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. 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.

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.

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 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.

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 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.

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 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.

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 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.

Previous wording

(3)Includes COVID-19 Sample Management Solutions product revenues.

Current wording

(3)Includes COVID-19 Sample Management Solutions and COVID-19 Diagnostics product revenues.

Previous wording

Sample Management Solutions revenues remained largely flat at $9.1 million for the three months ended March 31, 2026 and 2025.

Current wording

Sample Management Solutions revenues remained largely flat at $9.9 million for the three months ended June 30, 2026 and 2025.

Previous 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.

Current 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.

Previous 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.

Current 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.

Previous 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.

Current 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.

Previous 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.

Current 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.

Previous 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.

Current 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.

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 March 31, 2026 and 2025, the Company recorded income tax benefits of $0.4 million and $0.5 million, respectively.

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 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.

Previous 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.

Current 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.

Previous 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.

Current 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.

Previous 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.

Current 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.

Previous 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.

Current 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.

Previous 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.

Current 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.

Previous 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.

Current 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.

Previous 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.

Current 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.

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 three months ended March 31, 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. No material changes have been made to such critical accounting policies during the six months ended June 30, 2026.