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LHDX Lucira Health

Lucira Health is a medical technology company focused on the development and commercialization of transformative and innovative infectious disease test kits. Lucira has developed a testing platform that produces centralized-laboratory-accurate molecular testing in a single-use and consumer-friendly test kit that is powered by two AA batteries and fits in the palm of a hand. Lucira designed its test kits to provide accurate, reliable and on-the-spot molecular test results anywhere and at any time. The LUCIRA COVID19 All-In-One Test Kit is designed to provide a clinically relevant COVID-19 result within 30 minutes from sample collection.

LHDX stock data

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Investment data

Data from SEC filings
Securities sold
Number of investors

Calendar

13 Aug 21
23 Sep 21
31 Dec 21
Quarter (USD)
Jun 21 Mar 21 Dec 20
Revenue
Cost of revenue
Operating income
Operating margin
Net income
Net profit margin
Cash on hand
Change in cash
Diluted EPS
Annual (USD)
Dec 20
Revenue
Cost of revenue
Operating income
Operating margin
Net income
Net profit margin
Cash on hand
Change in cash
Diluted EPS

Financial data from company earnings reports.

Cash burn rate (estimated) Burn method: Change in cash Burn method: Operating income/loss Burn method: FCF (opex + capex)
Cash on hand (at last report) 4.64M 4.64M 4.64M
Cash burn (monthly) (positive/no burn) 5.43M (positive/no burn)
Cash used (since last report) n/a 15.23M n/a
Cash remaining n/a -10.59M n/a
Runway (months of cash) n/a -2.0 n/a

Beta Read what these cash burn values mean

Date Owner Security Transaction Code Indirect 10b5-1 $Price #Shares $Value #Remaining
18 Jun 21 Dan George Common Stock Grant Acquire A No No 0 15,000 0 43,653
18 Jun 21 Hansgregory C. Hartmann Common Stock Grant Acquire A No No 0 30,000 0 100,000
10 Mar 21 Brezoczky Kelly Lewis Common Stock Grant Acquire A No No 0 11,250 0 34,481

Data for the last complete 13F reporting period. To see the most recent changes to ownership, click the ownership history button above.

42.0% owned by funds/institutions
13F holders
Current Prev Q Change
Total holders 45 50 -10.0%
Opened positions 19 50 -62.0%
Closed positions 24 0 NEW
Increased positions 6 0 NEW
Reduced positions 16 0 NEW
13F shares
Current Prev Q Change
Total value 107.93M 233.39M -53.8%
Total shares 16.26M 19.29M -15.7%
Total puts 70.6K 0 NEW
Total calls 31.1K 0 NEW
Total put/call ratio 2.3
Largest owners
Shares Value Change
EPIQ Capital 13.29M $88.27M +0.5%
Foresite Capital Management V 485K $3.22M 0.0%
Vanguard 427.95K $2.84M -32.6%
JS Capital Management 400K $2.66M 0.0%
Pura Vida Investments 400K $2.66M NEW
Board of Trustees of The Leland Stanford Junior University 376.71K $2.5M 0.0%
Geode Capital Management 94.67K $628K -40.1%
Parian Global Management 84.04K $558K -60.2%
WFC Wells Fargo & Co. 81.15K $538K +364.0%
FHI Federated Hermes 75K $498K -87.0%
Largest transactions
Shares Bought/sold Change
Capital Research Global Investors 0 -1.12M EXIT
FHI Federated Hermes 75K -499.76K -87.0%
BLK Blackrock 28.25K -441.27K -94.0%
Pura Vida Investments 400K +400K NEW
JPM JPMorgan Chase & Co. 0 -286.07K EXIT
Logos Global Management 0 -250K EXIT
Vanguard 427.95K -206.95K -32.6%
Parian Global Management 84.04K -126.96K -60.2%
Pictet Asset Management 0 -122.11K EXIT
NTRS Northern Trust 19.16K -93.47K -83.0%

Financial report summary

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Risks
  • Risks Related to Our Business and Strategy
  • We have incurred losses since our inception and we anticipate that we will continue to incur losses for the foreseeable future, which could harm our future business prospects.
  • We recently received EUAs from the FDA for our COVID-19 test kit. If the FDA revokes or terminates our EUA applications after issuance, such as when the federally-declared COVID-19 public health emergency ends, we will be required to stop commercial distribution of our COVID-19 test kit immediately unless we can obtain FDA clearance for our COVID-19 test kit under a traditional regulatory pathway, which is lengthy and expensive, which could harm our future business prospects.*
  • We are allocating most of our resources to the development, manufacturing and commercialization of our COVID-19 test kit for the foreseeable future, and our long-term business success could be negatively impacted by our diversion of resources from our legacy business of diagnostic testing for influenza.
  • Our near-term success is highly dependent on the successful commercialization of our COVID-19 test kit, and it may not attain or maintain market acceptance or be successfully commercialized in the United States, which could negatively impact our business.*
  • We are an early-stage company and have a limited operating history, which may make it difficult to evaluate our current business and predict our future performance. If we do not successfully manage the development and launch of our COVID-19 test kit and any future test kits, our financial results could be adversely affected.
  • We rely substantially on Jabil for the manufacturing, quality-testing and assembly of our COVID-19 test kit. Any termination or loss of significant rights under the Jabil MSA would harm our commercialization of our COVID-19 test kit. In addition, Jabil may fail to obtain and maintain regulatory approval for its facilities, fail to provide us with sufficient quantities of our COVID-19 test kit or fail to do so at acceptable quality levels or prices.*
  • The diagnostic testing market, particularly with respect to COVID-19 diagnostic tests, is highly competitive, and many of our competitors are larger, better established and have greater technical and marketing capabilities and financial and other resources than we have. In addition, we expect competition with respect to testing solutions for COVID-19 to continue to increase and our success will depend on widespread market acceptance of our COVID-19 test kit.*
  • The production and widely administered use of an efficacious vaccine or treatment for COVID-19 may reduce the demand for diagnostic tests and, as a result, the COVID-19 diagnostic testing market may not develop or substantially grow.
  • We rely on a limited number of suppliers or, in many cases, a single supplier, for test kit materials and may not be able to find replacements or immediately transition to alternative suppliers, which could have a material adverse effect on our business, financial condition and results of operations.
  • We may be subject to an order from federal or state governments, including pursuant to the Defense Production Act of 1950, as amended, or the DPA, to distribute our COVID-19 test kit directly to the government or as directed by the government, which could adversely affect our business, financial condition and results of operations.
  • The results of our earlier research and development and clinical trials for our influenza test kit may not be replicable in an influenza test kit or in a combination COVID-19 and influenza test kit and may not be sufficient to support the authorization of an influenza test kit or a combination COVID-19 and influenza test kit.
  • If our test kits fail to achieve the broad degree of adoption by the medical community necessary for commercial success, our operating results and financial condition will be adversely affected, which may delay, prevent or limit our ability to generate revenue and continue our business.
  • If we do not have the support of physicians or KOLs, it may be difficult to drive adoption of our test kits, which could limit our revenue growth and our ability to achieve profitability.
  • We may be unable to obtain and maintain adequate levels of coverage and reimbursement from third-party payors for our test kits.
  • Our operating results may fluctuate significantly, which makes our future operating results difficult to predict and could cause our operating results to fall below expectations or any guidance we may provide.
  • We may not be able to achieve or maintain satisfactory pricing and margins for our test kits, which could harm our business and results of operations.
  • Our results of operations will be harmed if we are unable to accurately forecast and meet customer and user demand for our test kits and manage our inventory.*
  • We depend on intellectual property licensed from Eiken and the termination of our license could result in the loss of significant rights, which would harm our business.
  • If we are not successful in leveraging our platform to discover, develop and commercialize additional test kits, our ability to expand our business and achieve our strategic objectives would be impaired.
  • If our test kits do not perform as expected, our operating results, reputation and business will suffer.
  • If we are unable to successfully expand our sales and marketing to match our growth, our business may be adversely affected.
  • We are highly dependent on our senior management team and key personnel and our business could be harmed if we are unable to attract and retain personnel necessary for our success.
  • We have increased the size of our organization and expect to further increase it in the future, and we may experience difficulties in managing this growth. If we are unable to manage the anticipated growth of our business, our future revenue and operating results may be harmed.
  • We may need to raise additional capital to fund our existing operations, develop our platform, commercialize new products or expand our operations.
  • The sizes of the markets for our test kits may be smaller than we estimate.
  • Interim, topline and preliminary data from our clinical trials that we announce or publish from time to time may change as more data become available and are subject to audit and verification procedures that could result in material changes in the final data.
  • Deficiencies in the components of our test kits could result in field actions, recalls, substantial costs and write-downs and could harm our reputation, business and financial results.
  • If we were to be sued for product liability, we could face substantial liabilities that exceed our resources.
  • Litigation and other legal proceedings may harm our business.
  • Business disruptions could seriously harm our future revenue and financial condition and increase our costs and expenses.
  • If we or our third-party collaborators, including Jabil, experience significant disruptions in performing their services for us, our business may be harmed.
  • We may acquire other businesses or form other joint ventures or make investments in other companies or technologies that could negatively affect our operating results, dilute our stockholders’ ownership, increase our debt or cause us to incur significant expense.
  • Our ability to use our net operating losses, or NOLs, to offset future taxable income may be subject to certain limitations.
  • Risks Related to Government Regulation and Our Industry
  • We received two EUAs for our COVID-19 test kit and we submitted an amendment to our POC EUA. The FDA may not timely grant any additional or amended EUAs, if at all. For our existing EUAs and any new or amended EUA, the FDA may revoke any EUA where it is determined that the underlying health emergency no longer exists or warrants such authorization, which would adversely impact our ability to market our test in the United States.*
  • Our business and sale of our test kits are subject to extensive regulatory requirements, including compliance with labelling, manufacturing and reporting controls. If our existing EUAs for our COVID-19 test kit are revoked or withdrawn, we will need to utilize other pathways to obtain marketing authorization. Our influenza test kit also will require marketing authorization from the FDA. If we fail or are unable to timely obtain the necessary EUA, 510(k) clearances, de-novo authorizations, or premarket approval, or PMA, approvals for new products or for the use of our test kits for additional indications, our ability to generate revenue could be materially harmed.
  • Modifications to our test kits may require new regulatory clearances or approvals or may require us to recall or cease marketing our test kits until clearances or approvals are obtained.
  • Our test kits are and will continue to be, subject to extensive regulation and compliance obligations, which are costly and time-consuming, and such regulation may cause unanticipated delays or prevent the receipt of the required approvals to commercialize our test kits.
  • If our test kits cause or contribute to patient injuries or otherwise malfunction in certain ways, we will be subject to medical device reporting regulations, which can result in voluntary corrective actions or agency enforcement actions.
  • Our test kits or any component thereof may be subject to product recalls in the future. A recall of our test kits, either voluntarily or at the direction of the FDA or another governmental authority, or the discovery of serious safety issues with our test kits, could have a significant adverse impact on us.
  • The misuse or off-label use of our test kits may harm our reputation or the image of our test kits in the marketplace, or result in injuries that lead to product liability suits, which could be costly to our business. Moreover, we could be subject to FDA sanctions if we are deemed to have engaged in off-label promotion.
  • Clinical trials necessary to support a future test kit submission will be expensive and may require the enrollment of large numbers of subjects, and suitable subjects may be difficult to identify and recruit. Delays or failures in our clinical trials will prevent us from commercializing any modified or new test kits and will adversely affect our business, operating results and prospects.
  • If the third parties on which we rely to conduct our clinical trials and to assist us with pre-clinical development do not perform as contractually required or expected, we may not be able to obtain regulatory approval for or commercialize our test kits.
  • Our collection, use, storage, disclosure, transfer and other processing of personal information, could give rise to significant costs, liabilities and other risks, including as a result of investigations, inquiries, litigation, fines, legislative and regulatory action and negative press about our privacy and data protection practices, which may harm our business, financial conditions, results of operations and prospects.
  • If we fail to comply with U.S. federal and state fraud and abuse and other healthcare laws and regulations, including those relating to kickbacks and false claims, we could face substantial penalties and our business operations and financial condition could be harmed.
  • Healthcare reform initiatives and other administrative and legislative proposals may harm our business, financial condition, results of operations and cash flows in our key markets.*
  • Our operations involve hazardous materials and we and third parties with whom we contract must comply with environmental laws and regulations, which can be expensive and restrict how we do business, and could expose us to liability if our use of such hazardous materials causes injury.
  • Risks Related to Our Intellectual Property
  • If we are unable to obtain and maintain patent or other intellectual property protection for any test kits we develop or for our platform, or if the scope of the patent and other intellectual property protection obtained is not sufficiently broad, our competitors could develop and commercialize test kits and platform similar or identical to ours, and our ability to successfully commercialize any test kits we may develop, and our platform, may be harmed.
  • We are dependent on patents and other intellectual property licensed from others and may become dependent on other patents or other intellectual property licensed from others in the future. If we lose our licenses for intellectual property that is important to our business, we may not be able to continue developing or selling our test kits.
  • Patents covering our current, and any future test kits, or our technologies could be found invalid or unenforceable if challenged in court or before administrative bodies in the United States or abroad, which could harm our business, financial condition and results of operations.
  • We rely substantially on our trademarks and trade names. If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be harmed.
  • The medical device industry is characterized by intellectual property litigation and in the future could become subject to, litigation that could be costly, result in the diversion of management’s time and efforts, require us to pay damages or prevent us from marketing our existing or future test kits.
  • We have limited foreign intellectual property rights and may not be able to protect our intellectual property and proprietary rights throughout the world, which could harm our business, financial condition and results of operations.
  • Changes in U.S. patent law could diminish the value of patents in general, thereby impairing our ability to protect our current and any future test kits.
  • We may be subject to claims challenging the ownership or inventorship of our patents and other intellectual property and, if unsuccessful in any of these proceedings, we may be required to obtain licenses from third parties, which may not be available on commercially reasonable terms, or at all, or to cease the development, manufacture and commercialization of one or more of our current and any future test kits.
  • Third-party claims of intellectual property infringement, misappropriation or other violation against us or our collaborators may prevent or delay the sale and marketing of our current and any future test kits.
  • We may become involved in lawsuits to protect or enforce our patents and other intellectual property rights, which could be expensive, time-consuming and unsuccessful.
  • We may be subject to claims that our employees, consultants or advisors have wrongfully used or disclosed alleged trade secrets of their current or former employers or claims asserting ownership of what we regard as our own intellectual property. Such claims could harm our business, financial condition and results of operations.
  • Intellectual property rights do not necessarily address all potential threats, and limitations in intellectual property rights could harm our business, financial condition and results of operations.
  • Our reliance on third parties requires us to share our trade secrets, which increases the possibility that a competitor will discover them or that our trade secrets will be misappropriated or disclosed. If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
  • If our third-party manufacturing partner, Jabil, does not respect our intellectual property and trade secrets and produce competitive test kits using our designs or intellectual property, our business, financial condition and results of operations would be harmed.
  • Risks Related to Ownership of Our Common Stock
  • Our stock price may be volatile, and the value of our common stock may decline.
  • Substantial future sales and issuances of our common stock could cause the market price of our common stock to decline.
  • Concentration of ownership of our common stock among our executive officers, directors and principal stockholders may prevent new investors from influencing significant corporate decisions.
  • We are an emerging growth company and a smaller reporting company and our compliance with the reduced reporting and disclosure requirements applicable to emerging growth companies and smaller reporting companies could make our common stock less attractive to investors.
  • Anti-takeover provisions under our charter documents and Delaware law could delay or prevent a change of control which could limit the market price of our common stock and may prevent or frustrate attempts by our stockholders to replace or remove our current management.
  • Our amended and restated certificate of incorporation and amended and restated bylaws provide that the Court of Chancery of the State of Delaware will be the exclusive forum for substantially all disputes between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.
  • We have incurred and will continue to incur significant increased costs as a result of operating as a public company, and our management will be required to devote substantial time to new compliance initiatives.
  • As a result of being a public company, we are obligated to develop and maintain proper and effective internal control over financial reporting, and any failure to maintain the adequacy of these internal controls may adversely affect investor confidence in our company and, as a result, the value of our common stock.
  • If our estimates or judgments relating to our critical accounting policies are based on assumptions that change or prove to be incorrect, our operating results could fall below our publicly announced guidance or the expectations of securities analysts and investors, resulting in a decline in the market price of our common stock.
  • Changes in tax law and regulations may have a material adverse effect on our business, financial condition and results of operations.
  • We are subject to U.S. and certain foreign export and import controls, sanctions, embargoes, anti-corruption laws and anti-money laundering laws and regulations. Compliance with these legal standards could impair our ability to compete in domestic and international markets. We can face criminal liability and other serious consequences for violations, which can harm our business.
  • We are subject to numerous laws and regulations related to anti-bribery and anti-corruption laws, such as the FCPA, in which violations of these laws could result in substantial penalties and prosecution.
  • We could be subject to securities class action litigation.
Management Discussion
  • We began to generate sales during December 2020 after we received an EUA from the FDA for POC and prescription-at-home use of our COVID-19 test kit. We did not conduct revenue generating activities during the year ended December 31, 2019.
  • Research and development expenses increased $13.2 million, or 115%, in the year ended December 31, 2020 compared to year ended December 31, 2019. This increase was primarily due to increased expenses related to our development and clinical activities to support our initial EUA application with respect to our COVID-19 test kit. We supported research and development activities such as test kit development and testing, clinical trials and pre-commercial manufacturing related to our COVID-19 test kit through increased personnel-related expenses of $1.3 million, third-party consultants of $6.3 million, and $5.3 million in laboratory supplies and materials purchased, which was additionally supported by a $0.3 million in increased facilities costs allocation. During the year ended December 31, 2019, we had limited working capital and incurred less expenditures related to research and development for our influenza test kit. While certain costs of our research and development activities related to our influenza test kit were previously reimbursed through grants provided by government agencies such as BARDA, we are not reliant on future grant income to fund our current COVID-19 test kit programs. Therefore, we do not believe discontinuing our grant-related research and development activities will have a material impact on our planned operations.
  • Selling, general and administrative expenses increased $3.2 million, or 133%, in the year ended December 31, 2020 compared to the year ended December 31, 2019. This increase was primarily due to an increase in headcount of key, executive-level employees and professional expenses to support our research and development efforts, impending commercial activities and preparation for the initial public offering that closed on February 9, 2021.
Content analysis
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Positive
Negative
Uncertain
Constraining
Legalese
Litigous
Readability
H.S. senior Good

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