We have a history of losses, and we expect to incur net losses for the foreseeable future and may never achieve or sustain profitability.
We have incurred net losses since our inception. For the year ended December 31, 2019,2022, we had a net loss of $12.6$36.6 million and as of December 31, 2019,2022, we had an accumulated deficit of $246.7$393.7 million. We expect to incur additional losses in the future, and we may never achieve revenue sufficient to offset our expenses. OverWe have experienced and may continue to experience decreases in total test volume due to the next coupleimpact of years, weCOVID-19, including as a result of additional COVID-19 variants. Additionally, in 2022, widespread inflationary pressures in the U.S. and across global economies resulted in higher costs for our raw materials, non-material costs, labor and other business costs, and significant increases in the future could adversely affect our results of operations. We expect to continue to devote substantially all of our resources to increase adoption of and reimbursement for our Afirma, Percepta and Envisia classifiers and Prosigna test,molecular diagnostic portfolio of tests, and the development of additional tests. We may never achieve or sustain profitability, and our failure to achieve and sustain profitability in the future could cause the market price of our common stock to decline.
Most of our revenue to date has been derived from the sale of our Afirma tests, which are used in the diagnosis of thyroid cancer. We also derive significant revenue from our Decipher urological tests. Over the next few years, we expect to continue to derive a substantial portion of our revenue from sales of our Afirma and Decipher tests. In the third quarter of 2017, we began recognizing revenue from the sale of our Percepta test, used in the diagnosis of lung cancer. We also launched our Envisia test to help improve the diagnosis of interstitial lung disease, specifically IPF, and began recognizing revenue from Envisia in the second quarter of 2019. In December 2019, we acquired the rights to the Prosigna test from NanoString Technologies, Inc. and commenced marketing and selling Prosigna test kits to U.S. and international customers. Once genomic tests are clinically validated and commercially available for patient testing, we must continue to develop and publish evidence that our tests are informing clinical decisions in order for them to receive positive coverage decisions by payers. Without coverage policies, our tests may not be reimbursed and we will not be able to recognize revenue. We cannot guarantee that tests we commercialize will gain and maintain positive coverage decisions and therefore, we may never realize revenue from tests we commercialize. In addition, we are in various stages of research and development for other diagnostic solutionstests that we may offer, but there can be no assurance that we will be able to identify other diseases that can be effectively addressed or, if we are able to identify such diseases, whether or when we will be able to successfully commercialize solutions for these diseases and obtain the evidence and coverage decisions from payers. If we are unable to increase sales and expand reimbursement for our Afirma Percepta, Envisia and ProsignaDecipher Prostate tests, or develop and commercialize other solutions,tests, our revenue and our ability to achieve and sustain profitability would be impaired, and the market price of our common stock could decline.
We depend on a few payers for a significant portion of our revenue and if one or more significant payers stops providing reimbursement or decreases the amount of reimbursement for our tests, our revenue could decline.
Revenue for tests performed on patients covered by Medicare and UnitedHealthcare Group was 26%31% and 11%10%, respectively, of our revenue for the twelve monthsyear ended December 31, 2019,2022, compared with 29%30% and 12%10%, respectively, for the twelve monthsyear ended December 31, 2018.2021. The percentage of our revenue derived from significant payers is expected to fluctuate from period to period as our revenue fluctuates, as additional payers provide reimbursement for our tests or if one or more payers were to stop reimbursing for our tests or change their reimbursed amounts. Effective January 2012, Palmetto GBA, the regional Medicare Administrative Contractor, or MAC, that handled claims processing for Medicare services over our jurisdiction at that time, issued coverage and payment determinations for our Afirma Classifiers now covered by Noridian Healthcare Solutions, the current MAC for our jurisdiction, through the Molecular Diagnostics Services Program, or MolDX program, administered by Palmetto GBA, under a Local Coverage Determination, oran LCD.
Although we have entered into contracts with certain third-party payers that establish in-network allowable rates of reimbursement for many of our Afirma tests, payers may suspend or discontinue reimbursement at any time, with or without notice, for technical or other reasons, may require or increase co-payments from patients, or may reduce the reimbursement rates paid to us. Reductions in private payer amounts could decrease the Medicare payment rates for our tests under PAMA. In addition, private payers have begun requiring prior authorization for molecular diagnostic tests. Potential reductions in reimbursement rates or increases in the difficulty of achieving payment could have a negative effect on our revenue.
If payers do not provide reimbursement, rescind or modify their reimbursement policies, delay payments for our tests, recoup past payments, or if we are unable to successfully negotiate additional reimbursement contracts, our commercial success could be compromised.
Physicians might not order our tests unless payers reimburse a substantial portion of the test price. There is significant uncertainty concerning third-party reimbursement of any test incorporating new technology, including our tests. Reimbursement by a payer may depend on a number of factors, including a payer’s determination that these tests are:
•not experimental or investigational;
•pre-authorized and appropriate for the specific patient;
•cost-effective;
cost-effective;
•supported by peer-reviewed publications; and
•included in clinical practice guidelines.
Since each payer makes its own decision as to whether to establish a coverage policy or enter into a contract to reimburse our tests, seeking these approvals is a time-consuming and costly process.
We are an out-of-network provider with some commercial payers in the U.S. and thus, we do not have acontrol over rates or terms of reimbursement. Without contracted rate of reimbursement with some payers for our tests. Without a contracted raterates for reimbursement, our claims are often denied upon submission, and we must appeal the claims. The appeals process is time consuming and expensive and may not result in payment. In cases where there is no contracted rate for reimbursement,we are out-of-network, there is typically a greater patient co-insurance or co-payment requirementcost-share responsibility which may result in further delay delays and/or decreased likelihood of collection. Payers may attempt to recoup prior payments after review, sometimes after significant time has passed, which would impact future revenue.
We expect to continue to focus substantial resources on increasing adoption, coverage and reimbursement for the Afirma, PerceptaDecipher Prostate, Prosigna, Envisia and Envisia classifiers, Prosigna,Decipher Bladder and any other future tests we may develop. We believe it will take several years to achieve coverage and contracted reimbursement with a majority of third-party payers. However, weWe cannot predict whether, under what circumstances, or at what payment levels payers will reimburse for our tests. Also, payer consolidation is underway and creates uncertainty as to whether coverage and contracts with existing payers will remain in effect. Finally, if there is a decrease in the Medicare payment rates for our tests, the payment rates for some of our commercial payers may also decrease if they tie their allowable rates to the Medicare rates. Reductions in private payer amounts could decrease the Medicare payment rates for our tests under PAMA. Our failure to establish broad adoption of and reimbursement for our tests, or our inability to maintain existing reimbursement from payers, will negatively impact our ability to generate revenue and achieve profitability, as well as our future prospects and our business.
We may experience limits on our revenue if physicians decide not to order our tests.
If we are unable to create or maintain demand for our tests in sufficient volume, we may not become profitable. To generate demand, we will need to continue to educate physicians about the benefitsclinical utility and cost-effectiveness of our tests through published papers, presentations at scientific conferences, marketing campaigns and one-on-one education by our sales force. In addition, our ability to obtain and maintain adequate reimbursement from third-party payers will be critical to generating revenue. Moreover, certain patients have been deferring elective procedures and medical visits as a result of the COVID-19 pandemic, and we have experienced, and expect to continue to experience, a reduction in patient demand or physician recommendations, which has and may continue to adversely affect our business.
The Afirma genomic classifier is included in most physician practice guidelines in the United States for the assessment of patients with thyroid nodules. However, historical practice recommended a full or partial thyroidectomy in cases where cytopathology results were indeterminate to confirm a diagnosis.
The strength of the clinical data supporting the use of the Decipher Prostate Biopsy and Decipher Prostate RP tests have led to the tests’ inclusion in national guidelines. For example, in the 2020 NCCN Practice Guidelines for Prostate Cancer, the Decipher Prostate RP test is “recommended” for use to improve therapy decision making. It is the only test to achieve this designation for post-surgery patients with localized prostate cancer. Further, in September 2021, the 2022 NCCN guidelines were released and recommend specific treatment decisions for patients based on their Decipher Prostate RP score. Subsequently, Decipher also received a “Level 1” evidence designation in the NCCN’s update to the 2023 prostate cancer guidelines.
Although Decipher Prostate Biopsy and Decipher Prostate RP have been integrated into the NCCN guidelines, if we are unsuccessful in maintaining and increasing the level of recommendation of our genomic tests within these guidelines, are unable to cause any new genomic tests we develop to be included in these guidelines, are unable to cause our genomic tests to be included in other influential guidelines, or if our competitors are successful at achieving similar or more extensive guidelines for their tests, we may be at a disadvantage in gaining market acceptance and market share relative to our competitors.
Our lung products are not yet integrated into practice guidelines and physicians may be reluctant to order tests that are not recommended in these guidelines. The Prosigna test is included in practice guidelines in the United States and internationally but faces competition from other products. products globally.
Because our Afirma, PerceptaDecipher Prostate Biopsy, Decipher Prostate RP, Envisia, and EnvisiaDecipher Bladder testing services are performed by our certified laboratorylaboratories under the Clinical Laboratory Improvement Amendments of 1988, or CLIA, rather than by the local laboratory or pathology practice, pathologists may be reluctant to support our testing services as well. Guidelines that include our tests currently may subsequently be revised to recommend another testing protocol, and these changes may result in physicians deciding not to use our tests. Lack of guideline inclusion could limit the adoption of our tests and our ability to generate revenue and achieve profitability. To the extent international markets have existing practices and standards of care that are different than those in the United States, we may face challenges with the adoption of our tests in international markets.
We may experience limits on our revenue if patients decide not to use our tests.tests as a result of increased costs, fees or changing insurer policies.
Some patients may decide not to use our tests because of price, all or part of which may be payable directly by the patient if the patient’s insurer denies reimbursement in full or in part. There is a growing trend among insurers to shift more of the cost of healthcare to patients in the form of higher co-payments or premiums, and this trend is accelerating which puts patients in the position of having to pay more for our tests. In addition, rising interest rates and ongoing inflation in the U.S. and globally may put further pressure on insurers and other providers to raise prices or reduce reimbursement, increasing the cost to the patient. We expect to continue to see pressure from payers to limit the utilization of tests,
generally, and we believe more payers are deploying costs containment tactics, such as pre-authorization and employing laboratory benefit managers to reduce utilization rates. Implementation of provisions of the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Affordability Reconciliation Act, collectively the ACA, has also resulted in increases in premiums and reductions in coverage for some patients. In addition, Congressional efforts to repeal the ACA could result in an increase in uninsured patients. These events may result in patients delaying or forgoing medical checkups or treatment due to their inability to pay for our tests, which could have an adverse effect on our revenue. Many patients have been deferring elective procedures and medical visits as a result of the COVID-19 pandemic, and we have experienced, and may continue to experience, a significant reduction in patient demand, which has and may continue to adversely affect our business.
If we fail to comply with federal and state licensing requirements, we could lose the ability to perform our tests or experience disruptions to our business.
We are subject to CLIA, a federal law that regulates clinical laboratories that perform testing on specimens derived from humans for the purpose of providing information for the diagnosis, prevention or treatment of disease. CLIA regulations mandate specific personnel qualifications, facilities administration, quality systems, inspections, and proficiency testing. CLIA certification is also required for us to be eligible to bill state and federal healthcare programs, as well as many private third-party payers. To renew these certifications, we are subject to survey and inspection every two years. Moreover, CLIA inspectors may makeconduct random inspections of our clinical reference laboratories. If we in the future fail to maintain CLIA certificates in our
South San Francisco, orCalifornia, San Diego, California, Austin, Texas or Richmond, Virginia laboratory locations, we would be unable to bill for services provided by state and federal healthcare programs, as well as many private third-party payers, which may have an adverse effect on our business, financial condition and results of operations.
We are also required to maintain state licenses to conduct testing in our laboratories. California, New York, and Texas, among other states’ laws, require that we maintain a license and comply with state regulation as a clinical laboratory. Other states may have similar requirements or may adopt similar requirements in the future. In addition, bothall of our clinical laboratories are required to be licensed on a test-specific basis by New York State.York. We have received approval for the Afirma, PerceptaDecipher Prostate, Envisia and EnvisiaDecipher Bladder tests. We will be required to obtain approval for other tests we may offer in the future. If we were to lose our CLIA certificate or California license for our South San Francisco laboratory,or San Diego laboratories, whether as a result of revocation, suspension, limitation or limitation,otherwise, we would no longer be able to perform our molecular tests, which would eliminate our primary source of revenue and harm our business. If we fail to meet the state licensing requirements for our Austin laboratory, we would need to move the receipt and storagewhether as a result of FNAs, as well as the slide preparation for cytopathology, to South San Francisco, whichrevocation, suspension, limitation or otherwise, it could result in a delay in processing tests during that transition and increased costs. If we were to lose our licenses issued by New York or by other states where we are required to hold licenses, we would not be able to test specimens from those states. New tests we may develop may be subject to new approvals by regulatory bodies such as the New York State Department of Health, and we may not be able to offer our new tests until such approvals are received.
Our quarterly operating results may fluctuate significantly or may fall below the expectations of investors or securities analysts for various reasons, including in response to the way we recognize revenue and/or the amount of cash we generate, which may cause our stock price to fluctuate or decline.
Our quarterly financial and operating results depend on sales of our products in the markets we operate and are sensitive to a number of factors, including patient and clinician demand, market conditions in the US and globally, and the prevalence of the indications we seek to address. In addition, we cannot be sure that we will be able to successfully complete development of or commercialize any of our planned future products, or that they will prove to be capable of reliably being used. Before we can successfully develop and commercialize any of our currently planned or other new diagnostic solutions, we will need to:
•conduct substantial research and development;
•obtain the necessary testing samples and related data;
•conduct analytical and clinical validation studies, as well as clinical utility studies;
•expend significant funds;
•expand and scale-up our laboratory processes;
•expand and train our sales force;
•gain acceptance from ordering clinicians at a larger number of hospitals;
•gain acceptance from ordering laboratories; and
•seek and obtain regulatory clearances, approvals or certifications of our new solutions, as required by applicable regulatory bodies.
This process involves a high degree of risk and may take up to several years or more. Our test development and commercialization efforts may be delayed or fail for many reasons, including:
•failure of the test at the research or development stage;
•difficulty in accessing suitable testing samples, especially testing samples with known clinical results;
•lack of analytical and clinical validation data to support the effectiveness of the test, or lack of clinical utility data to support the value of the test;
•delays resulting from the failure of third-party suppliers or contractors to meet their obligations in a timely and cost-effective manner;
•failure to obtain or maintain necessary clearances, approvals or certifications to market the test;
•manufacturing constraints due to limited energy supply in Europe or other supply constraints; or
•lack of commercial acceptance by patients, clinicians or third-party payers.
Few research and development projects result in commercial products, and success in early clinical studies often is not replicated in later studies. At any point, we may abandon development of new diagnostic tests, or we may be required to expend considerable resources repeating clinical studies, which would adversely impact the timing for generating potential revenue from those new diagnostic tests. In addition, as we develop diagnostic tests, we will have to make additional investments in our sales and marketing operations, which may be prematurely or unnecessarily incurred if the commercial launch of a test is abandoned or delayed. If a clinical validation study fails to demonstrate the prospectively defined endpoints of the study, we would likely abandon the development of the test or test feature that was the subject of the clinical study, which could harm our business. If a clinical utility study fails to demonstrate the value of a particular test, we may not be able to obtain reimbursement for the test.
In addition, we recognize test revenue upon delivery of the patient report to the prescribing physician based on the amount we expect to ultimately realize. We determine the amount we expect to ultimately realize based on payer reimbursement history, contracts, and coverage. Upon ultimate collection, the amount received is compared to the estimates and the amount accrued is adjusted accordingly. We cannot be certain as to when we will receive payment for our diagnostic tests, and we must appeal negative payment decisions, which delays collections. Should judgments underlying estimated reimbursement change or be incorrect at the time we accrued such revenue, our financial results could be negatively impacted in future quarters. Furthermore, most of our European sales are denominated in Euros, and as the U.S. dollar has strengthened in recent periods relative to the Euro, our results of operations may be adversely affected even where our underlying business is performing as anticipated. As a result, comparing our operating results on a period-to-period basis may not be meaningful. You should not rely on our past results as an indication of our future performance. In addition, these fluctuations in revenue may make it difficult for us, for securities analysts and for investors to accurately forecast our revenue and operating results. If our revenue or operating results fall below expectations, the price of our common stock would likely decline.
If we are not successful in integrating the assets acquired from NanoString or if our general strategy of seeking growth through such acquisitions and collaborations is not successful, or if we do not successfully integrate companies or assets that we acquire into our business, our prospects and financial condition will suffer.
We have recentlyAs an element of our growth strategy, we may pursue opportunities to license assets or purchase companies or assets that we believe would complement our current business or help us expand into new markets. For example, we acquired assets, such as the nCounter FLEX Analysis System and Prosigna in December 2019,test from NanoString; we also acquired Decipher Biosciences and weHalioDx. We may pursue additional acquisitions of complementary businesses or assets as part of our business strategy. To date, we have limited experience with respect to acquisitions and the formation of strategic alliances and joint ventures. There can be no assurance that we will successfully integrate the assets acquired from NanoString successfullysuch acquisitions into our existing business, in general, or that our exclusive worldwide license to the nCounter systemAnalysis System for in vitro diagnostic use granted by NanoString will allow us to expand our international reach as anticipated. This and any future acquisitions made by us also could result in significant write-offs or the incurrence of debt and contingent liabilities, any of which could harm our operating results. Integration of acquired companies or businesses we may acquire in the future also may require management resources that otherwise would be available for ongoing development of our existing business. We may not identify or complete these transactions in a timely manner, on a cost-effective basis, or at all, and we may not realize the anticipated benefits of any acquisition, technology license, strategic alliance, joint venture or investment.
To finance any acquisitions or investments, we have previously issued and may choose in the future to issue shares of our stock as consideration, which would dilute the ownership of our stockholders. If the price of our common stock is low or volatile, we may not be able to acquire other companies for stock. Alternatively, it may be necessary for us to raise additional funds for these activities through public or private financings. Additional funds may not be available on terms that are favorable to us, or at all. If these funds are raised through the sale of equity or convertible debt securities, dilution to our stockholders could result.
Our Loanfuture success and Security Agreement with Silicon Valley Bank contains covenants that could limitinternational growth depends, in part, on our ability to sell debt securities or obtain additional debt financing arrangements, which could affectadapt and manufacture select tests to be performed on the nCounter Analysis System.
Our strategy to expand into international markets depends on our ability to finance acquisitions or investments other than throughsuccessfully acquire and distribute the issuancenCounter Analysis System, adapt our menu of stock.
diagnostic tests for the platform, and secure necessary regulatory approvals. Currently, the Prosigna breast cancer assay is the only commercially-available test on the platform. If we are not successful in advancingable to adapt our collaborations with Johnson & Johnson and others,other current or future genetic tests to be performed on the nCounter Analysis System, or if our general strategy of seeking growth through such collaborations is not successful,the nCounter Analysis System fails to be competitive against other diagnostic platforms, our prospects for growth could suffer. In addition, to the extent
international markets have existing practices and financial condition will suffer.standards of care that are different than those in the United States, we may face challenges with the adoption of the nCounter Analysis System in international markets.
The growth that we are expecting in our biopharma services business may not transpire.
We have previously entered into technology licensing and collaboration arrangements, such as our collaborationcollaborations with Johnson & Johnson in December 2018, and with Acerta Pharma, the hematology research and development arm of AstraZeneca, in December 2019 reflectingand with CareDx in May 2020, which reflect an important elementselement of our business strategy. We also may pursue additional strategic alliances that leverage our core technologyWith the acquisition of Decipher Biosciences and industry experienceHalioDx, we continue to seek to expand the range of our biopharma services offerings to pharmaceutical partners with services such as clinically relevant biomarker identification, patient stratification for clinical trials, and development of companion diagnostics. The success of our biopharma services business depends in part on our ability to identify and successfully negotiate with appropriate pharma partners. We cannot guarantee that we will be successful in the identification of appropriate pharma partners or distribution,the successful and timely negotiation with such partners.
The COVID-19 pandemic has had, and may continue to have, an adverse effect on certain of our business, results of operations and financial condition.
The COVID-19 pandemic and the ongoing emergence of new variants has caused, and continues to cause, significant volatility in global financial markets. Public health problems resulting from COVID-19 and precautionary measures instituted by governments and businesses to mitigate its spread, including travel restrictions and quarantines, have contributed to a general slowdown in the global economy, adversely impacted patients, physicians, customers, suppliers, third-party contract manufacturers, and collaboration partners, and disrupted our operations. The global COVID-19 pandemic continues to evolve. Certain jurisdictions have begun re-opening only to return to restrictions due to increases in new COVID-19 cases and the emergence of new variant strains of COVID-19. Changes in our operations in response to COVID-19 or make investmentsemployee illnesses resulting from the pandemic may result in other companies. However, we have limited experience with respectinefficiencies or delays, including in sales and product development efforts, timing to receive patient sample shipments and additional costs related to business continuity initiatives, that cannot be fully mitigated through succession planning, employees working remotely or teleconferencing technologies. To date, the formationFDA has approved several vaccines, certain of strategic allianceswhich are subject to an Emergency Use Authorization, or EUA, for certain uses. Although vaccines are increasingly available in the United States and joint ventures. ThereEurope, and certain countries in South America, Asia and Oceania, there can be no assuranceguarantee that the vaccines will be effective against new strains of the virus or that the vaccines will be broadly accepted. Also there can be no guarantee that federal, state, local and foreign agencies will not continue to take other cautionary steps to combat the virus to reduce the incidence of new cases, which could negatively impact our volumes and revenue and limit our ability to reliably forecast our test volumes and levels of revenue.
COVID-19 and related governmental reactions have had and may continue to have a negative impact on our business, liquidity, results of operations, and stock price due to the occurrence of some or all of the following events or circumstances among others:
•Inability of healthcare providers to deliver anticipated total test volumes due to temporary or permanent staff attrition.
•We may not be able to manage our business effectively due to key employees becoming ill, working from home inefficiently and being unable to travel to our facilities.
•We and our customers, suppliers, third-party contract manufacturers, and collaboration partners may be prevented from operating worksites, including manufacturing facilities, due to employee illness, reluctance to appear at work or “stay-at-home” regulations.
•Interruptions in manufacturing (including the sourcing of reagents or supplies) and shipment of our products. We believe the rapid increase in daily testing volumes is consuming reagents and supplies otherwise available to genomic testing companies like ours across the United States. When not limited by the expiration date of products and when we feel it reasonable and feasible to do so, we are taking steps to increase our level of supplies and inventory reserves, to develop alternative sources of supply and to implement procedures to mitigate the impact on our supply chain or our ability to process samples in our laboratories. Though we are in regular contact with our key suppliers, we do not have, nor expect to have, the necessary insight into our vendors’ supply chain issues that we may need to know to effectively mitigate the impact to our business. Though we attempt to mitigate the impact to our business, these interruptions in manufacturing (including the sourcing of reagents or supplies) may negatively impact our total test volumes or levels of revenue.
•Reduced patient demand for, or provider capacity to deliver, diagnostic testing and elective procedures generally (which may impact our ability to deliver to our revenue estimates).
•Disruptions of the operations of our third-party contract manufacturers and suppliers, which could impact our ability to purchase components at efficient prices and in sufficient amounts.
•We may need to raise capital, and if we raise capital by issuing equity securities, our common stock may be diluted.
•The market price of our common stock may drop or remain volatile.
•We may incur significant employee health care costs under our insurance programs.
•Inability or delay of regulatory bodies to conduct inspections/surveys, review or clear/approve our regulatory filings and submissions, and perform other activities necessary for us to conduct our business.
The extent of the impact of COVID-19 on our business and financial results will successfully identify or complete these transactions in a timely manner,depend largely on a cost-effective basis, orfuture developments, including the deployment, efficacy, availability and utilization of vaccines, the emergence of new variant strains of COVID-19, the impact on capital and financial markets and the related impact on the financial circumstances of patients, physicians, suppliers, third-party contract manufacturers, and collaboration partners, all of which are highly uncertain and cannot be predicted. This situation is changing rapidly, and additional impacts may arise that we are not aware of at all, and we may not realize the anticipated benefits of any technology license, strategic alliance, joint venture or investment.this time.
We rely on sole suppliers for some of the reagents, equipment chips and other materials used to perform our tests, and we may not be able to find replacements or transition to alternative suppliers.
We rely on sole suppliers for critical supply of reagents, equipment chips and other materials and services that we use to perform our tests, and for the manufacture of the nCounter FLEX Dx systemsAnalysis System for diagnostic use and Prosigna test kits sold to customers. We also purchase components used in our sample collection kits from sole-source suppliers. Some of these items are unique to these suppliers and vendors. In addition, we utilize a sole source to assemble and distribute our sample collection kits.
We rely on NanoString for the supply of the nCounter FLEX DxAnalysis System for diagnostic use and Prosigna test kits. As part of the HalioDx Acquisition we intended to, and have begun to migrate manufacture of the test kits for the nCounter from NanoString to HalioDx. In the future, we may need to transition the manufacture of the nCounter Analysis System for diagnostic use from NanoString to Veracyte. While we are preparing for such transition, we cannot be certain that we will be successful in effectively manufacturing the system or acquiring or retaining the talent, skillset, or suppliers required to manufacture the system.
While we have developed alternate sourcing strategies for these materials and vendors, we cannot be certain whether these strategies will be effective or the alternative sources will be available when we need them. Moreover, the supply of key reagents and testing materials has been severely challenged by the COVID-19 pandemic. Periodically, as a result of the COVID-19 pandemic and other challenges to global supply chains, we experienced supply chain disruptions in the supply of plastic materials used in the processing of samples, although this has not resulted in delays in our ability to timely return test results. If these suppliers can no longer provide us with the materials we need to perform the tests and for our sample collection kits, if the materials do not meet our quality specifications or are otherwise unusable, if we cannot obtain acceptable substitute materials, or if we elect to change suppliers, an interruption in test processing or system and test kit deliveries could occur, we may not be able to deliver tests to physicians or deliver patient reports and we may incur higher one-time switching costs. Carriers responsible for transporting samples to us are currently operating at lower than usual capacity because of COVID-19, causing delays in the timeliness of our receipt of samples. Any such interruption may significantly affect our future revenue, cause us to incur higher costs, and harm our customer relationships and reputation. In addition, in order to mitigate these risks, we maintain inventories of these supplies at higher levels than would be the case if multiple sources of supplies were available. If our total test volume decreases or we switch suppliers, we may hold excess supplies with expiration dates that occur before use which would adversely affect our losses and cash flow position. As we introduce any new test, we may experience supply issues as we ramp test volume. Moreover, the COVID-19 pandemic has disrupted supply chains globally, and could adversely affect our ability to source essential reagents, equipment and other materials in a timely manner or at all.
We depend on a specialized cytopathology practice to perform the cytopathology component of our Afirma test, and our ability to perform our diagnostic solution would be harmed if we were requiredunexpectedly unable to secure a replacement.
We rely on TCP to provide cytopathology professional diagnoses on thyroid FNA samples pursuant to a pathology services agreement. Pursuant to this agreement, as amended, TCP has the exclusive right to provide our cytopathology diagnoses on FNA samples at a fixed price per test. Until February 2019, TCP also previously subleased a portion of our
facility in Austin, Texas. Our agreement with TCP is effective through October 31, 2022,2023, and thereafter automatically renews every year unless either party provides notice of intent not to renew at least 12 months prior to the end of the then-current term.
If TCP were not ableunexpectedly unable to support our current test volume or future increases in total test volume or to provide the quality of services we require, or if we were unable to agree on commercial terms and our relationship with TCP were to terminate, our business wouldcould be harmed until we were able to secure the services of another cytopathology provider. There can be no assurance that we would be successful in finding a replacement that would be able to conduct cytopathology diagnoses at the same volume or with the same high-quality results as TCP. Locating another suitable cytopathology provider could be time consuming and would result in delays in processing Afirma tests until a replacement was fully integrated with our test processing operations.
Due to how we recognize revenue, our quarterly operating results are likely to fluctuate.
We recognize test revenue upon delivery of the patient report to the prescribing physician based on the amount we expect to ultimately realize. We determine the amount we expect to ultimately realize based on payer reimbursement history, contracts, and coverage. Upon ultimate collection, the amount received is compared to the estimates and the amount accrued is adjusted accordingly. We cannot be certain as to when we will receive payment for our diagnostic tests, and we must appeal negative payment decisions, which delays collections. Should judgments underlying estimated reimbursement change or were incorrect at the time we accrued such revenue, our financial results could be negatively impacted in future quarters. As a result, comparing our operating results on a period-to-period basis may not be meaningful. You should not rely on our past results as an indication of our future performance. In addition, these fluctuations in revenue may make it difficult for us, for research analysts and for investors to accurately forecast our revenue and operating results. If our revenue or operating results fall below expectations, the price of our common stock would likely decline.
We may be unable to manage our future growth effectively, which could make it difficult to execute our business strategy.
In addition to the need to scale our testing capacity, future growth, including our transition to a multi-product company with international operations, will impose significant added responsibilities on management, including the need to identify, recruit, train and integrate additional employees with the necessary skills to support the growing complexities of our business. Rapid and significant growth may place strain on our administrative, financial and operational infrastructure. Our ability to manage our business and growth will require us to continue to improve our operational, financial and management controls, reporting systems and procedures. We have implemented an internally-developed data warehouse, which is critical to our ability to track our diagnostic services and patient reports delivered to physicians, as well as to support our financial reporting systems. The time and resources required to optimize these systems is uncertain, and failure to complete optimization in a timely and efficient manner could adversely affect our operations. If we are unable to manage our growth effectively, it may be difficult for us to execute our business strategy and our business could be harmed.
If we are unable to support demand for our commercial tests, services or products, our business could suffer.
As demand for our tests, grows,services and products grow, we will need to continue to scale our testing capacity, and processing technology, expand customer service, billing and systems processes, and enhance our internal quality assurance program.program and expand our manufacturing capacity. We will also need additional certified laboratory scientists andas well as other scientific and technical personnel to process higher volumes of our tests.volumes. We cannot assure you that any increases in scale, related improvements and quality assurance will be successfully implemented or that appropriate personnel will be available.available and able to be hired. Failure to implement necessary procedures, transition to new processes or hire the necessary personnel could result in higher costs of processing tests, quality control issues or inability to meet demand. There can be no assurance that we will be able to perform our testing or fulfill our product, testing, or service commitments on a timely basis at a level consistent with demand, or that our efforts to scale our operations will not negatively affect the quality of test results. If we encounter difficulty meeting market demand or quality standards, our reputation could be harmed and our future prospects and our business could suffer.
Changes in healthcare policy, including legislation reforming the U.S. healthcare system, may have a material adverse effect on our financial condition and operations.
The ACA, enacted in March 2010, made changes that significantly affected the pharmaceutical and medical device industries and clinical laboratories. Along with the now-repealed 2.3% excise tax on the sale of certain medical devices sold outside of the retail setting, 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.
In the beginning of 2017, the U.S. Congress and the Administration took actions to repeal the ACA and indicated an intent to replace it with another act andaddition, various efforts to repeal or amend the ACA are ongoing. We cannot predict if, or when, the ACA will be repealed or amended, and cannot predict the impact that an amendment or repeal of the ACA will have on our business.
In addition to the ACA, various healthcare reform proposals have also periodically emerged from federal and state governments. For example, in February 2012, Congress passed the Middle Class Tax Relief and Job Creation Act of 2012, which in part reset the clinical laboratory payment rates on the Medicare Clinical Laboratory Fee Schedule, or CLFS, by 2% in 2013. In addition, under the Budget Control Act of 2011, which is effective for dates of service on or after April 1, 2013, Medicare payments, including payments to clinical laboratories, are subject to a reduction of 2% due to the automatic expense reductions (sequester) until fiscal year 2024. In March 2020, Congress passed the CARES Act, which suspended the 2%
reduction in Medicare fee-for-service payments from May 1, 2020 through December 31, 2020. To account for this temporary suspension, the legislation also extends the effect of sequestration by a year (now through fiscal year 2031). Reductions resulting from the Congressional sequester are applied to total claims payment made; however, they do not currently result in a rebasing of the negotiated or established Medicare or Medicaid reimbursement rates. In December 2020, Congress passed the Consolidated Appropriations Act of 2021, or CAA, which extended the suspension through March 31, 2021. Legislation enacted April 14, 2021 further extended the suspension through December 31, 2021. The Protecting Medicare and American Farmers from Sequester Cuts Act, enacted on December 10, 2021, extends the suspension through March 31, 2022, after which a 1.0% sequestration would apply for Medicare payments made between April 1, 2022 and June 30, 2022. The legislation also applies a 2.25% sequestration to Medicare payments made during the first six months of fiscal year 2030, and a 3% reduction to payments made during the last six months of fiscal year 2030.
State legislation on reimbursement applies to Medicaid reimbursement and managed Medicaid reimbursement rates within that state. Some states have passed or proposed legislation that would revise the reimbursement methodology for clinical laboratory payment rates under those Medicaid programs. For example, effective July 2015, California’s Department of Health Care Services implemented a new rate methodology for clinical laboratories and laboratory services. This methodology involvesinvolved the use of a range of rates that fell between zero and 80% of the calculated California-specific Medicare rate and the calculation of a weighted average (based on units billed) of such rates. Effective for dates of service on or after July 1, 2022, the cap at 80% of the Medicare rate has been replaced with a cap at 100% of the lowest maximum allowance established by the federal Medicare program for the same or similar services.
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 do or may do business, or the effect any future legislation or regulation will have on us. The taxes imposed by the new federal legislation, cost reduction measures and the expansion in the role of the U.S. government in the healthcare industry may result in decreased revenue, lower reimbursement by payers for our tests or reduced medical procedure volumes, all of which may adversely affect our business, financial condition and results of operations. In addition, sales of our tests outside the United States subject our business to foreign regulatory requirements and cost-reduction measures, which may also change over time.
Ongoing calls for deficit reduction at the federal government level and reforms to programs such as the Medicare program to pay for such reductions may affect the pharmaceutical, medical device and clinical laboratory industries. Currently, clinical laboratory services are excluded from the Medicare Part B co-insurance and co-payment as preventative services. Any requirement for clinical laboratories to collect co-payments from patients may increase our costs and reduce the amount ultimately collected.
CMS bundles payments for clinical laboratory diagnostic tests together with other services performed during hospital outpatient visits under the Hospital Outpatient Prospective Payment System. CMS currently maintains an exemption for molecular pathology tests and “Criterion A” ADLTs from this bundling provision. It is possible that this exemption could be removed by CMS in future rule making, which might result in lower reimbursement for tests performed in this setting.
PAMA includes a substantial new payment system for clinical laboratory tests under the CLFS. Under PAMA, laboratories that receive the majority of their Medicare revenuesrevenue from payments made under the CLFS and the Physician Fee Schedule would report on a triennial basesbasis (or annually for advanced diagnostic laboratory tests, or ADLTs), private payer rates and volumes for their tests with specific CPT codes based on final payments made during a set data collection period (the first of which was January 1 through June 30, 2016). We believe that PAMA and its implementing regulations are generally favorable to us. We reported to CMS the data required under PAMA before the March 31, 2017 deadline. The new payment rate for the Afirma genomic classifier based on the volume-weighted median of private payer rates took effect January 1, 2018, increasing from $3,220 to $3,600 through December 31, 2020. In December 2019, through the Further Consolidated Appropriations Act of 2020, Congress delayed the next data reporting period from 2020 to 2021 for final payments made between January 1 and June 30, 2019, extending the applicability of the current rate for Afirma through December 31, 2021. The volume-weighted median ofIn March 2020, through the private payer ratesCARES Act, Congress further delayed the next reporting period to 2022 for final payments made between January 1 and June 30, 2019, will now setextending the applicability of the payment rates based on 2017 reporting through December 31, 2022. In December 2021, through the Protecting Medicare payment rate forand American Farmers from Sequester Cuts Act, Congress further delayed the Afirma classifier from January 1,next reporting period to 2023. In December 2022, through December 31,the Consolidated Appropriations Act of 2023, Congress further delayed the next reporting period to 2024. There can be no assurance that the payment rate for Afirma or Prosigna will not decrease in the future or that the payment rates for PerceptaDecipher Prostate Biopsy, Decipher Prostate RP or EnvisiaDecipher Bladder will not be adversely affected by the PAMA law and regulations.
We believe our Afirma genomic
Our Envisia classifier was approved by CMS as well as our Percepta and Envisia classifiers would be considered ADLTs under PAMA.a New ADLT on September 17, 2020. The initial payment rate (for a period not to exceed nine months) under PAMA for a newNew ADLT (an ADLT for which payment has not been made under the CLFS prior to January 1, 2018) will be set at the “actual list charge” for the test as reported by the laboratory. Insofar as the actual list charge substantially exceedsEffective July 1, 2021, Envisia is priced based on private payer rates (by more than 30%), CMS will have the ability to recoup excess payments made during the initial nine-month payment period.collected and reported annually. We can determine whether to seek ADLT status for our tests, but there can be no assurance that our tests will be designated ADLTs or that the payment rates for our tests, including Envisia, will not be adversely affected by such designation.
There have also been recent and substantial changes to the payment structure for physicians, including those passed as part of the Medicare Access and CHIP Reauthorization Act of 2015, or MACRA, which was signed into law on April 16, 2015. MACRA created the Merit-Based Incentive Payment System which, beginning in 2019, more closely aligns physician payments with composite performance on performance metrics similar to three existing incentive programs (i.e., the Physician Quality Reporting System, the Value-based modifier program and the Electronic Health Record Meaningful Use program) and incentivizes physicians to enroll in alternative payment methods. At this time, we do not know whether these changes to the physician payment systems will have any impact on orders or payments for our tests.
In December 2016, Congress passed the 21st Century Cures Act, which, among other things, revised the process for LCDs. Additionally, effective June 11, 2017, a MAC is required to, among other things, publish a summary of the evidence that it considered when developing an LCD, including a list of sources, and an explanation of the rationale that supports the MAC’s determinations. In October 2018, CMS issued additional guidance revising the requirements for the development of LCDs. We cannot predict whether these revisions will delay future LCDs and result in impeded coverage for our test products, which could have a material negative impact on revenue.
Congress is considering legislation to limit balance billing of patients who receive services from out-of-network providers (including laboratories) at in-network facilities and to set a methodology for paymentIn December 2020, in its enactment of the CAA, Congress enacted the No Surprises Act. This law, which takes effect January 1, 2022, prohibits an out-of-network provider from billing a patient at an amount in such circumstances. This legislation, if enacted,excess of the in-network cost sharing for services furnished with respect to a visit at certain in-network health-care facilities. The law establishes an independent dispute resolution process between the provider and the payer to determine the appropriate payment rate to the provider. As written, the No Surprises Act may apply to laboratory tests furnished by an independent laboratory with respect to a hospital visit. The law establishes a notice and consent exception that generally does not apply to laboratory tests, although it allows for the Secretary of the Department of Health and Human Services, or HHS, to apply the exception to certain advanced tests. HHS, the Department of Labor, and the Department of the Treasury have implemented the No Surprises Act through rulemakings issued on July 1, 2021, September 30, 2021, and August 19, 2022. The No Surprises Act, and regulations and subregulatory guidance promulgated thereunder, could limit our ability to achieve payment in full for our testing services.
Because of Medicare billing rules, we may not receive reimbursement for all tests provided to Medicare patients.
Under previous Medicare billing rules, hospitals were required to bill for our molecular pathology tests when performed on Medicare beneficiaries who were hospital outpatients at the time of tissue specimen collection when these tests were ordered less than 14 days following the date of the patient's discharge.
Effective January 1, 2018, CMS revised its billing rules to allow the performing laboratory to bill Medicare directly for molecular pathology tests and Criterion A ADLTs performed on specimens collected from hospital outpatients, even when those tests are ordered less than 14 days after the date of discharge, if certain conditions are met. We believe that our Afirma, Percepta,Decipher Prostate Biopsy, Decipher Prostate RP, Envisia, and EnvisiaDecipher Bladder classifiers, along with Prosigna, should be covered by this policy. Accordingly, we bill Medicare for these tests when we perform them on specimens collected from hospital outpatients and meet the conditions set forth in CMS's revised billing rules.
This change does not apply to tests performed on specimens collected from hospital inpatients. We will continue to bill hospitals for tests performed on specimens collected from hospital inpatients when the test was ordered less than 14 days after the date of discharge.
In the CY 2020 Hospital Outpatient Prospective Payment System Proposed Rule, CMS solicited comments on potential revisions to these billing rules that could have impacted our ability to bill Medicare directly for our Afirma, Percepta,Decipher Prostate Biopsy, Decipher Prostate RP, Envisia, and EnvisiaDecipher Bladder classifiers, as well as for Prosigna, when performed on specimens collected from hospital outpatients. Although these changes were not finalized, if CMS makes similar changes in the future, it could negatively impact our business.
In addition, we must maintain CLIA compliance and certification to sell our tests and be eligible to bill for diagnostic services provided to Medicare beneficiaries.
If the FDA or foreign authorities were to begin regulating those of our tests that arethey do not currently regulated,regulate, we could incur substantial costs and delays associated with trying to obtain premarket clearance, approval or approval.certification.
Clinical laboratory tests have long been subject to comprehensive regulations under CLIA, as well as by applicable state laws. Most clinical diagnostic tests developed and run within a single CLIA-certified clinical laboratory (known as “laboratory developed tests,tests” or LDTs,“LDTs”), are not currently subject to regulation under the FDA's enforcement discretion policy although reagents, instruments, software or components provided by third parties and used to perform LDTs may be subject to regulation.concerning LDTs. While the FDA maintains its authority to regulate LDTs, it has chosencontinues to exercise its enforcement discretion not to enforce the premarket review, quality system/current Good Manufacturing Practices regulations, and other applicable medical device requirements for LDTs.against most LDT developers and users. Certain reagents, instruments, software or components manufactured and sold by third parties and used by their customers to manufacture or perform diagnostic tests may be subject to regulation under certain circumstances. We believe that the Afirma, PerceptaDecipher Prostate Biopsy, Decipher Prostate RP, Envisia, and EnvisiaDecipher Bladder classifiers, have been developed and are LDTs that fall under the FDA'sperformed in a manner consistent with FDA’s enforcement discretion policy. policy concerning LDTs.
In October 2014, the FDA issued draft guidance, entitled "Framework for Regulatory Oversight of LDTs," proposing a risk-based framework of oversight and a phased-in enforcement of premarket review requirements for most LDTs. In 2016, the FDA announced that it would not be finalizing the guidance.
In January 2017, the FDA issued a "Discussion Paper on Laboratory Developed Tests" following input it received from multiple stakeholders who had commented on its 2014 draft guidance. The FDA specifically states in its Discussion Paper that the proposals contained in the document do not represent a final version of the LDTtwo draft guidance documents and are only designedstating that the FDA intended to providemodify its policy of enforcement discretion with respect to LDTs in a possiblerisk-based manner consistent with the existing classification of medical devices. Although the FDA halted finalization of the guidance in November 2016 to allow for further public discussion on an appropriate oversight approach to spark further dialogue. The suggested LDT framework could grandfather many types of LDTs without requiring new premarket reviewand to give Congressional authorizing committees the opportunity to develop a legislative solution, it is unclear if Congress or quality management requirements. It also suggests a four-year phased implementation of the premarket review requirements for some types of tests. In a December 2018 statement, the FDA said that there is a need for “a unifiedwill modify the current approach to the regulation of LDTs in a way that would subject our current or future services marketed as LDTs to FDA regulatory requirements. The FDA Commissioner and the Director of the Center for Devices and Radiological Health, or CDRH, have expressed significant concerns regarding disparities between some LDTs and in vitro clinicaldiagnostics that have been reviewed, cleared, authorized or approved by the FDA. If the FDA were to determine that Afirma, Decipher Prostate Biopsy, Decipher Prostate RP, Envisia and Decipher Bladder classifiers are not within the scope of FDA's enforcement discretion policy for LDTs for any reason, including new rules, policies or guidance, or due to changes in statute, our tests may become subject to protect patient safety, support innovation,extensive FDA requirements, or our business may otherwise be adversely affected. If the FDA were to disagree with our LDT status or modify its approach to regulating LDTs, we could experience reduced revenue or increased costs, which could adversely affect our business, prospects, results of operations and keep pace with the rapidly evolving technology that’s helping us find new treatments for disease.” The FDA listed key principles of an approach it would support.financial condition.
In March 2017, a draft bill on the regulation of LDTs, entitled "The Diagnostics Accuracy and Innovation Act", or DAIA, was released for discussion. In December 2018, the sponsors of DAIA released a new version of the legislation called the “Verifying Accurate, Leading-edge IVCT Development Act,Act", or VALID Act. The VALID Act proposes a risk-based approach to regulate LDTs and creates a new in vitro clinical test category, which includes LDTs, and a new regulatory structure under the FDA. Similar versions of the VALID Act have since been introduced. The most recent version was included in the Food and Drug Administration (FDA) Safety and Landmark Advancements Act (FDASLA) reported to the Senate on July 13, 2022. As proposed, the bill would create a precertification program for lower risk tests not otherwise required to go through premarket review. It would grandfather certain existing tests from some requirements but would allow the FDA to subject otherwise grandfathered tests to premarket review under certain conditions. Similarly, the Verified Innovative Testing in American Laboratories (VITAL) Act was introduced in December 2020 and re-introduced in May 2021. In contrast with the VALID Act, the VITAL Act would prevent FDA from regulating LDTs and would instead assign regulatory authority over LDTs entirely to CMS. We cannot predict whether thiseither of these or other draft billbills governing LDTs will become legislation and cannot quantify the effect of thissuch draft billbills on our business.
In addition, changes in the way the European Union, or EU, regulates LDTs could result in additional expenses for offering our current and any future tests or possibly delay or suspend development, or commercialization of such tests. The EU Regulation (EU) 2017/746 of April 5, 2017, repealing the IVDD, referred to as the IVD Medical Devices Regulation, or IVDR, became applicable on May 26, 2022 (subject to certain transition provisions). Under the IVDR, the general safety and performance requirements set out in Annex I are also applicable to devices that are not placed on the market but used in the context of a commercial activity. If our tests do not qualify for an exemption, we may be subject to the full application of the IVDR with respect to some or all of our existing, as well as future, tests, and we would be required to expend additional time and resources to complying with the requirements of the IVDR. Following Brexit, the IVDR will not be applicable in Great Britain (although it will apply in Northern Ireland), but the UK government is currently undertaking a consultation on the
regime applicable to in vitro diagnostics in the UK, and it is anticipated that similar provisions will be introduced as under the IVDR.
If the FDA or foreign authorities were to require us to seek clearance, approval or approvalcertification for our existing tests that are not currently cleared, approved, or certified or any of our future products for clinical use, we may not be able to obtain such clearances, approvals or certifications on a timely basis, or at all. While we believeit is possible that our Afirma, PerceptaDecipher Prostate Biopsy, Decipher Prostate RP, Envisia, and EnvisiaDecipher Bladder classifiers, would likely qualify for thebe “grandfathered” tests treatment,and therefore exempted from some new regulatory requirements, there can be no assurance of what the FDA might ultimately require if it issued final guidance.issues a rule or if legislative reforms are enacted. If premarket reviews wereor certifications are required, our business could be negatively impacted if we wereare required to stop selling our products pending their clearance, approval or approval.certification. In addition, the launch of any new products that we develop or modifications we make to existing products could be delayed by the implementation of future FDA guidance.or foreign regulations. The cost of complying with premarket review or certification requirements, including obtaining clinical data, could be significant. In addition, any future regulation by the FDA or foreign authorities could subject our business to further regulatory risks and costs. Failure to comply with applicable regulatory requirements of the FDA could result in enforcement action, including receiving untitled or warning letters, fines, injunctions, or civil or criminal penalties. Any such enforcement action would have a material adverse effect on our business, financial condition and operations. In addition,For example, our sample collection containerskits are listed as Class I devices with the FDA. If the FDA were to determine that they are not Class I devices or otherwise not exempt from 510(k) clearance requirements, we would be required to file 510(k) applicationspremarket notifications and obtain FDA clearance to use the containers, which could be time consuming and expensive.
Some of the materials weThe FDA has raised potential concerns where companies manufacture and label finished clinical test kits or clinical testing components as “research use for our tests and that we may use for future tests are labeled for research use only,only”, or RUO, or investigational“investigational use only,only”, or IUO. In November 2013, the FDA finalized guidance regarding the saleIUO, and either knowingly use of products labeled RUOthem or IUO. Among other things, the guidance advises that the FDA continues to be concerned about distribution of research or investigationalsell them for use only products intended for clinical diagnostic use and that the manufacturer’s objective intent for the product’s intended use will be determined by examining the totality of circumstances, including advertising, instructions for clinical interpretation, presentations that describe clinical use, and specialized technical support, surrounding the distribution of the product in question.patient care. The FDA has advisedtaken the position that if evidence demonstrates that a product which otherwise meets the definition of a regulated medical device is inappropriately labeled for researchas RUO or investigational-use only,IUO, the device would be considered misbranded and adulterated withindistribution, sale, or use of the meaningproduct could violate the misbranding or adulteration provisions of the Federal Food, Drug, and Cosmetic Act, or the FDC Act. In the EU, under the IVDD, RUO products which are intended to be used for research purposes, without any medical objective, are not regarded as devices for performance evaluation used in diagnostic procedures. More importantly, the IVDR expressly provides that products intended for RUO are excluded from the scope of the regulation. A material intended for RUO, without any medical purpose or objective, is therefore not considered as an IVD MD and is not subject to compliance with the IVD MDs requirements. Depending on the product in question, other regulations may be applicable to the RUO products. Some of the reagents, instruments, software or components obtained by us from suppliers for use in our products are currently labeled by those suppliers as RUO“RUO” or IUO.“IUO”. If the FDA or foreign bodies were to determine that any of these reagents, instruments, software or components are improperly labeled as RUO or IUO and undertake enforcement actions, some of our suppliers might cease selling these reagents, instruments, software or components to us or be forced to recall them, and any failure to obtain an acceptable substitute could significantly and adversely affect our business, financial condition and results of operations, including increasing the cost of testing or delaying, limiting or prohibiting the purchase of reagents, instruments, software or components necessary to perform testing. Such actions could also lead FDA to investigate our purchase and use of supplier products and for the Agency to question whether or not Veracyte has violated the FDC Act.
Failure to comply with applicable regulatory requirements of the FDA or foreign authorities could result in enforcement action, including receiving untitled or warning letters, fines, injunctions, or civil or criminal penalties. Any such enforcement action would have a material adverse effect on our business, financial condition and operations.
Obtaining marketing authorization or certification by the FDA and foreign regulatory authorities or notified regulatory bodies for our diagnostic tests will take significant time and require significant research, development and clinical study expenditures and ultimately may not succeed.
Before we begin to label and market some of our products for use as clinical diagnostics in the United States, unless an exemption applies, we are required to obtain clearance from the FDA by submitting a premarket notification under section 510(k) of the FDC Act or 510(k), or approval from the FDA by submitting a premarket approval, or PMA. WeAlternatively, we may also be able to obtain marketing authorization through a de novoDe Novo classification process rather than through a PMA for class I or class II devices if the 510(k) pathway is not available. In September 2013, Prosigna obtainedwas granted FDA 510(k) clearance as a prognostic indicator for distant recurrence-free survival at ten years in post-menopausal
women with Stage I/II lymph node-negative or Stage II lymph node-positive (1-3 positive nodes), hormone receptor-positive breast cancer to be treated with adjuvant endocrine therapy alone, when used in conjunction with other clinicopathological factors after theyhave undergone surgery in conjunction with locoregional treatment and consistent with the standard of care.
The FDA issued a final guidance document titled In"In Vitro Companion Diagnostic Devices. In the guidance, FDADevices" that defined an IVD companion diagnostic device as an in vitro diagnostic device that provides information that is essential for the safe and effective use of a corresponding therapeutic product. The use of an IVD companion diagnostic device with a therapeutic product is stipulated in the instructions for use in the labeling of both the diagnostic device and the corresponding therapeutic product, including the labeling of any generic equivalents of the therapeutic product. The FDA stated that an IVD companion diagnostic should be submitted for review and approvedcleared or clearedapproved through an appropriate device submission contemporaneously with the review and approval of the therapeutic product to facilitate concurrent review. The FDA guidance also stated that while there may be cases when a companion diagnostic could come to market through the 510(k) pathway, the FDA expects that most companion diagnostics will be Class III devices. Class III devices generally require the approval of a PMA before they can be marketed. An IVD diagnostic device that is not a companion diagnostic device, because it is not essential for the safe and effective use of a corresponding therapeutic product, may still be beneficial for use with a therapeutic product, but may not be identified in the labeling of the therapeutic product. It is possible that revenue from a cleared or approved beneficial or complementary IVD diagnostic device may be less than revenue from a cleared or approved IVD companion diagnostic device. There
The FDA issued another draft guidance in December 2018 specific to oncology companion diagnostic tests, which it finalized in April 2020. The guidance explained that some oncology companion diagnostic tests can be developed in a way that results in labeling for a specific group of oncology therapeutic products, rather than a single therapeutic product. However, there is no assurance that we would be able to obtain clearance or approval for any of our diagnostic devices in development as a companion diagnostic device.device or that any such clearance or approval will occur without significant delay.
Any marketing authorization we obtain for any future device product would be subject to regulatory requirements that would affect how we are able to market and sell the device. The FDC Act and FDA regulations place considerable requirements on our products,medical devices, including, but not limited to, compliance with the quality system regulation, or QSR, establishment registration and product listing with the FDA, and compliance with labeling, marketing, complaint handling, medical device reporting requirements, and reporting certain corrections and removals. Obtaining FDA clearance or approval for diagnostics can be expensive and uncertain, generally may take several months to several years, and generally requires detailed and comprehensive scientific and clinical data, as well as compliance with FDA regulations for investigational devices. In addition, we have limited experience in obtaining PMA, 510(k) clearance, or De Novo authorization approval from the FDA and are therefore supplementing our operational capabilities to manage the more complex processes needed to obtain and maintain PMAs.marketing authorization. Notwithstanding the expense, these efforts may never result in FDA clearance or approval. Even if we were to obtain marketing authorization, it may not be for the uses we believe are important or commercially attractive, in which case we would not market our product for those uses.
Sales of our diagnostic productstests outside the United States are subject to foreign regulatory requirements governing clinical studies, vigilance reporting, marketing approval, manufacturing, regulatory inspections, product licensing, pricing and reimbursement. These regulatory requirements vary greatly from country to country. As a result, the time required to obtain approvals or certifications outside the United States may differ from that required to obtain FDA marketing authorization, and we may not be able to obtain foreign regulatory approvals on a timely basis or at all. Marketing authorization from the FDA does not ensure approval or certification by regulatory authorities in other countries, and approval or certification by any foreign regulatory authority does not ensure marketing authorization or certifications by regulatory authorities in other countries or by the FDA. Foreign regulatory authorities could require additional testing beyond what the FDA requires. In addition, the FDC Act imposes requirements on the export of medical devices, such as labeling requirements, and foreign governments impose requirements on the import of medical devices from the United States. Failure to comply with these regulatory requirements or to obtain required approvals, clearances, and export certifications could impair our ability to commercialize our diagnostic products outside of the United States.
For instance, in order to sell some of our products in the EU, those products must comply with the General Safety and Performance Requirements of the IVDR. Compliance with these requirements is a prerequisite to place IVD products on the EU market. All medical devices placed on the market in the EU must meet the General Safety and Performance Requirements laid down in Annex I to the IVDR, including the requirement that an IVD MD must be designed and manufactured in such a way that it will not compromise the clinical condition or safety of patients, or the safety and health of users and others. In addition, the device must achieve the performances intended by the manufacturer and be designed, manufactured, and packaged in a suitable manner. To demonstrate compliance with the General Safety and Performance Requirements we must undergo a conformity assessment procedure, which varies according to the type of medical device and its (risk) classification. As a general rule, demonstration of conformity of IVD MDs and their manufacturers with the essential requirements must be based, among other things, on the evaluation of clinical data supporting the safety and performance of the products during normal conditions
of use. Specifically, a manufacturer must demonstrate that the device achieves its intended performance during normal conditions of use, that the known and foreseeable risks, and any adverse events, are minimized and acceptable when weighed against the benefits of its intended performance, and that any claims made about the performance and safety of the device are supported by suitable evidence.
The EU regulatory landscape concerning medical devices has significantly changed, and the new IVDR governing IVD MDs became applicable on May 26, 2022 (subject to certain transitional provisions meaning that were such transitional provisions apply, the products can continue to be placed on the market under the IVDD for a certain period of time). The new requirements in the IVDR have a significant effect on the way we conduct our business in the EU and the EEA. In particularly, substantially more IVDs require the involvement of a notified body to be able to affix a CE Mark to the product, which may lead to delay in being able to place such products on the market.
On April 5, 2017, the IVDR was adopted to establish a modernized and more robust EU legislative framework, with the aim of ensuring better protection of public health and patient safety. Unlike directives, the IVDR does not need to be transposed into national law and therefore reduces the risk of discrepancies in interpretation across the different European markets. The IVDR increases the regulatory requirements applicable to IVD MDs in the EU and would require that we re-classify and obtain new certificates of conformity for our existing CE-marked IVD MDs by May 25, 2022, unless a transitional provision applies to the product, meaning that where such transitional provisions apply, the products can continue to be placed on the market under the IVDD for a certain period of time. For most IVD MDs, the manufacturer used to self-declare the conformity of its products with the essential requirements of the IVDD. Under the IVDR, the majority of IVD MDs require now the intervention of a notified body for conformity assessment. Notified bodies are independent organizations designated by EU member states to assess the conformity of devices before being placed on the market. The notified body audits and examines the product’s technical documentation and the manufacturer’s quality system. If satisfied that the relevant product conforms to the General Safety and Performance Requirements, the notified body issues a certificate of conformity. The manufacturer may then apply the CE Mark to the device, which allows the device to be placed on the market throughout the EU. If we fail to remain in compliance with applicable EU laws and directives, we would be unable to continue to affix the CE mark to our products, which would prevent us from selling them within the EU and European Economic Area, or EEA (which consists of the 27 EU member states plus Norway, Liechtenstein and Iceland).
The IVDR will not be implemented in Great Britain, and since January 1, 2021, the Medicines and Healthcare products Regulatory Agency, or MHRA, has become the sovereign regulatory authority responsible for the Great Britain (i.e., England, Wales and Scotland) medical device market according to the requirements provided in the Medical Devices Regulations 2002 (SI 2002 No 618, as amended). The UK regulation implemented the three pre-existing EU directives, including the IVDD. Following the end of the Brexit transitional period on January 1, 2021, new regulations require medical devices to be registered with the MHRA before being placed on the Great Britain market. The MHRA only registers devices where the manufacturer or their United Kingdom, or UK, Responsible Person has a registered place of business in the UK. Manufacturers based outside the UK need to appoint a UK Responsible Person that has a registered place of business in the UK to register devices with the MHRA. By July 1, 2023, in Great Britain, all medical devices will require a UK Conformity Assessed, or UKCA, mark but CE marks issued by EU notified regulatory bodies will remain valid until this time. Manufacturers may choose to use the UKCA mark on a voluntary basis until June 30, 2023.
For the time being, the regulatory regime for medical devices and IVD MDs in Great Britain (England, Scotland and Wales) continues to be based on the requirements derived from current EU legislation. An MHRA public consultation was opened until end of November 2021 on the post-Brexit regulatory framework for medical devices and diagnostics. The MHRA seeks to amend the UK Medical Devices Regulations 2002, in particular to create a new access pathway to support innovation, create an innovative framework for regulating software and artificial intelligence as medical devices, reform IVD MD regulation, and foster sustainability through the reuse and remanufacture of medical devices. The regime is expected to come into force in July 2023, coinciding with the end of the acceptance period for EU CE marks in Great Britain, subject to appropriate transitional arrangements. The consultation indicated that the MHRA will publish guidance in relation to the changes to the regulatory framework and may rely more heavily on guidance to add flexibility to the regime.
Subject to the outcome of the MHRA public consultation on the post-Brexit regulatory framework for medical devices and diagnostics, the UK may choose to retain regulatory flexibility or align with the EU Medical Devices Regulation and the IVDR going forward. EU CE markings will continue to be recognized in the UK, and certificates issued by EU-registered notified regulatory bodies will be valid in the UK, until June 30, 2023. For medical devices, including IVD MDs, placed on the
market in Great Britain after this period, the UKCA marking will be mandatory. In contrast, UKCA marking and certificates issued by UK notified regulatory bodies are not recognized on the EU market.
The rules for placing medical devices on the Northern Ireland market differ from those in Great Britain, and the IVDR will apply in Northern Ireland. Under the terms of the Northern Ireland Protocol of the Withdrawal Agreement between the EU and UK, Northern Ireland follows EU rules on medical devices, including the IVDR when applicable. Therefore, devices marketed in Northern Ireland will require assessment according to the EU regulatory regime. Such assessment may be conducted by an EU notified body, in which case a CE mark is required before placing the device on the market in the EU or Northern Ireland. Alternatively, if a UK notified body conducts such assessment, a ‘UKNI’ mark is applied and the device may only be placed on the market in Northern Ireland and not the EU.
A mutual recognition agreement (MRA) aligning in vitro diagnostic (IVD) regulations between the European Union and Switzerland has officially expired following the In Vitro Diagnostic Medical Devices Regulation’s (IVDR) May 26, 2022 date of application, impacting certification and authorized representation requirements for manufacturers. The Swiss government has issued its own Ordinance on In Vitro Diagnostic Medical Devices (IvDO). The Swiss regulation aligns closely with the IVDR in terms of requirements for manufacturers, and follows the IVDR’s transitional timelines regarding compliance deadlines according to IVD risk classifications as well as designations of Swiss Authorized Representatives.
These modifications may have an effect on the way we intend to conduct our business in these countries.
If we are unable to obtain marketing authorizations or certifications, approvals, clearances or certifications to market Prosigna or our other assays on the nCounter Analysis System in additional countries or if regulatory limitations are placed on our diagnostic kit products, our business and growth will be harmed.
The FDA cleared the Prosigna test for marketing in the United States;States. Prosigna also has ais CE markmarked which permits us to market the test in the European Union;EU and Prosigna received marketing authorizations in selected other jurisdictions. We intend to seek regulatory authorizations or certifications for Prosigna in other jurisdictions and, potentially, for other indications.
In addition, pursuant to our collaborations with pharmaceutical companies for the development of companion diagnostic tests for use with their drugs, we are responsible for obtaining regulatory authorizations or certifications to use the companion diagnostic tests in clinical trialsstudies as well as the marketing authorizations or certifications to sell the companion diagnostic tests following completion of such trials.studies. Some of the compensation we expect to receive pursuant to these collaborations is based on the receipt of marketing authorizations.authorizations or certifications. Any failure to obtain marketing authorizations or certifications for our diagnostic kits in a particular jurisdiction may also reduce sales of our
the nCounter systemsAnalysis System for clinical use in that jurisdiction, as the lack of a robust menu of available diagnostic tests would make those systems less attractive to testing laboratories.
In the EU, the IVDR has introduced a new classification system for companion diagnostics which are now specifically defined as a device which is essential for the safe and effective use of a corresponding medicinal product to: (a) identify, before and/or during treatment, patients who are most likely to benefit from the corresponding medicinal product; or (b) identify, before and/or during treatment, patients likely to be at increased risk of serious adverse reactions as a result of treatment with the corresponding medicinal product. Companion diagnostics have to undergo a conformity assessment by a notified body. Before it can issue a certificate of conformity, the notified body will have to seek a scientific opinion from the European Medicines Agency or the relevant national competent authority on the suitability of the companion diagnostic to the medicinal product concerned.
We cannot assure investors that we will be successful in obtaining or maintaining regulatory clearances, certifications, approvals, or marketing authorizations. If we do not obtain or maintain regulatory clearances, certifications, approvals, or marketing authorizations for future diagnostic kit products or expand future indications for diagnostic purposes, if additional regulatory limitations are placed on our diagnostic kit products or if we fail to successfully commercialize such products, the market potential for our diagnostic kit products would be constrained, and our business and growth prospects would be adversely affected.
We are subject to ongoing and increasingly extensive regulatory requirements, which may be subject to change, and our failure to comply with these requirements could substantially harm our business.
Certain of our products are regulated as in vitro diagnostic medical devices,IVD MDs, including Prosigna and the nCounter FLEX Analysis System. Accordingly, we and certain of our contract manufacturers are subject to ongoing International Organization for Standardization, or ISO, obligations as well as requirements under CLIA and state laboratory quality statutes and regulations, the FDC Act and devicerelated FDA regulations, enforced by the FDA and other statutory and regulatory requirements enforced by other government authorities. These may include routine inspections by Notified Bodies,notified bodies, FDA, CMS, and other health authorities, of our manufacturing facilities and our records for compliance with standards such as ISO 13485 and the QSR, regulations, which establish extensive requirements for quality assurance and control as well as manufacturing and change control procedures, among other things. These inspections may include the manufacturing facilities of any suppliers. In the event that a supplier fails to maintain compliance with regulatory or our quality requirements, we may have to qualify a new supplier and could experience manufacturing delays as a result. We are also subject to other regulatory obligations, such as registration of our company offices and facilities and the listing of our devices with the FDA;FDA (and similar listings and certifications in certain other countries); continued adverse event and malfunction reporting; reporting certain corrections and removals; and labeling and promotional requirements.
The IVDR increases the regulatory requirements applicable to in vitro diagnostics in the EU and would require that we re-classify and obtain new certificates of conformity for our existing CE-marked IVD products by May 25, 2022, unless a transitional provision applies to the product. Failure to secure these re-certifications in time will halt our ability to commercialize our products in relevant countries. Currently Prosigna is our only test that will require recertification. Moreover, complying with the stricter regulatory requirements of the IVDR, including with respect to clinical evaluation requirements, quality systems, and post-market surveillance, may require us to incur significant expenditures. Failure to meet these requirements could adversely impact our business in the EU and EEA and other regions that tie their product registrations or regulations to the EU requirements.
The IVDR became applicable five years after publication on May 26, 2022 and once applicable to a particular product, the IVDR will among other things:
•strengthen the rules on placing devices on the market and reinforce surveillance once they are available;
•establish explicit provisions on manufacturers’ responsibilities for the follow-up of the quality, performance and safety of devices placed on the market;
•establish explicit provisions on importers’ and distributors’ obligations and responsibilities;
•impose an obligation to identify a responsible person who is ultimately responsible for all aspects of compliance with the requirements of the new regulation;
•improve the traceability of medical devices throughout the supply chain to the end-user or patient through the introduction of a unique identification number, to increase the ability of manufacturers and regulatory authorities to trace specific devices through the supply chain and to facilitate the prompt and efficient recall of medical devices that have been found to present a safety risk;
•set up a central database (Eudamed) to provide patients, healthcare professionals and the public with comprehensive information on products available in the EU;
•establish recourse for damage caused by a defective device; and
•strengthen rules for the assessment of certain high-risk devices that may have to undergo an additional check by experts before they are placed on the market.
Other regulatory bodies may also issue guidelines and regulations that could impact the development of our products, including companion diagnostic tests. For example, the European Medicines Agency a European Union agency which is responsible for the scientific evaluation of medicines used in the European Union, recently launched an initiative to determine guidelines for the use of genomic biomarkers in the development and life-cyclelifecycle of drugs. On April 5, 2017,The guidelines may impose greater requirements for demonstrating the European Union Parliament passed Regulation (EU) 2017/746, referredclinical validity and utility of our biomarker-based tests and may interfere with our ability to as the IVD Device Regulation,develop companion diagnostics or IVDR, which increases the regulatory requirements applicable to in vitro diagnostics in the EU and would require that we re-classify andotherwise obtain approval, registration, or clearancemaintain marketing authorization or certifications for our existing CE-marked IVD products within a five-year grace period (by May 25, 2022).diagnostic tests.
We may also be subject to additional FDA or globalforeign regulatory authority post-marketing obligations or requirements by the FDA or globalforeign regulatory authority to change our current product classifications which would impose additional regulatory obligations on us. For example, FDA has issued a proposed rule to revise the QSR to more closely align with ISO 13485:2016
but that also includes proposed clarifications and additional definitions and requirements. The promotional claims we can make for Prosigna in the United States are limited to the indications for use in the United States as cleared by the FDA or outside the United States as authorized or certified by the applicable regulatory authority. If we are not able to maintain regulatory compliance, we may not be permitted to market our medical device products and/or may be subject to enforcement actions by the FDA or other governmental authorities such as the issuance of warning or untitled letters, fines, injunctions, and civil penalties; recall or seizure of products; operating restrictions; and criminal prosecution. In addition, we may be subject to similar regulatory regimes of foreign jurisdictions as we continue to commercialize our products in new markets outside of the United States and Europe. Adverse Notified Body,notified body, EU Competent Authoritycompetent authority or FDA or global regulatory authority action in any of these areas could significantly increase our expenses and limit our revenue and profitability.
If we are unable to compete successfully, we may be unable to increase or sustain our revenue or achieve profitability.
Our principal competition for our tests comes from traditional methods used by physicians to diagnose and manage patient care decisions. For example, with our Afirma genomic classifier practice guidelines in the United States have historically recommended that patients with indeterminate diagnoses from cytopathology results be considered for surgery to remove all or part of the thyroid to rule out cancer. This practice has been the standard of care in the United States for many years, and we need to continue to educate physicians about the benefits of the Afirma genomic classifier to change clinical practice.
We also face competition from companies and academic institutions that use next generation sequencing technology or other methods to measure mutational markers such as BRAF and KRAS, along with numerous other mutations. These organizations include, Interpace Diagnostics Group, Inc., CBLPath, Inc./University of Pittsburgh Medical Center and others who are developing new products or technologies that may compete with our tests. In the future, we may also face competition from companies developing new products or technologies.
Our Decipher Prostate test faces competition from Myriad Genetics and MDx Health, which offer genomic testing for prognostic purposes within localized prostate cancer. Additionally, traditional methods used by pathologists and clinicians to estimate risk of disease progression pose competitive threats to our business in addition to new technologies such as artificial intelligence and digital pathology. In bladder cancer, we are not currently aware of a direct competitor offering genomic testing for prognostic purposes that match the intended use population for the Decipher Bladder test. However, DNA mutational analysis and traditional clinical methods and nomograms are currently in use by physicians for similar purposes.
We believe our primary competition in pulmonology with our Percepta and Envisia classifiers will similarly come from traditional methods used by physicians to diagnose the related diseases. For the Percepta Nasal Swab test, we expect competition from companies
focused on lung cancer such as Oncocyte Corporation and Biodesix, Inc. We believe our principal competitor in the breast cancer diagnostics market is Exact Sciences, Inc. (having combined with Genomic Health, Inc.), which currently commands a substantial majority of the market. Other competitors in the breast cancer diagnostics market include Myriad Genetics, Inc. and Agendia, Inc.
As we expand our portfolio of tests, to address clinical questions across the clinical care continuum, we may also face competition from companies focused on screening at-risk patients for cancer or companies informing treatment decisions such as Guardant Health or GRAIL.Foundation Medicine, Inc. Competition could also emerge using alternative samples, such as blood, urine or sputum. However, such “liquid biopsies” are currently being used to gauge risk of recurrence or response to treatment in patients already diagnosed with lung cancer.
In general, we also face competition from commercial laboratories, such as Laboratory Corporation of America Holdings and Sonic Healthcare USA, with strong infrastructure to support the commercialization of diagnostic services. We face potential competition from companies such as Illumina, Inc. and Thermo Fisher Scientific Inc., both of which have entered the clinical diagnostics market. Other potential competitors include companies that develop diagnostic products, such as Roche Diagnostics, a division of Roche Holding Ltd, Siemens AG and Qiagen N.V., and we also may face competition from competitors of our biopharma services such as Neogenomics, Adapative, Tempus and Akoya.
In addition, competitors may develop their own versions of our solutions in countries we may seek to enter where we do not have patents or where our intellectual property rights are not recognized, and compete with us in those countries, including encouraging the use of their solutions by physicians in other countries.
To compete successfully, we must be able to demonstrate, among other things, that our diagnostic test results are accurate and cost effective, and we must secure a meaningful level of reimbursement for our products.
Many of our potential competitors have widespread brand recognition and substantially greater financial, technical and research and development resources, and selling and marketing capabilities than we do. Others may develop products with prices lower than ours that could be viewed by physicians and payers as functionally equivalent to our solutions or offer solutions at prices designed to promote market penetration, which could force us to lower the list price of our solutions and affect our ability to achieve profitability. If we are unable to change clinical practice in a meaningful way or compete successfully against current and future competitors, we may be unable to increase market acceptance and sales of our products,
which could prevent us from increasing our revenue or achieving profitability and could cause the market price of our common stock to decline. As we add new tests, products and services, we will face many of these same competitive risks for these new tests.risks.
The loss of members ofWe depend on our senior management team, and the loss of one or more of our executive officers, or any inability to attract and retain highly-skilled employees and other key personnel could adversely affect our business.
Our success depends largelyin part on the skills, experience and performance of key members of our executive management team and others in key management positions. The efforts of each of these persons together willWe have in the past and may in the future experience changes in our executive management, which may be criticaldisruptive to us as we continueour business. Executive transitions may impact our ability to developimplement our technologiesbusiness strategy and test processes and focuscould have a material adverse effect on our growth. If we were to lose one or more of these key employees, we may experience difficulties in competing effectively, developing our technologies and implementing our business strategy.business.
In addition, our research and development programs and commercial laboratory operations depend on our ability to attract and retain highly skilled scientists. We may not be able to attract or retain qualified scientists and technicians in the future due to the intense competition for qualified personnel among life science businesses, particularly in the San Francisco Bay Area.businesses. Our success in the development and commercialization of advanced diagnostics requires a significant medical and clinical staff to conduct studies and educate physicians and payers on the merits of our tests in order to achieve adoption and reimbursement. We are in a highly competitive industry to attract and retain this talent.talent, and the labor market in our industry is becoming increasingly competitive. Additionally, our success depends on our ability to attract and retain qualified sales people. We recently significantly expanded our sales force as we invest in our multi-product sales strategy, which includes assignment of a single contact to successfully develop and implement relationships with our customers. salespeople.
There can be no assurance that we will be successful in maintaining and growing our business. Additionally, as we increase our sales channels for new tests we commercialize, including the Percepta and Envisia tests, or acquire, such as Prosigna, we may have difficulties recruiting and training additional sales personnel or retaining qualified salespeople, which could cause a delay or decline in the rate of adoption of our tests. As a public company located in the San Francisco Bay Area, we also face intense competition for highly skilled finance and accounting personnel. If we are unable to attract and retain finance and accounting personnel experienced in public company financial reporting, we risk being unable to close our books and file our public documents on a timely basis. Finally, our
Our business requires specialized capabilities in reimbursement, billing, and other areas and there may be a shortage of qualified individuals. If we are not able to attract and retain the necessary personnel to accomplish our business objectives, we may experience constraints that could adversely affect our ability to support our research and development, clinical laboratory,
sales and reimbursement, billing and finance efforts. All of our U.S. employees are at will, which means that either we or the employee may terminate their employment at any time. We do not carry key manperson insurance for any of our employees.
Finally, we rely, in part, on equity awards to compensate and incentivize our employees to drive our further growth. As the equity capital markets have been highly volatile in recent periods and the price of our common stock has declined, certain of our employees’ equity awards have lost some or all of their value, which may limit their effectiveness as retention tools and, in the event we fail to retain such employees, may adversely affect our business, results of operations and financial condition.
Billing for our diagnostic tests is complex, and we must dedicate substantial time and resources to the billing process to be paid.
Billing for clinical laboratory testing services is complex, time-consuming and expensive. Depending on the billing arrangement and applicable law, we bill various payers, including Medicare, commercial insurance companies and patients, all of which have different billing requirements. We generally bill third-party payers for our diagnostic tests and pursue reimbursement on a case-by-case basis where pricing contracts are not in place. To the extent laws or contracts require us to bill patient co-payments or co-insurance, we must also comply with these requirements. We may also face increased risk in our collection efforts, including potential write-offs of accounts receivable and long collection cycles, which could adversely affect our business, results of operations and financial condition.condition including cash collections. Furthermore, third-party payers may reduce or refuse to pay for our tests, with or without notice.
Several factors make the billing process complex, including:
•differences between the list price for our tests and the reimbursement rates of payers;
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•compliance with complex federal and state regulations related to billing government payers, such as Medicare and Medicaid, including requirements to have an active CLIA certificate;
• | compliance with complex federal and state regulations related to billing government payers, such as Medicare and Medicaid, including requirements to have an active CLIA certificate;
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risk of government audits related to billing Medicare and other government payers;
•disputes among payers as to which party is responsible for payment;
•differences in coverage and in information and billing requirements among payers, including the need for prior authorization and/or advanced notification;
•the effect of patient co-payments or co-insurance;
•individual payers may argue technical contract noncompliance and withhold payment;
•changes to billing codes used for our tests;
•incorrect or missing billing information; and
•the resources required to manage the billing and claims appeals process.
We use standard industry billing codes, known as CPT codes, to bill for our tests, including cytopathology. In addition,Through December 31, 2020, we useused the CPT code 81545 to bill for our Afirma classifier. Effective January 1, 2021, we began using the new CPT codes do not existcode 81546 to bill for our other proprietary molecular diagnostic tests. Therefore, until such time thatAfirma classifier, and code 81545 was retired. Effective January 1, 2020, we are assigned and are able to use a designatedbegan using CPT code specific81542 to Perceptabill for Decipher Prostate Biopsy and Decipher Prostate RP tests. Effective January 1, 2021, we began using the new CPT code 81554 to bill for our Envisia classifier. Effective October 1, 2020, we use “unlisted” codesbegan using CPT code 0016M to bill for claim submissions, which can lead to delays in payers adjudicating our claims or denying payment altogether. Moreover, theseDecipher Bladder test.
CPT codes can change over time. When codes change, there is a risk of an error being made in the claim adjudication process. These errors can occur with claims submission, third-party transmission or in the processing of the claim by the payer. Claim adjudication errors may result in a delay in payment processing or a reduction in the amount of the payment received. Coding changes, therefore, may have an adverse effect on our revenues.total revenue. Even when we receive a designated CPT code specific to our tests, such as the 81545 code for the Afirma GEC that became effective January 1, 2016, there can be no assurance that payers will recognize these codes in a timely manner or that the process of transitioning to such a code and updating their billing systems and ours will not result in errors, delays in payments and a related increase in accounts receivable balances.
As we introduce new tests, we will need to add new codes to our billing process as well as our financial reporting systems. Failure or delays in effecting these changes in external billing and internal systems and processes could negatively affect our collection rates, revenue and cost of collecting.
Correct coding is subject to the coding policies of the American Medical Association CPT Editorial Panel, or AMA CPT. With respect to claims submitted to Medicare and Medicaid, it is also subject to coding policies developed through the National Correct Coding Initiative, or NCCI. Other payers may develop their own payer-specific coding policies. The broader coding policies of the AMA CPT, NCCI, and other payers are subject to change. For instance, the NCCI recently adopted an update to
its Coding Policy Manual effective January 1, 2019, to limit instances when multiple codes may be billed for molecular pathology testing. Although the NCCI appears to have moderated this change in its updates effective January 1, 2020, such coding policy changes may negatively affect our revenuestotal revenue and cash flow.
Additionally, our billing activities require us to implement compliance procedures and oversight, train and monitor our employees, challenge coverage and payment denials, assist patients in appealing claims, and undertake internal audits to evaluate compliance with applicable laws and regulations as well as internal compliance policies and procedures. Payers also conduct external audits to evaluate payments, which addadds further complexity to the billing process. If the payer makes an overpayment determination, there is a risk that we may be required to return some portion of prior payments we have received. Additionally, the ACA established a requirement for providers and suppliers to report and return any overpayments received from government payers under the Medicare and Medicaid programs within 60 days of identification. Failure to identify and return such overpayments exposes the provider or supplier to liability under federal false claims laws. These billing complexities, and the related uncertainty in obtaining payment for our tests, could negatively affect our revenue and cash flow, our ability to achieve profitability, and the consistency and comparability of our results of operations.
We rely on a third-party provider to transmit claims to payers, and any delay in transmitting claims could have an adverse effect on our revenue.
While we manage the overall processing of claims, we rely on a third-party provider to transmit the actual claims to payers based on the specific payer billing format. We have previously experienced delays in claims processing when our third-party provider made changes to its invoicing system, and again when it did not submit claims to payers within the timeframe we require. Additionally, coding for diagnostic tests may change, and such changes may cause short-term billing errors that may take significant time to resolve. If claims are not submitted to payers on a timely basis or are erroneously submitted, or if we are required to switch to a different provider to handle claim submissions, we may experience delays in our ability to process these claims and receipt of payments from payers, or possibly denial of claims for lack of timely submission, which would have an adverse effect on our revenue and our business.
If our internal sales force is less successful than anticipated, our business expansion plans could suffer and our ability to generate revenuesrevenue could be diminished. In addition, we have limited history selling our molecular diagnostics tests on a direct basis and our limited history makes forecasting difficult.
We acquired several international sales employees from NanoString, and expect to build upon this team as we offer additional tests internationally in the future. If our internal sales force is not successful however, or new additions to our sales team fail to gain traction among our customers, we may not be able to increase market awareness and sales of our molecular diagnostic tests.tests and products. If we fail to establish our molecular diagnostic tests and products in the marketplace, it could have a negative effect on our ability to sell subsequent molecular diagnostic tests and hinderproducts, thereby hindering the desired expansion of our business. We have growing, however limited, historical experience forecasting the direct sales of our molecular diagnostics tests and products. Our ability to produce total test volumes that meet customer demand is dependent upon our ability to forecast accurately and plan production capacities accordingly.
Developing new products involves a lengthy and complex process, and if we do not achieve our projected development and commercialization goals in the time frames we announce and expect, our business will suffer and our stock price may decline.
From time to time, we expect to estimate and publicly announce the anticipated timing of the accomplishment of various clinical and other product development goals. The actual timing of accomplishment of these targets could vary dramatically compared to our estimates, in some cases for reasons beyond our control, including the impact of the COVID-19 pandemic. We cannot be certain that we will meet our projected targets and if we do not meet these as publicly announced, the commercialization of our tests may be delayed or may not be able to commercialize on a timely basis, oroccur at all other products we are developing.and, as a result, our business will suffer and our stock price may decline.
We continually seek to develop enhancements to our current test offerings and additional diagnostic solutionstests that requires us to devote considerable resources to research and development. There can be no assurance that we will be able to identify other diseases that can be effectively addressed with our molecular cytology platform. In addition, if we identify such diseases, we may not be able to develop products with the diagnostic accuracy necessary to be clinically useful and commercially successful. We may face challenges obtaining sufficient numbers of samples to validate a genomic signature for a molecular diagnostic product. Afterour products. We must provide sufficient clinical and analytical validity, as well as clinical utility studies that meet individual payer evidence requirements to obtain reimbursement. Even after launching new products, we still must complete additional studies that meet the clinical evidence required by individual payers to obtain reimbursement. Moreover, we may experience delays in the development and introduction of new products due to the effects of the current COVID-19 pandemic.
In order to develop and commercialize diagnostic tests to be run in our CLIA lab, we need to:
•expend significant funds to conduct substantial research and development;
•conduct successful analytical and clinical studies;
•scale our laboratory processes to accommodate new tests; and
•build the commercial, regulatory, and compliance infrastructure to market and sell new products.
Our product development process involves a high degree of risk and may take several years. Our test and product development efforts may fail for many reasons, including:
•failure to identify a genomic signature in biomarker discovery;
•inability to secure sufficient numbers of samples at an acceptable cost and on an acceptable timeframe to conduct analytical and clinical studies; or
•failure of clinical validation studies to support the effectiveness of the test.
Typically, few research and development projects result in commercial products, and success in early clinical studies often is not replicated in later studies. At any point, we may abandon development of a product candidate, or we may be required to expend considerable resources repeating clinical studies, which would adversely affect the timing for generating potential revenue from a new product and our ability to invest in other products in our pipeline. If a clinical validation study fails to demonstrate the prospectively-definedprospectively defined endpoints of the study or if we fail to sufficiently demonstrate analytical validity, we might choose to abandon the development of the product, which could harm our business. If a clinical utility study fails to demonstrate the value of a particular test, we may not be able to obtain reimbursement for the test. In addition, competitors may develop and commercialize competing products or technologies faster than us or at a lower cost.
If we cannot enter into new clinical study collaborations, our product development and subsequent commercialization could be delayed.
In the past, we have entered into clinical study collaborations, and our success in the future depends in part on our ability to enter into additional collaborations with highly regarded institutions. This can be difficult due to internal and external constraints placed on these organizations. Some organizations may limit the number of collaborations they have with any one company so as to not be perceived as biased or conflicted. Organizations may also have insufficient administrative and related infrastructure to enable collaboration with many companies at once, which can extend the time it takes to develop, negotiate and implement a collaboration. Moreover, it may take longer to obtain the samples we need which could delay our trials, publications, and product launches and reimbursement. Additionally, organizations often insist on retaining the rights to publish the clinical data resulting from the collaboration. The publication of clinical data in peer-reviewed journals is a crucial step in commercializing and obtaining reimbursement for our diagnostic tests, and our inability to control when and if results are published may delay or limit our ability to derive sufficient revenue from them.
If we are unable to develop products to keep pace with rapid technological, medical and scientific change, our operating results and competitive position could be harmed.
In recent years, there have been numerous advances in technologies relating to diagnostics, particularly diagnostics that are based on genomic information. These advances require us to continuously develop our technology and to work to develop new solutions to keep pace with evolving standards of care. Our solutions could become obsolete unless we continually innovate and expand our product offerings to include new clinical applications. If we are unable to develop new products or to demonstrate the applicability of our products for other diseases, our sales could decline, and our competitive position could be harmed.
Our Loan and Security Agreement provides our lenders with a first-priority lien against substantially all of our assets, excluding our intellectual property, and contains financial covenants and other restrictions on our actions, which could limit our operational flexibility and otherwise adversely affect our financial condition.
Our Loan and Security Agreement restricts our ability to, among other things, incur liens, make investments, incur indebtedness, merge with or acquire other entities, dispose of assets, make dividends or other distributions to holders of its equity interests, engage in any new line of business, or enter into certain transactions with affiliates, in each case subject to certain exceptions. It also requires us to achieve certain revenue levels tested quarterly on a trailing twelve-month basis. However, failure to maintain the revenue levels will not be considered a default if the sum of our unrestricted cash and cash equivalents maintained
with Silicon Valley Bank and amount available under the revolving line of credit is at least $40.0 million. Our ability to comply with these and other covenants is dependent upon a number of factors, some of which are beyond our control.
Our failure to comply with the financial covenants, or the occurrence of other events specified in our Loan and Security Agreement, could result in an event of default under the Loan and Security Agreement, which would give our lenders the right to terminate their commitments to provide additional loans under the Loan and Security Agreement and to declare all borrowings outstanding, together with accrued and unpaid interest and fees, to be immediately due and payable. In addition, we have granted our lenders a first-priority lien against all of our assets, excluding our intellectual property, as collateral. Failure to comply with the covenants or other restrictions in the Loan and Security Agreement could result in a default. If the debt under our Loan and Security Agreement was to be accelerated, we may not have sufficient cash on hand or be able to sell sufficient collateral to repay it, which would have an immediate adverse effect on our business and operating results. This could potentially cause us to cease operations and result in a complete loss of your investment in our common stock.
Complying with numerous statutes and regulations pertaining to our business is an expensive and time-consuming process, and any failure to comply could result in substantial penalties.
Our operations are subject to other extensive federal, state, local, and foreign laws and regulations, all of which are subject to change. These laws and regulations currently include, among others:
•the Federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which established comprehensive federal standards with respect to the privacy and security of protected health information and requirements for the use of certain standardized electronic transactions, and amendments made to those standards in 2013 pursuant to HIPAA under the Health Information Technology for Economic and Clinical Health Act, or HITECH Act, which strengthenstrengthened and expandexpanded HIPAA privacy and security compliance requirements, increaseincreased penalties for violators, extendextended enforcement authority to state attorneys general, and imposeimposed new requirements for breach notification;
•Medicare billing and payment regulations applicable to clinical laboratories, including requirements to have an active CLIA certificate;
•the Federal Anti-kickback Statute (and state equivalents), which prohibits knowingly and willfully offering, paying, soliciting, or receiving remuneration, directly or indirectly, in exchange for or to induce either the referral of an individual, or the furnishing, arranging for, or recommending of an item or service that is reimbursable, in whole or in part, by a federal healthcare program;
•the Eliminating Kickbacks in Recovery Act of 2018, which prohibits the solicitation, receipt, payment or offering of any remuneration in return for referring a patient or patronage to a recovery home, clinical treatment facility, or laboratory for services covered by both government and private payers;
•the Federal Stark physician self-referral law (and state equivalents), which prohibits a physician from making a referral for certain designated health services covered by the Medicare program, including laboratory and pathology services, if the physician or an immediate family member has a financial relationship with the entity providing the designated health services, unless the financial relationship falls within an applicable exception to the prohibition;
•the Federal Civil Monetary Penalties Law, which prohibits, among other things, the offering or transfer of remuneration to a Medicare or state health carehealth-care program beneficiary if the person knows or should know it is likely to
influence the beneficiary’s selection of a particular provider, practitioner, or supplier of services reimbursable by Medicare or a state health carehealth-care program, unless an exception applies;
•the Federal False Claims Act, which imposes liability on any person or entity who knowingly presents, or causes to be presented, a false, fictitious, or fraudulent claim for payment to the federal government;
•the Physician Payments Sunshine Act, enacted as part of the ACA, which imposes annual reporting requirements on manufacturers of certain devices, drugs and biologics for certain payments and transfers of value by them and in some cases their distributors to covered recipients, including physicians, as defined by such law, teaching hospitals, and certain healthcare providers as well as ownership or investment interests that physicians or physicians’ immediate family members hold with the reporting entity;
•other federal and state fraud and abuse laws, such as anti-kickback laws, prohibitions on self-referral, fee-splitting restrictions, prohibitions on the provision of products at no or discounted cost to induce physician or patient adoption, and false claims acts, which may extend to services reimbursable by any third-party payer, including private insurers;
•the prohibition on reassignment of Medicare claims, which, subject to certain exceptions, precludes the reassignment of Medicare claims to any other party;
•the Protecting Access to Medicare Act of 2014, which requires us to report private payer rates and test volumes for specific CPT codes on a triennial basis and imposes penalties for failures to report, omissions, or misrepresentations;
•the No Surprises Act and its implementing regulations (effective January 1, 2022), which prohibit an out-of-network provider from billing a patient at an amount in excess of the in-network cost sharing for services furnished with respect to a visit at certain in-network health-care facilities, as well as various state laws restricting balance billing of patients;
•the rules regarding billing for diagnostic tests reimbursable by the Medicare program, which prohibit a physician or other supplier from marking up the price of the technical component or professional component of a diagnostic test ordered by the physician or other supplier and supervised or performed by a physician who does not “share a practice” with the billing physician or supplier;
•state laws that prohibit other specified practices related to billing such as billing physicians for testing that they order, waiving co-insurance, co-payments, deductibles, and other amounts owed by patients, and billing a state Medicaid program at a price that is higher than what is charged to other payers;
•the Foreign Corrupt Practices Act of 1977, and other similar laws, which apply to our international activities;
•unclaimed property (escheat) laws and regulations, which may require us to turn over to governmental authorities the property of others held by us that has been unclaimed for a specified period of time; and
•enforcing our intellectual property rights.rights; and
•foreign laws and regulations equivalent to the above.
We have adopted policies and procedures designed to comply with applicable laws and regulations. In the ordinary course of our business, we conduct internal reviews of our compliance with these laws. Our compliance with some of these laws and regulations is also subject to governmental review. The growth of our business, and sales organization and our expansion outside of the United States may increase the potential of violating these laws or our internal policies and procedures. We believe that we are in material compliance with all statutory and regulatory requirements, but there is a risk that one or more government agencies could take a contrary position.
In recent years U.S. Attorneys’ Offices have increased scrutiny of the healthcare industry, as have Congress, the Department of Justice, the Department of Health and Human Services’ Office of the Inspector General and the Department of Defense. These bodies have all issued subpoenas and other requests for information to conduct investigations of, and commenced civil and criminal litigation against, healthcare companies based on financial arrangements with health carehealth-care providers, regulatory compliance, product promotional practices and documentation, and coding and billing practices.
Whistleblowers have filed numerous qui tam lawsuits against healthcare companies under the federal and state False Claims Acts in recent years, in part because the whistleblower can receive a portion of the government’s recovery under such suits.
Many member states in the EU have adopted specific anti-gift statutes that further limit commercial practices for medical devices (including IVD MDs), in particular vis-à-vis healthcare professionals and organizations. Additionally, there has been a recent trend of increased regulation of payments and transfers of value provided to healthcare professionals or entities and many EU member states have adopted national “Sunshine Acts” which impose reporting and transparency requirements (often on an annual basis), similar to the requirements in the United States, on medical device manufacturers.
These laws and regulations are complex and are subject to interpretation by the courts and by government agencies. If one or more such agencies alleges that we may be in violation of any of these requirements, regardless of the outcome, it could damage our reputation and adversely affect important business relationships with third parties, including managed care organizations and other commercial third-party payers. Any action brought against us for violation of these or other laws or regulations, even if we successfully defend against it, could cause us to incur significant legal expenses and divert our management’s attention from the operation of our business. If our operations are found to be in violation of any of these laws and regulations, we may be subject to any applicable penalty associated with the violation, including civil and criminal penalties, damages and fines, we could be required to refund payments received by us, and we could be required to curtail or cease our operations. Any of the foregoing consequences could seriously harm our business and our financial results.
If we use hazardous materials in a manner that causes contamination or injury, we could be liable for resulting damages.
We are subject to federal, state and local laws, rules and regulations governing the use, discharge, storage, handling and disposal of biological material, chemicals and waste. We cannot eliminate the risk of accidental contamination or injury to employees or third parties from the use, storage, handling or disposal of these materials. In the event of contamination or injury, we could be held liable for any resulting damages, remediation costs and any related penalties or fines, and any liability could exceed our resources or any applicable insurance coverage we may have. The cost of compliance with these laws and regulations may become significant, and our failure to comply may result in substantial fines or other consequences, and either could negatively affect our operating results.
International expansionWe must successfully integrate the HalioDx and Decipher Biosciences businesses to realize the financial goals that we currently anticipate.
Risks we face in connection with the ongoing integration of HalioDx and Decipher Biosciences include:
•We may have difficulties managing acquired products and tests or retaining key personnel from the acquired businesses;
•We may not successfully integrate the acquired businesses as planned (including, for example, systems integration), there could be unanticipated adverse impacts on the acquired businesses, or we may otherwise not realize the expected return on our investments, which could adversely affect our business or operating results and potentially cause impairment to assets that we record as a part of an acquisition including intangible assets and goodwill;
•Our operating results or financial condition may be adversely impacted by (i) claims or liabilities related to the acquired businesses including, among others, claims from U.S. or international regulatory or other governmental agencies, terminated employees, current or former customers or business partners, or other third parties; (ii) pre-existing contractual relationships of the acquired businesses that we would not have otherwise entered into, the termination or modification of which may be costly or disruptive to our business; (iii) unfavorable accounting treatment as a result of the acquired businesses' practices; and (iv) intellectual property claims or disputes;
•Neither HalioDx nor Decipher Biosciences was required to maintain an internal control infrastructure that would meet the standards of a public company, including the requirements of the Sarbanes-Oxley Act of 2002. The costs that we may incur to implement such controls and procedures may be substantial and we could encounter unexpected delays and challenges in this implementation. In addition, we may discover significant deficiencies or material weaknesses in the quality of HalioDx's or Decipher Biosciences' respective financial and disclosure controls and procedures;
•We may experience a failure of development activities on behalf of a HalioDx customer where HalioDx bears development risk resulting in a refund of development fees;
•We may fail to transition manufacturing of the test kits for the nCounter, currently produced by NanoString, to HalioDx’s manufacturing facility in Marseille, France in a timely manner or at all, or we may experience manufacturing irregularities or challenges in connection with the transition, including rolling blackouts due to energy shortages in Europe;
•We may not realize the anticipated accretion to our gross margins as a result of transitioning manufacturing of test kits to HalioDx;
•We may experience disagreements with the French employee work council; and
•We may have failed to identify or assess the magnitude of certain liabilities, shortcomings or other circumstances prior to acquiring either of the acquired businesses, which could result in unexpected litigation or regulatory exposure, unfavorable accounting treatment, a diversion of management’s attention and resources, and other adverse effects on our business, financial condition, and operating results.
We are exposed to risks associated with transactions denominated in foreign currency.
Changes in the value of the relevant currencies may affect the cost of certain items required in our operations and contractual agreements. Changes in currency exchange rates, such as the recent strengthening of the U.S. dollar relative to the Euro, may also affect the relative prices at which we are able to sell products in the same market. Our revenue from international customers may be negatively impacted as increases in the U.S. dollar relative to our international customers local currency could make our products more expensive, impacting our ability to compete. Our costs of materials from international suppliers may increase if, in order to continue doing business with us, they raise their prices as the value of the U.S. dollar decreases relative to their local currency. Foreign policies and actions regarding currency valuation could result in actions by the United States and other countries to offset the effects of such fluctuations. Recent global financial conditions have led to a high level of volatility in foreign currency exchange rates and that level of volatility may continue, which could adversely affect our business, financial condition, or results of operations.
Aspects of our international business exposesexpose us to business, regulatory, political, operational, financial and economic risks associated with doing business outside of the United States.
Our business strategy currently includes international presence and expansion in select countries and may include developing and maintaining physician outreach and education capabilities outside of the United States, establishing agreements with laboratories, and expanding our relationships with international payers. In 2021, we acquired HalioDx, an immuno-oncology diagnostics company that is based in Marseille, France, and operates globally. Doing business internationally involves a number of risks, including:
•multiple, conflicting and changing laws and regulations such as tax laws, privacy laws, export and import restrictions, employment laws, regulatory requirements and other governmental approvals, permits and licenses;
•difficulties in maintaining the manufacturing output we anticipate at the Marseille, France facility as a result of rolling blackouts due to energy shortages in Europe resulting from the Russian invasion of Ukraine;
•failure by us to obtain regulatory approvals or certifications where required for the use of our solutions in various countries;
•complexities associated with managing multiple payer reimbursement regimes, government payers or patient self-pay systems;systems, including payers mandating additional evidence requirements for reimbursement consideration;
•logistics and regulations associated with shipping tissue samples, including infrastructure conditions and transportation delays;
•challenges associated with establishing laboratory partners, including proper sample collection techniques, management of supplies, sample logistics, billing and promotional activities;
•limits on our ability to penetrate international markets if we are not able to process tests locally;
•financial risks, such as longer payment cycles, difficulty in collecting from payers, the effect of local and regional financial crises, and exposure to foreign currency exchange rate fluctuations;
•natural disasters, political and economic instability, including wars, terrorism, and political unrest, outbreak of disease, including COVID-19, boycotts, curtailment of trade and other business restrictions;restrictions (including as a direct or indirect result of the conflict in Ukraine); and
•regulatory and compliance risks that relate to maintaining accurate information and control over activities that may fall within the purview of the Foreign Corrupt Practices Act of 1977, including both its books and records provisions and its anti-bribery provisions.
Any of these factors could significantly harm our future international expansion and operations and, consequently, our revenue and results of operations.
Our operating results may be adversely affected by unfavorable macroeconomic and market conditions.
Our business or financial results may be adversely impacted by uncertain economic conditions, including: the impact of the COVID-19 pandemic, adverse changes in interest rates, foreign currency exchange rates, tax laws or tax rates; inflation; a recession; contraction in the availability of credit in the marketplace due to legislation or other economic conditions, which may potentially impair our ability to access the capital markets on terms acceptable to us or at all; and the effects of government initiatives to manage economic conditions. Many of the countries in which we operate, including the U.S. and those in Europe, have experienced and continue to experience uncertain economic conditions, including increased inflation rates, resulting from global as well as local factors. For example, in February 2022, Russia launched a significant military action against Ukraine, the short and long-term implications of which are difficult to predict at this time. The impact to Ukraine as well as actions taken by other countries, including new and stricter sanctions imposed by the U.S. and the European Union, and other countries and companies and organizations, could adversely affect the global economy and financial markets and thus could affect our business and results of operations, as well as the price of our common stock and our ability to raise additional capital when needed on acceptable terms.
Moreover, we cannot predict how future economic conditions will affect our customers, suppliers and distributors and any negative impact on our critical customers, suppliers or distributors may also have an adverse impact on our results of operations or financial condition. A severe or prolonged economic downturn, as result of a global pandemic such as the COVID-19 pandemic or otherwise, could result in a variety of risks to our business, including weakened demand for our products and services and our ability to raise additional capital when needed on favorable terms, if at all. A weak or declining economy could strain our collaborators, possibly resulting in supply disruption, or cause delays in their payments to us. Any of the foregoing could harm our business and we cannot anticipate all of the ways in which the current economic climate and financial market conditions could adversely impact our business.
Our reliance on distributors for sales of our products outside of the United States, and on clinical laboratories for delivery of Prosigna testing services, could limit or prevent us from selling our products and impact our revenue.
We have established distribution agreements for ourthe nCounter FLEX Analysis System for diagnostic use and related consumablediagnostic kit products in certain countries where we do not sell directly. We intend to continue to grow our business internationally, and to do so we must attract additional distributors and retain existing distributors to maximize the commercial opportunity for our products. There is no guarantee that we will be successful in attracting or retaining desirable sales and distribution partners or that we will be able to enter into such arrangements on favorable terms. Distributors may not commit the necessary resources to market and sell our products to the level of our expectations or may choose to favor marketing the products of our competitors. If current or future distributors do not perform adequately, or we are unable to enter into effective arrangements with distributors in particular geographic areas, we may not realize long-term international revenue growth.
Similarly, we or our distributors have entered into agreements with clinical laboratories globally to provide Prosigna testing services. We do not provide testing services directly and, thus, we are reliant on these clinical laboratories to actively promote and sell Prosigna testing services. These clinical laboratories may take longer than anticipated to begin offering Prosigna testing services and may not commit the necessary resources to market and sell Prosigna testing services to the level of our expectations. Furthermore, we intend to contract with additional clinical laboratories to offer Prosigna testing services, including physician-owned laboratories, and we may be unsuccessful in attracting and contracting with new clinical laboratory
providers. If current or future Prosigna testing service providers do not perform adequately, or we are unable to enter into contracts with
additional clinical laboratories to provide Prosigna testing services, we may not be successful selling Prosigna and our future revenue prospects may be adversely affected.
If we are sued forErrors or defects in our products or services could harm our reputation, decrease market acceptance of our products or services or expose us to product liability or errorsclaims, and omissions liability, we could face substantial liabilities that exceed our resources.
TheWe are creating new tests, products and services, many of which are initially based on novel technologies. Our new tests and products may contain undetected errors or defects that are not identified until after they are first introduced to the market. As all of our tests, products and services progress, we or others may determine that we made unintended scientific or technological mistakes or omissions. Furthermore, the testing processes utilize a number of complex and sophisticated biochemical, informatics, optical and mechanical processes, many of which are highly sensitive to external factors and variation between testing runs. Refinements to our processes may initially result in unanticipated issues that reduce efficiency or increase variability. In particular, sequencing, which is a key component of these processes, could be inefficient with higher-than-expected variability. This could increase total sequencing costs and reduce the number of samples we can process in a given time period, which may negatively impact customer turnaround time. Additionally, our laboratory operations could result in any number of errors or defects. Our quality assurance system or product development processes may fail to prevent us from inadvertent problems with samples, sample quality, lab processes including sequencing, software, data upload or analysis, raw materials, reagent manufacturing, assay quality or design, or other components or processes. Moreover, our assays may have quality or design errors, and we may have inadequate procedures or instrumentation to process samples, assemble our proprietary primer mixes and commercial materials, upload and analyze data, or otherwise conduct our laboratory operations. Additionally, the marketing, sale and use of our current or future tests could lead to product liability claims if someone were to allege that the tests failed to perform as they were designed. We may also be subject to liability for errors in the results we provide to physicians or for a misunderstanding of, or inappropriate reliance upon, the information we provide. Our Afirma classifiers are performed on FNA samples that are diagnosed as indeterminate by standard cytopathology review. We report results as benign or suspicious to the prescribing physician. Under certain circumstances, we might report a result as benign that later proves to have been malignant. This could be the result of the physician having poor nodule sampling in collecting the FNA, performing the FNA on a different nodule than the one that is malignant or failure of the classifier to perform as intended. We may also be subject to similar types of claims related to our Percepta,Decipher Prostate, Prosigna, Envisia, and ProsignaDecipher Bladder tests, as well as tests we may develop or acquire in the future.
Any of the foregoing defects or errors could harm our reputation, decrease market acceptance of our products or services or expose us to product liability claims. A product liability or errors and omissions liability claim could further result in substantial damages and be costly and time consuming for us to defend. Although we maintain product liability and errors and omissions insurance, we cannot assure you that our insurance would fully protect us from the financial impact of defending against these types of claims or any judgments, fines or settlement costs arising out of any such claims. Any product liability or errors and omissions liability claim brought against us, with or without merit, could increase our insurance rates or prevent us from securing insurance coverage in the future. Additionally, any product liability lawsuit could cause injury to our reputation, decrease market acceptance of our products or cause us to recall or suspend sales of our products and solutions. The occurrence of any of these events could have an adverse effect on our business and results of operations.
If a catastrophe strikes eitherOur business and the operations of our laboratories are subject to the risk of disruptions caused by pandemics, political events, war, terrorism, earthquakes, fire, power outages, severe weather, floods, and other catastrophic events.
War, terrorism, geopolitical uncertainties, including any developments or if eitherconsequences of the conflict in Ukraine or related sanctions, trade restrictions, public health issues, natural disasters and other catastrophic events may cause damage or disruption to the economy and commerce on a global, regional or country-specific basis, and could disrupt supply or delivery of, or demand for, our laboratories becomes inoperable for anyproducts. For example, the COVID-19 outbreak has had, and may continue to have, a negative effect on consumer confidence and spending, and other reason,impacts, which could adversely affect our business.
In addition, we will be unable to perform our testing services and our business will be harmed.
We perform all of the Afirma Percepta and Envisia genomic classifier testing at our laboratory in South San Francisco, California, near major earthquake faults known for seismic activity.activity and in a region affected by wildfires. We perform our urology tests in our laboratory in San Diego, California. Our laboratory in Austin, Texas accepts and stores the majority of our Afirma FNA samples pending transfer to our California laboratory for genomic test processing. Our manufacturing facility in Marseille, France, produces many of our Prosigna tests, as well as products for our IVD manufacturing business, and is subject to the risk of power outages resulting from constrained European energy supply.
The laboratories and equipment we use to perform our tests would be costly to replace and could require substantial lead time to replace and qualify for use if they became inoperable. Either of our facilities may be harmed or rendered inoperable by natural or man-made disasters, including earthquakes, flooding and power outages, which may render it difficult or impossible for us to perform our testing services for some period of time or to receive and store samples. The inability to perform our tests 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 maintain 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, if at all.
Our inability to raise additional capital on acceptable terms in the future may limit our ability to develop and commercialize new solutions and technologies and expand our operations.
We expect continued capital expenditures and operating losses over the next few years as we expand our infrastructure, commercial operations and research and development activities. We may seek to raise additional capital through equity offerings, debt financings, collaborations or licensing arrangements. Additional funding may not be available to us on acceptable terms, or at all. If we raise funds by issuing equity securities, dilution to our stockholders could result. Any equity securities issued also may provide for rights, preferences or privileges senior to those of holders of our common stock. The terms of debt securities issued or borrowings could impose significant restrictions on our operations. The incurrence of additional indebtedness or the issuance of certain equity securities could result in increased fixed payment obligations and could also result in restrictive covenants, such as limitations on our ability to incur additional debt or issue additional equity, limitations on our ability to acquire or license intellectual property rights, and other operating restrictions that could adversely affect our ability to conduct our business. Our Loan and Security Agreement imposes restrictions on our operations, increases our fixed payment obligations, and has restrictive covenants. In addition, the issuance of additional equity securities by us, or the possibility of such issuance, may cause the market price of our common stock to decline. In the event that we enter into collaborations or licensing arrangements to raise capital, we may be required to accept unfavorable terms. These agreements may require that we relinquish or license to a third-party on unfavorable terms our rights to technologies or product candidates that we otherwise would seek to develop or commercialize ourselves, or reserve certain opportunities for future potential arrangements when we might be able to achieve more favorable terms. The trading prices for our common stock and other companies have been highly volatile as a result of the COVID-19 pandemic, which may reduce our ability to access capital on favorable terms or at all. In addition, a recession, depression or other sustained adverse market event resulting from the spread of COVID-19 could materially and adversely affect our business and the value of our common stock. If we are not able to secure additional funding when needed, we may have to delay, reduce the scope of or eliminate one or more research and development programs or selling and marketing initiatives. In addition, we may have to work with a partner on one or more of our products or development programs, which could lower the economic value of those programs to our company.
Security breaches, loss of data and other disruptions to usour or our third-party service providersproviders' data systems could compromise sensitive information related to our business or prevent us from accessing critical information and expose us to liability, which could adversely affect our business and our reputation.
In the ordinary course of our business, we and our third-party service providers collect and store sensitive data, including legally protected health information, other personally identifiable information, about our patients, credit card information, intellectual property, and our proprietary business and financial information. We manage and maintain our applications and data utilizing a combination of on-site systems, managed data center systems and cloud-based data center systems. We face a number of risks related to our protection of, and our service providers’ protection of, this critical information, including loss of access, inappropriate disclosure and inappropriate access, as well as risks associated with our ability to identify and audit such events. System failures or outages, including any potential disruptions due to significantly increased global demand on certain cloud-based systems during the COVID-19 pandemic, could compromise our ability to protect sensitive information and prevent business interference, which could harm our ability to conduct business and/or delay our financial reporting. Such failures could materially adversely affect our operating results and financial condition.
The secure processing, storage, maintenance and transmission of this critical information is vital to our operations and business strategy, and we devote significant resources to protecting such information. Although we take measures to protect sensitive information from unauthorized access or disclosure, our information technology and infrastructure may be vulnerable to attacks by hackers or viruses or otherwise breached due to employee error, malfeasance or other activities. While we are not currently aware of any such attack or breach having occurred, if such an event wouldwere to occur and cause interruptions in our operations, our networks would be compromised and the information we store on those networks could potentially be accessed
by unauthorized parties, publicly disclosed, lost or stolen. Any such access, disclosure or other loss of information could result in legal claims or proceedings, liability, and penalties under federal, state, and international laws and regulations that protect the privacy and security of personal information, such as the HIPAA regulations and regulatory penalties.the EU General Data Protection Regulation, or GDPR. Unauthorized access, loss or dissemination of such data also could also disrupt our operations, including our ability to process tests, provide test results, bill payers or patients, process claims and appeals, provide customer assistance services, conduct research and development activities, collect, process, and prepare company financial information, provide information about our tests and other patient and physician education and outreach efforts through our website, and manage the administrative aspects of our business, and damage our reputation, any of which could adversely affect our business.business, including by materially damaging our reputation.
In addition, the interpretation and application of consumer, health-related and data protection laws in the United States, Europe and elsewhere are often uncertain, contradictory, and in flux. It is possible that these laws may be interpreted and appliedenforced in a manner that is inconsistent withwe have not anticipated in designing our practices.practices and compliance policies. If so, this could result in government-imposed fines or orders requiring that we change our practices, which could adversely affect our business. Certain health-related and data protection requirements have been modified under section 319 of the Public Health Service Act during the Public Health Emergency, or PHE, first declared January 31, 2020, which was most recently extended effective January 11, 2023. The Biden Administration has announced that it intends to lift the PHE declaration on May 11, 2023. In addition, we are subject to various state laws, including the California Consumer Privacy Act, or CCPA, which, was enacted in California in 2018 and components of which went into effect on January 1, 2020. The CCPA, among other things, requires covered companies to provide disclosures to California consumers concerning the collection and sale of personal information, and gives such consumers the right to opt-outopt out of certain sales of personal information. Amendments to the CCPA have been made since its enactment in 2018, most significantly in the form of amendments and expansions pursuant to the California Privacy Rights Act adopted by ballot measure in November 2020, and it remains unclear what, if any, further amendments will be made to this legislation or how it will be interpreted. We cannot yet predict the impact of the CCPA or similar laws on our business or operations, but itthey may require us to modify our data processing practices and policies and to incur substantial costs and expenses in an effort to comply.
Risks associated with data privacy issues, including evolving laws, regulations and associated compliance efforts, may adversely impact our business and financial results.
Legislation in various countries around the world with regard to cybersecurity, privacy and data protection is rapidly expanding and creating a complex compliance environment. We are subject to many federal, state, and foreign laws and regulations, including those related to privacy, rights of publicity, data protection, content regulation, intellectual property, health and safety, competition, protection of minors, consumer protection, employment, and taxation.
Recent developments in Europe have created compliance uncertainty regarding the processing of personal data from Europe. For example, the General Data Protection Regulation, or GDPR, which became effective in the European UnionEU on May 25, 2018, applies to our activities conducted from an establishment in the EU or related to products and services that we offer to European UnionEU users. The GDPR createsimposed new compliance obligations applicable to our business, whichincluding accountability obligations requiring data controllers and processors to maintain a record of their data processing and implement policies as part of its mandated privacy governance framework. It also requires data controllers to be transparent and to disclose to data subjects how their personal data is to be used, protected, and shared; imposes limitations on retention of personal data; introduces mandatory data breach notification requirements; and sets higher standards for data controllers to demonstrate that they have obtained valid consent for certain data processing activities. Continued compliance with these obligations could cause us to change our business practices, and increaseswe risk financial penalties for noncompliance (including possible fines of up to 4% of global annual turnover for the preceding financial year or €20 million (whichever is higher) for the most serious infringements). AsIn addition, the GDPR prohibits the transfer of personal data from the EEA to the United States and other jurisdictions that the European Commission does not recognize as having “adequate” data protection laws unless a result, wedata-protective transfer mechanism has been put in place. On July 16, 2020, the Court of Justice of the European Union, or CJEU, issued a decision undermining the validity of the data-protective transfer mechanisms previously relied on, creating widespread uncertainty about compliance with the GDPR rules on data transfers to non-“adequate” jurisdictions. The EU Commission announced in December 2022 that it had begun the process of adopting an adequacy decision that would apply to the United States based on an executive order issued by President Biden in October 2022; even if the EU Commission approves the adequacy decisions, however, it is widely expected that the new data transfer framework may be challenged before the CJEU.
While the CJEU generally confirmed the validity of the European Commission-approved “Standard Contractual Clauses”, or SCCs, as a personal data-protective transfer mechanism, it made clear that reliance on the SCCs alone may not necessarily be
sufficient in all circumstances. Use of the SCCs must now be assessed on a case-by-case basis taking into account the legal regime applicable in the destination country, in particular applicable surveillance laws and rights of individuals and additional measures and/or contractual provisions may need to modifybe put in place, however, the waynature of these additional measures is currently uncertain. In response to the CJEU decision, the European Commission has published revised SCCs; existing SCC arrangements were required to be migrated to the revised SCCs by December 27, 2022. We were required to implement the revised SCCs, in relation to relevant existing contracts and certain additional contracts and arrangements, by that date. In addition, the revised SCCs are not to be relied on for data transfers to non-EEA entities subject to the GDPR, and we treatare waiting for further guidance on valid mechanisms for data transfers from the EEA to such information.entities.
Following the United Kingdom’s withdrawal from the EEA and the EU, and the expiry of the transition period, companies processing the information of EU data subjects have to comply with both the GDPR and the GDPR as incorporated into United Kingdom national law, the latter regime having the ability to separately fine up to the greater of £17.5 million or 4% of global turnover. The European Commission has adopted an adequacy decision in favor of the United Kingdom, enabling data transfers from EU member states to the United Kingdom without additional safeguards. However, the UK adequacy decision will automatically expire in June 2025 unless the European Commission re-assesses and renews/ extends that decision, and remains under review by the Commission during this period. The relationship between the United Kingdom and the EU in relation to certain aspects of data protection law remains unclear, and it is unclear how UK data protection laws and regulations will develop in the medium to longer term, and how data transfers to and from the United Kingdom will be regulated in the long term. These developments may lead to additional costs and increase our overall risk exposure.
In the United States, numerous federal and state laws and regulations, including federal health information privacy laws, state data breach notification laws, state health information privacy laws and federal and state consumer protection laws (e.g., Section 5 of the Federal Trade Commission Act), that govern the collection, use, disclosure and protection of health-related and other personal information could apply to our operations or the operations of our collaborators. In addition, we may obtain health information from third parties (including research institutions from which we obtain clinical trial data) that are subject to privacy and security requirements under HIPAA, as amended by HITECH. Depending on the facts and circumstances, we could be subject to civil and criminal penalties if we obtain, use, or disclose individually identifiable health information maintained by a HIPAA-covered entity in a manner that is not authorized or permitted by HIPAA.
The CCPA established individual privacy rights for California consumers and places increased privacy and data security obligations on entities handling personal information of consumers or households. The CCPA was amended several times after its enactment, most recently by the California Privacy Rights Act, or the CPRA, which, as of its effective date of January 1, 2023, gives California residents expanded privacy rights, including the right to opt out of certain personal information sharing, the use of “sensitive personal information,” and the use of personal information for automated decision-making or targeted advertising. The CCPA and CPRA provide for civil penalties and a private right of action for data breaches that is expected to increase data breach litigation. The CCPA and CPRA may increase our compliance costs and potential liability. Following the lead of California, several other states, including Colorado, Utah, Virginia and Connecticut have each enacted laws similar to the CCPA/CPRA and other states are considering enacting privacy laws as well. The multiple layers of privacy law within the United States could increase our potential liability, increase our compliance costs, and adversely affect our business.
Other countries outside of the United States and Europe have enacted or are considering enacting similar cross-border data transfer restrictions and laws requiring local data residency and restricting cross-border data transfer, which could increase the cost and complexity of delivering our services and operating our business. For example, Brazil recently enacted the General Data Protection Law (Lei Geral de Proteção de Dados Pessoais or LGPD) (Law No. 13,709/2018), and effective November 1, 2021 was China’s Personal Information Protection Law (个人信息保护法, PIPL), both of which broadly regulate the processing of personal information and impose compliance obligations and penalties comparable to those of the GDPR.
These recent developments are likely to require us to review and amend the legal mechanisms by which we make and/ or receive personal data transfers to/in the United States and other countries outside of the EEA. As supervisory authorities issue further guidance on personal data export mechanisms, including circumstances where the SCCs cannot be used, and/or commence enforcement actions, we could suffer additional costs, complaints and/or regulatory investigations or fines, and/or if we are otherwise unable to transfer personal data between and among countries and regions in which we operate, it could affect the manner in which we provide our services and/or the geographical location or segregation of our relevant systems and operations, and could adversely affect our financial results.
If we cannot license rights to use technologies on reasonable terms, we may not be able to commercialize new products in the future.
In the future, we may license third-party technology to develop or commercialize new products. In return for the use of a third-party’s technology, we may agree to pay the licensor royalties based on sales of our solutions. Royalties are a component of cost of revenue and affect the margins on our solutions. We may also need to negotiate licenses to patents and patent applications after introducing a commercial product. Our business may suffer if we are unable to enter into the necessary licenses on acceptable terms, or at all, if any necessary licenses are subsequently terminated, if the licensors fail to abide by the terms of the license or fail to prevent infringement by third parties, or if the licensed patents or other rights are found to be invalid or unenforceable.
If we are unable to protect our intellectual property effectively, our business would 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. 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 apply for and in-license 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, or we may fail to apply for patents in potentially relevant jurisdictions. Our issued patents expire between 2029 and 2035 and are related to methods used in thyroid diagnostics, lung diagnostics, breast cancer diagnostics, and the nCounter FLEX analysis platform.
It is possible that none of our pending patent applications will result in issued patents in a timely fashion or at all, and even if patents are granted, they may not provide a basis for intellectual property protection of commercially viable products, may not provide us with any competitive advantages, or may be challenged and invalidated by third parties. It is possible that others will design around our current or future patented technologies. We may not be successful in defending any challenges made against our patents or patent applications. Any successful third-party challenge to our patents could result in the unenforceability or invalidity of such patents and increased competition to our business. The outcome of patent litigation can be uncertain and any attempt by us to enforce our patent rights against others may not be successful, or, if successful, may take substantial time and result in substantial cost, and may divert our efforts and attention from other aspects of our business.
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 or elsewhere. Courts frequently render opinions in the biotechnology field that may affect the patentability of certain inventions or discoveries, including opinions that may affect the patentability of methods for analyzing or comparing nucleic acids.
In particular, the patent positions of companies engaged in the development and commercialization of genomic diagnostic tests are particularly uncertain. Various courts, including the U.S. Supreme Court, have rendered decisions that affect the scope of patentability of certain inventions or discoveries relating to certain diagnostic tests and related methods. These decisions state, among other things, that patent claims that recite laws of nature (for example, the relationship between blood levels of certain metabolites and the likelihood that a dosage of a specific drug will be ineffective or cause harm) are not themselves patentable. What constitutes a law of nature is uncertain, and it is possible that certain aspects of genomic diagnostics tests would be considered natural laws. Accordingly, the evolving case law in the United States may adversely affect our ability to obtain patents and may facilitate third-party challenges to any owned and licensed patents.
The laws of some foreign countries do not protect intellectual property rights to the same extent as the laws of the United States, and we may encounter difficulties protecting and defending such rights in foreign jurisdictions. The legal systems of many other 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 in such countries. 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. We may not develop additional proprietary products, methods and technologies that are patentable.
In addition to pursuing patents on our technology, we take steps to protect our intellectual property and proprietary technology by entering into agreements, including confidentiality agreements, non-disclosure agreements and intellectual property assignment agreements, with our employees, consultants, academic institutions, 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. If we are required to assert our rights against such party, it could result in significant cost and distraction.
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.
We may also be subject to claims that our employees have inadvertently or otherwise used or disclosed trade secrets or other proprietary information of their former employers, or to claims that we have improperly used or obtained such trade secrets. 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 and face increased competition to our business. A loss of key research personnel work product could hamper or prevent our ability to commercialize potential products, which could 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.
Further, competitors could 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. Others may independently develop similar or alternative products and technologies or replicate any of our products and technologies. If our intellectual property does not adequately protect us against competitors’ products and methods, our competitive position could be adversely affected, as could our business.
We have not registered certain of our trademarks in all of our potential geographic markets. If we apply to register these trademarks, our applications may not be allowed for registration in a timely fashion or at all, 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. If some other business in one of these markets already owns a trademark that is confusingly similar to one of our trademarks, we may be prohibited from entering that market under our trademark unless we re-brand our product in that location. Similarly, if we develop a new product line, there is no guarantee that one of our existing trademarks will be available as the brand for that new product line. Under those circumstances, we may incur the cost of developing a new trademark for this new product line.
To the extent our 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 coverage of 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 be involved in litigation related to intellectual property, which could be time-intensive and costly and may adversely affect our business, operating results or financial condition.
We may receive notices of claims of direct or indirect infringement or misappropriation or misuse of other parties’ proprietary rights from time to time. Some of these claims may lead to litigation. We cannot assure you that we will prevail in such actions, or that other actions alleging misappropriation or misuse by us of third-party trade secrets, infringement by us of third-party patents and trademarks or other rights, or the validity of our patents, trademarks or other rights, will not be asserted or prosecuted against us.
We might not have been the first to make the inventions covered by each of our pending patent applications and we might not have been the first to file patent applications for these inventions. To determine the priority of these inventions, we may have to participate in interference proceedings, derivation proceedings, or other post-grant proceedings declared by the U.S. Patent and Trademark Office that could result in substantial cost to us. No assurance can be given that other patent applications will not have priority over our patent applications. In addition, recent changes to the patent laws of the United States allow for various post-grant opposition proceedings, that have not been extensively tested, and their outcome is therefore uncertain.can be difficult to predict. Furthermore, if third parties bring these proceedings against our patents, we could experience significant costs and management distraction.
Litigation may be necessary for us to enforce our patent and 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, and we might not be able to obtain licenses to technology that we require on acceptable terms or at all. Further, we could encounter delays in product introductions, or interruptions in product sales, as we develop alternative methods or products. In addition, if we resort to legal proceedings to enforce our intellectual property rights or to determine the validity, scope and coverage of the intellectual property or other proprietary rights of others, the proceedings could be burdensome and expensive, even if we were to prevail. Any litigation that may be necessary in the future could result in substantial costs 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 or growth in those markets. 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 making, having made, using, selling, offering to sell or importing 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 ongoing royalties, 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 on acceptable terms, if at all. We could incur substantial costs related to royalty payments for licenses obtained from third parties, which could negatively affect our financial results. 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 could prevent us from commercializing products, and the prohibition of sale of any of our products could materially affect our business and our ability to gain market acceptance for our products. With respect to trademarks, infringement litigation or threats of infringement litigation may require us to re-brand our product in order to enter into the new mark.
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 customers, suppliers or other entities with whom we do business require us to defend or indemnify these parties to the extent they become involved in infringement claims, including the types of 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 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.
Our ability to use our net operating loss carryforwards may be limited and may result in increased future tax liability to us.
We have incurred net losses since our inception and may never achieve profitability. As of December 31, 2019,2022, we had net operating loss, or NOL, carryforwards of approximately $236.9$402.0 million, $58.3$78.8 million and $45.2$126.1 million available to reduce future taxable income, if any, for federal, California and other state income tax purposes, respectively. The U.S. federal NOL carryforwards will begin to expire in 20262031 while for state purposes, the NOL carryforwards begin to expire in 2028.2023. In addition, as of December 31, 2022, we had foreign net operating loss carryforwards of approximately $69.9 million and $44.2 million available to reduce future taxable income, if any, for Canadian and French income tax purposes, respectively. The Canada net operating loss carryforwards will begin to expire in 2034, while for French purposes, the net operating losses will carryforward indefinitely. These NOL carryforwards could expire unused and be unavailable to offset future income tax liabilities. Under the Tax Cuts and Jobs Acts, or Tax Act, which was enacted in December 2017, federal NOLs incurred in tax years beginning after December 31, 2017 may be carried forward indefinitely, but the deductibility of such federal NOLs is limited. It is uncertain if and to what extent various states will conform to the newly enacted federal tax law.
To the extent that we continue to generate taxable losses, unused losses will carry forward to offset future taxable income, if any, until such unused losses expire. We may be limited in the portion of NOL carryforwards that we can use in the future to offset taxable income for U.S. federal and state income tax purposes, and federal tax credits to offset federal tax liabilities. Sections 382 and 383 of Internal Revenue Code limit the use of NOLs and tax credits after a cumulative change in corporate ownership of more than 50% occurs within a three-year period. The limitation could prevent a corporation from using some or all its NOL and tax credits before they expire within their normal 20-year lifespan, as it places a formula limit of how much NOL and tax credits a loss corporation can use in a tax year. In the event we have undergone an ownership change under Section 382 of the Internal Revenue Code, if we earn net taxable income, our ability to use our pre-change NOL carryforwards to offset U.S. federal taxable income may become subject to limitations, which could potentially result in increased future tax liability to us.
IfOn March 27, 2020, the CARES Act was signed into law. The CARES Act changes certain provisions of the 2017 Tax Act. Under the CARES Act, NOLs arising in taxable years beginning after December 31, 2017 and before January 1, 2021 may be carried back to each of the five taxable years preceding the tax year of such loss, but NOLs arising in taxable years beginning after December 31, 2020 may not be carried back. In addition, the CARES Act eliminates the limitation on the deduction of NOLs to 80% of current year taxable income for taxable years beginning before January 1, 2021, and increases the amount of interest expense that may be deducted to 50% of adjusted taxable income for taxable years beginning in 2019 or 2020. Notwithstanding the reduction in the corporate income tax rate, the overall impact of the Tax Act, as modified by the CARES Act, is uncertain and our business, financial conditions, results of operations and growth prospects could be materially and adversely affected.
Changes to Internal Revenue Code Section 174 under the 2017 Tax Cuts and Jobs Act went into effect in 2022. The revised code no longer permits a deduction for research and development expenditures in the tax year that such costs are incurred. Instead, such costs must be capitalized and amortized over five or 15 years for U.S. and foreign costs, respectively. The new rules will change the utilization of our NOLs and it is uncertain whether the new rules will be repealed or modified in the future.
Impairment in the value of our goodwill or other intangible assets become impaired, we may be required to recordcould have a significant charge to earnings.material adverse effect on our operating results and financial condition.
We review ourrecord goodwill and intangible assets at fair value upon the acquisition of a business. Goodwill represents the excess of amounts paid for acquiring businesses over the fair value of the net assets acquired. Goodwill and indefinite-lived intangible assets are evaluated for impairment annually, or more frequently if conditions warrant, by comparing the carrying value of a reporting unit to its estimated fair value. Intangible assets with definite lives are reviewed for impairment when events or changes in circumstances indicate thethat their carrying value may not be recoverable, such asrecoverable. Declines in operating results, divestitures, sustained market declines and other factors that impact the fair value of our reporting unit could result in stock price, market capitalization, or cash flows and slower growth rates in our industry. Goodwill is required to be tested for impairment at least annually. If we are required to record a significant charge in our financial statements during the period in which anyan impairment of our goodwill or intangible assets and, in turn, a charge to net income. Any such charges could have a material adverse effect on our results of operations or financial condition.
Our effective tax rate may fluctuate and we may incur obligations in tax jurisdictions in excess of amounts that have been accrued.
We are subject to income taxes in the United States and various foreign jurisdictions. Our effective tax rate may be lower or higher than experienced in the past due to numerous factors, including a change in the mix of our revenue from country to country, the establishment or release of valuation allowances against our deferred tax assets, and changes in tax laws. In addition, we have recorded gross unrecognized tax benefits in our consolidated financial statements that, if recognized, would impact our effective tax rate. We are subject to tax audits in various jurisdictions, including the United States, and tax authorities may disagree with certain positions we have taken and assess additional taxes. There can be no assurance that we will accurately predict the outcomes of these audits, and the actual outcomes could have a material impact on our net income or financial condition. Any of these factors could cause us to experience an effective tax rate significantly different from previous periods or our current expectations, which could have an adverse effect on our business and results of operations. The recognition of deferred tax assets is determined,reduced by a valuation allowance if it is more likely than not that would negatively affectthe tax benefits will not be realized. We regularly review our operating results.deferred tax assets for recoverability and establish a valuation allowance based on historical income, projected future income, the expected timing of the reversals of existing temporary differences, and the implementation of tax-planning strategies.
Changes in financial accounting standards or practices may cause adverse, unexpected financial reporting fluctuations and affect our reported operating results.
U.S. GAAP is subject to interpretation by the Financial Accounting Standards Board, the Securities and Exchange Commission, or the SEC, and various bodies formed to promulgate and interpret appropriate accounting principles. A change in accounting standards or practices can have a significant effect on our reported results and may even affect our reporting of transactions completed before the change is effective. New accounting pronouncements and varying interpretations of accounting pronouncements have occurred and may occur in the future. Changes to existing rules or the questioning of current practices may adversely affect our reported financial results or the way we conduct our business.
Our consolidated financial statements are subject to change and if our estimates or judgments relating to our critical accounting policies prove to be incorrect, our operating results could be adversely affected.
The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in our consolidated financial statements and related notes. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances, as provided in the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in this Annual Report on Form 10-K.The results of these estimates form the basis for making judgments about the carrying values of assets, liabilities, and equity, and the amount of revenue and expenses that are not readily apparent from other sources. Critical accounting policies and estimates used in preparing our consolidated financial statements include those related toto: revenue recognition, finite-livedrecognition; write-down of supplies; the useful lives of property and equipment; the recoverability of long-lived assets; the incremental borrowing rate for leases; the estimation of the fair value of intangible assets goodwill, and stock-based compensation expense.contingent consideration; variable interest entity assessment; impairment of equity investment, at cost; stock options; income tax uncertainties, including a valuation allowance for deferred tax assets; reserve on accounts receivable and contingencies. Our operating results may be adversely affected if our assumptions change or if actual circumstances differ from those in our assumptions, which could cause our operating results to fall below the expectations of securities analysts and investors, resulting in a decline in the price of our common stock.
Risks Related to Being a Public Company
We will continue to incur increased costs and demands on management as a result of compliance with laws and regulations applicable to public companies, which could harm our operating results.
As a public company, we will continue to incur significant legal, accounting, consulting and other expenses that we did not incur as a private company, including costs associated with public company accounting and reporting requirements. In addition, the Sarbanes-Oxley Act of 2002 and the Dodd-Frank Act of 2010, as well as rules implemented by the SEC, and The Nasdaq Stock Market LLC, impose a number of requirements on public companies, including with respect to corporate governance practices. Our management and other personnel will need to devote a substantial amount of time to these compliance and disclosure obligations. Moreover, these rules and regulations have and will continue to increase our legal, accounting and
financial compliance costs and make some activities more complex, time-consuming and costly. We also expect that it will continue to be expensive for us to maintain director and officer liability insurance.
If we are unable to implement and maintain effective internal control over financial reporting, investors may lose confidence in the accuracy and completeness of our reported financial information and the market price of our common stock may be negatively affected.
As a public company, we are required to maintain internal control over financial reporting and to report any material weaknesses in such internal control. Section 404 of the Sarbanes-Oxley Act of 2002 requires that we evaluate and determine the effectiveness of our internal control over financial reporting and provide a management report on our internal controls on an annual basis. If we have material weaknesses in our internal control over financial reporting, we may not detect errors on a timely basis and our consolidated financial statements may be materially misstated. We have only recently compiledwill need to maintain and enhance the systems, processes and documentation necessary to comply with Section 404 of the Sarbanes-Oxley Act. We will need to maintain and enhance these processes and controlsAct as we grow, and we will require additional management and staff resources to do so. Additionally, even if we conclude our internal controls are effective for a given period, we may in the future identify one or more material weaknesses in our internal
controls, in which case our management will be unable to conclude that our internal control over financial reporting is effective. We are nowalso required to include an attestation report from our independent registered public accounting firm on the effectiveness of our internal control over financial reporting annually. Further, our recent acquisitions of Decipher Biosciences and HalioDx, both of which were previously private companies and were not subject to audits of internal controls, require or will require us to incorporate additional controls to such businesses, which may be difficult, costly and time-consuming. Even if our management concludes that our internal control over financial reporting is effective, our independent registered public accounting firm may conclude that there are material weaknesses with respect to our internal controls or the level at which our internal controls are documented, designed, implemented or reviewed.
If we are unable to conclude that our internal control over financial reporting is effective, or if our auditors were to express an adverse opinion on the effectiveness of our internal control over financial reporting because we had one or more material weaknesses, investors could lose confidence in the accuracy and completeness of our financial disclosures, which could cause the price of our common stock to decline. Irrespective of compliance with Section 404, any failure of our internal control over financial reporting could have a material adverse effect on our reported operating results and harm our reputation. Internal control deficiencies could also result in a restatement of our financial results.
Investors’ expectations of our performance relating to environmental, social and governance factors may impose additional costs and expose us to new risks.
There is an increasing focus from certain investors, employees, regulators and other stakeholders concerning corporate responsibility, specifically related to environmental, social and governance, or ESG, matters. Some investors may use these non-financial performance factors to guide their investment strategies and, in some cases, may choose not to invest in us if they believe our policies and actions relating to corporate responsibility are inadequate. We may face reputational damage in the event that we do not meet the ESG standards set by various constituencies.
Furthermore, if our competitors’ corporate social responsibility performance is perceived to be better than ours, potential or current investors may elect to invest with our competitors instead. In addition, in the event that we communicate certain initiatives and goals regarding environmental, social and governance matters, we could fail, or be perceived to fail, in our achievement of such initiatives or goals, or we could be criticized for the scope of such initiatives or goals. If we fail to satisfy the expectations of investors, employees and other stakeholders or our initiatives are not executed as planned, our reputation and business, results of operations, and financial condition could be adversely affected.
Risks Related to Our Common Stock
Our stock price may be volatile, and you may not be able to sell shares of our common stock at or above the price you paid.
The trading price of our common stock is likely to continue to 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 variations in our and our competitors’ results of operations;
•the global macroeconomic impact of the current COVID-19 outbreak, rising interest rates or inflationary pressures;
•announcements by us or our competitors of new products, commercial relationships or capital commitments;
•changes in reimbursement by current or potential payers, including governmental payers;
•issuance of new securities analysts’ reports or changed recommendations for our stock;
•fluctuations in our revenue, due in part to the way in which we recognize revenue;
•actual or anticipated changes in regulatory oversight of our products;
•developments or disputes concerning our intellectual property or other proprietary rights;
•commencement of, or our involvement in, litigation;
•announced or completed acquisitions of businesses or technologies by us or our competitors;competitors, including the effect of additional equity we or our competitors issue as consideration for such acquisitions;
•any major change in our management; and
•general economic conditions, including inflation and changes in interest rates, and slow or negative growth of our markets.
In addition, the stock market in general, and the market for stock of life sciences companies and other emerging growth companies in particular, has experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of those companies. Broad market and industry factors may seriously affect the market price of our common stock, regardless of our actual operating performance. These fluctuations may be even more pronounced ifcause the trading volume of our stock remains low.to decrease. In addition, in the past, following periods of volatility in the overall market and the market price of a particular company’s securities, securities class action litigation has often been instituted against these companies. This litigation, if instituted against us, could result in substantial costs and a diversion of our management’s attention and resources.
If securities or industry analysts issue an adverse opinion regarding our stock or do not publish research or reports about our company, our stock price and trading volume could decline.
The trading market for our common stock will depend in part on the research and reports that equity research analysts publish about us, our business and our competitors. We do not control these analysts or the content and opinions or financial models included in their reports. Securities analysts may elect not to provide research coverage of our company, and such lack of research coverage may adversely affect the market price of our common stock. The price of our common stock could also decline if one
or more equity research analysts downgrade our common stock or if those analysts issue other unfavorable commentary or cease publishing reports about us or our business. If one or more equity research analysts cease coverage of our company, we could lose visibility in the market, which in turn could cause our stock price to decline.
Anti-takeover provisions in our charter documents and under Delaware law could discourage, delay or prevent a change in control and may affect the trading price of our common stock.
Provisions in our restated certificate of incorporation and our amended and restated bylaws may have the effect of delaying or preventing a change of control or changes in our management. Our restated certificate of incorporation and amended and restated bylaws include provisions that:
•authorize our board of directors to issue, without further action by the stockholders, up to 5.0 million shares of undesignated preferred stock;
•require that any action to be taken by our stockholders be effected at a duly called annual or special meeting and not by written consent;
•specify that special meetings of our stockholders can be called only by our board of directors, our chairman of the board, or our chief executive officer;
•establish an advance notice procedure for stockholder approvals to be brought before an annual meeting of our stockholders, including proposed nominations of persons for election to our board of directors;
•establish that our board of directors is divided into three classes, Class I, Class II and Class III, with each class serving staggered terms;
•provide that our directors may be removed only for cause;
•provide that vacancies on our board of directors may, except as otherwise required by law, be filled only by a majority of directors then in office, even if less than a quorum;
•provide that the federal district courts of the United States shall be the exclusive forum for the resolution of any complaint asserting a cause of action arising under the Securities Act of 1933, as amended;
•specify that no stockholder is permitted to cumulate votes at any election of directors; and
•require a super-majority of votes to amend certain of the above-mentioned provisions.
In addition, we are subject to the provisions of Section 203 of the Delaware General Corporation Law regulating corporate takeovers. Section 203 generally prohibits us from engaging in a business combination with an interested stockholder subject to certain exceptions.
We have never paid dividends on our capital stock, and we do not anticipate paying dividends in the foreseeable future.
We have never paid dividends on any of our capital stock and currently intend to retain any future earnings to fund the growth of our business. In addition, our Loan and Security Agreement restricts our ability to pay cash dividends on our common stock and weWe may also enter into credit agreements or other borrowing arrangements in the future that will restrict our ability to declare or pay cash dividends on our common stock. Any determination to pay dividends in the future will be at the discretion of our board of directors and will depend on our financial condition, operating results, capital requirements, general business conditions and other factors that our board of directors may deem relevant. As a result, capital appreciation, if any, of our common stock will be the sole source of gain for the foreseeable future.
ITEM 1B. UNRESOLVED STAFF COMMENTS
None.
ITEM 2. PROPERTIES
On April 29, 2015, we signed a non-cancelableWe lease agreement for approximately 59,000 square feet to serve as ouroffice and laboratory facilities in South San Francisco California headquarters(approximately 59,000 square feet) and laboratory. The lease began in June 2015 and ends in March 2026, and contains extension of lease term and expansion options. Certain expansion options were waived by us on February 8, 2017 in exchange for consideration of $500,000. We also lease approximatelySan Diego (approximately 28,400 square feet), California; Austin, Texas (approximately 10,400 square feetfeet); Marseille, France (approximately 31,400 square feet); and Richmond, Virginia (approximately 8,200 square feet). We believe our facilities are in good condition and adequate for their current use. We may expand or improve our current facilities or add additional facilities as appropriate to meet the needs of office and laboratory space in Austin, Texas, under a lease that expires in January 2029 and includes options for expansion and early termination in 2025.our operations.
ITEM 3. LEGAL PROCEEDINGS
We are not currently a party to any material legal proceedings. We may from time to time become involved in legal proceedings arising in the ordinary course of business.
ITEM 4. MINE SAFETY DISCLOSURE
Not applicable.
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 Global Market under the symbol "VCYT".
Holders of Record
As of February 24, 2023, there were 14 holders of record of our common stock. Because many of our shares of common stock are held in street name by brokers and other nominees on behalf of stockholders, we are unable to estimate the total number of beneficial owners of our commons stock represented by these holders of record.
Dividend Policy
We have never declared or paid dividends on our common stock and do not expect to pay dividends on our common stock for the foreseeable future. Instead, we anticipate that all of our earnings in the foreseeable future will be used for the operation and growth of our business. Any future determination to declare dividends will be subject to the discretion of our board of directors and will depend on various factors, including applicable laws, our results of operations, financial condition, future prospects, and any other factors deemed relevant by our board of directors. In addition, the terms of our credit agreement restrict our ability to pay dividends on our common stock, and we may also enter into credit agreements or other borrowing arrangements in the future that will further restrict our ability to declare or pay dividends on our common stock.
Recent Sale of Unregistered Securities and Use of Proceeds
None.
Recent SalePurchases of UnregisteredEquity Securities by the Issuer and Affiliated Purchasers
On December 3, 2019, we issued 376,732 shares of our common stock as consideration to NanoString Technologies, Inc. in connection with our acquisition of certain of its assets. The sales of these securities were exempt from registration under the Securities Act of 1933, as amended, or the Securities Act, in reliance upon Section 4(a)(2) of the Securities Act.
None.
Stock Performance Graph
The following information is not deemed to be "soliciting material" or to be "filed" with the Securities and Exchange Commission or subject to Regulation 14A or 14C under the Securities Exchange Act of 1934, as amended, or the Exchange Act, or to the liabilities of Section 18 of the Exchange Act, and will not be deemed to be incorporated by reference into any filing under the Securities Act or the Exchange Act, except to the extent we specifically incorporate it by reference into such a filing.
The graph below showscompares the cumulative total stockholder return (change in stock price plus reinvested dividends) assuming the investment of $100.00 on the date specified in each of our common stock to the Nasdaq Global Market Index and the Nasdaq Biotechnology Index forIndex. The graph and table below assume that $100 was invested on the period commencingstarting date and dividends, if any, were reinvested on October 30, 2013 (the first daythe date of tradingpayment without payment of our common stock) and ending on December 31, 2019.any commissions. The comparisons in the table are required by the SEC and are not intended to forecast or be indicative of future performance of our common stock.
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| | December 31, 2017 | | December 31, 2018 | | December 31, 2019 | | December 31, 2020 | | December 31, 2021 | | December 31, 2022 |
Veracyte, Inc. | | $ | 100.00 | | | $ | 193.00 | | | $ | 428.00 | | | $ | 749.00 | | | $ | 631.00 | | | $ | 363.00 | |
Nasdaq Global Market Index | | $ | 100.00 | | | $ | 96.00 | | | $ | 130.00 | | | $ | 187.00 | | | $ | 227.00 | | | $ | 152.00 | |
Nasdaq Biotechnology Index | | $ | 100.00 | | | $ | 94.00 | | | $ | 117.00 | | | $ | 148.00 | | | $ | 148.00 | | | $ | 133.00 | |
|
| | | | | | | | | | | | | | | | | | | | | | | | |
| | December 31, 2014 | | December 31, 2015 | | December 31, 2016 | | December 31, 2017 | | December 31, 2018 | | December 31, 2019 |
Veracyte, Inc. | | $ | 73.00 |
| | $ | 54.00 |
| | $ | 58.00 |
| | $ | 49.00 |
| | $ | 95.00 |
| | $ | 211.00 |
|
Nasdaq Global Market Index | | $ | 121.00 |
| | $ | 128.00 |
| | $ | 137.00 |
| | $ | 176.00 |
| | $ | 169.00 |
| | $ | 229.00 |
|
Nasdaq Biotechnology Index | | $ | 148.00 |
| | $ | 165.00 |
| | $ | 129.00 |
| | $ | 157.00 |
| | $ | 147.00 |
| | $ | 184.00 |
|
ITEM 6. SELECTED FINANCIAL DATA
The information set forth below should be read in conjunction with "Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations" and our audited consolidated financial statements and related notes included elsewhere in this annual report. The selected consolidated balance sheet data at December 31, 2019 and 2018 and the selected consolidated statements of operations data for each of the years ended December 31, 2019, 2018 and 2017 have been derived from our audited consolidated financial statements that are included elsewhere in this report. The selected consolidated balance sheet data at December 31, 2017, 2016 and 2015 and the selected consolidated statements of operations data for the years ended December 31, 2016 and 2015 have been derived from our audited consolidated financial statements not included in this report. The financial data are historical and are not necessarily indicative of results to be expected in any future period (in thousands, except share and per share data and genomic classifiers reported):
[RESERVED]
|
| | | | | | | | | | | | | | | | | | | |
| Year Ended December 31, |
| 2019 | | 2018 | | 2017 | | 2016 | | 2015 |
Consolidated Statements of Operations Data: | |
| | |
| | |
| | |
| | |
|
Revenue: | | | | | | | | | |
Testing revenue | $ | 107,355 |
| | $ | 91,058 |
| | $ | 71,953 |
| | $ | 65,085 |
| | $ | 49,503 |
|
Product revenue | 923 |
| | — |
| | — |
| | — |
| | — |
|
Biopharmaceutical revenue | 8,090 |
| | 950 |
| | — |
| | — |
| | — |
|
Collaboration revenue | 4,000 |
| | — |
| | — |
| | — |
| | — |
|
Total revenue | $ | 120,368 |
| | $ | 92,008 |
| | $ | 71,953 |
| | $ | 65,085 |
| | $ | 49,503 |
|
Operating expenses: | | | | | | | |
| | |
|
Cost of testing revenue(1) | 36,077 |
| | 33,078 |
| | 28,195 |
| | 25,462 |
| | 21,497 |
|
Cost of product revenue | 446 |
| | — |
| | — |
| | — |
| | — |
|
Research and development(1) | 14,851 |
| | 14,820 |
| | 13,881 |
| | 15,324 |
| | 12,796 |
|
Selling and marketing(1) | 53,691 |
| | 41,313 |
| | 32,260 |
| | 28,248 |
| | 25,293 |
|
General and administrative(1) | 29,029 |
| | 23,963 |
| | 23,088 |
| | 23,787 |
| | 22,583 |
|
Intangible asset amortization | 1,401 |
| | 1,067 |
| | 1,067 |
| | 1,067 |
| | 800 |
|
Total operating expenses(1) | 135,495 |
| | 114,241 |
| | 98,491 |
| | 93,888 |
| | 82,969 |
|
Loss from operations | (15,127 | ) | | (22,233 | ) | | (26,538 | ) | | (28,803 | ) | | (33,466 | ) |
Interest expense | (677 | ) | | (1,963 | ) | | (4,941 | ) | | (2,757 | ) | | (378 | ) |
Other income, net | 3,205 |
| | 1,197 |
| | 476 |
| | 202 |
| | 140 |
|
Net loss and comprehensive loss | $ | (12,599 | ) | | $ | (22,999 | ) | | $ | (31,003 | ) | | $ | (31,358 | ) | | $ | (33,704 | ) |
Net loss per common share, basic and diluted | $ | (0.27 | ) | | $ | (0.62 | ) | | $ | (0.91 | ) | | $ | (1.09 | ) | | $ | (1.30 | ) |
Shares used in computing net loss per common share, basic and diluted | 46,138,177 |
| | 37,020,246 |
| | 33,925,617 |
| | 28,830,472 |
| | 25,994,193 |
|
Other Operating Data: | |
| | |
| | |
| | |
| | |
|
Reported genomic test volume | 39,612 |
| | 31,710 |
| | 26,026 |
| | 23,237 |
| | 19,421 |
|
63
_____________________________________________
| |
(1) | Includes stock-based compensation as follows: |
|
| | | | | | | | | | | | | | | | | | | |
| Year Ended December 31, |
| 2019 | | 2018 | | 2017 | | 2016 | | 2015 |
Cost of testing revenue | $ | 277 |
| | $ | 130 |
| | $ | 133 |
| | $ | 126 |
| | $ | 100 |
|
Research and development | 1,856 |
| | 1,018 |
| | 1,495 |
| | 1,322 |
| | 1,178 |
|
Selling and marketing | 2,938 |
| | 1,866 |
| | 1,899 |
| | 1,594 |
| | 1,326 |
|
General and administrative | 4,736 |
| | 2,944 |
| | 3,090 |
| | 3,336 |
| | 2,998 |
|
Total stock-based compensation | $ | 9,807 |
| | $ | 5,958 |
| | $ | 6,617 |
| | $ | 6,378 |
| | $ | 5,602 |
|
Consolidated Balance Sheets Data:
|
| | | | | | | | | | | | | | | | | | | |
| As of December 31, |
| 2019 | | 2018 | | 2017 | | 2016 | | 2015 |
Cash and cash equivalents | $ | 159,317 |
| | $ | 77,995 |
| | $ | 33,891 |
| | $ | 59,219 |
| | $ | 39,084 |
|
Working capital | 170,218 |
| | 83,893 |
| | 41,900 |
| | 62,093 |
| | 33,192 |
|
Total assets | 275,212 |
| | 120,638 |
| | 78,669 |
| | 101,034 |
| | 75,247 |
|
Accumulated deficit | (246,685 | ) | | (234,086 | ) | | (211,087 | ) | | (180,084 | ) | | (148,726 | ) |
Total stockholders' equity | 239,455 |
| | 79,755 |
| | 37,225 |
| | 59,581 |
| | 51,252 |
|
ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussion and analysis of financial condition and results of operations should be read together with the consolidated financial statements and the related notes included in Item 8 of Part II of this Annual Report on Form 10-K. This discussion and analysis contains certain forward-looking statements that involve risks and uncertainties. Our actual results may differ materially from those discussed below. Factors that could cause or contribute to such differences include, but are not limited to, those identified below and those set forth under the section entitled "Risk Factors" in Item 1A, and other documents we file with the Securities and Exchange Commission. Historical results are not necessarily indicative of future results.
Overview
We are a leading genomicglobal diagnostics company that is creating value through innovation. We were foundedempowers clinicians with the high-value insights they need to guide and assure patients at pivotal moments in 2008 with a mission of improving diagnostic accuracy. Today, our growing menu ofthe race to diagnose and treat cancer. Our high-performing tests leverage advances in genomic science and technologyenable clinicians to improve care throughout the patient journey, enablingmake more confident diagnostic, prognostic and treatment decisions, helping patients avoid unnecessary procedures and interventions, and speed time to appropriate treatment, thereby improving outcomes for patients all over the world.
We currently offer tests in thyroid cancer (Afirma); prostate cancer (Decipher Prostate); breast cancer (Prosigna); interstitial lung diseases (Envisia); and bladder cancer (Decipher Bladder). Our Percepta Nasal Swab test is being run in our CLIA lab in support of clinical studies and our tests for kidney cancer and other challenging diseases. Welymphoma are creating new standards of care by enabling more patients to avoid risks of unnecessary invasive procedures and removing costs fromin development, the healthcare system, while speeding the time to diagnosis and treatment decisions.
latter as a companion diagnostic.
We performserve global markets with two complementary models. In the United States, we offer LDTs through our genomic tests for thyroid cancer, lung cancer and idiopathic pulmonary fibrosis, or IPF, in our CLIA-certified laboratorycentralized CLIA certified laboratories in South San Francisco California. and San Diego, California, supported by our cytopathology expertise in Austin, Texas. Additionally, primarily outside of the United States, we provide tests to patients through distribution to laboratories and hospitals that can perform the tests locally. Today, this includes our Prosigna test, and in the future, we intend to offer the Envisia, Decipher Prostate and Percepta Nasal Swab tests as in IVD tests that run on the nCounter Analysis System. We believe our broad menu of advanced diagnostic tests, combined with our ability to deliver them globally, uniquely positions us in the diagnostics industry.
In December 2019,March 2021, we announcedacquired Decipher Biosciences, expanding our genomic testing menu into urologic cancers. The acquisition from NanoString Technologies,also provided us with Decipher GRID (Genomics Resource for Intelligent Discovery), a platform and database that helps drive biopharmaceutical partnerships, KOL engagement and pipeline development in urologic cancers.
In August 2021, we acquired HalioDx SAS and HalioDx Inc., or NanoString,historically a wholly owned subsidiary of HalioDx SAS, (collectively referred to as “HalioDx”), giving us the exclusive global diagnostics licensecapabilities and expertise to the nCounter FLEX Analysis System, as well as the Prosigna breast cancer prognostic gene signature assay, which is commercially available, and the LymphMark lymphoma subtyping assay, which is in development. Both tests are designedmanufacture our own IVD test kits for use on the nCounter system. Analysis System. The acquisition also deepened our scientific expertise and capabilities in the rapidly growing area of immuno-oncology further strengthening our offerings to biopharmaceutical and other partners.
COVID-19 and Macroeconomic Factors
We believe this strategic transaction positions usthe COVID-19 outbreak, including its numerous variants, impacted our total test volumes primarily during 2020 and 2021. Our customers, third-party contract manufacturers, carriers, suppliers and collaboration partners have been affected by the closure of hospitals, doctors' offices, manufacturing sites, or country borders, among other measures put in place around the world. Layoffs, furloughs and unplanned loss of staff in the medical industry and otherwise during the pandemic have had, and will continue to have, negative impacts on the demand for and supply of medical care and diagnostic tests, which affects the frequency with which tests are ordered, and the ability of doctors and hospitals to administer such tests. Further the inability to travel and conduct face-to-face meetings can also make it more difficult to expand utilization of our business globally withproducts into new geographies and to drive awareness of our products.
Our Decipher Prostate test has been least impacted by the pandemic because our customers are mostly community-based urology practices, which generally remained more accessible to patients and our sales reps. Our Afirma thyroid cancer test was impacted by COVID-19 in 2020 and portions of 2021 as a broad menumajority of advanced genomic tests that may be offered as distributed kitsour samples come from large institutions which are less accessible to patients and performed in local laboratories worldwide.our reps. We believe our current and pipeline products address a collective $40 billion global market.
We currently offer five commercialized genomic tests that are changing disease diagnosis and patient care. All five tests are available in the United States and one is available internationally. These include the Afirma Genomic Sequencing Classifier, or GSC (its predecessor was the Afirma Gene Expression Classifier, or GEC) for thyroid cancer; the Percepta GSC (its predecessor was the Percepta Bronchial Genomic Classifier) for lung cancer; the Envisia Genomic Classifier for IPF; the Afirma Xpression Atlas, which provides information onpulmonology businesses were the most commonimpacted since the bronchoscopy procedures used to collect samples for our Envisia test are considered elective procedures and emerging gene alterations associated with thyroid cancer, enabling physicians to confidently tailor surgical and treatment decisions at time of diagnosis; and the Prosigna breast cancer test for assessing risk of distant recurrence, which is available for use on the nCounter platform in the United States and internationally.
Our ability to leverage RNA whole-transcriptome sequencing data in large biorepositories of patient-consented samples in oncology and other indications presents an opportunity for biopharmaceutical companies to enhance their research and development capabilities. In April 2018, we announced a collaboration with Loxo Oncology (now a wholly owned subsidiary of Eli Lilly and Company) to advance our development of highly selective medicines for patients with genetically defined cancers, including thyroid cancer. In December 2018, we entered into a long-term strategic collaboration with Johnson & Johnson Innovation and the Lung Cancer Initiative at Johnson & Johnson to advance the development and commercialization of novel diagnostic tests to detect lung cancer at its earliest stages, when the disease is most treatable. The collaboration builds upon foundational "field of injury" science where genomic changes associated with lung cancer can be identified with a simple brushing of a person's airway to develop new interventions that can save lives. Additionally, in January 2020, we announced an agreement with Acerta Pharma, the hematology research and development arm of AstraZeneca, to provide genomic information that will support its development of oncology therapeutics in lymphoma.
Patients access our tests through their physician. Our Afirma, Percepta and Envisia tests are used as part of the diagnostic process and genomic testing services are performed in our CLIA laboratory located in San Francisco, California. Cytopathology serviceshospital settings, which have been more restrictive. Further these tests are ordered by pulmonologists who could be largely preoccupied with caring for Afirma testing are performed in our reference laboratory in Austin, Texas. The Prosigna test is indicated in female breast cancer patients who have undergone surgery in conjunction with locoregional treatment consistent with standardCOVID-19 patients.
In addition, ongoing interest rate increases and inflation in the United States.
Fourth QuarterU.S. and Full-Year 2019 Financial Results
Forother markets globally may heighten the three months ended December 31, 2019,risk of an economic downturn or recession and volatility and dislocation in the capital or credit markets in the U.S. or globally. Moreover, the continued strengthening of the U.S. dollar compared to other currencies (including the prior year:Euro, in which a material portion of our European sales and costs are denominated), has impacted and may continue to impact our results of operations. We intend to continue to monitor macroeconomic conditions closely and may determine to take certain financial or operational actions in response to such conditions as appropriate. Finally, the measures taken by Russia in response to European support for Ukraine have increased the risk of disruptions to energy supplies in Europe, which may impact our ability to manufacture tests from our facility in Marseille, France.
| |
• | Total Revenue
was $29.7 million, an increase of 15%;
|
| |
• | Gross Margin was 66%, unchanged;
|
| |
• | Operating Expenses, Excluding Cost of Revenue, were $27.8 million, an increase of 38%;
|
| |
• | Net Loss and Comprehensive Loss was ($7.5) million, an increase of 140%;
|
| |
• | Basic and Diluted Net Loss Per Common Share was ($0.15), an increase of 88%;
|
| |
• | Net Cash Provided by Operating Activities was $1.8 million, compared to $1.2 million used; and
|
| |
• | Cash and Cash Equivalents was $159.3 million at December 31, 2019.
|
ForThe extent of the year ended December 31, 2019, compared toimpact of COVID-19 and other macroeconomic factors on our future liquidity and operational performance will depend on certain developments, including the prior year:
| |
• | Total Revenue was $120.4 million, an increase of 31%;
|
| |
• | Gross Margin was 70%, an increase of six percentage points;
|
| |
• | Operating Expenses, Excluding Cost of Revenue, were $99.0 million, an increase of 22%;
|
| |
• | Net Loss and Comprehensive Loss was ($12.6) million, an improvement of 45%;
|
| |
• | Basic and Diluted Net Loss Per Common Share was ($0.27), an improvement of 56%; and
|
| |
• | Net Cash Used in Operating Activities was $3.2 million, an improvement of 76%.
|
2019 Full-Yeardeployment and Recent Business Highlights
Commercial Growth:
Achieved strong total revenue growth across our testinglong-term efficacy of vaccines; the duration and product portfolio delivering $29.5 millionspread of the outbreak particularly in the fourth quarter and $108.3 million for 2019, an increaseform of 16% and 19%, respectively, compared tomore transmissible variants; the prior year.
Accelerated pulmonology testing revenue to $2.0 million and $5.5 million forimpact on our customers' operations; the fourth quarter and full year, respectively, a 123% and 174% increase compared to prior year.
Grew total genomic volume (Afirma, Percepta and Envisia) by 18% to 10,846 tests in the fourth quarter of 2019 and by 25% to 39,612 tests in 2019, compared to prior year.
Increased genomic volume for our pulmonology products by 136% in 2019 compared to prior year, achieving growth targets for both the Percepta and Envisia classifiers.
| |
• | Received final Medicare coverage in March 2019 for the Envisia classifier and published strong clinical validation and clinical utility data in The Lancet Respiratory Medicine, propelling nationwide commercial expansion of the test in the second half of 2019.
|
Expanded payer contracts by 14.4 million lives, making Veracyte an in-network genomic testing provider to health plans representing over 225 million members.
Continued to build an extensive library of clinical data across our portfolio in 2019, including 8 publications and 11 presentations at leading medical meetings, demonstrating our Afirma and pulmonology tests’ performance and clinical utility.
| |
• | Eleven abstracts were presented at the San Antonio Breast Cancer Symposium in December 2019, including data showing a benefit of Prosigna® over other genomic testing to identify patients’ long-term risk of developing distant metastases. In addition, data were presented showing the test’s ability to identify patients with intrinsic breast cancer subtypes that may potentially benefit from CDK4/6 inhibitors in place of standard chemotherapy.
|
Biopharmaceutical Collaborations/Pipeline Advancement:
In January 2019, announced a long-term strategic collaboration with Johnson & Johnson Innovation LLC to advance the development and commercialization of novel diagnostic tests to detect lung cancer at its earliest stages, when the disease is most treatable.
Presented preliminary data at the American College of Chest Physicians (CHEST) annual meeting for our first-of-its-kind noninvasive nasal swab classifier for improved lung cancer diagnosis. The test, being developed through our Johnson & Johnson collaboration, is expected to launch in early 2021.
Launched the second-generation Percepta GSC, completing the transition of our core classifiersimpact to our RNA whole-transcriptome sequencing platform.sales and renewal cycles; changes in central bank policies and interest rates; rates of inflation; and changes in foreign currency exchange rates. See Risk Factors for further discussion.
Announced a multi-year collaboration with Acerta Pharma, the hematology research and development arm of AstraZeneca plc, to provide genomic information that will support the biopharmaceutical company’s development of oncology therapeutics in lymphoma.
Global Expansion:
Acquired the exclusive global diagnostic rights to the NanoString nCounter FLEX Analysis System, as well as the Prosigna breast cancer assay and the in-development LymphMark lymphoma subtyping test. We believe this transaction positions us to access a $40 billion global market for our current and pipeline products, by offering a broad menu of advanced genomic tests in oncology and other indications using a distributed-kit model.
Factors Affecting Our Performance
Reported GenomicTotal Test Volume
Our performance depends on the number of genomic tests that we perform and report as completed in our CLIA laboratories.CLIA-certified laboratories and Prosigna tests processed on the nCounter Analysis System. Factors impacting the number of tests that we report as completed include, but are not limited to:
•the impact of COVID-19 on patients seeking to have tests performed;
•the availability of hospital staff to perform and support procedures needed to collect samples for our tests;
•the number of samples that we receive that meet the medical indication for each test performed;
•the quantity and quality of the sample received;
•receipt of the necessary documentation, such as physician order and patient consent, required to perform, bill and collect for our tests;
•the patient's ability to pay or provide necessary insurance coverage for the tests performed;
•the time it takes us to perform our tests and report the results;
•the seasonality inherent in our business, such as the impact of work days per period, timing of industry conferences and the timing of when patient deductibles are exceeded, which also impacts the reimbursement we receive from insurers; and
•our ability to obtain prior authorization or meet other requirements instituted by payers, benefit managers, or regulators necessary to be paid for our tests.
We generate substantially all our revenue from genomic testing services, including the rendering of a cytopathology diagnosis as part of the Afirma solution. For the Afirma classifier, we do not accrue revenue for approximately 5% - 10% of the tests that we perform and report as complete due principally to insufficient RNA from which to render a result and tests performed for which we do not reasonably expect to be paid.
Continued Adoption of and Reimbursement for our Products
Revenue growth depends on our ability to secure coverage decisions, achieve broader reimbursement at increased levels from third-party payers, expand our base of prescribing physicians and increase our penetration in existing accounts. Because some payers consider our products experimental and investigational, we may not receive payment for tests and payments we receive may not be at acceptable levels. We expect our revenue growth to increase if more payers make a positive coverage decision and as payers enter into contracts with us, which should enhance our revenue and cash collections. To drive increased adoption of our products, we increased our sales force and marketing efforts over the last several years. Our sales team is structuredteams are aligned under our general manager-based structure to sell all of our products; we do not maintain a separate sales force for each product.focus on specific products and global markets. If we are unable to expand the base of prescribing physicians and penetration within these accounts at an acceptable rate, or if we are not able to execute our strategy for increasing reimbursement and associated collections, we may not be able to effectively increase our revenue. We expect to continue to see pressure from payers to limit the utilization of tests, generally, and we believe more payers are deploying cost containment tactics, such as pre-authorization, reduction of the payer portion of reimbursement and employing laboratory benefit managers to reduce utilization rates.
Integrating acquired assets and advances to our collaborations
Revenue growth, operational results and advances to our business strategy depends on our ability to integrate the assets acquired into our existing business. The integration of acquired assets may impact our revenue growth, increase the cost of operations, cause significant write-offs of intangible assets, or may require management resources that otherwise would be available for ongoing development of our existing business. The integration of assets acquired from NanoString in December 2019 may
impact our revenue and operating results through integration of a sales force, development of a product supply operation and the expansion of our business internationally with a broad menu of advanced genomic tests that may be offered.
Revenue growth or reimbursement from our collaborations depends on our ability to deliver services or information and achieve milestones required from our collaborative partners. Our collaboration parters pay us for the provision of data, other services and the achievement of milestones. Under a collaboration with Johnson & Johnson in 2018, we provided data services required under this agreement for $7.0 million in 2019, however, there remains $9.0 of revenue associated with development and commercialization milestones yet to be achieved.
How We Recognize Revenue
Testing Revenue
We commenced recognizingrecognize revenue in accordance with the provisions of ASC 606, Revenue from Contracts with Customers starting January 1, 2018. Prior, or ASC 606. This process involves identifying the contract with a customer, determining the performance obligations in the contract,
determining the contract price, allocating the contract price to January 1, 2018, we recognizedthe distinct performance obligations in the contract, and recognizing revenue in accordance withwhen the provisionsperformance obligations have been satisfied.
Testing Revenue
We bill for testing services at the time of ASC 954-605, Health Care Entities - Revenue Recognition.
Most of our revenue is generated from the provision of diagnostic services. These services are completed upontest completion as defined by the delivery of test results to the prescribing physician, at which time we bill for the services.results. We recognize revenue related to billings on an accrual basis based on estimates of the amount that will ultimately be realized. In determining the amount to accrue for a delivered test, we consider factors such as payment history, payer coverage, whether there is a reimbursement contract between the payer and us, payment as a percentage of agreed upon rate (if applicable), amount paid per test and any current developments or changes that could impact reimbursement. These estimates require significant judgment by management. Actual results could differ from those estimates and assumptions.
As of December 31, 2019, cumulative amounts billed at list price for tests processed which were not recognized as revenue upon delivery of a patient report because our accrual revenue recognition criteria were not met and for which we have not collected cash or written off as uncollectible, totaled approximately $159.3 million. Of this amount, we did not collect any amounts in the year ended December 31, 2019 and we have no expectation of future collection because we began accruing for substantially all revenue upon delivery of a patient report in the third quarter of 2016.
Generally, cash we receive is collected within 12 months of the date the test is billed. We cannot provide any assurance as to when, if ever, or to what extent any of these amounts will be collected. Notwithstanding our efforts to obtain payment for these tests, payers may deny our claims, in whole or in part, and we may never receive payment for these tests.
We bill list price regardless of contract rate, but only recognize revenue from amounts that we estimate are collectible and meet our revenue recognition criteria. Revenue may not be equal to the billed amount due to a number of factors that we consider when determining revenue accrual rates, including differences in reimbursement rates, the amounts of patient co-payments and co-insurance, the existence of secondary payers, claims denials and the amount we expect to ultimately collect. Finally, when we increase our list price, it will increase the cumulative amounts billed but may not positively impact accrued revenue. In addition, payer contracts generally include the right of offset and payers may offset payments prior to resolving disputes over tests performed.
Generally, we calculate thedetermine accrual rates by calculating an average of reimbursement from our products from all payers for tests thatperformed over a four-quarter period as it reduces the effects of temporary volatility and seasonality. The periods selected to determine accrual rates typically are on average a yearat least six months old sincebecause it can taketakes a significant period of time to collect from some payers. Except in situations where we believe the rate we reasonably expect to collect to vary due to aWe may also determine accrual rates based on other factors such as coverage decision, contract,decisions, contracts, or more recent reimbursement data or evidence to the contrary, we use an average of reimbursement for tests provided over four quarters as it reduces the effects of temporary volatility and seasonal effects. Thus, the average reimbursement per product represents the total cash collected to date against genomic classifier tests, including variants, performed during the relevant period divided by the number of these tests performed during that same period.appropriate.
The average genomic classifiertest reimbursement raterates will change over time due to a number of factors, including medical coverage decisions by payers, the effects of contracts signed with payers, changes in allowed amounts by payers, our ability to successfully win appeals for payment, and our ability to collect cash payments from third-party payers and individual patients. Historical average reimbursement is not necessarily indicative of future average reimbursement. For the year ended December 31, 2019, we accrued, on average, between $2,800 and $2,900 for the Afirma genomic classifier tests, including variants, that met our revenue recognition standard, which was between 90% - 95% of the reported Afirma classifier test volume.
From the fourth quarter of 2018 to the fourth quarter of 2019, we accrued between $1.0 million and $2.4 million in revenue per quarter from providing cytopathology services associated with our Afirma solution.
We incur expense for tests in the period in which the test is conducted and recognize revenue for tests in the period in which our revenue recognition criteria are met.
Product Revenue
We began recognizing product revenue in December 2019 in accordance withOur products consist of the provisions of ASC 606, Revenue from Contracts with Customers, when we executed an agreement with NanoString for the exclusive worldwide license toProsigna breast cancer assay, the nCounter platform for in vitroAnalysis System and related diagnostic use.
kits. We recognize product revenue when control of the promised goods or services is transferred to our customers, in an amount that reflects the consideration expected to be received in exchange for those products and services.products. This process involves identifying the contract with a customer, determining the performance obligations in the contract, determining the contract price, allocating the contract price to the distinct performance obligations in the contract, and recognizing revenue when the performance obligations have been satisfied. A performance obligation is considered distinct from other obligations in a contract when it provides a benefit to the customer either on its own or together with other resources that are readily available to the customer and is separately identified in the contract. Performance obligations are considered satisfied once we have transferred control of a product or service to the customer, meaning the customer has the ability to use and obtain the benefit of the product or service.product. We recognize product revenue for satisfied performance obligations only when there are no uncertainties regarding payment terms or transfer of control. Shipping and handling costs incurred for product shipments are charged to our customers and included in product revenue.
Our products consist of the nCounter Analysis System and related consumables. Services consist of instrument service contracts and service fees for assay processing. Revenues are Revenue is presented net of the taxes that are collected from customers and remitted to governmental authorities.
Biopharmaceutical and Collaboration RevenuesOther Revenue
From time to time, weWe enter into arrangements forto license or provide access to our assets or services, including testing services, clinical services, research and development, and/or commercializationcontract manufacturing and development, as well as other services. Such arrangements may require us to deliver various rights, data, services, manufactured diagnostic test kits, access and/or samples, including intellectual property rights/licenses, R&Dtesting services and/or commercialization services. The underlying terms of these arrangements generally provide for consideration to us in the form of nonrefundable upfront license fees, development and commercial performance milestone payments, royalty payments, and/or profit sharing.
The terms of the Company’spartner biopharmaceutical companies. One such arrangement is a collaborative arrangements typically include one or more of the following: (i) up-front fees; (ii) milestone payments related to the achievement of development, regulatory, or commercial goals; and (iii) royalties on net sales of licensed products. Each of these payments may result in collaboration revenues or an offset against research and development expense.
Arrangements with partners may fallarrangement that falls under the scope of ASC Topic 808, Collaborative Arrangements, (“or ASC 808”). While808. The underlying terms of these arrangements generally provide for consideration paid to us in the form of nonrefundable fees; payments on delivery of data, test results or manufactured products; costs of service plus margin; performance milestone payments; expense reimbursements and possibly royalty and/or other payments. Net sales of data or other services to our customers are recognized in accordance with ASC 606 and are classified under biopharmaceutical and other revenue. Milestone payments which fall under the scope of ASC 808, we may analogizeare recognized in the same manner as milestone payments from customers and are considered to ASC 606 for some aspectsbe collaboration revenue. Payments received that are not related to sales or services to a customer or collaboration revenue are recorded as offsets against research and development expense or cost of these arrangements. We analogize to ASC 606 for certain activities within the collaborative arrangement for the deliverybiopharmaceutical and other revenue in our consolidated statements of a good or service (i.e., a unit of account) that is part of our ongoing major or central operations.
In arrangements involving more than one performance obligation,good or service delivered to a customer, each required performance obligationgood or service is evaluated to determine whether it qualifies as a distinct performance obligation based on whether (i) the customer can benefit from the good or service either on its own or together with other resources that are readily available and (ii) the good or service is separately identifiable from other promises in the contract. The consideration under the arrangement is then allocated to each separate distinct performance obligation based on its respective relative stand-alone selling price. The estimated selling price of each deliverable reflects our best estimate of what the selling price would be if the deliverable was regularly sold by us on a stand-alone basis or using an adjusted market assessment approach if the selling price on a stand-alone basis is not available.
The consideration allocated to each distinct performance obligation is recognized as revenue when control of the related goods is transferred which may be at a point in time or services are performed.over time. Consideration associated with at-risk substantive performance milestones is recognized as revenue when it is probable that a significant reversal of the cumulative revenue recognized will not occur. Should
there be royalties, we utilize the sales and usage-based royalty exception in arrangements that resulted from the license of intellectual property, recognizing revenuesrevenue generated from royalties or profit sharing as the underlying sales occur.
Net sales of data or other services to our customers are classified under biopharmaceutical revenue and collaboration revenue, such as milestones, are classified under collaboration revenue in our consolidated statements of operations and comprehensive loss. Payments made to us that are not net sales of data or other services to our customers are recorded as an offset against research and development expense in our consolidated statements of operations and comprehensive loss.
Development of Additional Tests
We continue to advance our portfolio of diagnostic tests that leverage innovations in genomic science, sequencing technology and machine learning methodologies to further improve patient care. In May 2017, we introduced the Afirma GSC, supported by rigorous clinical validation data showing that the RNA sequencing-based test can help significantly more patients avoid unnecessary surgery in thyroid cancer diagnosis, compared to the original Afirma classifier. In March 2018, we unveiled our Afirma Xpression Atlas, which uses the same RNA sequencing data from the platform as the Afirma GSC and enables us to extract rich genomic content - including gene expression, DNA variants and RNA fusions in over 500 genes that are associated with thyroid cancer - from thyroid FNA samples. We believe that this offering will provide clinicians with valuable genomic information that may inform surgery strategy and treatment options for patients with suspected thyroid cancer.
Together with our Afirma GSC and our tests for the BRAF v600E mutation and medullary thyroid cancer, or Malignancy Classifiers, the Afirma Xpression Atlas rounds out a comprehensive solution for physicians evaluating thyroid nodules. This innovation also enables us to enter into research collaboration with biopharmaceutical companies, which is intended to support their development of targeted therapies for genetically defined cancers, including thyroid cancer.
We have also expanded our ability to provide important clinical answers - without the need for surgery - into pulmonology. Our Percepta Bronchial Genomic Classifier, introduced in April 2015, is the first genomic test to receive Medicare coverage for use in lung cancer diagnosis, where it improves the performance of diagnostic bronchoscopy. In June 2019, we began making our “next-generation” Percepta Genomic Sequencing Classifier available to physicians, providing them with expanded lung cancer risk information that can further guide next steps for patients with suspicious lung nodules, as compared to the Percepta Bronchial Genomic Classifier.
Additionally, our Envisia Genomic Classifier, launched in October 2016, is the first commercial test to improve the diagnosis of IPF among patients with a suspected interstitial lung disease. In March 2019, we received final Medicare coverage for the Envisia classifier through the MolDX program, with an effective date of April 1, 2019.
We also believe our Xpression Atlas platform can be transferred to our pulmonology indications, to further improve patient care and advance precision medicine in lung cancer and IPF.
We are currently exploring opportunities to utilize the same “field of injury” technology that powers our Percepta classifier to develop a nasal swab test that can enable earlier lung cancer detection - and ultimately help reduce lung cancer deaths. In October 2019, we announced preliminary clinical data showing for our noninvasive nasal swab classifier - the first test of its kind. The findings show that the novel genomic test can accurately classify lung cancer risk in patients with lung nodules so that these patients can obtain the prompt diagnosis and potential treatment they need or may be monitored noninvasively.
Timing of Our Research and Development Expenses
We deploy state-of-the-art and costly genomic technologies in our biomarker discovery experiments, and our spending on these technologies may vary substantially from quarter to quarter. We also spend a significant amount on activities to secure clinical samples that can be usedtrial results in discoverysupport of our testing and product development portfolio and on-market tests, as well as clinical validation and utilization studies. The timing of these research and development activities is difficult to predict, as is the timing of clinical trial enrollments and sample acquisitions. If a substantial number of clinical samples are acquired in a given quarter or if a high-cost experiment is conducted in one quarter versus the next, the timing of these expenses can affect our financial results. We conduct clinical studies to validate our new products, as well as on-going clinical studies to further the published evidence to support our commercialized tests. As these studies are initiated, start-up costs for each site can be significant and concentrated in a specific quarter. Spending on research and development, for both experiments and studies, may vary significantly by quarter depending on the timing of these various expenses.
Financial Overview
Testing Revenue
Through December 31, 2019,2022, we had derived a substantial majoritymost of our revenue from the sale of Decipher and Afirma tests, delivered primarily to physicians in the United States. We generally invoice third-party payers upon delivery of a patient report to the prescribing physician. As such, we take the assignment of benefits and the risk of cash collection from the third-party payer and
individual patients. Third-party payers and other customers in excess of 10% of total revenue and their related revenue as a percentage of total revenue were as follows:
| | | | | | | | | | | | | | | | | |
| Year Ended December 31, |
| 2022 | | 2021 | | 2020 |
Medicare | 31 | % | | 30 | % | | 24 | % |
UnitedHealthcare | 10 | % | | 10 | % | | 11 | % |
| 41 | % | | 40 | % | | 35 | % |
|
| | | | | | | | |
| Year Ended December 31, |
| 2019 | | 2018 | | 2017 |
Medicare | 26 | % | | 29 | % | | 26 | % |
UnitedHealthcare | 11 | % | | 12 | % | | 14 | % |
| 37 | % | | 41 | % | | 40 | % |
For tests performed, we recognize the related revenue upon delivery of a patient report to the prescribing physician based on the amount that we expect to ultimately receive. In determining the amount to accrue for a delivered test, we consider factors such as payment history, payer coverage, whether there is a reimbursement contract between the payer and us, payment as a percentage of agreed upon reimbursement rate (if applicable), amount paid per test and any current development or changes that could impact reimbursement. Upon ultimate collection, the amount received is compared to previous estimates and the amount accrued is adjusted accordingly. Our ability to increase our revenue will depend on our ability to penetrate the market, obtain positive coverage policies from additional third-party payers, obtain reimbursement and/or enter into contracts with additional third-party payers for our current and new tests, and increase reimbursement rates for tests performed. Finally, should the judgments underlying our estimated reimbursement change, our accrued revenue and financial results could be negatively impacted in future periods.
Cost of Testing Revenue
The components of our cost of testing revenue are laboratory expenses, sample collection kit costs, sample collection expenses, compensation expense, license fees and royalties, depreciation, and amortization, other expenses such as equipment and laboratory supplies, and allocations of facility and information technology expenses. Costs associated with performing tests are recorded as the test is processed regardless of whether and when revenue is recognized with respect to that test. As a result, our cost of testing revenue as a percentage of testing revenue may vary significantly from period to period because we may not recognize all revenue in the period in which the associated costs are incurred. We expect cost of testing revenue in absolute dollars to increase as the number of tests we perform increases. However, we expect that the cost per test will decrease over time due to leveraging fixed costs, efficiencies we may gain as test volume increases and from automation, process efficiencies and other cost reductions. As we introduce new tests, initially our cost of testing revenue will be high as we expect to run suboptimal batch sizes, run quality control batches, test batches, registry samples, and generally incur costs that may suppress or reduce gross margins. This will disproportionately increase our aggregate cost of testing revenue until we achieve efficiencies in processing these new tests.
Cost of Product Revenue
CostOur cost of product revenue consists primarily of costs of purchasing instruments and consumablesdiagnostic kits from third-party contract manufacturers, installation, warranty, service and packaging and delivery costs. In addition, cost of product revenue includes royalty costs for licensed technologies included in our products provisions for slow-moving and obsolete inventory and stock-based compensation expense. labor expenses. As our Prosigna test kits are sold in various configurations with different number of tests, our product cost per test will vary based on the specific kit configuration purchased by customers.
Cost of product revenue for instrumentsBiopharmaceutical and consumables is recognized in the period the related revenue is recognized. Shipping and handling costs incurred for product shipments are included inOther Revenue
Our cost of product inbiopharmaceutical and other revenue are the consolidated statementscosts of operations.performing activities under arrangements that require us to perform research and development, commercialization, contract manufacturing and development, and contract testing services on behalf of a customer. This cost is mainly composed of compensation expense, laboratory supplies and pass-through costs.
Research and Development
Research and development expenses include expenses incurred to develop our technology, collect clinical samples and conduct clinical studies to develop and support our products and pipeline. These expenses consist of compensation expenses, direct research and development expenses such as prototype materials, laboratory supplies and costs associated with setting up and conducting
conducting clinical studies at domestic and international sites, professional fees, depreciation and amortization, other miscellaneous expenses and allocation of facility and information technology expenses. We expense all research and development costs in the periods in which they are incurred. We expect to incur significant research and development expenses as we continue to invest in research and development activities related to developing additional products and evaluating various platforms. We incurred research and development expenses on ongoing evidence development for our Afirma, Percepta and Envisia classifiers in 2019 . We believe a majority of our research and development expenses in years ended December 31, 2022 and after 2020 will be predominantlyDecember 31, 2021 in support of our pipeline products.early-stage products, including Percepta Nasal Swab. Going forward, we expect to incur significant expense as we invest in the development of our innovation engine, early-stage products, including required clinical studies, the development of current tests for the nCounter instrument and the transition of manufacturing to our Veracyte SAS facility.
Selling and Marketing
Selling and marketing expenses consist of compensation expenses, direct marketing expenses, professional fees, other expenses such as travel and communications costs, andas well as allocation of facility and information technology expenses. WeOur sales team of approximately 120 representatives is organized by business unit, with separate teams calling on thyroid cancer, urologic cancers, and pulmonology physicians. The business units have expanded our internal sales forcededicated marketing support, as we invest in our multi-product sales strategy to assign a single point of contact to successfully develop and implement relationships with our customers and increased our marketing spending. We have also incurred increased selling and marketing expensewell as a resultmarketing operations team that serves the commercial organization broadly. Prosigna sales outside of investments in our lung product portfoliothe U.S. are led by country managers that call on laboratories and believe total sellingbreast cancer oncologists and have dedicated marketing expenses will continue to increase as we launch and promote our new tests.support.
General and Administrative
General and administrative expenses include compensation expenses for executive officers and administrative, billing and client service personnel, professional fees for legal and audit services, occupancy costs, depreciation and amortization, and other expenses such as information technology and miscellaneous expenses offset by allocation of facility and information technology expenses to other functions. ForGeneral and administrative expenses include costs related to the year ended December 31, 2019, approximately 67%acquisitions of the average headcount classified asDecipher Biosciences and HalioDx, which were included in general and administrative encompass our billingcompensation expense and customer care teams.professional fees. We expect general and administrative expenses to continue to increase as we build our general and administration infrastructure to scale revenue growth, and to stabilize thereafter.
Intangible Asset Amortization
Our finite-lived intangible assets, acquired in business combinations, are being amortized over 5 to154 to 15 years, using the straight-line method. Amortization expense is expected to be approximately $5.1$21.3 million per year through 2024 and decrease thereafter.
Interest Expense
Interest expense is attributable to our borrowings under debt agreements and capital leases as well as costs associated with the pre-paymentprepayment of debt.
Other Income, Net
Other income, net consists primarily of sublease rental incomerealized and unrealized gains and losses on foreign currency transactions, French research tax credits, interest expense on our debt and interest income from our cash held in interest bearing accounts. The French research tax credits (crédit d’impôt recherche or CIR) are generated by our wholly owned subsidiary, Veracyte SAS, in connection with its research efforts performed in Marseille, France.
Critical Accounting Policies and Estimates
Our management's discussion and analysis of our financial condition and results of operations is based on our audited consolidated financial statements, which have been prepared in accordance with United States generally accepted accounting principles, or U.S. GAAP. The preparation of the consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the consolidated financial statements, as well as the reported revenue generated and expenses incurred during the reporting periods. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions and any such differences may be material. We believe that the accounting policies discussed below are critical to
understanding our historical and future performance, as these policies relate to the more significant areas involving management's judgments and estimates.
Testing Revenue
We bill for testing services at the time of test completion as defined by the delivery of test results. We recognize revenue related to billings on an accrual basis based on estimates of the amount that will ultimately be realized. In determining the amount to accrue for a delivered test, we consider factors such as payment history, payer coverage, whether there is a reimbursement contract between the payer and us, payment as a percentage of the agreed upon rate (if applicable), amount paid per test and any current developments or changes that could impact reimbursement. These estimates require significant judgment by management.
Generally, we determine accrual rates based on theby calculating an average of reimbursement from all payers for tests that are on averageperformed over a yearfour-quarter period as it reduces the effects of temporary volatility and seasonality. The periods selected to determine accrual rates tend to be at least six months old sincebecause it can taketakes a significant period of time to collect from some payers. Except in situations where we believe the rate we reasonably expect to collect to vary due to aWe may also determine accrual rates based on other factors such as coverage decision, contract,decisions, contracts, or more recent reimbursement data or evidence to the contrary, we use an average of reimbursement for tests provided over four quarters as it reduces the effects of temporary volatility and seasonal effects.appropriate.
We use judgment in determining accrual rates and our judgments will continue to evolve in the future as we continue to gain reimbursement experience.
Product Revenue
Our products consist of the Prosigna breast cancer assay, the nCounter Analysis System and related diagnostic kits. We recognize product revenue when control of the promised goods is transferred to our customers, in an amount that reflects the consideration expected to be received in exchange for those products. Shipping and handling costs incurred for product shipments are charged to our customers and included in product revenue. Revenues are presented net of the taxes that are collected from customers and remitted to governmental authorities.
Biopharmaceutical and Collaboration RevenueOther Revenues
From timeFor biopharmaceutical and other revenue, we develop estimates and assumptions that require judgment to time, we enter into arrangementsdetermine the underlying stand-alone selling price for the research and development and/or commercialization of services. Such arrangements may require us to deliver various rights, services and/or samples, including intellectual property rights/licenses, research and development services, and/or commercialization of services. The underlying terms of these arrangements generally provide for consideration to us in the form of nonrefundable upfront license fees, development and commercial performance milestone payments, royalty payments and/or profit sharing.
In arrangements involving more than oneeach performance obligation which determines how the transaction price is allocated among the performance obligations. The estimation of the stand-alone selling price may include independent evidence of market price, forecasted revenues or costs, development timelines, discount rates, and probabilities of technical and regulatory success. We evaluate each requiredperformance obligation to determine if they can be satisfied at a point in time or over time, and we measure the services delivered to the collaborative partner which are periodically reviewed based on the progress of the related program. For licenses that are bundled with other promises, we utilize judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time. The effect of any change made to an estimated input component and, therefore revenue or expense recognized, would be recorded as a change in estimate. In addition, variable consideration must be evaluated to determine whetherif it qualifies as a distinct performance obligation based on whether (i) the customer can benefitis constrained and, therefore, excluded from the good or service either on its own or together with other resourcestransaction price.
At the inception of each arrangement that includes milestone payments (variable consideration), we evaluate whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price. Milestone payments that are readily availablenot within either party’s control, such as non-operational developmental and (ii)regulatory approvals, are generally not considered probable of being achieved until those approvals are received. At the good or service is separately identifiable from other promisesend of each reporting period, we re-evaluate the probability of achievement of milestones that are within either party’s control, such as operational developmental milestones and any related constraint, and if necessary, adjusts our estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect revenues and earnings in the contract. The consideration under the arrangement is then allocatedperiod of adjustment. Revisions to each separate distinct performance obligation based on its respective relative stand-alone selling price. The estimated selling price of each deliverable reflects our best estimate of what the sellingtransaction price would be ifmay also result in negative revenues and earnings in the deliverable was regularly sold by us on a stand-alone basis or using an adjusted market assessment approach if selling price on a stand-alone basis is not available.
Arrangementsperiod of adjustment. One collaboration arrangement with partners may fallmilestone payments falls under the scope of ASC Topic 808, Collaborative Arrangements (“ASC 808”). While these arrangements808. These milestone payments are recognized in the scope of ASC 808, we may analogize to ASC 606 for some aspects of these arrangements. We analogize to ASC 606 for certain activities within the collaborative arrangement for the delivery of a good or service (i.e., a unit of account) that is part of our ongoing major or central operations.
The consideration allocated to each distinct performance obligation is recognizedsame manner as revenue when control of the related goods or services is transferred. Consideration associated with at-risk substantive performance milestones is recognized as revenue when it is probable that a significant reversal of the cumulative revenue recognized will not occur. Should there be royalties, we utilize the salesmilestone payments from customers and usage-based royalty exception in arrangements that resulted from the license of intellectual property, recognizing revenues generated from royalties or profit sharing as the underlying sales occur.
Net sales of data or other services to our customers are classified under biopharmaceutical revenue and collaboration revenue, such as milestones, are classified under collaboration revenue in our consolidated statementsother revenue.
Other Significant Accounting Policies
Acquisitions
We first determine whether a set of assets acquired and liabilities assumed constitute a business and should be accounted for as a business combination. If the assets acquired are not a business, we account for the transaction as an asset acquisition. Business combinations are accounted for by using the acquisition method of accounting. Under the acquisition method, assets acquired, and liabilities assumed are recorded at their respective fair values as of the acquisition date in our consolidated financial statements. The excess of the fair value of consideration transferred over the fair value of the net assets acquired is recorded as goodwill.
Contingent consideration obligations incurred in connection with a business combination are recorded at fair value on the acquisition date and remeasured at each subsequent reporting period until the related contingencies are resolved, with the resulting changes in fair value recorded in earnings. The estimation of the fair value of the contingent consideration is based on the present value of the expected payments calculated by assessing the likelihood of when the related milestones would be achieved, discounted using our estimated borrowing rate.
Finite-lived Intangible AssetsAsset Amortization
Finite-livedWe have acquired finite-lived and indefinite-lived intangible assets consist of in business combinations. These intangible assets acquiredare measured at their respective fair values as part of business combinations. We amortizethe acquisition date and are subject to potential adjustments within the measurement period, which may be up to one year from the acquisition dates. The fair values of the intangible assets are generally determined using income approaches such as the multi-period excess earnings method, the with-and-without method and the relief from royalty method. These income approaches are based on various estimates for each asset including the estimate of future cash flows including, revenue assumptions (such as projected testing volumes, growth rates), discount rates and the expected economic life/obsolescence factors of the respective assets. Our finite-lived intangible assets are being amortized using the straight-line method over their estimated useful lives of five4 to 15 years, based on management's estimate of the period over which their economic benefits will be realized, product life and patent life. Our in-process research and development, or IPR&D, is not amortized until it becomes commercially viable and placed in service. At the time when the IPR&D is placed in service, we will determine a useful life. We test these finite-lived intangible assets for impairment on an annual basis or when events or circumstances indicate a reduction in the fair value below their carrying amounts. There was no impairment recognized during the years ended December 31, 2019, 2018, or 2017.
Goodwill
Goodwill is reviewed for impairment on an annual basis or more frequently if events or circumstances indicate that it may be impaired. Our goodwill evaluation is based on both qualitative and quantitative assessments regarding the fair value of goodwill relative to its carrying value. We have determined that we operate in a single segment and have a single reporting unit associated with the development and commercialization of diagnostic products. In the event we determine that it is more likely than not the carrying value of the reporting unit is higher than its fair value, quantitative testing is performed comparing recorded values to estimated fair values. If impairment is present, the impairment loss is measured as the excess of the recorded goodwill over its implied fair value. We perform our annual evaluation of goodwill during the fourth quarter of each fiscal year. There was no impairment recognized during the years ended December 31, 2019, 2018,2022, 2021, or 2017.2020.
Stock-based Compensation
We recognize stock-based compensation expense for only those shares underlying stock options and restricted stock units that we expect to vest on a straight-line basis over the requisite service period of the award. We estimate the fair value of stock options using a Black-Scholes option-pricing model, which requires the input of highly subjective assumptions, including the option's expected term and stock price volatility. In addition, judgment is also required in estimating the number of stock-based awards that are expected to be forfeited. Forfeitures are estimated based on historical experience at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. Performance-based stock units, which vest upon the achievement of certain performance conditions, are subject to the employees’ continued service with us. The probability of vesting is assessed at each reporting period and compensation cost is adjusted based on this probability assessment. The assumptions used in calculating the fair value of share-based payment awards represent management's best estimates, but these estimates involve inherent uncertainties and the application of management's judgment. As a result, if factors change and we use different assumptions, our stock-based compensation expense could be materially different in the future.
Supplies and Inventory
Supplies consists of materials and reagents consumed in the performance of testing services. Inventory consists of raw materials consumed in the contract manufacturing process as well as finished and semi-finished components used in the assembly of diagnostic kits related to product sales. Inventory is stated at the lower of cost or net realizable value on a weighted average basis. We periodically analyze supply and inventory levels and expiration dates, and write down supply or inventory that has become obsolete, that has a cost basis in excess of its net realizable value, or in excess of expected sales requirements as cost of revenue. We record an allowance for excess or obsolete supplies and inventory using an estimate based on historical trends and evaluation of near-term expirations.
Leases
We determine if an arrangement is, or contains, a lease at inception. Operating leases are included in right-of-use assets - operating leases and operating lease liabilities in our consolidated balance sheets, representing our right to use an underlying asset for the lease term and the obligation to make lease payments arising from the lease. Right-of-use, or ROU, assets and lease liabilities are recognized at commencement based on the present value of lease payments over the lease term. We use our incremental borrowing rate based on the estimated rate of interest for collateralized borrowing over a similar term of the lease payments. The ROU assets also includes any lease payments made and is adjusted for lease incentives. Lease terms may include options to extend or terminate the lease which are recognized when it is reasonably certain that we will exercise that option. Lease expense is recognized on a straight-line basis over the lease terms. Lease and non-lease components are accounted for as a single lease component. Financing leases are immaterial and are included in property and equipment, net and other liabilities in the consolidated balance sheets. Leases with terms of 12 months or less are not recorded on our balance sheet.
Foreign Currency Translation
The functional currency of our foreign subsidiary, Veracyte SAS, is the Euro. Assets and liabilities denominated in foreign currencies are translated to U.S. dollars using the exchange rates at the balance sheet date. Foreign currency translation adjustments are recorded as a component of accumulated other comprehensive loss within stockholders’ equity. Revenue and expenses from our foreign subsidiaries are translated using the monthly average exchange rates in effect during the period in which the transactions occur. Foreign currency transaction gains and losses are recorded in other income, net, on the consolidated statements of operations.
Comprehensive Loss
Comprehensive loss is the change in stockholders’ equity from transactions and other events and circumstances other than those resulting from investments by stockholders and distributions to stockholders. Our comprehensive loss includes our net loss and gains and losses from the foreign currency translation of the assets and liabilities of our foreign subsidiaries.
Results of Operations
Comparison of the Years Ended December 31, 20192022 and 20182021 (in thousands of dollars, except percentages)percentages and test volume)
| | | | | | | | | | | | | | | | | | | | | | | |
| Year Ended December 31, |
| 2022 | | Change | | % | | 2021 |
Revenue: | | | | | | | |
Testing revenue | $ | 250,544 | | | $ | 62,362 | | | 33 | % | | $ | 188,182 | |
Product revenue | 12,632 | | | 1,168 | | | 10 | % | | 11,464 | |
Biopharmaceutical and other revenue | 33,360 | | | 13,492 | | | 68 | % | | 19,868 | |
Total revenue | 296,536 | | | 77,022 | | | 35 | % | | 219,514 | |
Operating expense: | | | | | | | |
Cost of testing revenue | 75,317 | | | 16,457 | | | 28 | % | | 58,860 | |
Cost of product revenue | 7,820 | | | 1,933 | | | 33 | % | | 5,887 | |
Cost of biopharmaceutical and other revenue | 18,445 | | | 8,792 | | | 91 | % | | 9,653 | |
Research and development | 40,603 | | | 10,760 | | | 36 | % | | 29,843 | |
Selling and marketing | 97,560 | | | 17,720 | | | 22 | % | | 79,840 | |
General and administrative | 76,518 | | | (24,835) | | | (25) | % | | 101,353 | |
Intangible asset amortization | 21,354 | | | 5,373 | | | 34 | % | | 15,981 | |
Total operating expenses | 337,617 | | | 36,200 | | | 12 | % | | 301,417 | |
Loss from operations | (41,081) | | | 40,822 | | | 50 | % | | (81,903) | |
Other income, net | 4,654 | | | 4,400 | | | 1,732 | % | | 254 | |
Loss before income tax benefit | (36,427) | | | 45,222 | | | (55) | % | | (81,649) | |
Income tax provision (benefit) | 133 | | | 6,219 | | | (102) | % | | (6,086) | |
Net loss | $ | (36,560) | | | $ | 39,003 | | | 52 | % | | $ | (75,563) | |
Other Operating Data: | | | | | | | |
Diagnostic tests reported | 93,340 | | | 22,891 | | | 32 | % | | 70,449 | |
Product tests sold | 9,184 | | | 1,068 | | | 13 | % | | 8,116 | |
Total test volume | 102,524 | | | 23,959 | | | 30 | % | | 78,565 | |
| | | | | | | |
Depreciation and amortization expense | $ | 25,928 | | | $ | 6,335 | | | 32 | % | | $ | 19,593 | |
Stock-based compensation expense | $ | 27,456 | | | $ | 4,937 | | | 22 | % | | $ | 22,519 | |
|
| | | | | | | | | | | | | | |
| Year Ended December 31, |
| 2019 | | Change | | % | | 2018 |
Revenue: | | | | | | | |
Testing revenue | $ | 107,355 |
| | 16,297 |
| | 18 | % | | $ | 91,058 |
|
Product revenue | 923 |
| | 923 |
| | — | % | | — |
|
Biopharmaceutical revenue | 8,090 |
| | 7,140 |
| | 752 | % | | 950 |
|
Collaboration revenue | 4,000 |
| | 4,000 |
| | — | % | | — |
|
Total revenue | 120,368 |
| | $ | 28,360 |
| | 31 | % | | $ | 92,008 |
|
Operating expense: | | | |
| | |
| | |
Cost of testing revenue | 36,077 |
| | 2,999 |
| | 9 | % | | 33,078 |
|
Cost of product revenue | 446 |
| | 446 |
| | — | % | | — |
|
Research and development | 14,851 |
| | 31 |
| | — | % | | 14,820 |
|
Selling and marketing | 53,691 |
| | 12,378 |
| | 30 | % | | 41,313 |
|
General and administrative | 29,029 |
| | 5,066 |
| | 21 | % | | 23,963 |
|
Intangible asset amortization | 1,401 |
| | 334 |
| | 31 | % | | 1,067 |
|
Total operating expenses | 135,495 |
| | 21,254 |
| | 19 | % | | 114,241 |
|
Loss from operations | (15,127 | ) | | 7,106 |
| | 32 | % | | (22,233 | ) |
Interest expense | (677 | ) | | 1,286 |
| | (66 | )% | | (1,963 | ) |
Other income, net | 3,205 |
| | 2,008 |
| | 168 | % | | 1,197 |
|
Net loss and comprehensive loss | $ | (12,599 | ) | | $ | 10,400 |
| | 45 | % | | $ | (22,999 | ) |
Other Operating Data: | | | | | | | |
Genomic classifiers reported | 39,612 |
| | 7,902 |
| | 25 | % | | 31,710 |
|
Revenue
Revenue increased $28.4$77.0 million, or 31%35%, for the year ended December 31, 20192022 compared to 2018,2021. This was primarily due to an increase in testing revenue from a 25% increase in genomic classifiers reported. We had a $15.8$62.4 million increase in testing revenue fordriven by a 32% volume increase, as well as a $13.5 million increase in our Afirma, Percepta,Biopharmaceutical and Envisia classifiers inother revenue. Testing revenue and volume reported for the year ended December 31, 2019 compared2022 increased primarily due to 2018. We also make adjustments, as necessary, for testingDecipher Prostate tests, which contributed $56.6 million of the increase and was partially impacted by the closing of the Decipher Bioscience acquisition on March 12, 2021. The remaining increase was driven by growth in our Afirma test volume. Product revenue accrued in prior periods as collections are made if the amount we expect to collect changes. The adjustment for testing revenue accrued in prior periods was $1.0 million and $2.0increased $1.2 million for the yearsyear ended December 31, 2019 and 2018, respectively, a net decrease of $1.0 million between the years. We also recognized $0.9 million from2022 compared to 2021, driven primarily by product tests kits as well as sales of Prosigna,the nCounter Analysis System. This growth was partially offset by a decline in currency exchange rates, which negatively impacted product revenue by $1.1 million. Biopharmaceutical and other revenue increased by $13.5 million for the year ended December 31, 2022 driven primarily by the contribution of the HalioDx acquisition and partially offset by a $4.0 million milestone payment received in the prior year period that we acquired from NanoString in December 2019. We recognized $8.1did not repeat. Currency exchange rates negatively impacted our total revenue by $4.7 million of biopharmaceutical revenuewhen compared to $1.0 million in 2018prior year rates, primarily duerelated to the performanceour Biopharmaceutical and other revenue.
Comparison of revenue for the years endingended December 31, 20182021 and 20172020 is included in Item 8 of Part II of the Annual Report on Form 10-K filed with the Securities and Exchange Commission dated February 28, 2022.
Cost of revenue
Comparison of the years ended December 31, 2022 and 2021 was as follows (in thousands of dollars, except percentages):
| | | | | | | | | | | | | | | | | | | | | | | |
| Year Ended December 31, |
| 2022 | | Change | | % | | 2021 |
Cost of testing revenue: | | | | | | | |
Laboratory expense | $ | 37,502 | | | $ | 5,312 | | | 17 | % | | $ | 32,190 | |
Sample collection expense | 9,633 | | | 4,210 | | | 78 | % | | 5,423 | |
Compensation expense | 17,018 | | | 5,243 | | | 45 | % | | 11,775 | |
License fees and royalties | 75 | | | (856) | | | (92) | % | | 931 | |
Depreciation and amortization | 1,247 | | | 106 | | | 9 | % | | 1,141 | |
Other expenses | 4,080 | | | 1,170 | | | 40 | % | | 2,910 | |
Allocations | 5,762 | | | 1,272 | | | 28 | % | | 4,490 | |
Total | $ | 75,317 | | | $ | 16,457 | | | 28 | % | | $ | 58,860 | |
| | | | | | | |
Cost of product revenue: | | | | | | | |
Product costs | $ | 5,879 | | | $ | 1,128 | | | 24 | % | | $ | 4,751 | |
License fees and royalties | 1,089 | | | 28 | | | 3 | % | | 1,061 | |
Depreciation and amortization | 151 | | | 76 | | | 101 | % | | 75 | |
Other expenses | 620 | | | 620 | | | NM | | — | |
Allocations | 81 | | | 81 | | | NM | | — | |
Total | $ | 7,820 | | | $ | 1,933 | | | 33 | % | | $ | 5,887 | |
| | | | | | | |
Cost of biopharmaceutical and other revenue: | | | | | | | |
Compensation expense | $ | 8,935 | | | $ | 4,678 | | | 110 | % | | $ | 4,257 | |
License fees and royalties | 170 | | | 69 | | | 68 | % | | 101 | |
Depreciation and amortization | 400 | | | 166 | | | 71 | % | | 234 | |
Other expenses | 8,732 | | | 3,638 | | | 71 | % | | 5,094 | |
Allocations | 208 | | | 241 | | | (730) | % | | (33) | |
Total | $ | 18,445 | | | $ | 8,792 | | | 91 | % | | $ | 9,653 | |
Cost of testing revenue increased $16.5 million, or 28.0%, for the year ended December 31, 2022 compared to 2021. The increase in cost of testing revenue is due to increased volume in testing, primarily related to Afirma and Decipher Prostate as well as approximately $1.3 million of costs related to sample collection kits that were classified as marketing expense in the prior year.
Cost of product revenue is related to sales of Prosigna and nCounter Analysis Systems. Cost of product revenue increased $1.9 million, or 33%, for the year ended December 31, 2022 compared to the same period in 2021, driven by increased test volume, system sales and transitional costs related to in-sourcing the manufacturing of the product line to our facilities in Marseille, France. This was partially offset by a $0.3 million currency exchange impact.
Cost of biopharmaceutical and other revenue includes labor costs incurred by our employees working on customer projects and laboratory supplies and pass-through expenses incurred on these projects. Cost of biopharmaceutical and other
revenue increased by $8.8 million driven by the operations of HalioDx following its acquisition on August 2, 2021, including a $1.9 million favorable currency exchange impact when compared to prior year rates.
Comparison of cost of revenue for the years ended December 31, 2021 and 2020 are included in Item 8 of Part II of the Annual Report on Form 10-K filed with the Securities and Exchange Commission dated February 25, 2019. There was no product revenue, biopharmaceutical revenue or collaboration revenue in 2017.28, 2022.
Cost of revenueResearch and development
Comparison of the years ended December 31, 20192022 and 20182021 was as follows (in thousands of dollars, except percentages):
| | | | | | | | | | | | | | | | | | | | | | | |
| Year Ended December 31, |
| 2022 | | Change | | % | | 2021 |
Research and development expense | | | | | | | |
Compensation expense | $ | 27,383 | | | $ | 6,276 | | | 30 | % | | $ | 21,107 | |
Direct research and development expense | 5,675 | | | 1,171 | | | 26 | % | | 4,504 | |
Depreciation and amortization | 524 | | | 212 | | | 68 | % | | 312 | |
Other expenses | 4,146 | | | 2,389 | | | 136 | % | | 1,757 | |
Allocations | 2,875 | | | 712 | | | 33 | % | | 2,163 | |
Total | $ | 40,603 | | | $ | 10,760 | | | 36 | % | | $ | 29,843 | |
|
| | | | | | | | | | | | | | |
| Year Ended December 31, |
| 2019 | | Change | | % | | 2018 |
Cost of testing revenue: | |
| | |
| | |
| | |
|
Laboratory expense | $ | 20,166 |
| | $ | 1,108 |
| | 6 | % | | $ | 19,058 |
|
Sample collection expense | 4,801 |
| | 635 |
| | 15 | % | | 4,166 |
|
Compensation expense | 6,013 |
| | 1,492 |
| | 33 | % | | 4,521 |
|
License fees and royalties | 10 |
| | (795 | ) | | (99 | )% | | 805 |
|
Depreciation and amortization | 1,020 |
| | 220 |
| | 28 | % | | 800 |
|
Other expenses | 1,749 |
| | 18 |
| | 1 | % | | 1,731 |
|
Allocations | 2,318 |
| | 321 |
| | 16 | % | | 1,997 |
|
Total | $ | 36,077 |
| | $ | 2,999 |
| | 9 | % | | $ | 33,078 |
|
| | | | | | | |
Cost of product revenue | $ | 446 |
| | $ | 446 |
| | — | % | | $ | — |
|
Cost of testing revenueResearch and development expense increased $3.0$10.8 million or 9%,36% for the year ended December 31, 20192022 compared to 2018. The increase in laboratory costs was primarily due to a 25% increase in reported genomic classifiers volume, partially offset by lower pricing on supplies and improved efficiencies following the completion of the transition from the Afirma GEC to Afirma GSC in the third quarter of 2018. The increase in sample collection costs was primarily related to the increase in the overall volume of samples received, partially offset by lower shipping costs from modifications to our collection kits.2021. The increase in compensation expense wasand other expenses were primarily due to an average laboratoryincrease in headcount, increaseincluding the additions of 16%. The decrease in license feesnew personnel from the acquisitions of Decipher Biosciences and royalties was due to the completed transition to the Afirma GSC in the third quarter of 2018, for which we do not pay license fees as we did in connection with the Afirma GEC.HalioDx. The increase in depreciationdirect research and amortizationdevelopment expense was primarily related to our on-going clinical studies including but not limited to furthering the support and evidence of our Percepta Nasal Swab test. We recognized a $0.9 million favorable impact from more equipment being placed into service. The increase in allocations was dueforeign currency exchange when compared to higher allocated costs from the increased headcount. Cost of product revenue was $0.4 million from sales of Prosigna in 2019, a product that we acquired from NanoString in December 2019.prior year rates.
Comparison of cost of testing revenueresearch and development expense for the years endingended December 31, 20182021 and 20172020 are included in Item 8 of Part II of the Annual Report on Form 10-K filed with the Securities and Exchange Commission dated February 25, 2019. There was no cost of product revenue in 2017.28, 2022.
Selling and marketing
Research and development
Comparison of the years ended December 31, 20192022 and 20182021 was as follows (in thousands of dollars, except percentages):
| | | | | | | | | | | | | | | | | | | | | | | |
| Year Ended December 31, |
| 2022 | | Change | | % | | 2021 |
Selling and marketing expense: | | | | | | | |
Compensation expense | $ | 72,258 | | | $ | 14,847 | | | 26 | % | | $ | 57,411 | |
Direct marketing expense | 6,138 | | | (1,073) | | | (15) | % | | 7,211 | |
Other expenses | 13,485 | | | 3,045 | | | 29 | % | | 10,440 | |
Allocations | 5,679 | | | 901 | | | 19 | % | | 4,778 | |
Total | $ | 97,560 | | | $ | 17,720 | | | 22 | % | | $ | 79,840 | |
|
| | | | | | | | | | | | | | |
| Year Ended December 31, |
| 2019 | | Change | | % | | 2018 |
Research and development expense | |
| | |
| | |
| | |
|
Compensation expense | $ | 9,444 |
| | $ | 1,209 |
| | 15 | % | | $ | 8,235 |
|
Direct research and development expense | 2,924 |
| | (792 | ) | | (21 | )% | | 3,716 |
|
Professional fees | 548 |
| | (242 | ) | | (31 | )% | | 790 |
|
Depreciation and amortization | 287 |
| | (113 | ) | | (28 | )% | | 400 |
|
Other expenses | 443 |
| | 38 |
| | 9 | % | | 405 |
|
Allocations | 1,205 |
| | (69 | ) | | (5 | )% | | 1,274 |
|
Total | $ | 14,851 |
| | $ | 31 |
| | — | % | | $ | 14,820 |
|
ResearchSelling and developmentmarketing expense was flat inincreased $17.7 million, or 22%, for the year ended December 31, 20192022 compared to 2018. Compensation2021. The increase in compensation expense increased $1.2 million,was primarily due to higher stock-based compensation expense fromadditional employees and commissions to support the growth of Decipher test volume. Following our acquisition of HalioDx in August 2021, HalioDx's operations contributed to the increase in our stock pricecompensation expenses, inclusive of a $1.0 million favorable impact from foreign currency exchange rates when compared to the prior year rates. The increase in other expenses was primarily due to increased travel and incentive compensation, partially offset by severance costs incurred in 2018 that were not incurred in 2019.entertainment to also support
the Decipher test volume. The decreasereduction in direct research and developmentmarketing expense was dueis related to one-time sequencing costs and materials and supplies purchasedthe reclassification of sample collection kit expense to cost of revenue for research and development projects in 2018. The decrease in professional fees was due to lower consulting costs.the year ended December 31, 2022.
Comparison of researchselling and developmentmarketing expense for the years endingended December 31, 20182021 and 20172020 are included in Item 8 of Part II of the Annual Report on Form 10-K filed with the Securities and Exchange Commission dated February 25, 2019.28, 2022.
SellingGeneral and marketingadministrative
Comparison of the years ended December 31, 20192022 and 20182021 was as follows (in thousands of dollars, except percentages):
| | | | | | | | | | | | | | | | | | | | | | | |
| Year Ended December 31, |
| 2022 | | Change | | % | | 2021 |
General and administrative expense: | | | | | | | |
Compensation expense | $ | 51,357 | | | $ | (13,585) | | | (21) | % | | $ | 64,942 | |
Occupancy costs | 5,816 | | | 761 | | | 15 | % | | 5,055 | |
Depreciation and amortization | 2,245 | | | 398 | | | 22 | % | | 1,847 | |
Other expenses | 31,705 | | | (9,202) | | | (22) | % | | 40,907 | |
Allocations | (14,605) | | | (3,207) | | | 28 | % | | (11,398) | |
Total | $ | 76,518 | | | $ | (24,835) | | | (25) | % | | $ | 101,353 | |
|
| | | | | | | | | | | | | | |
| Year Ended December 31, |
| 2019 | | Change | | % | | 2018 |
Selling and marketing expense: | |
| | |
| | |
| | |
|
Compensation expense | $ | 33,239 |
| | $ | 7,346 |
| | 28 | % | | $ | 25,893 |
|
Direct marketing expense | 6,015 |
| | 1,148 |
| | 24 | % | | 4,867 |
|
Professional fees | 2,234 |
| | 727 |
| | 48 | % | | 1,507 |
|
Other expenses | 9,008 |
| | 2,459 |
| | 38 | % | | 6,549 |
|
Allocations | 3,195 |
| | 698 |
| | 28 | % | | 2,497 |
|
Total | $ | 53,691 |
| | $ | 12,378 |
| | 30 | % | | $ | 41,313 |
|
SellingGeneral and marketingadministrative expense increased $12.4decreased $24.8 million, or 30%25%, for the year ended December 31, 20192022 compared to 2018. The2021. This decrease is driven by expenses recognized for the year ended December 31, 2021 related to the acquisitions of Decipher Biosciences and HalioDx, including $27.0 million of stock-based compensation and $20.1 million of professional fees and other costs associated with the transactions. Following the acquisitions of Decipher Biosciences in March 2021 and HalioDx in August 2021, their operations contributed to an increase in compensationgeneral and administrative expenses. Additionally, we recorded expense was dueof $3.3 million for the year ended December 31, 2022 related to a 41%the impairment of an intangible asset. The remaining increase in average headcount, higher incentive compensation and higher stock-based compensation expense. The increase in direct marketing expense was due to higher general marketing expenditures. The increase in professional fees was due to higher consulting expenses. The increase in other expenses was primarily due to higher travelannual compensation adjustments and entertainmentinvestments in infrastructure. General and administrative expenses related to the increase in headcount, which also increasedoccupancy costs and information technology costs are allocated costs.
Comparison ofmonthly to general and administrative expense, selling and marketing expense, research and development expense, and cost of revenue based on the headcount and employee location. Foreign currency exchange had a $1.8 million favorable impact on general and administrative expense when compared to prior year rates.
Comparison of general and administrative expense for the years endingended December 31, 20182021 and 20172020 are included in Item 8 of Part II of the Annual Report on Form 10-K filed with the Securities and Exchange Commission dated February 25, 2019.28, 2022.
General and administrativeOther income, net
Comparison of the years ended December 31, 2019 and 2018 was as follows (in thousands of dollars, except percentages):
|
| | | | | | | | | | | | | | |
| Year Ended December 31, |
| 2019 | | Change | | % | | 2018 |
General and administrative expense: | |
| | |
| | |
| | |
|
Compensation expense | $ | 18,537 |
| | $ | 2,479 |
| | 15 | % | | $ | 16,058 |
|
Professional fees | 8,854 |
| | 2,652 |
| | 43 | % | | 6,202 |
|
Occupancy costs | 2,518 |
| | 143 |
| | 6 | % | | 2,375 |
|
Depreciation and amortization | 1,408 |
| | (245 | ) | | (15 | )% | | 1,653 |
|
Other expenses | 4,430 |
| | 987 |
| | 29 | % | | 3,443 |
|
Allocations | (6,718 | ) | | (950 | ) | | 16 | % | | (5,768 | ) |
Total | $ | 29,029 |
| | $ | 5,066 |
| | 21 | % | | $ | 23,963 |
|
General and administrative expenseOther income, net, increased $5.1$4.4 million or 21%, for the year ended December 31, 20192022 compared to 2018. The increase in compensation expense was2021, primarily due to higher stock-based compensation expensean increase of $0.9 million from the CIR related to operations in France, an increase in our stock price. The increase in professional fees was mainly due to $1.5of $1.8 million of interest and dividend income and an increase of $1.3 million of unrealized foreign currency gain (loss). The CIR are generated by our wholly owned subsidiary, Veracyte SAS, in connection with its research efforts performed in Marseille, France. We recognize other income from the CIR over time based on when the research and development expenses associated with our acquisition of NanoString Technologies. Inc.'s diagnostics business, $0.6 million in other increases in legal spend, and $0.3 million higher investor relations costs. The increase in other expenses was mainly from higher IT expenses to support the higher company headcount. The increase in expenses allocated to other departments was due to higher headcount in departments associated with selling and marketing and cost of revenue.are incurred.
Comparison of general and administrative expenseOther income, net, for the years endingended December 31, 20182021 and 20172020 are included in Item 8 of Part II of the Annual Report on Form 10-K filed with the Securities and Exchange Commission dated February 25, 2019.28, 2022.
Interest expense
Interest expense decreased $1.3 million, or 66%, for the year ended December 31, 2019 compared to 2018, primarily due to the prepayments of $12.5 million and $12.4 million of the principal amount of our Term Loan Advance in January 2019 and May 2019, respectively. The average Term Loan Advance interest rate was 6.70% and 6.14% for the years ended December 31, 2019 and 2018, respectively.
Comparison of interest expense for the years ending December 31, 2018 and 2017 are included in Item 8 of Part II of the Annual Report on Form 10-K filed with the Securities and Exchange Commission dated February 25, 2019.
Other income, net
Other income, net, increased $2.0 million for the year ended December 31, 2019 compared to 2018, primarily due to higher interest income from our cash and cash equivalents, which had higher balances in 2019 following our public offering of common stock in July 2018 and May 2019.
Comparison of Other income, net, for the years ending December 31, 2018 and 2017 are included in Item 8 of Part II of the Annual Report on Form 10-K filed with the Securities and Exchange Commission dated February 25, 2019.
Liquidity and Capital Resources
From inception through December 31, 2019,2022, we have been financed primarily through net proceeds from the sale of our equity securities and borrowings under our credit facilities.securities. We have incurred net losses since our inception. For the years ended December 31, 2019, 20182022, 2021 and 2017,2020, we had net losses of $12.6$36.6 million, $23.0$75.6 million and $31.0$34.9 million, respectively, and we expect to incur additional losses in 20202023 and potentially in future years. As of December 31, 2019,2022, we had an accumulated deficit of $246.7$393.7 million.
We believe our existing cash and cash equivalents and short-term investments of $159.3$178.9 million as of December 31, 2019, our available revolving line of credit,2022, and cash flows generated by our revenue during the next 12 months will be sufficient to meet our anticipated cash requirements for at least the next 12 months. We expect that our near- and longer-term liquidity requirements will continue to consist of costs to run our laboratories, research and development expenses, selling and marketing expenses, general and administrative expenses, working capital, costs to service our Loan and Security Agreement (See Note 8 to our audited consolidated financial statements included in this Annual Report on Form 10-K for more information about our Loan and Security Agreement), capital expenditures, lease obligations and general corporate expenses associated with the growth of our business. However, we may also use cash to acquire or invest in complementary businesses, technologies, services or products that would change our cash requirements. If we are not able to generate cash flows from our revenue to finance our cash requirements, we will need to finance future cash needs primarily through public or private equity offerings, debt financings, borrowings or strategic collaborations or licensing arrangements. If we raise funds by issuing equity securities, dilution to stockholders could result. Any equity securities issued also may provide for rights, preferences or privileges senior to those of holders of our common stock. The terms of debt securities issued or borrowings could impose significant restrictions on our operations. The incurrence of indebtedness or the issuance of certain equity securities could result in increased fixed payment obligations and could also result in restrictive covenants, such as limitations on our ability to incur additional debt or issue additional equity, limitations on our ability to acquire or license intellectual property rights, restrictions on our cash and other operating restrictions that could adversely affect our ability to conduct our business. In addition, the issuance of additional equity securities by us, or the possibility of such issuance, may cause the market price of our common stock to decline. In the event that we enter into collaborations or licensing arrangements to raise capital, we may be required to accept unfavorable terms. These agreements may require that we relinquish or license to a third-party on unfavorable terms our rights to technologies or product candidates that we otherwise would seek to develop or commercialize ourselves, or reserve certain opportunities for future potential arrangements when we might be able to achieve more favorable terms. If we are not able to secure additional funding when needed, we may have to delay, reduce the scope of or eliminate one or more research and development programs or selling and marketing initiatives, or forgo potential acquisitions or investments. In addition, we may have to work with a partner on one or more of our products or development programs, which could lower the economic value of those programs to us.
Public Offering of Common Stock
On May 7, 2019,In February 2021, we issued and sold 6,325,0008,547,297 shares of common stock in a registered public offering, including 825,0001,114,864 shares issued and sold upon the underwriters’ exercise in full of their option to purchase additional shares, at a price to the public of $23.25$74.00 per share. Our net proceeds from the offering were approximately $137.8$593.8 million, after deducting underwriting discounts and commissions and offering expenses of $9.2$38.7 million.
In July 30, 2018,August 2020, we issued and sold 5,750,0006,900,000 shares of common stock in a registered public offering, including 750,000900,000 shares issued and sold upon the underwriters’underwriters' exercise in full of their option to purchase additional shares, at a price to the public of $10.25$30 per share. Our net proceeds from the offering were approximately $55.0$193.8 million, after deducting underwriting discounts and commissions and estimated offering expenses of $3.9$13.2 million.
Operating Leases
We lease office and laboratory facilities in South San Francisco and San Diego, California; Austin, Texas; Marseille, France; and Richmond, Virginia, and lease certain equipment under various non-cancelable lease agreements. The lease terms extend to October 2030 and contain extension of lease term and expansion options. As of December 31, 2022, the leases have a weighted average remaining lease term of 3.9 years and total future minimum lease payments of $16.6 million.
As of December 31, 2022, Veracyte SAS has signed a lease agreement for facilities which will be constructed in Marseille, France. The lease will commence upon completion of the construction of the office building which we currently expect to occur in the fourth quarter of 2023 at which time we will record a lease liability and a corresponding right-of-use asset. The initial term of the lease will be twelve years with annual rent of approximately $1.4 million, which is subject to change based on final construction.
Supplies Purchase Commitments
We had non-cancelable purchase commitments with suppliers to purchase a minimum quantity of supplies for approximately $10.1 million at December 31, 2022.
Acquisition-Related Contingent Consideration
In December 2019, we acquired from NanoString the exclusive global diagnostics license to the nCounter Analysis System, the Prosigna breast cancer prognostic gene signature assay, and the LymphMark lymphoma subtyping assay. Pursuant to the terms of the agreement, we paid NanoString $40.0 million in cash and $10.0 million in Veracyte common stock, and may pay up to an additional $10.0 million in cash, contingent upon first achievement or occurrence, by or on behalf of Veracyte, of the commercial launch of the first, second and third diagnostic tests for use on the nCounter multiplex analysis system. As of December 31, 2022, the achievement of two of the milestones is forecasted to occur within the next 12 months, requiring payments totaling $7.0 million.
HalioDx Acquisition-Related Payments
In connection with the HalioDx Acquisition, 11,031 unvested HalioDx free ordinary share awards, or free shares, were modified to provide us the right to purchase the vested free shares (call option) from the holders and the holders the right to sell the vested free shares to us (put option) from time to time through late 2023. As a result of the call and put options, the free shares are liability classified. Additionally, in connection with the HalioDx Acquisition, all of HalioDx's equity-classified options that were outstanding prior to the HalioDx Acquisition were terminated and cancelled at the acquisition date. We committed to pay cash consideration of $1.5 million to holders of unvested options on the date the employee satisfies the original service requirement.
As part of the agreement, we held back $16.8 million of the cash consideration, or the holdback, which will be payable to the founders of HalioDx based on their continuous employment with us. Fifty percent of the holdback was placed in escrow on the founders' behalf on the first anniversary of the closing date and the remainder will be paid directly to the founders on the second anniversary.
As of December 31, 2022, the remaining amount to be paid for all HalioDx related items was $9.6 million subject to holders continued service, excluding any potential associated social charges.
Loan and Security Agreement
On November 3, 2017, we entered into the Loan and Security Agreement with Silicon Valley Bank. The Loan and Security Agreement allowsallowed us to borrow up to $35.0 million, with a $25.0 million term loan, or Term Loan, and a revolving line of credit of up to $10.0 million, or the Revolving Line of Credit, subject to, with respect to the Revolving Line of Credit, a borrowing base of 85% of eligible accounts receivable. The Term Loan was advanced upon the closing of the Loan and Security Agreement. Borrowings underIn October 2022, the Loan and Security Agreement mature in October 2022. The Term Loan bears interest at a variable rate equal to (i) the thirty-day U.S. London Interbank Offer Rate, or LIBOR, plus (ii) 4.20%, with a minimum rate of 5.43% per annum. Principal amounts outstanding under the Revolving Line of Credit bear interest at a variable rate equal to (i) LIBOR plus (ii) 3.50%, with a minimum rate of 4.70% per annum. We are also required to pay an annual facility fee on the Revolving Line of Credit of $25,000. The average Term Loan Advance interest rate for the year ended December 31, 2019 was 6.70%.
We may prepaymatured, and we repaid the outstanding principal amount under the Term Loan plus accrued and unpaid interest and, if the Term Loan is repaid in full, a prepayment premium. The prepayment premium will equal (i) $750,000, if the prepayment is made on or before November 3, 2018, (ii) $500,000, if the prepayment is made after November 3, 2018 and on or prior to November 3, 2019 and (iii) $250,000, if the prepayment is made after November 3, 2019. In addition, a final payment on the Term Loan in the amount oftotaling $1.2 million is due upon the earlier of the maturity date of the Term Loan or its payment in full. In January 2019 and May 2019, we prepaid $12.5 million and $12.4 million of the principal amount of the Term Loan Advance, respectively, and did not incur any prepayment premium as we did not repay the Term Loan Advance in full. These prepayments cover scheduled principal payments from November 2019 to September 2022.
The Loan and Security Agreement contains customary representations, warranties, and events of default such as a material adverse change in our business, operations or financial conditions, as well as affirmative and negative covenants. The negative covenants include, among other provisions, covenants that limit or restrict our ability to incur liens, make investments, incur indebtedness, merge with or acquire other entities, dispose of assets, make dividends or other distributions to holders of our equity interests, engage in any new line of business, or enter into certain transactions with affiliates, in each case subject to certain exceptions. As of December 31, 2019, the principal balance outstanding was $0.1 million and we were in compliance with debt covenants.
The Loan and Security Agreement also requires us to comply with certain financial covenants, including achieving certain revenue levels tested quarterly on a trailing twelve-month basis. However, failure to maintain the revenue levels will not be considered a default if the sum of our unrestricted cash and cash equivalents maintained with Silicon Valley Bank and amount available under the Revolving Line of Credit is at least $40.0 million.
Our obligations under the Loan and Security Agreement are secured by substantially all of our assets (excluding intellectual property), subject to certain customary exceptions.
Cash Flows
The following table summarizes our cash flows for the years ended December 31, 2019, 20182022, 2021 and 20172020 (in thousands of dollars):
| | | | | | | | | | | | | | | | | |
| Years Ended December 31, |
| 2022 | | 2021 | | 2020 |
Net cash provided by (used in) operating activities | $ | 7,535 | | | $ | (31,621) | | | $ | (9,711) | |
Net cash used in investing activities | (29,387) | | | (739,206) | | | (3,837) | |
Net cash provided by financing activities | 3,494 | | | 596,320 | | | 203,595 | |
|
| | | | | | | | | | | |
| Years Ended December 31, |
| 2019 | | 2018 | | 2017 |
Cash used in operating activities | $ | (3,232 | ) | | $ | (13,521 | ) | | $ | (23,915 | ) |
Cash used in investing activities | (42,733 | ) | | (1,874 | ) | | (1,315 | ) |
Cash provided by (used in) financing activities | 127,287 |
| | 59,499 |
| | (218 | ) |
Cash Flows from Operating Activities
Cash used inprovided by operating activities for the year ended December 31, 20192022 was $3.2$7.5 million. The net loss of $12.6$36.6 million includes non-cash charges of $9.8$26.7 million of stock-based compensation expense, and $4.1$25.9 million of depreciation and amortization, which includes $1.4including $21.4 million of intangible asset amortization, and $0.2$3.3 million of end-of-term debt obligation accruals.impairment of intangible asset, noncash lease expense of $3.3 million, and $0.5 million of foreign currency loss. Cash used as a result of changes in operating assets and liabilities was $4.8$16.4 million, primarily comprised ofcomprising an increase in accounts receivable of $6.2$4.5 million, a decrease in accrued liabilities of $3.9 million, a decrease in operating lease liability of $3.4 million, an increase in supplies and inventory of
$3.0 million, and an increase in other assets of $0.4$3.0 million, partially offset by an increasea decrease in accrued liabilitiesprepaid expense and deferred rentother current assets of $5.2$1.4 million.
Cash used in operating activities for the year ended December 31, 20182021 was $13.5$31.6 million. The net loss of $23.0$75.6 million includes non-cash charges of $6.0$22.5 million of stock-based compensation expense, and $3.9$19.6 million of depreciation and amortization, which includes $1.1including $16.0 million of intangible asset amortization. It also includes $0.3amortization, $6.3 million of end-of-term debt obligation accruals.deferred income taxes, noncash lease expense of $1.6 million, $1.2 million of foreign currency loss, and a $0.8 million expense for the revaluation of the contingent consideration related to the NanoString transaction. Cash provided by changes in operating assets and liabilities was $4.2 million, primarily comprised of an increase in accrued liabilities of $14.4 million and an increase in accounts payable of $5.2 million, partially offset by an increase in accounts receivable of $8.6 million, an increase in prepaid expense and other current assets of $3.3 million, an increase in supplies of $1.5 million and a decrease in operating lease liability of $1.8 million.
Cash used in operating activities for the year ended December 31, 2020 was $9.7 million. The net loss of $34.9 million includes non-cash charges of $13.0 million of stock-based compensation expense, $7.9 million of depreciation and amortization, including $5.1 million of intangible asset amortization, a $1.1 million write-down of supplies, noncash lease expense of $1.0 million, an impairment loss of $1.0 million and a $1.5 million expense for the revaluation of the contingent consideration related to the NanoString transaction. Cash used as a result of changes in operating assets and liabilities of $0.7was $0.5 million, was primarily due tocomprised of a decrease in accounts payableaccrued liabilities of $1.6$0.9 million, a decrease in operating lease liability of $1.4 million, and an increase in other assets of $0.8 million and increases in prepaid expensesexpense and other current assets and accounts receivable of $0.9$1.0 million, partially offset by a decrease in supplies of $1.9 million and an increase in accrued liabilities and deferred rent of $0.7 million.
Cash used in operating activities for the year ended December 31, 2017 was $23.9 million. The net loss of $31.0 million includes non-cash charges of $6.6 million of stock-based compensation expense and $3.8 million of depreciation and amortization, which includes $1.1 million of intangible asset amortization. It also includes a $1.5 million prepayment penalty for exiting our previous credit agreement which is a financing cash flow, and the amortization and write-off of $0.5 million of debt issuance costs. Cash used as a result of changes in operating assets and liabilities of $5.4 million was primarily due to an increase in accounts receivable of $4.0$1.0 million, an increase in supplies inventory of $1.8 million and a decrease in accrued liabilities and deferred rent of $1.2 million, partially offset by an increase in accounts payable of $1.7$0.7 million and a decrease in supplies of $1.1 million.
Cash Flows from Investing Activities
Cash used in investing activities for the year ended December 31, 20192022 was $42.7 million, consisting of $40.0$29.4 million for the acquisitionpurchase and maturity of NanoString Technologies, Inc.'s diagnostics business,short-term investments and $2.7 million for the acquisition of property and equipment, net of proceeds from the disposal of property and equipment.
Cash used in investing activities for the year ended December 31, 20182021 was $1.9$739.2 million consisting of $574.4 million for the acquisition of Decipher Biosciences, $162.4 million for the acquisition of HalioDx and $5.4 million for the acquisition of property and equipment.equipment partially offset by $3.0 million of proceeds from the sale of an equity investment.
Cash used in investing activities for the year ended December 31, 20172020 was $1.2 million, mainly comprising $1.8$2.8 million for the acquisition of property and equipment partially offset by $0.4and $1.0 million for the purchase of proceeds from the saleequity securities of property and equipment.MAVIDx, Inc.
Cash Flows from Financing Activities
Cash provided by financing activities for the year ended December 31, 20192022 was $127.3$3.5 million, consisting of $137.8 million in net proceeds from the issuance of common stock in a public offering in May 2019 and $14.6$7.9 million in proceeds from the exercise of options to purchase our common stock and purchase of stock under our Employee Stock Purchase Plan, or ESPP, during the year, partially offset by $24.9$3.2 million in tax payments during the period related to the vesting of loan principal repaymentsrestricted stock units granted to employees and finance lease payments$1.3 million in payment of $0.3 million.long-term debt.
Cash provided by financing activities for the year ended December 31, 20182021 was $59.5$596.3 million, consisting of $55.0$593.8 million in net proceeds from the issuance of common stock in a public offering in the second quarter of 2018, $4.4February 2021, $11.5 million in proceeds from the exercise of options to purchase our common stock and purchasespurchase of stock under our ESPP and $0.4 million in proceeds from a legal settlement, partially offset by capital lease$9.0 million in tax payments of $0.3 million during the period.period related to the vesting of restricted stock units granted to employees.
Cash used inprovided by financing activities for the year ended December 31, 20172020 was $0.2$203.6 million, consisting of a $25.4$193.8 million payment of the principal on prior credit agreement, $1.5 million payment for the prepayment premium for terminating the prior credit agreement and $0.3 million of capital lease payments, partially offset by $24.9 million ofin net proceeds from our new loan and security agreement, $1.9the issuance of common stock in a public offering in August 2020, $13.7 million in proceeds from the purchase of stock under our ESPP and exercise of options to purchase our common stock.stock and purchase of stock under our ESPP partially offset by $3.8 million in tax payments during the period related to the vesting of restricted stock units granted to employees.
Contractual Obligations
The following table summarizes certain contractual obligations as of December 31, 2019 (in thousands of dollars):
|
| | | | | | | | | | | | | | | | | | | |
| Payments Due by Period |
| Fiscal Year 2020 | | Fiscal Year 2021 to 2022 | | Fiscal Year 2023 to 2024 | | Fiscal Year 2025 and Beyond | | Total |
Operating lease obligations (1) | $ | 2,332 |
| | $ | 4,873 |
| | $ | 5,157 |
| | $ | 4,161 |
| | $ | 16,523 |
|
Long-term debt obligations (2) | — |
| | 1,288 |
| | — |
| | — |
| | 1,288 |
|
Supplies purchase commitments | 5,693 |
| | 1,913 |
| | — |
| | — |
| | 7,606 |
|
Capital lease obligation | — |
| | — |
| | — |
| | — |
| | — |
|
Total | $ | 8,025 |
| | $ | 8,074 |
| | $ | 5,157 |
| | $ | 4,161 |
| | $ | 25,417 |
|
(1) Represents minimum operating lease payments under operating leases for facilities. (2) Debt obligations include principal, estimate of variable rate interest and end-of-term debt obligation. In January 2019 and May 2019, we paid off $12.5 million and $12.4 million of principal from our Loan and Security Agreement, respectively. |
Off-balance Sheet Arrangements
We have not entered into any off-balance sheet arrangements.
Recent Accounting Pronouncements
In February 2016,October 2021, the FASB issued ASU No. 2016-2,2021-08, LeasesBusiness Combinations (Topic 842)805): Accounting for Contract Assets and Contract Liabilities from Contracts with Customers, which requires entities to recognize and measure contract assets and contract liabilities acquired in a business combination in accordance with ASC 2014-09, Revenue from Contracts with Customers (Topic 606). This ASUThe update will generally result in an entity recognizing contract assets and contract liabilities at
amounts consistent with those recorded by the acquiree immediately before the acquisition date rather than at fair value. The new standard is aimed at making leasing activities more transparent and comparable, and requires substantially all leases be recognized by lesseeseffective on their balance sheet as a right-of-use asset and corresponding lease liability, including leases currently accountedprospective basis for as operating leases. The ASU was effective for interim and annual periodsfiscal years beginning after December 15, 2018. Additionally, the FASB issued ASU No. 2018-11, Leases (Topic 842): Targeted Improvements, which offers an additional transition method whereby entities may apply the new leases standard at the adoption date and recognize a cumulative-effect adjustment to the opening balance of retained earnings rather than application of the new leases standard at the beginning of the earliest period presented in the financial statements. We elected this transition method and adopted ASC 842 on January 1, 2019 and as a result, recorded operating lease right-of-use ("ROU") assets of $9.8 million, including offsetting deferred rent of $4.3 million, along with the associated operating lease liabilities of $14.1 million. On January 1, 2019, we had finance lease ROU assets of $0.8 million and associated finance lease liabilities of $0.3 million for leases classified as finance leases prior to the adoption of ASC 842. The adoption of ASC 842 had an immaterial impact on the our consolidated statement of operations and comprehensive loss, consolidated statement of stockholders' equity and consolidated statement of cash flows for the year ended December 31, 2019. In addition, we elected the package of practical expedients permitted under the transition guidance within the new standard which allowed it to carry forward the historical lease
classification. Additional information and disclosures required by this new standard are contained in Note 7, Commitments and Contingencies.
In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments-Credit Losses: Measurement of Credit Losses on Financial Instruments. This ASU requires measurement and recognition of expected credit losses for financial assets. This guidance will become effective for us beginning January 1, 20202022, with early adoption permitted. We are currently evaluating the potential effect of this standard on its financial statements. We do not expect to have a material impact on our consolidated financial statements and related disclosures from the adoption of this guidance.
In November 2018, the FASB issued ASU No. 2018-18, Collaborative Arrangements (Topic 808). Under this ASU, transactions in collaborative arrangements are to 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. Also, entities are precluded from presenting consideration from transactions with a counterparty that is not a customer together with revenue recognized from ASC 606. This ASU is effective for all interim and annual reporting periods beginning on or after December 15, 2019, with early adoption permitted. We adopted the ASU in 2019 with no cumulative-effect adjustments or retrospective impact.
ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Interest Rate Risk
We are exposed to market risks in the ordinary course of our business. These risks primarily relate to interest rates. We had cash and cash equivalents and short-term investments of $159.3$178.9 million as of December 31, 20192022 which consisted of bank deposits, money market funds and overnight reverse repurchase agreements.U.S. treasury securities. Such interest-bearing instruments carry a degree of risk; however, As of December 31, 2022, a hypothetical 10% change in interest rates during any of the periods presented would not have had a material impact on our consolidated financial statements.
Foreign Currency Risk
As of December 31, 2022, we held $3.6 million of bank deposits denominated in Euros. Such Euro denominated deposits carry a degree of risk from changes in currency exchange rates as the gains or losses from changes in exchange rates are included in our net loss and comprehensive loss. As of December 31, 2022 a hypothetical 10% appreciation or depreciation of the U.S. dollar relative to the Euro would not have had a material impact on our consolidated financial statements.
Inflation Risk
We are facing inflation headwinds in compensation, travel, supply and inventory costs, however we do not believe that inflation has had a material effect on our business, financial condition, or operating results to date.
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
Veracyte, Inc.
Index to Consolidated Financial Statements
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Stockholders and the Board of Directors of Veracyte, Inc.
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of Veracyte, Inc. (the Company) as of December 31, 20192022 and 2018,2021, the related consolidated statements of operations, and comprehensive loss, stockholders' equity and cash flows for each of the three years in the period ended December 31, 2019,2022, 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 at December 31, 20192022 and 2018,2021, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2019,2022, in conformity with U.S. generally accepted accounting principles.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the Company's internal control over financial reporting as of December 31, 2019,2022, based on criteria established in Internal Control-Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 Framework), and our report dated February 25, 202028, 2023 expressed an unqualified opinion thereon.
Basis for Opinion
These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on the Company’s financial statements based on our audits. We are a public accounting firm registered with the 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 financial statements are free of material misstatement, whether due to error or fraud. Our audits included performing procedures to assess the risks of material misstatement of the 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 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 financial statements. We believe that our audits provide a reasonable basis for our opinion.
Critical Audit Matters
The critical audit mattersmatter communicated below are mattersis a matter arising from the current period audit of the financial statements that werewas communicated or required to be communicated to the audit committee and that: (1) relaterelates to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective or complex judgments. The communication of the critical audit mattersmatter does not alter in any way our opinion on the consolidatedfinancial statements, taken as a whole, and we are not, by communicating the critical audit mattersmatter below, providing a separate opinionsopinion on the critical audit mattersmatter or on the accounts or disclosures to which they relate.it relates.
| | | | | |
| |
| Revenue from diagnostic services |
Description of the Matter | During the year ended December 31, 2019,2022, the Company’s revenue from diagnostic services was approximately $107.4$250.5 million. As discussed in Note 2, the Company’s diagnostic services revenue is recognized upon the delivery of test results to the prescribing physician, at which time the Company bills for its services. The Company recognizes revenue related to billings based on estimates of the amount that will ultimately be realized.
Auditing the measurement of the Company’s diagnostic services revenue was complex due to the judgments used in estimating the amount to be realized per test. In determining the amount to recognize for a delivered test the Company considers factors such as payment history, amount collected per test, payer coverage, and whether there is a reimbursement contract between the payer and the Company. The Company also considers whether historical collections per test are indicative of future collections or if there are any current or expected developments or changes that could affect reimbursement rates, which is an estimate that requires significant judgment by the Company. |
How We Addressed the Matter in Our Audit | We obtained an understanding, evaluated the design, and tested the operating effectiveness of controls used by management in making this estimate. For example, we tested controls over management’s review of changes in collection trends, payer rates, contract terms, and payer behavior and expectations of how those changes are expected to impact future collections and the amount of revenue to be recognized per test.
To test management’s estimate of the amount of revenue to be recognized per test delivered our audit procedures included, among others, evaluating the methodology used, understanding and testing the significant assumptions discussed above, and testing the underlying data used by the Company (including the completeness and accuracy of historical data). We tested payment history and amount collected per test on a sample basis, including agreeing selections to supporting documentation such as physician requisition, cash collected, write-offs of receivables, and proof of delivery, as applicable. We evaluated and tested management’s assessment of changes in payer trends, behaviors, and contract terms and how those changes will impact future cash collections as well as management’s consideration of any contrary factors. We also assessed and tested management’s review of differences between prior period accrual rates and actual cash collections and how those differences were factored into management’s estimate of current period accrual rates. |
|
| |
| Valuation of intangible assets and contingent consideration |
Description of the Matter | On December 3, 2019, the Company entered into an agreement to acquire a license and certain assets for consideration of $60 million, including up to $10 million of contingent consideration upon achievement of certain milestones. As discussed in Note 4 to the consolidated financial statements, the Company accounted for this transaction as a business combination.
Auditing the accounting for this business combination was complex due to the significant estimation uncertainty in determining the fair value of identified intangible assets and contingent consideration. The significant estimation uncertainty was primarily due to the sensitivity of the fair value estimates to the significant underlying assumptions about the forecasted results of the acquired business. The significant assumptions used to form the basis of the forecasted results included revenue growth rates, profit margins, timing of cash flows, and the discount rate. These significant assumptions are forward-looking and could be affected by future economic and market conditions.
|
How We Addressed the Matter in Our Audit | We obtained an understanding, evaluated the design, and tested the operating effectiveness of the Company’s controls over the valuation of intangible assets and contingent consideration related to the business combination. This included testing controls over the estimation process supporting the recognition and measurement of identified intangible assets and contingent consideration and management’s judgment and evaluation of underlying assumptions and estimates with regards to these fair values.
To test these fair values, our audit procedures included, among others, involvement of a specialist to assist us in the evaluation of the Company’s valuation methodology and testing of the discount rate, evaluating prospective financial information, and testing the completeness and accuracy of underlying data. For example, we compared the significant assumptions to current industry and market trends, historical results and other relevant factors.
|
/s/ Ernst & Young LLP
We have served as the Company’s auditor since 2014.
Redwood City,
San Diego, California
February 25, 202028, 2023
VERACYTE, INC.
Consolidated Balance Sheets
(in thousands, except share and per sharepar value amounts)
| | | As of December 31, | | As of December 31, |
| 2019 | | 2018 | | 2022 | | 2021 |
Assets | | | | Assets | | | |
Current assets: | | | | Current assets: | |
Cash and cash equivalents | $ | 159,317 |
| | $ | 77,995 |
| Cash and cash equivalents | $ | 154,247 | | | $ | 173,197 | |
Short-term investments | | Short-term investments | 24,605 | | | 3,964 | |
Accounts receivable | 19,329 |
| | 13,168 |
| Accounts receivable | 44,021 | | | 41,461 | |
Supplies | 6,806 |
| | 3,402 |
| |
Supplies and inventory | | Supplies and inventory | 14,294 | | | 11,225 | |
Prepaid expenses and other current assets | 2,235 |
| | 2,387 |
| Prepaid expenses and other current assets | 11,469 | | | 13,255 | |
Total current assets | 187,687 |
| | 96,952 |
| Total current assets | 248,636 | | | 243,102 | |
Property and equipment, net | 8,933 |
| | 8,940 |
| Property and equipment, net | 17,702 | | | 15,098 | |
Right-of-use assets - operating lease | 8,808 |
| | — |
| |
Finite-lived intangible assets, net | 65,019 |
| | 12,000 |
| |
Right-of-use assets - operating leases | | Right-of-use assets - operating leases | 13,160 | | | 16,043 | |
Intangible assets, net | | Intangible assets, net | 174,866 | | | 202,731 | |
Goodwill | 2,725 |
| | 1,057 |
| Goodwill | 695,891 | | | 707,904 | |
Restricted cash | 603 |
| | 603 |
| Restricted cash | 749 | | | 749 | |
Other assets | 1,437 |
| | 1,086 |
| Other assets | 5,418 | | | 2,198 | |
Total assets | $ | 275,212 |
| | $ | 120,638 |
| Total assets | $ | 1,156,422 | | | $ | 1,187,825 | |
Liabilities and Stockholders' Equity | | | | Liabilities and Stockholders' Equity | | | |
Current liabilities: | | | | Current liabilities: | |
Accounts payable | $ | 2,328 |
| | $ | 2,516 |
| Accounts payable | $ | 11,911 | | | $ | 12,360 | |
Accrued liabilities | 13,734 |
| | 9,186 |
| Accrued liabilities | 37,774 | | | 39,475 | |
Current portion of long-term debt | — |
| | 1,357 |
| Current portion of long-term debt | — | | | 1,127 | |
Current portion of operating lease liability | 1,407 |
| | — |
| |
Current portion of deferred revenue | | Current portion of deferred revenue | 2,613 | | | 4,646 | |
Current portion of acquisition-related contingent consideration | | Current portion of acquisition-related contingent consideration | 6,060 | | | 2,682 | |
Current portion of operating lease liabilities | | Current portion of operating lease liabilities | 4,070 | | | 3,630 | |
Current portion of other liabilities | | Current portion of other liabilities | 186 | | | 231 | |
Total current liabilities | 17,469 |
| | 13,059 |
| Total current liabilities | 62,614 | | | 64,151 | |
Long-term debt | 694 |
| | 23,925 |
| |
Deferred rent, net of current portion | — |
| | 3,899 |
| |
Acquisition related contingent consideration | 6,088 |
| | — |
| |
Operating lease liability, net of current portion | 11,506 |
| | — |
| |
Deferred revenue, net of current portion | | Deferred revenue, net of current portion | — | | | 343 | |
Deferred tax liability | | Deferred tax liability | 4,531 | | | 5,592 | |
Acquisition-related contingent consideration, net of current portion | | Acquisition-related contingent consideration, net of current portion | 2,498 | | | 5,722 | |
Operating lease liabilities, net of current portion | | Operating lease liabilities, net of current portion | 10,648 | | | 14,096 | |
Other liabilities | | Other liabilities | 931 | | | 1,407 | |
Total liabilities | 35,757 |
| | 40,883 |
| Total liabilities | 81,222 | | | 91,311 | |
Commitments and contingencies |
|
| |
|
| Commitments and contingencies | | | |
Stockholders' equity: | | | | Stockholders' equity: | |
Preferred stock, $0.001 par value; 5,000,000 shares authorized, no shares issued and outstanding as of December 31, 2019 and 2018 | — |
| | — |
| |
Common stock, $0.001 par value; 125,000,000 shares authorized, 49,625,341 and 40,863,202 shares issued and outstanding as of December 31, 2019 and 2018, respectively | 50 |
| | 41 |
| |
Preferred stock, $0.001 par value; 5,000,000 shares authorized, no shares issued and outstanding as of December 31, 2022 and 2021 | | Preferred stock, $0.001 par value; 5,000,000 shares authorized, no shares issued and outstanding as of December 31, 2022 and 2021 | — | | | — | |
Common stock, $0.001 par value; 125,000,000 shares authorized, 71,959,454 and 71,123,108 shares issued and outstanding as of December 31, 2022 and 2021, respectively | | Common stock, $0.001 par value; 125,000,000 shares authorized, 71,959,454 and 71,123,108 shares issued and outstanding as of December 31, 2022 and 2021, respectively | 72 | | | 71 | |
Additional paid-in capital | 486,090 |
| | 313,800 |
| Additional paid-in capital | 1,500,191 | | | 1,468,683 | |
Accumulated deficit | (246,685 | ) | | (234,086 | ) | Accumulated deficit | (393,717) | | | (357,157) | |
Accumulated other comprehensive loss | | Accumulated other comprehensive loss | (31,346) | | | (15,083) | |
Total stockholders' equity | 239,455 |
| | 79,755 |
| Total stockholders' equity | 1,075,200 | | | 1,096,514 | |
Total liabilities and stockholders' equity | $ | 275,212 |
| | $ | 120,638 |
| Total liabilities and stockholders' equity | $ | 1,156,422 | | | $ | 1,187,825 | |
The accompanying notes are an integral part of these consolidated financial statements.
VERACYTE, INC.
Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except share and per share amounts)
| | | Year Ended December 31, | | Year Ended December 31, |
| 2019 | | 2018 | | 2017 | | 2022 | | 2021 | | 2020 |
Revenue: | | | | | | Revenue: | | | | | |
Testing revenue | $ | 107,355 |
| | $ | 91,058 |
| | $ | 71,953 |
| Testing revenue | $ | 250,544 | | | $ | 188,182 | | | $ | 101,970 | |
Product revenue | 923 |
| | — |
| | — |
| Product revenue | 12,632 | | | 11,464 | | | 9,845 | |
Biopharmaceutical revenue | 8,090 |
| | 950 |
| | — |
| |
Collaboration revenue | 4,000 |
| | — |
| | — |
| |
Biopharmaceutical and other revenue | | Biopharmaceutical and other revenue | 33,360 | | | 19,868 | | | 5,668 | |
Total revenue | 120,368 |
| | 92,008 |
| | 71,953 |
| Total revenue | 296,536 | | | 219,514 | | | 117,483 | |
| | | | | | | | | | | |
Operating Expenses: | | | | | | |
Operating expenses: | | Operating expenses: | |
Cost of testing revenue | 36,077 |
| | 33,078 |
| | 28,195 |
| Cost of testing revenue | 75,317 | | | 58,860 | | | 35,913 | |
Cost of product revenue | 446 |
| | — |
| | — |
| Cost of product revenue | 7,820 | | | 5,887 | | | 4,921 | |
Cost of biopharmaceutical and other revenue | | Cost of biopharmaceutical and other revenue | 18,445 | | | 9,653 | | | 621 | |
Research and development | 14,851 |
| | 14,820 |
| | 13,881 |
| Research and development | 40,603 | | | 29,843 | | | 17,204 | |
Selling and marketing | 53,691 |
| | 41,313 |
| | 32,260 |
| Selling and marketing | 97,560 | | | 79,840 | | | 52,389 | |
General and administrative | 29,029 |
| | 23,963 |
| | 23,088 |
| General and administrative | 76,518 | | | 101,353 | | | 36,729 | |
Intangible asset amortization | 1,401 |
| | 1,067 |
| | 1,067 |
| Intangible asset amortization | 21,354 | | | 15,981 | | | 5,095 | |
Total operating expenses | 135,495 |
| | 114,241 |
| | 98,491 |
| Total operating expenses | 337,617 | | | 301,417 | | | 152,872 | |
Loss from operations | (15,127 | ) | | (22,233 | ) | | (26,538 | ) | Loss from operations | (41,081) | | | (81,903) | | | (35,389) | |
Interest expense | (677 | ) | | (1,963 | ) | | (4,941 | ) | |
Other income, net | 3,205 |
| | 1,197 |
| | 476 |
| Other income, net | 4,654 | | | 254 | | | 480 | |
Net loss and comprehensive loss | $ | (12,599 | ) | | $ | (22,999 | ) | | $ | (31,003 | ) | |
Loss before income tax benefit | | Loss before income tax benefit | (36,427) | | | (81,649) | | | (34,909) | |
Income tax provision (benefit) | | Income tax provision (benefit) | 133 | | | (6,086) | | | — | |
Net loss | | Net loss | $ | (36,560) | | | $ | (75,563) | | | $ | (34,909) | |
Net loss per common share, basic and diluted | $ | (0.27 | ) | | $ | (0.62 | ) | | $ | (0.91 | ) | Net loss per common share, basic and diluted | $ | (0.51) | | | $ | (1.11) | | | $ | (0.66) | |
Shares used to compute net loss per common share, basic and diluted | 46,138,177 |
| | 37,020,246 |
| | 33,925,617 |
| Shares used to compute net loss per common share, basic and diluted | 71,549,204 | | | 67,890,328 | | | 53,239,231 | |
The accompanying notes are an integral part of these consolidated financial statements.
VERACYTE, INC.
Consolidated Statements of Comprehensive Loss
(in thousands)
| | | | | | | | | | | | | | | | | |
| Year Ended December 31, |
| 2022 | | 2021 | | 2020 |
Net loss | $ | (36,560) | | | $ | (75,563) | | | $ | (34,909) | |
Other comprehensive loss: | | | | | |
Change in currency translation adjustments | (16,263) | | | (15,083) | | | — | |
| | | | | |
| | | | | |
| | | | | |
| | | | | |
| | | | | |
| | | | | |
| | | | | |
| | | | | |
Net comprehensive loss | $ | (52,823) | | | $ | (90,646) | | | $ | (34,909) | |
The accompanying notes are an integral part of these consolidated financial statements.
VERACYTE, INC.
Consolidated Statements of Stockholders' Equity
(in thousands, except shares)thousands)
| | | | | | | | | | | | | | Additional Paid-in Capital | | Accumulated Deficit | | Accumulated Other Comprehensive Loss | | Total Stockholders' Equity |
| | | | | Additional Paid-in Capital | | Accumulated Deficit | | Total Stockholders' Equity | | Common Stock | |
| Common Stock | | | Shares | | Amount | |
| Shares | | Amount | | |
Balance at December 31, 2016 | 33,762,278 |
| | $ | 34 |
| | $ | 239,631 |
| | $ | (180,084 | ) | | $ | 59,581 |
| |
Balance at December 31, 2019 | | Balance at December 31, 2019 | 49,625 | | | $ | 50 | | | $ | 486,090 | | | $ | (246,685) | | | $ | — | | | $ | 239,455 | |
Sale of common stock in a public offering, net of offering costs of $13,169 | | Sale of common stock in a public offering, net of offering costs of $13,169 | 6,900 | | | 7 | | | 193,824 | | | — | | | — | | | 193,831 | |
Issuance of common stock on exercise of stock options and vesting of restricted stock units | 295,059 |
| | — |
| | 1,374 |
| | — |
| | 1,374 |
| Issuance of common stock on exercise of stock options and vesting of restricted stock units | 1,573 | | | 1 | | | 11,667 | | | — | | | — | | | 11,668 | |
Issuance of common stock under employee stock purchase plan (ESPP) | 153,051 |
| | — |
| | 656 |
| | — |
| | 656 |
| Issuance of common stock under employee stock purchase plan (ESPP) | 103 | | | — | | | 2,037 | | | — | | | — | | | 2,037 | |
Tax portion of vested restricted stock units | | Tax portion of vested restricted stock units | — | | | — | | | (3,845) | | | — | | | — | | | (3,845) | |
Stock-based compensation expense (employee) | — |
| | — |
| | 6,352 |
| | — |
| | 6,352 |
| Stock-based compensation expense (employee) | — | | | — | | | 12,017 | | | — | | | — | | | 12,017 | |
Stock-based compensation expense (non-employee) | — |
| | — |
| | 19 |
| | — |
| | 19 |
| Stock-based compensation expense (non-employee) | — | | | — | | | 51 | | | — | | | — | | | 51 | |
Stock-based compensation expense (ESPP) | — |
| | — |
| | 246 |
| | — |
| | 246 |
| Stock-based compensation expense (ESPP) | — | | | — | | | 927 | | | — | | | — | | | 927 | |
Net loss and comprehensive loss | — |
| | — |
| | — |
| | (31,003 | ) | | (31,003 | ) | |
Balance at December 31, 2017 | 34,210,388 |
| | 34 |
| | 248,278 |
| | (211,087 | ) | | 37,225 |
| |
Net loss | | Net loss | — | | | — | | | — | | | (34,909) | | | — | | | (34,909) | |
Balance at December 31, 2020 | | Balance at December 31, 2020 | 58,201 | | | 58 | | | 702,768 | | | (281,594) | | | — | | | 421,232 | |
Sale of common stock in a public offering, net of offering costs of $38,677 | | Sale of common stock in a public offering, net of offering costs of $38,677 | 8,547 | | | 9 | | | 593,812 | | | — | | | — | | | 593,821 | |
Issuance of common stock for acquisition | | Issuance of common stock for acquisition | 3,347 | | | 3 | | | 147,086 | | | — | | | — | | | 147,089 | |
Issuance of common stock on exercise of stock options and vesting of restricted stock units | 756,231 |
| | 1 |
| | 3,432 |
| | — |
| | 3,433 |
| Issuance of common stock on exercise of stock options and vesting of restricted stock units | 947 | | | 1 | | | 9,174 | | | — | | | — | | | 9,175 | |
Issuance of common stock under employee stock purchase plan (ESPP) | 146,583 |
| | — |
| | 790 |
| | — |
| | 790 |
| |
Sale of common stock in a public offering, net of issuance costs of $3,890 | 5,750,000 |
| | 6 |
| | 55,032 |
| | — |
| | 55,038 |
| |
Issuance of common stock under ESPP | | Issuance of common stock under ESPP | 81 | | | — | | | 2,353 | | | — | | | — | | | 2,353 | |
Tax portion of vested restricted stock units | | Tax portion of vested restricted stock units | — | | | — | | | (9,029) | | | — | | | — | | | (9,029) | |
Stock-based compensation expense (employee) | — |
| | — |
| | 5,602 |
| | — |
| | 5,602 |
| Stock-based compensation expense (employee) | — | | | — | | | 20,795 | | | — | | | — | | | 20,795 | |
Stock-based compensation expense (non-employee) | — |
| | — |
| | 24 |
| | — |
| | 24 |
| Stock-based compensation expense (non-employee) | — | | | — | | | 61 | | | — | | | — | | | 61 | |
Stock-based compensation expense (ESPP) | — |
| | — |
| | 332 |
| | — |
| | 332 |
| Stock-based compensation expense (ESPP) | — | | | — | | | 1,663 | | | — | | | — | | | 1,663 | |
Legal settlement from short-swing profits, net of tax | — |
| | — |
| | 310 |
| | — |
| | 310 |
| |
Net loss and comprehensive loss | — |
| | — |
| | — |
| | (22,999 | ) | | (22,999 | ) | |
Balance at December 31, 2018 | 40,863,202 |
| | 41 |
| | 313,800 |
| | (234,086 | ) | | 79,755 |
| |
Net loss | | Net loss | — | | | — | | | — | | | (75,563) | | | — | | | (75,563) | |
Comprehensive loss | | Comprehensive loss | — | | | — | | | — | | | — | | | (15,083) | | | (15,083) | |
Balance at December 31, 2021 | | Balance at December 31, 2021 | 71,123 | | | 71 | | | 1,468,683 | | | (357,157) | | | (15,083) | | | 1,096,514 | |
Issuance of common stock on exercise of stock options and vesting of restricted stock units | 1,924,156 |
| | 2 |
| | 13,376 |
| | — |
| | 13,378 |
| Issuance of common stock on exercise of stock options and vesting of restricted stock units | 681 | | | 1 | | | 4,193 | | | — | | | — | | | 4,194 | |
Issuance of common stock under employee stock purchase plan (ESPP) | 136,251 |
| | — |
| | 1,266 |
| | — |
| | 1,266 |
| |
Sale of common stock in a public offering, net of issuance costs of $9,208 | 6,325,000 |
| | 6 |
| | 137,842 |
| | — |
| | 137,848 |
| |
Issuance of common stock for acquisition | 376,732 |
| | 1 |
| | 9,999 |
| | — |
| | 10,000 |
| |
Issuance of common stock under ESPP | | Issuance of common stock under ESPP | 155 | | | — | | | 3,748 | | | — | | | — | | | 3,748 | |
Tax portion of vested restricted stock units | | Tax portion of vested restricted stock units | — | | | — | | | (3,167) | | | — | | | — | | | (3,167) | |
Stock-based compensation expense (employee) | — |
| | — |
| | 8,883 |
| | — |
| | 8,883 |
| Stock-based compensation expense (employee) | — | | | — | | | 24,781 | | | — | | | — | | | 24,781 | |
Stock-based compensation expense (non-employee) | — |
| | — |
| | 181 |
| | — |
| | 181 |
| Stock-based compensation expense (non-employee) | — | | | — | | | 11 | | | — | | | — | | | 11 | |
Stock-based compensation expense (ESPP) | — |
| | — |
| | 743 |
| | — |
| | 743 |
| Stock-based compensation expense (ESPP) | — | | | — | | | 1,942 | | | — | | | — | | | 1,942 | |
Net loss and comprehensive loss | — |
| | — |
| | — |
| | (12,599 | ) | | (12,599 | ) | |
Balance at December 31, 2019 | 49,625,341 |
| | $ | 50 |
| | $ | 486,090 |
| | $ | (246,685 | ) | | $ | 239,455 |
| |
Net loss | | Net loss | — | | | — | | | — | | | (36,560) | | | — | | | (36,560) | |
Comprehensive loss | | Comprehensive loss | — | | | — | | | — | | | — | | | (16,263) | | | (16,263) | |
Balance at December 31, 2022 | | Balance at December 31, 2022 | 71,959 | | | $ | 72 | | | $ | 1,500,191 | | | $ | (393,717) | | | $ | (31,346) | | | $ | 1,075,200 | |
|
The accompanying notes are an integral part of these consolidated financial statements.
VERACYTE, INC.
Consolidated Statements of Cash Flows
(in thousands of dollars)
| | | | | | | | | | | | | | | | | |
| Year Ended December 31, |
| 2022 | | 2021 | | 2020 |
Operating activities | | | | | |
Net loss | $ | (36,560) | | | $ | (75,563) | | | $ | (34,909) | |
Adjustments to reconcile net loss to net cash used in operating activities: | | | | | |
Depreciation and amortization | 25,928 | | | 19,593 | | | 7,944 | |
Loss on disposal of property and equipment | 206 | | | — | | | — | |
Stock-based compensation | 26,734 | | | 22,519 | | | 12,995 | |
Provision for (benefit from) income taxes | 133 | | | (6,258) | | | — | |
Interest on end-of-term debt obligation | 161 | | | 216 | | | 216 | |
Write-down of excess supplies | — | | | — | | | 1,088 | |
Noncash lease expense | 3,320 | | | 1,632 | | | 964 | |
Revaluation of acquisition-related contingent consideration | 154 | | | 810 | | | 1,506 | |
Impairment loss | 3,318 | | | — | | | 1,000 | |
Effect of foreign currency on operations | 522 | | | 1,211 | | | (34) | |
Changes in operating assets and liabilities: | | | | | |
Accounts receivable | (4,495) | | | (8,571) | | | 955 | |
Supplies and inventory | (3,011) | | | (1,464) | | | 1,061 | |
Prepaid expenses and other current assets | 1,390 | | | (3,316) | | | (970) | |
Other assets | (3,049) | | | (216) | | | 37 | |
Operating lease liability | (3,448) | | | (1,794) | | | (1,407) | |
Accounts payable | 152 | | | 5,155 | | | 711 | |
Accrued liabilities and deferred revenue | (3,920) | | | 14,425 | | | (868) | |
Net cash provided by (used in) operating activities | 7,535 | | | (31,621) | | | (9,711) | |
Investing activities | | | | | |
Purchase of short-term investments | (33,519) | | | — | | | — | |
Proceeds from maturity of short-term investments | 12,681 | | | — | | | — | |
Acquisition of Decipher Biosciences, net of cash acquired | — | | | (574,411) | | | — | |
Acquisition of HalioDx, net of cash acquired | — | | | (162,419) | | | — | |
Proceeds from sale of equity securities | — | | | 3,000 | | | — | |
Purchase of equity securities | — | | | — | | | (1,000) | |
Purchases of property and equipment | (8,549) | | | (5,376) | | | (2,837) | |
Net cash used in investing activities | (29,387) | | | (739,206) | | | (3,837) | |
Financing activities | | | | | |
Proceeds from issuance of common stock in a public offering, net of issuance costs | — | | | 593,821 | | | 193,831 | |
Payment of long-term debt | (1,281) | | | — | | | (100) | |
Payment of taxes on vested restricted stock units | (3,167) | | | (9,029) | | | (3,845) | |
Proceeds from the exercise of common stock options and employee stock purchases | 7,942 | | | 11,528 | | | 13,709 | |
Net cash provided by financing activities | 3,494 | | | 596,320 | | | 203,595 | |
(Decrease) increase in cash, cash equivalents and restricted cash | (18,358) | | | (174,507) | | | 190,047 | |
Effect of foreign currency on cash, cash equivalents and restricted cash | (592) | | | (1,514) | | | — | |
Net (decrease) increase in cash, cash equivalents and restricted cash | (18,950) | | | (176,021) | | | 190,047 | |
Cash, cash equivalents and restricted cash at beginning of year | 173,946 | | | 349,967 | | | 159,920 | |
Cash, cash equivalents and restricted cash at end of year | $ | 154,996 | | | $ | 173,946 | | | $ | 349,967 | |
| | | | | |
Supplementary cash flow information of non-cash investing and financing activities: | | | | | |
Shares issued for purchase consideration for a business combination | $ | — | | | $ | 147,089 | | | $ | — | |
Purchases of property and equipment included in accounts payable and accrued liabilities | — | | | 392 | | | 294 | |
Supplementary cash flow information: | | | | | |
Cash paid for interest on debt | 9 | | 9 | | 13 |
Cash paid for tax | 570 | | 112 | | 112 |
|
| | | | | | | | | | | |
| Year Ended December 31, |
| 2019 | | 2018 | | 2017 |
Operating activities | |
| | |
| | |
|
Net loss | $ | (12,599 | ) | | $ | (22,999 | ) | | $ | (31,003 | ) |
Adjustments to reconcile net loss to net cash used in operating activities: | |
| | |
| | |
|
Depreciation and amortization | 4,117 |
| | 3,920 |
| | 3,841 |
|
(Gain) loss on disposal of property and equipment | (23 | ) | | — |
| | 12 |
|
Stock-based compensation | 9,807 |
| | 5,958 |
| | 6,617 |
|
Other income | — |
| | (93 | ) | | — |
|
Amortization and write-off of debt discount and issuance costs | 83 |
| | 32 |
| | 472 |
|
Interest on end-of-term debt obligation and prepayment penalty | 229 |
| | 312 |
| | 1,589 |
|
Changes in operating assets and liabilities: | |
| | |
| | |
|
Accounts receivable | (6,161 | ) | | (452 | ) | | (3,960 | ) |
Supplies | (3,404 | ) | | 1,922 |
| | (1,849 | ) |
Prepaid expenses and other current assets | 154 |
| | (517 | ) | | (7 | ) |
Right-of-use assets - operating lease and operating lease liability | (171 | ) | | — |
| | — |
|
Other assets | (351 | ) | | (760 | ) | | (192 | ) |
Accounts payable | (141 | ) | | (1,568 | ) | | 1,728 |
|
Accrued liabilities and deferred rent | 5,228 |
| | 724 |
| | (1,163 | ) |
Net cash used in operating activities | (3,232 | ) | | (13,521 | ) | | (23,915 | ) |
Investing activities | |
| | |
| | |
|
Cash paid for acquisition | (40,000 | ) | | — |
| | — |
|
Purchases of property and equipment | (2,756 | ) | | (1,874 | ) | | (1,755 | ) |
Proceeds from the sale of property and equipment | 23 |
| | — |
| | 440 |
|
Net cash used in investing activities | (42,733 | ) | | (1,874 | ) | | (1,315 | ) |
Financing activities | |
| | |
| | |
|
Proceeds from the issuance of long-term debt, net of debt issuance costs | — |
| | — |
| | 24,880 |
|
Proceeds from issuance of common stock in a public offering, net of issuance costs | 137,848 |
| | 55,038 |
| | 200 |
|
Payment of long-term debt | (24,900 | ) | | — |
| | (25,385 | ) |
Payment of end-of-term debt obligation and prepayment penalty | — |
| | — |
| | (1,536 | ) |
Proceeds from legal settlement regarding short-swing profits | — |
| | 403 |
| | — |
|
Payment of financial lease liability | (308 | ) | | (292 | ) | | (274 | ) |
Proceeds from the exercise of common stock options and employee stock purchases | 14,647 |
| | 4,350 |
| | 1,897 |
|
Net cash provided by (used in) financing activities | 127,287 |
| | 59,499 |
| | (218 | ) |
Net increase (decrease) in cash, cash equivalents and restricted cash | 81,322 |
| | 44,104 |
| | (25,448 | ) |
Cash, cash equivalents and restricted cash at beginning of year | 78,598 |
| | 34,494 |
| | 59,942 |
|
Cash, cash equivalents and restricted cash at end of year | $ | 159,920 |
| | $ | 78,598 |
| | $ | 34,494 |
|
| | | | | |
Supplementary cash flow information of non-cash investing and financing activities: | |
| | |
| | |
|
Operating lease liability arising from obtaining right-of-use assets - operating lease at beginning of period | $ | 14,118 |
| | $ | — |
| | $ | — |
|
Shares issued for purchase consideration for a business combination | 10,000 |
| | — |
| | — |
|
Deferred purchase consideration for a business combination | 6,088 |
| | — |
| | — |
|
Purchases of property and equipment included in accounts payable and accrued liabilities | 226 |
| | 273 |
| | 42 |
|
Supplementary cash flow information: | | | | | |
Cash paid for interest on debt | 332 |
| | 1,547 |
| | 2,718 |
|
Cash paid for tax | 35 |
| | 79 |
| | 21 |
|
Cash, Cash Equivalents and Restricted Cash:
| | | | | | | | | | | | | | | | | |
| December 31, |
| 2022 | | 2021 | | 2020 |
Cash and cash equivalents | $ | 154,247 | | | $ | 173,197 | | | $ | 349,364 | |
Restricted cash | 749 | | | 749 | | | 603 | |
Total cash, cash equivalents and restricted cash | $ | 154,996 | | | $ | 173,946 | | | $ | 349,967 | |
|
| | | | | | | | | | | |
| December 31, |
| 2019 | | 2018 | | 2017 |
Cash and cash equivalents | $ | 159,317 |
| | $ | 77,995 |
| | $ | 33,891 |
|
Restricted cash | 603 |
| | 603 |
| | 603 |
|
Total cash, cash equivalents and restricted cash | $ | 159,920 |
| | $ | 78,598 |
| | $ | 34,494 |
|
The accompanying notes are an integral part of these consolidated financial statements.
VERACYTE, INC.
Notes to Consolidated Financial Statements
1. Organization and Description of Business
Veracyte, Inc. (“Veracyte”, or Veracyte, or the “Company”)Company, is a leading genomicglobal diagnostics company that is creating value through innovation. The Company was foundedempowers clinicians with the high-value insights they need to guide and assure patients at pivotal moments in 2008 with a missionthe race to improve diagnostic accuracy. Today, the Company's growing menu ofdiagnose and treat cancer. Veracyte's high-performing tests leverage advances in genomic science and technologyenable clinicians to improve care throughout the patient journey, enablingmake more confident diagnostic, prognostic and treatment decisions, in cancer and other challenging diseases. The Company is creating new standards of care by enabling morehelping patients to avoid risks of unnecessary invasive procedures and removing costs from the healthcare system, while speeding theinterventions, and speed time to diagnosis andappropriate treatment, decisions.thereby improving outcomes for patients all over the world.
Veracyte was incorporated in the state of Delaware on August 15, 2006, as Calderome, Inc. Calderome operated as an incubator until early 2008. On March 4, 2008, the Company changed its name to Veracyte, Inc. The Company’s operationsheadquarters are based in South San Francisco, California, and it also has operations in San Diego, California; Austin, Texas,Texas; Richmond, Virginia; and it operates in 1 segment.Marseille, France.
The Company performscurrently offers tests in thyroid cancer (Afirma); prostate cancer (Decipher Prostate); breast cancer (Prosigna); interstitial lung diseases (Envisia); and bladder cancer (Decipher Bladder). The Company’s Percepta Nasal Swab test is being run in its genomicCLIA lab in support of clinical studies and its tests for thyroid cancer, lungkidney cancer and idiopathic pulmonary fibrosis,lymphoma are in development, the latter as a companion diagnostic.
The Company serves global markets with two complementary models. In the United States, it offers laboratory developed tests, or IPF, in our CLIA-certified laboratoryLDTs, through its centralized, Clinical Laboratory Improvement Amendments of 1988, or CLIA, certified laboratories in South San Francisco California. In December 2019, we announced our acquisitionand San Diego, California, supported by its cytopathology expertise in Austin, Texas. Additionally, primarily outside of the exclusive global diagnostics licenseUnited States, the Company provides its Prosigna test to patients through distribution to laboratories and hospitals that can perform the NanoStringtests locally as an in vitro diagnostic, or IVD, test that runs on the nCounter FLEX Analysis System,System.
In March 2021, the Company acquired Decipher Biosciences, expanding the Company's genomic testing menu into urologic cancers. The acquisition also provided it with Decipher GRID (Genomics Resource for Intelligent Discovery), a platform and database that helps drive biopharmaceutical partnerships, key opinion leaders engagement and pipeline development in urologic cancers.
In August 2021, the Company acquired HalioDx SAS and HalioDx Inc., historically a wholly owned subsidiary of HalioDx SAS, collectively referred to as well asHalioDx, giving it the Prosigna breast cancer prognostic gene signature assay, which is commercially available,capabilities and expertise to manufacture the LymphMark lymphoma subtyping assay, which is in development. Both tests are designedCompany's own IVD test kits for use on the nCounter system.
Analysis System. The Company offers genomic testsacquisition also deepened its scientific expertise and capabilities in thyroid cancer; lung cancer; IPFthe rapidly growing area of immuno-oncology further strengthening its offerings to biopharmaceutical and breast cancer:
other partners.
Afirma Genomic Sequencing Classifier and Xpression Atlas.The Company's Afirma offerings include the Afirma GSC and Xpression Atlas, to help guide next steps for patients with potentially cancerous thyroid nodules. The offerings are intended to provide physicians with clinically actionable results from a single fine needle aspiration, or FNA biopsy. The Afirma GSC was developed with RNA whole-transcriptome sequencing and machine learning, and is used to identify patients with benign thyroid nodules among those with indeterminate cytopathology results in order to rule out unnecessary thyroid surgery.
The Company commercially launched the Afirma Xpression Atlas in 2018 to complement the Afirma GSC. The Xpression Atlas provides physicians with genomic alteration content from the same FNA samples that are used in Afirma GSC testing and may help physicians decide with greater confidence on the surgical or therapeutic pathway for their patients.
Percepta Genomic Sequencing Classifier. The Percepta classifier improves lung cancer diagnosis by enhancing the performance of diagnostic bronchoscopies, thus identifying more patients with lung nodules who are at low risk of cancer and may avoid further, invasive procedures. This second-generation test was developed on our RNA whole-transcriptome sequencing platform and commercially introduced in June 2019, provides expanded clinical utility by also identifying patients as high risk of cancer so they may obtain faster diagnosis and treatment. The test is built upon foundational "field of injury" science - through which genomic changes associated with lung cancer in current and former smokers can be identified with a simple brushing of a person's airway - without the need to sample the often hard-to-reach nodule directly.
Envisia Genomic Classifier. The Envisia classifier improves diagnosis of IPF by helping physicians better differentiate IPF from other interstitial lung diseases, or ILDs, without the need for surgery. The test identifies the genomic pattern of usual interstitial pneumonia, or UIP, a hallmark of IPF, with high accuracy on patient samples that are obtained through transbronchial biopsy, a nonsurgical procedure that is commonly used in lung evaluation.
Prosigna Breast Cancer Prognostic Gene Signature Assay. The Prosigna test, acquired in December 2019 through our strategic transaction with NanoString, uses advanced genomic technology to inform next steps for patients with early-stage breast cancer, based on the genomic make-up of their disease. The test leverages a collection of 50 genes known as the PAM50 gene signature and can provide a breast cancer patient and physician with prognostic score that indicates the probability of cancer recurrence over ten years. Physicians use Prosigna to help guide therapeutic decisions so that patients receive a therapeutic intervention, such as chemotherapy, only if clinically warranted.
VERACYTE, INC.
Notes to Consolidated Financial Statements (Continued)
The Company’s approach also provides multiple opportunities for partnerships with biopharmaceutical companies. In developing the Company's products, the Company has built or gained access to unique biorepositories, proprietary technology and bioinformatics that it believes are important to the development of new targeted therapies, determining clinical trial eligibility and guiding treatment selection.
All of the Company's testing services are made available through its clinical reference laboratories located in South San Francisco, California and Austin, Texas.
2. Summary of Significant Accounting Policies
Basis of Presentation
The Company's consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States, ("or U.S. GAAP").GAAP. The consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary, which was created in 2019 to process certain administrative functions associated with the business combination in Note 4, Business Combination.subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation.
Reclassifications
Certain amountsprior period balances have been reclassified to conform to current period presentation of the Company’s consolidated financial statements and accompanying notes. Such reclassifications have no effect on previously reported results of operations, accumulated deficit, subtotals of operating, investing or financing cash flows or consolidated balance sheet totals; however, for the period December 31, 2021, the Company reclassified $4.0 million of short-term investments from the prepaid expenses and other current assets caption in the consolidated statementsbalance sheets.
VERACYTE, INC.
Notes to Consolidated Financial Statements (Continued)
Use of Estimates
The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities as of the date of the consolidated financial statements and the reported amounts of revenue and expenses during the reporting period. Significant items subject to such estimates include: revenue recognition; thewrite-down of supplies; useful lives of property and equipment; the recoverability of long-lived assets; the incremental borrowing rates for leases; accounting for acquisitions; the estimation of the fair value of intangible assets;assets and contingent consideration; stock options;based compensation; income tax uncertainties, including a valuation allowance for deferred tax assets; credit related losses on investments; and allowance for credit losses and contingencies. The Company bases these estimates on historical and anticipated results, trends, and various other assumptions that the Company believes are reasonable under the circumstances, including assumptions as to future events. These estimates form the basis for making judgments about the carrying values of assets and liabilities and recognizedrecorded revenue and expenses that are not readily apparent from other sources. Actual results could differ from those estimates and assumptions.
Liquidity
The Company has incurred net losses since its inception and as of December 31, 2019,2022, the Company had an accumulated deficit of $246.7$393.7 million. The Company believes its cash and cash equivalents and short-term investments of $159.3$178.9 million as of December 31, 20192022, and its revenue from sales in 20202023 will be sufficient to meet its anticipated cash requirements through at least February 2021.2024.
On May 7, 2019,In February 2021, the Company issued and sold 6,325,0008,547,297 shares of common stock in a registered public offering, including 825,000 shares issued and sold upon the underwriters’ exercise in full of their option to purchase additional shares, at a price to the public of $23.25 per share. The Company's net proceeds from the offering were approximately $137.8 million, after deducting underwriting discounts and commissions and offering expenses of $9.2 million.
In July 2018, the Company issued and sold 5,750,000 shares of common stock in a registered public offering, including 750,0001,114,864 shares issued and sold upon the underwriters' exercise in full of their option to purchase additional shares, at a price to the public of $10.25$74.00 per share. The Company's net proceeds from the offering were approximately $55.0$593.8 million, after deducting underwriting commissions and offering expenses of $3.9$38.7 million.
In November 2017,August 2020, the Company entered intoissued and sold 6,900,000 shares of common stock in a Loanregistered public offering, including 900,000 shares issued and Security Agreementsold upon the underwriters' exercise in full of their option to purchase additional shares, at a price to the public of $30 per share. The Company's net proceeds from the offering were approximately $193.8 million, after deducting underwriting commissions and drew down a term loan advanceoffering expenses of $25.0 million of which the entire amount was used to pay the outstanding balance of the Company's previous long-term debt as discussed in Note 8 - Debt.$13.2 million.
VERACYTE, INC.
Notes to Consolidated Financial Statements (Continued)
If the Company is not able to generate cash proceeds from revenue sufficient to satisfy its cash obligations, the Company will need to finance future cash needs primarily through public or private equity offerings, debt financings, borrowings or strategic collaborations or licensing arrangements. If the Company is not able to secure additional funding when needed, on acceptable terms, it may have to delay, reduce the scope of or eliminate one or more research and development programs or selling and marketing initiatives which may have a material adverse effect on the Company's business, results of operations, financial condition and/or its ability to fund its scheduled obligations on a timely basis or at all.
Concentrations of Credit Risk and Other Risks and Uncertainties
The worldwide spread of coronavirus, or COVID-19, has created significant uncertainty in the global economy. There have been no comparable recent events that provide guidance as to the effect the spread of COVID-19 as a global pandemic may have. As a result, the ultimate impact of COVID-19 and the extent to which COVID-19 impacts the Company’s business, results of operations and financial condition will depend on future developments, which are highly uncertain and difficult to predict. If the financial markets or the overall economy are impacted for an extended period, the Company’s liquidity, revenue, supplies, goodwill and intangibles may be adversely affected. The Company considers the effects, to the extent knowable, of the COVID-19 pandemic in developing its estimates.
The majority of the Company'sCompany’s cash and cash equivalents are deposited with 1one major financial institution in the United States. Deposits in this institution may exceed the amount of insurance provided on such deposits. The Company has not experiencedrealized any losses on its deposits of cash and cash equivalents.equivalents other than exchange rate losses related to foreign currency denominated accounts.
VERACYTE, INC.
Notes to Consolidated Financial Statements (Continued)
Several of the components of the Company's sample collection kitkits and test reagents, and itsthe nCounter FLEX DX systemsAnalysis system and related testdiagnostic kits, are obtained from single-source suppliers. If these single-source suppliers fail to satisfy the Company's requirements on a timely basis, itthe Company could suffer delays in being able to deliver its diagnostic solutions, suffer a possible loss of revenue, or incur higher costs, any of which could adversely affect its operating results.
Through December 31, 2022, the Company has derived most of its revenue from the sale of Decipher and Afirma testing. To date, Decipher and Afirma testing have been delivered primarily to physicians in the United States.
The Company is also subject to credit risk from its accounts receivable related to its sales. Credit risk for accounts receivable from testing revenue is incorporated in testing revenue accrual rates as the Company assesses historical collection rates and current developments to determine accrual rates and amounts the Company will ultimately collect. The Company generally does not perform evaluations of customers'customers’ financial condition for testing revenue and generally does not require collateral.
Through The Company assesses credit risk and the amount of accounts receivable the Company will ultimately collect for product, biopharmaceutical and other revenue based on collection history, current developments and credit worthiness of the customer. The estimate of credit losses is not material at December 31, 2019, most of the2022.
The Company's revenue have been derived from the sale of Afirma. To date, Afirma has been delivered primarily to physicians in the United States. The Company'stotal third-party payers and other customers in excess of 10% of total revenue and their related revenue as a percentage of total revenue were as follows:
|
| | | | | | | | |
| Year Ended December 31, |
| 2019 | | 2018 | | 2017 |
Medicare | 26 | % | | 29 | % | | 26 | % |
UnitedHealthcare | 11 | % | | 12 | % | | 14 | % |
| 37 | % | | 41 | % | | 40 | % |
| | | | | | | | | | | | | | | | | |
| Year Ended December 31, |
| 2022 | | 2021 | | 2020 |
Medicare | 31 | % | | 30 | % | | 24 | % |
UnitedHealthcare | 10 | % | | 10 | % | | 11 | % |
| 41 | % | | 40 | % | | 35 | % |
The Company's significant third-party payers and other customers in excess of 10% of total accounts receivable and their related accounts receivable balance as a percentage of total accounts receivable were as follows:
|
| | | | | |
| As of December 31, |
| 2019 | | 2018 |
Medicare | 15 | % | | 20 | % |
Johnson and Johnson Services, Inc. | 10 | % | | — | % |
UnitedHealthcare | 9 | % | | 11 | % |
| | | | | | | | | | | |
| As of December 31, |
| 2022 | | 2021 |
Medicare | 14 | % | | 12 | % |
UnitedHealthcare | 10 | % | | 9 | % |
Cash Equivalents
Cash equivalents consist of short-term,The Company considers demand deposits in a bank, money market funds and highly liquid investments with an original maturitiesmaturity of three months90 days or less to be cash equivalents.
Short-Term Investments
The Company's short-term investments consist of U.S. treasury securities and time deposits with a bank with maturities at the time of purchase that were between 90 days and one year. The Company classifies these investments as held-to-maturity debt securities, which are reported at amortized cost. Discounts or premiums from the datepurchase of purchase. Cash equivalents consistthe securities are recognized as a component of amounts investedinterest income in a money market account primarily consistingother income (loss), net in the consolidated statements of U.S. Treasury reserves, and overnight reverse repurchase agreementsoperations. Investments are initially recorded net of an allowance for expected credit losses, if any, which are tri-party repurchase agreementsremeasured each period and any impairments are collateralized by U.S. Treasury and agency securities of at least 102% of the principal amount. In a tri-party repurchase agreement, a third-party custodian bank functionsrecognized as an independent intermediary to facilitate transferexpense. Unrealized gains and losses are not recognized in income. As of cashboth December 31, 2022 and holdingDecember 31, 2021, no allowances for expected credit losses had been recorded and there have been no impairment or credit losses on the collateral on behalfCompany's short term investments.
Restricted Cash
VERACYTE, INC.
Notes to Consolidated Financial Statements (Continued)
Restricted Cash
The Company had deposits of $603,000$0.7 million included in long-term assets as of both December 31, 20192022 and December 31, 2018,2021, restricted from withdrawal and held by a bankbanks in the form of collateral for an irrevocable standby letterletters of credit held as security for the lease of the Company's South San Francisco facility.leases.
Acquisitions
The Company first determines whether a set of assets acquired and liabilities assumed constitute a business and should be accounted for as a business combination. If the assets acquired are not a business, the Company accounts for the transaction as an asset acquisition. Business combinations are accounted for by using the acquisition method of accounting. Under the acquisition method, assets acquired, and liabilities assumed are recorded at their respective fair values as of the acquisition date in ourthe Company's consolidated financial statements. The estimated fair value of intangible assets acquired are based on discounted cash flows utilizing certain assumptions including revenues (such as projected testing volumes, growth rates), discount rates and expected economic life/obsolescence factors of the respective assets. The excess of the fair value of consideration transferred over the fair value of the net assets acquired is recorded as goodwill. Contingent consideration obligations incurred in connection with a business combination are recorded at fair value on the acquisition date and remeasured at each subsequent reporting period until the related contingencies are resolved, with the resulting changes in fair value recorded in earnings.general and administrative expense in the consolidated statements of operations.
Accounts ReceivableEquity Investment
In July 2020, the Company invested $1.0 million in the preferred stock of MAVIDx, Inc., or MAVIDx, a company developing a diagnostic platform for infectious diseases testing. MAVIDx is a variable interest entity, or VIE, and Allowancethe Company's investment is a variable interest. The Company has determined that it is not the primary beneficiary of the VIE due to the fact that the Company does not have the power to direct the activities that impact the economic performance of MAVIDx or the obligation to fund its operations with ongoing financial support or contributions. MAVIDx is a private company and its equity securities are not traded or quoted in any securities exchange or in the over-the-counter market, and therefore does not have a readily determinable fair value. As such, the Company has elected to measure its investment in the preferred stock at cost, less any impairment, plus or minus changes resulting from observable price changes in orderly transactions for Doubtful Accounts for Product Salesan identical or similar equity financings of MAVIDx, in accordance with Accounting Standards Codification, or ASC 321, Investments—Equity Securities. Based on the fourth quarter of 2020 operating performance of MAVIDx and the volatile nature of the market in which it operates, the Company determined that the investment in MAVIDx was fully impaired as of December 31, 2020. As a result, an impairment loss of $1.0 million was recorded in the fourth quarter of 2020 and is included in general and administrative expense in the consolidated statements of operations.
Accounts receivable areSupplies and Inventory
Supplies consists of materials and reagents consumed in the performance of testing services. Inventory consists of raw materials consumed in the contract manufacturing process as well as finished and semi-finished components used in the assembly of diagnostic kits related to product sales. Inventory is stated at the amount management expects to collect from customers based on their outstanding invoices. Management reviews accounts receivable regularly to determine if any receivable will potentially be uncollectible and to estimate the amountlower of allowance for doubtful accounts necessary to reduce accounts receivable to its estimatedcost or net realizable value by analyzing the statuson a weighted average basis. The Company periodically analyzes supply and inventory levels and expiration dates, and writes down supply or inventory that has become obsolete, that has a cost basis in excess of significant past due receivables. Productits net realizable value, or in excess of expected sales commenced in December 2019 and there was norequirements as cost of revenue. The Company records an allowance for doubtful accounts at either December 31, 2019excess or 2018.obsolete supplies and inventory using an estimate based on historical trends and evaluation of near-term expirations.
Property and Equipment
Property and equipment are stated at cost less accumulated depreciation and amortization. Depreciation is computed using the straight-line method over the estimated useful lives of the assets, generally between three and five years. Leasehold improvements are amortized using the straight-line method over the shorter of the estimated useful life of the asset or the term of the lease. Maintenance and repairs are charged to expense as incurred, and improvements and betterments are capitalized. When assets are retired or otherwise disposed of, the cost and accumulated depreciation are removed from the balance sheet and any resulting gain or loss is reflected in the statements of operations and comprehensive loss in the period realized.
VERACYTE, INC.
Notes to Consolidated Financial Statements (Continued)
Leases
The Company determines if an arrangement is, or contains, a lease at inception. Operating leases are included in right-of-use assets - operating leases and operating lease liabilities in the consolidated balance sheets, representing the right to use an underlying asset for the lease term and the obligation to make lease payments arising from the lease. Right-of-use, or ROU, assets and lease liabilities are recognized at commencement based on the present value of lease payments over the lease term. The Company uses its incremental borrowing rate based on the estimated rate of interest for collateralized borrowing over a similar term of the lease payments. The ROU assets also includes any lease payments made and is adjusted for lease incentives. Lease terms may include options to extend or terminate the lease which are recognized when it is reasonably certain that the Company will exercise that option. Lease expense is recognized on a straight-line basis over the lease terms. Lease and non-lease components are accounted for as a single lease component. Financing leases are immaterial and are included in property and equipment, net and other liabilities in the consolidated balance sheets. Leases with terms of 12 months or less are not recorded on our balance sheet.
Finite-lived Intangible Assets
Finite-lived intangible assets consist of intangible assets acquired as part of business combinations. The Company amortizes finite-lived intangible assets using the straight-line method over their estimated useful lives of 54 to 15 years, based on management's estimate of the period over which their economic benefits will be realized, product life and patent life. The Company tests these finite-lived intangible assets for impairment when events or circumstances indicate a reduction in the fair value below their carrying amounts. There was 0The Company recorded a $3.3 million impairment charge for the year ended December 31, 2022 and no impairment charge for the years ended December 31, 2019, 20182021 or 2017.2020. See Note 5 Balance Sheet Components for more information on the 2022 impairment testing.
Indefinite-lived Intangible Assets
Indefinite-lived intangible assets consist of in-process research and development, or IPR&D, acquired as part of business combinations. The IPR&D is not amortized until it becomes commercially viable and placed in service. At the time when the intangible assets are placed in service the Company will determine a useful life. The Company also tests these indefinite-lived intangible assets for impairment when events or circumstances indicate a reduction in the fair value below their carrying amounts. There was no impairment of indefinite-lived intangible assets for the years ended December 31, 2022, 2021 or 2020.
Goodwill
Goodwill, derived from the Company's acquisition of Allegro Diagnostics Corp. in September 2014 and the exclusive global diagnostics license to the NanoString nCounter FLEX Analysis System and Prosigna and LymphMark assays in December 2019, is reviewed for impairment on an annual basis or more frequently if events or circumstances indicate that it may be impaired. The Company's goodwill evaluation is done annually on October 31 and is based on both qualitative and quantitative assessments regarding the fair value of goodwill relative to its carrying value. The Company has determined that it operates in a single segment and has a single reporting unit associated with the development and commercialization of diagnostic products. In the event the Company determines that it is more likely than not the carrying value of the reporting unit is higher than its fair value, quantitative testing is performed comparing recorded values to estimated fair values. If impairment is present, the impairment loss is measured as the excess of the recorded goodwill over its implied fair value. There was 0no impairment of goodwill for the years ended December 31, 2019, 20182022, 2021 or 2017.2020.
VERACYTE, INC.
Notes to Consolidated Financial Statements (Continued)
The carrying amounts of certain financial instruments including cash and cash equivalents, accounts receivable, prepaid expenses and other current assets, accounts payable and accrued liabilities approximate fair value due to their relatively short maturities.