generally provide that vesting is accelerated only in certain circumstances, that delivery of the underlying shares of common stock is conditioned on the grantee’s satisfying certain vesting conditions outlined in the award, and that the grantee’s employment continue with the Company through the vesting date. Additionally, dividend equivalentsunit awards may be creditedsubject to vesting in respect of shares coveredaccordance with a vesting schedule to be determined by an RSU award.the Plan Administrator. Except as otherwise provided in the applicablea participant’s restricted stock unit award agreement RSUsor other written agreement with us, restricted stock units that have not vested will be forfeited upon the participant’s cessationtermination of continuous service for any reason.
Stock Appreciation Rights. Stock appreciation rights are granted pursuantPerformance Awards. The 2020 Plan allows us to stock appreciation grant agreements adopted byperformance awards. A performance award is an award that may vest or may be exercised, or that may become earned and paid, contingent upon the plan administrator. The plan administrator determinesattainment of certain performance goals during a performance period. A performance award may require the strike price for a stock appreciation right, which generally cannot be less than 100% of the fair market value of our common stock on the date of grant. Upon the exercisecompletion of a stock appreciation right, wespecified period of continuous service. The length of any performance period, the performance goals to be achieved during the performance period, and the measure of whether and to what degree such performance goals have been attained will pay the participant an amount equal to the product of (1) the excess of the per share fair market value of our common stock on the date of exercise overthe strike price, multiplied by (2) the number of shares of common stock with respect to which the stock appreciation right is exercised. A stock appreciation right granted under the 2014 Plan vests at the rate specified in the stock appreciation right agreement asbe determined by the plan administrator.
The plan administrator determines the term of stock appreciation rights granted under the 2014 Plan up to a maximum of ten years. Unless the terms of a participant’s stock appreciation right agreement provide otherwise, if a participant’s service relationship with us or any of our affiliates ceases for any reason other than cause, disability or death, the participant may generally exercise any vested stock appreciation right for a period of three months following the cessation of service. The stock appreciation right term may be further extendedAdministrator in the event that exercise of the stock appreciation right following such a termination of service is prohibited by applicable securities laws. If a participant’s service relationship with us, or any of our affiliates, ceases due to disability or death, or a participant dies within a certain period following cessation of service, the participant or a beneficiary may generally exercise any vested stock appreciation right for a period of 12 months in the event of disability and 18 months in the event of death.its discretion. In the event of a termination for cause, stock appreciation rights generally terminate immediately upon the occurrence of the event giving rise to the termination of the individual for cause. In no event may a stock appreciation right be exercised beyond the expiration of its term.
Performance Awards. The 2014 Plan permits the grant of performance-based stock and cash awards that, prior to the repeal of the exemption from the deduction limit under Section 162(m) of the Code for “performance-based compensation,” could qualify as performance-based compensation that is not subject to the $1,000,000 limitation on the income tax deductibility of compensation paid to a covered executive officer imposed by Section 162(m) of the Code.
The performance goals that may be selected include one or more of the following: (1) earnings (including earnings per share and net earnings); (2) earnings before interest, taxes and depreciation; (3) earnings before interest, taxes, depreciation and amortization; (4) earnings before interest, taxes, depreciation, amortization and legal settlements; (5) earnings before interest, taxes, depreciation, amortization, legal settlements and other income (expense); (6) earnings before interest, taxes, depreciation, amortization, legal settlements, other income (expense) and stock-based compensation; (7) earnings before interest, taxes, depreciation, amortization, legal settlements, other income (expense), stock-based compensation and changes in deferred revenue; (8) earnings before interest, taxes, depreciation, amortization, legal settlements, other income (expense), stock-based compensation, other non-cash expenses and changes in deferred revenue; (9) total stockholder return; (10) return on equity or average stockholder’s equity; (11) return on assets, investment, or capital employed; (12) stock price; (13) margin; (14) income (before or after taxes); (15) operating income; (16) operating income after taxes; (17) pre-tax profit; (18) operating cash flow; (19) sales or revenue targets; (20) increases in revenue or product revenue; (21) expenses and cost reduction goals; (22) improvement in or attainment of working capital levels; (23) economic value added (or an equivalent metric); (24) market share; (25) cash flow; (26) cash flow per share; (27) cash balance; (28) cash burn; (29) cash collections; (30) share price performance; (31) debt reduction; (32) implementation or completion of projects or processes (including, without limitation, clinical study initiation, clinical study enrollment and dates, clinical study results, regulatory filing submissions, regulatory filing acceptances, regulatory or advisory committee interactions, regulatory approvals, and product supply); (33) stockholders’ equity; (34) capital expenditures; (35) debt levels; (36) operating profit or net operating profit; (37) workforce diversity; (38) growth of net income or operating income; (39) billings; (40) bookings; (41) employee retention; (42) initiation of studies by specific dates; (43) budget management; (44) submission to, or approval by, a regulatory body (including, but not limited to the FDA) of an applicable filing or a product; (45) regulatory milestones; (46) progress of internal research or development programs; (47) acquisition of new customers; (48) customer retention and/or repeat order rate; (49) improvements in sample and test processing times; (50) progress of partnered programs; (51) partner satisfaction; (52) timely completion of clinical studies; (53) submission of 510(k)s or premarket approvals and other regulatory achievements; (54) milestones related to samples received and/or tests or panels run; (55) expansion of sales in additional geographies or markets; (56) research progress, including the development of programs; (57) strategic partnerships or transactions (including in-licensing and out-licensing of intellectual property); and (58)addition, to the extent permitted by applicable law and the applicable award agreement, the Plan Administrator may determine that an award is not intendedcash may be used in payment of performance awards.
Performance goals under the 2020 Plan will be established by the board of directors for a performance period. The performance criteria used to comply with Section 162(m) of the Code, other measuresestablish such goals may be based on any measure of performance selected by our Boardthe board of Directors.directors.
The performance90
Performance goals may be based on a company-wideCompany-wide basis, with respect to one or more business units, divisions, affiliates or business segments, and in either absolute terms or relative to the performance of one or more comparable companies or the performance of one or more relevant indices. Unless specified otherwise by the Plan Administrator (i) in the award agreement at the time the award is granted or (ii) in such other document setting forth the performance goals at the time the performance goals are established, wethe Plan Administrator will appropriately make adjustments in the method of calculating the attainment of the performance goals for a performance period as follows: (1) to exclude restructuring and/or other nonrecurring charges; (2) to exclude exchange rate effects; (3) to exclude the effects of changes to generally accepted accounting principles; (4) to exclude the effects of any statutory adjustments to corporate tax rates; (5) to exclude the effects of any “extraordinary items”items that are “unusual” in nature or occur “infrequently” as determined under generally accepted accounting principles; (6) to exclude the dilutive effects of acquisitions or joint ventures; (7) to assume that any business divested by usthe Company achieved performance objectives at targeted levels during the balance of a performance period following such divestiture; (8) to exclude the effect of any change in the outstanding shares of our common stock of the Company by reason of any stock dividend or split, stock repurchase, reorganization, recapitalization, merger, consolidation, spin-off, combination or exchange of shares or other similar corporate change, or any distributions to common stockholders other than regular cash dividends; (9) to exclude the effects of stock-basedstock based compensation and the award of bonuses under ourthe Company’s bonus plans; (10) to exclude costs incurred in connection with potential acquisitions or divestitures that are required to be expensed under generally accepted accounting principles; (11) to exclude the goodwill and intangible asset impairment charges that are required to be recorded under generally accepted accounting principles; (12) to exclude the effect of any other unusual, non-recurring gain or loss or other extraordinary item; and (13) to exclude the effects of the timing of acceptance for review and/or approval of submissions to the FDAU.S. Food and Drug Administration or any other regulatory body.
In addition, we retainthe Plan Administrator retains the discretion to define the manner of calculating the performance criteria it selects to use for a performance period and to reduce, increase or eliminate the compensation or economic benefit due upon the attainment of theany performance goals and to define the mannergoal.
Other Awards. Other forms of calculating the performance criteria we select to use for such performance period. The performance goals may differ from participant to participant and from award to award.
Other Stock Awards. The plan administrator may grant other awards basedvalued in whole or in part by reference to, or otherwise based on, our common stock. The plan administratorstock, may be granted either alone or in addition to other awards under the 2020 Plan; provided that any such award will setbe treated as a Full Value Award. Subject to the terms of the 2020 Plan, the Plan Administrator will have sole and complete authority to determine the persons to whom and the time or times at which such other awards will be granted, the number of shares under theof our common stock awardto be granted and all other terms and conditions of such other awards.
Clawback Policy. Awards granted under the 2020 Plan will be subject to recoupment in accordance with any clawback policy that we are required to adopt pursuant to the listing standards of any national securities exchange or association on which our securities are listed or as is otherwise required by the Dodd-Frank Wall Street Reform and Consumer Protection Act or other applicable law, and any other clawback policy that the Company adopts. In addition, the board of directors may impose such other clawback, recovery or recoupment provisions in an award agreement as the board of directors determines necessary or appropriate, including but not limited to a reacquisition right in respect of previously acquired shares of common stock or other cash or property upon the occurrence of cause.
Changes to Capital Structure. Structure. In the event that there is a specified type of change in our capital structure, such as a stock split or recapitalization, appropriatecertain capitalization adjustments, the Plan Administrator will be made to (1)appropriately and proportionately adjust: (i) the classclass(es) and maximum number of shares reserved for issuance underof our common stock subject to the 2014 Plan, (2)2020 Plan; (ii) the classclass(es) and maximum number of shares by which the share reserve may increase automatically each year, (3) the class and maximum number of sharesour common stock that may be issued uponpursuant to the exercise of ISOs, (4)ISOs; and (iii) the class and maximum number of shares subject to stock awards that can be granted in a calendar year (as established under the 2014 Plan pursuant to Section 162(m) of the Code) and (5) the classclass(es) and number of shares of our common stock and the exercise, price, strike price, or purchase price ifper share of our common stock subject to outstanding awards.
Corporate Transaction and Change in Control. The following applies to each outstanding award under the 2020 Plan in the event of a corporate transaction (as defined in the 2020 Plan and described below) or a change in control (as defined in the 2020 Plan and described below), unless provided otherwise in the applicable of all outstanding stock awards.award agreement or in any other written agreement between a participant and the Company or an affiliate. The term “Transaction” will mean such corporate transaction or change in control.
Corporate Transactions. 91
In the event of certain specified significant corporate transactions,a Transaction, any awards outstanding under the plan administrator has the discretion to take2020 Plan may be assumed, continued or substituted for by any of the following actions with respect to stock awards:
arrange for the assumption, continuation or substitution of a stock award by a surviving or acquiring corporation (or its parent company) (such entity, or parent company;
arrange for the assignment of“acquiring entity”), and any reacquisition or repurchase rights held by us with respect to the surviving oraward may be assigned to the acquiring entity. If the acquiring entity does not assume, continue or parent company;
acceleratesubstitute for such awards, then with respect to any such awards that are held by participants whose continuous service has not terminated prior to the effective time of the Transaction (such participants, the “current participants”), the vesting (and exercisability, if applicable) of such awards will be accelerated in full to a date prior to the effective time of the stock awardTransaction (contingent upon the effectiveness of the Transaction), and provide for its terminationsuch awards will terminate if not exercised (if applicable) at or prior to the effective time of the corporate transaction;
arrange for the lapse ofTransaction, and any reacquisition or repurchase rightrights held by us;
cancel or arrange forus with respect to such awards will lapse (contingent upon the cancellationeffectiveness of the stockTransaction). With respect to the vesting of performance awards that will accelerate upon the occurrence of a Transaction, unless otherwise provided in the relevant award in exchangeagreement, the vesting of such performance awards will accelerate at 100% of the target level upon the occurrence of the Transaction. If the acquiring entity does not assume, continue or substitute for such cash consideration,awards, then any such awards that are held by persons other than current participants will terminate if not exercised (if applicable) at or prior to the effective time of the Transaction, except that any as our Boardreacquisition or repurchase rights held by us with respect to such awards will not terminate and may continue to be exercised notwithstanding the Transaction.
In the event an award will terminate if not exercised at or prior to the effective time of Directorsa Transaction, the Plan Administrator may deem appropriate; or
makeprovide that the holder of such award may not exercise such award but instead will receive a payment equal in value to the excess, if any, of (1)(i) the value of the property the participant would have received upon the exercise of the stock award, over (2) the(ii) any exercise price otherwise payable by such holder in connection with such exercise.
Under the stock award.
Our plan administrator is not obligated to treat all stock awards, even those that are2020 Plan, a “corporate transaction” generally means the consummation of any one or more of the same type, in the same manner.
Under the 2014 Plan, a corporate transaction is generally the consummation offollowing events: (1) a sale or other disposition of all or substantially all of our assets,assets; (2) a sale or other disposition of at least 90%50% of our outstanding securities,securities; (3) a merger, consolidation or similar transaction following whichwhere we aredo not survive the surviving corporation,transaction; or (4) a merger, consolidation or similar transaction following whichwhere we aredo survive the surviving corporationtransaction but the shares of our common stock outstanding immediately prior tobefore such transaction are converted or exchanged into other property by virtue of the transaction.
ChangeUnder the 2020 Plan, a “change in control” generally means the occurrence of Control. The plan administrator may provide, in an individual award agreementany one or in any other written agreement between a participant and us that the stock award will be subject to additional acceleration of vesting and exercisability in the event of a change of control. For example, certain of our employees may receive an award agreement that provides for vesting acceleration upon the individual’s termination without cause or resignation for good reason (including a material reduction in the individual’s base salary, duties, responsibilities or authority, or a material relocationmore of the individual’s principal place of employment with us) in connection with a change of control. Under the 2014 Plan, a change of control is generallyfollowing events: (1) the acquisition by aany person, entity or entitygroup of our securities representing more than 50% of ourthe combined voting power of our then outstanding securities, other than by virtue of a merger, consolidation, or similar transaction; (2) a consummated merger, consolidation or similar transaction immediately afterin which our stockholders cease toimmediately before such transaction do not own, directly or indirectly, more than 50% of the combined voting power of the surviving entity;entity (or the parent of the surviving entity) in substantially the same proportions as their ownership immediately prior to such transaction; or (3) a consummated sale, lease, or exclusive license or other disposition of all or substantially all of our assets; or (4)assets, other than to an entity, more than 50% of the combined voting power of which is owned by our stockholders approve a planin substantially the same proportions as their ownership of our complete dissolution or liquidation or our complete dissolution or liquidation otherwise occurs.
All stock options granted under the 2014 Plan to our named executive officers provide that vesting and exercisability of such stock options will be accelerated in full following a change in control if,outstanding voting securities immediately prior to or within 12 months after the effective time of such change in control, the optionholder’s continuous service terminates due to an involuntary termination without cause or due to a voluntary termination with good reason. Several terms are specifically defined in the 2014 transaction.
Plan for purposes of this “double-trigger” provision; in particular, (i) “good reason” is generally defined as (1) a material reduction in the optionholder’s annual base salary, except pursuant to a salary reduction program affecting substantially all of our employees that does not disproportionately affect the optionholder; (2) a material reduction in the optionholder’s authority, duties or responsibilities; (3) any failure by us to continue any material benefit plan or program in which the optionholder was participating immediately prior to the change in control, or any action by us that would adversely affect the optionholder’s participation in or reduce his/her benefits under such benefit plan or program, or deprive him/her of any fringe benefit enjoyed immediately prior to the change in control, unless, taken as a whole, we provide for optionholder participation in comparable benefit plans or programs; (4) a relocation of the optionholder’s principal place of employment more than 50 miles; or (5) a material breach by us of any provision of the 2014Amendments and Termination. The Plan or an option agreement under the 2014 Plan or any other material agreement between the optionholder and us concerning the terms and conditions of employment or service with us; and (ii) “cause” is generally defined as the occurrence of any of the following events: (A) the optionholder’s commission of any felony or any crime involving fraud, dishonesty or moral turpitude under the laws of the United States or any state thereof; (B) the optionholder’s attempted commission of, or participation in, a fraud or act of dishonesty against us; (C) the optionholder’s intentional, material violation of any contract or agreement between the optionholder and us or of any statutory duty owed to us; (D) the optionholder’s unauthorized use or disclosure of our confidential information or trade secrets; or (E) the optionholder’s gross misconduct.
Amendment and Termination. Our Board of Directors hasAdministrator will have the authority to amend suspend, or terminate the 20142020 Plan at any time. However, except as otherwise provided that such action does notin the 2020 Plan, no amendment or termination of the 2020 Plan may materially impair a participant’s rights under his or her outstanding awards without the existing rightsparticipant’s consent. We will obtain stockholder approval of any participant without such participant’s written consent. No ISOs may be granted afteramendment to the tenth anniversary of the date our2020 Plan as required by applicable law and listing requirements.
2014 Equity Incentive Plan
Our Board of Directors adopted the 2014 Plan in December 2014 and our stockholders approved the 2014 Plan in April 2015. The 2014 Plan became effective on May 5, 2015 in connection with our initial public offering. In August 2020, upon the effective date of the 2020 Plan, the 2014 Plan ceased to be available for new grants of equity awards, and any shares remaining available for issuance under the 2014 Plan (excluding shares available for the granting of inducement awards under the 2014 Plan’s inducement share pool) became available for issuance under the 2020 Plan.
In May 2019, 1,111 shares were reserved for issuance under the 2014 Plan pursuant to an amendment approved by our Board of Directors pursuant to Rule 5635(c)(4) of the Nasdaq Listing Rules, to be used exclusively for the grant of awards to individuals who were not previously employees or non-employee directors of the Company, as inducement material to the individuals’ entering into employment (“Inducement Awards”).
As of December 31, 2022, option awards covering an aggregate of 12,672 shares of our common stock have been granted under the 2014 Plan and were outstanding.
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2011 Equity Incentive Plan
General. Our Board of Directors and our stockholders approved our 2011 Plan in March 2011. The 2011 Plan was subsequently amended by our Board of Directors and our stockholders, most recently in February 2014. The 2011 Plan is the successor to and continuation of our 2001 Plan. As of December 31, 2019,2022, option awards under the 2011 Plan covering an aggregate of 313,596637 shares of our common stock were outstanding. No additional awards will be granted under the 2011 Plan and all outstanding awards granted under the 2011 Plan that are repurchased, forfeited, expire or are cancelled will become available for grant under the 20142020 Plan in accordance with its terms. Our Board of Directors, or a duly authorized committee thereof, has the authority to administer the 2011 Plan. Our Board of Directors may also delegate certain authority to one or more of our officers. The plan administrator has the authority to modify outstanding awards under our 2011 Plan, including the authority to reduce the exercise, purchase or strike price of any outstanding stock award, cancel any outstanding stock award in exchange for new stock awards, cash or other consideration, or take any other action that is treated as a repricing under generally accepted accounting principles, with the consent of any adversely affected participant.
Stock Options. ISOs and NSOs are granted pursuant to stock option agreements adopted by the plan administrator. The plan administrator determines the exercise price for a stock option, within the terms and conditions of the 2011 Plan, provided that the exercise price of a stock option generally cannot be less than 100% of the fair market value of our common stock on the date of grant. Stock options granted under the 2011 Plan vest at the rate specified by the plan administrator.
The plan administrator determines the term of stock options granted under the 2011 Plan, up to a maximum of 10 years. Unless the terms of an optionholder’s stock option agreement provide otherwise, if an optionholder’s service relationship with us, or any of our affiliates, ceases for any reason other than disability, death or cause, the optionholder may generally exercise any vested stock options for a period of three months following the cessation of service. The stock option term may be extended in the event that exercise of the option following such a termination of service is prohibited by applicable securities laws or our insider trading policy. If an optionholder’s service relationship with us or any of our affiliates ceases due to disability or death, or an optionholder dies within a certain period following cessation of service, the optionholder or a beneficiary may generally exercise any vested stock options for a period of 12 months in the event of disability and 18 months in the event of death. In the event of a termination for cause, stock options generally terminate immediately upon the termination of the individual for cause. In no event may an option be exercised beyond the expiration of its term.
Corporate Transactions. Unless otherwise provided in a stock award agreement or other written agreement between us and a participant, in the event of certain specified significant corporate transactions, the plan administrator has the discretion to take any of the following actions with respect to stock awards:
arrange for the assumption, continuation or substitution of a stock award by a surviving or acquiring entity or parent company;
arrange for the assignment of any reacquisition or repurchase rights held by us to the surviving or acquiring entity or parent company;
accelerate the vesting, in whole or in part, of the stock award and provide for its termination prior to the effective time of the corporate transaction;
arrange for the lapse of any reacquisition or repurchase right held by us;
cancel or arrange for the cancellation of the stock award in exchange for such cash consideration, if any, as our Board of Directors may deem appropriate; or
make a payment equal to the excess of (a) the value of the property the participant would have received upon exercise of the stock award over (b) the exercise price otherwise payable in connection with the stock award.
Our plan administrator is not obligated to treat all stock awards, even those that are of the same type, in the same manner.
Under the 2011 Plan, a corporate transaction is generally defined as the consummation of (1) a sale or other disposition of all or substantially all of our assets, (2) a sale or other disposition of at least 90% of our outstanding securities, (3) a merger, consolidation or similar transaction following which we are not the surviving corporation, or (4) a merger, consolidation or similar transaction following which we are the surviving corporation but the shares of our common stock outstanding immediately prior to such transaction are converted or exchanged into other property by virtue of the transaction.
Change of Control. The plan administrator may provide, in an individual award agreement or in any other written agreement between a participant and us that the stock award will be subject to additional acceleration of vesting and exercisability in the event of a change of control. Under the 2011 Plan, a change of control is generally defined as (1) the acquisition by a person or entity of more than 50% of our combined voting power other than by merger, consolidation or similar transaction, (2) a consummated merger, consolidation or similar transaction immediately after which our stockholders cease to own more than 50% of the combined voting power of the surviving entity, (3) approval by the stockholders or our Board of Directors of a plan of complete dissolution or liquidation of us or our complete dissolution or liquidation occurs or (4) a consummated sale, lease or exclusive license or other disposition of all or substantially of our assets.
Certain stock options granted under the 2011 Plan, including the stock options held by our named executive officers, provide that if immediately prior to a change of control the participant’s service with the Company has not terminated, the option will accelerate vesting with respect to 25% of the then-unvested portion of the option; if the option continues, the remaining 75% of the unvested option will continue to vest on the option’s original schedule prior to the change of control and will accelerate vesting in full in the event that the participant’s continuous service is terminated without cause or by the participant for good reason within the 12 months following the change of control. “Good reason” for purposes of this “double-trigger” provision is generally defined as (1) an assignment of duties or responsibilities to the participant that results in a material diminution of the participant’s function; (2) a material reduction in the participant’s annual base salary; (3) failure to continue the participant’s benefit plans or programs, any action that would adversely affect the participant’s participation in any benefit plan, reduce the participant’s benefits under any benefit plan or deprive the participant of any fringe benefit; or (4) a relocation of the participant’s business office more than 50 miles.
2001 Stock Option Plan
Our Board of Directors and our stockholders approved our 2001 Plan, which became effective in February 2001. The 2001 Plan terminated and no further awards were granted under the 2001 Plan upon the effective date of the 2011 Plan. As of December 31, 2019, there were outstanding stock options under our 2001 Plan covering a total of 12,094 shares of our common stock.
2014 Employee Stock Purchase Plan
General. Our Board of Directors adopted the 2014 ESPP in December 2014 and our stockholders approved the 2014 ESPP in April 2015. The 2014 ESPP became effective on May 5, 2015 in connection with our initial public offering. The purpose of the ESPPour employee stock purchase plans is to retain the services of new employees and secure the services of new and existing employees while providing incentives for such individuals to exert maximum efforts toward our success and that of our affiliates. The ESPP isemployee stock purchase plans are intended to qualify as an “employee stock purchase plan” within the meaning of Section 423 of the Code. As of the date hereof, no shares of our common stock have been purchased under the ESPP. Our Board of Directors has delegated its authority to administer the ESPP to our compensation committee.
The 2014 ESPP initially authorized the issuance of 110,820615 shares of our common stock pursuant to purchase rights granted to our employees or to employees of any of our designated affiliates. The number of shares of our common stock reserved for issuance automatically increases on January 1 of each calendar year, from January 1, 2016 through January 1, 2024 by the least of (1) 1% of the total number of shares of our common stock outstanding on December 31 of the preceding calendar year, (2) 195,0001,083 shares, or (3) a number determined by our Board of Directors that is less than (1) and (2).
In August 2021, the Company’s stockholders, upon the recommendation of the Company’s Board of Directors, approved the Amended and Restated 2014 Employee Stock Purchase Plan (the “Amended 2014 ESPP”). Upon approval of the Amended 2014 ESPP, 41,666 shares of the Company’s common stock were reserved for issuance under the Amended 2014 ESPP in addition to 2,023 shares of the Company’s common stock reserved for issuance under the original 2014 Employee Stock Purchase Plan. The Amended 2014 ESPP does not contain an evergreen provision.
Offerings and Purchases. The Amended 2014 ESPP is implemented through a series of offerings of purchase rights to eligible employees. Under the Amended 2014 ESPP, we may specify offerings with durations of not more than 27 months and may specify shorter purchase periods within each offering. Each offering will have one or more purchase dates on which shares of our common stock will be purchased for employees participating in the offering. Generally, all regular employees, including executive officers, subject to certain restrictions, employed by us or by any of our designated affiliates, may participate in the Amended 2014 ESPP and may contribute, normally through payroll deductions, up to 15% of their earnings for the purchase of our common stock under the Amended 2014 ESPP. Unless otherwise determined by our Board of Directors, common stock will be purchased for accounts of employees participating in the Amended 2014 ESPP at a price per share equal to the lower of (1) 85% of the fair market value of a share of our common stock on the first date of an offering or (2) 85% of the fair market value of a share of our common stock on the date of purchase.
Changes to Capital Structure. In the event that there occurs a change in our capital structure through such actions as a stock split, merger, consolidation, reorganization, recapitalization, reincorporation, stock dividend, dividend in property other than cash, large nonrecurring cash dividend, liquidating dividend, combination of shares, exchange of shares, change in corporate structure or similar transaction, the board of directors will make appropriate adjustments to (1) the number of shares reserved under the Amended 2014 ESPP, (2) the maximum number of shares by which the share reserve may increase automatically each year and (3) the number of shares and purchase price of all outstanding purchase rights.
Corporate Transactions. In the event of certain significant corporate transactions, including the consummation of: (1) a sale of all our assets, (2) the sale or disposition of 90% of our outstanding securities, (3) a merger or consolidation where we do not survive the transaction and (4) a merger or consolidation where we do survive the transaction but the shares of our common stock outstanding immediately prior to such transaction are converted or exchanged into other property by virtue of the transaction, any then-outstanding rights to purchase our stock under the Amended 2014 ESPP may be assumed, continued or substituted for by any surviving or acquiring entity (or its parent company). If the surviving or acquiring entity (or its parent company) elects not to assume, continue or substitute for such purchase rights, then the participants’ accumulated payroll contributions will be used to purchase shares of our common stock within ten business days prior to such corporate transaction, and such purchase rights will terminate immediately.
Plan Amendments, Termination. Our Board of Directors has the authority to amend or terminate our Amended 2014 ESPP, provided that except in certain circumstances any such amendment or termination may not materially impair any outstanding purchase rights without the holder’s consent. We will obtain stockholder approval of any amendment to our Amended 2014 ESPP as required by applicable law or listing requirements.
401(k) Plan93
We maintain a tax-qualified retirement plan that provides eligible employees with an opportunity to save for retirement on a tax advantaged basis. All participants’ interests in their deferrals are 100% vested when contributed. In 2019, we made no matching contributions into the 401(k) plan. Pre-tax contributions are allocated to each participant’s individual account and are then invested in selected investment alternatives according to the participants’ directions. The 401(k) plan is intended to qualify under Sections 401(a) and 501(a) of the Code. As a tax-qualified retirement plan, contributions to the 401(k) plan and earnings on those contributions are not taxable to the employees until distributed from the 401(k) plan, and all contributions are deductible by us when made.
Director Compensation
The following table sets forth in summary form information concerning the compensation that we paid or awarded during the year ended December 31, 20192022 to each of our non-employee directors:
| | | | | | | | | | | | |
Name | | Fees Earned or Paid in Cash ($) | | | Option Awards ($) (1) | | | Total ($) | |
Ann F. Hanham | | | 75,000 | | | | 5,048 | | | | 80,048 | |
Thomas W. Dubensky Jr. (2) | | | 4,830 | | | | 6,174 | | | | 11,004 | |
Michelle R. Griffin | | | 52,229 | | | | 2,524 | | | | 54,753 | |
Donnie M. Hardison | | | 47,000 | | | | 2,524 | | | | 49,524 | |
Christopher P. Kiritsy (3) | | | 32,473 | | | | 21,359 | | | | 53,832 | |
Lee R. McCracken | | | 46,883 | | | | 2,524 | | | | 49,407 | |
Harry A. George (4) | | | 37,580 | | | | — | | | | 37,580 | |
James T. LaFrance (4) | | | 42,002 | | | | — | | | | 42,002 | |
Name | | Fees Earned or Paid in Cash ($) | | Stock Awards ($) (1) | | Option Awards ($) (2) | | Total ($) |
Ann F. Hanham | | | 72,838 | | | 2,600 | | | 10,400 | | | 85,838 |
Michelle R. Griffin | | | 53,526 | | | 2,600 | | | 10,400 | | | 66,526 |
Harry A. George | | | 42,500 | | | 2,600 | | | 10,400 | | | 55,500 |
Donnie M. Hardison | | | 45,850 | | | 2,600 | | | 10,400 | | | 58,850 |
James T. LaFrance | | | 48,405 | | | 2,600 | | | 10,400 | | | 61,405 |
Lee R. McCracken | | | 44,313 | | | 2,600 | | | 10,400 | | | 57,313 |
As of December 31, 2022, the aggregate number of outstanding options to purchase our common stock held by our non-employee directors were: Dr. Hanham: 1,530, Dr. Dubensky: 666, Ms. Griffin: 1,165, Mr. Hardison: 1,230; Mr. Kiritsy: 999, and Mr. McCracken: 1,229. The dollar amounts in this column represent the aggregate grant date fair value of stock option awards granted in 2022. These amounts have been computed in accordance with FASB ASC Topic 718, using the Black-Scholes option pricing model. For further discussion of valuation assumptions, see Note 14 “Stockholders’ Equity” to our consolidated financial statements included elsewhere in this Annual Report on Form 10-K.
(2)Began serving as a non-employee director in August 2022.
(3)Began serving as a non-employee director in January 2022.
(4)Served as a non-employee director until his resignation in August 2022.
(1)
| As of December 31, 2019, the aggregate number of unvested stock awards (other than options) held by our non-employee directors were: 2,500 for each of Dr. Hanham, Ms. Griffin, Mr. George, Mr. Hardison, Mr. LaFrance, and Mr. McCracken. The dollar amounts in this column represent the aggregate grant date fair value of RSU awards granted in 2019. For further discussion of valuation assumptions, see Note 14 “Stockholders’ Equity” to our consolidated financial statements included elsewhere in this Annual Report on Form 10-K.
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(2)
| As of December 31, 2019, the aggregate number of outstanding options to purchase our common stock held by our non-employee directors were: Dr. Hanham: 36,000, Ms. Griffin: 30,000, Mr. George: 38,000; Mr. Hardison: 42,000; Mr. LaFrance: 42,000; and Mr. McCracken: 42,000. The dollar amounts in this column represent the aggregate grant date fair value of stock option awards granted in 2019. These amounts have been computed in accordance with FASB ASC Topic 718, using the Black-Scholes option pricing model. For further discussion of valuation assumptions, see Note 14 “Stockholders’ Equity” to our consolidated financial statements included elsewhere in this Annual Report on Form 10-K.
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We have reimbursed and will continue to reimburse all of our non-employee directors for their travel, lodging and other reasonable expenses incurred in attending meetings of our Board of Directors and committees of our Board of Directors, and will pay for the travel, lodging and other reasonable expenses incurred by our employee directors to attend meetings of our Board of Directors and, as applicable, committees of our Board of Directors.
Pursuant to our non-employee director compensation policy, non-employee director compensation for service on our Board of Directors was as follows as of January 1, 2019:2022:
•an annual cash retainer of $35,000;
•an additional annual cash retainer of $30,000 for service as lead independent directorChair of our Board of Directors;
•an additional annual cash retainer of $15,000, $10,000$12,000 and $7,500$10,000 for service as the chair of our Audit Committee, Compensation Committee and Nominating and Governance Committee, respectively;
•an additional annual cash retainer of $7,500, $5,000$6,000 and $3,750$5,000 for service as member of our Audit Committee, Compensation Committee and Nominating and Governance Committee, respectively;
•an automatic annual option grant to purchase 10,000 shares of our common stock and an automatic RSU award for 2,500333 shares of our common stock for each non-employee director who is serving on the boardour Board of directorsDirectors on the date of each annual stockholder meeting and who has served as a member of our Board of Directors for a minimum of six months, in each case vesting on the earliest to occur of (i) the date that is 12 months following the grant date and (ii) the following year’s annual stockholder meeting; and
•upon first joining our Board of Directors an automatic initial option grant to purchase 20,000666 shares of our common stock on the date of grant. One-third of the shares will vest twelve months after the date of grant and the remaining shares will vest monthly in equal installments over a two-year period thereafter such that the stock option is fully vested on the third anniversary of the date of grant. A director who, in the one year prior to his or her initial election to serve on the board of directors as a non-employee director, served as an employee of the company will not be eligible for an initial grant.
In August 2019, the non-employee director compensation policy was amended and restated, as a result of an analysis conducted by third-party independent consultants, such that non-employee director compensation for service on our Board of Directors is now as follows:
an annual cash retainer of $35,000;
an additional annual cash retainer of $30,000 for service as lead independent director of our Board of Directors;
an additional annual cash retainer of $15,000, $12,000 and $8,000 for service as the chair of our Audit Committee, Compensation Committee and Nominating and Governance Committee, respectively;
| •
| an additional annual cash retainer of $7,500, $6,000 and $4,000 for service as member of our Audit Committee, Compensation Committee and Nominating and Governance Committee, respectively;
|
an automatic annual option grant to purchase 10,000 shares of our common stock and an automatic RSU award for 2,500 shares of our common stock for each non-employee director who is serving on the board of directors on the date of each annual stockholder meeting and who has served as a member of our Board of Directors for a minimum of six months, in each case vesting on the earliest to occur of (i) the date that is 12 months following the grant date and (ii) the following year’s annual stockholder meeting; and
upon first joining our Board of Directors an automatic initial option grant to purchase 25,000 shares of our common stock on the date of grant. One-third of the shares will vest twelve months after the date of grant and the remaining shares will vest monthly in equal installments over a two-year period thereafter such that the stock option is fully vested on the third anniversary of the date of grant. A director who, in the one year prior to his or her initial election to serve on the board of directors as a non-employee director, served as an employee of the company will not be eligible for an initial grant.
Each of the option grants described above will vest and become exercisable subject to the director’s continuous service with us through each applicable vesting date, provided that each option will vest in full upon a change of control, as defined under the 20142020 Plan. The stock options will be granted under the 20142020 Plan, the terms of which are described in more detail above under “– Equity Benefit Plans – 20142020 Equity Incentive Plan.”
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Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.
Securities Authorized for Issuance under Equity Compensation Plans
The following table provides certain information with respect to all of the Company’s equity compensation plans in effect as of December 31, 2019.2022.
Equity Compensation Plan Information
| | | | | | | | | | | | |
Plan Category | | Number of
securities to be
issued upon
exercise of
outstanding
options, warrants
and rights (a) | | | Weighted-average exercise price of
outstanding
options, warrants
and rights (b) | | | Number of
securities
remaining
available for
issuance under equity compensation
plans (excluding
securities reflected
in column (a) (c) | |
Equity compensation plans approved by security
holders: | | | | | | | | | |
2011 Equity Incentive Plan | | | 637 | | | | 596.40 | | | | — | |
2014 Equity Incentive Plan (1) | | | 12,672 | | | | 293.71 | | | | — | |
2014 Employee Stock Purchase Plan (2) | | | — | | | N/A | | | | 35,120 | |
2020 Equity Incentive Plan | | | 54,042 | | | | 35.65 | | | | 16,668 | |
Equity compensation plans not approved by security holders (3) (4) | | | 9,997 | | | | 47.90 | | | | 13,961 | |
Total | | | 77,348 | | | | | | | 51,788 | |
Plan Category | | Number of securities to be issued upon exercise of outstanding options, warrants and rights (a) | | | Weighted-average exercise price of outstanding options, warrants and rights (b) | | | Number of securities remaining available for issuance under equity compensation plans (excluding securities reflected in column (a) (c) | |
Equity compensation plans approved by security holders: | | | | | | | | | | | | |
2001 Stock Option Plan | | | 12,094 | | | $ | 4.30 | | | | — | |
2011 Equity Incentive Plan | | | 313,596 | | | | 3.08 | | | | — | |
2014 Equity Incentive Plan (1) (2) | | | 2,722,953 | | | | 2.29 | | | | — | |
2014 Employee Stock Purchase Plan (3) | | | — | | | N/A | | | | 273,111 | |
Equity compensation plans not approved by security holders (4) | | | 80,000 | | | | 1.69 | | | | 120,000 | |
Total | | | 3,128,643 | | | | | | | | 393,111 | |
On January 1 of each year from January 1, 2016 through and including January 1, 2020, the number of shares authorized for issuance under the 2014 Plan was automatically increased by a number equal to 4% of the total number of shares of our common stock outstanding on December 31 of the preceding calendar year, or such lesser number of shares determined by our Board of Directors. Upon adoption of the 2020 Plan in August 2020, there were no additional annual authorized share increases.
(2)On January 1 of each year from January 1, 2016 through and including January 1, 2020, the number of shares authorized for issuance under our 2014 Employee Stock Purchase Plan was automatically increased by a number equal to the least of: (a) 1% of the total number of shares of our common stock outstanding on December 31 of the preceding calendar year; (b) 1,083 shares; and (c) a number determined by the board of directors that is less than the amounts set forth in the foregoing clauses (a) and (b). In August 2021, the Company’s stockholders, upon the recommendation of the Company’s Board of Directors, approved the Amended 2014 ESPP. Upon approval of the Amended 2014 ESPP, 41,666 shares of the Company’s common stock were reserved for issuance under the Amended 2014 ESPP in addition to 2,023 shares of the Company’s common stock reserved for issuance under the original 2014 Employee Stock Purchase Plan. The Amended 2014 ESPP does not contain an evergreen provision.
(3)In July 2021, the Company’s Board of Directors adopted the Company’s 2021 Inducement Plan (the “2021 Inducement Plan”), pursuant to which 25,000 shares were initially authorized and reserved for issuance exclusively for the grant of awards to individuals who were not previously employees or non-employee directors of the Company, as inducement material to the individuals’ entering into employment with the Company (“Inducement Awards”). There were 13,961 shares of the Company’s stock available for issuance under the 2021 Inducement Plan as of December 31, 2022.
(4)The number of shares to be issued upon exercise of outstanding options, RSUs, warrants and rights under the 2021 Inducement Plan includes 1,249 outstanding RSU awards. These shares have been excluded from weighted-average exercise price in column (b) above.
(1)
| On January 1 of each year from January 1, 2016 through and including January 1, 2024, the number of shares authorized for issuance under the 2014 Plan is automatically increased by a number equal to 4% of the total number of shares of our common stock outstanding on December 31 of the preceding calendar year, or such lesser number of shares determined by our Board of Directors. On January 1, 2019, the available shares for purchase under the 2014 Plan was increased by 2,323,609 shares.
|
(2)
| The number of shares to be issued upon exercise of outstanding options, RSUs, warrants and rights under the 2014 Equity Incentive Plan includes 223,745 outstanding RSU awards which have been excluded from weighted-average exercise price in column (b) above.
|
(3)
| On January 1 of each year from January 1, 2016 through and including January 1, 2024, the number of shares authorized for issuance under our ESPP is automatically increased by a number equal to the least of: (a) 1% of the total number of shares of our common stock outstanding on December 31 of the preceding calendar year; (b) 195,000 shares; and (c) a number determined by the board of directors that is less than the amounts set forth in the foregoing clauses (a) and (b). On January 1, 2019, the available shares for purchase under our ESPP was increased by 195,000 shares.
|
(4)
| In May 2019, 200,000 shares of our common stock were reserved for issuance under the 2014 Equity Incentive Plan pursuant to an amendment approved by our Board of Directors pursuant to Rule 5635(c)(4) of the Nasdaq Listing Rules, to be used exclusively for the grant of awards to individuals who were not previously employees or non-employee directors, as inducement material to the individuals’ entering into employment with us. As of December 31, 2019, there were 120,000 Inducement Awards available for issuance under the 2014 Plan.
|
Principal Stockholders
The following table sets forth certain information regarding the ownership of the Company’s common stock as of February 28, 2020March 1, 2023 by: (i) each director; (ii) each of our executive officers named in the Summary Compensation Table above; and (iii) all executive officers and directors of the Company as a group; and (iv) all those known by thegroup. The Company to bewas not aware of any beneficial owners of more than five percent of its common stock.stock as of this date.
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The table is based upon information supplied by officers, directors and principal stockholders, Schedules 13G filed with the SEC and other sources believed to be reliable by us. Unless otherwise indicated in the footnotes to this table and subject to community property laws where applicable, the Company believes that each of the stockholders named in this table has sole voting and investment power with respect to the shares indicated as beneficially owned. Applicable percentages are based on 56,995,9362,214,155 shares outstanding on February 28, 2020,March 1, 2023, adjusted as required by rules promulgated by the SEC. Unless otherwise indicated, the address for each person or entity listed in the table is c/o HTG Molecular Diagnostics, Inc., 3430 E. Global Loop, Tucson, Arizona 85706.
| | | | | | | | |
| | Common Stock Beneficially Owned | |
| | Shares | | | Percentage | |
Directors and named executive officers | | | | | | |
John L. Lubniewski (1) | | | 15,904 | | | * | |
Shaun D. McMeans (2) | | | 7,266 | | | * | |
Byron T. Lawson (3) | | | 3,521 | | | * | |
Ann Hanham (4) | | | 904 | | | * | |
Michelle R. Griffin (5) | | | 845 | | | * | |
Donnie M. Hardison (6) | | | 966 | | | * | |
Lee McCracken (7) | | | 923 | | | * | |
Christopher P. Kiritsy (8) | | | 296 | | | * | |
All current executive officers and directors as a
group (9 persons) (9) | | | 33,912 | | | | 1.5 | % |
* Represents beneficial ownership of less than one percent.
| | Common Stock Beneficially Owned | |
Name and address of beneficial owner | | Shares | | | Percentage | |
Greater than 5% stockholders | | | | | | | | |
Stonepine Capital Management (1) | | | 5,913,912 | | | | 10.4 | % |
919 NW Bond Street, Suite 204 | | | | | | | | |
Bend, OR 97703 | | | | | | | | |
Blue Water Life Science Master Fund, Ltd. (2) | | | 5,790,269 | | | | 10.2 | % |
c/o Harneys Fiduciary (Cayman) Limited | | | | | | | | |
4th Floor, Harbour Place, 103 South Church Street | | | | | | | | |
PO Box 10240, KY1-1002, Grand Cayman, Cayman Islands | | | | | | | | |
Nantahala Capital Management, LLC (3) | | | 5,000,000 | | | | 8.8 | % |
130 Main Street 2nd Floor | | | | | | | | |
New Canaan, CT 06840 | | | | | | | | |
Cowen Prime Advisors, a division of Cowen Prime Services LLC (4) | | | 3,573,000 | | | | 6.3 | % |
599 Lexington Avenue, Floor 21 | | | | | | | | |
New York, NY 10022 | | | | | | | | |
Samjo Capital, LLC, Samjo Management, LLC and Andrew N. Wiener (5) | | | 3,362,000 | | | | 5.9 | % |
1345 Avenue of the Americas, 3rd Floor | | | | | | | | |
New York, NY 10105 | | | | | | | | |
Directors and named executive officers | | | | | | | | |
John L. Lubniewski (6) | | | 560,589 | | | * | |
Shaun D. McMeans (7) | | | 296,048 | | | * | |
Timothy B. Johnson (8) | | | 571,783 | | | | 1.0 | % |
Ann Hanham (9) | | | 30,804 | | | * | |
Harry A. George (10) | | | 208,896 | | | * | |
Michelle R. Griffin (11) | | | 11,114 | | | * | |
Donnie M. Hardison (12) | | | 42,000 | | | * | |
James T. LaFrance (13) | | | 42,000 | | | * | |
Lee McCracken (14) | | | 34,500 | | | * | |
All current executive officers and directors as a group (10 persons) (15) | | | 1,933,435 | | | | 3.3 | % |
Includes 14,727 shares that Mr. Lubniewski has the right to acquire from us within 60 days of March 1, 2023 pursuant to the exercise of stock options.
*
| Represents beneficial ownership of less than one percent.
|
(1)
| Stonepine Capital Management, LLC, a California limited liability company is the general partner and investment advisor of investment funds, including Stonepine Capital, L.P., a Delaware limited partnership. Jon M. Plexico and Timothy P. Lynch are the control persons of the general partner. These filers have filed a Schedule 13G jointly, but not as members of a group, and each disclaims membership in a group. Each filer also disclaims beneficial ownership of the stock except to the extent of that person’s pecuniary interest therein. In addition, the filing of the Schedule 13G on behalf of Stonepine Capital, L.P. should not be construed as an admission that it is, and it disclaims that it is, a beneficial owner, as defined in Rule 13d-3 under the Securities Act of 1934, as amended, of any of the stock covered by the 13G. This information is based on the Schedule 13G filed on February 13, 2020 with the SEC. Beneficial ownership reported does not include 3,176,762 shares of the Company’s common stock that Stonepine Capital, LP has the right to acquire through common stock warrants, subject to a 9.99% beneficial ownership blocker.
|
(2)Includes 6,386 shares that Mr. McMeans has the right to acquire from us within 60 days of March 1, 2023 pursuant to the exercise of stock options.
(3)Includes 3,019 shares that Mr. Lawson has the right to acquire from us within 60 days of March 1, 2023 pursuant to the exercise of stock options.
(2)
| Blue Water Life Science Master Fund, Ltd. is the record owner of 5,790,269 shares of the Company’s common stock. Blue Water Life Science Fund, LP currently owns approximately 80% of the outstanding shares of Blue Water Life Science Master Fund, Ltd. As a result, Blue Water Life Science Fund, LP is deemed to be an indirect beneficial owner of 80% of the Company’s common stock owned by Blue Water Life Science Master Fund, Ltd. Blue Water Advisors, LLC, an investment advisor registered with the SEC, currently serves as the investment manager to Blue Water Life Science Master Fund, Ltd. and Blue Water Life Science Fund, LP. As such Blue Water Life Science Advisors, LLC may be deemed to be a beneficial owner of the Company’s common stock held by Blue Water Life Science Master Fund, Ltd. insofar as Blue Water Life Science Advisors, LLC may be deemed to share the power to direct the voting or disposition of such shares. Nathaniel T. Cornell is currently the managing member of Blue Water Life Science Advisors, LLC. As such, Mr. Cornell may be deemed to be a beneficial owner of the shares of the Company’s common stock held by Blue Water Life Science Master Fund, Ltd. Insofar as he may be deemed to share the power to direct the voting or disposition of such shares in his capacity as the managing member of Blue Water Life Science Advisors, LLC, the investment manager to Blue Water Life Science Master Fund, Ltd. In addition, the filing of the Schedule 13G on behalf of Blue Water Life Science Master Fund, Ltd. should not be deemed to constitute an admission that any of the above entities and/or individuals is the beneficial owner of the shares of the Company’s common stock currently held by Blue Water Life Science Master Fund, Ltd., and such beneficial ownership has been expressly disclaimed. Further, the filing of a combined 13G should not be construed to be an admission that any of the reporting persons are members of a group for purposes of Sections 13(d) and 13(g) of the Securities Act of 1934, as amended. This information is based on the Schedule 13G filed on September 25, 2019 with the SEC. Beneficial ownership reported does not include 2,234,925 shares of the Company’s common stock that Blue Water Life Science Master Fund, LP has the right to acquire through common stock warrants, subject to a 9.99% beneficial ownership blocker.
|
(4)Includes 864 shares that Dr. Hanham has the right to acquire from us within 60 days of March 1, 2023 pursuant to the exercise of stock options.
(3)
| Natahala Capital Management, LLC may be deemed to be the beneficial owner of 5,000,000 shares of Company’s common stock held by funds and separately managed accounts under its control, and as the managing members of Natahala Capital Management, LLC, each of Wilmot B. Harkey and Daniel Mack may be deemed to be a beneficial owner of these shares. This information is based on the Schedule 13G filed on February 14, 2020 with the SEC.
|
(5)Includes 832 shares that Ms. Griffin has the right to acquire from us within 60 days of March 1, 2023 pursuant to the exercise of stock options.
(4)
| Cowen Prime Advisors (“CPA”), a division of Cowen Prime Services LLC Cowen Prime Advisors (“CPA”), a division of Cowen Prime Services LLC (“CPS”) is a registered investment adviser under the Investment Advisers Act of 1940. CPS is also registered as a broker-dealer with the SEC, as an Introducing Broker with the CFTC, a member of FINRA and a member of NFA. In its role as investment adviser, CPA possesses discretionary investment authority to determine the identity and amount of securities to be bought and sold, including 3,573,000 shares of the Company’s common stock. These securities are owned by various clients, who have retained sole proxy voting authority over all of the shares. However, CPA has sole authority to dispose of the position as appropriate. The filing of the Schedule 13G should not be construed as an admission that CPA or any of its affiliates is the beneficial owner of any securities covered by the Schedule 13G for any purpose other than filings required to be made under Section 13(d) of the Securities Exchange Act of 1934 and related rules. CPA reported the same total number of shares beneficially owned by CPA as discretionary investment manager in the Information Table filed by CPA as part of its 4th quarter 2019 Form 13F filing. Andrew N. Wiener, one of the portfolio managers of the CPA Samjo Investment Program (“SI”), is also the sole Managing Member of Samjo Capital, LLC and Samjo Management, LLC which serve as the General Partner and Management Company, respectively, of Samjo Partners, LP, an investment partnership (hedge fund) and HAFF Partners LP, a family investment partnership, both of which employ investment strategies that are similar to those employed in the CPA SI program. Samjo Capital, LLC, Samjo Management, LLC, Samjo Partners, LP and HAFF Partners LP are not affiliated with CPA. Mr. Wiener, along with his fellow CPA SI portfolio managers identified below, is responsible for the decision to invest client accounts of CPA SI in shares of this issuer. In addition to Mr. Wiener’s portfolio management responsibilities for CPA SI, Mr. Wiener may invest, and from time to time has, invested assets of his non-CPA clients in shares of this same issuer. However, because these non-CPA clients are an unaffiliated outside business activity of Mr. Wiener over which CPA has no control or other relationship, CPA does not make joint filings with respect to any shares of the issuer held by any non-CPA clients. To the best of CPA’s knowledge and belief, Mr. Wiener reports the ownership of shares by such non-CPA clients separately to the extent required and is identified as the reporting person. This information is based on the Schedule 13G filed on February 4, 2020 with the SEC.
|
(6)Includes 897 shares that Mr. Hardison has the right to acquire from us within 60 days of March 1, 2023 pursuant to the exercise of stock options.
(5)
| Samjo Capital, LLC and Samjo Management, LLC, Delaware limited liability companies and Andrew N. Wiener, as sole managing member of these entities have reported shared voting power over 3,300,000 shares of the Company’s common stock. In addition, Mr. Wiener has reported sole power to dispose or to direct the disposition of an additional 62,000 shares of the Company’s common stock. All shares of the Company’s common stock reported in this Schedule 13G are owned by advisory clients of Samjo Capital. None of the advisory clients individually owns more than 5% of the outstanding common stock of the Company. Mr. Wiener is also one of the portfolio managers of the CPA SI employed by CPA. The clients of Samjo Management and Samjo Capital employ investment strategies that are similar to those employed in the CPA SI program. Samjo Capital, Samjo Management and their clients are not affiliated with CPA and Mr. Wiener does not have beneficial ownership over the shares held in the CPA SI program except for shares held in accounts owned by Mr. Wiener and his immediate family members. As a result, Samjo Capital and Samjo Management do not make joint filings with respect to any shares of the Company held by any CPA clients except with respect to shares held in accounts owned by Mr. Wiener and his immediate family members. To the best of Samjo Capital’s, Samjo Management’s and Mr. Wiener’s knowledge and belief, CPA reports the ownership of shares by such CPA clients separately to the extent required and is identified as the reporting person. This information is based on the Schedule 13G filed on January 31, 2020 with the SEC.
|
(7)Includes 896 shares that Mr. McCracken has the right to acquire from us within 60 days of March 1, 2023 pursuant to the exercise of stock options.
(8)Reflects 296 shares that Mr. Kiritsy has the right to acquire from us within 60 days of March 1, 2023 pursuant to the exercise of stock options.
(6)
| Includes 432,377 shares that Mr. Lubniewski has the right to acquire from us within 60 days of February 28, 2020 pursuant to the exercise of stock options and the vesting of RSUs.
|
(9)The number of shares beneficially owned consists of (a) the shares described in Notes (1) through (8) and (b) 736 shares owned and 2,551 shares that Stephen A. Barat has the right to acquire from us within 60 days of March 1, 2023, pursuant to the exercise of stock options and the vesting of RSUs. Dr. Barat was designated an executive officer by the Board of Directors in February 2023.
(7)
| Includes 195,138 shares that Mr. McMeans has the right to acquire from us within 60 days of February 28, 2020 pursuant to the exercise of stock options and the vesting of RSUs.
|
(8)
| Includes 363,915 shares that Mr. Johnson has the right to acquire from us within 60 days of February 28, 2020 pursuant to the exercise of stock options and the vesting of RSUs.
|
(9)
| Includes 26,000 shares that Dr. Hanham has the right to acquire from us within 60 days of February 28, 2020 pursuant to the exercise of stock options.
|
(10)
| Consists of (i) 144,366 shares beneficially owned by Solstice Capital II LP and (ii) 28,000 shares that Mr. George has the right to acquire from us within 60 days of February 28, 2020 pursuant to the exercise of stock options. Mr. George is the managing member of Solstice Capital II LP and has joint voting and investment power over the shares held by Solstice Capital II LP.
|
(11)
| Includes 11,114 shares that Ms. Griffin has the right to acquire from us within 60 days of February 28, 2020 pursuant to the exercise of stock options.
|
(12)
| Includes 32,000 shares that Mr. Hardison has the right to acquire from us within 60 days of February 28, 2020 pursuant to the exercise of stock options.
|
(13)
| Includes 32,000 shares that Mr. LaFrance has the right to acquire from us within 60 days of February 28, 2020 pursuant to the exercise of stock options.
|
(14)
| Includes 32,000 shares that Mr. McCracken has the right to acquire from us within 60 days of February 28, 2020 pursuant to the exercise of stock options.
|
(15)
| The number of shares beneficially owned consists of (a) the shares described in Notes (6) through (14) and (b) 135,701 shares beneficially owned by another executive officer, including 105,452 shares that such executive officer has the right to acquire from us within 60 days of February 28, 2020 pursuant to the exercise of stock options and the vesting of RSUs.
|
Item 13. Certain Relationships and Related Transactions, and Director Independence.
We have adopted a written related-person transactions policy that sets forth our policies and procedures regarding the identification, review, consideration and oversight of “related-person transactions.” For purposes of our policy only, a “related-person transaction” is a transaction, arrangement or relationship (or any series of similar transactions, arrangements or relationships) in which we and any “related person” are participants involving an amount that exceeds the lesser of $120,000 or one percent of the average of the Company’s total assets at year-end for the last two completed fiscal years.
Transactions involving compensation for services provided to us as an employee, consultant or director are not considered related-person transactions under this policy. A “related person” is any executive officer, director or a holder of more than five percent of our common stock, including any of their immediate family members and any entity owned or controlled by such persons.
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Under the policy, where a transaction has been identified as a related-person transaction, management must present information regarding the proposed related-person transaction to our Audit Committee (or, where review by our Audit Committee would be inappropriate, to another independent body of our Board of Directors) for review. Thepresentation must include a description of, among other things, the material facts, the direct and indirect interests of the related persons, the benefits of the transaction to us and whether any alternative transactions are available. To identify related-person transactions in advance, we rely on information supplied by our executive officers, directors and certain significant stockholders. In considering related-person transactions, our Audit Committee or other independent body of our Board of Directors takes into account the relevant available facts and circumstances including, but not limited to:
•the risks, costs and benefits to us;
•the impact on a director’s independence in the event the related person is a director, immediate family member of a director or an entity with which a director is affiliated;
•the terms of the transaction;
•the availability of other sources for comparable services or products; and
•the terms available to or from, as the case may be, unrelated third parties or to or from our employees generally.
In the event a director has an interest in the proposed transaction, the director must recuse himself or herself from the deliberations and approval.
The following sections summarize transactions since January 1, 20182021 to which we have been a party, in which the amount involved in the transaction exceeded the lesser of $120,000 or one percent of the average of the Company’s total assets at year-end for the last two completed fiscal years, and in which any of our directors, executive officers or, to our knowledge, beneficial owners of more than 5% of our capital stock or any member of the immediate family of any of the foregoing persons had or will have a direct or indirect material interest, other than equity and other compensation, termination, change in control and other arrangements, which are described under “Executive Compensation” and “Director Compensation.”
Transactions with QIAGEN Manchester Limited and Affiliates
In November 2016, we entered into a Master Assay Development, Commercialization and Manufacturing Agreement (“Governing Agreement”) with QIAGEN Manchester Limited (“QML”), and we concurrently entered into a stock purchase agreement with QIAGEN North American Holdings, Inc. (“QNAH”). Both QML and QNAH are wholly owned subsidiaries of QIAGEN N.V. Pursuant to the shares of our common stock acquired by QNAH under the stock purchase agreement, QNAH became a greater than 5% holder of our common stock.
In June 2017, we entered into a first statement of work (“SOW One”) with QML under the Governing Agreement. SOW One addressed the initial activities to be performed by us and QML in support of the development and potential commercialization of a NGS-based companion diagnostic assay (the “Project”) that is the subject of a sponsor project agreement between QML and a biopharmaceutical company (“Pharma One”). We amended SOW One on December 18, 2017 and March 30, 2018 in connection with the completion of initial-phase development activities under SOW One. The second amendment to SOW One relates to next-phase development activities, including assay design verification and preparation for regulatory submission, for the Project (“Next-Phase Activities”). Under SOW One, as amended, QML agreed to pay us low, single-digit millions of dollars for the Pharma One development work performed under the SOW, and we and QML agreed to share any net profits resulting from performance of the development work as determined pursuant to the Governing Agreement. QML also agreed to pay us milestone payments up to an amount in the low, single-digit millions of dollars in the aggregate upon the achievement of certain development milestones during the Next-Phase Activities. On May 16, 2018, we received written notice from QML that it had terminated SOW One following the termination of the Project by Pharma One. For additional details regarding the terms of SOW One, please refer to Note 9 to our consolidated financial statements contained in this Annual Report.
In connection with SOW One, the Governing Agreement was amended to provide that neither party may terminate SOW One or the Governing Agreement to the extent it relates to SOW One in the event of a change of control.
In October 2017, we entered into a second statement of work (“SOW Two”) under the Governing Agreement with QML. SOW Two was made effective as of June 2, 2017 (“Onset Date”), and was amended on August 7, 2018, August 13, 2018 and September 27, 2018. SOW Two addresses development activities conducted by us and QML since the Onset Date and those expected to be further conducted by parties in connection with a sponsor project agreement, dated June 2, 2017, between QML and Bristol-Myers Squibb. The initial-phase investigational use only (“IUO”) development activities under SOW Two have been completed and the first two amendments of SOW Two relate to the next phases, which include the use of the IUO assay developed in the initial-phase in a retrospective clinical trial and in additional disease indications. The third amendment to SOW Two provides that profit sharing relating to the original development activities and the development activities contemplated by the first SOW Two amendment will, in each case, commence upon the later of (i) the third amendment effective date, which is September 27, 2018, and (ii) the completion of the respective development activities, rather than at the end of each calendar quarter, provided that such modification to the profit-sharing commencement date only applies to development activities that had not yet been subject to profit-sharing as of the third amendment effective date. Under SOW Two, as amended, QML has agreed to pay us mid-single digit millions of dollars for the development work performed and expected to be performed by us and QML under SOW Two. In addition, we will share in any net profits (as determined under the Governing Agreement) generated during the work on an approximately quarterly basis throughout the term of SOW Two, except as otherwise specified in the third amendment to SOW Two. For additional details regarding the terms of SOW Two, please refer to Note 9 to our consolidated financial statements contained in this Annual Report.
In January 2018, we entered into a third statement of work (“SOW Three”) under the Governing Agreement with QML. SOW Three addresses the development activities for a NGS‑based clinical‑trial assay (“SOW Three Project”) in connection with a sponsor project agreement between QML and a pharmaceutical company (“Pharma Three”). We amended SOW Three on September 21, 2018 in connection with the completion of initial assay development activities under SOW Three. The first amendment to SOW Three provides for the development of an IUO assay, subsequent retrospective testing of clinical trial samples, design verification and, subject to satisfactory achievement of relevant performance and regulatory milestones, regulatory submissions in the United States and European Union necessary for the commercialization of a companion diagnostic for a corresponding Pharma Three drug. Under SOW Three, as amended, QML has agreed to pay us low, single-digit millions of dollars for the development work performed and expected to be performed by us and QML under SOW Three. In addition, we will share in any net profits (as determined under the Governing Agreement) generated during the work on an approximately quarterly basis throughout the term of SOW Three. For additional details regarding the terms of SOW Three, please refer to Note 9 to our consolidated financial statements contained in this Annual Report.
In October 2017, we issued a subordinated convertible promissory note (the “QNAH Convertible Note”) to QIAGEN North American Holdings, Inc. (“QNAH”) in the principal amount of $3.0 million against receipt of cash proceeds equal to such principal amount. The QNAH Convertible Note bears simple interest at the rate of 3.0% per annum and matures on October 26, 2020. Our indebtedness under the QNAH Convertible Note is expressly subordinated in right of payment to the prior repayment in full of our indebtedness under our Growth Term Loan. QNAH may elect to convert all or any portion of the outstanding principal balance of the QNAH Convertible Note and all unpaid accrued interest thereon at any time prior to the maturity date into shares of our common stock at a conversion price of $3.984 per share.
Since October 26, 2017, the outstanding principal amount of the QNAH Convertible Note has remained at $3.0 million. No accrued interest has been paid and all accrued interest will become due on the maturity date of October 26, 2020.
We terminated the Governing Agreement in November 2019.
Employment Arrangements
We currently have written employment agreements with our executive officers. For information about our employment agreements with our named executive officers, refer to “Executive Compensation – Agreements with our Named Executive Officers.”
Stock Options Granted to Executive Officers and Directors
We have granted stock options to our executive officers and directors, as more fully described in “Executive Compensation – Outstanding Equity Awards at Fiscal Year-End.”
Indemnification Agreements
We have entered into, and intend to continue to enter into, separate indemnification agreements with our directors and executive officers, in addition to the indemnification provided for in our amended and restated bylaws. These agreements, among other things, require us to indemnify our directors and executive officers forcertain expenses, including attorneys’ fees, judgments, fines and settlement amounts incurred by a director or executive officer in any action or proceeding arising out of their services as one of our directors or executive officers or any other company or enterprise to which the person provides services at our request. We believe that these bylaw provisions and indemnification agreements are necessary to attract and retain qualified persons as directors and officers.
The limitation of liability and indemnification provisions in our amended and restated certificate of incorporation and amended and restated bylaws may discourage stockholders from bringing a lawsuit against directors for breach of their fiduciary duties. They may also reduce the likelihood of derivative litigation against directors and officers, even though an action, if successful, might benefit us and our stockholders. A stockholder’s investment may be harmed to the extent we pay the costs of settlement and damage awards against directors and officers pursuant to these indemnification provisions.
Director Independence
Our Board of Directors has determined that all of our directors other than Mr. Lubniewski and Mr. Johnson are independent directors, as defined by Rule 5605(a)(2) of the Nasdaq Listing Rules. The Nasdaq independence definition includes a series of objective tests, including that the director is not, and has not been for at least three years, one of our employees and that neither the director nor any of his family members has engaged in various types of business dealings with us. In addition, as required by Nasdaq rules, our Board of Directors has made a subjective determination as to each independent director that no relationships exist, which, in the opinion of our Board of Directors, would interfere with the exercise of independent judgment in carrying out the responsibilities of a director. In making these determinations, our Board of Directors reviewed and discussed information provided by the directors and us with regard to each director’s business and personal activities and relationships as they may relate to us and our management.
97
Item 14. Principal AccountingAccounting Fees and Services.
The following table summarizes the fees of BDO USA, LLP, our independent registered public accounting firm, for 20192022 and 2018.2021.
| | | | | | | | |
| | December 31, | |
| | 2022 | | | 2021 | |
Fee Category | | | | | | |
Audit fees (1) | | $ | 746,500 | | | $ | 409,889 | |
Audit-related fees | | | — | | | | — | |
Tax fees | | | — | | | | — | |
All other fees | | | — | | | | — | |
Total fees | | $ | 746,500 | | | $ | 409,889 | |
| | December 31, | |
| | 2019 | | | 2018 | |
Fee Category | | | | | | | | |
Audit fees (1) | | $ | 581,796 | | | $ | 419,213 | |
Audit-related fees | | | — | | | | — | |
Tax fees | | | — | | | | — | |
All other fees | | | — | | | | — | |
Total fees | | $ | 581,796 | | | $ | 419,213 | |
Audit fees consist of fees for professional services provided primarily in connection with the annual audit of our consolidated financial statements, quarterly reviews and services associated with SEC registration statements and other documents issued in connection with securities offerings including comfort letters and consents.
(1)
| Audit fees consist of fees for professional services provided primarily in connection with the annual audit of our consolidated financial statements, quarterly reviews and services associated with SEC registration statements and other documents issued in connection with securities offerings including comfort letters and consents.
|
Pre-Approval Policies and Procedures
Pursuant to its charter, the audit committee must review and approve, in advance, the scope and plans for the audits and the audit fees and approve in advance (or, where permitted under the rules and regulations of the SEC, subsequently) all non-audit services to be performed by the independent auditor that are not otherwise prohibited by law and any associated fees. The audit committee may delegate to one or more members of the committee the authority to pre-approve audit and permissible non-audit services, as long as this pre-approval is presented to the full committee at scheduled meetings. All fees described above were pre-approved by the audit committee.
98
PART IV
Item 15. Exhibits, Financial Statement Schedules.
(a)(1)
| Consolidated Financial Statements - The consolidated financial statements filed as part of this Annual Report on Form 10-K are listed on the Index to Financial Statements in Item 8.
|
(a)(2)
| Financial Statement Schedules
|
(a)(1) Consolidated Financial Statements - The consolidated financial statements filed as part of this Annual Report on Form 10-K are listed on the Index to Financial Statements in Item 8.
(a)(2) Financial Statement Schedules
All schedules are omitted because they are not applicable or the required information is shown in the consolidated financial statements or the notes thereto.
(a)(3) Exhibits
The exhibits required by Item 601 of Regulation S-K are listed in paragraph (b) below.
(b) Exhibits.
The exhibits listed on the Exhibit Index immediately preceding the signature page to this Annual Report on Form 10-K are filed herewith or are incorporated by reference to exhibits previously filed with the SEC.
99
Exhibit Index
| | |
Exhibit Number |
| Description |
|
|
|
2.1 |
| Asset Purchase Agreement dated January 9, 2001, as amended by and between the Registrant, NuvoGen, LLC, Stephen Felder and Richard Kris (incorporated by reference to Exhibit 2.1 to the Registrant’s registration Statement on Form S-1, as amended (File No. 333-201313), originally filed with the SEC on December 30, 2014). |
|
|
|
3.1 |
| Amended and Restated Certificate of Incorporation of the Registrant (incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K, filed with the SEC on May 12, 2015). |
|
|
|
3.2 |
| Certificate of DesignationAmendment to Amended and Restated Certificate of Preferences, Rights and LimitationsIncorporation of Series A Convertible Preferred Stockthe Registrant (incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K, (Filefiled with the SEC on November 19, 2020). |
|
|
|
3.3 |
| Certificate of Amendment to Amended and Restated Certificate of Incorporation of HTG Molecular Diagnostics, Inc. (incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K (File. No. 0001-37369)001-37369), filed with the SEC on February 26, 2020)December 20, 2022). |
|
|
|
3.33.4
|
| Amended and Restated Bylaws of the Registrant (incorporated by reference to Exhibit 3.2 to the Registrant’s Current Report on Form 8-K, filed with the SEC on May 12, 2015). |
|
|
|
4.13.5
|
| Amendment to Amended and Restated Bylaws (incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K (File No. 001-37369), filed with the SEC on August 18, 2022). |
|
|
|
4.1 |
| Reference is made to Exhibits 3.1,3.2, 3.23.3, 3.4and 3.3.3.5. |
|
|
|
4.2 |
| Form of Common Stock Certificate of the Registrant (incorporated by reference to Exhibit 4.1 to4.2 of the Registrant’s Registration Statement on Form S-1 as amended (File No. 333-201313)333-268681), originally filed with the SEC on December 30, 2014).31, 2022. |
|
|
|
4.3 |
| Common Stock Warrant issued by the Registrant to the University of Arizona, dated March 13, 2009 (incorporated by reference to Exhibit 4.2 to the Registrant’s Registration Statement on Form S-1, as amended (File No. 333-201313), originally filed with the SEC on December 30, 2014).
|
| | |
4.4
| | Series E Preferred Stock Warrant issued by the Registrant to Silicon Valley Bank, dated August 22, 2014 (incorporated by reference to Exhibit 4.4 to the Registrant’s Registration Statement on Form S-1, as amended (File No. 333-201313), originally filed with the SEC on December 30, 2014). |
|
|
|
4.54.4
|
| Series E Preferred Stock Warrant issued by the Registrant to Oxford Finance LLC, dated August 22, 2014 (incorporated by reference to Exhibit 4.5 to the Registrant’s Registration Statement on Form S-1, as amended (File No. 333-201313), originally filed with the SEC on December 30, 2014). |
|
|
|
4.64.5
|
| Form of Warrant issued by Registrant to bridge financing investors (incorporated by reference to Exhibit 4.6 to the Registrant’s Registration Statement on Form S-1, as amended (File No. 333-201313), originally filed with the SEC on December 30, 2014).
|
| | |
4.7
| | Form of Warrant issued by Registrant to bridge financing investors (incorporated by reference to Exhibit 4.7 to the Registrant’s Registration Statement on Form S-1, as amended (File No. 333-201313), originally filed with the SEC on December 30, 2014).
|
| | |
4.8
| | Common Stock Warrant issued by the Registrant to Oxford Finance LLC, dated March 28, 2016 (incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K, filed with the SEC on June 30, 2016). |
|
|
|
4.94.6
|
| Subordinated Convertible Promissory Note, dated October 26, 2017, by and between the Company and QIAGEN North American Holdings, Inc. (incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K, filed with the SEC on October 27, 2017).
|
| | |
4.10
| | Warrant issued to MidCap Funding XXVIII Trust, dated March 26, 2018 (incorporated by reference to Exhibit 4.10 to the Registrant’s Quarterly Report on Form 10-Q (File No. 001-37369), filed with the SEC on May 10, 2018). |
|
|
|
4.114.7
|
| Form of Pre-Funded Warrant to Purchase Shares of Common Stock, dated Septemberissued to Silicon Valley Bank on June 24, 20192020 (incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K, filed with the SEC on September 23, 2019)June 25, 2020).
|
|
|
|
4.8 |
| Form of Pre-Funded Warrant issued on March 21, 2022 (incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K (File No. 001-37369), filed with the SEC on March 21, 2022). |
|
|
|
4.124.9
|
| DescriptionForm of CapitalCommon Stock Warrant (24-month term) issued on March 21, 2022 (incorporated by reference to Exhibit 4.2 to the Registrant’s Current Report on Form 8-K (File No. 001-37369), filed with the SEC on March 21, 2022).
|
|
|
|
10.1+4.10
|
| Form of Common Stock Warrant (66-month term) issued on March 21, 2022 (incorporated by reference to Exhibit 4.3 to the Registrant’s Current Report on Form 8-K (File No. 001-37369), filed with the SEC on March 21, 2022). |
|
|
|
4.11 |
| Registration Rights Agreement, dated as of March 17, 2022 between the Registrant and the purchaser party thereto (incorporated by reference to Exhibit 4.4 to the Registrant’s Current Report on Form 8-K (File No. 001-37369), filed with the SEC on March 21, 2022). |
|
|
|
4.12 |
| Description of Common Stock. |
|
|
|
100
| | |
4.13 |
| Form of Series A-1 Warrant to Purchase Common Stock, issued on December 23, 2022 (incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K (File. No. 001-37369), filed with the SEC on December 23, 2022). |
|
|
|
4.14 |
| Form of Series A-2 Warrant to Purchase Common Stock, issued on December 23, 2022 (incorporated by reference to Exhibit 4.2 to the Registrant’s Current Report on Form 8-K (File. No. 001-37369), filed with the SEC on December 23, 2022). |
|
|
|
4.15 |
| Form of Pre-funded Warrant to Purchase Common Stock, issued on December 23, 2022 (incorporated by reference to Exhibit 4.3 to the Registrant’s Current Report on Form 8-K (File. No. 001-37369), filed with the SEC on December 23, 2022). |
|
|
|
4.16 |
| Form of Placement Agent Warrant, issued on December 23, 2022 (incorporated by reference to Exhibit 4.4 to the Registrant’s Current Report on Form 8-K (File No. 001-37369), filed with the SEC on December 23, 2022). |
|
|
|
10.1+ |
| Form of Indemnity Agreement by and between the Registrant and its directors and officers (incorporated by reference to Exhibit 10.1 to the Registrant’s Registration Statement on Form S-1, as amended (File No. 333-201313), originally filed with the SEC on December 30, 2014). |
|
| |
Exhibit
Number
| | Description
|
10.2+ |
| HTG Molecular Diagnostics, Inc. 2001 Stock Option Plan and Forms of Stock Option Agreement and Stock Option Grant Notice thereunder (incorporated by reference to Exhibit 10.2 to the Registrant’s Registration Statement on Form S-1, as amended (File No. 333-201313), originally filed with the SEC on December 30, 2014).
|
| | |
10.3+
| | HTG Molecular Diagnostics, Inc. 2011 Equity Incentive Plan and Forms of Stock Option Agreement, Notice of Exercise and Stock Option Grant Notice thereunder (incorporated by reference to Exhibit 10.3 to the Registrant’s Registration Statement on Form S-1, as amended (File No. 333-201313), originally filed with the SEC on December 30, 2014). |
|
|
|
10.4+10.3+
|
| HTG Molecular Diagnostics, Inc. 2014 Equity Incentive Plan as amended (incorporated(incorporated by reference to Exhibit 10.7 to the Registrant’s Quarterly Report on Form 10-Q (File No. 001-37369), filed with the SEC on May 9, 2019). |
|
|
|
10.5+10.4+
|
| Standard Forms of Stock Option Agreement, Notice of Exercise and Stock Option Grant Notice under the HTG Molecular Diagnostics, Inc. 2014 Equity Incentive Plan, as amended (incorporated by reference to Exhibit 10.8 to the Registrant’s Quarterly Report on Form 10-Q (File No. 001-37369), filed with the SEC on May 9, 2019). |
|
|
|
10.6+10.5+
|
| Forms of Stock Option Agreement, Notice of Exercise and Stock Option Grant Notice for Inducement Award Recipients under the HTG Molecular Diagnostics, Inc. 2014 Equity Incentive Plan, as amended (incorporated by reference to Exhibit 10.9 to the Registrant’s Quarterly Report on Form 10-Q (File No. 001-37369), filed with the SEC on May 9, 2019). |
|
|
|
10.7+10.6+
|
| HTG Molecular Diagnostics, Inc. 2020 Equity Incentive Plan. |
|
|
|
10.7+ |
| Form of Stock Option Grant Notice, Option Agreement and Notice of Exercise under the HTG Molecular Diagnostics, Inc. 2020 Equity Incentive Plan (incorporated by reference to Exhibit 99.2 to the Registrant’s Registration Statement on Form S-8 (File No. 333-248207), filed with the Commission on August 20, 2020). |
|
|
|
10.8+ |
| Form of Restricted Stock Unit Grant Notice and Restricted Stock Unit Award Agreement under the HTG Molecular Diagnostics, Inc. 2020 Equity Incentive Plan (incorporated by reference to Exhibit 99.3 to the Registrant’s Registration Statement on Form S-8 (File No. 333-248207), filed with the Commission on August 20, 2020). |
|
|
|
10.9+ |
| HTG Molecular Diagnostics, Inc. Amended and Restated 2014 Employee Stock Purchase Plan. |
|
|
|
10.10 |
| HTG Molecular Diagnostics, Inc. 2021 Inducement Plan. |
|
|
|
10.11 |
| Form of Stock Option Grant Notice, Option Agreement and Notice of Exercise under the HTG Molecular Diagnostics, Inc. 2021 Inducement Plan (incorporated by reference to Exhibit 99.2 to the Registrant’s Registration Statement on Form S-8 (File No. 333-258977), filed with the Commission on August 20, 2021). |
|
|
|
10.12 |
| Form of Restricted Stock Unit Grant Notice and Restricted Stock Unit Award Agreement under the HTG Molecular Diagnostics, Inc. 2021 Inducement Plan (incorporated by reference to Exhibit 99.3 to the Registrant’s Registration Statement on Form S-8 (File No. 333-258977), filed with the Commission on August 20, 2021). |
|
|
|
10.13 |
| HTG Molecular Diagnostics, Inc. Amended and Restated Stock Purchase Plan (incorporated by reference to Exhibit 10.510.3 to the Registrant’s Registration StatementQuarterly Report on Form S-1, as amended (File10-Q (File No. 333-201313)001-37369), originally filed with the SEC on December 30, 2014)August 9, 2016). |
|
|
|
10.8+10.14+
|
| HTG Molecular Diagnostics, Inc. Amended and Restated Non-Employee Director Compensation PolicyPolicy. |
|
|
|
101
| | |
10.15+ |
| HTG Molecular Diagnostics, Inc. Severance and Change in Control Plan (incorporated by reference to Exhibit 10.110.13 to the Registrant’s Annual Report on Form 10-K (File No. 001-37369), filed with the SEC on March 25, 2021). |
|
|
|
10.16+ |
| Employment Agreement, dated April 1, 2019, by and between John L. Lubniewski and the Registrant (incorporated by reference to Exhibit 10.2 to the Registrant’s Current Report on Form 8-K, filed with the SEC on April 2, 2019). |
|
|
|
10.17+ |
| Employment Agreement, dated July 28, 2019, by and between Shaun D. McMeans and the Registrant (incorporated by reference to Exhibit 10.2 to the Registrant’s Quarterly Report on Form 10-Q (File No. 001-37369), filed with the SEC on November 12, 2019). |
|
|
|
10.9+10.18+
|
| Employment Letter Agreement, dated December 24, 2014July 28, 2019, by and between Byron Lawson and the Registrant and Timothy Johnson (incorporated by reference to Exhibit 10.710.47 to the Registrant’s Registration StatementAnnual Report on Form S-1, as amended10-K (File No. 333-201313)001-37369), originally filed with the SEC on December 30, 2014)March 25, 2020). |
|
|
|
10.10+10.19
|
| Employment Letter Agreement dated December 18, 2014 by and between the Registrant and John Lubniewski (incorporated by reference to Exhibit 10.8 to the Registrant’s Registration Statement on Form S-1, as amended (File No. 333-201313), originally filed with the SEC on December 30, 2014).
|
| | |
10.11+
| | Employment Letter Agreement dated December 15, 2014 by and between the Registrant and Shaun McMeans (incorporated by reference to Exhibit 10.10 to the Registrant’s Registration Statement on Form S-1, as amended (File No. 333-201313), originally filed with the SEC on December 30, 2014).
|
| | |
10.12*
| | Standard Commercial-Industrial Multi Tenant Triple Net Lease dated July 11, 2008 by and between the Registrant and Pegasus Properties LP (incorporated by reference to Exhibit 10.12 to the Registrant’s Registration Statement on Form S-1, as amended (File No. 333-201313), originally filed with the SEC on December 30, 2014). |
|
|
|
10.13*10.20
|
| Standard Commercial-Industrial Multi Tenant Triple NetSecond Amendment to Lease Agreement (Suite 300 – Laboratory), dated May 11, 2011December 8, 2020, by and between the Registrant and Pegasus Properties, LPL.P. (incorporated by reference to Exhibit 10.13 to the Registrant’s Registration Statement on Form S-1, as amended (File No. 333-201313), originally filed with the SEC on December 30, 2014).
|
| | |
10.14*
| | First Amendment to Lease Agreement (Suite 100 - Administration), dated August 4, 2015, by and between Pegasus Properties, L.P. and the Registrant (incorporated by reference to Exhibit 10.1 to the Registrant’s Quarterly Report on Form 10-Q (File No. 001-37369), filed with the SEC on November 12, 2015).
|
| | |
10.15*
| | First Amendment to Lease Agreement (Suite 300 - Laboratory), dated August 4, 2015, by and between Pegasus Properties, L.P. and the Registrant (incorporated by reference to Exhibit 10.2 to the Registrant’s Quarterly Report on Form 10-Q (File No. 001-37369), filed with the SEC on November 12, 2015).
|
Exhibit
Number
| | Description
|
| | |
10.16*
| | Termination of Security Agreement, Release of Security Interest and Understanding Regarding Asset Purchase Agreement, dated August 22, 2014, by and between the Registrant and NuvoGen Research LLC (incorporated by reference to Exhibit 10.16 to the Registrant’s Registration Statement on Form S-1, as amended (File No. 333-201313), originally filed with the SEC on December 30, 2014).
|
| | |
10.17
| | HTG Molecular Diagnostics, Inc. Amended and Restated Stock Purchase Plan (incorporated by reference to Exhibit 10.3 to the Registrant’s Quarterly Report on Form 10-Q (File No. 001-37369), filed with the SEC on August 9, 2016).
|
| | |
10.18*
| | Master Assay Development, Commercialization and Manufacturing Agreement, dated November 16, 2016, by and between Registrant and QIAGEN Manchester Limited (incorporated by reference to Exhibit 10.23 to the Registrant’s Annual Report on Form 10-K filed with the SEC on March 23, 2017).
|
| | |
10.19*
| | Controlled Equity Offering Sales Agreement, by and between the Registrant and Cantor Fitzgerald & Co., dated April 13, 2017 (incorporated by reference to Exhibit 99.1 to the Registrant’s Current Report on Form 8-K (File No. 001-37369), filed with the SEC on April 13, 2017).
|
| | |
10.20
| | Registration Rights Letter Agreement, effective June 2, 2017, by and between the Registrant and Novo Holdings A/S (f/k/a Novo A/S) (incorporated by reference to Exhibit 10.2 to the Registrant’s Quarterly Report on Form 10-Q (File No. 001-37369), filed with the SEC on August 8, 2017).
|
| | |
10.21*
| | Amended and Restated Development and Component Supply Agreement, effective May 31, 2017, by and between the Registrant and Illumina, Inc. (incorporated by reference to Exhibit 10.3 to the Registrant’s Quarterly Report on Form 10-Q (File No. 001-37369), filed with the SEC on August 8, 2017).
|
| | |
10.22
| | First Amendment to Master Assay Development, Commercialization and Manufacturing Agreement, dated June 14, 2017, by and between the Registrant and QIAGEN Manchester Limited (incorporated by reference to Exhibit 10.4 to the Registrant’s Quarterly Report on Form 10-Q (File No. 001-37369), filed with the SEC on August 8, 2017).
|
| | |
10.23*
| | Statement of Work No. 2, dated October 26, 2017, under Master Assay Development, Commercialization and Manufacturing Agreement between the Registrant and QIAGEN Manchester Limited (incorporated by reference to Exhibit 10.3010.18 to the Registrant’s Annual Report on Form 10-K (File No. 001-37369), filed with the SEC on March 23, 2018)25, 2021).
|
|
|
|
10.24*10.21
|
| Statement of Work No. 3, dated January 12, 2018, under Master Assay Development, Commercialization and Manufacturing Agreement between the Registrant and QIAGEN Manchester Limited (incorporated by reference to Exhibit 10.1 to the Registrant’s Quarterly Report on Form 10-Q (File No. 001-37369), filed with the SEC on May 10, 2018).
|
| | |
10.25*
| | First Amendment to Statement of Work No. 3, dated September 21, 2018, under Master Assay Development, Commercialization and Manufacturing Agreement between the Registrant and QIAGEN Manchester Limited (incorporated by reference to Exhibit 10.6 to the Registrant’s Quarterly Report on Form 10-Q (File No. 001-37369), filed with the SEC on November 8, 2018).
|
| | |
10.26
| | First Amendment to Statement of Work No. 2, dated August 7, 2018, under Master Assay Development, Commercialization and Manufacturing Agreement between the Registrant and QIAGEN Manchester Limited (incorporated by reference to Exhibit 10.2 to the Registrant’s Quarterly Report on Form 10-Q (File No. 001-37369), filed with the SEC on November 8, 2018).
|
| | |
10.27
| | Second Amendment to Statement of Work No. 2, dated August 13, 2018, under Master Assay Development, Commercialization and Manufacturing Agreement between the Registrant and QIAGEN Manchester Limited (incorporated by reference to Exhibit 10.3 to the Registrant’s Quarterly Report on Form 10-Q (File No. 001-37369), filed with the SEC on November 8, 2018).
|
| | |
10.28
| | Third Amendment to Statement of Work No. 2, dated September 27, 2018, under Master Assay Development, Commercialization and Manufacturing Agreement between the Registrant and QIAGEN Manchester Limited (incorporated by reference to Exhibit 10.5 to the Registrant’s Quarterly Report on Form 10-Q (File No. 001-37369), filed with the SEC on November 8, 2018).
|
Exhibit
Number
| | Description
|
| | |
10.29*
| | Supplement Agreement, dated October 26, 2017, by and among the Registrant, QIAGEN Manchester Limited and Bristol-Myers Squibb Company, as amended (incorporated by reference to Exhibit 10.31 to the Registrant’s Annual Report on Form 10-K (File No. 001-37369), filed with the SEC on March 23, 2018).
|
| | |
10.30
| | Amendment to the Supplement Agreement, dated August 13, 2018, by and among the Registrant, QIAGEN Manchester Limited and Bristol-Myers Squibb Company (incorporated by reference to Exhibit 10.4 to the Registrant’s Quarterly Report on Form 10-Q (File No. 001-37369), filed with the SEC on November 8, 2018).
|
| | |
10.31
| | Credit and Security Agreement (Term Loan) by and among the Registrant, the lenders party thereto from time to time and MidCap Financial Trust, as agent, dated March 26, 2018 (incorporated by reference to Exhibit 10.2 to the Registrant’s Quarterly Report on Form 10-Q (File No. 001-37369), filed with the SEC on May 10, 2018).
|
| | |
10.32
| | Credit and Security Agreement (Revolving Loan) by and among the Registrant, the lenders party thereto from time to time and MidCap Funding IV Trust (assignee of MidCap Financial Trust), as agent, dated March 26, 2018 (incorporated by reference to Exhibit 10.2 to the Registrant’s Quarterly Report on Form 10-Q (File No. 001-37369), filed with the SEC on May 10, 2018).
|
| | |
10.33
| | Amendment No. 1 to Credit and Security Agreement (Term Loan) by and among the Registrant, the lenders party thereto from time to time and MidCap Financial Trust, as agent, dated November 28, 2018.
|
| | |
10.34
| | Amendment No. 1 to Credit and Security Agreement (Revolving Loan) by and among the Registrant, the lenders party thereto from time to time and MidCap Funding IV Trust (assignee of MidCap Financial Trust), as agent, dated June 25, 2018.
|
| | |
10.35
| | Amendment No. 2 to Credit and Security Agreement (Revolving Loan) by and among the Registrant, the lenders party thereto from time to time and MidCap Funding IV Trust (assignee of MidCap Financial Trust), as agent, dated November 28, 2018.
|
| | |
10.36
| | Amendment No. 2 to Credit and Security Agreement (Term Loan) by and among the Registrant, the lenders party thereto from time to time and MidCap Financial Trust, as agent, dated February 26, 2020 (incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K (File No. 0001-37369), filed with the SEC on February 27, 2020).
|
| | |
10.37
| | Amendment No. 3 to Credit and Security Agreement (Revolving Loan) by and among the Registrant, the lenders party thereto from time to time and MidCap Funding IV Trust (assignee of MidCap Financial Trust), as agent, dated February 26, 2020 (incorporated by reference to Exhibit 10.2 to the Registrant’s Current Report on Form 8-K (File No. 0001-37369), filed with the SEC on February 27, 2020).
|
| | |
10.38
| | Second Amendment to Lease Agreement (Suite 100 - Administration - to include Suite 200), dated January 28, 2019, by and between Pegasus Properties, L.P. and the Registrant (incorporated(incorporated by reference to Exhibit 10.34 to the Registrant’s Annual Report on Form 10-K, filed with the SEC on March 7, 2019). | |
| | |
10.39
|
|
|
10.22 |
| FourthThird Amendment to Statement of Work No. 2,Lease Agreement (Suite 100 – Administration), dated February 15, 2019, under Master Assay Development, CommercializationDecember 8, 2020, by and Manufacturing Agreement between the Registrant and QIAGEN Manchester LimitedPegasus Properties, L.P. (incorporated by reference to Exhibit 10.510.20 to the Registrant’s QuarterlyAnnual Report on Form 10-Q10-K (File No. 001-37369), filed with the SEC on May 9, 2019)March 25, 2021).
| |
|
|
| |
10.4010.23
|
| Sales Agreement,Third Amendment, dated as of March 13, 2019, bySeptember 27, 2021, to Standard Commercial-Industrial Multi Tenant Triple Net Lease, dated July 11, 2008, between the Company and between HTG Molecular Diagnostics, Inc. and Cowen and Company, LLC (incorporatedPegasus Properties L.P. (incorporated by reference to Exhibit 1.110.1 to the Registrant’s Current Report on Form 8-K (File No. 0001-37369), filed with the SEC on March 13, 2019)September 29, 2021).
| |
|
|
| |
10.41+10.24
|
| EmploymentFourth Amendment, dated September 27, 2021, to Standard Commercial-Industrial Multi Tenant Triple Net Lease, dated May 11, 2011, between the Company and Pegasus Properties L.P. (incorporated by reference to Exhibit 10.2 to the Registrant’s Current Report on Form 8-K (File No. 0001-37369), filed with the SEC on September 29, 2021).
|
|
|
|
10.25 |
| Loan and Security Agreement dated March 31, 2019,June 24, 2020, by and between Timothy B. Johnsonamong the Registrant and the RegistrantSilicon Valley Bank (incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K (File No. 001-37369), filed with the SEC on April 2, 2019)June 24, 2020). | |
|
|
| |
10.42+10.26
|
| EmploymentFirst Amendment to Loan and Security Agreement, dated April 1, 2019,July 14, 2022, by and between John L. LubniewskiSilicon Valley Bank and the RegistrantCompany (incorporated by reference to Exhibit 10.210.1 to the Registrant’s Current Report on Form 8-K filed with the SEC on April 2, 2019).
| |
| | | |
10.43
| | First Amendment to Amended and Restated IVD Test Development and Component Supply Agreement, dated April 23, 2019, by and between Illumina, Inc. and the Registrant (incorporated by reference to Exhibit 10.6 to the Registrant’s Quarterly Report on Form 10-Q (File No. 001-37369), filed with the SEC on May 9, 2019)July 8, 2022).
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Exhibit
Number
| | Description
|
10.44+10.27
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| EmploymentSecond Amendment to Loan and Security Agreement, dated July 28, 2019,September 8, 2022, by and between Shaun D. McMeansSilicon Valley Bank and the RegistrantCompany (incorporated by reference to Exhibit 10.2 to the Registrant’s Quarterly Report on Form 10-Q (File No. 001-37369), filed with the SEC on November 12, 2019)10, 2022).
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10.4510.28
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| Securities Purchase Agreement, dated September 20, 2019, by and among the Registrantas of March 17, 2022, between HTG Molecular Diagnostics, Inc. and the Purchasers named thereinpurchaser party thereto (incorporated by reference to Exhibit 10.199.2 to the Registrant’s Current Report on Form 8-K (File No. 001-37369), filed with the SEC on September 23, 2019)March 21, 2022). |
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|
10.4623.1
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| Controlled Equity OfferingSM Sales Agreement, dated as of November 14, 2019, by and between HTG Molecular Diagnostics, Inc. and Cantor Fitzgerald & Co (incorporated by reference to Exhibit 1.1 to the Registrant’s Current Report on Form 8-K, filed with the SEC on November 15, 2019).
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| | |
10.47+
| | Employment Agreement, dated July 28, 2019, by and between Byron Lawson and the Registrant.
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23.1
| | Consent of Independent Registered Public Accounting FirmFirm.. |
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24.1 |
| Power of Attorney. Reference is made to the signature page hereto. |
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31.1 |
| Certification of Principal Executive Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
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31.2 |
| Certification of Principal Financial Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
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102
+ Indicates management contract or compensatory plan. | Indicates management contract or compensatory plan.
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*
| We have requested confidential treatment for certain portions of this agreement. Omitted portions have been filed separately with the SEC.
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Item 16. Form 10-K Summary.
None.
103
SIGNATURES
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this Report to be signed on its behalf by the undersigned, thereunto duly authorized.
| | | |
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| HTG Molecular Diagnostics, Inc. |
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Date: March 25, 202030, 2023 |
| By: | /s/ John L. Lubniewski |
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| John L. Lubniewski |
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| Chief Executive Officer (Principal Executive Officer) |
KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints John L. Lubniewski and Shaun D. McMeans, jointly and severally, his or her attorneys-in-fact, each with the power of substitution, for him or her in any and all capacities, to sign any amendments to this report, and to file the same, with exhibits thereto and other documents in connection therewith with the Securities and Exchange Commission, hereby ratifying and confirming all that each of said attorneys-in-fact, or his or her substitute or substitutes may do or cause to be done by virtue hereof.
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the Registrant in the capacities and on the dates indicated:
| | | | |
Signature |
| Title |
| Date |
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/s/ John L. Lubniewski |
| President and Chief Executive Officer and Director |
| March 25, 202030, 2023 |
John L. Lubniewski |
| (Principal Executive Officer) |
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|
/s/ Shaun D. McMeans |
| Senior Vice President and Chief Financial Officer |
| March 25, 202030, 2023 |
Shaun D. McMeans |
| (Principal Financial Officer) |
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|
/s/ Laura L. Godlewski |
| Senior Vice President of Finance and Principal Accounting OfficerAdministration |
| March 25, 202030, 2023 |
Laura L. Godlewski |
| (Principal Accounting Officer) |
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|
/s/ Timothy B. Johnson
| | Executive Chairman and Director
| | March 25, 2020
|
Timothy B. Johnson
| | | | |
| | | | |
/s/ Ann F. Hanham |
| Lead Independent DirectorChair of Board of Directors
|
| March 25, 202030, 2023 |
Ann F. Hanham |
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/s/ Harry A. GeorgeThomas W. Dubensky, Jr. |
| Director |
| March 25, 202030, 2023 |
Harry A. GeorgeThomas W. Dubensky, Jr.
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|
/s/ Michelle R. Griffin |
| Director |
| March 25, 202030, 2023 |
Michelle R. Griffin |
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|
/s/ Donnie M. Hardison |
| Director |
| March 25, 202030, 2023 |
Donnie M. Hardison |
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|
/s/ James T. LaFranceChristopher P. Kiritsy |
| Director |
| March 25, 202030, 2023 |
James T. LaFranceChristopher P. Kiritsy
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|
/s/ Lee R. McCracken |
| Director |
| March 25, 202030, 2023 |
Lee R. McCracken |
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104