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]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2020 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 No. 001-16537 ORASURE TECHNOLOGIES, INC. (Exact Name of Registrant as Specified in Its Charter) Delaware 36-4370966 (State or Other Jurisdiction ...

OraSure Technologies, Inc. (NASDAQ:OSUR) Q3 2020 Earnings Conference Call November 4, 2020 5:00 PM ET Company Participants Jeanne Mell - Vice President of Corporate Communications Stephen Tang - President & Chief Executive Officer Roberto Cuca - Chief Financial Officer Conference Call Participants Vijay Kumar - Evercore ISI Frank Takkinen - Lake Street Capital Casey Woodring - JPMorgan Andrew Cooper - Raymond James Patrick Donnelly - Citigroup Jacob Johnson - Stephens Operator Good afternoon, everyone, and ...

OraSure Technologies INVESTOR PRESENTATION SEPTEMBER 2020 DNAgenoтeк" & Diversigen' novosanis UrSure 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 inclu ...

Financial Data and Key Metrics Changes - Net product and service revenues for Q2 2020 decreased by 24% compared to Q2 2019, primarily due to lower sales in genomics products and domestic HIV, HCV, and microbiome products impacted by COVID-19 [28][32] - Total product and service revenues for the DNA Genotek business unit were $18.1 million in Q2 2020, representing a 4% increase from Q2 2019 [30] - COVID-19 related revenues from molecular collection products reached $8.5 million in Q2 2020, contributing to expectations of higher total revenues in 2020 compared to 2019 [24][34] Business Line Data and Key Metrics Changes - International sales of OraQuick HIV products decreased by 28% compared to Q2 2019, attributed to shipment delays, although the underlying business showed strong year-to-date growth [29] - Laboratory service revenue increased to $2.2 million in Q2 2020 from $1.2 million in Q2 2019, driven by the performance of laboratory services subsidiaries [31] - The company expects non-COVID-19 revenues in infectious disease and molecular collections to decline in 2020, but COVID-19 product sales are anticipated to offset this decline [32][34] Market Data and Key Metrics Changes - The company is positioned to meet the global testing needs created by the COVID-19 pandemic, with existing distribution channels across public health, laboratories, and direct-to-consumer markets [8][12] - The demand for saliva collection devices is increasing as in-clinic blood collection remains challenging due to COVID-19 [47] - The company is exploring partnerships to expand its capacity to meet anticipated demands across all areas [41] Company Strategy and Development Direction - The company is focusing on expanding its COVID-19 testing capabilities, including antigen and antibody tests, to capture significant revenue opportunities [5][6] - Investments are being made to increase manufacturing capacity for COVID-19 related products, with expectations to ramp up production significantly in the coming quarters [36][39] - The acquisition of UrSure, Inc. supports the strategy of expanding the core offerings to include additional diagnostic products, particularly in the HIV space [45] Management's Comments on Operating Environment and Future Outlook - Management believes the second half of 2020 will show strong revenue growth, driven by COVID-19 related products and a recovery in non-COVID-19 business lines [6][34] - The company is optimistic about the long-term need for expanded testing options, even with the potential availability of vaccines [14][21] - Management highlighted the importance of rapid testing solutions for schools and workplaces as part of the strategy to support safe reopening [75] Other Important Information - The company ended Q2 2020 with $265.8 million in cash and no debt, positioning itself well for future growth [41] - The company is currently in clinical trials for its antigen test, with a target launch in Q4 2020 [59][60] - The company is also developing an ELISA test for COVID-19 antibodies, with plans to file for EUA in Q4 2020 [21] Q&A Session Summary Question: Can you elaborate on the switch to nostril collection for the antigen test? - The decision was based on scientific findings indicating that nasal swabs provide higher accuracy and viral load compared to oral fluid tests [58] Question: What are the expected milestones for the antigen test before the Q4 launch? - The next internal milestone is a prototype block, with the expectation of submitting for EUA in Q4 [59] Question: What end markets are being targeted for the antigen test? - The company is in discussions with large employers, schools, and government agencies for potential contracts [61][63] Question: Did the company recognize any revenues from CRL in Q2? - Specific customer contributions to revenue are not disclosed, but there is optimism for the second half of the year [70] Question: How does the recent FDA guidance impact the rapid test? - The company does not foresee any surprises in the FDA guidelines and believes it aligns with their product strategy [71] Question: What is the expected revenue visibility for the third quarter? - The company expects revenues to be substantially greater than the $8.5 million achieved in Q2, but specific numbers are not provided due to unpredictability [76]