ORASURE TECHNOLOGIES INC

Previous wording

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

Current wording

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

Previous wording

The Company's business also includes sample management solutions and services that are used by clinical laboratories, direct-to-consumer laboratories, researchers, pharmaceutical companies, and animal health service and product providers. The revenues from sample management solutions are derived from product sales to commercial customers and sales into the academic and research markets. Customers span the disease risk management, diagnostics, pharmaceutical, biotech, companion animal and environmental markets. The Company has also developed collection devices for the emerging microbiome market, which focuses on studying microbiomes and their effect on human and animal health. The Company also has a urine collection device which allows for the volumetric collection of first void urine. This product is in its early stages, and initial sales are occurring primarily through distributors and collaborations in the liquid biopsy and sexually transmitted disease markets.

Current wording

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

Previous wording

In the third quarter of 2024, the Company announced the discontinuance of sales of its risk assessment product line which was completed in the second quarter of 2025. Sales of its risk assessment products did not contribute to revenues during the three months ended September 30, 2025. Sales of its risk assessment products contributed $1.9 million to revenues during the three months ended September 30, 2025 and 2024. Sales of its risk assessment products contributed $1.9 million and $6.3 million to revenues during the nine months ended September 30, 2025 and 2024, respectively. During the first quarter of 2025, the Company sold certain assets that made up the risk assessment product line including certain intellectual property, contracts, permits, and equipment.

Current wording

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

Previous wording

All dollar amounts in tables are presented in thousands.

Current wording

Results of Operations (all dollar amounts in tables are presented in thousands)

Previous wording

(1)Includes HIV, HCV, Syphilis, and SureQuick® product revenues.

Current wording

(1)Includes HIV, HCV, Syphilis, SickleSCAN® and SureQuick® product revenues.

Previous wording

Sales of the Company's Diagnostics products decreased 34% to $14.5 million for the three months ended September 30, 2025 from $22.0 million for the three months ended September 30, 2024. This decrease in revenues is largely due to lower international HIV revenues driven by reduced funding and customer ordering patterns. Sales of domestic HIV also declined driven by reduced funding and due to a decrease in orders under the Together Take Me Home program.

Current wording

Sales of the Company's Diagnostics products decreased 5% to $16.9 million for the three months ended March 31, 2026 from $17.7 million for the three months ended March 31, 2025. This decrease in revenues is largely due to lower international HCV revenues driven by customer ordering patterns and funding constraints. This decline in revenues was offset by an increase in Company's Syphilis product sales to new customers in the women's health market.

Previous wording

COVID-19 Diagnostics revenues decreased 96% to $0.09 million for the three months ended September 30, 2025 compared to $2.2 million for the three months ended September 30, 2024 due to decreased sales of the Company's InteliSwab® tests through its U.S. government procurement contracts. We expect this level of revenue to continue throughout the remainder of 2025 and for the foreseeable future due to the fulfillment of these contracts and lower overall demand for COVID-19 testing.

Current wording

COVID-19 Diagnostics sales decreased 96% to $18.0 thousand for the three months ended March 31, 2026 from $0.5 million for the three months ended March 31, 2025, due to completion of the Company's InteliSwab® tests contract with the U.S. government and lower overall demand for COVID-19 testing.

Previous wording

Non-product and services revenues increased 565% to $1.7 million for the three months ended September 30, 2025 from $0.3 million for the three months ended September 30, 2024 primarily due to the recognition of revenue under funded R&D contracts that were assumed by the Company as a result of the Sherlock acquisition at the end of 2024 as well as an increase in funded R&D under other BARDA contracts.

Current wording

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

Previous wording

Consolidated gross profit margin increased to 43.5% for the three months ended September 30, 2025 compared to 42.8% for the three months ended September 30, 2024. The largest drivers of the margin increase were an improved product mix of higher margin product sales and higher non-product revenues which contribute 100% to gross margin. Offsetting these increases in gross margin was lower manufacturing absorption as a result of lower sales volume and higher scrap expense in the quarter.

Current wording

Consolidated gross profit margin increased to 42.3% for the three months ended March 31, 2026 compared to 41.1% for the three months ended March 31, 2025. The drivers of the margin increase were better absorption of fixed overhead costs due to operational efficiencies, improved product mix, and higher non-product revenues which contribute 100% to gross margin. An increase in scrap expense in the quarter partially offset the increases in gross margin.

Previous wording

Consolidated operating loss for the three months ended September 30, 2025 was $16.1 million compared to a $6.0 million operating loss reported for the three months ended September 30, 2024. The higher operating loss reported in the third quarter of 2025 was largely a result of lower revenues coupled with an increased spend on clinical trials.

Current wording

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

Previous wording

Research and development expenses increased 80% to $10.1 million for the three months ended September 30, 2025 from $5.6 million for the three months ended September 30, 2024 largely due to higher spend incurred for clinical trials associated with the Chlamydia Trachomatis (CT) and Neisseria Gonorrhoeae (NG) device and additional R&D operational expense layered in from the acquired Sherlock companies.

Current wording

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

Previous wording

Sales and marketing expenses decreased 17% to $6.3 million for the three months ended September 30, 2025 from $7.6 million for the three months ended September 30, 2024 due to lower employee costs as a result of reduced headcount from reduction in force initiatives taken in 2024.

Current wording

Sales and marketing expenses decreased 1% to $6.8 million for the three months ended March 31, 2026 from $6.9 million for the three months ended March 31, 2025.

Previous wording

General and administrative expenses increased 13% to $11.1 million for the three months ended September 30, 2025 from $9.8 million for the three months ended September 30, 2024 largely due an increase in legal fees and additional general and administrative costs incurred from the newly acquired Sherlock companies.

Current wording

General and administrative expenses increased 3% to $14.6 million for the three months ended March 31, 2026 from $14.1 million for the three months ended March 31, 2025 largely due to an increase in professional services and severance charges.

Previous wording

During the three months ended September 30, 2025, the Company recorded a non-cash adjustment of $0.4 million, reflecting the change in the estimated fair value of the Sherlock acquisition-related contingent consideration. The Sherlock acquisition was completed in December 2024 and there was no comparable amount in the third quarter of 2024.

Current wording

The Company recorded non-cash adjustments of $0.1 million for the three months ended March 31, 2026, reflecting the change in the estimated fair value of the Sherlock acquisition-related contingent consideration.

Previous wording

All of the above contributed to the Company's operating loss of $16.1 million for the three months ended September 30, 2025, which included non-cash charges of $2.8 million for stock-based compensation, $2.5 million for depreciation and amortization, and $0.4 million for the change in the estimated fair value of acquisition-related contingent consideration. The Company's operating loss of $6.0 million for the three months ended September 30, 2024 included non-cash charges of $2.9 million for stock-based compensation, and $3.0 million for depreciation and amortization.

Current wording

All of the above contributed to the Company's operating loss of $23.3 million for the three months ended March 31, 2026, which included non-cash charges of $2.8 million for stock-based compensation, $2.3 million for depreciation and amortization, and $0.1 million for the change in the estimated fair value of acquisition-related contingent consideration. The Company's operating loss of $17.8 million for the three months ended March 31, 2025 included non-cash charges of $2.7 million for stock-based compensation, $2.8 million for depreciation and amortization, and $0.5 million for the change in the estimated fair value of acquisition-related contingent consideration.

Previous wording

Other income for the nine months ended September 30, 2025 was $5.7 million compared to $9.3 million for the nine months ended September 30, 2024. The decrease in other income is primarily due to lower interest income and foreign currency losses in 2025 versus foreign currency gains in 2024.

Current wording

Other income for the three months ended March 31, 2026 was $1.5 million compared to $1.8 million for the three months ended March 31, 2025. The decrease in other income is due to lower interest income and increased foreign currency losses.

Previous wording

The Company continues to believe the full valuation allowance established against its total U.S. deferred tax asset is appropriate as the facts and circumstances necessitating the allowance have not changed. For the three months ended September 30, 2025 and 2024, the Company recorded income tax expense of $47.0 thousand and $0.7 million, respectively. The decrease in the income tax expense is largely due to lower pre-tax earnings in both state and foreign jurisdictions.

Current wording

The Company continues to believe the full valuation allowance established against its total U.S. and U.K. deferred tax asset is appropriate as the facts and circumstances necessitating the allowance have not changed. For the three months ended March 31, 2026 and 2025, the Company recorded income tax benefits of $0.4 million and $0.5 million, respectively.

Previous wording

The Company's cash and cash equivalents decreased to $216.5 million at September 30, 2025 from $267.8 million at December 31, 2024. $84.7 million, or 39%, of the Company's $216.5 million in cash, cash equivalents and available-for-sale securities is held by DNAG, the Company's Canadian subsidiary.

Current wording

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

Previous wording

The Company's working capital decreased to $242.8 million at September 30, 2025 from $299.7 million at December 31, 2024. Working capital is primarily a function of sales, purchase volumes, inventory requirements, and vendor payment terms.

Current wording

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

Previous wording

During the nine months ended September 30, 2025, net cash used in operating activities was $40.0 million. Cash flows from operations can be significantly impacted by factors such as timing of receipt from customers, inventory purchases, and payments to vendors. The Company's net loss of $49.4 million included non-cash charges of stock-based compensation expense of $8.7 million and depreciation and amortization expense of $7.8 million, a loss on equity investment of $1.7 million, change in estimated fair value of acquisition-related contingent consideration of $1.6 million and other non-cash charges aggregating to $1.2 million.

Current wording

During the three months ended March 31, 2026, net cash used in operating activities was $13.9 million. Cash flows from operations can be significantly impacted by factors such as timing of receipts from customers, inventory purchases, and payments to vendors. The Company's net loss of $22.4 million included non-cash charges of stock-based compensation expense of $2.8 million, depreciation and amortization expense of $2.3 million, a loss on equity investment of $1.1 million, and other non-cash charges aggregating to $0.4 million.

Previous wording

Cash used by the Company's working capital accounts included a decrease in accrued expenses and other liabilities of $5.3 million largely consisting of the payment of year-end bonuses in March 2025, an increase in prepaid expenses and other assets of $1.9 million as the Company is prepaying for clinical trials, a decrease of $1.7 million in accounts payable, and a decrease in deferred revenue of $1.1 million as work on grant projects is completed and earned. Offsetting these uses of cash is a decrease in inventory of $0.9 million as the Company experienced a decline in sales.

Current wording

Changes in the Company's working capital accounts contributed to cash and included an increase of $4.1 million in accounts payable associated with the timing of spend on consulting services and inventory purchases, a decrease in overall inventory balances of $0.7 million due to maintaining lower COVID-19 inventory levels attributable to decreased demand, a decrease in prepaid expenses and other assets of $0.6 million, and an increase in accrued expenses and other liabilities of $0.6 million. These contributions to cash were offset by an increase in accounts receivable of $2.6 million due to timing of shipments and invoicing and a decrease in deferred revenue of $0.6 million as work on grant projects is completed and earned.

Previous wording

Net cash used in investing activities was $2.4 million for the nine months ended September 30, 2025, associated with proceeds from sale of property and equipment offset by the acquisition of new property and equipment.

Current wording

Net cash used in investing activities was $0.9 million for the three months ended March 31, 2026, for purchases of property and equipment.

Previous wording

Net cash used in financing activities was $11.8 million for the nine months ended September 30, 2025, which was largely comprised of $10.0 million to repurchase common stock and $1.8 million used for the repurchase of common stock to satisfy withholding taxes related to the vesting of restricted stock awarded to the Company's employees.

Current wording

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

Previous wording

A more detailed review of the Company's critical accounting policies is contained in its Annual Report on Form 10-K for the year ended December 31, 2024 filed with the SEC. No material changes have been made to such critical accounting policies during the nine months ended September 30, 2025.

Current wording

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