| PART I. FINANCIAL INFORMATION | Page |
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| Item 1. · Financial Statements |
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| Condensed Consolidated Balance Sheets as of March 31, 2025 and December 31, 2024 (unaudited) | 6 | |
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| Condensed Consolidated Statements of Operations for the three months ended March 31, 2025 and 2024 (unaudited) | 7 | |
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| Condensed Consolidated Statements of Comprehensive loss for the three months ended March 31, 2025 and 2024 (unaudited) | 8 | |
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| Condensed Consolidated Statements of Equity for the three months ended March 31, 2025 and 2024 (unaudited) | 9 | |
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| Condensed Consolidated Statements of Cash Flows for the three months ended March 31, 2025 and 2024 (unaudited) | 11 | |
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| Notes to Condensed Consolidated Financial Statements (unaudited) | 12 | |
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| Item 2. | Management’s Discussion and Analysis of Financial Condition and Results of Operations | 47 |
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| Item 3. | Quantitative and Qualitative Disclosures About Market Risk | 57 |
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| Item 4. | Controls and Procedures | 58 |
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| PART II. OTHER INFORMATION |
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| Item 1. | Legal Proceedings | 59 |
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| Item 1A. | Risk Factors | 59 |
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| Item 2. | Unregistered Sales of Equity Securities and Use of Proceeds | 59 |
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| Item 3. | Defaults Upon Senior Securities | 59 |
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| Item 4. | Mine Safety Disclosures | 60 |
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| Item 5. | Other Information | 60 |
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| Item 6. | Exhibits | 60 |
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| Signatures | 61 | |
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CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q contains “forward-looking statements,” as that term is defined under the Private Securities Litigation Reform Act of 1995 (“PSLRA”), Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Forward-looking statements include statements about our expectations, beliefs or intentions regarding our product development efforts, business, financial condition, results of operations, strategies or prospects, operating results, cash flows and/or financial condition. You can identify forward-looking statements by the fact that these statements do not relate strictly to historical or current matters. Rather, forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause our actual results to differ materially from any future results expressed or implied by the forward-looking statements. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including, but not limited to, economic, political, regulatory and market conditions and fluctuations, including policy changes, inflation, tariffs, interest rate and foreign currency risk inherent in U.S. and international operations. These factors also include those described below and in “Item 1A-Risk Factors” of our Annual Report on Form 10-K for the year ended December 31, 2024, and described from time to time in our other filings with the Securities and Exchange Commission (the “SEC”). We do not undertake any obligation to update forward-looking statements, except to the extent required by applicable law. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA. These forward-looking statements are only predictions and reflect our views as of the date they are made with respect to future events and financial performance.
Risks and uncertainties, the occurrence of which could adversely affect our business, include the following:
| • | we have had a history of losses and may not generate sustained positive cash flow sufficient to fund our operations and research and development programs; |
| • | our need for, and ability to obtain, additional financing when needed on favorable terms, or at all; |
| • | adverse results in material litigation matters or governmental inquiries; |
| • | the risks inherent in developing, obtaining regulatory approvals for and commercializing new, commercially viable and competitive products and treatments; |
| • | our research and development activities may not result in commercially viable products; |
| • | that earlier clinical results of effectiveness and safety may not be reproducible or indicative of future results; |
| • | that we may not generate or sustain profits or cash flow from our laboratory operations or substantial revenue from NGENLA® (Somatrogon), Rayaldee and our other pharmaceutical and diagnostic products; |
| • | our ability to manage our changing operations; |
| • | that our acquisition of ModeX Therapeutics, Inc. will be successful and the products in the R&D pipeline will ultimately be commercialized; |
| • | that currently available over-the-counter and prescription products, as well as products under development by others, may prove to be as or more effective than our products for the indications being studied; |
| • | our ability and our distribution and marketing partners’ ability to comply with regulatory requirements regarding the sales, marketing and manufacturing of our products and product candidates and the operation of our laboratories; |
| • | the performance of our third-party distribution partners, licensees and manufacturers over which we have limited control; |
| • | changes in regulation and policies in the U.S. and other countries, including increasing downward pressure on healthcare reimbursement; |
| • | increased competition, including price competition; |
| • | our success is dependent on the involvement and continued efforts of our Chairman and Chief Executive Officer; |
| • | integration challenges for acquired businesses; |
| • | changing relationships with payors, including the various state and multi-state programs, suppliers and strategic partners; |
| • | efforts by third-party payors to reduce utilization and reimbursement for clinical testing services; |
| • | our ability to maintain reimbursement coverage for our products and services, including Rayaldee and the 4Kscore test; |
| • | failure to timely or accurately bill and collect for our services; |
| • | the information technology systems that we rely on may be subject to unauthorized tampering, cyberattack or other data security or privacy incidents that could impact our billing processes or disrupt our operations; |
| • | failure to obtain and retain new clients and business partners, or a reduction in tests ordered or specimens submitted by existing clients; |
| • | failure to establish, and perform to, appropriate quality standards to assure that the highest level of quality is observed in the performance of our testing services; |
| • | failure to maintain the security of patient-related information; |
| • | our ability to obtain and maintain intellectual property protection for our products; |
| • | our ability to defend our intellectual property rights with respect to our products; |
| • | our ability to operate our business without infringing the intellectual property rights of others; |
| • | our ability to attract and retain key scientific and management personnel; |
| • | the risk that the carrying value of certain assets may exceed the fair value of the assets causing us to impair goodwill or other intangible assets; |
| • | our ability to comply with the terms of our 2022 Corporate Integrity Agreement with the U.S. Office of Inspector General of the Department of Health and Human Services; |
| • | failure to obtain and maintain regulatory approval for our products and services outside the U.S.; |
| • | legal, economic, political, regulatory, currency exchange, and other risks associated with international operations; |
| • | disruptions to operations, including impact on employees, and business continuity, including physical damage or impaired access to company facilities, office of technology from the recent conflicts in the Middle East; |
| • | unstable economic and market conditions may have adverse consequences on our business and financial condition; and |
| • | changes in personnel and funding for government agencies, including the FDA, could negatively impact our business and financial condition. |
PART I. FINANCIAL INFORMATION
Unless the context otherwise requires, all references in this Quarterly Report on Form 10-Q to the “Company”, “OPKO”, “we”, “our”, “ours”, and “us” refer to OPKO Health, Inc., a Delaware corporation, including our consolidated subsidiaries.
Item 1. Financial Statements
