PART I. FINANCIAL INFORMATION [Item 1. Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) Net revenues increased to $147.9 million, but a $38.8 million net loss was incurred due to lower gross margins and higher operating expenses [Consolidated Balance Sheets](index=3&type=section&id=Consolidated%20Balance%20Sheets) - Total assets decreased from **$461.0 million** at year-end 2021 to **$429.3 million** as of June 30, 2022, primarily due to a reduction in cash, cash equivalents, and investments[8](index=8&type=chunk) - Current assets decreased slightly, with a significant drop in cash and short-term investments (**$153.0M** to **$95.8M**) being partially offset by increases in accounts receivable (**$45.3M** to **$62.9M**) and inventories (**$53.1M** to **$71.3M**)[8](index=8&type=chunk) Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2022 | December 31, 2021 | | :--- | :--- | :--- | | **Current Assets** | | | | Cash and cash equivalents | $66,159 | $116,762 | | Inventories | $71,304 | $53,138 | | Total current assets | $267,306 | $288,431 | | **Total Assets** | **$429,254** | **$460,990** | | **Total Liabilities** | **$85,062** | **$80,457** | | **Total Stockholders' Equity** | **$344,192** | **$380,533** | [Consolidated Statements of Operations](index=4&type=section&id=Consolidated%20Statements%20of%20Operations) - For the six months ended June 30, 2022, the company reported a net loss of **$38.8 million**, a significant downturn from the **$2.4 million** net income in the same period of 2021[10](index=10&type=chunk) - A loss on impairment of **$10.5 million** was recorded in the first six months of 2022, with no comparable charge in 2021, contributing significantly to the operating loss[10](index=10&type=chunk) Statement of Operations Summary (in thousands, except per share data) | Metric | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :--- | :--- | :--- | | Net Revenues | $147,938 | $116,189 | | Gross Profit | $51,856 | $68,999 | | Operating Income (Loss) | $(37,267) | $12,220 | | Net Income (Loss) | $(38,769) | $2,410 | | Diluted EPS | $(0.54) | $0.03 | [Consolidated Statements of Cash Flows](index=6&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) - Net cash used in operating activities increased significantly to **$45.5 million** for the six months ended June 30, 2022, compared to **$3.5 million** in the prior-year period[16](index=16&type=chunk) - The increase in cash used for operations was driven by the net loss of **$38.8 million** and significant investments in working capital, including a **$20.4 million** increase in inventories and an **$18.6 million** increase in accounts receivable[16](index=16&type=chunk) - Cash and cash equivalents decreased by **$50.6 million** during the first half of 2022, ending the period at **$66.2 million**[16](index=16&type=chunk) [Notes to the Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20the%20Consolidated%20Financial%20Statements) Key notes detail asset and goodwill impairment charges, $109 million DOD funding for InteliSwab® manufacturing, and significant COVID-19 product revenue - The company recorded a pre-tax asset impairment charge of **$6.9 million** during Q2 2022 to write down three idle manufacturing cells to their estimated fair values due to changes in forecasted demand[30](index=30&type=chunk) - In September 2021, the company entered an agreement for **$109 million** in funding from the U.S. Department of Defense (DOD) to build additional manufacturing capacity for its InteliSwab® COVID-19 Rapid Tests[38](index=38&type=chunk) - A goodwill impairment test triggered by a decline in market capitalization resulted in a pre-tax impairment charge of **$3.6 million**, fully impairing the goodwill of the Diagnostics reporting unit[53](index=53&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=19&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management attributes 27% revenue growth to InteliSwab® sales, but a net loss resulted from lower gross margins (35% vs 59%) and increased operating expenses [Overview and Recent Developments](index=21&type=section&id=Overview%20and%20Recent%20Developments) - The company operates through two segments: **Diagnostics** (rapid tests for COVID-19, HIV, HCV, and substance abuse) and **Molecular Solutions** (sample collection kits and lab services)[89](index=89&type=chunk)[90](index=90&type=chunk)[91](index=91&type=chunk) - **Carrie Eglinton Manner** was appointed President and CEO, effective June 4, 2022, succeeding interim CEO Dr Nancy Gagliano[96](index=96&type=chunk) - In conjunction with the new CEO appointment, the Board of Directors concluded its review of strategic alternatives, opting to move forward under the new leadership[98](index=98&type=chunk) [Results of Operations](index=22&type=section&id=Results%20of%20Operations) Q2 2022 revenues grew 39% to $80.2 million, driven by InteliSwab®, despite a 49% decline in Molecular Solutions, with gross margin falling to 34% Consolidated Net Revenues - Q2 (in thousands) | Segment | Q2 2022 | Q2 2021 | % Change | | :--- | :--- | :--- | :--- | | Diagnostics | $59,976 | $18,252 | 229% | | Molecular Solutions | $19,191 | $37,489 | (49)% | | **Total Product & Services** | **$79,167** | **$55,741** | **42%** | Consolidated Net Revenues - H1 (in thousands) | Segment | H1 2022 | H1 2021 | % Change | | :--- | :--- | :--- | :--- | | Diagnostics | $96,372 | $31,585 | 205% | | Molecular Solutions | $48,031 | $80,735 | (41)% | | **Total Product & Services** | **$144,403** | **$112,320** | **29%** | - Consolidated gross profit margin decreased to **34%** in Q2 2022 from **53%** in Q2 2021, primarily due to a less favorable product mix and increased scrap expense associated with reserves for excess inventory[123](index=123&type=chunk) - For the six-month period, consolidated gross margin fell to **35%** from **59%** in the prior year, caused by unfavorable product mix, manufacturing inefficiencies, inventory reserves, and the expiration of the Gates Foundation subsidy[159](index=159&type=chunk) [Liquidity and Capital Resources](index=29&type=section&id=Liquidity%20and%20Capital%20Resources) Liquidity Position (in thousands) | Metric | June 30, 2022 | December 31, 2021 | | :--- | :--- | :--- | | Cash and cash equivalents | $66,159 | $116,762 | | Available for sale securities | $29,625 | $53,288 | | **Total Cash & Investments** | **$95,784** | **$170,050** | | Working capital | $201,820 | $220,367 | - Net cash used in operating activities was **$45.5 million** in the first six months of 2022, a significant increase from **$3.5 million** in the same period of 2021[101](index=101&type=chunk)[174](index=174&type=chunk) - The company repatriated **$65.0 million** of cash from its Canadian subsidiary to the U.S. in Q1 2022, incurring approximately **$1.7 million** in Canadian withholding tax[178](index=178&type=chunk) - Management expects current cash, equivalents, and securities to be sufficient to fund operating and capital needs for the next twelve months[178](index=178&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=31&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk is foreign currency exchange from Canadian and Belgian subsidiaries, with $130.9 million in net assets subject to translation risk - The company's main market risk is **foreign currency exchange risk** from its Canadian and Belgian subsidiaries, with business conducted in Canadian dollars and Euros[185](index=185&type=chunk) - As of June 30, 2022, foreign subsidiaries had net assets of **$130.9 million** subject to currency translation risk[185](index=185&type=chunk) - A **10%** adverse change in the Canadian-to-U.S. dollar and Euro-to-U.S. dollar exchange rates would have reduced comprehensive income by about **$13.1 million** in the first half of 2022[185](index=185&type=chunk) [Item 4. Controls and Procedures](index=31&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective as of June 30, 2022, with no material changes to internal control over financial reporting - Management concluded that the company's disclosure controls and procedures were **effective** as of June 30, 2022[186](index=186&type=chunk) - There were no changes in internal control over financial reporting during the quarter that materially affected, or are reasonably likely to materially affect, the company's internal controls[187](index=187&type=chunk) PART II. OTHER INFORMATION [Item 1. Legal Proceedings](index=31&type=section&id=Item%201.%20Legal%20Proceedings) The company is involved in ongoing patent litigation with Spectrum Solutions, LLC, concerning saliva collection devices, with counterclaims filed - The company filed a patent infringement lawsuit against Spectrum Solutions, LLC in March 2021 regarding saliva collection devices[189](index=189&type=chunk) - Spectrum has responded with counterclaims, including assertions that the patent is invalid and alleging inequitable conduct and antitrust violations[189](index=189&type=chunk) [Item 1A. Risk Factors](index=31&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant customer concentration risk, with a single non-commercial customer accounting for 56% and 39% of net revenues for Q2 and H1 2022, respectively - A single non-commercial customer accounted for **56%** of net consolidated revenues for the three months and **39%** for the six months ended June 30, 2022[191](index=191&type=chunk) - The company's business is at risk due to this **high customer concentration**, as a reduction in purchases from this customer could adversely affect financial results[192](index=192&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=32&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company repurchased 141,606 shares in Q2 2022, primarily to satisfy tax withholdings for vested employee shares, not under its public repurchase program Share Repurchases Q2 2022 | Period | Total Shares Purchased | Average Price Paid per Share | | :--- | :--- | :--- | | April 2022 | 107,316 | $7.08 | | May 2022 | 21,979 | $5.17 | | June 2022 | 12,311 | $3.83 | | **Total** | **141,606** | **N/A** | - The shares purchased were retired to satisfy minimum tax withholdings in connection with the vesting of restricted and performance shares, not as part of the public repurchase plan[194](index=194&type=chunk)

Financial Data and Key Metrics Changes - The company reported total revenue of $67.7 million for Q1 2022, representing a year-over-year growth of 16% [37] - Non-COVID-19 products grew by 21% year-over-year, indicating strong core business performance [37] - Gross margin percentage for the quarter was 36%, impacted by high scrap rates and inefficiencies in production [38][39] Business Line Data and Key Metrics Changes - The Diagnostics business unit revenue was $38.3 million, growing 163% year-over-year, primarily driven by InteliSwab [11] - Excluding InteliSwab, the global diagnostics business grew 11% year-over-year, with domestic diagnostics growing 7% [11][12] - The Molecular Solutions business saw a 28% increase in sales compared to Q1 2021, with a 50% growth in the commercial segment [29] Market Data and Key Metrics Changes - International diagnostics grew 20% year-over-year, with a 34% increase when excluding the impact of the Bill and Melinda Gates subsidy [15][16] - The company launched its HIV self-test in six European countries, contributing to international growth [17] Company Strategy and Development Direction - The company is focused on scaling InteliSwab production and improving operational efficiency, with a long-term vision for a highly automated manufacturing process [9][22] - There is an emphasis on improving the cost structure to enhance gross margins, which will allow for further investment in R&D and marketing [22][41] - The company is exploring new market segments and innovative product opportunities, particularly in point-of-care and home testing [9][26] Management's Comments on Operating Environment and Future Outlook - Management anticipates robust government demand for InteliSwab through the end of the year and is optimistic about expanding the commercial footprint [7][24] - The company expects modest revenue growth in Q2 2022, with improvements in gross margins and a reduction in operating loss [44][45] - The ongoing strategic alternative process and CEO search are expected to be completed by the end of June [57] Other Important Information - The company has $112 million in cash and cash equivalents, with an additional $17 million due from the government related to a contract for manufacturing capacity [43] - A $33 million grant opportunity from the CDC for HIV self-testing is anticipated to benefit the company, as it is the only FDA-approved OTC HIV self-test in the U.S. [13] Q&A Session Summary Question: Government plans for InteliSwab revenue - Management confirmed ongoing strong relationships with the government and consistent weekly orders, but did not provide specific forward-looking guidance on revenue from the $205 million contract [51][52] Question: Production capacity increase - Production capacity increased fourfold during the quarter, with management indicating they are currently at installed capacity and can increase production as needed [52][54] Question: Strategic review process update - The strategic review process is active and expected to be completed by the end of June, with the CEO search ongoing in tandem [57] Question: Clarification on the $205 million contract terms - The $205 million target is not a firm commitment but an anticipated amount, with actual orders potentially being higher or lower based on demand [60] Question: Inventory levels in distribution channels - Management is monitoring inventory levels closely, noting that there was a shift from supply shortages to excess inventory as demand fluctuated [64][66]

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 March 31, 2022. 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 ...

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, 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 No. 001-16537 ORASURE TECHNOLOGIES, INC. (Exact name of registrant as specified in its charter) Delaware 36-4370966 (State or other jurisdiction ...

OraSure 4Q21 Earnings February 23, 2022 raSure Technologies DNAgenotek" 》 novosanis Forward-Looking Statements Disclaimer This presentation contains certain forward-looking statements, including with respect to products, product development activities, regulatory submissions and authorizations and other matters. 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 express ...

OraSure Technologies, Inc. (NASDAQ:OSUR) Q4 2021 Earnings Conference Call February 23, 2022 5:00 PM ET Company Participants Stephen Tang - President and Chief Executive Officer Scott Gleason - Interim Chief Financial Officer, Senior Vice President Corporate Communications and Investor Relations Lisa Nibauer - President of Diagnostics Kathleen Weber - President of Molecular Solutions Conference Call Participants Kevin Casey - J.P. Morgan Andrew Cooper - Raymond James Operator Welcome to the OraSure Technolo ...

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 September 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 . UNITED STATES SECURITIES AND EXCHANGE COMMISSION Commission File Number 001-16537 ORASURE TECHNOLOGIES, INC. (Exact Name of Registrant as Specified in Its Charter) (State or Other Jurisdiction of I ...

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 ...