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Note 1 - Business and Organization
6 Months Ended
Jun. 30, 2025
Organization, Consolidation and Presentation of Financial Statements [Abstract]  
Business and Organization

NOTE 1 BUSINESS AND ORGANIZATION

OPKO Health, Inc., a Delaware corporation (“OPKO”, the “Company”, “we”, “us”, or “our”), is a diversified healthcare company that seeks to establish industry-leading positions in large and rapidly growing medical markets. Our pharmaceutical business features Somatrogon (hGH-CTP), a once-weekly human growth hormone injection. We have partnered with Pfizer Inc. (“Pfizer”) for further development and commercialization of Somatrogon (hGH-CTP). Regulatory approvals for Somatrogon (hGH-CTP) for the treatment of children and adolescents, as young as three years of age, with growth disturbance due to insufficient secretion of growth hormone, have been secured in more than 50 markets worldwide, including in the United States, European Union Member States, Japan, Canada, and Australia under the brand name NGENLA®. Also, through our pharmaceutical division, we manufacture and sell Rayaldee, a U.S. Food and Drug Administration (“FDA”) approved treatment for secondary hyperparathyroidism (“SHPT”) in adults with stage 3 or 4 chronic kidney disease (“CKD”) and vitamin D insufficiency.

Our subsidiary, ModeX Therapeutics, Inc. (“ModeX”), which we acquired in May 2022, is a biotechnology company focused on developing innovative multi-specific immune therapies for cancer and infectious disease candidates. ModeX has a robust early-stage pipeline with assets in key areas of immuno-oncology and infectious diseases, and we intend to further expand our pharmaceutical product pipeline through ModeX’s portfolio of development candidates.

Our diagnostics business, BioReference Health, LLC (“BioReference”), is a highly specialized laboratory in the United States, with a sales and marketing team focused on growth and new product integration, including the 4Kscore® prostate cancer test. BioReference® offers a broad spectrum of diagnostic testing services for oncology, urology (4Kscore), and corrections nationwide, setting new standards with its industry-leading turnaround times. BioReference also provides comprehensive clinical and women’s health testing in New York and New Jersey. Our test offerings are backed by a team of board-certified medical professionals and driven by the latest healthcare guidelines and standards. We market our laboratory testing services directly to physicians, geneticists, hospitals, clinics, correctional and other health facilities. As described below, we entered into agreements with Laboratory Corporation of America Holdings (“Labcorp”) in 2024 and 2025 for the sale of certain BioReference assets, including its oncology testing services.

We operate several established, revenue-generating pharmaceutical platforms internationally, with our principal operations located in Spain, Ireland, Chile, and Mexico. These key platforms contribute to positive cash flow and facilitate future market entry for our products currently in development. Beyond these platforms, our operations include a development and commercial supply pharmaceutical company, as well as a global supply chain operation.

We have a highly experienced management team, composed of individuals with solid industry experience and extensive development, regulatory and commercialization expertise, as well as relationships that provide access to commercial opportunities.

On March 11, 2025, the Company and BioReference entered into an agreement with Labcorp (the “Labcorp Oncology Purchase Agreement”) pursuant to which Labcorp agreed to acquire BioReference's oncology diagnostics business and related clinical testing services assets (the “Oncology Transaction”). The Oncology Transaction is expected to close in the second half of 2025, with Labcorp paying up to $225 million in consideration, including $192.5 million in cash at closing and up to $32.5 million in cash in performance-based contingent consideration, as detailed in the Labcorp Oncology Purchase Agreement. These assets are within our diagnostics segment and encompass BioReference’s U.S. oncology testing services.

As of March 31, 2025, the assets to be sold under the Labcorp Oncology Purchase Agreement met the held-for-sale accounting criteria. Accordingly, such assets have been classified as held for sale in our condensed consolidated balance sheet as of June 30, 2025.

On September 16, 2024, we consummated the sale of certain assets of BioReference to Labcorp pursuant to an agreement entered into on March 27, 2024 (the “Labcorp Asset Purchase Agreement”). Pursuant to the Labcorp Asset Purchase Agreement, Labcorp acquired select assets of BioReference, which were part of our diagnostics segment and included BioReference's laboratory testing businesses focused on clinical diagnostics, reproductive health, and women's health across the United States, excluding BioReference's New York and New Jersey operations. Upon closing, Labcorp paid to the Company aggregate consideration of $237.5 million in cash, of which approximately $23.7 million was withheld at closing and deposited by Labcorp into an escrow account to satisfy potential indemnity claims. The escrow will be released to the Company on the twelve-month anniversary of the closing date, subject to any outstanding or liquidated indemnity claims. The Company recorded the escrow within other current assets on the Condensed Consolidated Balance Sheet.