ORASURE TECHNOLOGIES INC 10-Q

Item 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS The following discussion and analysis of the Company's financial condition and results of operations should be read in conjunction with (i) the Company's unaudited condensed consolidated financial statements and related notes appearing elsewhere in this Quarterly Report on Form 10-Q and (ii) the Company's audited consolidated financial statements and related notes and management’s discussion and analysis of financial condition and results of operations included in the Company's Annual Report on Form 10-K for the year ended December 31, 2023 filed with the Securities and Exchange Commission on March 11, 2024. Some of the information contained in this discussion and analysis or set forth elsewhere in this Quarterly Report on Form 10-Q, including information with respect to the Company's plans and strategy for its business and impact and potential impacts on its business, includes forward-looking statements that involve risks and uncertainties. As a result of many factors, including, without limitation, those factors set forth in the “Risk Factors” section of the Company's Annual Report on Form 10-K for the year ended December 31, 2023 and the “Risk Factors” section of subsequent Quarterly Reports on Form 10-Q, the Company's actual results or timing of certain events could differ materially from the results or timing described in, or implied by, these forward-looking statements. Business Overview 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 COVID-19, HIV and Hepatitis C that are performed on a rapid basis at the point of care, and tests for drugs of abuse that are processed in a laboratory. 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 COVID-19 and HIV 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. The Company's business also includes molecular 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. Additionally, the Company offers laboratory and bioinformatics services for both genomics and microbiome customers. These services are primarily provided to pharmaceutical, biotech companies, and research institutions. Recent Developments Novosanis During the three months ended March 31, 2024, the Company made a strategic decision to commence wind-down of its operations at its Novosanis subsidiary located in Belgium. The Company intends to continue to sell and manufacture its Colli-Pee® product under the DNAG product line of collection devices. In addition, during the three months ended March 31, 2024, the Company initiated steps to wind down and exit the molecular services business offered by its Diversigen subsidiary while providing transition continuity for clients. This business contributed $0.9 million to revenues during the three months ended March 31, 2024 and contributed $4.5 million for the full year of 2023. Sapphiros In January 2024, the Company announced that it is leading the Series B financing and have entered wide-ranging strategic distribution agreements with KKR Sapphiros L.P. ("Sapphiros"), a privately held consumer diagnostics portfolio company based in Boston, and certain of its related entities. Through this strategic relationship, the Company expects to be able to 17 Table of Contents offer a more comprehensive range of low-cost diagnostic tests and molecular sample management solutions to the Company's customers globally. The Company has funded approximately $28.3 million an interest in Sapphiros, with an aggregate commitment of up to $30.0 million to be funded by June 2024, contingent on certain terms and conditions being met. Results of Operations For the three months ended March 31, 2024 compared to March 31, 2023. CONSOLIDATED NET REVENUES The table below shows an outline of total consolidated net revenues (dollars in thousands) for the three months ended March 31, 2024 and 2023: Three Months Ended March 31, Dollars % Change Percentage of Total Net Revenues 2024 2023 2024 2023 COVID-19 Diagnostics $ 23,097 $ 118,254 (80) % 43 % 76 % Diagnostics (1) 16,380 17,090 (4) 30 11 Molecular Sample Management Solutions (2) 10,822 12,942 (16) 20 8 Other products and services (3) 2,576 3,094 (17) 5 2 Molecular Services 873 1,379 (37) 2 1 COVID-19 Molecular Products 31 155 (80) — — Net product and services revenues 53,779 152,914 (65) 99 99 Non-product and services revenues (4) 353 2,049 (83) 1 1 Net revenues $ 54,132 $ 154,963 (65) % 100 % 100 % (1) Includes HIV and HCV product revenues. (2) Includes Genomics, Microbiome and Novosanis product revenues. (3) Includes Risk assessment testing and other product and services revenues. (4) Non-product and services revenues include funded research and development contracts, royalty income and grant revenues. Product and Services Revenues Consolidated net revenues decreased 65% to $54.1 million for the three months ended March 31, 2024 from $155.0 million for the three months ended March 31, 2023. COVID-19 Diagnostics revenues decreased by 80% to $23.1 million for the three months ended March 31, 2024 compared to $118.3 million in three months ended March 31, 2023 due to decreased sales of the Company's InteliSwab ® tests through its U.S. government procurement contracts. We expect this decline in revenue to continue throughout 2024 due to the fulfillment of these contracts and lower overall demand for COVID-19 testing. Sales of the Company's Diagnostics products decreased 4% to $16.4 million for the three months ended March 31, 2024 from $17.1 million for the three months ended March 31, 2023. This decrease in revenues was primarily driven by customer ordering patterns. Molecular Sample Management Solutions revenues decreased 16% to $10.8 million for the three months ended March 31, 2024 from $12.9 million for the three months ended March 31, 2023. Sales of the Company's Molecular Products are being impacted by reduced consumer demand for products in which our genomics collection devices are used, economic pressures and reduction on funding for programs in which our collection devices are used, and the overall decline in the microbiome market. Other products and services revenues decreased 17% to $2.6 million for the three months ended March 31, 2024 from $3.1 million for the three months ended March 31, 2023. 18 Table of Contents Molecular Services revenues, which are derived from the Company's microbiome molecular sequencing services, decreased 37% to $0.9 million for the three months ended March 31, 2024 from $1.4 million for the three months ended March 31, 2023. The decrease in services revenues was largely due to discontinuance of customer's clinical trial projects. Non-Product and Services Revenues Non-product and services revenues decreased 83% to $0.4 million for the three months ended March 31, 2024 from $2.0 million for the three months ended March 31, 2023 as a result lower funding for research and development activities largely as a result of the end of our agreement with Biomedical Advanced Research Authority ("BARDA") which provided funding to obtain clearance of a premarket notification ("510(k)") and Clinical Laboratory Improvement Amendments of 1988 ("CLIA") waiver of our InteliSwab® tests. The Company has communicated to BARDA that it does not intend to pursue further development of this clearance. CONSOLIDATED OPERATING RESULTS Consolidated gross profit margin increased to 44.5% for the three months ended March 31, 2024 from 42.5% for the three months ended March 31, 2023. This increase in margins was driven by increased average selling price on InteliSwab® sales and lower scrap expense . These improvement in margins were partially offset by a decrease in non-product revenues which contribute 100% to gross margin. Consolidated operating loss for the three months ended March 31, 2024 was $7.1 million, a $31.4 million decline from the $24.3 million operating income reported for the three months ended March 31, 2023. Results for the three months ended March 31, 2024 were negatively impacted by lower revenues and higher impairment losses offset by increased gross profit margins and lower operating expense spend. Results for the three months ended March 31, 2024 included $3.3 million of impairment losses compared to $1.1 million for the three months ended March 31, 2023. Impairment losses in the first quarter of 2024 were comprised of the impairment of Novosanis and Diversigen property plant and equipment, including leased assets while impairment losses in 2023 were associated with idle manufacturing lines. Operating expenses in the first quarter of 2024, excluding the impairment charge, decreased $12.6 million compared to the first quarter of 2023 reflecting the impact of the Company's cost saving measures and headcount reductions. Research and development expenses decreased 27% to $7.7 million for the three months ended March 31, 2024 from $10.6 million for the three months ended March 31, 2023 largely due to a decrease in employee costs associated with a reduction in headcount, decrease in spend on COVID-19 product development, and no related project management fees for our $109 million manufacturing expansion contract which ended during the fourth quarter of 2023. Sales and marketing expenses decreased 30% to $8.4 million for the three months ended March 31, 2024 from $12.1 million for the three months ended March 31, 2023 due to lower employee costs associated with a decrease in headcount, and decreased spend on advertising and consulting fees. General and administrative expenses decreased 34% to $11.6 million for the three months ended March 31, 2024 from $17.7 million for the three months ended March 31, 2023 largely due to lower legal fees and lower staffing costs due to a reduction in headcount. All of the above contributed to the Company's operating loss of $7.1 million for the three months ended March 31, 2024, which included a non-cash impairment charge of $3.3 million, non-cash charges of $2.7 million for depreciation and amortization, and non-cash charges of $3.0 million for stock-based compensation. The Company's operating income of $24.3 million for the three months ended March 31, 2023 included a non-cash impairment charge of $1.1 million, non-cash charges of $3.7 million for depreciation and amortization, and $2.7 million for stock-based compensation. OTHER INCOME Other income for the three months ended March 31, 2024 was $3.5 million compared to $2.7 million for the three months ended March 31, 2023. This increase is due to higher interest income. CONSOLIDATED INCOME TAXES 19 Table of Contents 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 March 31, 2024 and 2023, the Company recorded a U.S. state income tax benefit of $0.2 million. For the three months ended March 31, 2024 the state tax benefit was partially offset by foreign tax expense of $0.2 million. No foreign taxes were recorded for the three months ended March 31, 2023 due to it being more likely than not that the Canadian subsidiary would not produce sufficient income to receive a tax benefit for the year to date loss. Liquidity and Capital Resources March 31, 2024 December 31, 2023 (in thousands) Cash and cash equivalents $ 247,145 $ 290,407 Short-term investments 16,627 — Working capital 319,400 346,923 The Company's cash and cash equivalents and short-term investments decreased to $263.8 million at March 31, 2024 from $290.4 million at December 31, 2023. $84.5 million or 32% of the $263.8 million in cash and cash equivalents and short-term investments is held by DNAG, the Company's Canadian subsidiary. The Company's working capital decreased to $319.4 million at March 31, 2024 from $346.9 million at December 31, 2023. Working capital decreased primarily due to the decrease in cash and cash equivalents. Working capital is primarily a function of sales, purchase volumes, inventory requirements, and vendor payment terms. Analysis of the Company's Cash Flows Operating Activities During the three months ended March 31, 2024, net cash provided by operating activities was $6.7 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 $3.6 million included non-cash charges of depreciation and amortization expense of $2.7 million, stock-based compensation expense of $3.0 million, and impairment losses of $3.3 million. Cash provided by the working capital accounts included a decrease in accounts receivable of $6.2 million largely associated with lower overall sales and collections of balances due, a decrease in inventory of $4.3 million as the Company fulfilled demand for its InteliSwab® product, and a decrease in accrued expenses of $9.7 million as the Company paid out year end bonuses in March 2024. Investing Activities Net cash used in investing activities was $46.5 million for the three months ended March 31, 2024, which reflects proceeds from the maturities of investments of $9.2 million, offset by $25.9 million in purchases of investments. Investing activities also include a $28.3 million investment in Sapphiros, and $1.6 million to acquire property and equipment to support the normal operations of the business. Financing Activities Net cash used in financing activities was $1.3 million for the three months ended March 31, 2024, which is largely comprised of $1.5 million used for the repurchase of common stock to satisfy withholding taxes related to the vesting of restricted shares awarded to the Company's employees. Resources The Company expects existing cash and cash equivalents will be sufficient to fund its operating expenses and capital expenditure requirements over the next twelve months. The Company's cash requirements, however, may vary materially from those now planned due to many factors, including, but not limited to, the scope and timing of future strategic acquisitions, the progress of its research and development programs, the scope and results of clinical testing, the cost of any future litigation, the magnitude of capital expenditures, changes in existing and potential relationships with business partners, the timing and cost of obtaining regulatory approvals, the timing and cost of future stock purchases, the costs 20 Table of Contents involved in obtaining and enforcing patents, proprietary rights and any necessary licenses, the cost and timing of expansion of sales and marketing activities, market acceptance of new products, competing technological and market developments, the impact of the current economic environment and other factors. A summary of the Company's obligations to make future payments under contracts existing at December 31, 2023 is included in Item 7, Management’s Discussion and Analysis of Financial Condition and Results of Operations, of its Annual Report on Form 10-K for the year ended December 31, 2023. As of March 31, 2024, there were no significant changes to this information. Critical Accounting Policies and Estimates 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, 2023 filed with the SEC. No material changes have been made to such critical accounting policies during the three months ended March 31, 2024. Item 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK There has been no material change in the Company's assessment of its sensitivity to market risk since its presentation set forth in Item 7A, "Quantitative and Qualitative Disclosures About Market Risk," in its Annual Report on Form 10-K for the year ended December 31, 2023.