OSUR 10-K & 10-Q changes, risk factors and insider trading

•The Company's stock price could continue to be volatile.

In an effort to increase the Company's molecular revenues, it has devoted increasing time and attention to expanding sales of its genomics products both domestically and internationally, with both new and existing accounts, including co-clearances and co-promotions with strategic partners. While the Company believes these new markets represent large growth opportunities, there is no assurance that it will be successful in capitalizing on these opportunities or that it will be able to increase the Company's product sales consistent with the Company's expectations. Factors that may impact the success of our genomics products include, but are not limited to, the market acceptance of the Company's products, available funding, cost containment strategies implemented by customers, increasing competition and regulatory constraints could limit sales of the Company's genomics products. To the extent that the Company is unsuccessful or limited in expanding the its business into new markets, the Company's revenues and results of operations could be negatively affected.

The Company's future success will depend, in part, on the market acceptance, and the timing of such acceptance, of existing products such as InteliSwab®, OraQuick® HIV Self-Test, OraQuick® Ebola test and OMNIgene® • GUT product offerings, and other new products or technologies that may be developed or acquired. In addition, the Company's future revenues will depend on market acceptance of newurine usesas fora thesample Company'stype saliva collection products,, and the Company's newother serviceproduct offerings, such as Syphilisthe HealthCompany's Check®anticipated CT/NG test and OraQuickColli-Pee® HCV Self-Test.device. To commercially market new uses of the Company's products and to achieve market acceptance, it will likely be required to undertake clinical studies to validate the new uses for its products and spend significant funds to complete product development and clinical studies and then undertake substantial marketing efforts to inform potential customers and the public of the existence and perceived benefits of these products and services. In addition, governmental funding may be needed to help complete development, obtain required regulatory approvals, clearances or EUAs and create market acceptance and expand the use of these products and services.

There may be limited evidence on which to evaluate the market reaction to products and services that may be developed and the Company's marketing efforts for new products and services or products with new uses may not be successful. The market for microbiome products and services is in its early stages and its future development and acceptance by the Company's customers is uncertain. Also, the Company continues to develop and seek 510(k) regulatory clearance for the InteliSwab® tests, and it is uncertain whether it will be successful in the development and validation efforts or whether these products will prove effective, receive applicable regulatory approvals and gain widespread acceptance in the marketplace. As such, there can be no assurance that any products or services will obtain significant market acceptance and fill the market need that is perceived to exist on a timely basis, or at all. It is possible that the Company's expenses to develop and market any such products, including, without limitation the Company's InteliSwab® tests,products will exceed any benefit in revenues, which may be short-lived. In addition, other products that compete with the Company's may achieve 510(k) clearance earlier than the Company's do, providing market advantages.

However, clinicalClinical reference laboratories and hospital-based laboratories currently provide the majority of diagnostic tests used by physicians and other healthcare providers in the U.S. In certain international markets such as Europe, diagnostic testing is performed primarily by centralized laboratories. The Company's future sales will depend, in part, on the Company's ability to expand market acceptance of rapid point-of-care testing by physicians, other healthcare providers and consumers and successfully compete against laboratory testing methods and products. Even if the Company can demonstrate that its products are more cost effective, save time, or have better performance or other benefits, physicians, other healthcare providers and consumers may resist changing to rapid point-of-care tests and instead may choose to obtain diagnostic results through laboratory tests. The Company's failure to achieve and expand market acceptance of its rapid point-of-care diagnostic tests with customers would have a negative effect on its future sales growth.

The sales cycles for certain of the Company's products can be lengthy and unpredictable, which makes it more difficult to accurately forecast revenues in a given period and may cause revenues and operating results to vary from period to period. Sales of the Company's products often involve purchasing decisions by large public and private institutions, may require many levels of approval and may be dependent on economic or political conditions and the availability of grants or funding from governmental or public health agencies which can vary from period to period in both amount and timing. For example, in past years the Company's OraQuick ADVANCE® HIV-1/2 test has been purchased through bulk procurement or other funding provided by governmental agencies. The Company's OraQuick® HCV test has been purchased by customers who receive government funding, and the Company believes increased funding from government agencies will be required to substantially increase the volume of HCV testing, especially in the public health market. There can be no assurance that purchases or funding from these agencies will occur or continue. In addition, government funding is subject to the political process, which is inherently fluid and unpredictable. For example, the National Institutes of Health (“NIH”) announced on February 7, 2025, a policy significantly reducing research grants by limiting payments for indirect costs. While, as of the date of this filing, thea orderlower court has imposed a permanent injunction preventing the NIH from adopting the policy, which as been temporarilysubsequently stayed,affirmed by a U.S. Circuit Court of Appeals, there can be no assurance that it will not take effect or that otherfurther adverse actions will not be taken. Further, our revenue may be adversely affected if our clients delay purchases as a result of uncertainties surrounding the approval of government budget proposals, including reduced allocations to government agencies. In addition, government funding is subject to the political process, which is inherently fluid and unpredictable. As a result, the Company may expend considerable resources on unsuccessful sales efforts or it may not be able to complete transactions at all or on a schedule and in an amount consistent with its objectives or previous order patterns.

One of the Company's strategic priorities is to substantially expand its product sales internationally. An opportunity to accomplish this objective is with the sale of the Company's OraQuick® HIV Self-Test in support of large self-testing programs in certain African countries and elsewhere. The Company's OraQuick® HIV Self-Test is also currently available in six European countries: United Kingdom, Germany, France, Italy, Spain and Portugal. The Company is also working to expand international sales of its professional HIV and HCV products and its sample management solutions. The Company is also pursuing opportunities to obtain certain governmental or economic incentives by establishing in‑country value‑added assembly or manufacturing operations (“near‑shoring”) in select international markets, including in parts of Africa, which are intended to provide cost, logistics, or market-access benefits.

In September 2022, the Company entered into an $8.6 million contract with BARDA to develop aan second generationupdated Ebola test on the OraQuick® testing platform, which was subsequently modified in September 2023 to add an additional $6.8 in funding to be used to obtain the appropriate regulatory approvals. Also in September, 2022, the Company was selected to provide its OraQuick® In-Home HIV testsSelf-Tests in support of the CDC "Together Take me Home," HIV self-test program. Under the program, the CDC is expected to provide $41.5 million over a five-year period to support community testing. During the third quarter of 2022, the Company entered into a contract with the Defense Logistics Agency ("DLA") for the second procurement of the Company's InteliSwab® COVID-19 Rapid Test for OTC use. During the same quarter, the Company entered into a contract with the BARDA to provide it with up to $13.6 million in funding to obtain an FDA 510(k) clearance and CLIA waiver for the Company's InteliSwab® test. The Company continued development work and analytical testing on this test throughout 2023. However, in early 2024, the Company has communicated to BARDA that it does not intend to pursue further development of this product. In September 2021, the Company entered into a contract with the U.S. DOD in coordination with the HHS for $109 million in funding to build additional manufacturing capacity in the United States for the Company's InteliSwab® test.

In February 2024, the FDA issued the Quality Management System Regulation (QMSR) Final Rule to amend the QSR, incorporating by reference the international standard for medical device quality management systems set by the International Organization for Standardization (ISO), ISO 13485:2016. The rule will become effective on February 2, 2026. Until then, manufacturers are required to comply with the QSR. We believe that our facilities and procedures are in material compliance with the FDA’s QSRQMSR requirements, the European Union’s Quality Management Systems requirements, ISO 13485:2016, but the regulations are subject to change or may be unclear, and we cannot be sure that FDA investigators will agree with our compliance with the FDA’s post-market requirements.

The Company currently purchases certain critical components of its products from sole supply sources or other third-party suppliers. For example, the biological antigens and antibodies, nitrocellulose and certain other components required to make the Company's OraQuick® HIV, HCV and Ebola products are currently purchased from sole-source suppliers. The Company has contracted with third parties in Thailand for parts of the assembly of OraQuick® HIV device and the OraQuick® HIV Self-Test in order to supply certain international markets. In addition, the Company's subsidiary, DNAG, usesuses, on a limited basis, third-party manufacturers to supply certain products, including its Colli-Pee®, Oragene® and ORAcollect® lines of collection kits.

One of the Company's customers accounted for approximately 24%3% of its net consolidated revenues for the year ended December 31, 2024.2025. Certain parts of the Company's business may continue to have a high customer concentration and depend disproportionately on a few large customers. To the extent that such a large customers fail to meet their purchase commitments, change their ordering patterns or business strategies, or otherwise reduce their purchases or stop purchasing the Company's products, or if it experiences difficulty in meeting the high demand by these larger customers for its products, the Company's revenues and results of operations could be adversely affected.

A portion of our revenues is derived from sales to customers that rely on funding from the U.S. government, including federal agencies, state programs, and entities receiving grants and contracts from the HHS, the U.S. Agency for International Development (“USAID”), the Centers for Disease Control and Prevention (“CDC”), and other government programs. In 2025, the U.S. government implemented funding freezes and delays that have directly affected healthcare and life sciences procurement. Any reduction, delay, or uncertainty in the availability of such funding could adversely affect the purchasing patterns of these customers, impacting our business, financial condition, and results of operations.

Since the beginning of 2019, theThe Company has acquired or made investments in several companies through which it has gained access to new technologies, products and services which are complementary to its existing business and aligned with its long-term business strategy. For example, in January 2024, the Company announced its investment and entry into wide ranging strategic distribution agreements with KKR Sapphiros L.P. ("Sapphiros"), and in December 2024, the Company acquired Sherlock Biosciences, Inc. ("Sherlock"),Sherlock, expanding the Company's product pipeline with the addition of Sherlock's molecular diagnostics platform.platform, and in November 2025, the Company acquired BioMedomics, also expanding the Company's product pipeline with the addition of BioMedomics' SickleSCAN™ test for sickle cell disease. The Company will likely continue to pursue strategic acquisitions or investments as a way to expand its business. These activities, and their impact on the Company's business, are subject to many risks, including the following:

Government funding is subject to the political process, which is inherently fluid and unpredictable. Under the Trump administration, the NIH announced on February 7, 2025, a policy significantly reducing research grants by limiting payments for indirect costs. Indirect costs represented more than 25% of total grant dollars awarded by the NIH in 2023. Our research customers may face increased financial pressure due to this change or any future caps on indirect costs. While, as of the date of this filing, a lower court has imposed a permanent injunction preventing the orderNIH from adopting the policy, which has been temporarilysubsequently stayed,affirmed by a U.S. Circuit Court of Appeals, there can be no assurance that it will not take effect or that otherfurther adverse actions will not be taken. Further, our revenue may be adversely affected if our research customers delay purchases as a result of uncertainties surrounding the approval of government budget proposals, including reduced allocations to government agencies, such as the NIH.

All in vitro diagnostic productsdevices that are to be soldplaced on the market in the EU must bear thea CE mark indicating conformanceconformity with the applicable requirements of the relevant EU in vitro diagnostic medical devices legislation.IVDR. The EU IVDR became applicable on May 26, 2022 and repealed the previous IVDD. There is a transitional period during which products that have a declaration of conformity issued under the IVDD prior to May 26, 2022 may continue to be placed on the EU market for a certain period before requiring certification under the EU IVDR, subject to compliance with certain requirements under the EU IVDR (see the section titled "Governmental Regulation - International" for further Informationinformation). The Company has obtained the CE mark for several of its existing products under the IVDD. It also intends to apply for CE marks for certain of its future products and is not aware of any material reason why it would be unable to obtain those marks. However, there can be no assurance that compliance with all provisions of the EU IVDR will be demonstrated and the CE mark will be obtained or maintained for all products that the Company desires to sell in the EU. The failure to obtain or maintain the CE mark for one or more of the Company's products could lead to the termination of strategic alliances and agreements for sales of those products in the EU and mean that the Company is unable to sell such products in the EU.

Regulation by the FDA and other federal, state and foreign regulatory agencies impacts many aspects of the Company's operations and the operations of its suppliers and distributors, including manufacturing, labeling, packaging, adverse event reporting, recalls, distribution, storage, advertising, promotion and recordkeeping. The Company is subject to routine inspection by the FDA and other agencies to determine compliance with QSRQMSR and FDA regulatory requirements in the United States and other applicable regulations worldwide, including but not limited to ISO standards. The Company believes that its facilities and procedures are in material compliance with the FDA requirements and ISO standards, but the regulations may be unclear and are subject to change, and the Company cannot be sure that the FDA or other regulators will agree with its compliance with these requirements. The FDA and foreign regulatory agencies may require post-marketing testing and surveillance to monitor the performance of approved or cleared products or impose conditions on any product clearances or approvals that could restrict the distribution or commercial applications of those products. Regulatory agencies may impose restrictions on the Company or its distributors’ advertising and promotional activities or preclude these activities altogether if a noncompliance is believed to exist. In addition, the subsequent discovery of previously unknown problems with a product may result in restrictions on the product or additional regulatory actions, including withdrawal of the product from the market.

Some of the Company's products, particularly those sold by DNAG, are sold for research purposes in the U.S. The Company does not promote these products for clinical diagnostic use and they are labeled “For Research Use Only” ("RUO"). If the FDA were to disagree with the Company's RUO designation of a product, it could allege that we had misbranded or adulterated our RUO products. If the CompanyFDA asserts that our RUO products are subject to marketing authorization, or that our RUO products are adulterated or misbranded, our business, financial condition or results of operations could be forcedadversely to recall and/or stop selling the product until appropriate regulatory clearance or approval has been obtained.affected.

The Company believes that its products and procedures are in material compliance with all applicable FDA regulations, ISO requirements, and other applicable regulatory requirements, but the regulations regarding the manufacture and sale of its products, the QSRQMSR and ISO requirements, and other requirements may be unclear and are subject to change. Newly promulgated regulations could require changes to the Company's products, necessitate additional clinical trials or procedures, or make it impractical or impossible for it to market its products for certain uses, in certain markets, or at all. The FDA and other regulatory authorities also have the ability to change the requirements for obtaining product approval or clearance and/or impose new or additional requirements as part of the approval or clearance process. These changes or new or additional requirements may occur after the completion of substantial clinical work and other costly development activities. The implementation of such changes or new or additional requirements may result in additional clinical trials and substantial additional costs and could delay or make it more difficult or complicated to obtain approvals and sell the Company's products.

The Company is subject to European data protection regulations where it collects and uses personal data related to Europe. This includes the EU General Data Protection Regulation (“EU GDPR”) as well as other national data protection legislation in force in relevant European Economic Area (“EEA”) member states, and the EU GDPR in such form as incorporated into the laws of the UK ("UK GDPR", together with EU GDPR, "GDPR"), which govern the collection, use, storage, disclosure, transfer, or other processing of personal data: (i) regarding individuals in the EEA; and/or (ii) carried out in the context of the activities of the Company's establishment in any EEA member state. Failure to comply with the GDPR, and any supplemental European Economic Area (“EEA”) country’s national data protection laws which may apply by virtue of the location of the individuals whose personal data the Company collects, may result in fines and other administrative penalties, including fines of up to the greater of 4% of worldwide turnover and €20 million (or £17.5 million in the UK). The GDPR also confers a private right of action on data subjects and consumer associations to lodge complaints with supervisory authorities, seek judicial remedies, and obtain compensation for damages resulting from violations of the GDPR. The GDPR imposes several mandatory requirements on companies that process personal data, including requirements relating to the processing of special category personal data (such as health sensitive data), ensuring a legal basis or condition applies to the processing of personal data, which may include obtaining the consent of the individuals to whom the personal data relates, providing notice to individuals about personal data processing activities, having data processing agreements with third parties who process personal data, notification of personal data breaches to data protection authorities and individuals, and the implementing of safeguards to protect the security and confidentiality of the personal data. The GDPR also imposes strict rules on the transfer of personal data out of the EEA/UK to third countries, including the United States in certain circumstances, unless a derogation exists or a valid GDPR transfer mechanism (for example, the European Commission approved Standard Contractual Clauses, or SCCs, or the EU-US Data Privacy Framework) applies. Any inability to transfer personal data from the EEA/UK to the United States in compliance with data protection laws may impede the Company's ability to conduct trials and may adversely affect its business and financial position. Complying with the enhanced obligations imposed by the GDPR imposes additional obligations and risk upon the Company's business, and may result in significant costs to its business and require it to amend certain of its business practices. Further, the Company has no assurances that violations will not occur, particularly given the complexity of the GDPR.

The Company is also subject to the California Consumer Privacy Act (“CCPA”), which creates individual privacy rights and places stringent privacy and security obligations on businesses covered by the law, including obligations to provide detailed disclosures to California consumers about their data collection, use and sharing practices and provide such consumers with ways to opt out of certain uses of sensitive personal information, including health information. It also provides for civil penalties for violations and allows for a private right of action for data breaches that is expected to increase data breach litigation. The law also created a new state regulatory agency that was vested with authority to implement and enforce the CCPA. Failure to comply with the CCPA or other data processing or security laws, or any changes in these laws, could adversely impact the Company's business and its business plans. Similar laws have been passed and proposed in other states and at the federal level, and if passed, such laws may have potentially conflicting requirements that would make compliance challenging.Inchallenging. In addition to these comprehensive consumer privacy laws and proposals, a number of other states have passed or proposed more limited privacy laws that focus on specific privacy issues such as biometric data and the privacy of health and medical information, such as Washington state’s My Health My Data Act, which went into effect in March 2024. The My Health My Data Act imposes new state restrictions and requirements on the processing and sale of consumer health data and creates a private right of action, which further increases the relevant compliance risk. Connecticut and Nevada have also passed similar laws regulating consumer health data. The effects of state and federal privacy laws are potentially significant and may require us to modify our data processing practices and policies and to incur substantial costs and potential liability in an effort to comply with such legislation.

We may builduse and integrate AI into our business practices, andincluding through the adoption of commercially available tools. The evolving nature of AI technologies and the surrounding legal and regulatory environment presents risks and uncertainties related to cybersecurity, data privacy, IT, intellectual property, regulatory, legal, operational, competitive, and reputational challenges that could affect our business. Specifically, risks related to accuracy, bias, artificial intelligence hallucinations, discrimination, harmful content, misinformation, fraud, scams, targeted attacks (including model poisoning or data poisoning), surveillance, data leakage, inequality, environmental harms, and other harms may flow from our development, use, or deployment of AI technologies. The use of AI technology can give rise to intellectual property risks, including disclosures or other compromises to proprietary intellectual property and intellectual property infringement.infringement, Additionally,or weby expectundermining our ability to seeassert increasingor governmentdefend regulationownership relatedrights in intellectual property created with the assistance of AI tools. Over the past year, states have advanced, and in some cases passed, dozens of laws focusing on AI governance and regulation, including on deployment of AI in healthcare settings. At the federal level, the Trump Administration has endorsed a federal moratorium on the enforcement of state AI laws, including through a December 11, 2025, executive order on “Ensuring a National Policy Framework for Artificial Intelligence.” So far, these efforts have not been successful at curtailing state action on AI regulation, contributing to artificiala intelligencecomplicated uselegislative and ethics,patchwork, which may alsobe significantlylitigated increasein the burdenstate and costfederal of research, development and compliance in this area. For example, in the U.S., a number of states have proposed and passed laws regulating various uses of AI.courts. In Europe, the EU’sEU begin implementing the Artificial Intelligence Act (“AI Act”) —on August 1, 2024, with a significant part of the law scheduled to come into effect in August 2026. As currently enacted, the AI Act, which may be amended as part of the EU’s Digital Omnibus, which entered into force on August 1, 2024 and, with some exceptions, will begin to apply as of August 2, 2026 —2026, imposes significant obligations on providers and deployers of high-risk artificial intelligence systems, and encourages providers and deployers of artificial intelligence systems to account for EU ethical principles in their development and use of these systems. If we develop or deploy AI systems that are governed by these laws and regulations, we may be required to adopt higher standards of data quality, transparency, and human oversight, and adhere to specific and potentially burdensome and costly ethical, accountability, and administrative requirements. Even in the absence of dedicatededicated AI laws and regulations, we may be subject to novel legal and business risks relating to our adoption of these new technologies. In addition, the use of generative AI models in our internal or third-party systems may create new attack surfaces or methods for adversaries, which could impact us and our vendors. Our vendors may in turn incorporate AI tools into their own offerings, and the providers of these AI tools may not meet existing or rapidly evolving regulatory or industry standards, including with respect to privacy and data security. Further, bad actors around the world use increasingly sophisticated methods, including the use of AI, to engage in illegal activities involving the theft and misuse of personal information, confidential information, and intellectual property. Any of these outcomes could damage our reputation, result in the loss of valuable property and information, and adversely impact our business.

The FDA has regulatory responsibility over instruments, test kits, reagents and other devices used to perform diagnostic testing by clinical laboratories. In the past, the FDA has taken the position that it has regulatory authority over laboratory-developed tests ("LDTs"), but has exercised enforcement discretion in not regulating most LDTs performed by high complexity CLIA-certified laboratories. LDTs are tests designed, developed, and performed in-house by a laboratory. Such laboratories are subject to regulation under CLIA but have not been subject to regulation by the FDA under the agency’s medical device requirements. A significant portion of the total volume of genetic or molecular testing is performed with LDTs.

In recent years, the Department of Justice indicted a number of telemedicine companies and cancer genetic testing laboratories for allegedly submitting fraudulent insurance claims to Medicare. AIn the past, a number of these companies were customerspurchasing ofDNAG DNAG.products. As a result of these activities, the FDA has issued letters to genetic testing laboratories indicating that it plans to increase oversight of this market which has caused some of these companies to stop providing testing options or to change how they are reporting the information provided by the testing. The activities have negatively affected this market andand, should these enforcement actions continue despite the district court's ruling on FDA's final rule on LDT's, there is a risk that these enforcement actions will continue to negatively affect this market by forcing laboratories to either stop offering such services or restricting the use of such services. Such a reduction in testing could result in decreased sales of the Company's DNA collection devices.

The Company has experienced annual net losses during the five years prior to 2015, between 2020 through 2022 and again recorded net losses for the yearyears ended December 31, 2024.2024 and 2025. In addition, as of December 31, 2024,2025, the Company had an accumulated deficit of $103.4$172.2 million. Even though the Company achieved profitability in 2015 through 2019 and in 2023, there can be no assurance that it will be able to achieve or sustain profitability in the future.

TheGeopolitical and macroeconomic developments, including the imposition or expansion of tariffs, non-tariff barriers,barriers and trade restrictions, or other importprotectionist and export restrictionsmeasures have contributed to increased uncertainty and volatility in global economicmarkets. uncertainty.These Theactions risecould increase the cost of economicmaterials, nationalismcomponents, couldor finished goods, make it more difficult for us to attract new customers, retain existing customers, continue to produce and source in an optimal manner, maintain our supply chain, or maintain sales at existing levels, both in the United States and in other countries. Trade‑related measures have in the past, and may in the future change with limited notice and could be accompanied by retaliatory actions by other countries. Geopolitical and economic risks, together with trade protectionism have increased over the past few years in many regions of the world, including in the United States. Any of these risks, ensuing retaliation, or the further deterioration of trade relations between countries could make our offerings more expensive or non-competitive in the affected countries. Growing tensions, protectionist trade policies, and tariffs may also lead to a fragmentation of the global economy, a general reduction of international trade in goods and services, and a reduction in the integration of financial markets, any of which could materially and adversely affect our business results, cash flows, financial condition, or prospects. Changes in political leadership, statutory frameworks, or regulatory policy in the United States and abroad may further affect the interpretation, implementation, or enforcement of laws and regulations applicable to our business. If regulatory disruptions, staffing constraints, funding limitations, or trade actions continue or intensify, our business, financial condition, results of operations, and prospects could be materially and adversely affected.

In addition, the revenues and expenses of the Company's subsidiary, DNAG, are recorded in Canadian dollars and the revenues and expenses of its subsidiary Novosanis are recorded in Euros.dollar. Revenues and expenses denominated in foreign currencies are translated into U.S. dollars for purposes of reporting consolidated financial results. The Company's expectation is that the businesses of its foreign subsidiariessubsidiary will continue to grow and its exposure to foreign currency exchange rates may be more significant than in past years.

Exchange rate fluctuations may affect the revenues and expenses of the Company's foreign subsidiariessubsidiary and the translation of those financial results into U.S. dollars. Favorable movement in exchange rates have benefited the Company in prior periods. However, where there are unfavorable currency exchange rate fluctuations, the Company's consolidated financial statements including its balance sheet, revenues and results of operations, could be negatively affected. In addition, fluctuations in exchange rates could affect year-to-year comparability of operating results. In the past, the Company has not generally entered into hedging instruments to manage its currency exchange rate risk, but it may need to do so in the future. However, the Company's attempts to hedge against these risks may not be successful. If the Company is unable to successfully hedge against unfavorable foreign currency exchange rate movements, its consolidated financial results may be adversely impacted.

•The performance of the Company's business, including its efforts to increase sales of OraQuick® HIV, HCV and sample management solutions and its OraQuick® In-Home HIV test and HIV Self-Test;

The Company's business consists of the development, manufacture, marketingmarketing, sale and saledistribution of simple, easy to use diagnostic products and specimen collection devices using the Company'sits proprietary technologies, as well as other diagnostic products including immunoassays and other in vitro diagnostic tests that are used on other specimen types. TheseOur diagnostic products include tests for diseases including COVID-19, HIV, Hepatitis C, Syphilis, Sickle Cell and SyphilisCOVID-19 that are performed on a rapid basis at the point of care, and tests for drugs of abuse that are processed in a laboratory.care. These products are sold in the United States and internationally to various clinical laboratories, hospitals, clinics, community-based organizations, and other public health organizations, distributors, government agencies, physicians’ offices, and commercial and industrial entities. The Company's COVID-19HIV and HIVCOVID-19 products are also sold in a consumer-friendly format in the over-the-counter (“OTC”) market in the U.S. and, in the case of the HIV product,and HCV products, as a self-test to individuals in a number of other countries, includingincluding, for the HIV products, as an oral swab in-home test for HIV-1 and HIV-2 in Europe.Europe, and for the HCV products, as an OTC test. In December 2025, the Company submitted a 510(k) to the FDA for clearance of its rapid molecular self-test for CT/NG, which is currently under review.

The Company's business also includes sample management solutions and services that are used by clinical laboratories, direct-to-consumer laboratories, researchers, pharmaceutical companies, and animal health service and product providers. The revenues from sample management solutions are derived from product sales to commercial customers and sales into the academic and research markets. Customers span the disease risk management, diagnostics, pharmaceutical, biotech, and companion animal andmarket environmental markets.segments. The Company has also developed collection devices for the emerging microbiome market, which focuses on studying microbiomes and their effect on human and animal health. The Company also has a urine collection device which allows for the volumetric collection of first void urine. ThisInitial sales of this product isfor inresearch itsuse early stages, and initial salesonly are occurring primarily through distributors and collaborations in the liquid biopsy and sexually transmitted disease markets. In December 2025, the Company also submitted a 510(k) to the FDA for clearance of its Colli-Pee® at-home urine collection device for sexually transmitted infections, which is currently under review.

In Octoberthe third quarter of 2024, the Company announced the discontinuance of the sales of its risk assessment product line which is expected to bewas completed in the firstsecond halfquarter of 2025. Sales of its risk assessment products contributed $8.4$1.9 million and $9.7$8.4 million to revenues during the yearstwelve months ended December 31, 2024,2025 and 2023,2024, respectively. During the first quarter of 2025, the Company sold certain assets that made up the risk assessment product line including certain intellectual property, contracts, permits, and equipment.

The Company's consolidated net loss for the year ended December 31, 20242025 was $19.5$68.7 million, or $0.26$0.94 per share on a fully diluted basis, compared to consolidated net incomeloss of $53.7$19.5 million, or $0.72$0.26 per share on a fully diluted basis, for the year ended December 31, 2023.2024.

The table below shows a summary of total consolidated net revenues (dollars in thousands) for the years ended December 31, 20242025 and 2023.2024:

(1)Includes HIV, HCVHCV, Syphilis, and SyphilisSureQuick® product revenues.

(2)Includes Genomics, MicrobiomeMicrobiome, and Colli-Pee® product revenues.

(4)Includes fundedCOVID-19 researchSample andManagement developmentSolutions contracts, royalty income and grantproduct revenues.

Sales of the Company's Diagnostics products increaseddecreased 3%12% to $66.5 million for the year ended December 31, 2025 from $75.9 million for the year ended December 31, 2024 from $73.7 million for the year ended December 31, 2023.2024. This increasedecrease in revenues is largely due to higherlower international HIV revenues primarily driven by a decrease in funding and customer ordering patterns in Africa offsetand byAsia. lowerLower sales intoof Asia.the AlsoCompany's contributingHIV domestic products due to a decrease in overall funding impacting HIV programs also contributed to the decline in diagnostic revenuerevenues. increaseOffsetting these decreases in revenues is an increase in sales of the Company's HCV domestic product and higher Syphilis revenues. Offsetting these increases in revenues is a decline in HIV domestic revenue resulting from fundingthe delays or reductionslaunch in fundingthe forsecond HIVquarter productsof and customer ordering patterns.2024.

Sample Management Solutions revenues decreased by 6%25% to $38.4 million for the year ended December 31, 2025 compared to $51.0 million for the year ended December 31, 2024 compared to $54.3 million for the year ended December 31, 2023.2024. Sales of the Company's Sample Management Solutions are being impacted by reduceda consumerlarge demandcustomer's for products in which the Company's genomics collection devices are used, economic pressures, and the overall decline in the microbiome market.bankruptcy.

Risk assessmentAssessment testing revenues decreased 14%78% to $1.9 million for the year ended December 31, 2025 from $8.4 million for the year ended December 31, 2024 from $9.7 million for the year ended December 31, 2023 due to the loss of customers to competing products.2024. The Company hasdiscontinued announcedthis line of business at the discontinuanceend thisof product line2024 and expects minimal sales through the firstbusiness halfwound ofdown 2025in asearly it fulfills existing customer orders.2025.

Molecular Services revenues, which arewere largely derived from the Company's microbiome molecular sequencing services, decreasedwere 62%nil for the year ended December 31, 2025 compared to $1.7 million for the year ended December 31, 2024 from $4.5 million for the year ended December 31, 2023.2024. The decrease in services revenues was due to the decision to exit this line of business.

Non-product and services revenues decreasedincreased 63%391% to $6.0 million for the year ended December 31, 2025 from $1.2 million for the year ended December 31, 2024 fromprimarily $3.3due million forto the yearrecognition endedof Decemberrevenue 31,under 2023funded R&D contracts that were assumed by the Company as a result lowerof fundingthe forSherlock researchacquisition andat developmentthe activitiesend andof lower2024 royaltyas income.well as an increase in funded R&D under other BARDA contracts.

Consolidated operating loss for the year ended December 31, 20242025 was $28.3$72.0 million, compared to a $60.9 million decline from the $32.7$28.3 million operating incomeloss reported for the year ended December 31, 2023.2024. Results for the year ended December 31, 20242025 were negatively impacted by the decrease in revenues, lower gross margins earned on the revenues and were positively impacted by reducedhigher operating expenses. Results for the year ended December 31, 20242025 included $4.4change in the estimated fair value of acquisition-related contingent consideration of $4.6 million offset by gain on sale of impairmentassets lossesof compared$0.7 tomillion. $10.8 millionResults for the year ended December 31, 2023.2024 included impairment charges of $4.4 million.

Sales and marketing expenses decreased 15%16% to $26.1 million for the year ended December 31, 2025 from $31.0 million for the year ended December 31, 2024 from $36.3 million for the year ended December 31, 2023 primarily due to decreased employee costs associated with a reduction in headcount, and lower advertisingmarket research and consultingadvertising spend. Amortization also decreased as $6.2 million of intangibles were impaired in 2023. These decreases are partially offset by increases in bad debt expense and severance charges related to the discontinuance of the risk assessment product line.

General and administrative expenses decreasedincreased 21%3% to $47.7 million for the year ended December 31, 2025 from $46.2 million for the year ended December 31, 2024 from $58.2 million for the year ended December 31, 2023 largely due to lowerhigher legal fees relating to the SpectrumNowDx litigation (discussed further in Note 15,14, Commitments and Contingencies, to the consolidated financial statements included herein) and lower employee costs associated with reduced headcount partially offset by increase in non-cash stock compensation expense and transaction expenses associated with the Company'sSherlock acquisitionacquisition. ofAlso contributing to the increase were additional general and administrative expenses layered in from the acquired Sherlock companies which occurred in December.December 2024. Lower stock compensation expense, consulting fees, and decreased employee costs partially offset the increase in general and administrative spend.

The Company continues to believe the full valuation allowance established against its total U.S. deferred tax asset is appropriate as the facts and circumstances necessitating the allowance have not changed. Although theThe Company has not achieved U.S. cumulative pre-tax earnings based on a rolling three year window as the Company has not achieved a level of sustained profitability that would, in its judgement,judgment, support the release of the valuation allowance. For the yearyears ended December 31, 2025 and 2024, the Company recorded income tax expense of $1.8 million. 2024 income tax expense is comprised of $0.4 million of U.S. federal and state income tax expense, and foreign income tax expense of $1.4 million. For the year ended December 31, 2023, the Company recorded income tax expense of $2.6 million. 2023 income tax expense is comprised of U.S. state income tax expense of $1.9 million, and foreign income tax expense of $0.7 million.

The Company's cash and cash equivalents decreased to $199.3 million at December 31, 2025 from $267.8 million at December 31, 20242024. fromThe $290.4Company millionhas at December 31, 2023. $82.0$86.9 million, or 31%,44% of theits Company's $267.8$199.3 million inof cash, cash equivalents and available-for-sale securities is held by DNAG, the Company's Canadian subsidiary.

The Company's working capital decreased to $222.1 million at December 31, 2025 from $299.7 million at December 31, 2024 from $346.9 million at December 31, 2023. The decrease in cash and cash equivalents and working capital is primarily due to the investment in Sapphiros of $30.0 million and the initial payment for the acquisition of Sherlock for $5.0 million.2024. Working capital is primarily a function of sales, purchase volumes, inventory requirements, and vendor payment terms.

During the year ended December 31, 2024,2025, net cash providedused byin operating activities was $27.4$49.0 million. Cash flows from operations can be significantly impacted by factors such as timing of receiptreceipts from customers, inventory purchases, and payments to vendors. The Company's net loss of $19.5$68.7 million included non-cash charges of depreciation and amortization expense of $10.9$10.2 million, stock-based compensation expense of $11.9$10.1 million, impairmentchange chargesin takenestimated forfair idle equipment and right-of-use assets associated with Diversigen and Novosanisvalue of $4.4acquisition-related contingent consideration of $4.6 million, a loss on equity investment of 1.7$2.3 millionmillion, and other non-cash charges aggregating to $0.8$1.2 million.

Net cash used in investing activities was $39.0$6.8 million for the year ended December 31, 2024,2025, whichassociated reflectswith proceeds from thesale maturitiesof property and redemptions of investments of $53.1 million,equipment offset by $53.2the millionacquisition usedof tonew purchase investmentsproperty and $30.0 million used to purchase an equity stake in Sapphiros.equipment. Investing activities also includedincludes $3.8$3.6 million to acquire property and equipment to support normal operations of thecash businessused andfor the acquisition of Sherlock of $5.0 million.BioMedomics.

Net cash used in financing activities was $4.2$16.9 million for the year ended December 31, 2024,2025, which reflectswas $3.5largely comprised of $15.0 million to repurchase common stock pursuant to the Company's stock repurchase plan and $1.8 million used for the repurchase of common stock to satisfy withholding taxes related to the vesting of restricted stock awarded to the Company's employees and payments for lease liabilities of $0.8 million.employees.

Revenue Recognition.Recognition

Product sales. Revenue from product sales is recognized upon transfer of control of a product to a customer based on an amount that reflects the consideration the Company is entitled to, net of allowances for any discounts or rebates.

The Company generally does not grant product return rights to its customers, except for warranty returns and return rights on sales of its OraQuick® In-Home HIV testSelf-Test to the retail trade, and InteliSwab® products to the retail trade and certain other customers.

Service revenues represent microbiome laboratory testing and analytical services. The Company recognizes revenues when it satisfies its performance obligations for services rendered. Service revenue was discontinued with the closure of the molecular services line of business in 2024.

In arrangements involving more than one performance obligation, which largely applies to the Company's service revenue stream, each required performance obligation 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 each respective relative stand-alone selling price. The estimated selling price of each deliverable is determined using an observable cost plus margin approach. The consideration allocated to each distinct performance obligation is recognized as revenue when control is transferred for the related goods or services or when the performance obligation has been satisfied.

The Company's inventories are stated at the lower of cost or net realizable value, with cost determined on aan first-in,average first-outcost basis,method, and include the cost of raw materials, labor and overhead. The majority of the Company's inventories are subject to expiration dating, which can be extended in certain circumstances. The Company continually evaluates quantities on hand and the carrying value of its inventories to determine the need for net realizable value adjustments for excess and obsolete inventories, based primarily on prior experience with consideration of expected changes in the business and estimated forecasts of product sales. The Company reserves for unidentifiedinventory scrapexpiring within ninety days, with the exception of inventory that will be consumed or spoilagewill basedhave onexpiration historicaldates write-off rates.extended. It also considers items identified through specific identification procedures in assessing the adequacy of its reserve. Although the Company makes every effort to ensure the accuracy of its forecasts of future product demand, any significant unanticipated changes in demand could have a significant impact on the carrying value of its inventories and reported operating results.

The Company's business consists of the development, manufacture, marketing, sale and distribution of simple, easy to use diagnostic products and specimen collection devices using its proprietary technologies, as well as other diagnostic products including immunoassays and other in vitro diagnostic tests that are used on other specimen types. The Company's diagnostic products include tests for diseases including HIV, Hepatitis C, Syphilis, Sickle Cell and COVID-19 that are performed on a rapid basis at the point of care. These products are sold in the United States and internationally to various clinical laboratories, hospitals, clinics, community-based organizations, and other public health organizations, distributors, government agencies, physicians’ offices, and commercial and industrial entities. The Company's HIV and COVID-19 products are also sold in a consumer-friendly format in the over-the-counter ("OTC") market in the U.S. and, in the case of the HIV and HCV products, as a self-test to individuals in a number of other countries, including, for the HIV products, as an oral swab in-home test for HIV-1 and HIV-2 in Europe, and for the HCV products, as an OTC test. In December 2025, the Company submitted a 510(k) to the FDA for clearance of its rapid molecular self-test for CT/NG, which is currently under review.

The Company's business also includes sample management solutions and services that are used by clinical laboratories, direct-to-consumer laboratories, researchers, pharmaceutical companies, and animal health service and product providers. The revenues from sample management solutions are derived from product sales to commercial customers and sales into the academic and research markets. Customers span the disease risk management, diagnostics, pharmaceutical, biotech, and companion animal market segments. The Company has also developed collection devices for the emerging microbiome market, which focuses on studying microbiomes and their effect on human and animal health. The Company also has a urine collection device which allows for the volumetric collection of first void urine. Initial sales of this product for research use only are occurring primarily through distributors and collaborations in the liquid biopsy and sexually transmitted disease markets. In December 2025, the Company also submitted a 510(k) to the FDA for clearance of its Colli-Pee® at-home urine collection device for sexually transmitted infections, which iswas currentlyapproved underin review.June 2026.

During the third quarter of 2024, the Company announced the discontinuance of sales of its risk assessment product line, which was completed in the second quarter of 2025. Sales of its risk assessment products did not contribute to revenues during the threesix months ended MarchJune 31,30, 2026. Sales of its risk assessment products contributed $1.4$0.4 million to revenues during the three months ended MarchJune 31,30, 2025 and $1.9 million for the six months ended June 30, 2025. During the first quarter of 2025, the Company sold certain assets that made up the risk assessment product line including certain intellectual property, contracts, permits, and equipment.

For the three months ended MarchJune 31,30, 2026 compared to MarchJune 31,30, 2025.

The table below shows total consolidated net revenues for the three months ended MarchJune 31,30, 2026 and 2025:

(3)Includes COVID-19 Sample Management Solutions and COVID-19 Diagnostics product revenues.

Consolidated net revenues decreased 7%2% to $27.9$30.6 million for the three months ended MarchJune 31,30, 2026 from $29.9$31.2 million for the three months ended MarchJune 31,30, 2025.

Sample Management Solutions revenues remained largely flat at $9.1$9.9 million for the three months ended MarchJune 31,30, 2026 and 2025.

Non-product and services revenues increaseddecreased 66%34% to $1.5 million for the three months ended March 31, 2026 from $0.9 million for the three months ended MarchJune 31,30, 2026 from $1.4 million for the three months ended June 30, 2025 primarily due to the recognitioncompletion of revenue under various funded R&D contracts.

Consolidated gross profit margin increased to 42.3%43.5% for the three months ended MarchJune 31,30, 2026 compared to 41.1%42.1% for the three months ended MarchJune 31,30, 2025. The drivers of the margin increase wereare attributable to better absorption of fixed overhead costs due to operational efficiencies, improvedpartially offset by a negative product mix,mix and higherlower non-product revenues which contribute 100% to gross margin. An increase in scrap expense in the quarter partially offset the increases in gross margin.

Consolidated operating lossincome for the three months ended MarchJune 31,30, 2026 was $23.3$5.4 million compared to $17.8an operating loss of $18.0 million for the three months ended MarchJune 31,30, 2025. The higher operating loss reported in 2026 was largely a result of lower revenues coupled with increased research and development spend.

Research and development expenses increaseddecreased 42%17% to $13.7$9.4 million for the three months ended MarchJune 31,30, 2026 from $9.6$11.4 million for the three months ended MarchJune 31,30, 2025 largelyprimarily due to higher spend incurred forlower clinical trialstrial costs associated with the Chlamydia Trachomatis (CT) and Neisseria Gonorrhoeae (NG) device and the Colli-Pee® device. The increase in research and development expenses is also due to additional severance charges associated with the Company's reduction in its workforce in February 2026.

Sales and marketing expenses decreasedincreased 1%4% to $6.8$6.6 million for the three months ended MarchJune 31,30, 2026 from $6.9$6.4 million for the three months ended MarchJune 31,30, 2025.

General and administrative expenses increased 3%14% to $14.6$14.4 million for the three months ended MarchJune 31,30, 2026 from $14.1$12.7 million for the three months ended MarchJune 31,30, 2025 largely due to an increase in legal fees and in professional services related to the proxy statement and severancerelated charges.stockholder activism costs.

All of the above contributed to the Company's operating lossincome of $23.3$5.4 million for the three months ended MarchJune 31,30, 2026, which included non-cash charges of $2.8$2.4 million for depreciation and amortization and $2.3 million for stock-based compensation, $2.3and $22.6 million forin depreciationnon-cash andincome amortization,reflected and $0.1 million forin the change in the estimated fair value of acquisition-related contingent consideration. The Company's operating loss of $17.8$18.0 million for the three months ended MarchJune 31,30, 2025 included non-cash charges of $2.7$3.2 million for stock-based compensation, $2.8$2.5 million for depreciation and amortization, and $0.5$0.7 million for the change in the estimated fair value of acquisition-related contingent consideration.

Other income for the three months ended MarchJune 31,30, 2026 was $1.5$1.4 million compared to $1.8$1.1 million for the three months ended MarchJune 31,30, 2025. The decreaseincrease in other income is due to lower interest income andoffset increasedby lower foreign currency losses.

The Company continues to believe the full valuation allowance established against its total U.S. and U.K. deferred tax asset is appropriate as the facts and circumstances necessitating the allowance have not changed. For the three months ended MarchJune 31,30, 2026 and 2025, the Company recorded income tax benefitsexpense of $0.4$0.1 million and $0.5$2.0 million, respectively. During the three months ended June 30, 2026 and 2025, the Company had an effective tax rate of 0.8% and (11.8)%, respectively. The increase in the Company's tax rate was primarily due to the recording of a uncertain tax position in 2025 and projected break-even results in foreign operations in 2026 versus projected losses in 2025.

The Company's cash and cash equivalents decreased to $177.0$160.6 million at MarchJune 31,30, 2026 from $199.3 million at December 31, 2025. The Company has $84.9$84.6 million, or 48%,53%, of its $177.0$160.6 million of cash and cash equivalents held by DNAG, the Company's Canadian subsidiary.

The Company's working capital decreased to $196.7$197.8 million at MarchJune 31,30, 2026 from $222.1 million at December 31, 2025. Working capital is primarily a function of sales, purchase volumes, inventory requirements, and vendor payment terms.

During the threesix months ended MarchJune 31,30, 2026, net cash used in operating activities was $13.9$23.8 million. Cash flows from operations can be significantly impacted by factors such as timing of receipts from customers, inventory purchases, and payments to vendors. The Company's net loss of $22.4$16.1 million included non-cash charges of a change in the estimated fair value of acquisition-related contingent consideration of $22.5 million, stock-based compensation expense of $2.8$5.1 million, depreciation and amortization expense of $2.3$4.7 million, a loss on equity investment of $1.1$1.6 million, and other non-cash charges aggregating to $0.4$0.2 million.

Changes in the Company's working capital accounts contributed to cash and included an increase in accrued expenses and other liabilities of $4.1$2.9 million largely associated with higher compensation-related accruals, a decrease in prepaid expenses and other assets of $2.5 million resulting from lower deposits paid, an increase of $1.3 million in accounts payable associated with the timing of spend on consulting services and inventory purchases, aand an overall decrease in overall inventory balances of $0.7$0.9 million due to maintainingan increase in inventory reserves associated with expired inventory and lower COVID-19 inventory levels attributabledue to decreased demand, a decrease in prepaid expenses and other assets of $0.6 million, and an increase in accrued expenses and other liabilities of $0.6 million.demand. These contributions to cash were offset by an increase in accounts receivable of $2.6$3.7 million due to timing of shipments and invoicing and a decrease in deferred revenue of $0.6 million as work on grant projects is completed and earned.

Net cash used in investing activities was $0.9$3.3 million for the threesix months ended MarchJune 31,30, 2026, for purchases of property and equipment.

Net cash used in financing activities was $6.3$8.5 million for the threesix months ended MarchJune 31,30, 2026, which was largely comprised of $5.0$7.0 million to repurchase common stock pursuant to the Company's stock repurchase plan and $1.3$1.5 million used for the repurchase of common stock to satisfy withholding taxes related to the vesting of restricted stock awarded to the Company's employees.

A more detailed review of the Company's critical accounting policies is contained in its Annual Report on Form 10-K for the year ended December 31, 2025 filed with the SEC. No material changes have been made to such critical accounting policies during the threesix months ended MarchJune 31,30, 2026.