OraSure 3Q21 Earnings November 3, 2021 aSure Technologies DNAgenotek" 》l novosanis Forward-Looking Statements Disclaimer This document contains certain forward-looking statements, including with respect to expected revenues and earnings/loss per share. Forward-looking statements are not guarantees of future performance or results. Known and unknown factors that could cause actual performance or results to be materially different from those expressed or implied in these statements include, but are not limite ...

Financial Data and Key Metrics Changes - Total revenue for Q3 2021 was $53.9 million, up from $48 million in the prior year, representing a year-over-year growth of 12% [39] - Core business revenue, excluding COVID-19 revenue, grew 37% year-over-year to over $40 million [39] - Diagnostic revenue reached a record $23.5 million, reflecting a 44% increase from $16.3 million in the previous year [40] - Gross margin percentage decreased to 39.8% from 63.1% in the same period last year, primarily due to production scale-up inefficiencies and higher shipping costs [48] Business Line Data and Key Metrics Changes - InteliSwab revenue for the quarter was $7.7 million, driven by strong customer demand [43] - Molecular Solutions revenue was $30.4 million, a decline of 4% year-over-year, primarily due to lower sales of molecular collection kits for COVID-19 [45] - Excluding COVID-19 testing, Molecular Solutions revenue grew 87% year-over-year [46] - Microbiome services revenue was $2.4 million, growing 6% year-over-year, but was negatively impacted by the timing of pharmaceutical partner contracts [47] Market Data and Key Metrics Changes - The company received over $400 million in customer orders, including from major retailers and Fortune 500 companies, which had to be turned away due to manufacturing constraints [11] - The global testing market is projected to reach approximately 1.1 billion rapid antigen tests by 2025 [10] - The company anticipates generating approximately $30 million in total InteliSwab revenue for the year [22] Company Strategy and Development Direction - The company is focused on capitalizing on COVID-19 testing opportunities and expanding its sample collection and molecular services businesses [8] - Plans to invest in automation and efficiency to enhance operational profile and competitive positioning [7] - The company aims to emerge from the pandemic as a larger and faster-growing organization, with a focus on effortless diagnostics [59] Management's Comments on Operating Environment and Future Outlook - Management believes that COVID-19 testing will remain integral to the business long-term, with a durable demand for InteliSwab [9] - The company is optimistic about the future, citing the importance of rapid antigen tests in addressing public health challenges [10] - Management expects to transition to a meaningful operating profit in fiscal year 2022 despite current production inefficiencies [54] Other Important Information - The company signed three major U.S. government contracts, including a $205 million procurement contract for InteliSwab [12] - The company is working to resolve manufacturing challenges related to raw material variability and processing steps [72] - The company plans to launch a new GUT metatranscriptome collection kit and related services in the first quarter of next year [24] Q&A Session Summary Question: What is causing the decline in base business growth for Q4? - The decline is attributed to changes in ordering patterns from larger consumer-focused customers and a conservative outlook for COVID molecular collection kits [65][66] Question: Can you elaborate on the capacity ramps and challenges? - The challenges are related to raw materials and processing steps, which are not new issues but have been narrowed down to a few critical factors [71][72] Question: What is the durability of the $400 million in orders? - The demand is influenced by the delta variant and back-to-school programs, with expectations for recurring demand due to new testing requirements [90][91] Question: What are the expectations for gross margins moving forward? - Gross margins are expected to be in the mid to high-50s for the core business, with lower margins for InteliSwab impacting overall margins [94][102] Question: What is the status of the GUT microbiome product? - The product is intended for use in clinical trials and is expected to arrive at a point of inflection for commercial use [122][123]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2021. OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . Commission File Number 001-16537 ORASURE TECHNOLOGIES, INC. (Exact Name of Registrant as Specified in Its Charter) Delaware 36-4370966 (State or Other Ju ...

OraSure Technologies, Inc. (NASDAQ:OSUR) Q2 2021 Earnings Conference Call August 3, 2021 5:00 PM ET Company Participants Scott Gleason - SVP, IR & Corporate Communications Stephen Tang - President, CEO & Director Roberto Cuca - CFO & Principal Accounting Officer Conference Call Participants Vijay Kumar - Evercore ISI Patrick Donnelly - Citigroup Frank Takkinen - Lake Street Capital Jacob Johnson - Stephens Inc. Andrew Cooper - Raymond James & Associates Operator Welcome to the OraSure Technologies, Inc. 202 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION FORM 10-Q Washington, D.C. 20549 (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2021. OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . Commission File Number 001-16537 ORASURE TECHNOLOGIES, INC. (Exact Name of Registrant as Specified in Its Charter) (State or Other Jurisdiction of Incor ...

Financial Data and Key Metrics Changes - Total net revenues increased by 85% to $58.6 million in Q1 2021 from $31.6 million in Q1 2020, driven primarily by strong sales of molecular sample collection kits for COVID-19 testing and higher genomics product sales [21][5][7] - Gross profit percentage improved to 65% in Q1 2021 compared to 51% in the same period of 2020, attributed to an improved product mix [24] - Net income for Q1 2021 was $3.8 million, or $0.05 per share, compared to a net loss of $7.3 million, or $0.12 per share, in Q1 2020 [25] Business Line Data and Key Metrics Changes - The Molecular Solutions Business Unit generated $44 million in revenue during Q1 2021, a 219% increase from Q1 2020, including $27.4 million from COVID-19 molecular testing kits [22][7] - Domestic sales of the OraQuick HIV tests increased by 26% compared to the prior year, largely due to higher sales of the over-the-counter OraQuick In-Home HIV test [23] - International HIV and HCV revenues declined by 42% year-over-year, primarily due to large distributor orders in Q1 2020 and timing variations [23] Market Data and Key Metrics Changes - The global antigen testing market for COVID-19 is estimated at $19 billion annually, with $5 billion in the U.S. [50] - The global molecular testing market is projected to be around $17 billion annually, with ongoing demand for sample collection kits [51] Company Strategy and Development Direction - The company submitted a COVID-19 rapid antigen test for Emergency Use Authorization (EUA) and plans to launch both prescription home tests and professional tests for point-of-care use [6][15] - The company is expanding its manufacturing capacity for COVID-19 products, aiming for 120 million units annually by Q2 2022 [27][29] - The company is focused on leveraging its strong balance sheet to maximize COVID-19 opportunities while funding R&D in non-COVID businesses [38] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the sustained market potential for COVID-19 solutions, emphasizing the importance of testing amid vaccination efforts and the emergence of new variants [19][9] - The company anticipates continued strong performance in its non-COVID businesses, with signs of recovery in molecular and genomics markets [31][32] Other Important Information - Cash and investments totaled $240.5 million as of March 31, 2021, with expected revenues of $55 million to $60 million in Q2 2021 [26] - The company is actively working on international regulatory approvals for its rapid antigen test [20] Q&A Session Summary Question: Guidance for Q2 2021 - The company provided guidance of $55 million to $60 million for Q2 2021, excluding contributions from post-EUA sales of antigen or antibody tests due to uncertain authorization timing [41] Question: International Market Approval Process - The company is exploring regulatory requirements for its rapid antigen tests outside the U.S. and will focus on attractive markets post-EUA [42] Question: Antigen Test Pricing and Competition - The company aims to be competitive in pricing for its antigen tests, emphasizing ease of use and differentiation from existing products [47][49] Question: Collection Kits and Market Trends - The company remains optimistic about ongoing demand for molecular testing and collection kits, despite a slowdown in lab-based testing [51][52] Question: OTC Antigen Test Submission - The company is preparing for OTC submissions and is confident in its relationship with the FDA to facilitate the process [59][60] Question: Demand and Contracts in the U.S. - Strong inbound interest from universities, employers, and public health entities has been noted, with discussions progressing towards contracts pending EUA [72]

OraSure Technologies INVESTOR PRESENTATION MARCH 2021 DNAgenoTeK" % Diversigen" novosanis Forward-Looking Statements Disclaimer This presentation contains certain forward-looking statements, including with respect to expected revenues and earnings/loss per share. Forward-looking statements are not guarantees of future performance or results. Known and unknown factors that could cause actual performance or results to be materially different from those expressed or implied in these statements include, but are ...

OraSure Technologies INVESTOR PRESENTATION MARCH 2021 DNAgenoTeK" % Diversigen" novosanis Forward-Looking Statements Disclaimer This presentation contains certain forward-looking statements, including with respect to expected revenues and earnings/loss per share. Forward-looking statements are not guarantees of future performance or results. Known and unknown factors that could cause actual performance or results to be materially different from those expressed or implied in these statements include, but are ...

Financial Data and Key Metrics Changes - In Q4 2020, net revenues increased by 27% to $62.9 million from $49.7 million in Q4 2019, primarily due to strong sales of COVID-19 molecular sample collection kits and increased international sales of HIV self-tests [30][31] - Net product and services revenues were $60.4 million, a 28% increase from Q4 2019 [31] - Gross profit percentage improved to 61% in Q4 2020 from 60% in Q4 2019 due to a better product mix [32] - Net income for Q4 2020 was $1.9 million or $0.03 per share, compared to $2.4 million or $0.04 per share in Q4 2019 [33] Business Line Data and Key Metrics Changes - The molecular business unit generated $40.3 million in revenues during Q4 2020, a 58% increase from Q4 2019, driven by $22.5 million in sales of COVID-19 molecular testing kits [31] - International sales of OraQuick HIV tests increased by 16% compared to Q4 2019, largely due to higher sales in Africa [32][39] - Total diagnostic revenues decreased by 7% in Q4 2020 compared to Q4 2019, but the HIV self-test segment showed resilience with a 16% growth [40][78] Market Data and Key Metrics Changes - The company expects the demand for COVID-19 testing to remain strong, with the Biden administration proposing $50 billion in spending to increase testing capacity [10][29] - The global need for testing is projected to be significant, especially with the emergence of new variants of the virus [11][12] - The company is focusing on expanding its market presence in both high-income and low-middle-income countries for COVID-19 testing [88] Company Strategy and Development Direction - The company is advancing three distinct COVID-19 testing opportunities: molecular testing, rapid antigen self-tests, and lab-based oral fluid antibody tests [13][22] - Plans to submit for Emergency Use Authorization (EUA) for both prescription and professional self-tests by the end of the month [8][20] - The company aims to leverage its strong balance sheet to pursue transformative business development opportunities while maximizing COVID-19 market potential [47][116] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the resilience of legacy businesses and the ongoing recovery in non-COVID segments [81] - The company anticipates continued growth in COVID-19 molecular revenues into 2021 and expects to emerge from the pandemic as a larger and more innovative entity [46][48] - Management highlighted the importance of testing as a key part of disease management even as vaccination efforts progress [12][29] Other Important Information - Cash and investments totaled $257.1 million at the end of 2020, providing a strong financial position for future growth [34] - The company is expanding manufacturing capacity to support the production of 120 million rapid antigen self-tests annually by Q2 2022 [27] Q&A Session Summary Question: Can you comment on the performance of the antigen test versus other at-home tests? - Management confirmed substantial progress and emphasized the simplicity of their test as a key advantage, with confidence in meeting FDA requirements [52][53] Question: What is the expected demand for antigen tests? - Management indicated strong expressions of interest from potential customers, although demand is not locked in until EUA approval is obtained [54][56] Question: Can you provide guidance on Q1 revenue expectations? - Management expects sequential growth in COVID-19 molecular collection devices but did not provide detailed guidance beyond Q1 due to regulatory uncertainties [62][63] Question: What is the timeline for international market access? - Management is focusing on higher-income countries first, with plans to expand to lower-middle-income countries later in the year [88] Question: How does the company view the opportunity for home testing? - Management sees significant potential in effortless diagnostics and plans to explore new opportunities in this area [102][104] Question: What is the status of the antibody test EUA submission? - Management is working on the necessary studies and aims to submit the EUA as soon as possible [106] Question: How does the company view its relationship with a major genomics customer going public? - Management remains optimistic about the relationship and sees it as a strong strategic partnership moving forward [109]

Financial Performance - Consolidated net revenues for the year ended December 31, 2020, increased by 11% to $171.7 million, compared to $154.6 million in 2019 [349]. - Net product and service revenues rose by 12% to $166.4 million, driven by COVID-19 testing revenues, higher international sales of OraQuick® HIV Self-Test, and increased laboratory services [349]. - The consolidated net loss for 2020 was $14.9 million, or $(0.22) per share, compared to a net income of $16.7 million, or $0.27 per share, in 2019 [350]. - Cash provided by operating activities decreased to $5.8 million in 2020 from $9.8 million in 2019 [351]. - Consolidated operating loss was $5.2 million in 2020, a decline from the operating income of $18.6 million in 2019, impacted by increased operating expenses related to COVID-19 product development [372]. Revenue Breakdown - The Diagnostics segment reported a revenue decline of 18% to $63.6 million, while the Molecular Solutions segment saw a 45% increase to $102.8 million [353]. - International sales accounted for 24% of total net revenues in 2020, down from 31% in 2019, totaling $40.9 million [354]. - Domestic HIV revenues decreased 16% to $15.2 million in 2020 from $18.0 million in 2019, primarily due to a decline in domestic HIV testing caused by the COVID-19 pandemic [359]. - International HIV revenues increased 16% to $29.0 million in 2020 from $25.1 million in 2019, driven by higher sales of OraQuick® HIV Self-Test in Africa [360]. - Net revenues from the Molecular Solutions segment increased 45% to $102.8 million in 2020 from $70.8 million in 2019, with significant contributions from COVID-19 related products [366]. - Laboratory services revenues increased 41% to $9.6 million in 2020 compared to $6.8 million in 2019, attributed to the acquisition of Diversigen [368]. Cash and Financing - Cash and cash equivalents increased to $160.8 million in 2020 from $75.7 million in 2019, with total cash and available-for-sale securities rising to $257.1 million [385]. - Net cash provided by financing activities was $92.5 million in 2020, primarily from the issuance of common stock in a public offering [388]. - The company expects current cash balances to be sufficient to fund operating and capital needs, with $99.4 million or 39% of cash held by its Canadian subsidiary [390]. Acquisitions and Investments - The company completed a public offering in June 2020, raising approximately $95.0 million from the sale of 9,200,000 shares at $11.00 per share [347]. - The acquisition of UrSure was completed on July 22, 2020, for $3.0 million, aimed at expanding the product offerings in point-of-care tests [348]. Research and Development - Research and development expenses increased 75% to $21.3 million in 2020 from $12.2 million in 2019, largely due to COVID-19 product development [374]. - The company is developing a rapid COVID-19 antigen test and a laboratory-based oral fluid SARS-CoV-2 antibody test, seeking Emergency Use Authorization (EUA) [346]. Inventory and Deferred Revenue - As of December 31, 2020, deferred revenue included customer prepayments of $3.2 million, up from $1.9 million in 2019, indicating a growth in customer commitments [398]. - The company recorded inventory write-offs of $2.6 million in 2020, compared to $1.3 million in both 2019 and 2018, highlighting increasing quality and expiration issues [402]. Tax and Currency - Federal Net Operating Loss (NOL) carryforwards amounted to $136.3 million as of December 31, 2020, with net deferred tax assets of $35.4 million before valuation allowance [403]. - Sales denominated in foreign currencies accounted for 5.0% of total revenues for the year ended December 31, 2020, with foreign subsidiaries holding net assets of $161.5 million [410]. - A 10% unfavorable change in the Canadian-to-U.S. dollar and Euro-to-U.S. dollar exchange rates would have decreased comprehensive income by approximately $12.9 million in 2020 [410]. - The company maintains a full valuation allowance against U.S. deferred tax assets, indicating a cautious approach to realizing these assets [404]. Revenue Recognition - Revenue from product sales is recognized upon transfer of control, net of allowances for discounts or rebates, ensuring accurate revenue reporting [393]. - Service revenues, including microbiome laboratory testing, are recognized when performance obligations are satisfied, reflecting the company's commitment to service quality [395]. - Acquired businesses are accounted for using the acquisition method, with any excess purchase price recorded as goodwill, reflecting the company's strategic growth through acquisitions [406].