ORASURE TECHNOLOGIES INC

Previous 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.

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. 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.

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, 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 submitted a 510(k) to the FDA for clearance of its Colli-Pee® at-home urine collection device for sexually transmitted infections, which was approved in June 2026.

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. In June 2026, the Company received FDA 510(k) clearance for its Colli-Pee™•Dx Urine Collection Kit, a prescription device for the at-home self-collection of first-void urine for use with FDA-cleared sexually transmitted infection (STI) molecular assays with which the device has been validated. The device has been validated for use with Roche’s cobas® CT/NG and cobas® TV/MG assays.

Previous 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 six months ended June 30, 2026. Sales of its risk assessment products contributed $0.4 million to revenues during the three months ended June 30, 2025 and $1.9 million for the six months ended June 30, 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.

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 and as such the Company had no sales of its risk assessment products during the three and nine months ended September 30, 2026. There were no sales of the Company's risk assessment products during the three months ended September 30, 2025 and $1.9 million of sales for the nine months ended September 30, 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

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

Current wording

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

Previous wording

(5)Includes funded research and development contracts, royalty income and grant revenues.

Current wording

(3)Includes funded research and development contracts, royalty income and grant revenues.

Previous wording

Non-product and services revenues decreased 34% to $0.9 million for the three months ended June 30, 2026 from $1.4 million for the three months ended June 30, 2025 primarily due to the completion of various funded R&D contracts.

Current wording

Non-product and services revenues decreased 53% to $0.8 million for the three months ended September 30, 2026, from $1.7 million for the three months ended September 30, 2025, primarily due to the completion of various funded R&D contracts.

Previous wording

Consolidated gross profit margin increased to 43.5% for the three months ended June 30, 2026 compared to 42.1% for the three months ended June 30, 2025. The drivers of the margin increase are attributable to better absorption of fixed overhead costs due to operational efficiencies, partially offset by a negative product mix and lower non-product revenues which contribute 100% to gross margin.

Current wording

Consolidated gross profit margin increased to 45.2% for the three months ended September 30, 2026, compared to 43.5% for the three months ended September 30, 2025. The drivers of the margin increase are attributable to better absorption of fixed overhead costs due to operational efficiencies, partially offset by higher scrap and lower non-product revenues which contribute 100% to gross margin.

Previous wording

Consolidated operating income for the three months ended June 30, 2026 was $5.4 million compared to an operating loss of $18.0 million for the three months ended June 30, 2025.

Current wording

Consolidated operating loss for the three months ended September 30, 2026 was $13.0 million compared to an operating loss of $16.1 million for the three months ended September 30, 2025.

Previous wording

Sales and marketing expenses increased 4% to $6.6 million for the three months ended June 30, 2026 from $6.4 million for the three months ended June 30, 2025.

Current wording

Sales and marketing expenses increased 4% to $6.6 million for the three months ended September 30, 2026 from $6.3 million for the three months ended September 30, 2025.

Previous wording

General and administrative expenses increased 14% to $14.4 million for the three months ended June 30, 2026 from $12.7 million for the three months ended June 30, 2025 largely due to an increase in legal fees and in professional services related to the proxy statement and related stockholder activism costs.

Current wording

General and administrative expenses increased 8% to $12.0 million for the three months ended September 30, 2026 from $11.1 million for the three months ended September 30, 2025 largely due to higher legal fees.

Previous wording

All of the above contributed to the Company's operating income of $5.4 million for the three months ended June 30, 2026, which included non-cash charges of $2.4 million for depreciation and amortization and $2.3 million for stock-based compensation, and $22.6 million in non-cash income reflected in the change in the estimated fair value of acquisition-related contingent consideration. The Company's operating loss of $18.0 million for the three months ended June 30, 2025 included non-cash charges of $3.2 million for stock-based compensation, $2.5 million for depreciation and amortization, and $0.7 million for the change in the estimated fair value of acquisition-related contingent consideration.

Current wording

All of the above contributed to the Company's operating loss of $13.0 million for the three months ended September 30, 2026, which included non-cash charges of $2.3 million for stock-based compensation and $2.2 million for depreciation and amortization. The Company's operating loss of $16.1 million for the three months ended September 30, 2025, 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.

Previous wording

Other income for the three months ended June 30, 2026 was $1.4 million compared to $1.1 million for the three months ended June 30, 2025. The increase in other income is due to lower interest income offset by lower foreign currency losses.

Current wording

Other income for the three months ended September 30, 2026 was $1.2 million compared to $2.8 million for the three months ended September 30, 2025. The decrease in other income is due to lower interest income and lower foreign currency gains.

Previous 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 June 30, 2026 and 2025, the Company recorded income tax expense of $0.1 million and $2.0 million, respectively. During the three months ended June 30, 2026 and 2025, the Company had an effective tax rate of 0.8% and (11.8)%, respectively. The increase in the Company's tax rate was primarily due to the recording of a uncertain tax position in 2025 and projected break-even results in foreign operations in 2026 versus projected losses in 2025.

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 September 30, 2026 and 2025, the Company recorded income tax expense of $0.7 million and $47.0 thousand, respectively. During the three months ended September 30, 2026 and 2025, the Company had an effective tax rate of (6.0)% and (0.4)%, respectively. The decrease in the Company's tax rate was primarily due to the recording of a reduction in an uncertain tax position made in the third quarter of 2025 that did not reoccur in the third quarter of 2026.

Previous wording

The table below shows an outline of total consolidated net revenues for the six months ended June 30, 2026 and 2025:

Current wording

The table below shows an outline of total consolidated net revenues for the nine months ended September 30, 2026 and 2025:

Previous wording

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

Current wording

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

Previous wording

Sales of the Company's Diagnostics products decreased 2% to $36.2 million for the six months ended June 30, 2026 from $36.9 million for the six months ended June 30, 2025. This decline is primarily attributable to lower international HCV revenues driven by reduced reimbursement subsidies in the Asian market and a large order shipped into Africa in the second quarter of 2025 that did not recur. Domestic HCV revenues also declined as a result of a large customer's HCV testing programs ending and not being renewed, as well as reduced funding associated with other programs. In addition, domestic HIV revenues decreased due to lower purchases under the Together Take Me Home program partially offset by higher international revenues associated with timing of customer orders. These decreases were partially offset by higher syphilis sales driven by new customers in the women's health market and the inclusion of SickleSCAN®revenues, a new revenue stream acquired through the BioMedomics, Inc. acquisition completed in November 2025.

Current wording

Sales of the Company's Diagnostics products increased 3% to $53.0 million for the nine months ended September 30, 2026 from $51.4 million for the nine months ended September 30, 2025. This increase is primarily attributable to higher HIV international revenues associated with the Company's near shoring efforts in Africa, stabilization of African markets, and due to the timing of customer orders. The increase in revenues is also driven by higher syphilis sales associated with new customers in the women's health market and the inclusion of Sickle SCAN®revenues, a new revenue stream acquired through the BioMedomics, Inc. acquisition completed in November 2025. These increases in revenues were offset by lower international HCV revenues driven by reduced reimbursement subsidies in the Asian market and a large order shipped into Africa in the second quarter of 2025 that did not recur. Domestic HIV revenues also declined due to lower purchases under the Together Take Me Home program.

Previous wording

COVID-19 Diagnostics revenues decreased 96% to $19.0 thousand for the six months ended June 30, 2026 from $485.0 thousand for the six months ended June 30, 2025 due to lower overall demand for COVID-19 testing.

Current wording

COVID-19 Diagnostics revenues decreased 93% to $41.0 thousand for the nine months ended September 30, 2026, from $574.0 thousand for the nine months ended September 30, 2025 due to lower overall demand for COVID-19 testing.

Previous wording

Risk Assessment testing revenues decreased to zero for the six months ended June 30, 2026 from $1.9 million for the six months ended June 30, 2025. The Company discontinued this line of business at the end of 2024 and the business wound down in early 2025.

Current wording

Risk Assessment testing revenues was zero for nine months ended September 30, 2026, compared to $1.9 million for the nine months ended September 30, 2025. The Company discontinued this line of business at the end of 2024 and the business wound down in early 2025.

Previous wording

Consolidated gross profit margin increased to 42.9% for the six months ended June 30, 2026 from 41.6% for the six months ended June 30, 2025. The largest driver of the margin improvement is better absorption of fixed overhead costs due to operational efficiencies partially offset by higher scrap expense.

Current wording

Consolidated gross profit margin increased to 43.7% for the nine months ended September 30, 2026, from 42.2% for the nine months ended September 30, 2025. The largest driver of the margin improvement is better absorption of fixed overhead costs due to operational efficiencies partially offset by higher scrap expense.

Previous wording

Consolidated operating loss for the six months ended June 30, 2026 was $17.8 million, compared to a $35.8 million operating loss reported for the six months ended June 30, 2025. Results for the six months ended June 30, 2026 benefited from a $22.5 million change in the estimated fair value of acquisition-related contingent consideration but were negatively impacted by the decrease in revenues and by higher operating expenses.

Current wording

Consolidated operating loss for the nine months ended September 30, 2026 was $30.8 million, compared to a $51.9 million operating loss reported for the nine months ended September 30, 2025. Results for the nine months ended September 30, 2026 benefited from a $22.5 million change in the estimated fair value of acquisition-related contingent consideration but were negatively impacted by higher operating expenses.

Previous wording

Research and development expenses increased 10% to $23.1 million for the six months ended June 30, 2026 from $21.0 million for the six months ended June 30, 2025 largely due to higher spend incurred for clinical trials for the CT/NG and Colli-Pee® devices.

Current wording

Research and development expenses decreased 1% to $30.7 million for the nine months ended September 30, 2026, from $31.1 million for the nine months ended September 30, 2025 largely due to lower spend incurred for clinical trials for the CT/NG and Colli-Pee® devices as the clinical trials were completed in second quarter of 2026.

Previous wording

General and administrative expenses increased 8% to $29.0 million for the six months ended June 30, 2026 from $26.8 million for the six months ended June 30, 2025, largely due to higher professional, consulting, and legal fees associated with the proxy statement, including stockholder activism costs.

Current wording

General and administrative expenses increased 8% to $41.0 million for the nine months ended September 30, 2026, from $37.9 million for the nine months ended September 30, 2025, largely due to higher professional, consulting, and legal fees associated with litigation, and stockholder activism costs.

Previous wording

All of the above contributed to the Company's operating loss of $17.8 million for the six months ended June 30, 2026, which included non-cash income of $22.5 million reflected in the change in the estimated fair value of acquisition-related contingent consideration, and non-cash charges of $5.1 million for stock-based compensation, and $4.7 million for depreciation and amortization. The Company's operating loss of $35.8 million for the six months ended June 30, 2025 included a non-cash charge of $5.9 million for stock-based compensation, $5.3 million for depreciation and amortization, and $1.2 million for the change in the estimated fair value of acquisition-related contingent consideration.

Current wording

All of the above contributed to the Company's operating loss of $30.8 million for the nine months ended September 30, 2026, which included non-cash income of $22.5 million reflected in the change in the estimated fair value of acquisition-related contingent consideration, and non-cash charges of $7.3 million for stock-based compensation, and $6.9 million for depreciation and amortization. The Company's operating loss of $51.9 million for the nine months ended September 30, 2025 included a non-cash charge of $8.7 million for stock-based compensation, $7.8 million for depreciation and amortization, and $1.6 million for the change in the estimated fair value of acquisition-related contingent consideration.

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. The Company has not achieved U.S. cumulative pre-tax earnings based on a rolling three year window as the Company has not achieved a level of sustained profitability that would, in its judgment, support the release of the valuation allowance. For the six months ended June 30, 2026 and 2025, the Company recorded income tax benefit and expense of $0.4 million and $1.5 million, respectively. During the six months ended June 30, 2026 and 2025, the Company had an effective tax rate of 2.5% and (4.7)%, respectively. The increase in the Company's tax rate was primarily due to the recording of a uncertain tax position in 2025 and projected break-even results in foreign operations in 2026 versus projected losses in 2025.

Current 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. The Company has not achieved U.S. cumulative pre-tax earnings based on a rolling three-year window as the Company has not achieved a level of sustained profitability that would, in its judgment, support the release of the valuation allowance. For the nine months ended September 30, 2026 and 2025, the Company recorded income tax expense of $0.3 million and $1.6 million, respectively, reflecting effective tax rates of (1.2)% and (3.4)%, respectively. The increase in the Company's tax rate was primarily due to the recording of an uncertain tax position in 2025 and a estimated increase in foreign pre-tax income in 2026.

Previous wording

The Company's cash and cash equivalents decreased to $160.6 million at June 30, 2026 from $199.3 million at December 31, 2025. The Company has $84.6 million, or 53%, of its $160.6 million of cash and cash equivalents held by DNAG, the Company's Canadian subsidiary.

Current wording

The Company's cash and cash equivalents decreased to $148.2 million at September 30, 2026, from $199.3 million at December 31, 2025. The Company has $82.1 million, or 55%, of its $148.2 million of cash and cash equivalents held by DNAG, the Company's Canadian subsidiary.

Previous wording

The Company's working capital decreased to $197.8 million at June 30, 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.

Current wording

The Company's working capital decreased to $190.2 million at September 30, 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 six months ended June 30, 2026, net cash used in operating activities was $23.8 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 $16.1 million included non-cash charges of a change in the estimated fair value of acquisition-related contingent consideration of $22.5 million, stock-based compensation expense of $5.1 million, depreciation and amortization expense of $4.7 million, a loss on equity investment of $1.6 million, and other non-cash charges aggregating to $0.2 million.

Current wording

During the nine months ended September 30, 2026, net cash used in operating activities was $34.7 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 $29.2 million included a $22.5 million non-cash benefit from the change in the estimated fair value of acquisition-related contingent consideration, partially off set by stock-based compensation expense of $7.3 million, depreciation and amortization expense of $6.9 million, a loss on equity investment of $2.2 million, and other non-cash charges aggregating to $1.2 million.

Previous wording

Changes in the Company's working capital accounts contributed to cash and included an increase in accrued expenses and other liabilities of $2.9 million largely associated with higher compensation-related accruals, a decrease in prepaid expenses and other assets of $2.5 million resulting from lower deposits paid, an increase of $1.3 million in accounts payable associated with the timing of spend on consulting services and inventory purchases, and an overall decrease in inventory balances of $0.9 million due to an increase in inventory reserves associated with expired inventory and lower COVID-19 inventory levels due to decreased demand. These contributions to cash were offset by an increase in accounts receivable of $3.7 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.

Current wording

Cash used by the Company's working capital accounts included an increase in accounts receivable of $8.7 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. These uses of cash were partially offset by an increase in accrued expenses and other liabilities of $3.7 million largely associated with an increase in the company's profit sharing accrual as it builds toward a payout in early 2027, a decrease in prepaid expenses and other assets of $3.0 million resulting from the timing of payment for the Company's insurance renewals, an increase of $1.6 million in accounts payable largely associated with the timing of spend on inventory purchases, and an overall decrease in inventory balances of $0.5 million.

Previous wording

Net cash used in investing activities was $3.3 million for the six months ended June 30, 2026, for purchases of property and equipment.

Current wording

Net cash used in investing activities was $5.0 million for the nine months ended September 30, 2026, for purchases of property and equipment.

Previous wording

Net cash used in financing activities was $8.5 million for the six months ended June 30, 2026, which was largely comprised of $7.0 million to repurchase common stock pursuant to the Company's stock repurchase plan and $1.5 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 $8.6 million for the nine months ended September 30, 2026, which was largely comprised of $7.0 million to repurchase common stock pursuant to the Company's stock repurchase plan and $1.5 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, 2025 filed with the SEC. No material changes have been made to such critical accounting policies during the six months ended June 30, 2026.

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 on March 9, 2026. No material changes have been made to such critical accounting policies during the nine months ended September 30, 2026.