Company Overview - OraSure Technologies, Inc. is a leader in the development, manufacture, and distribution of rapid diagnostic tests and sample collection devices designed to detect critical medical conditions [3] - The company aims to transform health through actionable insights and improve access, quality, and value of healthcare with innovative testing solutions [3] Upcoming Earnings Conference Call - OraSure has scheduled its earnings conference call for the second quarter of 2024 financial results on August 6, 2024, at 5 p.m. ET [1] - A webcast of the conference call will be available on the investor relations page of OraSure's website, and it will be archived for approximately 90 days after the call [2] Participation Details - Participants interested in asking questions during the conference call must preregister to receive access details via email [3]

Core Insights - OraSure Technologies, Inc. supports National HIV Testing Day initiatives to encourage HIV testing across the U.S. [1] - The CDC estimates 1.2 million people in the U.S. are living with HIV, with 14% unaware of their status, and Black/African American individuals represent 40% of infections despite being only 12% of the population [2] - The OraQuick® HIV Self-Test has empowered millions globally to learn their HIV status and connect to care [3] - OraSure's partnership with the CDC aims to distribute one million free HIV test kits over five years, targeting communities disproportionately affected by HIV [3] - The updated OraQuick® HIV Self-Test features improved sustainability, reducing packaging waste by 1,500 tons of paper and 450 tons of plastic annually [4] - National HIV Testing Day promotes awareness and testing, with OraSure providing tests for free rapid HIV testing in over 550 Walgreens stores [5] Company Overview - OraSure Technologies transforms health through actionable insights and enhances healthcare access and quality with innovative diagnostic tests and sample management solutions [6] - The company’s products are sold globally to various entities, including clinical laboratories, hospitals, and direct consumers [6]

Core Points - OraSure Technologies, Inc. supports HIV testing initiatives across the U.S. in recognition of National HIV Testing Day on June 27th, aiming to encourage testing among thousands of individuals [1][8] - The OraQuick® HIV Self-Test has empowered millions globally to learn their HIV status and connect to care, with a commitment to providing access to critical health information [2][6] - An updated version of the OraQuick® HIV Self-Test has been launched, featuring sustainability improvements such as reduced packaging, which is expected to save 1,500 tons of paper and 450 tons of plastic annually [2][6] - The CDC estimates that 1.2 million people in the U.S. are living with HIV, with approximately 14% unaware of their status, and Black/African American individuals disproportionately represent 40% of estimated infections [6][7] - OraSure supplies its OraQuick® HIV Self-Test to the CDC's Together Take Me Home program, aiming to distribute one million free test kits over five years, targeting communities most impacted by HIV [7] - As part of National HIV Testing Day, OraSure provided tests for free rapid HIV testing in over 550 Walgreens stores to promote awareness and encourage testing [8] Company Overview - OraSure Technologies is a leader in point-of-care and home diagnostic tests, focusing on improving access, quality, and value of healthcare through innovative testing solutions [9] - The company, along with its subsidiary DNA Genotek Inc., develops and distributes rapid diagnostic tests and sample collection devices for critical medical conditions [9]

PART I. FINANCIAL INFORMATION [Item 1. Financial Statements (Unaudited)](index=8&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) OraSure Technologies reported a significant Q1 2024 net revenue decrease and net loss, primarily due to declining COVID-19 test sales [Consolidated Balance Sheets](index=8&type=section&id=Consolidated%20Balance%20Sheets) Total assets decreased to $467.6 million by March 31, 2024, primarily due to reduced cash and a new $28.3 million equity investment Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $247,145 | $290,407 | | Total current assets | $348,505 | $386,459 | | Investment in equity method investee | $28,333 | $0 | | Total Assets | $467,558 | $482,845 | | **Liabilities & Equity** | | | | Total current liabilities | $29,105 | $39,536 | | Total Liabilities | $41,307 | $52,174 | | Total stockholders' equity | $426,251 | $430,671 | [Consolidated Statements of Operations](index=9&type=section&id=Consolidated%20Statements%20of%20Operations) Q1 2024 saw a net loss of $3.6 million, a reversal from prior year's net income, driven by a 65% revenue decline from COVID-19 product sales Q1 2024 vs Q1 2023 Performance (in thousands, except per share data) | Metric | Q1 2024 | Q1 2023 | | :--- | :--- | :--- | | Net Revenues | $54,132 | $154,963 | | Gross Profit | $24,065 | $65,815 | | Operating Income (Loss) | ($7,093) | $24,321 | | Net Income (Loss) | ($3,584) | $27,219 | | Diluted EPS | ($0.05) | $0.37 | [Consolidated Statements of Cash Flows](index=11&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) Operating activities generated $6.7 million, but significant investing activities, including a $28.3 million equity investment, led to a $43.3 million cash decrease Cash Flow Summary (in thousands) | Activity | Q1 2024 | Q1 2023 | | :--- | :--- | :--- | | Net cash provided by operating activities | $6,738 | $6,002 | | Net cash provided by (used in) investing activities | ($46,528) | $1,016 | | Net cash used in financing activities | ($1,297) | ($1,331) | | **Net (Decrease) in Cash** | **($43,262)** | **$6,214** | [Notes to the Consolidated Financial Statements](index=12&type=section&id=Notes%20to%20the%20Consolidated%20Financial%20Statements) Notes detail a $28.3 million Sapphiros investment, $3.3 million impairment charges, workforce reductions, an 80% decline in COVID-19 sales, and ongoing patent litigation - In January 2024, the company invested **$28.3 million** in Sapphiros, a privately held consumer diagnostics company, as part of a strategic distribution agreement. This investment is accounted for using the equity method[33](index=33&type=chunk)[69](index=69&type=chunk) - The company recorded pre-tax asset impairment charges of **$1.8 million** for property, plant, and equipment and **$1.5 million** for right-of-use assets in Q1 2024. These charges are a result of the strategic decision to exit the microbiome molecular sequencing services business (Diversigen) and close its Belgian operations (Novosanis)[37](index=37&type=chunk)[45](index=45&type=chunk) - A reduction in workforce was executed in Q1 2024, largely affecting COVID-19 manufacturing, resulting in **$0.4 million** of termination benefit charges[50](index=50&type=chunk) - A single non-commercial customer accounted for **40% of net consolidated revenues** for the three months ended March 31, 2024, down from 78% in the prior year period[51](index=51&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=22&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management attributes the 65% revenue decline to reduced COVID-19 sales, resulting in a $7.1 million operating loss despite improved gross margin and reduced operating expenses [Recent Developments](index=22&type=section&id=Recent%20Developments) Recent developments include winding down Novosanis and Diversigen operations, alongside a strategic investment and distribution agreement with Sapphiros - The company is winding down operations at its Novosanis subsidiary in Belgium and exiting the molecular services business offered by its Diversigen subsidiary[68](index=68&type=chunk) - Announced a strategic investment and distribution agreement with Sapphiros, a consumer diagnostics company, with a commitment of up to **$30.0 million**[69](index=69&type=chunk)[70](index=70&type=chunk) [Results of Operations](index=23&type=section&id=Results%20of%20Operations) Net revenues declined 65% to $54.1 million, primarily due to an 80% drop in COVID-19 Diagnostics sales, leading to a $7.1 million operating loss Net Revenues by Category (in thousands) | Category | Q1 2024 | Q1 2023 | % Change | | :--- | :--- | :--- | :--- | | COVID-19 Diagnostics | $23,097 | $118,254 | (80)% | | Diagnostics (HIV, HCV) | $16,380 | $17,090 | (4)% | | Molecular Sample Management Solutions | $10,822 | $12,942 | (16)% | | **Total Net Revenues** | **$54,132** | **$154,963** | **(65)%** | - The **80% decrease in COVID-19 Diagnostics revenue** was due to decreased sales through U.S. government procurement contracts, a decline expected to continue through 2024[74](index=74&type=chunk) - Consolidated gross profit margin increased to **44.5%** from 42.5% year-over-year, driven by higher average selling prices on InteliSwab® sales and lower scrap expense[80](index=80&type=chunk) - Operating expenses, excluding impairment charges, decreased by **$12.6 million** compared to Q1 2023, reflecting the impact of cost-saving measures and headcount reductions[82](index=82&type=chunk) [Liquidity and Capital Resources](index=25&type=section&id=Liquidity%20and%20Capital%20Resources) Cash and short-term investments decreased to $263.8 million, mainly due to a $28.3 million investment in Sapphiros, though operating activities generated $6.7 million Liquidity Position (in thousands) | Metric | March 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | Cash and cash equivalents | $247,145 | $290,407 | | Short-term investments | $16,627 | $0 | | Working capital | $319,400 | $346,923 | - Cash from operating activities was **$6.7 million**, driven by positive non-cash adjustments (depreciation, stock compensation, impairments) and favorable changes in accounts receivable and inventory, offset by payments for accrued year-end bonuses[93](index=93&type=chunk) - Net cash used in investing activities was **$46.5 million**, reflecting the **$28.3 million** investment in Sapphiros and net purchases of short-term investments[94](index=94&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=26&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) No material changes to the company's market risk assessment have occurred since the 2023 Annual Report on Form 10-K - There have been no material changes to the company's market risk disclosures since its 2023 Form 10-K[100](index=100&type=chunk) [Item 4. Controls and Procedures](index=26&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls and procedures were effective as of March 31, 2024, with no material changes to internal control over financial reporting - Management concluded that disclosure controls and procedures were effective as of March 31, 2024[101](index=101&type=chunk) - No material changes to internal control over financial reporting occurred during the first quarter of 2024[102](index=102&type=chunk) PART II. OTHER INFORMATION [Item 1. Legal Proceedings](index=27&type=section&id=Item%201.%20Legal%20Proceedings) Ongoing patent litigation with Spectrum Solutions includes an appealed noninfringement ruling and unfavorable PTO decisions, with no expected material adverse financial impact - The company is appealing a District Court's summary judgment of noninfringement in its patent litigation against Spectrum Solutions, with oral arguments expected in the second half of 2024[105](index=105&type=chunk) - The Patent and Trademark Office (PTO) has issued an unfavorable decision on one patent in the litigation and has instituted a review of a third related patent[105](index=105&type=chunk) [Item 1A. Risk Factors](index=27&type=section&id=Item%201A.%20Risk%20Factors) No material changes to the company's risk factors have been reported since the 2023 Annual Report on Form 10-K - No material changes to the risk factors from the 2023 Annual Report on Form 10-K have been reported[106](index=106&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=28&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company repurchased 193,478 shares in Q1 2024, primarily to satisfy tax withholding obligations for employee stock awards, not as part of a public program Share Repurchases in Q1 2024 | Period | Total Shares Purchased | Average Price Paid per Share | | :--- | :--- | :--- | | Jan 2024 | 59,151 | $8.19 | | Feb 2024 | 55,620 | $7.40 | | Mar 2024 | 78,707 | $7.18 | | **Total** | **193,478** | | - The repurchased shares were retired to satisfy minimum tax withholdings for employees upon the vesting of stock awards and were not part of the company's publicly announced share repurchase program[111](index=111&type=chunk) [Item 3. Defaults Upon Senior Securities](index=28&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reports no defaults upon senior securities - The company reports no defaults upon senior securities[112](index=112&type=chunk) [Item 4. Mine Safety Disclosures](index=28&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - This item is not applicable to the company[112](index=112&type=chunk) [Item 5. Other Information](index=28&type=section&id=Item%205.%20Other%20Information) The company reports no other information under this item - The company reports no other information under this item[112](index=112&type=chunk) [Item 6. Exhibits](index=29&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including CEO/CFO certifications and Inline XBRL documents - The exhibits filed include required certifications from the CEO and CFO, as well as Interactive Data Files (XBRL)[113](index=113&type=chunk)

Financial Data and Key Metrics Changes - In Q1 2024, the company reported total revenue of $54.1 million, with core revenue (excluding COVID-19 products) at $31 million, which was at the high end of guidance [48][22] - GAAP operating loss for Q1 was $7.1 million, while non-GAAP operating loss was $300,000 [23] - GAAP gross margin was 44.5%, and non-GAAP gross margin was 45.2%, consistent with expectations [49] Business Line Data and Key Metrics Changes - Molecular Sample Management Solutions revenue decreased by 16% year-over-year to $10.8 million [22] - COVID-19 products, primarily InteliSwab, generated $23.1 million in revenue, with stronger purchasing patterns than forecasted [22] - Core diagnostics revenue was $16.4 million in Q1, a decrease of 4% year-over-year [48] Market Data and Key Metrics Changes - The market environment for Molecular Sample Management Solutions remains muted post-COVID, influenced by regulatory uncertainty and evolving research priorities [19] - The company is experiencing a decline in microbiome services revenue and lacks visibility for near-term growth in this segment [16] Company Strategy and Development Direction - The company is focused on strengthening its foundation, elevating core growth, and accelerating profitable growth through operational efficiency and strategic partnerships [4][15] - Plans to exit the microbiome sequencing services business and close the Novosanis site in Belgium are expected to result in over $15 million in annual expense reductions [17][25] - The company aims to achieve breakeven in operating cash flow from its core business by the end of 2024 [25] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's position to execute its vision of transforming health through actionable insights [27] - The company anticipates slight sequential improvement in core revenue in Q3 and Q4 compared to Q2 outlook [52] - Management highlighted the importance of strategic partnerships and internal investments for future growth [31][47] Other Important Information - The company has a healthy balance sheet with zero debt and total cash, cash equivalents, and short-term investments of $264 million [52] - A multiyear deal with 23andMe was signed to provide the Oragene collection device for health and ancestry services [20] - The company published its 2023 to 2024 OraSure Cares ESG report, highlighting sustainability and governance initiatives [21] Q&A Session Summary Question: Opportunities for partnerships and M&A - Management discussed seven announced partnerships and expressed interest in M&A opportunities while focusing on internal investments [31] Question: Additional operational efficiencies - Management mentioned site consolidations and automation as key levers for operational efficiency beyond the current restructuring initiatives [33] Question: Impact of winding down Diversigen - Management clarified that the decision to wind down Diversigen was based on cost considerations and a lack of strategic alignment, emphasizing a focus on core strengths [67] Question: Cash flow expectations - Management indicated potential upside for cash flow from accounts receivable and inventory, aiming for core business to generate cash flow from operations [68]

OraSure Technologies (OSUR) came out with quarterly earnings of $0.04 per share, in line with the Zacks Consensus Estimate. This compares to earnings of $0.37 per share a year ago. These figures are adjusted for non-recurring items.A quarter ago, it was expected that this diagnostic test maker would post earnings of $0.13 per share when it actually produced earnings of $0.22, delivering a surprise of 69.23%.Over the last four quarters, the company has surpassed consensus EPS estimates two times.OraSure, whi ...

[Q1 2024 Financial Highlights and Strategic Overview](index=1&type=section&id=Item%201%20Q1%202024%20Financial%20Highlights%20and%20Strategic%20Overview) The company reported a significant revenue decline due to lower COVID-19 sales but is implementing major restructuring initiatives to achieve cost savings and breakeven [Executive Summary](index=1&type=section&id=Item%201.1%20Executive%20Summary) OraSure reported Q1 2024 revenue of $54.1 million and is undergoing restructuring to achieve $15 million in annualized cost reductions Q1 2024 Key Financial Metrics | Metric | Q1 2024 | Q1 2023 | % Change | | :----- | :------ | :------ | :------- | | Total Net Revenue | $54.1M | $155.0M | (65)% | | Core Business Revenue | $31.0M | $36.6M | (15)% | | COVID-19 Revenue | $23.1M | $118.4M | (80)% | | GAAP EPS | $(0.05) | $0.37 | NM | | Non-GAAP EPS | $0.04 | $0.47 | (91)% | - Restructuring initiatives are expected to result in **$15 million of annualized expense reductions** and position OraSure to achieve **cash flow breakeven** for the core business by the end of 2024[1](index=1&type=chunk)[3](index=3&type=chunk) - Initial orders for Syphilis Health Check were delivered as part of a distribution agreement with Diagnostics Direct[2](index=2&type=chunk) [Recent Business Developments and Strategic Initiatives](index=3&type=section&id=Item%201.2%20Recent%20Business%20Developments%20and%20Strategic%20Initiatives) The company initiated several strategic actions, including business exits and insourcing, to streamline operations and enhance efficiency - Initiated steps to wind down and exit the Diversigen microbiome laboratory and analytical sequencing services business by end of **Q3 2024**, expected to result in over **$10 million in annualized cost savings**; Diversigen generated **$4 million in revenue** over the last 12 months[7](index=7&type=chunk)[8](index=8&type=chunk) - Commenced projects to insource production of certain sample management products, expected to yield **$5 million in annual cost savings** upon completion within **18 months**[9](index=9&type=chunk) - Initiated steps to close the Novosanis site in Belgium by the **end of 2024** for further integration, while continuing to develop and sell the Colli-Pee® device[9](index=9&type=chunk) - Successfully launched sales and distribution partnerships with Diagnostics Direct and Anaerobe Systems to enter new market segments[9](index=9&type=chunk) - Remains on track to achieve **operating cash flow break-even** for the core business by the **end of 2024**[9](index=9&type=chunk) [Detailed Financial Results](index=1&type=section&id=Item%202%20Detailed%20Financial%20Results) The company's financials show a steep revenue decline from reduced COVID-19 sales, though gross margins improved, alongside a stable balance sheet [Consolidated Statements of Operations (Income Statement)](index=1&type=section&id=Item%202.1%20Consolidated%20Statements%20of%20Operations%20(Income%20Statement)) A significant drop in COVID-19 related revenue led to a net loss, although gross margin percentage improved year-over-year Consolidated Operations Summary | Metric | Q1 2024 ($000s) | Q1 2023 ($000s) | % Change | | :----------------------- | :-------------- | :-------------- | :------- | | Net revenues | $54,132 | $154,963 | (65)% | | Gross profit | $24,065 | $65,815 | (63)% | | Gross margin | 44.5% | 42.5% | 2.0 pp | | Non-GAAP gross profit | $24,447 | $66,277 | (63)% | | Non-GAAP gross margin | 45.2% | 42.8% | 2.4 pp | | Operating income (loss) | $(7,093) | $24,321 | NM | | Non-GAAP operating income (loss) | $(325) | $32,658 | NM | | Net income (loss) | $(3,584) | $27,219 | NM | | Non-GAAP net income (loss) | $3,086 | $34,556 | (91)% | [Revenue Performance by Segment](index=1&type=section&id=Item%202.1.1%20Revenue%20Performance%20by%20Segment) Revenue declined across all segments, driven by a sharp 80% drop in COVID-19 related sales Revenue by Segment | Revenue Segment | Q1 2024 ($000s) | Q1 2023 ($000s) | % Change | | :-------------------------- | :-------------- | :-------------- | :------- | | Core Business | $31,004 | $36,554 | (15)% | | COVID-19 | $23,128 | $118,409 | (80)% | | Total Net Revenue | $54,132 | $154,963 | (65)% | | COVID-19 Diagnostics | $23,097 | $118,254 | (80)% | | Diagnostics | $16,380 | $17,090 | (4)% | | Molecular Sample Management Solutions | $10,822 | $12,942 | (16)% | | Other products and services | $2,576 | $3,094 | (17)% | | Molecular Services | $873 | $1,379 | (37)% | | COVID-19 Molecular Products | $31 | $155 | (80)% | | Net product and services revenues | $53,779 | $152,914 | (65)% | | Non-product and services revenues | $353 | $2,049 | (83)% | - Core revenue decreased **15%** year-over-year, with Diagnostics revenue down **4%** and Molecular Sample Management Solutions revenue down **16%**[7](index=7&type=chunk) - COVID-19 revenue decreased **80%** year-over-year, consistent with expectations as government contract volumes tapered[7](index=7&type=chunk) [Profitability and Margins Analysis](index=3&type=section&id=Item%202.1.2%20Profitability%20and%20Margins%20Analysis) Both GAAP and Non-GAAP gross margins improved, while operating margins declined significantly due to lower revenues Key Margin Metrics | Metric | Q1 2024 | Q1 2023 | Change (pp) | | :-------------------- | :------ | :------ | :---------- | | GAAP Gross Margin | 44.5% | 42.5% | 2.0 | | Non-GAAP Gross Margin | 45.2% | 42.8% | 2.4 | | GAAP Operating Margin | (13.1)% | 15.7% | (28.8) | | Non-GAAP Operating Margin | (0.6)% | 21.1% | (21.7) | - Gross margin benefited from increased average selling price on InteliSwab® and lower manufacturing scrap expense year-over-year[7](index=7&type=chunk) [Earnings Per Share (EPS) Performance](index=1&type=section&id=Item%202.1.3%20Earnings%20Per%20Share%20(EPS)%20Performance) The company reported a GAAP net loss per share and a significant decline in Non-GAAP earnings per share compared to the prior year EPS Comparison | Metric | Q1 2024 | Q1 2023 | % Change | | :----------- | :------ | :------ | :------- | | GAAP EPS | $(0.05) | $0.37 | NM | | Non-GAAP EPS | $0.04 | $0.47 | (91)% | [Condensed Consolidated Balance Sheets](index=6&type=section&id=Item%202.2%20Condensed%20Consolidated%20Balance%20Sheets) The company maintained a strong cash position of $263.8 million, with a slight decrease in total assets from year-end 2023 Key Balance Sheet Items | Balance Sheet Item | March 31, 2024 ($000s) | December 31, 2023 ($000s) | | :------------------------- | :--------------------- | :----------------------- | | Cash and cash equivalents | $247,145 | $290,407 | | Short-term investments | $16,627 | — | | Total Assets | $467,558 | $482,845 | | Total Liabilities | $41,307 | $52,174 | | Stockholders' Equity | $426,251 | $430,671 | | Investment in equity method investee | $28,333 | — | - Cash, cash equivalents, and short-term investments totaled **$263.8 million** as of March 31, 2024, a **$26.6 million decrease** from the prior quarter, primarily due to a **$28.3 million investment** in Sapphiros[7](index=7&type=chunk) [Consolidated Statement of Cash Flows](index=6&type=section&id=Item%202.3%20Consolidated%20Statement%20of%20Cash%20Flows) Operating activities provided positive cash flow, but investing activities led to a net cash outflow due to strategic investments Summary of Cash Flows | Cash Flow Activity | Q1 2024 ($000s) | Q1 2023 ($000s) | | :-------------------------- | :-------------- | :-------------- | | Net cash provided by operating activities | $6,738 | $6,002 | | Net cash provided by (used in) investing activities | $(46,528) | $1,016 | | Net cash used in financing activities | $(1,297) | $(1,331) | | Net increase (decrease) in cash and cash equivalents | $(43,262) | $6,214 | - The **$28.3 million investment** in Sapphiros was a primary driver of the decrease in the cash balance during the first quarter[7](index=7&type=chunk) [Financial Guidance and Outlook](index=4&type=section&id=Item%203%20Financial%20Guidance%20and%20Outlook) The company provides its revenue outlook for the second quarter of 2024, detailing expectations for core and InteliSwab® sales [Q2 2024 Revenue Guidance](index=4&type=section&id=Item%203.1%20Q2%202024%20Revenue%20Guidance) OraSure projects Q2 2024 revenue between $50 million and $55 million, including contributions from its core and InteliSwab® businesses Q2 2024 Guidance | Q2 2024 Guidance | Range ($M) | | :----------------- | :--------- | | Total Revenue | $50 - $55 | | Core Revenue | $33 - $36 | | InteliSwab® Revenue | $17 - $19 | - Q2 2024 guidance includes approximately **$650 thousand of revenue** from the Diversigen business that the company plans to exit[9](index=9&type=chunk) [Company and Product Information](index=9&type=section&id=Item%204%20Company%20and%20Product%20Information) This section details the company's business focus on diagnostic tests and sample management, and provides information on its InteliSwab® product [About OraSure Technologies](index=9&type=section&id=Item%204.1%20About%20OraSure%20Technologies) OraSure Technologies is a leader in point-of-care diagnostics and sample management solutions for various global markets - OraSure Technologies provides access to accurate, essential information through effortless tests, collection kits, and services to improve global health and wellness[18](index=18&type=chunk) - The company's portfolio includes rapid diagnostic tests, sample collection and stabilization devices, and molecular services solutions[18](index=18&type=chunk) - Products are sold globally to clinical laboratories, hospitals, physician's offices, clinics, public health organizations, research institutions, government agencies, pharmaceutical companies, commercial entities, and direct to consumers[18](index=18&type=chunk) [About InteliSwab®](index=9&type=section&id=Item%204.2%20About%20InteliSwab®) InteliSwab® is an FDA-authorized, user-friendly COVID-19 rapid test designed for over-the-counter and professional use - InteliSwab® COVID-19 rapid tests have received Emergency Use Authorizations (EUA) from the FDA for OTC, professional, and prescription home use[19](index=19&type=chunk) - The test features a unique design with a built-in swab for lower nostril self-collection, providing results within 30 minutes with minimal "hands-on time" and no instruments required[19](index=19&type=chunk) - Development and manufacturing expansion for InteliSwab® were funded in whole or in part with federal funds from the Department of Health and Human Services and the American Rescue Plan Act[20](index=20&type=chunk) [Investor Information and Disclosures](index=9&type=section&id=Item%205%20Investor%20Information%20and%20Disclosures) This section provides details on the investor conference call, forward-looking statements, and the use of non-GAAP financial measures [Conference Call Information](index=9&type=section&id=Item%205.1%20Conference%20Call%20Information) The company hosted a conference call and webcast on May 8, 2024, to discuss its Q1 2024 financial results - A conference call and audio webcast were held on **May 8, 2024**, at 4:45 p.m. Eastern Time to discuss Q1 2024 results and business developments[16](index=16&type=chunk) - The webcast is available on OraSure's investor relations page and will be archived for approximately **90 days**[17](index=17&type=chunk) [Forward-Looking Statements](index=10&type=section&id=Item%205.2%20Forward-Looking%20Statements) This section outlines forward-looking statements and associated risks that could cause actual results to differ materially - The press release contains forward-looking statements concerning products, product development, regulatory submissions, revenue guidance, cost savings, and cash flow[21](index=21&type=chunk) - Actual performance or results could differ materially due to factors such as ability to satisfy customer demand, regulatory approvals, competition, economic conditions, and supply chain stability[21](index=21&type=chunk)[22](index=22&type=chunk) - Readers are cautioned not to place undue reliance on these statements, which are made as of the date of the press release, and the company undertakes no duty to update them[22](index=22&type=chunk) [Non-GAAP Financial Measures and Reconciliation](index=11&type=section&id=Item%205.3%20Non-GAAP%20Financial%20Measures%20and%20Reconciliation) The company utilizes non-GAAP measures to provide supplemental information for analyzing core operating performance - Non-GAAP financial measures (gross margin, operating income/loss, EPS) are provided to supplement GAAP results, offering useful information for analyzing core operating results and comparisons[23](index=23&type=chunk) - Management uses non-GAAP measures for financial and operational decision-making, budgeting, and to help investors analyze the business's health[23](index=23&type=chunk) - Non-GAAP results are not a substitute for GAAP measures and may not be comparable across companies[24](index=24&type=chunk) [Statement Regarding Use of Non-GAAP Financial Measures](index=11&type=section&id=Item%205.3.1%20Statement%20Regarding%20Use%20of%20Non-GAAP%20Financial%20Measures) Non-GAAP measures are used to supplement GAAP results by excluding certain items to facilitate period-over-period comparisons - Non-GAAP financial measures are used to provide useful supplemental information to investors, facilitate analysis of core operating results, and compare operating results across reporting periods by excluding certain expenses not indicative of recurring core business operations[23](index=23&type=chunk) - Management uses non-GAAP measures for financial and operational decision-making and budgeting, and they are utilized by institutional investors and the analysis community[23](index=23&type=chunk) - Investors are encouraged to consider GAAP results alongside non-GAAP information, as non-GAAP measures are not a substitute for GAAP and may not be calculated uniformly by all companies[24](index=24&type=chunk) [GAAP to Non-GAAP Reconciliation Tables](index=12&type=section&id=Item%205.3.2%20GAAP%20to%20Non-GAAP%20Reconciliation%20Tables) This section provides detailed tables reconciling GAAP financial results to the company's non-GAAP measures Reconciliation of GAAP to Non-GAAP Results | Metric | GAAP Q1 2024 ($000s) | Non-GAAP Q1 2024 ($000s) | GAAP Q1 2023 ($000s) | Non-GAAP Q1 2023 ($000s) | | :--------------------------------------- | :------------------- | :--------------------- | :------------------- | :--------------------- | | Cost of products and services sold | $30,067 | $29,685 | $89,148 | $88,686 | | Gross Margin | 44.5% | 45.2% | 42.5% | 42.8% | | Operating Income (Loss) | $(7,093) | $(325) | $24,321 | $32,658 | | Net Income (Loss) | $(3,584) | $3,086 | $27,219 | $34,556 | | Earnings (Loss) Per Share | $(0.05) | $0.04 | $0.37 | $0.47 | - Adjustments to GAAP measures include stock compensation, amortization of acquisition-related intangible assets, reduction in workforce severance, loss on impairment, transformation related expenses, government grant accounting, change in fair value of acquisition-related contingent consideration, and tax effect of non-GAAP adjustments[26](index=26&type=chunk)[28](index=28&type=chunk)

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 __________________________________________________________ FORM 10-K __________________________________________________________ (Mark One) x ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 or o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________ to Commission Fil ...

[Financial Performance Overview](index=1&type=section&id=Financial%20Performance%20Overview) [Q4 & Full-Year 2023 Financial Highlights](index=1&type=section&id=Q4%20%26%20Full-Year%202023%20Financial%20Highlights) OraSure reported Q4 2023 total net revenue of $75.9 million, a 38% decrease year-over-year, primarily due to a 53% decline in COVID-19 related revenue. Core business revenue remained flat. For the full year 2023, total net revenue increased by 5% to $405.5 million. The company achieved a Q4 GAAP EPS of $0.27 and a Non-GAAP EPS of $0.22, while significantly increasing its cash balance to $290.4 million Q4 & Full-Year 2023 Revenue Breakdown (in thousands) | Revenue Source | Three Months Ended Dec 31, 2023 | Three Months Ended Dec 31, 2022 | % Change | Year Ended Dec 31, 2023 | Year Ended Dec 31, 2022 | % Change | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Core Business | $34,217 | $34,084 | 0% | $147,693 | $144,154 | 2% | | COVID-19 | $41,664 | $88,994 | -53% | $257,779 | $243,325 | 6% | | **Total Net Revenue** | **$75,881** | **$123,078** | **-38%** | **$405,472** | **$387,479** | **5%** | Q4 & Full-Year 2023 Key Financial Metrics | Metric | Q4 2023 | Q4 2022 | FY 2023 | FY 2022 | | :--- | :--- | :--- | :--- | :--- | | GAAP EPS | $0.27 | $0.22 | $0.72 | $(0.24) | | Non-GAAP EPS | $0.22 | $0.36 | $1.04 | $0.36 | | Gross Margin | 46.3% | 40.5% | 42.3% | 38.3% | | Non-GAAP Gross Margin | 49.7% | 40.9% | 45.5% | 40.1% | | Operating Income (Loss) | $3.9M | $14.6M | $32.7M | $(22.2)M | | Non-GAAP Operating Income | $13.6M | $18.6M | $73.6M | $22.5M | - The company's cash, cash equivalents, and short-term investments balance grew to **$290.4 million** as of December 31, 2023. The **$65.5 million increase** during Q4 was driven by improved operational performance and a **$24.4 million receipt** from a U.S. government contract[1](index=1&type=chunk)[7](index=7&type=chunk) [Management Commentary](index=1&type=section&id=Management%20Commentary) The CEO emphasized significant progress in the company's transformation, highlighting positive operating cash flow and margin expansion in 2023. The company is focused on disciplined execution and innovation to elevate core growth as COVID-19 revenues decline, and is on track to achieve break-even cash flow from operations for its core business by the end of 2024 - The company is on track to achieve its target of **break-even in cash flow from operations** for the core business by the end of 2024[2](index=2&type=chunk) - The strategic focus for 2024 is on elevating core growth to offset the expected tapering of COVID-19 contract volumes[3](index=3&type=chunk) - OraSure is investing in its innovation roadmap through both organic development and inorganic partnerships, such as recent agreements with Sapphiros and Diagnostics Direct[3](index=3&type=chunk) [Business and Strategic Developments](index=2&type=section&id=Business%20and%20Strategic%20Developments) [Recent Business Highlights](index=2&type=section&id=Recent%20Business%20Highlights) OraSure has recently undertaken several strategic initiatives to enhance its product portfolio and operational efficiency. Key developments include a strategic partnership with Sapphiros to broaden its diagnostic test offerings, an agreement with Diagnostics Direct to enter the U.S. syphilis testing market, and the consolidation of a distribution facility to reduce costs - Entered a strategic distribution relationship and made an investment in Sapphiros, a consumer diagnostics company, to offer a more comprehensive range of low-cost diagnostic tests and sample management solutions[7](index=7&type=chunk) - Signed a strategic agreement with Diagnostics Direct to distribute Syphilis Health Check, the first CLIA-waived, 10-minute point-of-care syphilis test, marking the company's entry into this market[8](index=8&type=chunk) - Consolidated one of its distribution facilities into its Opus Way facility to drive additional operating efficiencies and cost savings[8](index=8&type=chunk) [Financial Guidance](index=4&type=section&id=Financial%20Guidance) [Q1 2024 Outlook](index=4&type=section&id=Q1%202024%20Outlook) For the first quarter of 2024, OraSure anticipates total revenue to be in the range of $50 million to $54 million. This forecast is composed of $29 to $31 million from its core business and $21 to $23 million from its InteliSwab® product Q1 2024 Revenue Guidance (in millions) | Revenue Category | Guidance Range | | :--- | :--- | | Core Revenue | $29 - $31 | | InteliSwab® Revenue | $21 - $23 | | **Total Revenue** | **$50 - $54** | [Detailed Financial Statements](index=5&type=section&id=Detailed%20Financial%20Statements) [Consolidated Results of Operations](index=5&type=section&id=Consolidated%20Results%20of%20Operations) For the full year 2023, OraSure reported a net income of $53.7 million, a significant turnaround from a net loss of $17.1 million in 2022. This improvement was driven by a 5% increase in total net revenues to $405.5 million and a 16% rise in gross profit. The Diagnostics segment was a key growth driver with a 41% revenue increase, while Molecular Sample Management Solutions and Molecular Services saw declines Full-Year Results of Operations (in thousands) | Line Item | 2023 | 2022 | | :--- | :--- | :--- | | Net revenues | $405,472 | $387,479 | | Gross profit | $171,652 | $148,438 | | Operating income (loss) | $32,684 | $(22,156) | | Net income (loss) | $53,655 | $(17,133) | | Diluted EPS | $0.72 | $(0.24) | Full-Year Revenue by Category (in thousands) | Category | 2023 | 2022 | % Change | | :--- | :--- | :--- | :--- | | COVID-19 Diagnostics | $257,493 | $233,666 | 10% | | Diagnostics | $73,694 | $52,181 | 41% | | Molecular Sample Management Solutions | $54,274 | $63,342 | -14% | | Molecular Services | $4,474 | $7,296 | -39% | | COVID-19 Molecular Products | $286 | $9,659 | -97% | [Consolidated Balance Sheets](index=6&type=section&id=Consolidated%20Balance%20Sheets) As of December 31, 2023, OraSure's balance sheet showed total assets of $482.8 million, up from $444.2 million at year-end 2022. The most significant change was the increase in cash and cash equivalents to $290.4 million from $84.0 million. Concurrently, inventories were nearly halved to $47.6 million, and accounts receivable decreased to $40.2 million, reflecting improved working capital management Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | Dec 31, 2023 | Dec 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $290,407 | $83,980 | | Accounts receivable, net | $40,171 | $70,797 | | Inventories | $47,614 | $95,704 | | Total assets | $482,845 | $444,180 | | **Liabilities & Equity** | | | | Total liabilities | $52,174 | $79,755 | | Stockholders' equity | $430,671 | $364,425 | | Total liabilities and stockholders' equity | $482,845 | $444,180 | [Consolidated Statement of Cash Flows](index=7&type=section&id=Consolidated%20Statement%20of%20Cash%20Flows) For the full year 2023, the company generated $141.6 million in cash from operating activities, a stark contrast to the $47.2 million used in 2022. This positive swing was primarily driven by the return to profitability and significant positive changes in working capital, including a $48.2 million reduction in inventories and a $31.1 million decrease in accounts receivable. Net cash from investing activities was $66.2 million, largely from maturities of short-term investments and government contract proceeds Full-Year Cash Flow Summary (in thousands) | Activity | 2023 | 2022 | | :--- | :--- | :--- | | Net cash provided by (used in) operating activities | $141,583 | $(47,202) | | Net cash provided by investing activities | $66,154 | $21,085 | | Net cash used in financing activities | $(3,023) | $(3,828) | | **Net increase (decrease) in cash** | **$206,427** | **$(32,782)** | - The turnaround in operating cash flow was driven by a net income of **$53.7 million** and favorable working capital changes, including a **$48.2 million decrease** in inventories and a **$31.1 million decrease** in accounts receivable[12](index=12&type=chunk) [Non-GAAP Financial Measures](index=11&type=section&id=Non-GAAP%20Financial%20Measures) [GAAP to Non-GAAP Reconciliation](index=11&type=section&id=GAAP%20to%20Non-GAAP%20Reconciliation) The company uses non-GAAP financial measures to provide investors with supplemental information by excluding items that may not be indicative of recurring core business operations. For the full year 2023, Non-GAAP net income was $77.6 million ($1.04 per share), compared to GAAP net income of $53.7 million ($0.72 per share). Major adjustments included stock compensation, impairment losses, accelerated depreciation, and transformation-related expenses - Management believes non-GAAP measures provide useful supplemental information, facilitate analysis of core operating results, and allow for greater transparency with key metrics used in decision-making[22](index=22&type=chunk) Full-Year 2023 GAAP to Non-GAAP Net Income Reconciliation (in thousands) | Description | Amount | | :--- | :--- | | **GAAP Net Income** | **$53,655** | | Stock compensation | $10,729 | | Loss on impairment | $10,829 | | Accelerated depreciation | $7,466 | | Inventory reserve for excess levels | $3,761 | | Reduction in workforce severance | $3,264 | | Additional profit from government contract | $(12,802) | | Other adjustments (net) | $2,807 | | Tax effect of Non-GAAP adjustments | $(2,124) | | **Non-GAAP Net Income** | **$77,585** | - Key adjustments to reconcile GAAP to Non-GAAP operating income for FY2023 include **$10.8 million** in impairment losses, **$10.7 million** in stock compensation, and **$7.5 million** in accelerated depreciation[24](index=24&type=chunk)

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ______________________________________ FORM 10-Q ______________________________________ (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023. OR o 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 ...