OPKO HEALTH, INC.
For the period ended Dec 31, 2025. Filed Feb 26, 2026.
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FY2025 · Filed Feb 26, 2026
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Notes to Consolidated Financial Statements
Note 1 Business and Organization
We are a diversified healthcare company that seeks to establish industry-leading positions in large and rapidly growing medical markets. Our pharmaceutical business features NGENLA®(somatrogon-ghla), also referred to as 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 business, 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. Rayaldee has secured marketing authorizations in 11 European countries, and we are advancing the development in mainland China through our strategic partner, Nicoya Macau Limited.
Our subsidiary, ModeX Therapeutics, Inc. (“ModeX”), 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.
We operate 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 may facilitate future market entry for our products currently in development. Our Irish subsidiary, EirGen Pharma Ltd. (“EirGen”), specializes in the development and commercial supply of high-potency oral solid dose pharmaceutical products and exports to more than 60 countries. Research and development activities are primarily conducted in facilities located in Weston, Massachusetts; Waterford, Ireland; Kiryat Gat, Israel; and Barcelona, Spain.
Our diagnostics business, BioReference Health, LLC (“BioReference”), is a highly specialized laboratory in the United States. Following the strategic divestitures described below, BioReference focuses on its core clinical and women’s health testing operations in the New York and New Jersey regions and its national specialty urology franchise, including its proprietary 4Kscore® prostate cancer test. We market our laboratory testing services directly to physicians, geneticists, hospitals, clinics, correctional and other health facilities.
Divestitures to Labcorp
On September 15, 2025, we consummated the sale of certain assets of BioReference to Labcorp (the “Oncology Transaction”), pursuant to an agreement entered into on March 10, 2025 (the “Labcorp Oncology Purchase Agreement”). Labcorp acquired BioReference's oncology diagnostics business and related clinical testing services assets. These assets were part of our diagnostics segment. Upon closing, Labcorp paid an aggregate of $192.5 million in cash consideration, of which $19.2 million was deposited in escrow. The escrow is to be released to us on the 12-month anniversary of the closing date, net of any outstanding or liquidated indemnity claims. The Company may also receive up to $32.5 million in performance-based contingent cash consideration in accordance with the terms of a post-closing earnout based upon revenue generated by certain customer accounts. We recognized a gain of $101.6 million from the Oncology Transaction for the year ended December 31, 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”). Labcorp acquired select assets of BioReference (the “BioReference Transaction”), 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 the Company aggregate consideration of $237.5 million in cash, net of $23.75 million deposited in escrow. The Company received $24.6 million of escrow funds in September 2025, including accrued interest. We recognized a gain of $121.5 million from the BioReference Transaction for the year ended December 31, 2024.
Note 2 Foreign exchange rates
For the years ended December 31, 2025, 2024, and 2023, approximately 28.0%,23.1%, and 29.6%of revenue was denominated in currencies other than the U.S. Dollar (USD). Our financial statements are reported in USD and, accordingly, fluctuationsin exchange rates affect the translation of revenues and expenses denominated in foreign currencies into USD for purposes of reporting our consolidated financial results. During the years ended December 31, 2025, 2024 and 2023, the most significant currency exchange rate exposures were to the Chilean Peso and Euro. Gross accumulated currency translation adjustments recorded as a separate component of shareholders’ equity were$17.6 million and$52.7 million at December 31, 2025 and 2024, respectively.
We are subject to foreign currency translation risk for fluctuations in exchange rates during the period of time between the consummation and cash settlement of transactions. We limit foreign currency transaction risk through hedge transactions with foreign currency forward contracts. Under these forward contracts, for any rate above or below the fixed rate, we receive or pay the difference between the spot rate and the fixed rate for the given amount at the settlement date. As of December 31, 2025, we held $13.6 millionin open foreign exchange forward contracts related to inventory purchases on letters of credit. We hadno such open contracts as of December 31, 2024.
Note 3 Summary of Significant Accounting Policies
Basis of presentation. The accompanying Consolidated Financial Statements have been prepared in accordance with accounting principles generally accepted in the U.S. and with the instructions to Form 10-K and of Regulation S-X.
Principles of consolidation. The accompanying Consolidated Financial Statements include the accounts of OPKO Health, Inc. and of our wholly-owned subsidiaries. All intercompany accounts and transactions are eliminated in consolidation.
Use of estimates. The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ significantly from these estimates.
Cash, cash equivalents and restricted cash. Cash, cash equivalents and restricted cash include short-term, interest-bearing instruments with original maturities of 90 days or less at the date of purchase. We also consider all highly liquid investments with original maturities at the date of purchase of 90 days or less as cash equivalents. These investments include money markets, bank deposits, certificates of deposit and U.S. treasury securities.
The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the Condensed Consolidated Balance Sheet to the sum of such amounts in the Condensed Consolidated Statements of Cash Flows:
| December 31, 2025 | December 31, 2024 | |
|---|---|---|
| Cash and cash equivalents | $364,409 | $426,582 |
| Restricted cash, current | 4,665 | 5,354 |
| Restricted cash, long-term | 13,668 | 13,679 |
| Total cash, cash equivalents, and restricted cash shown in the Condensed Consolidated Statements of Cash Flows | $382,742 | $445,615 |
The Company classifies cash deposits related to letters of credit securing insurance and lease obligations as restricted cash, which is included in other assets, non-current, within the Consolidated Balance Sheet.
Inventories. Inventories are valued at the lower of cost and net realizable value. Cost is determined by the first-in, first-out method. We consider such factors as the amount of inventory on hand, estimated time required to sell such inventories, remaining shelf-life, and current market conditions to determine whether inventories are stated at the lower of cost and net realizable value. Inventories at our diagnostics segment consist primarily of purchased laboratory supplies, which are used in our testing laboratories. Inventory obsolescence expense for the years ended December 31, 2025, 2024 and 2023 was$4.1 million,$2.1 million and $8.1 million, respectively.
Goodwill and intangible assets. Goodwill represents the difference between the purchase price and the estimated fair value of the net assets acquired accounted for by the acquisition method of accounting. Refer to Note 6. Goodwill, in-process research and development (“IPR&D”) and other intangible assets acquired in business combinations, licensing and other transactions was$1.2 billion and$1.3 billion at December 31, 2025 and 2024, respectively.
Assets acquired and liabilities assumed in business combinations, licensing and other transactions are generally recognized at the date of acquisition at their respective fair values. Any excess of the purchase price over the estimated fair values of the net assets acquired is recognized as goodwill. At acquisition, we generally determine the fair value of intangible assets, including IPR&D, using the “income method.”
Subsequent to acquisition, goodwill and indefinite lived intangible assets are tested at least annually as of October 1 for impairment, or when events or changes in circumstances indicate it is more likely than not that the carrying amount of such assets may not be recoverable.
Estimating the fair value of a reporting unit for goodwill impairment is highly sensitive to changes in projections and assumptions and changes in assumptions could potentially lead to impairment. We perform sensitivity analyses around our assumptions in order to assess the reasonableness of the assumptions and the results of our testing. Ultimately, potential changes in these assumptions may impact the estimated fair value of a reporting unit and result in an impairment if the fair value of such reporting unit is less than its carrying value. Goodwill was$484.3 million and$529.3 million, respectively, at December 31, 2025 and 2024.
Net intangible assets other than goodwill were$711.3 million and$811.6 million at December 31, 2025 and 2024, respectively, including IPR&D of $195.0 million at December 31,2025 and 2024. On September 15, 2025, $30.5 million of intangible assets were de-recognized upon consummation of the Oncology Transaction, and such assets were included in the sale of assets for the year ended December 31, 2025. Considering the high risk nature of research and development and the industry’s success rate of bringing developmental compounds to market, IPR&D impairment charges may occur in future periods. Estimating the fair value of IPR&D for potential impairment is highly sensitive to changes in projections and assumptions and changes in assumptions could potentially lead to impairment.
Upon regulatory approval, IPR&D assets are classified as finite-lived intangible assets. These assets are then amortized on a straight-line basis over their estimated useful lives. If a project is abandoned, the associated IPR&D costs are immediately expensed. We also regularly assess finite-lived intangible assets for impairment. This assessment involves comparing the carrying amount of an asset, which is its cost minus accumulated amortization, to its estimated future undiscounted cash flows. If an asset's carrying amount exceeds its estimated future cash flows, then an impairment charge is recognized to reflect the difference between the asset's carrying amount and its fair value.
While we believe our estimates and assumptions used in impairment testing (including for goodwill and IPR&D) are reasonable and reflect those used by market participants, there is a potential risk of material impairment charges. Our future performance, particularly for our Ireland reporting unit, which includes EirGen and Rayaldee, could be impacted by changing global trade policies and the imposition of new tariffs. Based on the current financial performance of our diagnostics segment and our Ireland reporting unit, we could be subject to such charges if their future performance deviates from our current estimates and assumptions. For reference, the goodwill of our diagnostics segment totaled$163.4 million and$219.7 million at December 31, 2025 and 2024, respectively. The decrease reflects the derecognition of $56.3 million of goodwill as part of the Oncology Transaction, which goodwill was included in the sale of assets. Separately, the goodwill of our Ireland reporting unit totaled$89.5 million and$79.4 million at December 31, 2025 and 2024, respectively. The$10.1 million increase was entirely attributable to the impact of foreign currency exchange rate fluctuations. No impairment charges were recognized for the years ended December 31,2025, 2024, or 2023.
We amortize intangible assets with definite lives on a straight-line basis over their estimated useful lives, ranging from 3 to 20 years. We use the straight-line method of amortization as there is no reliably determinable pattern in which the economic benefits of our intangible assets are consumed or otherwise used up. Amortization expense was$77.9 million,$82.6 million and $86.0 million for the years ended December 31,2025, 2024 and 2023, respectively. Amortization expense from operations for our intangible assets is expected to be $76.0 million, $74.7 million, $61.1 million, $57.2 million and $57.2 million for the years ended December 31, 2026, 2027, 2028, 2029 and 2030, respectively.
Fair value measurements. The carrying amounts of our cash, cash equivalents, restricted cash, accounts receivable, accounts payable and short-term debt approximate their fair value due to the short-term maturities of these instruments. Investments that are considered equity securities as of December 31, 2025 and 2024 are predominately carried at fair value.
In evaluating the fair value information, considerable judgment is required to interpret the market data used to develop the estimates. The use of different market assumptions and/or different valuation techniques may have a material effect on the estimated fair value amounts. Accordingly, the estimates of fair value presented herein may not be indicative of the amounts that could be realized in a current market exchange. Refer to Note 19.
Contingent consideration. Each period, we revalued contingent consideration obligations associated with certain prior acquisitions to their fair value and recorded changes in fair value as contingent consideration expense or a reduction thereof. Changes in fair value resulted from changes in the assumptions regarding probabilities of successful achievement of related milestones, the estimated timing in which the milestones were achieved, and the discount rate used to estimate the respective liabilities fair values. Contingent consideration expense for the year ended December 31, 2023 was $1.0 million. We didnot record contingent consideration expense during the years ended December 31, 2025 or 2024.
Derivative financial instruments. We record derivative financial instruments on our Consolidated Balance Sheet at their fair value and recognize the changes in the fair value in our Consolidated Statement of Operations when they occur, the only exception being derivatives that qualify as hedges. For a derivative instrument to qualify as a hedge, we are required to meet strict hedge effectiveness and contemporaneous documentation requirements at the initiation of the hedge and assess the hedge effectiveness on an ongoing basis over the life of the hedge. At December 31, 2025 and 2024, our foreign currency forward contracts held to economically hedge inventory purchases did not meet the documentation requirements to be designated as hedges. Accordingly, we recognize all changes in the fair values of our derivatives instruments, net, in our Consolidated Statement of Operations. Refer to Note 20.
Property, plant and equipment. Property, plant and equipment are recorded at cost or fair value if acquired in a business combination. Depreciation is provided using the straight-line method over the estimated useful lives of the assets and includes amortization expense for assets capitalized under finance leases. The estimated useful lives by asset class are as follows: software -3 years, machinery, medical and other equipment -5-8 years, furniture and fixtures -5-12 years, leasehold improvements - the lesser of their useful life or the lease term, buildings and improvements -10-40 years, and automobiles -3-5 years. Expenditures for repairs and maintenance are charged to expense as incurred. Assets held under finance leases are included within Property, plant and equipment, net in our Consolidated Balance Sheets and are amortized over the shorter of their useful lives or the expected term of their related leases. Depreciation expense was$13.7 million, $15.6 million and $19.3 million for the years ended December 31,2025, 2024 and 2023, respectively. Assets held under finance leases are included within Property, plant and equipment, net in our Consolidated Balance Sheets and are amortized over the shorter of their useful lives or the expected term of their related leases.
Impairment of long-lived assets. Long-lived assets, such as property and equipment and assets held for sale, are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to estimated undiscounted future cash flows expected to be generated by the asset. If the carrying amount of an asset exceeds its estimated future cash flows, then an impairment charge is recognized for the amount by which the carrying amount of the asset exceeds the fair value of the asset. During the year ended December 31, 2024, the Company determined the carrying amount of certain long-lived assets within our Finetech subsidiary was not recoverable. As a result, we recognized animpairment charge of $1.2 million related to these assets, which is included in selling, general and administrative expenses within our pharmaceutical segment.
Income taxes. Income taxes are accounted for under the asset-and-liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and the respective tax bases and for operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in operations in the period that includes the enactment date. We periodically evaluate the realizability of our net deferred tax assets. Our tax accruals are analyzed periodically and adjustments are made as events occur to warrant such adjustment. Valuation allowances on certain U.S. deferred tax assets and non-U.S. deferred tax assets are established, because realization of these tax benefits through future taxable income does not meet the more-likely-than-not threshold.
We operate in various countries and tax jurisdictions globally. For the year ended December 31, 2025, the tax rate differed from the U.S. federal statutory rate of 21% primarily due to the valuation allowance against certain U.S. and non-U.S. deferred tax assets, the relative mix in earnings and losses in the U.S. versus foreign tax jurisdictions, and the impact of certain discrete tax events and operating results in tax jurisdictions which do not result in a tax benefit.
Included in Other long-term liabilities is an accrual of $9.9 million related to uncertain tax positions involving income recognition. In connection with an examination of foreign tax returns for the 2014 through 2020 tax years, a foreign taxing authority has issued an income tax assessment of approximately $246 million (including interest). We are appealing this assessment, as we believe, other than for uncertain tax positions for which we have reserved, the issues are without technical merit. We intend to exhaust all judicial remedies necessary to resolve the matter, as necessary, which could be a lengthy process. There can be no assurance that this matter will be resolved in our favor, and an adverse outcome, or any future tax examinations involving similar assertions, could have a material effect on our financial condition, results of operations and cash flows.
Revenue recognition. We recognize revenue when a customer obtains control of promised goods or services in accordance with Accounting Standards Codification Topic 606, Revenue from Contracts with Customers (“Topic 606”). The amount of revenue that is recorded reflects the consideration that we expect to receive in exchange for those goods or services. We apply the following five-step model in order to determine this amount: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) we satisfy a performance obligation.
We apply the five-step model to contracts when it is probable that we will collect the consideration we are entitled to in exchange for the goods or services we transfer to the customer. At contract inception, once the contract is determined to be within the scope of Topic 606, we review the contract to determine which performance obligations we must deliver and which of these performance obligations are distinct. We recognize as revenue the amount of the transaction price that is allocated to the respective performance obligation when the performance obligation is satisfied or as it is satisfied. For a complete discussion of accounting for Revenues from services, Revenues from products and Revenue from transfer of intellectual property and other, refer to Note 15.
Concentration of credit risk and allowance for credit losses. Financial instruments that potentially subject us to concentrations of credit risk consist primarily of accounts receivable. Substantially all of our accounts receivable are with either companies in the healthcare industry or patients. However, credit risk is limited due to the number of our clients as well as their dispersion across many different geographic regions.
While we have receivables due from federal and state governmental agencies, such receivables are not a credit risk because federal and state governments fund the related healthcare programs. Payment is primarily dependent upon submitting appropriate documentation. At December 31, 2025 and 2024, receivable balances (net of explicit and implicit price concessions) from Medicare and Medicaid were 5.2% and 4.8%, respectively, of our consolidated Accounts receivable, net. The portion of our accounts receivable due from individual patients comprises the largest portion of credit risk. At December 31, 2025 and 2024, receivables due from patients represented approximately 1.5% and 1.7%, respectively, of our consolidated Accounts receivable, net.
We assess the collectability of accounts receivable balances by considering factors such as historical collection experience, customer credit worthiness, the age of accounts receivable balances, regulatory changes and current economic conditions and trends that may affect a customer’s ability to pay. Actual results could differ from those estimates. The allowance for credit losses was$2.1 million and$1.3 million at December 31, 2025 and 2024, respectively. The credit loss expense for the years ended December 31, 2025, 2024 and 2023 was$0.8 million, $0.1 million and $0.3 million, respectively.
Accounts receivable as of December 31, 2025 and 2024 included$2.3 million and$3.6 million, respectively, of government contract revenue earned under the BARDA Contract (as defined in Note 16). Refer to Note 15, Government Contract Revenue for further information government contracts and to Note 16, Strategic Alliances for further information on the BARDA Contract.
Equity-based compensation. We measure the cost of services received in exchange for an award of equity instruments based on the grant-date fair value of the award. That cost is recognized in the Consolidated Statement of Operations over the period during which an employee is required to provide service in exchange for the award. We record excess tax benefits realized from the exercise of stock options as cash flows from operations. For the years ended December 31, 2025, 2024 and 2023, we recorded$10.7 million,$11.0 million and $11.4 million, respectively, of equity-based compensation expense.
Research and development expenses. Research and development expenses include external and internal expenses. External expenses include clinical and non-clinical activities performed by contract research organizations, lab services, purchases of drug and diagnostic product materials and manufacturing development costs. Research and development employee-related expenses include salaries, benefits and equity-based compensation expense. Other internal research and development expenses are incurred to support overall research and development activities and include expenses related to general overhead and facilities. We expense these costs in the period in which they are incurred. We estimate our liabilities for research and development expenses in order to match the recognition of expenses to the period in which the actual services are received. As such, accrued liabilities related to third party research and development activities are recognized based upon our estimate of services received and degree of completion of the services in accordance with the specific third party contract.
Research and development expense includes costs for in-process research and development projects acquired in asset acquisitions which have not reached technological feasibility, and which have no alternative future use. For in-process research and development projects acquired in business combinations, the in-process research and development project is capitalized and evaluated for impairment until the development process has been completed. Once the development process has been completed the asset will be amortized over its remaining estimated useful life.
Segment reporting. Our chief operating decision-maker (“CODM”) is Phillip Frost, M.D., our Chairman and Chief Executive Officer. Dr. Frost reviews our operating results and operating plans and makes resource allocation decisions on a Company-wide or aggregate basis. We manage our operations intwo reportable segments, pharmaceutical and diagnostics. The pharmaceutical segment consists of our pharmaceutical operations in Chile, Mexico, Ireland, Israel and Spain, Rayaldee product sales and our pharmaceutical research and development. The diagnostics segment primarily consists of clinical laboratory operations through BioReference. There are no significant inter-segment sales. We evaluate the performance of each segment based on operating profit or loss. There is no inter-segment allocation of interest expense or income taxes. Refer to Note 18.
Shipping and handling costs. We do not charge customers for shipping and handling costs. Shipping and handling costs are classified as Cost of revenues in the Consolidated Statement of Operations.
Foreign currency translation. The financial statements of certain of our foreign operations are measured using the local currency as the functional currency. The local currency assets and liabilities are generally translated at the rate of exchange to the U.S. dollar on the balance sheet date, and the local currency revenues and expenses are translated at average rates of exchange to the U.S. dollar during the reporting periods. Foreign currency transaction gains (losses) have been reflected as a component of Other income (expense), net within the Consolidated Statement of Operations and foreign currency translation gains (losses) have been included as a component of the Consolidated Statement of Comprehensive Income (Loss). We recorded foreign currency transaction (losses) and gain of ($2.0 million), ($3.8 million), and $1.2 million for the years ended December 31,2025, 2024 and 2023, respectively.
Variable interest entities. The consolidation of a variable interest entity (“VIE”) is required when an enterprise has a controlling financial interest. A controlling financial interest in a VIE will have both of the following characteristics: (a) the power to direct the activities of a VIE that most significantly impact the VIE’s economic performance and (b) the obligation to absorb losses of the VIE that could potentially be significant to the VIE. Refer to Note 5.
Investments. We have made strategic investments in development stage and emerging companies. We record these investments as equity method investments or as equity securities based on our percentage of ownership and whether we have significant influence over the operations of the investees. For investments classified under the equity method of accounting, we record our proportionate share of their losses in Losses from investments in investees in our Consolidated Statement of Operations. Refer to Note 5. For investments classified as equity securities, we record changes in their fair value as Other income (expense) in our Consolidated Statement of Operations based on their closing price per share at the end of each reporting period, unless the equity security does not have a readily determinable fair value. Refer to Note 5.
Accounting standards yet to be adopted.
In November 2024, the FASB issued ASU 2024-03, Income Statement (Subtopic 220-40): Disaggregation of Income Statement Expenses is effective prospectively to financial statements issued for reporting period after the effective date or retrospectively to any or all prior periods presented in the financial statements, for annual periods beginning after December 15, 2026 and interim reporting periods beginning after December 15, 2027. Early adoption is permitted. We are currently evaluating the potential impact of adopting this new guidance on our consolidated financial statements and related disclosures.
Recently adopted accounting standards.
In November 2024, the FASB issued ASU 2024-04, Debt (Subtopic 470-20): Debt with Conversion and Other Options. (“ASU 2024-04”) clarifies the assessment of whether a transaction should be accounted for as an induced conversion or extinguishment of convertible debt when changes are made to conversion features as part of an offer to settle the instrument. ASU 2024-04 is effective for reporting periods beginning after December 15, 2025, and interim periods within those annual reporting periods. Early adoption is permitted for entities that have adopted ASU 2020-06. We adopted ASU 2024-04 prospectively effective January 1, 2025. The adoption of ASU 2024-04 did not have a material impact on our Condensed Consolidated Financial Statements.
In December 2023, the FASB issued ASU No. 2023-09, “Income Taxes (Topic 740): Improvements to Income Tax Disclosures” (“ASU 2023-09”), which modifies the rules on income tax disclosures to require entities to disclose (i) specific categories in the rate reconciliation, (ii) the income or loss from continuing operations before income tax expense or benefit
(separated between domestic and foreign) and (iii) income tax expense or benefit from continuing operations (separated by federal, state and foreign). ASU 2023-09 also requires entities to disclose their income tax payments to international, federal, state, and local jurisdictions, among other changes. The guidance is effective for annual periods beginning after December 15, 2024. Early adoption is permitted for annual financial statements that have not yet been issued or made available for issuance. ASU 2023-09 should be applied on a prospective basis, but retrospective application is permitted. The Company adopted ASU 2023-09 in the fourth quarter of fiscal year 2025. This guidance was applied prospectively.
In November 2023, the FASB issued ASU No 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures (“ASU 2023-07”). ASU 2023-07 enhances disclosures for significant segment expenses for all public entities required to report segment information in accordance with ASC 280. ASC 280 requires a public entity to report for each reportable segment a measure of segment profit or loss that its CODM uses to assess segment performance and to make decisions about resource allocations. The Company adopted ASU 2023-07 in the fourth quarter of fiscal year 2024. This guidance was applied prospectively. The adoption of ASU 2023-07 did not have a material impact on our Condensed Consolidated Financial Statements.
In 2021, the Organization for Economic Co-operation and Development (“OECD”) established an inclusive framework on base erosion and profit shifting and agreed on a two-pillar solution (“Pillar Two”) to global taxation, focusing on global profit allocation and a 15% global minimum effective tax rate. On December 15, 2022, the EU member states agreed to implement the OECD’s global minimum tax rate of 15%. The OECD issued Pillar Two model rules and continues to release guidance on these rules. Various participating countries have enacted or have announced plans to enact new tax laws to implement the global minimum tax, some effective beginning in 2024. We considered the applicable tax law changes on Pillar Two implementation in the relevant countries, and there is no material impact to our tax results for the period. We anticipate further legislative activity and administrative guidance, and will continue to evaluate the impacts of enacted legislation and pending legislation to enact Pillar Two Model Rules in the non-US tax jurisdictions we operate in.
Note 4 Loss Per Share
Basic loss per share is computed by dividing our net loss by the weighted average number of shares of our Common Stock outstanding during the period. Shares of Common Stock that had been outstanding under the share lending arrangement entered into in conjunction with the 2025 Notes (as defined in Note 7) were excluded from the calculation of basic and diluted earnings per share because the borrower of the shares was required under the share lending arrangement to refund any dividends paid on the shares lent. We terminated the share lending agreement on January 22, 2024. For diluted earnings per share, the dilutive impact of stock options and warrants is determined by applying the “treasury stock” method. The dilutive impact of the 2029 Convertible Notes, 2033 Senior Notes, the 2023 Convertible Notes and the 2025 Notes (each, as defined and discussed in Note 7) has been considered using the “if converted” method. For periods in which their effect would have been antidilutive, no effect is given in the dilutive computation to Common Stock issuable under outstanding options or warrants or the potentially dilutive shares issuable pursuant to the 2029 Convertible Notes, 2033 Senior Notes, the 2023 Convertible Notes and the 2025 Notes.
A total of 155,754,104,291,185,409 and 82,843,173 potential shares of Common Stock have been excluded from the calculation of diluted net loss per share for the years ended December 31,2025, 2024 and 2023, respectively, because their inclusion would be antidilutive. A full presentation of diluted earnings per share has not been provided because the required adjustments to the numerator and denominator resulted in diluted earnings per share equivalent to basic earnings per share.
During the year ended December 31, 2025, 57,500 options were exercised, and 850,146 restricted stock units vested, resulting in the issuance of 636,832 shares of Common Stock Of the 850,146 restricted stock units settled,270,814 shares of Common Stock were surrendered in lieu of a cash payment via the net exercise feature of the agreements.
During the year ended December 31, 2024, no options were exercised, and 549,687 restricted stock units vested, resulting in the issuance of 384,378 shares of Common Stock. Of the 549,687 restricted stock units settled,165,309 shares of Common Stock were surrendered in lieu of a cash payment via the net exercise feature of the agreements.
During the year ended December 31, 2023,18,750 options were exercised, and 549,680 restricted stock units vested, resulting in the issuance of 405,721 shares of Common Stock. Of the 549,680 restricted stock units settled,162,709 shares of Common Stock were surrendered in lieu of a cash payment via the net exercise feature of the agreements.
Note 5 Investments
Investments
The following table reflects the accounting method, carrying value and underlying equity in net assets of our unconsolidated investments as of December 31,2025 and 2024:
| (in thousands) · As of December 31, 2025 · As of December 31, 2024 | |||||
|---|---|---|---|---|---|
| Investment type · InvestmentCarryingValue · UnderlyingEquity inNet Assets · InvestmentCarryingValue · UnderlyingEquity inNet Assets | |||||
| Equity securities | $9,268 | 1,555 | $49,655 | 1,329 | |
| Equity securities with no readily determinable fair value | 4,139 | — | 4,139 | — | |
| Variable interest entity, equity method | 758 | 787 | |||
| Warrants and options | 3 | 3 | |||
| Total carrying value of investments | $14,168 | $54,584 | |||
Investments in Equity securities
We hold investments in various equity securities, which are accounted for based on the Company's level of influence over the particular investee and whether the particular equity security has a readily determinable fair value. We have determined that our ownership in these entities, along with that of related parties, does not provide the Company with significant influence over their operations, except as noted below. Accordingly, we account for our investments in these entities as equity securities and records changes in their fair values in other income (expense) each reporting period. Equity securities with readily determinable fair values are measured at fair value, while those without are adjusted to fair value when there is an observable price change.
GeneDx Holdings
During the year ended December 31, 2025, the Company sold its remaining 620,000 shares of GeneDx Holdings Corp. (formerly, Sema4 Holdings Corp., “GeneDx”) common stock at various prices for aggregate proceeds of $51.7 million, resulting in the Company holdingno GeneDx shares as of December 31, 2025. As of December 31, 2024, our ownership in GeneDx was 2.2%.
Other Equity Securities
We hold equity securities in Entera Bio Ltd. (“Entera”) (8.0%) (see Note 16 for further information), Niagen Bioscience, Inc. (“Niagen” formally known as ChromaDex Corporation) (0.04%), Eloxx Pharmaceuticals, Inc. (“Eloxx”) (1.0%), Xenetic Biosciences, Inc. (“Xenetic”) (1%), BioCardia (“BioCardia”) (0.14%), and CAMP4 Therapeutics Corporation (“CAMP4”) (1%). Our investment in HealthSnap, Inc. (4%) is accounted for under the measurement alternative for equity securities without readily determinable fair values.
Net gains and losses on our equity securities for the year ended December 31,2025, 2024 and 2023 were as follows:
| (in thousands) | 2025 | 2024 | 2023 |
|---|---|---|---|
| Equity Securities: | |||
| Net gains and (losses) recognized during the period on equity securities | $4,084 | $73,873 | $(532) |
| Less: Net gains realized during the period on equity securities | (4,324) | (54,026) | — |
| Unrealized net gains and losses recognized during the period on equity securities still held at the reporting date | $(240) | $19,847 | $(532) |
Investments in variable interest entities
We have determined that we hold variable interests in LeaderMed Health Group Limited ("LeaderMed") and Zebra Biologics, Inc. ("Zebra") based on our assessment that they do not have sufficient resources to carry out their principal activities without additional financial support.
LeaderMed
In September 2021, we and LeaderMed, a pharmaceutical development company with operations based in Asia, formed a joint venture to develop, manufacture and commercialize two of OPKO’s clinical stage, long-acting drug products in Greater China and eight other Asian territories. Under the terms of the agreements, we granted the joint venture exclusive rights to develop, manufacture and commercialize (a) OPK88003, an oxyntomodulin analog being developed for the treatment of obesity and diabetes, and (b) Factor VIIa-CTP, a novel long acting coagulation factor for treating hemophilia, in exchange for 4,703 shares, representing a 47% ownership interest in the joint venture. In addition, we received an upfront payment of $1.0 million and will be reimbursed for clinical trial material and technical support we provide the joint venture.
In order to determine the primary beneficiary of the joint venture, we evaluated our investment and our related parties’ investment, as well as our investment combined with the related parties’ investment to identify if we had the power to direct the activities that most significantly impact the economic performance of the joint venture. Based on the capital structure, governing documents and overall business operations of the joint venture, we determined that, while a VIE, we do not have the power to direct the activities that most significantly impact the joint venture’s economic performance and do not have an obligation to fund expected losses. We did determine that we can significantly influence control of the joint venture through our board representation and voting power. Therefore, we have the ability to exercise significant influence over the joint venture’s operations and account for our investment in the joint venture under the equity method.
Zebra
We owned 1,260,000 shares of Zebra’s Series A-2 Preferred Stock and 900,000 shares of Zebra restricted common stock (ownership 29%) at both December 31, 2025 and December 31, 2024. Zebra is a privately held biotechnology company focused on the discovery and development of biosuperior antibody therapeutics and complex drugs. Dr. Richard Lerner, M.D., a former member of our Board of Directors, was a founder of Zebra. Dr. Frost serves as a member of Zebra’s Board of Directors.
In order to determine the primary beneficiary of Zebra, we evaluated our investment and our related parties’ investment, as well as our investment combined with the related parties’ investment to identify if we had the power to direct the activities that most significantly impact the economic performance of Zebra. Based on the capital structure, governing documents and overall business operations of Zebra, we determined that, while a VIE, we do not have the power to direct the activities that most significantly impact Zebra’s economic performance and have no obligation to fund expected losses. We determined, however, that we can significantly influence control of Zebra through our board representation and voting power. Therefore, we have the ability to exercise significant influence over Zebra’s operations and account for our investment in Zebra under the equity method.
Sales of investments
Gains (losses) included in earnings from sales of our investments are recorded in Other income (expense), net in our Consolidated Statement of Operations. The cost of securities sold is based on the specific identification method.
Warrants and options
In addition to our equity method investments and equity securities, we held options to purchase 47 thousand shares of BioCardia, all of which were vested as of December 31, 2025 and 2024. We recorded the changes in the fair value of these options and warrants in Fair value changes of derivative instruments, net in our Consolidated Statement of Operations. We also recorded the fair value of the options and warrants in Investments, net in our Consolidated Balance Sheet. See further discussion of the Company’s options and warrants in Note 19 and Note 20.
Equity method investments
The Company accounts for certain investments under the equity method when it has the ability to exercise significant influence over the investee's operating and financial policies. This influence may be indicated by factors such as board representation or voting power. Under the equity method, we recognized our proportionate share of the investee's net income or loss in the Consolidated Statement of Operations.
Our equity method investments, as described below, consist of investments in Pharmsynthez (ownership 6%), Cocrystal Pharma, Inc. (“COCP”) (2%), Non-Invasive Monitoring Systems, Inc. (“NIMS”) (1%), and LeaderMed (47%).
The aggregate amount of assets, liabilities, and net losses of these equity method investees as of and for the year ended December 31, 2025 was$48.9 million,$17.5 million, and$13.9 million, respectively. The aggregate amount of assets, liabilities, and net losses of these equity method investees as of and for the year ended December 31, 2024 was$50.9 million,$18.3 million, and$31.1 million, respectively. The aggregate value of our equity method investments based on the quoted market prices of their respective shares of common stock and the number of shares held by us as of December 31, 2025 and 2024 was$0.2 million and$0.5 million, respectively.
Note 6 Composition of Certain Financial Statement Captions
| For the years ended December 31, | ||
|---|---|---|
| (In thousands) | 2025 | 2024 |
| Accounts receivable, net | ||
| Accounts receivable | $92,325 | $119,284 |
| Less: allowance for doubtful accounts | (2,070) | (1,267) |
| $90,255 | $118,017 | |
| Inventories, net | ||
| Finished products | $43,994 | $32,310 |
| Consumable supplies | 13,090 | 15,488 |
| Work in-process | 726 | 2,355 |
| Raw materials | 11,529 | 9,418 |
| Less: inventory reserve | (3,516) | (2,774) |
| $65,823 | $56,797 | |
| Other current assets and prepaid expenses | ||
| Escrow receivable | $19,411 | $23,750 |
| Prepaid supplies | 9,423 | 6,785 |
| Prepaid insurance | 3,276 | 3,818 |
| Taxes recoverable | 11,842 | 8,266 |
| Other receivables | 4,609 | 2,015 |
| Other | 8,168 | 10,705 |
| $56,729 | $55,339 | |
| Property, plant and equipment, net: | ||
| Machinery, medical and other equipment | $109,446 | $122,064 |
| Leasehold improvements | 14,354 | 20,942 |
| Furniture and fixtures | 8,691 | 9,074 |
| Building | 15,566 | 13,062 |
| Software | 14,610 | 14,171 |
| Automobiles | 6,694 | 8,054 |
| Land | 2,537 | 2,238 |
| Construction in process | 27,646 | 19,228 |
| Less: accumulated depreciation | (125,618) | (138,699) |
| $73,926 | $70,134 | |
| Intangible assets, net: | ||
| Technologies | $811,986 | $806,858 |
| Customer relationships | 186,865 | 255,430 |
| Trade names | 49,374 | 49,726 |
| Covenants not to compete | 11,426 | 12,906 |
| Licenses | 6,422 | 6,316 |
| Product registrations | 6,885 | 6,172 |
| Other | 7,518 | 5,729 |
| Less: accumulated amortization | (564,200) | (526,524) |
| $516,276 | $616,613 | |
| For the years ended December 31, | ||
|---|---|---|
| (In thousands) | 2025 | 2024 |
| Accrued expenses: | ||
| Employee benefits and severance | $33,777 | $34,167 |
| Taxes payable | 3,595 | 22,275 |
| Gross to net provision | 5,897 | 6,920 |
| Accrued interest | 5,439 | 8,313 |
| Inventory received but not invoiced | 4,098 | 2,146 |
| Commitments and contingencies | 3,529 | 9,850 |
| Clinical trials | 4,372 | 6,104 |
| Finance leases short-term | 1,690 | 1,679 |
| Royalties | 1,197 | 563 |
| Professional fees | 1,455 | 2,521 |
| Commissions | 1,047 | 1,434 |
| Other | 18,310 | 22,385 |
| $84,406 | $118,357 | |
| Other long-term liabilities: | ||
| Employee severance | $5,540 | $14,269 |
| Mortgages and other debts payable | 2,262 | 3,002 |
| Finance leases long-term | 3,394 | 4,064 |
| Other | 11,603 | 11,503 |
| $22,799 | $32,838 | |
Our intangible assets and goodwill relate principally to our completed acquisitions of OPKO Renal, OPKO Biologics, EirGen, BioReference and ModeX. We amortize intangible assets with definite lives on a straight-line basis over their estimated useful lives. The estimated useful lives by asset class are as follows: technologies -7-17 years; customer relationships -5-20 years; product registrations -7-10 years; covenants not to compete -5 years; trade names -5-10 years; and other 9-13 years. We do not anticipate capitalizing the cost of product registration renewals, rather we expect to expense these costs, as incurred. Our goodwill is not tax deductible for income tax purposes in any jurisdiction in which we operate.
Changes in value of the intangible assets and goodwill on December 31, 2025 and 2024, were primarily due to foreign currency fluctuations between the Chilean Peso, and the Euro against the U.S. dollar.
The following table reflects the changes in the allowance for doubtful accounts, provision for inventory reserve and tax valuation allowance accounts:
| (In thousands) · Beginningbalance · Charged toexpense · Written-off · Charged toother · Endingbalance | ||||||
|---|---|---|---|---|---|---|
| Allowance for doubtful accounts | $(1,267) | (766) | (37) | — | $(2,070) | |
| Inventory reserve | $(2,774) | (4,120) | 3,378 | — | $(3,516) | |
| Tax valuation allowance | $(226,603) | (5,746) | — | (15,606) | $(247,955) | |
| 2024 | — | |||||
| Allowance for doubtful accounts | $(2,000) | (49) | 782 | — | $(1,267) | |
| Inventory reserve | $(6,461) | (2,095) | 5,782 | — | $(2,774) | |
| Tax valuation allowance | $(294,563) | 61,165 | — | 6,795 | $(226,603) | |
The following table summarizes the changes in Goodwill by reporting unit during the years ended December 31,2025 and 2024.
| 2025 | 2024 | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| (In thousands) | Grossgoodwill atJanuary 1 | Cumulativeimpairmentat January 1 | Acquisitions,dispositionsand other | Foreignexchangeand other | Balance atDecember31st | Grossgoodwill atJanuary 1 | Cumulativeimpairmentat January 1 | Acquisitions,dispositionsand other | Foreignexchangeand other | Balance atDecember31st |
| Pharmaceuticals | ||||||||||
| CURNA | $4,827 | $(4,827) | $— | $— | $— | $4,827 | $(4,827) | $— | $— | $— |
| Rayaldee | 79,433 | — | — | 10,077 | 89,510 | 84,273 | — | — | (4,840) | 79,433 |
| FineTech | 11,698 | (11,698) | — | — | — | 11,698 | (11,698) | — | — | — |
| ModeX | 80,260 | — | — | — | 80,260 | 80,260 | — | — | — | 80,260 |
| OPKO Biologics | 139,784 | — | — | — | 139,784 | 139,784 | — | — | — | 139,784 |
| OPKO Chile | 3,220 | — | — | 333 | 3,553 | 3,642 | — | — | (422) | 3,220 |
| OPKO Health Europe | 6,848 | — | — | 892 | 7,740 | 7,276 | — | — | (428) | 6,848 |
| OPKO Mexico | 100 | (100) | — | — | — | 100 | (100) | — | — | — |
| Transition Therapeutics | 3,421 | (3,421) | — | — | — | 3,421 | (3,421) | — | — | — |
| Diagnostics | ||||||||||
| BioReference | 219,707 | — | (56,265) | — | 163,442 | 283,025 | — | (63,318) | — | 219,707 |
| OPKO Diagnostics | 17,977 | (17,977) | — | — | — | 17,977 | (17,977) | — | — | — |
| $567,275 | $(38,023) | $(56,265) | $11,302 | $484,289 | $636,283 | $(38,023) | $(63,318) | $(5,690) | $529,252 | |
Note 7 Debt
As of December 31,2025 and 2024, our debt consisted of the following:
| (In thousands) | As of December 31, 2025 | As of December 31, 2024 |
|---|---|---|
| 2044 Notes | $246,433 | $245,576 |
| 2029 Convertible Notes | 84,970 | 173,556 |
| 2025 Notes | — | 170 |
| 2033 Senior Notes | 50 | 50 |
| Chilean lines of credit | 8,515 | 13,465 |
| Spanish Current portion of notes payable | 1,736 | 1,384 |
| Long term portion of notes payable | 2,262 | 3,002 |
| Total | $343,966 | $437,203 |
| Balance sheet captions | ||
| Current portion of convertible notes | $— | $170 |
| Long term portion of convertible notes | 85,020 | 173,606 |
| Current portion of lines of credit and notes payable | 10,251 | 14,849 |
| Long Term notes payable included in long-term liabilities | 248,695 | 248,578 |
| Total | $343,966 | $437,203 |
2044 Note Purchase Agreement
On July 17, 2024, the Company completed a private offering of $250 million aggregate principal amount of senior secured notes (the “2044 Notes”), pursuant to a note purchase agreement dated July 17, 2024 (the “2044 Note Purchase Agreement”), by and among the Company, certain purchasers from time to time party thereto, the Company’s wholly owned subsidiaries, OPKO Biologics (“OBL”) and EirGen, as guarantors (OBL and EirGen collectively, the “2044 Note Guarantors”), and HCR Injection SPV, LLC, as agent.
The 2044 Notes mature on July 17, 2044 and bear interest at the 3-month SOFR subject to a 4.0% per annum floor, plus 7.5%per annum. Interest is payable on the 2044 Notes on a quarterly basis determined by profit share payments received by EirGen pursuant to the profit share arrangement with Pfizer, Inc. (the “Royalty Payments”) set forth in the Restated Pfizer Agreement (as defined and described in Note 14). In the event that the aggregate amount of the Royalty Payments received by EirGen during the quarter preceding any quarterly interest payment date are less than the accrued and unpaid interest payable on such date, the excess interest payable on such date shall be paid-in-kind and added to the outstanding principal amountof the 2044 Notes. The Company will be required to pay the noteholders a 3% exit fee in connection with any repayment in full of the 2044 Notes, whether at maturity or otherwise. In addition, in the event that the Company repays the 2044 Notes in full prior to the maturity date, the Company will be required to pay the noteholders a make whole payment in an amount necessary such that the noteholders shall have received aggregate payments of principal, interest and fees in respect of the 2044 Notes equal to at least 150% of the initial principal amount of the 2044 Notes, in the event that such prepayment shall occur on or prior to July 17, 2029, or 200% of the initial principal amount of the 2044 Notes, in the event that such prepayment shall occur following July 17, 2029. If the 2044 Notes have not been fully repaid by the maturity date, the Company may elect to either repay the unpaid balance of the principal amount in full, together with any accrued and unpaid interest thereon and the 3% exit fee, or elect to transfer 80% of all future Royalty Payments to the agent and the noteholders in satisfaction of the outstanding 2044 Notes. The Company may authorize the issuance of up to $50,000,000 aggregate principal amount of additional 2044 Notes to the purchasers on the same terms and conditions of the initial 2044 Notes. The 2044 Notes are secured by the Royalty Payments, and the 2044 Note Guarantors have guaranteed the obligations under the 2044 Notes by granting a security interest in certain assets of the 2044 Note Guarantors. The 2044 Note Purchase Agreement contains customary terms and covenants, including negative covenants, such as limitations on indebtedness, liens, amendments to certain material contracts and disposition of assets.
2029 Convertible 144A Notes
In January 2024, we completed a private offering of $230.0 million aggregate principal amount of our 3.75% Convertible Senior Notes due 2029 (the “2029 Convertible 144A Notes”) in accordance with the terms of a note purchase agreement (the “144A Note Purchase Agreement”) entered into by and between the Company and J.P. Morgan Securities LLC.
Net proceeds from the issuance of the 2029 Convertible 144A Notes totaled approximately $222.0 million after deducting fees and estimated offering expenses payable by us. We used approximately $50.0 million of the net proceeds to repurchase shares of our Common Stock. These repurchases were from purchasers of the 2029 Convertible 144A Notes in privately negotiated transactions. The purchase price per share of the Common Stock in these transactions equaled $0.9067, which was the closing sale of our Common Stock on January 4, 2024.
Contemporaneously with the closing of the offering of the 2029 Convertible 144A Notes, we issued and sold approximately $71.1 million aggregate principal amount of our 3.75% Convertible Senior Notes due 2029 (the “2029 Convertible Affiliate Notes” and, together with the 2029 Convertible 144A Notes, the “2029 Convertible Notes”) pursuant to the terms of a note purchase agreement entered into on January 4, 2024 by and among the Company and certain investors, Frost Gamma Investments Trust, a trust controlled by Dr. Phillip Frost, and Dr. Jane H. Hsiao (collectively, the “Affiliate Purchasers”). Pursuant to such agreement, we issued and sold the 2029 Convertible Affiliate Notes to the Affiliate Purchasers in exchange for the entirety of the $55.0 million aggregate principal amount of our outstanding 5% convertible promissory notes held by the Affiliate Purchasers, together with approximately $16.1 million of accrued but unpaid interest thereon.
On January 9, 2024, we recorded $125.6 million value of the embedded derivative liability within the 2029 Convertible Notes as a debt discount. To determine the fair value of this derivative, we employed the Binomial Lattice model. Key inputs and assumptions for this valuation included our common stock price, the derivative's exercise price, risk-free interest rate, volatility, annual coupon rate, and remaining contractual term. We are amortizing the debt discount as non-cash interest expense over the term of the 2029 Convertible Notes.
From the date the 2029 Convertible Notes were issued through June 30, 2024, we observed an increase in the market price of our Common Stock which resulted in a $26.25 million increase in the estimated fair value of our embedded derivatives recorded in Fair value changes of derivative instruments, net in our Condensed Consolidated Statements of Operations.
On April 1, 2025, the Company completed privately negotiated exchange transactions (the “Note Exchange Transactions”), pursuant to which the Company exchanged an aggregate of $159.2 million principal amount of its 2029 Convertible 144A Notes, for an aggregate of 121,437,998 shares of its Common Stock and approximately $63.5 million in cash, inclusive of accrued and unpaid interest. Upon closing, the exchanged 2029 Convertible 144A Notes were retired and are no longer outstanding. The Company accounted for the Note Exchange Transactions as an induced conversion in accordance with ASU 2024-04, resulting in a total charge recorded within Other loss, net in the Condensed Consolidated Statements of Operations. This charge comprised an induced conversion expense of $32.6 million and a loss on extinguishment of $59.1 million. The loss on extinguishment consisted of $54.7 million in unamortized debt discount and $4.4 million in debt issuance costs associated with the retired notes.
As of December 31, 2025 the 2029 Convertible 144A Notes were not convertible. Holders may convert their 2029 Convertible Notes at their option prior to the close of business on the business day immediately preceding September 15, 2028 only under the following circumstances: (1) during any calendar quarter commencing after the calendar quarter ending on March 31, 2024 (and only during such calendar quarter), if the last reported sale price of our Common Stock for at least 20 trading days (whether or not consecutive) during the period of 30 consecutive trading days ending on, and including, the last trading day of the immediately preceding calendar quarter is greater than or equal to 130% of the applicable conversion price on each applicable trading day; (2) during thefive consecutive business day period after anyten consecutive trading day period (the “convertible note measurement period”) in which the trading price per $1,000 principal amount of notes for each trading day of the convertible note measurement period was less than 98% of the product of the last reported sale price of our Common Stock and the applicable conversion rate on each such trading day; or (3) upon the occurrence of specified corporate events specified in the indenture governing the 2029 Convertible Notes. On or after September 15, 2028, until the close of business on the business day immediately preceding the maturity date, holders may convert their notes at any time, regardless of the foregoing conditions. Upon conversion of a note, we will pay or deliver, as the case may be, cash, shares of our Common Stock or a combination of cash and shares of our Common Stock, at our election.
The conversion rate is initially equal to 869.5652 shares of Common Stock per $1,000 principal amount of notes (equivalent to an initial conversion price of approximately $1.15 per share of Common Stock). The conversion rate for the 2029 Convertible Notes will be subject to adjustment upon the occurrence of certain events but will not be adjusted for any accrued and unpaid interest. In addition, following certain corporate events that occur prior to the maturity date of the notes, in certain circumstances we will increase the conversion rate of the 2029 Convertible Notes for a holder who elects to convert its notes in connection with such a corporate event.
We may not redeem the notes prior to the maturity date, and no sinking fund is provided for the notes. If we undergo a fundamental change, holders may require us to purchase the notes in whole or in part for cash at a fundamental change purchase price equal to 100% of the principal amount of the notes to be purchased, plus accrued and unpaid interest, if any, to, but excluding, the fundamental change purchase date. The 2029 Convertible Notes are our senior unsecured obligations and rank senior in right of payment to any indebtedness that is expressly subordinated in right of payment to the notes, and equal in right of payment with all of our existing and future unsecured indebtedness that is not so subordinated. The notes are effectively subordinated to all of our existing and future secured indebtedness to the extent of the value of the assets securing such indebtedness and structurally subordinated to all existing and future liabilities of our subsidiaries.
The indenture governing the notes provides for customary events of default which include (subject in certain cases to customary grace and cure periods), among others, the following: nonpayment of principal or interest; breach of covenants or other agreements in the indenture; defaults in failure to pay certain other indebtedness; judgment defaults; and certain events of bankruptcy or insolvency. Generally, if an event of default occurs and is continuing under the indenture, the trustee thereunder or the holders of at least 25% in aggregate principal amount of the notes then outstanding may declare 100% of the principal of and accrued and unpaid interest, if any on all then-outstanding notes to be immediately due and payable. In certain circumstances, we may, for a period of time, elect to pay additional interest on the notes as the sole remedy to holders of the notes in the case of an event of default related to certain failures by us to comply with certain reporting covenants in the indenture.
The following table sets forth information related to the 2029 Convertible Notes which is included in our Condensed Consolidated Balance Sheet as of December 31,2025:
| (In thousands) | 2029convertiblenotes | Discount | DebtIssuanceCosts | Total |
|---|---|---|---|---|
| Balance at December 31, 2024 | $280,594 | $(100,879) | $(6,159) | $173,556 |
| Amortization of debt discount and debt issuance costs | — | 10,891 | 653 | 11,544 |
| Repurchase | (159,221) | 54,701 | 4,390 | (100,130) |
| Balance at December 31, 2025 | $121,373 | $(35,287) | $(1,116) | $84,970 |
2025 Convertible Notes
In February 2019, we issued $200.0 million aggregate principal amount of Convertible Senior Notes due 2025 (the “2025 Notes”) in an underwritten public offering. The 2025 Notes bore interest at a rate of 4.50%per year, payable semiannually in arrears on February 15 and August 15 of each year, and matured on February 15, 2025. During the year ended December 31, 2025, the Company repurchased the remaining $170 thousand aggregate principal outstanding amount of the 2025 Notes.
2033 Senior Notes
In January 2013, we issued an aggregate of $175.0 million of our 3.0% Senior Notes due 2033 (the “2033 Senior Notes”) in a private placement. The 2033 Senior Notes bear interest at the rate of 3.0% per year, payable semiannually on February 1 and August 1 of each year and mature on February 1, 2033, unless earlier repurchased, redeemed or converted. From 2013 to 2016, holders of the 2033 Senior Notes converted $143.2 million in aggregate principal amount into Common Stock, and, on February 1, 2019, approximately $28.8 million aggregate principal amount of 2033 Senior Notes were tendered by holders pursuant to such holders’ option to require us to repurchase the 2033 Senior Notes. During the first quarter of 2023, we paid approximately $3.0 million to purchase 2033 Senior Notes in accordance with the indenture governing the 2033 Senior Notes, following which $50.6 thousand 2033 Senior Notes remained outstanding.
International Line of Credit Agreements
The Company had line of credit agreements with 12 other financial institutions as of December 31, 2025 and December 31, 2024 in the U.S., Chile and Spain. These lines of credit are used primarily as a source of working capital for inventory purchases.
The following table summarizes the amounts outstanding under the BioReference, Chilean and Spanish lines of credit:
| (Dollars in thousands) | Balance Outstanding | |||
|---|---|---|---|---|
| Interestrate onborrowings at | Credit line | December 31, | December 31, | |
| Lender | December 31, 2025 | capacity | 2025 | 2024 |
| Itau Bank | 5.50% | $2,363 | $459 | $200 |
| Bank of Chile | 6.60% | 2,500 | 1,165 | 2,202 |
| BICE Bank | 5.50% | 2,500 | 1,046 | 2,418 |
| Scotiabank | 5.50% | 5,500 | 2,091 | 3,497 |
| Santander Bank | 5.50% | 5,000 | 873 | 1,926 |
| Security Bank | 5.50% | 1,400 | — | 133 |
| Estado Bank | 5.50% | 4,000 | 1,351 | 1,154 |
| BCI Bank | 5.00% | 2,500 | 330 | 673 |
| Internacional Bank | 5.50% | 1,500 | 1,022 | 1,130 |
| Consorcio Bank | 5.00% | 2,000 | 178 | 133 |
| Banco De Sabadell | 1.75% | 587 | — | — |
| Santander Bank | 5.36% | 587 | — | — |
| Total | $30,436 | $8,515 | $13,466 | |
At December 31, 2025 and 2024, the weighted average interest rate on our lines of credit was approximately 5.5% for both periods.
At December 31,2025 and 2024, we had notes payable and other debt (excluding the 2033 Senior Notes, the 2023 Convertible Notes, the 2025 Notes, the BioReference Credit Agreement and amounts outstanding under lines of credit described above) as follows:
| December 31, | December 31, | |
|---|---|---|
| (In thousands) | 2025 | 2024 |
| Current portion of notes payable | $1,736 | $1,384 |
| Other long-term liabilities | 2,262 | 3,002 |
| Total | $3,998 | $4,386 |
The notes and other debt mature at various dates ranging from 2025 through 2032 bearing variable interest rates from 0.7% up to 4.5%. The weighted average interest rate on the notes and other debt was 2.0% and 1.8% on December 31, 2025 and 2024. The notes are partially secured by our office space in Barcelona.
Note 8 Shareholders’ Equity
Our authorized capital stock consists of 1,250,000,000 shares of Common Stock, par value $0.01 per share, and 10,000,000 shares of Preferred Stock, par value $0.01 per share.
Common Stock
Subject to the rights of the holders of any shares of Preferred Stock currently outstanding or which may be issued in the future, the holders of the Common Stock are entitled to receive dividends from our funds legally available when, as and if declared by our Board of Directors, and are entitled to share ratably in all of our assets available for distribution to holders of Common Stock upon the liquidation, dissolution or winding-up of our affairs subject to the liquidation preference, if any, of any then outstanding shares of Preferred Stock. Holders of our Common Stock do not have any preemptive, subscription, redemption or conversion rights. Holders of our Common Stock are entitled toone vote per share on all matters which they are entitled to vote upon at meetings of stockholders or upon actions taken by written consent pursuant to Delaware corporate law. The holders of our Common Stock do not have cumulative voting rights, which means that the holders of a plurality of the outstanding shares can elect all of our directors. All of the shares of our Common Stock currently issued and outstanding are fully-paid and nonassessable. No dividends have been paid to holders of our Common Stock since our incorporation, and no cash dividends are anticipated to be declared or paid on our Common Stock in the reasonably foreseeable future.
Preferred Stock
Under our certificate of incorporation, our Board of Directors has the authority, without further action by stockholders, to designate up to 10 million shares of Preferred Stock in one or more series and to fix or alter, from time to time, the designations, powers and rights of each series of Preferred Stock and the qualifications, limitations or restrictions of any series of Preferred Stock, including dividend rights, dividend rate, conversion rights, voting rights, rights and terms of redemption (including sinking fund provisions), redemption price or prices, and the liquidation preference of any wholly issued series of Preferred Stock, any or all of which may be greater than the rights of the Common Stock, and to establish the number of shares constituting any such series.
Of the authorized Preferred Stock,4,000,000 shares,500,000 shares and 2,000,000 shares were designated Series A Preferred Stock, Series C Preferred Stock and Series D Preferred Stock, respectively. As of December 31,2025 and 2024, there wereno shares of Series A Preferred Stock, Series C Preferred Stock or Series D Preferred Stock issued or outstanding.
Stock Repurchase Program
On July 18, 2024, the Company announced that its Board of Directors authorized the repurchase of $100.0 million of shares of Common Stock under a stock repurchase program (the "program"). On April 4, 2025, the Company announced that its Board of Directors increased the aggregate capacity of the program to $200.0 million. During the year ended December 31, 2024, the Company repurchased 25,825,785 shares of Common Stock at an average price per share of $1.56 for approximately $40.2 million. During the year ended December 31, 2025, the Company repurchased an aggregate of 34,557,844 shares of Common Stock at an average price of $1.36 per share for approximately $47.0 million. Of these repurchased shares,33,507,844 were retired prior to December 31, 2025, and 1,050,000 were retired in January 2026. As of December 31, 2025, the Company had repurchased a cumulative total of 60,383,629 shares under this program for approximately $87.2 million.
Under the program, the Company may repurchase shares of Common Stock from time to time through various methods, including open market purchases, block trades, privately negotiated transactions, accelerated share repurchases, and pursuant to pre-set trading plans under Rule 10b5-1(c) of the Exchange Act and otherwise in compliance with applicable laws. The timing and volume of repurchases are subject to market conditions, capital management, investment opportunities, and other factors. The program does not obligate the Company to repurchase any specific number of shares, has no set expiration date, and may be modified, suspended, or discontinued at any time at the Company's discretion.
Common Stock Repurchase
In conjunction with the completion of the 2029 Convertible 144A Notes, we used approximately $50.0 million from net proceeds to repurchase shares of our Common Stock in privately negotiated transactions with purchasers of the 2029 Convertible 144A Notes. The purchase price per share was $0.9067, which was the closing sale price of our Common Stock on January 4, 2024.
Note 9 Accumulated Other Comprehensive Income (Loss)
For the year ended December 31, 2025, changes in Accumulated other comprehensive income (loss), net of tax, were as follows:
| Foreign | |
|---|---|
| (In thousands) | currencytranslation |
| Balance at December 31, 2024 | $(56,130) |
| Other comprehensive loss | 35,113 |
| Balance at December 31, 2025 | $(21,017) |
For the year ended December 31, 2024, changes in Accumulated other comprehensive income, net of tax, were as follows:
| Foreign | |
|---|---|
| (In thousands) | currencytranslation |
| Balance at December 31, 2023 | $(38,030) |
| Other comprehensive income | (18,100) |
| Balance at December 31, 2024 | $(56,130) |
Note 10 Equity-Based Compensation
We maintain two equity-based incentive compensation plans, the 2016 Equity Incentive Plan and the 2007 Equity Incentive Plan that provide for grants of stock options and restricted stock to our directors, officers, key employees and certain outside consultants. Equity awards granted under our 2016 Equity Incentive Plan are exercisable for a period of up to 10 years from the date of grant. Equity awards granted under our 2007 Equity Incentive Plan are exercisable for a period of either 7 years or 10 years from the date of grant. Vesting periods range from immediate to 4 years. We currently grant equity awards under only the 2016 Equity Incentive Plan.
We classify the cash flows resulting from the tax benefit that arises when the tax deductions exceed the compensation cost recognized for those equity awards (excess tax benefits) as cash flows from operations. There wereno excess tax benefits for the years ended December 31,2025, 2024, and 2023.
Valuation and Expense Information
We recorded equity-based compensation expense of$10.7 million,$11.0 million and $11.4 million for the years ended December 31,2025, 2024, and 2023, respectively, all of which were reflected as operating expenses. Of the $10.7 million of equity-based compensation expense recorded for the year ended December 31, 2025, $5.3 million was recorded as selling, general and administrative expenses, $5.2 million was recorded as research and development expenses and $0.2 million was recorded as a cost of revenue. Of the $11.0 million of equity-based compensation expense recorded for the year ended December 31,2024, $5.9 million was recorded as selling, general and administrative expenses, $4.5 million was recorded as research and development expenses and $0.6 million was recorded as a cost of revenue. Of the $11.4 million of equity-based compensation expense recorded for the year ended December 31,2023, $6.5 million was recorded as selling, general and administrative expense, $4.2 million was recorded as research and development expenses and $0.7 million was recorded as cost of revenue.
As of December 31, 2025, there was $19.4 million of unrecognized compensation cost related to the equity awards granted under our equity-based incentive compensation plans. Such cost is expected to be recognized over a weighted-average period of approximately 1.97 years.
Stock Options
We estimate the fair value of each stock option on the date of grant using the Black-Scholes-Merton Model option-pricing formula and amortize the fair value to expense over the stock option’s vesting period using the straight-line attribution approach. We account for forfeitures as they occur and apply the following assumptions in our Black-Scholes-Merton Model option-pricing formula:
| Year Ended | Year Ended | Year Ended | |
|---|---|---|---|
| December 31, | December 31, | December 31, | |
| 2025 | 2024 | 2023 | |
| Expected term (in years) | 3.74 - 10.0 | 3.74 - 5.98 | 3.74 - 10.0 |
| Risk-free interest rate | 3.64% - 4.53% | 3.45% - 4.32% | 3.61% - 4.72% |
| Expected volatility | 60.18% - 70.73% | 65.45% - 76.47% | 63.11% - 76.43% |
| Expected dividend yield | 0% | 0% | 0% |
Expected Term: For the expected term of options grants, we used an estimate of the expected option life based on historical experience.
Risk-Free Interest Rate: The risk-free interest rate is based on the rates paid on securities issued by the U.S. Treasury with a term approximating the expected life of the option.
Expected Volatility: The expected volatility for stock options was based on the historical volatility of our Common Stock.
Expected Dividend Yield: We do not intend to pay dividends on Common Stock for the foreseeable future. Accordingly, we used a dividend yield ofzero in the assumptions.
We maintain incentive stock plans that provide for the grants of equity awards to our directors, officers, employees and non-employee consultants. As of December 31, 2025, there were 19,148,162 shares of Common Stock reserved for issuance under our equity-based incentive plans. We intend to issue new shares upon the exercise of stock options. Stock options granted under these plans were granted at an option exercise price equal to the closing market value of the Common Stock on the applicable date of the grant. Stock options granted under these plans to employees typically become exercisable over four years in equal annual installments after the date of grant, and stock options granted to non-employee directors become exercisable in fullone-year after the grant date, subject to, in each case, continuous service with us during the applicable vesting period. We assumed stock options to grant Common Stock as part of the mergers with Acuity Pharmaceuticals, Inc., Froptix, Inc., OPKO Biologics and BioReference, which reflected various vesting schedules, including monthly vesting to employees and non-employee consultants.
A summary of option activity under our stock option plans as of December 31,2025, and the change during the year is presented below:
| Weighted | ||||||
|---|---|---|---|---|---|---|
| Weighted · average | ||||||
| average · remaining · Aggregate | ||||||
| Number of · exercise · contractual · intrinsic value | ||||||
| Options · options · price · term (years) · (in thousands) | ||||||
| Outstanding at December 31, 2024 | 45,487,743 | $4.67 | 4.93 | $114 | ||
| Granted | 9,936,500 | $1.33 | ||||
| Exercised | (57,500) | $1.64 | ||||
| Forfeited | (706,215) | $1.70 | ||||
| Expired | (8,746,271) | $8.90 | ||||
| Outstanding at December 31, 2025 | 45,914,257 | $3.19 | 5.75 | $15 | ||
| Vested and expected to vest at December 31, 2025 | 45,914,257 | $3.19 | 5.75 | $15 | ||
| Exercisable at December 31, 2025 | 30,322,447 | $4.06 | 4.27 | $13 | ||
A summary of restricted stock unit activity as of December 31,2025, and the change during the year is presented below:
| Weighted | ||||
|---|---|---|---|---|
| Weighted · average | ||||
| average · remaining · Aggregate | ||||
| Number of | fair | contractual | intrinsic value | |
| Restricted stock units | options | value | term (years) | (in thousands) |
| Unvested at December 31, 2024 | 10,943,403 | $1.55 | 9.34 | $16,087 |
| Granted | 7,229,769 | $1.73 | ||
| Forfeited | (2,797,188) | $1.75 | ||
| Actual vested | (850,146) | $2.55 | ||
| Unvested and expected to vest at December 31, 2025 | 14,525,838 | $1.55 | 7.22 | $18,303 |
The total intrinsic value of stock options exercised for each of the years ended December 31, 2025, 2024, and 2023 was $0.0 million.
The weighted average grant date fair value of stock options granted for the years ended December 31, 2025, 2024, and 2023 was $0.71, $0.77, and $0.99, respectively. The weighted average grant date fair value of restricted stock units granted for the years ended December 31,2025, 2024, and 2023 was $1.73, $1.36 and $0.00, respectively.
The total fair value of stock options vested during the years ended December 31, 2025, 2024, and 2023 was $6.8 million, $8.8 million and $8.5 million, respectively. The total fair value of restricted stock units vested during the years ended December 31,2025, 2024, and 2023 was$2.2 million, $1.7 million and $1.8 million, respectively.
Note 11 Income Taxes
We operate and are required to file tax returns in the U.S. and various foreign jurisdictions.
The benefit (provision) for incomes taxes consists of the following:
| For the years ended December 31, | |||
|---|---|---|---|
| (In thousands) | 2025 | 2024 | 2023 |
| Current | |||
| Federal | $2,811 | $(5,306) | $(487) |
| State | 5,400 | (19,129) | 946 |
| Foreign | (7,497) | (3,665) | (4,750) |
| 714 | (28,100) | (4,291) | |
| Deferred | |||
| Federal | 2,967 | (21,536) | (52) |
| State | (63) | (3,375) | 298 |
| Foreign | 12,095 | 10,167 | (392) |
| 14,999 | (14,744) | (146) | |
| Total, net | $15,713 | $(42,844) | $(4,437) |
Deferred income tax assets and liabilities as of December 31,2025 and 2024 were comprised of the following:
| (In thousands) | December 31, 2025 | December 31, 2024 |
|---|---|---|
| Deferred income tax assets: | ||
| Federal net operating loss | $9,007 | $6,482 |
| State net operating loss | 25,479 | 26,253 |
| Foreign net operating loss | 31,584 | 17,298 |
| Research and development expense | 22,412 | 37,247 |
| Tax credits | 20,161 | 16,074 |
| Stock options | 17,317 | 28,373 |
| Accruals | 5,837 | 9,481 |
| Equity investments | 14,199 | 3,964 |
| Bad debts | 390 | 206 |
| Lease liability | 303 | 648 |
| Foreign credits | 9,609 | 9,659 |
| Available-for-sale securities | 1,490 | 2,622 |
| Operating lease asset | 13,458 | 17,588 |
| Fixed assets | 896 | 1,081 |
| Other | 2,395 | 1,615 |
| Deferred income tax assets | 174,537 | 178,591 |
| Deferred income tax liabilities: | ||
| Intangible assets | (34,910) | (73,023) |
| Operating lease liability | (13,227) | (15,428) |
| Other | (1,859) | (1,985) |
| Deferred income tax liabilities | (49,996) | (90,436) |
| Net deferred income tax assets | 124,541 | 88,155 |
| Valuation allowance | (247,955) | (226,603) |
| Net deferred income tax assets (liabilities) | $(123,414) | $(138,448) |
Note: Net deferred income tax liability balances at December 31, 2025 and 2024 include$2.8 million and$2.4 million, respectively, recorded to Other assets on the Consolidated Balance Sheets.
As of December 31, 2025, we had federal, state and foreign net operating loss carryforwards of approximately $61.5 million, $447.4 million and $131.4 million, respectively, that expire at various dates through 2045 unless indefinite in nature. As of December 31,2025, we have research and development tax credit carryforwards of approximately$20.2 million that expire in varying amounts through 2045. As of each reporting date, management considers new evidence, both positive and negative, that could affect its view of the future realization of deferred tax assets. We have determined a valuation allowance is required against all of our net deferred tax assets that we do not expect to be utilized by the reversing of deferred income tax liabilities.
Under Section 382 of the Internal Revenue Code of 1986, as amended ("IRC" or the "Internal Revenue Code"), certain significant changes in ownership may restrict the future utilization of our income tax loss carryforwards and income tax credit carryforwards in the U.S. The annual limitation is equal to the value of our stock immediately before the ownership change, multiplied by the long-term tax-exempt rate (i.e., the highest of the adjusted federal long-term rates in effect for any month in the three-calendar-month period ending with the calendar month in which the change date occurs). This limitation may be increased under the IRC Section 338 Approach (IRS approved methodology for determining recognized Built-In Gain). As a result, federal net operating losses and tax credits may expire before we are able to fully utilize them.
During 2008, we conducted a study to determine the impact of the various ownership changes that occurred during 2007 and 2008. As a result, we have concluded that the annual utilization of our net operating loss carryforwards (“NOLs”) and tax credits is subject to a limitation pursuant to Internal Revenue Code Section 382. Under the tax law, such NOLs and tax credits are subject to expiration from 15 to 20 years after they were generated. As a result of the annual limitation that may be imposed on such tax attributes and the statutory expiration period, some of these tax attributes may expire prior to our being able to use them. There is no current impact on these financial statements as a result of the annual limitation. This study did not conclude whether OPKO’s predecessor, eXegenics, Inc., pre-merger NOLs were limited under Section 382. As such, of the $61.5 million of federal net operating loss carryforwards, at least approximately $14.6 million may not be able to be utilized.
During 2020, we conducted a study to determine whether any ownership changes occurred from 2009 through 2020. In The study has since been updated annually, including through 2025, and we concluded that the annual utilization of our NOLs and tax credits is not subject to a limitation pursuant to Internal Revenue Code Section 382.
We file federal income tax returns in the U.S. and various foreign jurisdictions, as well as with various U.S. states and the Ontario and Nova Scotia provinces in Canada. We are subject to routine tax audits in all jurisdictions for which we file tax returns. Tax audits by their very nature are often complex and can require several years to complete. Other than the Israeli tax matter, we did not have any U.S. or foreign audits as of December 31, 2025.
U.S. Federal: Under the tax statute of limitations applicable to the Internal Revenue Code, we are no longer subject to U.S. federal income tax examinations by the Internal Revenue Service for years before 2021. However, because we are carrying forward income tax attributes, such as net operating losses and tax credits from those years, these attributes can still be audited when utilized on returns filed in the future.
State: Under the statute of limitations applicable to most state income tax laws, we are no longer subject to state income tax examinations by tax authorities for years before 2021 in states in which we have filed income tax returns. Certain states may take the position that we are subject to income tax in such states even though we have not filed income tax returns in such states and, depending on the varying state income tax statutes and administrative practices, the statute of limitations in such states may extend to years before 2021.
Foreign: Under the statute of limitations applicable to our foreign operations, we are generally no longer subject to tax examination for years before 2020 in jurisdictions where we have filed income tax returns.
One Big Beautiful Bill Act
On July 4, 2025, the One Big Beautiful Bill Act (“OBBBA”) was enacted in the United States. This comprehensive legislation includes several significant tax provisions, such as the permanent extension of certain expiring provisions of the 2017 Tax Cuts and Jobs Act (the “2017 Tax Act”), modifications to the international tax framework, and the restoration of key business provisions. The OBBBA has multiple effective dates, with certain provisions effective in 2025 and others implemented through 2027. Most notably for the Company, the legislation reverses the requirement to capitalize domestic research and experimental (R&E) costs under Section 174 of the Internal Revenue Code, allowing for immediate expense of these costs beginning with the tax year ended December 31, 2025. Management has evaluated the new legislation and determined that the enactment of the OBBBA did not have a material impact on the Company's annual effective tax rate.
Tax Cuts and Jobs Act
On December 22, 2017, the 2017 Tax Act was enacted into law, and the new legislation contained several key tax provisions, including a reduction of the corporate income tax rate from 35% to 21% effective January 1, 2018 and a one-time mandatory transition tax on accumulated foreign earnings, among others. We were required to recognize the effect of the tax law changes in the period of enactment, such as remeasuring our U.S. deferred tax assets and liabilities, as well as reassessing the net realizability of our deferred tax assets and liabilities.
The 2017 Tax Act provides for a Global Intangible Low Taxed Income provision (“GILTI”). Under the GILTI provision, certain foreign subsidiary earnings in excess of an allowable return on the foreign subsidiary’s tangible assets are included in U.S. taxable income. The Company has not recorded any deferred taxes for future GILTI inclusions as any future inclusions are expected to be treated as a period expense and offset by net operating loss carryforwards in the U.S, if available.
Unrecognized Tax Benefits
As of December 31, 2025, 2024, and 2023, the total amount of gross unrecognized tax benefits was approximately$16.7 million, $16.5 million, and $16.9 million, respectively. As of December 31,2025, 2024, and 2023, the total amount of unrecognized tax benefits that, if recognized, would affect our effective income tax rate was $(9.9) million. We account for any applicable interest and penalties on uncertain tax positions as a component of income tax expense and we recognized$0.0 million and $0.3 million of interest expense for the years ended December 31,2025 and 2024, respectively.
The following summarizes the changes in our gross unrecognized income tax benefits.
| For the years ended December 31, | ||
|---|---|---|
| (In thousands) | 2025 | 2024 |
| Unrecognized tax benefits at beginning of period | $16,509 | $16,931 |
| Gross increases – tax positions in current period | 248 | 265 |
| Lapse of Statute of Limitations | (42) | (687) |
| Unrecognized tax benefits at end of period | $16,715 | $16,509 |
Other Income Tax Disclosures
The significant elements contributing to the difference between the federal statutory tax rate and the Company's effective tax rate are as follows:
| (In thousands) | Amount | % |
|---|---|---|
| Pre-tax book income/loss | $(241,392) | |
| US federal statutory tax rate | (50,692) | 21.00% |
| State and local income taxes, net of federal income tax effect* | (5,396) | 2.24% |
| Foreign tax effects: | ||
| Israel | ||
| Changes in valuation allowances | 8,462 | (3.51)% |
| Other | (4,218) | 1.75% |
| Mexico | 1,379 | (0.57)% |
| Luxembourg | ||
| Changes in valuation allowances | 9,469 | (3.92)% |
| True-up adjustments | (8,246) | 3.42% |
| Other foreign jurisdiction | (350) | 0.14% |
| Effect of changes in tax laws or rates enacted in the current period: | ||
| Tax Credits | ||
| R&D tax credit | (500) | 0.21% |
| Changes in valuation allowance | (6,739) | 2.79% |
| Nontaxable or nondeductible items | ||
| Convertible debt | 20,770 | (8.61)% |
| Cancellation of stock options | 5,894 | (2.44)% |
| BioReference Asset Sale | 11,816 | (4.90)% |
| Imputed interest, net | 2,688 | (1.11)% |
| Other | 1,654 | (0.69)% |
| Changes in unrecognized tax benefits | 248 | (0.10)% |
| Other adjustments | (1,952) | 0.81% |
| Total | $(15,713) | 6.51% |
*State taxes in New York made up the majority (greater than 50%) of the tax effect in this category.
| For the years ended December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Federal statutory rate | 21.0% | 21.0% |
| State income taxes, net of federal benefit | (268.6)% | 4.7% |
| Foreign income tax | (18.6)% | (2.5)% |
| Income Tax Refunds | —% | (0.4)% |
| Research and development tax credits | 6.9% | 0.7% |
| Valuation allowance | 583.4% | (7.0)% |
| Rate change effect | (21.0)% | 0.4% |
| Non-deductible items | (4.8)% | (0.6)% |
| Unrecognized tax benefits | 1.7% | 0.7% |
| GILTI | (441.7)% | (14.8)% |
| Convertible Debt | (71.8)% | —% |
| Stock options excess tax benefit, cancellations & expirations | (39.7)% | (2.3)% |
| Imputed interest | (19.7)% | (0.8)% |
| True-Up to Adjustments | (12.3)% | (2.3)% |
| BioReference Asset Sale | (133.9)% | —% |
| Other | 6.3% | 0.8% |
| Total | (412.8)% | (2.4)% |
The following table presents the disaggregation of income taxes paid, net of refunds received, for the year ended December 31, 2025. They are classified by federal, state, and local jurisdictions, with individual jurisdictions disclosed separately if they represent 5% or more of the total net income taxes paid.
| Jurisdiction | Income Taxes Paid | % of total income taxes paid |
|---|---|---|
| (In thousands) | ||
| U.S. Federal | $4,210 | 17% |
| U.S. State - New York | 5,833 | 24% |
| U.S. City - New York | 10,732 | 44% |
| Mexico | 2,392 | 10% |
| Other Jurisdictions | 1,296 | 5% |
| Total Net Income Taxes Paid/(Refunded) | $24,463 | |
Certain operations in Israel have been granted “Beneficiary Enterprise” status by the Israeli Income Tax Authority, which makes us eligible for tax benefits under the Israeli Law for Encouragement of Capital Investments, 1959. Under the terms of the Beneficiary Enterprise program, beneficiary income that is attributable to our operations in Kiryat Gat, Israel will be exempt from income tax through 2023. For the years ended December 31, 2025, and 2024, the tax holiday had expired.
The following table reconciles our income (loss) before income taxes between U.S. and foreign jurisdictions:
| For the years ended December 31, | |||
|---|---|---|---|
| (In thousands) | 2025 | 2024 | 2023 |
| Pre-tax income (loss): | |||
| U.S. | $(188,516) | $45,796 | $(198,394) |
| Foreign | (52,877) | (56,176) | 13,968 |
| Total | $(241,393) | $(10,380) | $(184,426) |
In 2021, we revised our position regarding unrepatriated foreign earnings to a partially reinvested assertion. We assert that all foreign earnings will be indefinitely reinvested, with the exception of certain foreign investments in which earnings and cash generation are in excess of local needs, and if opportunities exist to repatriate funds in a tax efficient manner. With the passage of the Tax Act, dividends of earnings from non-U.S. operations are generally no longer subject to U.S. income tax. We continue to analyze and adjust the estimated impact of the non-U.S. income and withholding tax liabilities based on the source of these earnings, as well as the expected means through which those earnings may be taxed. As of December 31, 2025, we do not maintain any accrued withholding tax related to earnings that are not deemed to be permanently reinvested.
Note 12 Related Party Transactions
We lease office space from Frost Real Estate Holdings, LLC (“Frost Holdings”) in Miami, Florida, where our principal executive offices are located. Effective August 1, 2024, we entered into an amendment to our lease agreement with Frost Holdings to decrease the lease space from approximately 29,500 square feet to approximately 26,328 square feet of space. The amended lease provides for payments of approximately $91 thousand per month in the first year increasing annually to $103 thousand per month in the fifth year, plus applicable sales tax. The rent is inclusive of operating expenses, property taxes and parking.
In January 2024, in connection with the closing of the offering of the 2029 Convertible Notes, we issued and sold approximately $71.1 million aggregate principal amount of the 2029 Convertible Affiliate Notes to the Affiliate Purchasers, in exchange for $55.0 million aggregate principal amount of the 2023 Convertible Notes, together with approximately $16.1 million accrued but unpaid interest thereon, held by such Affiliate Purchasers. See Note 7 for additional information. Dr. Frost, an Affiliate Purchaser, subsequently purchased 2029 Convertible Notes on the open market in September 2024.
On October 12, 2023, the Company entered into an E-Commerce Distribution Agreement with NextPlat Corp (“NextPlat”), a global e-commerce provider, in which Dr. Frost owns more than a 20% interest. Under the terms of the agreement, NextPlat has agreed to launch an OPKO Health-branded online storefront on the Alibaba Group Holding Limited Tmall Global e-commerce platform in China, featuring an assortment of nutraceutical and veterinary products sold and distributed by OPKO Health Europe SLU, our wholly-owned subsidiary. The Company and NextPlat amended the agreement in October 2024 to extend the term of the agreement to 2026, and permit NextPlat to launch an online storefront on additional e-commerce platforms throughout Asia.
On May 4, 2023, the Company entered into an Assignment and Assumption Agreement (the “Assignment Agreement”) with Ruen-Hui Biopharmaceuticals, Inc., a Taiwanese entity (“Ruen-Hui”) in which Dr. Hsiao owns more than a 10% interest. Ruen-Hui assumed the Company's obligations under an exclusive license agreement with Academia Sinica in exchange for a number of potential milestone payments up to $1 million, commercial milestones ranging from low to double digit millions, and royalty payments. Ruen Hui is also responsible for any outstanding payment obligations under such license agreement, including patent maintenance costs, and any payments due to Academia Sinica.
On April 29, 2022, upon consummation of our sale of GeneDx, the Company entered into a Transition Services Agreement (the “Transition Services Agreement”) with GeneDx, pursuant to which the Company agreed to provide, at cost, certain customary support services in respect of GeneDx’s business through August 31, 2023, including human resources, information technology support, and finance and accounting. As of December 31, 2023, the Company had incurred aggregate expenses of $2.5 million for services rendered under the Transition Services Agreement. For the years ended December 31,2025, and 2024, the Company didnot incur expenses for services rendered under the Transition Services Agreement. As of December 31,2025, and 2024, GeneDx hadno outstanding balance payable to the Company under the Transition Services Agreement.
The Company owns approximately 6% of Pharmsynthez and Pharmsynthez holds shares of Xenetic, in which the Company has a 0.6% ownership interest as of December 31, 2025. See further discussion of our Xenetic investment in Note 5
We hold investments in Zebra (ownership 29%), ChromaDex Corporation (0.04%), COCP (2%), NIMS (0.5%), Eloxx (1%), BioCardia (0.1%) and LeaderMed Health Group Limited (47%). These investments were considered related party transactions as a result of our executive management’s ownership interests and/or board representation in these entities. We previously held an investment in GeneDx (Nasdaq: WGS), which represented a 2.2% ownership interest as of December 31, 2024, obtained as a result of our sale of GeneDx, Inc. and subsequent participation in an underwritten offering by GeneDx. Richard Pfenniger who sits on our Board of Directors also sits on the GeneDx Board. We sold our remaining investment in GeneDx during the first quarter of 2025.
Dr. Elias Zerhouni, our Vice Chairman and President, sits on the board of directors of Danaher Corporation (“Danaher”). Our subsidiary, BioReference, routinely procures products and services from several subsidiaries of Danaher, including Beckman Coulter, Integrated DNA Technologies Inc., and Leica Microsystems Inc., to which BioReference has paid $2.3 million, $2.6 million, and $0.3 million, respectively, during the year ended December 31,2025.
We reimburse Dr. Frost for Company-related use by Dr. Frost and our other executives of an airplane owned by a company that is beneficially owned by Dr. Frost. We do not reimburse Dr. Frost or any other executive for their personal use of the airplane. For the year ended December 31, 2025, no amounts were reimbursed or accrued for Company-related travel by Dr. Frost and other executives. For the years ended December 31, 2024, and 2023, we recognized approximately $131 thousand, and $79 thousand, respectively, for Company-related travel by Dr. Frost and other executives.
Note 13 Employee Benefit Plans
Effective January 1, 2007, the OPKO Health Savings and Retirement Plan (the “Plan”) permits employees to contribute up to 100% of qualified pre-tax annual compensation up to annual statutory limitations. The discretionary company match for employee contributions to the Plan is 100% up to the first 4% of the participant’s earnings contributed to the Plan. Our matching contributions to our plans, including the Plan and predecessor plans for BioReference, were approximately $5.2 million, $6.7 million and $7.3 million for the years ended December 31,2025, 2024, and 2023, respectively.
Note 14 Commitments and Contingencies
On December 29, 2022, the Israel Tax Authority (the “ITA”) issued an assessment against our subsidiary, OPKO Biologics in the amount of approximately $246 million (including interest) related to uncertain tax positions involving income recognition in connection with an examination of foreign tax returns for the 2014 through 2020 tax years. We recognize that local tax law is inherently complex, and the local taxing authorities may not agree with certain tax positions taken. We have appealed this assessment, as we believe, other than for uncertain tax positions for which we have reserved, the issues are without technical merit. The matter is currently before the courts. While the trial has concluded, there are certain other procedural matters under Israeli law that must occur before a judgment is rendered. We intend to continue to exhaust all judicial remedies necessary to resolve the matter, as necessary, which has been a lengthy process. There can be no assurance that this matter will be resolved in our favor, and an adverse outcome, or any future tax examinations involving similar assertions, could have a material adverse effect on our financial condition, results of operations and cash flows.
The Company and BioReference entered into (i) a settlement agreement (the “Settlement Agreement”), effective July 14, 2022, with the United States of America, acting through the United States Department of Justice and on behalf of the Office of Inspector General of the Department of Health and Human Services (“OIG-HHS”), and the Defense Health Agency, acting on behalf of the TRICARE Program (collectively, the “United States”), the Commonwealth of Massachusetts , the State of Connecticut, and the relator identified therein (“Relator”), and (ii) a Corporate Integrity Agreement, effective July 14, 2022 (the “CIA”), with the OIG-HHS, to resolve the investigation and related civil action concerning alleged fee-for-service claims for payment to the Medicare Program, the Medicaid Program, and the TRICARE Program (collectively, the “Federal Health Care Programs”).
Under the Settlement Agreement, the Company and BioReference admitted only to having made payments to certain physicians and physicians’ groups for office space rentals for amounts that exceeded fair market value, and that it didnot report or return any such overpayments to the Federal Health Care Programs (the “Covered Conduct”). The Covered Conduct had commenced prior to the Company’s acquisition of BioReference in 2015. With the exception of the Covered Conduct, the Company and BioReference expressly deny the allegations of the Relator as set forth in her civil action. The Company has paid a total of $10,000,000 plus accrued interest from September 24, 2021, at a rate of 1.5% per annum (the “Settlement Amount”). The Settlement Amount consisted of $9,853,958 payable to the United States, $141,041 payable to the Commonwealth and $5,001 payable to Connecticut, in each case plus interest and was paid on July 18, 2022. Conditioned upon payment of the Settlement Amount, the United States, Massachusetts and Connecticut agreed to release the Company and BioReference from any civil or administrative monetarily liability arising from the Covered Conduct. Upon payment of the Settlement Amount and the amount due under a separate agreement with the Relator, the Relator released the Company and BioReference from any and all claims and potential claims. Further, in consideration of the obligations of the Company and BioReference in the Settlement Agreement and the CIA, the OIG-HHS released and refrained from instituting any administrative action seeking to exclude the Company or BioReference from participating in Medicare, Medicaid or other Federal health care programs as a result of the Covered Conduct.
Under the CIA, which has a term of five years, BioReference is required to, among other things: (i) maintain a Compliance Officer, a Compliance Committee, board review and oversight of certain federal healthcare compliance matters, compliance programs, and disclosure programs; (ii) provide management certifications and compliance training and education; (iii) establish written compliance policies and procedures to meet federal health care program requirements; (iv) create procedures designed to ensure compliance with the Anti-Kickback Statute and/or Stark Law; (v) engage an independent review organization to conduct a thorough review of BioReference’s systems, policies, processes and procedures related to certain arrangements; (vi) implement a risk assessment and internal review process; (vii) establish a disclosure program for whistleblowers; and (viii) report or disclose certain events and physician payments. The Company’s or BioReference’s failure to comply with its obligations under the CIA could result in monetary penalties and the exclusion from participation in Federal Health Care Programs. The CIA does not apply to any of the Company’s subsidiaries other than BioReference, and its scope is generally limited to “focus arrangements”, which are those “arrangements” (as defined in the CIA) (i) between BioReference and any actual source or recipient of health care business or referrals and involves, directly or indirectly, the offer, payment, or provision of anything of value, or (ii) is between BioReference and any physician (or a physician’s immediate family member). Most of these measures have already been implemented at BioReference. Following its acquisition of BioReference, the Company and BioReference implemented robust compliance measures that substantially align with those actions required under the CIA.
From time to time, we may receive inquiries, document requests, CIDs or subpoenas from the Department of Justice, OCR, CMS, various payors and fiscal intermediaries, and other state and federal regulators regarding investigations, audits and reviews. In addition to the matters discussed in this note, we are currently responding to CIDs, subpoenas, payor audits, and document requests for various matters relating to our laboratory operations. Some pending or threatened proceedings against us may involve potentially substantial amounts as well as the possibility of civil, criminal, or administrative fines, penalties, or other sanctions, which could be material. Settlements of suits involving the types of issues that we routinely confront may require monetary payments as well as corporate integrity agreements. Additionally, qui tam or “whistleblower” actions initiated under the civil False Claims Act may be pending but placed under seal by the court to comply with the False Claims Act’s requirements for filing such suits. Also, from time to time, we may detect issues of non-compliance with federal healthcare laws pertaining to claims submission and reimbursement practices and/or financial relationships with physicians, among other things. We may avail ourselves of various mechanisms to address these issues, including participation in voluntary disclosure protocols. Participating in voluntary disclosure protocols can have the potential for significant settlement obligations or even enforcement action. The Company generally has cooperated, and intends to continue to cooperate, with appropriate regulatory authorities as and when investigations, audits and inquiries arise. No accrual has been made for these matters we are currently responding to, as there is no basis to conclude that a loss has been incurred or to estimate a range of potential loss outcomes.
We are a party to other litigation in the ordinary course of business. While we cannot predict the ultimate outcome of legal matters, we accrue a liability for legal contingencies when we believe that it is both probable that a liability has been incurred and that we can reasonably estimate the amount of the loss. It’s reasonably possible the ultimate liability could exceed amounts currently estimated and we review established accruals and adjust them to reflect ongoing negotiations, settlements, rulings, advice of legal counsel and other relevant information. To the extent new information is obtained and our views on the probable outcomes of claims, suits, assessments, investigations or legal proceedings change, changes in our accrued liabilities would be recorded in the period in which such determination is made. Because of the high degree of judgment involved in establishing loss estimates, the ultimate outcome of such matters will differ from our estimates and such differences may be material to our business, financial condition, results of operations, and cash flows.
At December 31, 2025, we were committed to make future purchases for inventory and other items in 2026 that occur in the ordinary course of business under various purchase arrangements with fixed purchase provisions aggregating approximately$33.1 million.
Note 15 Revenue Recognition
We generate revenues from services, products and intellectual property as follows:
Revenue from services
Revenue for laboratory services is recognized at the time test results are reported, which approximates when services are provided and the performance obligations are satisfied. Services are provided to patients covered by various third-party payor programs including various managed care organizations, as well as the Medicare and Medicaid programs. Billings for services are included in revenue net of allowances for contractual discounts, allowances for differences between the amounts billed and estimated program payment amounts, and implicit price concessions provided to uninsured patients which are all elements of variable consideration.
The following are descriptions of our payors for laboratory services:
Healthcare Insurers. Reimbursements from healthcare insurers are based on negotiated fee-for-service schedules. Revenues consist of amounts billed, net of contractual allowances for differences between amounts billed and the estimated consideration we expect to receive from such payors, which considers historical denial and collection experience and the terms of our contractual arrangements. Adjustments to the allowances, based on actual receipts from the third-party payors, are recorded upon settlement.
Government Payors. Reimbursements from government payors are based on fee-for-service schedules set by governmental authorities, including traditional Medicare and Medicaid. Revenues consist of amounts billed, net of contractual allowances for differences between amounts billed and the estimated consideration we expect to receive from such payors, which considers historical denial and collection experience and the terms of our contractual arrangements. Adjustments to the allowances, based on actual receipts from the government payors, are recorded upon settlement.
Client Payors. Client payors include physicians, hospitals, employers, and other institutions for which services are performed on a wholesale basis, and are billed and recognized as revenue based on negotiated fee schedules.
Patients. Uninsured patients are billed based on established patient fee schedules or fees negotiated with physicians on behalf of their patients. Insured patients (including amounts for coinsurance and deductible responsibilities) are billed based on fees negotiated with healthcare insurers. Collection of billings from patients is subject to credit risk and ability of the patients to pay. Revenues consist of amounts billed net of discounts provided to uninsured patients in accordance with our policies and implicit price concessions. Implicit price concessions represent differences between amounts billed and the estimated consideration that we expect to receive from patients, which considers historical collection experience and other factors including current market conditions. Adjustments to the estimated allowances, based on actual receipts from the patients, are recorded upon settlement.
The complexities and ambiguities of billing, reimbursement regulations and claims processing, as well as considerations unique to Medicare and Medicaid programs, require us to estimate the potential for retroactive adjustments as an element of variable consideration in the recognition of revenue in the period the related services are rendered. Actual amounts are adjusted in the period those adjustments become known. For the years ended December 31, 2025 and 2024, we recorded$1.3 million and$1.5 million, respectively, of negative revenue adjustments due to changes in estimates of implicit price concessions for performance obligations satisfied in prior periods mainly due to the composition of patient payer mix.
Third-party payors, including government programs, may decide to deny payment or recoup payments for testing they contend were improperly billed or not medically necessary, against their coverage determinations, or for which they believe they have otherwise overpaid (including as a result of their own error), and we may be required to refund payments already received. Our revenues may be subject to retroactive adjustment as a result of these factors among others, including without limitation, differing interpretations of billing and coding guidance and changes by government agencies and payors in interpretations, requirements, and “conditions of participation” in various programs. We have processed requests for recoupment from third-party payors in the ordinary course of our business, and it is likely that we will continue to do so in the future. If a third-party payor denies payment for testing or recoups money from us in a later period, reimbursement for our testing could decline.
As an integral part of our billing compliance program, we periodically assess our billing and coding practices, respond to payor audits on a routine basis, and investigate reported failures or suspected failures to comply with federal and state healthcare reimbursement requirements, as well as overpayment claims which may arise from time to time without fault on the part of the Company. We may have an obligation to reimburse Medicare, Medicaid, and third-party payors for overpayments regardless of fault. We have periodically identified and reported overpayments, reimbursed payors for overpayments and taken appropriate corrective action.
Settlements with third-party payors for retroactive adjustments due to audits, reviews or investigations are also considered variable consideration and are included in the determination of the estimated transaction price for providing services. These settlements are estimated based on the terms of the payment agreement with the payor, correspondence from the payor and our historical settlement activity, including an assessment of the probability a significant reversal of cumulative revenue recognized will occur when the uncertainty is subsequently resolved. Estimated settlements are adjusted in future periods as adjustments become known (that is, new information becomes available), or as years are settled or are no longer subject to such audits, reviews, and investigations. As of December 31, 2025 and 2024, we have liabilities of approximately$2.1 million and$2.0 million within Accrued expenses and Other long-term liabilities related to reimbursements for payor overpayments.
The composition of Revenue from services by payor for the years ended December 31,2025, 2024 and 2023 was as follows:
| For the years ended December 31, | |||
|---|---|---|---|
| (In thousands) | 2025 | 2024 | 2023 |
| Healthcare insurers | $213,603 | $289,158 | $315,560 |
| Government payors | 59,925 | 82,421 | 82,502 |
| Client payors | 87,608 | 93,310 | 100,171 |
| Patients | 9,139 | 15,778 | 17,042 |
| Total | $370,275 | $480,667 | $515,275 |
Revenue from products
We recognize revenue from product sales when a customer obtains control of promised goods or services. The amount of revenue that is recorded reflects the consideration that we expect to receive in exchange for those goods or services. Our estimates for sales returns and allowances are based upon the historical patterns of product returns and allowances taken, matched against the sales from which they originated, and our evaluation of specific factors that may increase or decrease the risk of product returns. Product revenues are recorded net of estimated rebates, chargebacks, discounts, co-pay assistance and other deductions (collectively, “Sales Deductions”) as well as estimated product returns which are all elements of variable consideration. Allowances are recorded as a reduction of revenue at the time product revenues are recognized. The actual amounts of consideration ultimately received may differ from our estimates. If actual results in the future vary from our estimates, we will adjust these estimates, which would affect Revenue from products in the period such variances become known.
Rayaldee is distributed in the U.S. principally through the retail pharmacy channel, which initiates with the largest wholesalers in the U.S. (collectively, “Rayaldee Customers”). In addition to distribution agreements with Rayaldee Customers, we have entered into arrangements with many healthcare providers and payors that provide for government-mandated and/or privately-negotiated rebates, chargebacks and discounts with respect to the purchase of Rayaldee.
We recognize revenue for shipments of Rayaldee at the time of delivery to customers after estimating Sales Deductions and product returns as elements of variable consideration utilizing historical information and market research projections. For the years ended December 31, 2025, 2024 and 2023, we recognized$29.8 million,$29.0 million and $31.0 million in net product revenue, respectively, from sales of Rayaldee.
The following table presents an analysis of product sales allowances and accruals as contract liabilities for the years ended December 31,2025, 2024 and 2023:
| (In thousands) · Chargebacks,discounts,rebates andfees · Governmental · Returns · Total | |||||
|---|---|---|---|---|---|
| Balance at December 31, 2024 | $2,070 | $5,365 | $2,465 | $9,900 | |
| Provision related to current period sales | 12,807 | 15,552 | 1,188 | 29,547 | |
| Credits or payments made | (13,503) | (16,406) | (1,106) | (31,015) | |
| Balance at December 31, 2025 | $1,374 | $4,511 | $2,547 | $8,432 | |
| Total gross Rayaldee sales | $59,389 | ||||
| Provision for Rayaldee sales allowances and accruals as a percentage of gross Rayaldee sales | 50% | ||||
| (In thousands) · Chargebacks,discounts,rebates andfees · Governmental · Returns · Total | |||||
|---|---|---|---|---|---|
| Balance at December 31, 2023 | $2,578 | $6,150 | $2,192 | $10,920 | |
| Provision related to current period sales | 15,877 | 23,042 | 1,386 | 40,305 | |
| Credits or payments made | (16,385) | (23,827) | (1,113) | (41,325) | |
| Balance at December 31, 2024 | $2,070 | $5,365 | $2,465 | $9,900 | |
| Total gross Rayaldee sales | $69,299 | ||||
| Provision for Rayaldee sales allowances and accruals as a percentage of gross Rayaldee sales | 58% | ||||
| (In thousands) · Chargebacks,discounts,rebates andfees · Governmental · Returns · Total | |||||
|---|---|---|---|---|---|
| Balance at December 31, 2022 | $1,532 | $5,063 | $1,683 | $8,278 | |
| Provision related to current period sales | 14,606 | 20,589 | 1,351 | 36,546 | |
| Credits or payments made | (13,560) | (19,502) | (842) | (33,904) | |
| Balance at December 31, 2023 | $2,578 | $6,150 | $2,192 | $10,920 | |
| Total gross Rayaldee sales | $67,547 | ||||
| Provision for Rayaldee sales allowances and accruals as a percentage of gross Rayaldee sales | 54% | ||||
Taxes collected from customers related to revenues from services and revenues from products are excluded from revenues.
Revenue from intellectual property and other
We recognize revenues from the transfer of intellectual property generated through license, development, collaboration and/or commercialization agreements. The terms of these agreements typically include payment to us for one or more of the following: non-refundable, up-front license fees; development and commercialization milestone payments; funding of research and/or development activities; and royalties on sales of licensed products. Revenue is recognized upon satisfaction of a performance obligation by transferring control of a good or service to the customer.
For research, development and/or commercialization agreements that result in revenues, we identify all material performance obligations, which may include a license to intellectual property and know-how, and research and development activities. In order to determine the transaction price, in addition to any upfront payment, we estimate the amount of variable consideration at the outset of the contract either utilizing the expected value or most likely amount method, depending on the facts and circumstances relative to the contract. We constrain (reduce) our estimates of variable consideration such that it is probable that a significant reversal of previously recognized revenue will not occur throughout the life of the contract. When determining if variable consideration should be constrained, we consider whether there are factors outside of our control that could result in a significant reversal of revenue. In making these assessments, we consider the likelihood and magnitude of a potential reversal of revenue. These estimates are re-assessed each reporting period as required.
Upfront License Fees: If a license to our intellectual property is determined to be functional intellectual property distinct from the other performance obligations identified in the arrangement, we recognize revenue from nonrefundable, upfront license fees based on the relative value prescribed to the license compared to the total value of the arrangement. The revenue is recognized when the license is transferred to the customer and the customer is able to use and benefit from the license. For licenses that are not distinct from other obligations identified in the arrangement, we utilize judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time. If the combined performance obligation is satisfied over time, we apply an appropriate method of measuring progress for purposes of recognizing revenue from nonrefundable, upfront license fees. We evaluate the measure of progress each reporting period and, if necessary, adjust the measure of performance and related revenue recognition.
Research and Development Activities: If we are entitled to reimbursement from our collaborators for specified research and development expenses, we account for them as separate performance obligations if distinct. We also determine whether the research and development funding would result in revenues or an offset to research and development expenses in accordance with provisions of gross or net revenue presentation. The corresponding revenues or offset to research and development expenses are recognized as the related performance obligations are satisfied.
BARDA Contract (as defined in Note 16): Revenue from the BARDA Contract is generated under terms that are cost plus fee. We recognize revenue using the incurred costs output method to measure progress. Revenue will only be recognized when research and development services are performed to the extent of actual costs incurred.
Sales-based Milestone and Royalty Payments: Our collaborators may be required to pay us sales-based milestone payments or royalties on future sales of commercial products. We recognize revenues related to sales-based milestone and royalty payments upon the later to occur of (i) achievement of the customer’s underlying sales or (ii) satisfaction of any performance obligation(s) related to these sales, in each case assuming the license to our intellectual property is deemed to be the predominant item to which the sales-based milestones and/or royalties relate.
Other Potential Products and Services: Arrangements may include an option for license rights, future supply of drug substance or drug product for either clinical development or commercial supply at the licensee’s election. We assess if these options provide a material right to the licensee and if so, they are accounted for as separate performance obligations at the inception of the contract and revenue is recognized only if the option is exercised and products or services are subsequently delivered or when the rights expire. If the promise is based on market terms and not considered a material right, the option is accounted for if and when exercised. If we are entitled to additional payments when the licensee exercises these options, any additional payments are generally recorded in license or other revenues when the licensee obtains control of the goods, which is upon delivery.
Revenue from the transfer of intellectual property and other: includes milestone payments, royalties, and other collaboration revenues, which totaled$79.7 million,$77.4 million, and $180.7 million for the years ended December 31,2025, 2024, and 2023, respectively.
For the year ended December 31, 2025, revenue from the transfer of intellectual property and other totaled$79.7 million, which included$28.5 million recognized under the BARDA Contract, $31.9 million in royalty revenue from Pfizer, which consisted of gross profit share and royalty payments for NGENLA® and Pfizer's Genotropin, a $7.0 million upfront payment from Regeneron, $4.3 million in royalty revenue from Eli Lilly following the commercial launch of Mazdutide in China and $7.4 million from contract manufacturers' commercial milestones.
For the year ended December 31, 2024, revenue from the transfer of intellectual property and other totaled$77.4 million, which included $30.0 million from Pfizer, inclusive of $28.3 million from gross profit share and royalty payments for both NGENLA® and Pfizer's Genotropin, $23.8 million from the BARDA Contract, a $12.5 million milestone payment from Merck under the Merck Agreement and $10.2 million from contract manufacturers' commercial milestones.
For the year ended December 31, 2023, revenue from the transfer of intellectual property and other totaled $180.7 million, which included $116.7 million from Pfizer, which included a $90.0 million milestone payment triggered by the FDA approval of NGENLA®, $22.6 million from gross profit share and royalty payments for both NGENLA® and Pfizer's Genotropin, $50.0 million from Merck in consideration for the rights granted under the Merck Agreement, $7.0 million from VFMCRP triggered by the German price approval for Rayaldee, $2.5 million from Nicoya due to Nicoya's submission of the investigational new drug application to China's Center for Drug Evaluation, $1.2 million from the BARDA Contract and $2.4 million from contract manufacturers' commercial milestones.
Note 16 Strategic Alliances
Regeneron Pharmaceuticals Inc
On October 28, 2025, ModeX entered into a license and collaboration agreement (the “Regeneron Collaboration Agreement”) with Regeneron Pharmaceuticals Inc. (“Regeneron”) to discover and develop multispecific antibodies for several therapeutic indications of mutual interest. The collaboration will leverage ModeX’s MSTAR platform and Regeneron’s proprietary binders to develop multispecific antibody candidates that target multiple distinct biological pathways in a single molecule.
Under the terms of the Regeneron Collaboration Agreement, ModeX received an upfront payment of $7.0 million.
ModeXis also eligible to receive potential future product selection payments, clinical and regulatory milestone payments, and commercial milestone payments that could exceed $200 million per selected molecule. The overall value of the collaboration could potentially exceed $1.0 billion if multiple products from the collaboration are successfully advanced. In addition, ModeX is eligible to receive tiered global net sales royalties, up to low double digits at the highest tier. Regeneron will fund and lead any preclinical, clinical development and commercialization activities for any products it elects to advance. There can be no assurance that any such value or royalties will be realized.
Entera Bio Ltd
On March 16, 2025, the Company and Entera entered into a collaboration and license agreement ("Entera Collaboration Agreement") to develop an oral dual agonist GLP-1/glucagon peptide as a potential treatment for obesity, metabolic, and fibrotic disorders, combining OPKO’s proprietary long-acting oxyntomodulin analog (OPK-88006) and Entera’s proprietary N-Tab™ technology.
Under the terms of the Entera Collaboration Agreement, the Company and Entera hold 60% and 40% pro-rata ownership interests in the development program, respectively, and are responsible for 60% and 40% of the program's development costs, respectively. In connection with the Entera Collaboration Agreement, the Company purchased 3,685,226 ordinary shares of Entera at a price of $2.17 per share, for an aggregate purchase price of approximately $8.0 million.
Entera has agreed to utilize the proceeds from this share purchase to fund its 40% share of the program's development costs through the completion of Phase 1. Following Phase 1, Entera has the option to continue funding its 40% share to maintain its pro-rata ownership. Should Entera elect not to continue funding, its ownership interest will be reduced to 15%, with the Company holding the remaining 85% interest and becoming responsible for all ongoing development funding and activities.
Entera granted the Company an exclusive, sublicensable, non-transferable, worldwide license to certain of its intellectual property and technology solely to develop, manufacture, and commercialize any GLP-1/glucagon dual agonist for the oral treatment of obesity, metabolic, cardiovascular, and fibrotic disorders. The Company's license is expressly limited to its use in performing the Company's obligations under the Entera Collaboration Agreement. While the Company may sublicense this technology for commercialization purposes, it retains full responsibility for such commercialization activities, and any sublicensee's use is restricted to performing these activities under the terms of the Entera Collaboration Agreement.
The Company granted to Entera a non-exclusive, non-sublicensable, non-transferable license to certain of the Company's technology, which collectively includes the Company foreground patents, and rights in joint information, inventions, and joint patents (including the Company’s proprietary long-acting oxyntomodulin analog OPK-88006). This license is provided to the extent necessary for Entera to fulfill its obligations under the development plan identified in the Entera Collaboration Agreement.
The Company has also agreed to a standstill period of 24 months during which it will not acquire or seek to acquire any equity interests in Entera, engage in proxy solicitations, call shareholder meetings, or attempt to influence Entera's management or policies without prior written consent from Entera's board of directors. Additionally, the Company is subject to a 12-month lock-up period during which it cannot sell, transfer, or hedge Entera shares without Entera's consent.
Biomedical Advanced Research and Development Authority
On September 28, 2023, ModeX was awarded a contract (as amended as described below, the “BARDA Contract”) by the Biomedical Advanced Research and Development Authority ("BARDA"), part of the Administration for Strategic Preparedness and Response at the U.S. Department of Health and Human Services. This contract aims to advance a platform and product candidates addressing various public health threats, specifically in viral infectious diseases. The funding enables the research, development, and clinical evaluation of multispecific antibodies based on ModeX's proprietary MSTAR technology. MSTAR is a flexible, plug-and-play platform capable of incorporating multiple independent antibody binding sites into a single molecule, expanding its therapeutic potential and enabling rapid responses to emerging infections, including viral variants like COVID-19, influenza, and other pathogens.
In September 2024, ModeX entered into two amendments (the “BARDA Amendments”) to modify the scope and funding of the BARDA Contract. The BARDA Amendments structured the funding thereunder as cost-plus-fixed-fee, which included a $26.9 million supplement to further advance the development of COVID-19 multispecific antibodies and provided $24.1 million for the development of a multispecific protein antibody for influenza or another pathogen.
In December 2025, the Company entered into a further bilateral modification to de-scope all mRNA development-related efforts using SARS-CoV-2 as an antigen model, as these activities were no longer a priority for the U.S. Department of Health and Human Services. As a result, the total value of the BARDA Contract decreased from $110.0 million to $103.5 million, and the total potential value of the overall contract, inclusive of all options, decreased from $205.0 million to $198.5 million.
As part of the research program, gene-based delivery methods for the multispecific antibodies will be developed using mRNA or DNA vectors to leverage the body's natural protein production processes. BARDA will make periodic progress assessments, and the continuation of the BARDA Contract depends on ModeX’s performance, the timeliness and quality of deliverables, and other factors. The BARDA Contract contains customary government contract provisions, including BARDA's right to terminate the contract in its discretion.
The Company evaluated the BARDA Contract under ASC Topic 606, Revenue from Contracts with Customers (“ASC 606”), and determined that the U.S. government meets the definition of a customer. The scope of the BARDA Contract includes preclinical, clinical, and manufacturing activities, as well as regulatory, quality assurance, management, and administrative activities. The research and development effort will progress in stages covering base and option segments, with ModeX completing specific tasks in each segment.
The Company identified three potential material promises under the BARDA Contract: (i) development of a tetravalent trispecific antibody for COVID-19; (ii) development of a multispecific protein antibody for influenza or another pathogen; and (iii) nucleic acid delivery of a multispecific antibody for influenza or another pathogen. The Company determined the promise to develop a tetravalent trispecific antibody for COVID-19 is a separate performance obligation, as it is distinct within the contract and provides standalone value. Similarly, the exercised option to develop a multispecific protein antibody for influenza or another pathogen is also a separate performance obligation. However, the Company determined that the nucleic acid delivery option does not offer incremental discounts beyond those typically provided for such goods and services, and therefore does not represent a material right. As such, the options in (iii) were not considered performance obligations at the outset of the BARDA Contract.
The Company concluded that research and development services performed under the BARDA Contract would be recognized as revenue when research and development services are performed to the extent of actual costs incurred including a fixed fee and will be reimbursed by BARDA. Costs incurred represent work performed, which corresponds with, and thereby best depicts, the transfer of control of the research and development to BARDA. Types of contract costs include labor, material, and third-party services. As such, the related BARDA revenue is recognized as revenue from transfer of intellectual property and other within the Company’s Consolidated Statements of Operations. For the years ended December 31, 2025, 2024 and 2023, we recorded $28.5 million, $23.8 million and $1.2 million, respectively, in revenue under the BARDA Contract. As of December 31, 2025, the aggregate amount of transaction price allocated to remaining performance obligations, excluding unexercised contract options, was $49.9 million. We expect to recognize this amount as revenue through February 2028.
Merck
On March 8, 2023, ModeX, the Company (with respect to certain sections), and Merck Sharp & Dohme LLC (“Merck”) entered into a License and Research Collaboration Agreement (the “Merck Agreement”) pursuant to which ModeX granted to Merck a license to certain patent rights and know-how in connection with the development of ModeX’s preclinical nanoparticle vaccine candidate targeting the Epstein-Barr Virus.
Under the terms of the Merck Agreement, ModeX granted to Merck an exclusive, sublicensable, royalty-bearing license to certain intellectual property to develop, manufacture, use and commercialize (i) a multivalent or monovalent vaccine assembled using our platform for Epstein-Barr Virus (“Vaccine”), and (ii) any pharmaceutical or biological preparation in final form containing a Vaccine for sale or for administration to human patients in a clinical trial for all uses (“Product”).
ModeX received an initial payment of $50.0 million and is eligible to receive up to an additional $860.0 million upon the achievement of certain commercial and development milestones. On January 7, 2025, ModeX announced the dosing of the first participant in a Phase 1 study for an EBV vaccine candidate being developed in collaboration with Merck. This achievement triggered a $12.5 million milestone payment from Merck. ModeX is also eligible to receive tiered royalty payments ranging from high single digits to low double digits upon the achievement of certain sales targets of the Product.
Certain of the rights subject to the license provided by us under the Merck Agreement were obtained by us from Sanofi pursuant to that certain License Agreement entered into as of July 1, 2021 (“Sanofi In-License Agreement”) between us and Sanofi, a French corporation (“Sanofi”), and a portion of the upfront payment and royalties received by us under the Merck Agreement may be payable to Sanofi under the terms of the Sanofi In-License Agreement.
As part of their strategic collaboration, ModeX and Merck have put in place a research plan to manage research and other development activities related to the development of a Vaccine or Product including a joint steering committee to facilitate the research program. As part of the research plan, they will use a third-party contract development and manufacturing organization (“CDMO”) to carry out such activities unless otherwise agreed. Development costs incurred by ModeX in furtherance of these development activities will be reimbursed by Merck. To date, we have spent $26.8 million of development costs related to the Epstein -Barr Virus, for which Merck has provided or will provide reimbursement.
The Merck Agreement will remain in effect until one or more Products receive marketing authorization, and, thereafter, until the expiration of all royalty obligations unless earlier terminated as permitted under the Merck Agreement. In addition to termination rights for material breach and bankruptcy, Merck is permitted to terminate the Merck Agreement in its entirety without cause after a specified notice period. If Merck terminates the Merck Agreement for convenience or by us for Merck’s uncured material breach, we may elect to receive a reversion license such that we can continue its work with Vaccines and Products which have not been terminated due to a material safety issue.
LeaderMed
On September 14, 2021, we and LeaderMed announced the formation of a joint venture to develop, manufacture and commercialize two of OPKO’s clinical stage, long-acting drug products in Greater China and eight other Asian territories.
Under the terms of the agreements, we have granted the joint venture exclusive rights to develop, manufacture and commercialize (a) OPK88003, an oxyntomodulin analog being developed for the treatment of obesity and diabetes, and (b) Factor VIIa-CTP, a novel long-acting coagulation factor for the treatment of hemophilia, in exchange for a 47% ownership interest in the joint venture. In addition, during 2021 we received an upfront payment of $1 million and will be reimbursed for clinical trial material and technical support we provide the joint venture.
LeaderMed is responsible for funding the joint venture’s operations, development and commercialization efforts and, together with its syndicate partners, initially invested $11 million in exchange for a 53% ownership interest. We retain full rights to oxyntomodulin and Factor VIIa-CTP in all other geographies.
Eli Lilly and Company
On February 25, 2010, Transition Therapeutics Inc. (“Transition”), our wholly owned subsidiary acquired in 2016, through its subsidiary Waratah Pharmaceuticals Inc., entered into a worldwide license agreement with Eli Lilly and Company (“Eli Lilly”) to develop and commercialize certain oxyntomodulin-based compounds, which agreement was amended on June 13, 2013 to include provisions for backup compounds (as amended, the “Eli Lilly Agreement”), including Mazdutide, which achieved its first commercial sales in China during the third quarter of 2025.
Mazdutide is a long-acting synthetic oxyntomodulin analog and a co-agonist of GLP-1 and glucagon receptors. Under the terms of the Eli Lilly Agreement, the Company is entitled to receive a 3% royalty on the worldwide annual net sales of any product containing a backup compound developed after the agreement's original effective date. The royalty term for a licensed product continues in a given country until the later of ten years from the first commercial sale, the expiration of applicable patents, and the expiration of any data exclusivity period in such country.
For the year ended December 31, 2025, the Company recognized approximately $4.3 million as revenue from transfer of intellectual property and other within the Company’s Consolidated Statements of Operations related to the Eli Lilly Agreement. No milestones were achieved during the year ended December 31, 2025.
NICOYA Macau Limited
On June 18, 2021, EirGen, our wholly owned subsidiary, and NICOYA Macau Limited (“Nicoya”), a Macau corporation and an affiliate of NICOYA Therapeutics, entered into a Development and License Agreement (the “Nicoya Agreement”) granting Nicoya the exclusive rights for the development and commercialization of extended release calcifediol (the “Nicoya Product”) in Greater China, which includes mainland China, Hong Kong, Macau, and Taiwan (collectively, the “Nicoya Territory”). Extended release calcifediol is marketed in the U.S. by OPKO under the tradename Rayaldee. The license grant to Nicoya covers the therapeutic and preventative use of the Nicoya Product for SHPT in non-dialysis and hemodialysis chronic kidney disease patients (the “Nicoya Field”).
EirGen received an initial upfront payment of $5 million and is eligible to receive an aggregate additional amount of $5 million tied to the first anniversary of the effective date of the Nicoya Agreement, as amended, of which EirGen has received $2.5 million plus accrued interest for the delayed payment. Furthermore, EirGen received the additional $2.5 million upon Nicoya’s submission of an investigational new drug (IND) application to the Center for Drug Evaluation (CDE) of China in
March 2023. EirGen is also eligible to receive up to an additional aggregate amount of $115 million upon the achievement of certain development, regulatory and sales-based milestones by Nicoya for the Nicoya Product in the Nicoya Territory. EirGen is eligible to receive tiered, double digit royalty payments at rates in the low double digits on net product sales within the Nicoya Territory and in the Nicoya Field.
Nicoya is, at its sole cost and expense, responsible for performing all development activities necessary to obtain all regulatory approvals for the Nicoya Product in the Nicoya Territory and will be responsible for all commercial activities pertaining to the Nicoya Product in the Nicoya Territory.
Unless earlier terminated, the Nicoya Agreement will remain in effect until such time as all royalty payment terms and extended payment terms have expired, and Nicoya shall have no further payment obligations to EirGen under the terms of the Nicoya Agreement. Nicoya’s royalty obligations expire on the later of (i) expiration of the last to expire valid patent claim covering the Nicoya Product sold in the Nicoya Territory, (ii) expiration of all regulatory and data exclusivity applicable to the Nicoya Product in the Nicoya Territory, and (iii) on a product-by-product basis, ten (10) years after such Nicoya Product’s first commercial sale in the Nicoya Territory. In addition to termination rights for material breach and bankruptcy, Nicoya is permitted to terminate the Nicoya Agreement after a specified notice period.
VFMCRP
In May 2016, EirGen and Vifor Fresenius Medical Care Renal Pharma Ltd. (“VFMCRP”) entered into a Development and License Agreement (the “VFMCRP Agreement”) for the development and commercialization of Rayaldee (the “Product”) worldwide, except for (i) the United States and Canada, (ii) any country in Central America or South America (including Mexico), (iii) Russia, (iv) China, (v) South Korea, (vi) Ukraine, (vii) Belorussia, (viii) Azerbaijan, (ix) Kazakhstan, (x) Taiwan (xi) the Middle East, and (xii) all countries of Africa (the “VFMCRP Territory”), as amended. The license to VFMCRP potentially covers all therapeutic and prophylactic uses of the Product in human patients (the “VFMCRP Field”), provided that initially the license is for the use of the Product for the treatment or prevention of SHPT related to patients with CKD and vitamin D insufficiency/deficiency (the “VFMCRP Initial Indication”).
In January 2023, the German Association of Statutory Health Insurance funds (GKV-SV) granted price approval for Rayaldee. This triggered a milestone payment of $7.0 million. In 2022, we recognized a separate milestone payment of $3.0 million in revenue from the transfer of intellectual property and other for the first sale of Rayaldee in Europe.
Effective May 23, 2021, we entered into an amendment to the VFMCRP Agreement pursuant to which the parties thereto agreed to include Japan as part of the VFMCRP Territory.
Effective May 5, 2020, we entered into an amendment to the VFMCRP Agreement pursuant to which the parties agreed to exclude Mexico, South Korea, the Middle East and all of the countries of Africa from the VFMCRP Territory. In addition, the parties agreed to certain amendments to the milestone structure and to reduce minimum royalties payable. As revised, the Company has received a $3 million payment triggered by the first marketing approval of Rayaldee in Europe, $7.0 million payment triggered by the Germany price approval by the local sick fund association, and is eligible to receive up to an additional $15 million in regulatory milestones and $200 million in milestone payments tied to launch, pricing and sales of Rayaldee, and tiered, double-digit royalties.
We plan to share responsibility with VFMCRP for the conduct of trials specified within an agreed-upon development plan, with each company leading certain activities within the plan. EirGen will lead the manufacturing activities within and outside the VFMCRP Territory and the commercialization activities outside the VFMCRP Territory and outside the VFMCRP Field in the VFMCRP Territory and VFMCRP will lead the commercialization activities in the VFMCRP Territory and the VFMCRP Field. For the initial development plan, the companies have agreed to certain cost sharing arrangements. VFMCRP will be responsible for all other development costs that VFMCRP considers necessary to develop the Product for the use of the Product for the VFMCRP Initial Indication in the VFMCRP Territory in the VFMCRP Field except as otherwise provided in the VFMCRP Agreement. The first of the clinical studies provided for in the development activities commenced in September 2018.
In connection with the VFMCRP Agreement, the parties entered into a letter agreement pursuant to which EirGen granted to VFMCRP an exclusive option (the “Option”) to acquire an exclusive license under certain EirGen patents and technology to use, import, offer for sale, sell, distribute and commercialize the Product in the U.S. solely for the treatment of SHPT in dialysis patients with CKD and vitamin D insufficiency (the “Dialysis Indication”). Upon exercise of the Option, VFMCRP has agreed to reimburse EirGen for all of the development costs incurred by EirGen with respect to the Product for the Dialysis Indication in the U.S. VFMCRP would also pay EirGen up to an additional aggregate amount of $555 millionof sales-based milestones upon the achievement of certain milestones and would be obligated to pay royalties at percentage rates that range from the mid-teens to the mid-twenties on sales of the Product in the U.S. for the Dialysis Indication. To date, VFMCRP has not exercised the Option.
Payments received for regulatory milestones and sales milestones are non-refundable. The regulatory milestones are payable if and when VFMCRP obtains approval from certain regulatory authorities and will be recognized as revenue in the period in which the associated milestone is achieved, assuming all other revenue recognition criteria are met. We account for the sales milestones as royalties and sales milestones payments will be recognized as revenue in the period in which the associated milestone is achieved or sales occur, assuming all other revenue recognition criteria are met.
Pfizer Inc.
In December 2014, we entered into an exclusive worldwide agreement with Pfizer for the development and commercialization of our long-acting Somatrogon (hGH-CTP) for the treatment of growth hormone deficiency (“GHD”) in adults and children, as well as for the treatment of growth failure in children born small for gestational age (the “Pfizer Transaction”). In May 2020, we entered into an amended and restated development and commercialization license with Pfizer, effective January 1, 2020 (the “Restated Pfizer Agreement”), pursuant to which the parties agreed, among other things, to share all costs for Manufacturing Activities, as defined in the Restated Pfizer Agreement, for developing a licensed product for the three indications included in the Restated Pfizer Agreement.
In June 2023, the FDA approved NGENLA® a once-weekly injection to treat pediatric growth hormone deficiency in the United States. In early 2022, the European Commission and Ministry of Health, Labour and Welfare in Japan approved NGENLA®. We have also received pricing approvals in Germany and Japan. NGENLA® is approved for the treatment of pediatric GHD in more than 50 markets, including Canada, Australia, Japan, and EU Member States. With the achievement of these milestones, including regulatory approvals and pricing clearances, the Company has received a total of $175 million in milestone payments under the Restated Pfizer Agreement.
On October 21, 2019, we and Pfizer announced that the global phase 3 trial evaluating Somatrogon dosed once-weekly in prepubertal children with GHD met its primary endpoint of non-inferiority to daily Genotropin® (somatropin) for injection, as measured by annual height velocity at 12 months.
Under the terms of the Restated Pfizer Agreement we received non-refundable and non-creditable upfront payments of $295.0 million and are eligible to receive up to an additional $275.0 million upon the achievement of certain regulatory milestones. Pfizer received the exclusive license to commercialize Somatrogon worldwide. In addition, we are eligible to receive regional, tiered gross profit sharing for both Somatrogon and Pfizer’s Genotropin® (somatropin) in all global markets, with the U.S. region commencing gross profit sharing in August 2023.
The Restated Pfizer Agreement will remain in effect until the last sale of the licensed product, unless earlier terminated in accordance with its terms. In addition to termination rights for material breach and bankruptcy, Pfizer is permitted to terminate the Restated Pfizer Agreement in its entirety, or with respect to one or more world regions, without cause after a specified notice period. If the Restated Pfizer Agreement is terminated by us for Pfizer’s uncured material breach, or by Pfizer without cause, provision has been made for transition of product and product responsibilities to us for the terminated regions, as well as continued supply of product by Pfizer or transfer of supply to us in order to support the terminated regions.
We recognized the non-refundable $295.0 million upfront payments as revenue as the research and development services were completed. As of December 31,2025, we hadno contract liabilities related to the Pfizer Transaction.
The Restated Pfizer Agreement includes up to $275.0 million in potential milestone payments. The milestones range from $20.0 million to $90.0 million each and are based on achievement of regulatory approval in the U.S. and regulatory approval and price approval in other major markets. The milestone payments will be recognized as revenue in the period in which the associated milestone is achieved, assuming all other revenue recognition criteria are met.
Other
We have completed strategic deals with numerous institutions and commercial partners. In connection with these agreements, upon the achievement of certain milestones we are obligated to make certain payments and have royalty obligations upon sales of products developed under the license agreements. At this time, we are unable to estimate the timing and amounts of payments as the obligations are based on future development of the licensed products.
Note 17 Leases
We have operating leases for office space, laboratory operations, research and development facilities, manufacturing locations, warehouses and certain equipment. We determine if a contract contains a lease at inception or modification of a contract. Our leases generally do not provide an implicit interest rate, and we therefore use our incremental borrowing rate as the discount rate when measuring operating lease liabilities. The incremental borrowing rate represents an estimate of the interest rate we would incur at lease commencement to borrow an amount equal to the lease payments on a collateralized basis over the term of the lease within a particular currency environment. We used the incremental borrowing rates as of January 1, 2019 for operating leases that commenced prior to that date. Many of our leases contain rental escalation, renewal options and/or termination options that are factored into our determination of lease payments as appropriate. Variable lease payment amounts that cannot be determined at the commencement of the lease are not included in the right-to-use assets or liabilities.
We elected the use of permitted practical expedients of not recording leases on our Consolidated Balance Sheet when the leases have terms of 12 months or less, and we elected not to separate nonlease components from lease components and instead account for each separate lease component and the nonlease components associated with that lease component as a single lease component.
On January 2, 2023, ModeX entered into a 10-year office lease agreement that commenced in October 2023. ModeX was previously located in Natick, Massachusetts and relocated to Weston, Massachusetts, upon lease commencement. The new location is approximately 33,056 square feet of office space. ModeX has two options to extend the lease term for an additional five years per extension, which would commence upon the expiration of the term in October 2033. Straight-line monthly expense for the lease is $243.5 thousand.
The following table presents the lease balances within the Consolidated Balance Sheet as of December 31,2025 and 2024:
| (in thousands) | Classification on the BalanceSheet | December 31, 2025 | December 31, 2024 |
|---|---|---|---|
| Assets | |||
| Operating lease assets | Operating lease right-of-use assets | $46,930 | $54,003 |
| Finance lease assets | Property, plant and equipment, net | 5,084 | 5,743 |
| Liabilities | |||
| Current | |||
| Operating lease liabilities | Current maturities of operating leases | 10,917 | 12,649 |
| Accrued expenses | Current maturities of finance leases | 1,690 | 1,679 |
| Long-term | |||
| Operating lease liabilities | Operating lease liabilities | 36,815 | 48,849 |
| Other long-term liabilities | Finance lease liabilities | $3,394 | $4,064 |
| Weighted average remaining lease term | |||
| Operating leases (years) | 6.1 | 6.4 | |
| Finance leases (years) | 7.1 | 7.1 | |
| Weighted average discount rate | |||
| Operating leases | 7.2% | 6.6% | |
| Finance leases | 4.7% | 5.3% | |
The following table reconciles the undiscounted future minimum lease payments (displayed by year and in the aggregate) under noncancelable operating leases with terms of more than one year to the total operating lease liabilities recognized on our Consolidated Balance Sheet as of December 31,2025:
| (in thousands) | Operating | Finance |
|---|---|---|
| 2026 | $11,489 | $1,785 |
| 2027 | 10,287 | 1,231 |
| 2028 | 9,176 | 264 |
| 2029 | 7,619 | 257 |
| 2030 | 6,169 | 252 |
| Thereafter | 13,659 | 1,725 |
| Total undiscounted future minimum lease payments | 58,399 | 5,514 |
| Less: Difference between lease payments and discounted lease liabilities | 10,667 | 430 |
| Total lease liabilities | $47,732 | $5,084 |
Expense under operating leases and finance leases was $21.3 million and $1.4 million, respectively, for the year ended December 31,2025, which included $1.4 million of variable lease costs. Expense under operating leases and finance leases was $30.6 million and $3.0 million, respectively, for the year ended December 31,2024, which includes $1.9 million of variable lease costs. Expense under operating leases and finance leases was $16.6 million and $2.9 million, respectively, for the year ended December 31, 2023, and includes $1.4 million of variable lease costs. Operating lease costs and finance lease costs are included within Operating loss in the Consolidated Statement of Operations. Short-term lease costs were not material.
Supplemental cash flow information is as follows:
| For the years ended December 31, | ||
|---|---|---|
| (in thousands) | 2025 | 2024 |
| Operating cash out flows from operating leases | $14,637 | $17,536 |
| Operating cash out flows from finance leases | 160 | 443 |
| Financing cash out flows from finance leases | 1,480 | 2,534 |
| Total | $16,277 | $20,513 |
Note 18 Segments
We manage our operations intwo reportable segments - pharmaceutical and diagnostics. The following is a brief description of our reportable segments and a description of business activities conducted by our corporate operations.
Pharmaceutical — segment consists of our operations in Chile, Mexico, Ireland, Israel, Spain, Brazil, and Uruguay, Rayaldee product sales, NGENLA® royalty and profit-sharing sales, and our pharmaceutical research and development.
Diagnostics — segment primarily consists of clinical laboratory operations through BioReference and our point-of-care operations.
To provide greater transparency into the factors affecting segment profitability, the Company discloses significant expense categories for each reportable segment in the tables below. Our CODM is Phillip Frost, M.D., our Chairman and Chief Executive Officer. Dr. Frost reviews our operating results and operating plans and makes resource allocation decisions on a Company-wide or aggregate basis. Our CODM may discuss and review financial information at the Pharmaceutical and Diagnostic operating segment level. The CODM uses segment information to evaluate segment profitability, monitor trends, identify risks and opportunities, allocate resources (such as capital expenditures and R&D funding), and set strategic priorities (including new product development and market expansion). These expenses, along with segment revenue, are used to calculate gross margin, a key profitability metric that the CODM uses to assess segment performance. In computing operating income, none of the following items have been included: interest expense, other non-operating income and expenses, and income taxes. Segment operating income (expense) is total revenue, less cost of revenue and operating expenses relative to each segment. There areno significant inter-segment sales, nor is there any inter-segment allocation of interest expense or income taxes.
The following are descriptions of the significant expense categories included in the segment reporting tables below:
For the pharmaceutical segment:
Cost of product revenue: Represents the direct costs of manufacturing and distributing pharmaceutical products, including raw materials, manufacturing overhead, and distribution costs.
Selling, general and administrative (SG&A) expenses: Encompasses operating expenses such as salaries, marketing and advertising costs, and administrative overhead.
Research and development (R&D) expenses: Incurred in developing new pharmaceutical products, including costs related to research, clinical trials, and regulatory approvals.
Intangible asset amortization: Represents the periodic expensing of acquired intangible assets, such as patents and licenses.
Other segment items: relates to contingent consideration attributable to changes in assumptions regarding the timing of achievement of future milestones
Depreciation: Relates to the depreciation of property, plant, and equipment used in the segment's operations.
For the diagnostics segment:
Cost of service revenue: Includes the direct costs of providing diagnostic testing services, such as laboratory supplies, equipment costs, and labor costs.
Selling, general and administrative (SG&A) expenses: Similar to the Pharmaceuticals segment, includes salaries, marketing expenses, and administrative overhead.
Research and development (R&D) expenses: Incurred in developing new diagnostic products and services, including costs related to research, clinical studies, regulatory submissions, and new technology development.
Intangible asset amortization: Represents the periodic expensing of acquired intangible assets, such as intellectual property and customer relationships.
Other segment items: Primarily consists of gains and losses recognized on the sale of businesses or assets.
Depreciation: Relates to the depreciation of property, plant, and equipment used in the segment's operations.
The tables below present information about reported segments, unallocated corporate operations as well as geographic information for the years ended December 31,2025, 2024 and 2023.
| For the years ended December 31, | |||
|---|---|---|---|
| (In thousands) | 2025 | 2024 | 2023 |
| Revenue from services: | |||
| Pharmaceutical | $— | $— | $— |
| Diagnostics | 370,275 | 480,667 | 515,275 |
| Corporate | — | — | — |
| $370,275 | $480,667 | $515,275 | |
| Revenue from products: | |||
| Pharmaceutical | $156,924 | $155,111 | $167,557 |
| Diagnostics | — | — | — |
| Corporate | — | — | — |
| $156,924 | $155,111 | $167,557 | |
| Revenue from transfer of intellectual property and other: | |||
| Pharmaceutical | $79,680 | $77,364 | $180,663 |
| Diagnostics | — | — | — |
| Corporate | — | — | — |
| $79,680 | $77,364 | $180,663 | |
| Cost of revenue: | |||
| Pharmaceutical | $93,589 | $92,523 | $99,538 |
| Diagnostics | 307,350 | 402,109 | 445,830 |
| Corporate | — | — | — |
| $400,939 | $494,632 | $545,368 | |
| Gross margin: | |||
| Pharmaceutical | $143,015 | $139,953 | $248,682 |
| Diagnostics | 62,925 | 78,558 | 69,445 |
| Corporate | — | — | — |
| $205,940 | $218,511 | $318,127 | |
| Selling, general and administrative: | |||
| Pharmaceutical | $53,866 | $58,007 | $55,687 |
| Diagnostics | 129,301 | 205,185 | 202,341 |
| Corporate | 39,835 | 41,028 | 42,531 |
| $223,002 | $304,220 | $300,559 | |
| Research and development: | |||
| Pharmaceutical | $121,905 | $103,022 | $87,007 |
| Diagnostics | 1,637 | 2,075 | 2,508 |
| Corporate | 491 | 117 | 78 |
| $124,033 | $105,214 | $89,593 | |
| Amortization of intangible assets: | |||
| Pharmaceutical | $65,586 | $65,718 | $65,837 |
| Diagnostics | 12,304 | 16,916 | 20,195 |
| Corporate | — | — | — |
| $77,890 | $82,634 | $86,032 | |
| Other segment items: | |||
| Pharmaceutical | $— | $— | $(1,036) |
| Diagnostics | (101,576) | (121,493) | — |
| Corporate | — | — | — |
| $(101,576) | $(121,493) | $(1,036) | |
| Segment operating income (loss): | |||
| Pharmaceutical | $(98,342) | $(86,795) | $41,184 |
| Diagnostics | 21,259 | (24,125) | (155,596) |
| Corporate | (40,326) | (41,145) | (42,609) |
| $(117,409) | $(152,065) | $(157,021) | |
| For the years ended December 31, | |||
|---|---|---|---|
| (In thousands) | 2025 | 2024 | 2023 |
| Depreciation and amortization: | |||
| Pharmaceutical | $72,257 | $71,958 | $71,548 |
| Diagnostics | 19,370 | 26,218 | 33,749 |
| Corporate | — | — | — |
| $91,627 | $98,176 | $105,297 | |
| Revenues: | |||
| U.S. | $436,061 | $546,300 | $597,822 |
| Ireland | 51,401 | 48,397 | 141,465 |
| Chile | 62,377 | 65,049 | 68,491 |
| Spain | 26,725 | 24,634 | 23,517 |
| Israel | 522 | 1,772 | 9,738 |
| Mexico | 25,520 | 23,867 | 20,216 |
| Other | 4,273 | 3,123 | 2,246 |
| $606,879 | $713,142 | $863,495 | |
Segment assets for the two reportable segments in which we operate are shown in the following tables. Corporate assets are principally cash and are not allocated to an operating segment. Identifiable assets by segment are those assets that are used in our operations in each segment. The accounting policies of the segments are the same as those described in Note 3 summary of significant accounting policies.
| (In thousands) | December 31, 2025 | December 31, 2024 |
|---|---|---|
| Assets: | ||
| Pharmaceutical | $1,326,400 | $1,359,270 |
| Diagnostics | 349,095 | 493,898 |
| Corporate | 256,449 | 347,044 |
| $1,931,944 | $2,200,212 | |
| Goodwill: | ||
| Pharmaceutical | $320,847 | $309,545 |
| Diagnostics | 163,442 | 219,707 |
| $484,289 | $529,252 | |
No customer represented more than 10% of our total consolidated revenue during the years ended December 31,2025, 2024 and 2023. As of December 31, 2025 and 2024, no customer represented more than 10% of our accounts receivable balance.
The following table reconciles our Property, plant and equipment, net between U.S. and foreign jurisdictions:
| (In thousands) | December 31, 2025 | December 31, 2024 |
|---|---|---|
| PP&E: | ||
| U.S. | $20,275 | $26,685 |
| Foreign | 53,651 | 43,449 |
| Total | $73,926 | $70,134 |
Note 19 Fair Value Measurements
We record fair values at an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement determined based on assumptions that market participants would use in pricing an asset or liability. We utilize a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value. These tiers are: Level 1, defined as observable inputs such as quoted prices in active markets; Level 2, defined as inputs other than quoted prices in active markets that are either directly or indirectly observable; and Level 3, defined as unobservable inputs in which little or no market data exists, therefore requiring an entity to develop its own assumptions.
As of December 31, 2025, our financial assets measured at fair value included equity securities, forward foreign currency exchange contracts for inventory purchases (refer to Note 20), options related to our BioCardia investment and consulting agreement (recorded at fair value), warrants from COCP, and restricted cash collateralized by money market funds, the latter being measured at fair value as a Level 1 financial instrument.
Our financial assets and liabilities measured at fair value on a recurring basis are as follows:
| Quoted prices · Significant | ||||
|---|---|---|---|---|
| in active · other · Significant | ||||
| markets for · observable · unobservable | ||||
| identical assets · inputs · inputs | ||||
| (In thousands) | (Level 1) | (Level 2) | (Level 3) | Total |
| Assets: | ||||
| Money market funds | $230,625 | $— | $— | $230,625 |
| Equity securities | 9,268 | — | — | 9,268 |
| Common stock options/warrants | — | 3 | — | 3 |
| Total assets | $239,893 | $3 | $— | $239,896 |
| Liabilities: | ||||
| Forward contracts | — | 230 | — | 230 |
| Total liabilities | $— | $230 | $— | $230 |
| Quoted prices · Significant | ||||
|---|---|---|---|---|
| in active · other · Significant | ||||
| markets for · observable · unobservable | ||||
| identical assets · inputs · inputs | ||||
| (In thousands) | (Level 1) | (Level 2) | (Level 3) | Total |
| Assets: | ||||
| Money market funds | $282,121 | $— | $— | $282,121 |
| Equity securities | 49,655 | — | — | 49,655 |
| Common stock options/warrants | — | 3 | — | 3 |
| Total assets | $331,776 | $3 | $— | $331,779 |
The table below presents the carrying amount, estimated fair value, and applicable fair value hierarchy tiers for our 2029 Convertible Notes. The fair value for these notes is determined using directly observable inputs other than quoted prices in active markets.
| Carrying · Total | |||||
|---|---|---|---|---|---|
| (In thousands) | Value | Fair Value | Level 1 | Level 2 | Level 3 |
| 2029 Convertible Notes | $84,970 | $182,007 | $— | $182,007 | $— |
There have been no transfers between Level 1 and Level 2 and no transfers to or from Level 3 of the fair value hierarchy.
Note 20 Derivative Contracts
The following table summarizes the fair values and the presentation of our derivative financial instruments in the Consolidated Balance Sheets:
| (In thousands) | Balance Sheet Component | December 31, 2025 | December 31, 2024 |
|---|---|---|---|
| Derivative financial instruments: | |||
| Common stock options/warrants | Investments, net | $3 | $3 |
| Forward contracts | Unrealized gains on forward contracts are recorded in Other current assets and prepaid expenses. Unrealized (losses) on forward contracts are recorded in Accrued expenses. | $(230) | $— |
We enter into foreign currency forward exchange contracts with respect to the risk of exposure to exchange rate differences arising from inventory purchases on letters of credit. Under these forward contracts, for any rate above or below the fixed rate, we receive or pay the difference between the spot rate and the fixed rate for the given amount at the settlement date.
To qualify the derivative instrument as a hedge, we are required to meet strict hedge effectiveness and contemporaneous documentation requirements at the initiation of the hedge and assess the hedge effectiveness on an ongoing basis over the life of the hedge. At December 31, 2025 and 2024, our derivative financial instruments did not meet the documentation requirements to be designated as hedges. Accordingly, we recognized the changes in Fair value of derivative instruments, net in our Consolidated Statement of Operations.
The following table summarizes the losses and gains recorded for the years ended December 31, 2025, 2024 and 2023:
| For the years ended December 31, | |||
|---|---|---|---|
| (In thousands) | 2025 | 2024 | 2023 |
| Derivative gain (loss): | |||
| Notes | $— | $(26,250) | $— |
| Common stock options/warrants | — | 1 | (25) |
| Forward contracts | (428) | 88 | (756) |
| Total | $(428) | $(26,161) | $(781) |
Note 21 Selected Quarterly Financial Data (Unaudited)
| For the 2025 Quarters Ended | ||||
|---|---|---|---|---|
| (In thousands, except per share data) | March 31 | June 30 | September 30 | December 31 |
| Total revenues | $149,952 | $156,807 | $151,669 | $148,451 |
| Total costs and expenses | 217,120 | 216,788 | 103,613 | 186,767 |
| Net income (loss) | (67,613) | (148,441) | 21,631 | (31,257) |
| Earnings (loss) per share, basic | $(0.10) | $(0.19) | $0.03 | $(0.04) |
| Earnings (loss) per share, diluted | $(0.10) | $(0.19) | $0.03 | $(0.04) |
| For the 2024 Quarters Ended | ||||
|---|---|---|---|---|
| (In thousands, except per share data) | March 31 | June 30 | September 30 | December 31 |
| Total revenues | $173,686 | $182,186 | $173,632 | $183,638 |
| Total costs and expenses | 245,158 | 243,856 | 159,416 | 216,777 |
| Net income (loss) | (81,836) | (10,305) | 24,890 | 14,027 |
| Earnings (loss) per share, basic | $(0.12) | $(0.01) | $0.04 | $0.02 |
| Earnings (loss) per share, diluted | $(0.12) | $(0.01) | $0.03 | $0.01 |
Note 22 Subsequent Events
On February 3, 2026, the Company, its wholly owned subsidiary, OPKO Biologics, and Entera entered into an amended and restated collaboration and license agreement, which amends and restates the Entera Collaboration Agreement to expand the scope of the agreement to include collaboration with respect to the preclinical and clinical development of a daily long acting PTH tablet (“LA-PTH”) for the treatment of hypoparathyroidism and other indications in addition to the original oral dual agonist GLP-1/glucagon peptide program. Development costs incurred by the parties with respect to the development of the LA-PTH program will be shared equally between the Company and Entera. The original Entera Collaboration Agreement otherwise remains unchanged. Under the terms of the expanded agreement, the Company and
Entera will each hold a 50% pro-rata ownership interest in the LA-PTH hypoparathyroidism program. The companies expect to file an investigational new drug (IND) application with the FDA for the LA-PTH program in late 2026.
Additionally, on February 4, 2026, Steven D. Rubin, the Company’s Executive Vice President of Administration and a member of the Company's Board of Directors, was appointed to the Board of Directors of Entera.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.