What changed in this filing

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Item 8. Financial Statements and Supplementary Data

2025-03-03 compared with 2024-03-01 · 499 added, 476 removed, 1394 unchanged (41% of the section changed)

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To the Shareholders and the Board of Directors of OPKO Health, Inc.

and subsidiaries

Opinion on the Financial Statements

We have audited the accompanying consolidated balance sheets of OPKO Health, Inc.

and subsidiaries (the Company) as of December 31, 2023 and 2022, the related consolidated statements of operations, comprehensive income (loss) , equity and cash flows for each of the three years in the period ended December 31, 2023, and the related notes and financial statement schedule included at Item 15(a)(1) (collectively referred to as the “consolidated financial statements”).

and subsidiaries (the Company) as of December 31, 2024 and 2023, the related consolidated statements of operations, comprehensive income (loss) , equity and cash flows for each of the three years in the period ended December 31, 2024, and the related notes (collectively referred to as the “consolidated financial statements”).

In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company at December 31, 2024 and 2023, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2024, in conformity with U.S.

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To the Shareholders and the Board of Directors of OPKO Health, Inc.

and subsidiaries

Opinion on Internal Control over Financial Reporting

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Current assets:

Cash and cash equivalents

Cash, cash equivalents and current restricted cash

$ 431,936 $ 95,881

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48,849 54,140

Convertible notes

Long term portion of convertible notes

173,606 214,325

Senior secured notes

Deferred tax liabilities

140,799 126,773

Other long-term liabilities, principally contract liabilities, contingent consideration and lines of credit

Other long-term liabilities, principally contingent consideration and lines of credit

32,838 27,189

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Total costs and expenses

Operating income (loss)

Operating loss

Other income and (expense), net:

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Other income (expense), net

Other expense, net

Other income (expense), net

Loss before income taxes and investment losses

Income tax benefit (provision)

Income tax (provision) benefit

Net loss before investment losses

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Equity-based compensation expense

Exercise of common stock options and warrants

Conversion of 2025 convertible notes

Exercise of common stock options

Adoption of ASU 2020-06

ModeX Acquisition

Other comprehensive loss

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Equity-based compensation expense

Exercise of common stock options and warrants

Adoption of ASU 2020-06

ModeX Acquisition

Other comprehensive loss

Exercise of common stock options

Other comprehensive income

Balance at December 31, 2023

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Equity-based compensation expense

Exercise of common stock options and warrants

Other comprehensive income

Exercise of common stock options/vesting of restricted stock units

2029 Convertible Notes

Repurchase of 2029 Convertible Notes

Shares repurchase

Other comprehensive loss

Balance at December 31, 2024

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Cash flows from operating activities:

Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities:

Adjustments to reconcile net loss to net cash provided by (used in) operating activities:

Depreciation and amortization

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Equity-based compensation – employees and non-employees

Non-cash revenue from the transfer of intellectual property

Realized loss (gain) on disposal of fixed assets and sales of equity securities

Loss on conversion of the 2025 Notes

Change in fair value of equity securities and derivative instruments

Loss on conversion convertible senior notes

Change in fair value of contingent consideration

Gain on sale of GeneDx

Deferred income tax provision

Gain on sale of assets

Changes in assets and liabilities, net of the effects of acquisitions:

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Foreign currency measurement

Contract liabilities

Accrued expenses and other liabilities

Net cash (used in) provided by operating activities

Net cash used in operating activities

Cash flows from investing activities:

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Capital expenditures

Net cash (used in) provided by investing activities

Proceeds from LabCorp Sale

Net cash provided by (used in) investing activities

Cash flows from financing activities:

Issuance of 3.00% convertible senior notes, net (including related parties)

Issuance of 2044 Notes

Debt issuance costs

Share repurchase

Net activity from the exercise of common stock options and warrants

Repurchase of 2029 Convertible Notes

Borrowings on lines of credit

Repayments of lines of credit

Redemption of 2033 Senior Notes

Net cash (used in) provided by financing activities

Effect of exchange rate changes on cash and cash equivalents

Net increase (decrease) in cash and cash equivalents

Cash and cash equivalents at beginning of period

Cash and cash equivalents at end of period

Redemption of 2025 Notes and 2033 Senior Notes

Net cash provided by (used in) financing activities

Effect of exchange rate changes on cash, cash equivalents and restricted cash

Net decrease in cash, cash equivalents and restricted cash

Cash, cash equivalents and restricted cash at beginning of period

Cash, cash equivalents and restricted cash at end of period

SUPPLEMENTAL INFORMATION:

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Shares issued upon the conversion of:

2025 convertible Notes

Common Stock options and warrants, surrendered in net exercise

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Note 1 Business and Organization

OPKO Health, Inc., a Delaware corporation ("OPKO", the "Company", "we", "us", or "our") is a diversified healthcare company that seeks to establish industry-leading positions in large and rapidly growing medical markets.

Our pharmaceutical business features 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, and Somatrogon (hGH-CTP), a once-weekly human growth hormone injection for which we have partnered with Pfizer Inc.

(“Pfizer”) with respect to Somatrogon (hGH-CTP)’s further development and commercialization.

Regulatory applications 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 approved in more than 50 markets worldwide, including the United States, European Union Member States, Japan, Canada, and Australia under the brand name NGENLA®.

Additionally, in May 2022, we acquired ModeX Therapeutics, Inc.

(“ModeX”), a biotechnology company focused on developing innovative multi-specific immune therapies for cancer and infectious disease candidates.

ModeX has a robust early-stage pipeline with assets in key areas of immuno-oncology and infectious diseases, and we intend to further expand our pharmaceutical product pipeline through ModeX’s portfolio of development candidates.

Our diagnostics business includes BioReference Health, LLC (“BioReference”), one of the nation’s largest full service laboratories with a significant sales and marketing team designed to drive growth and leverage new products.

Through BioReference, we offer our 4Kscore prostate cancer test.

Through BioReference, we provide laboratory testing services, primarily to customers in the larger metropolitan areas in New York, New Jersey, Florida, Texas, Maryland, Indiana, Virginia, California, Pennsylvania, Delaware, Washington, DC, Illinois and Massachusetts, as well as to customers in a number of other states.

We offer a comprehensive test menu of clinical diagnostics for blood, urine and tissue analysis.

This includes hematology, clinical chemistry, immunoassay, infectious disease, serology, hormones, and toxicology assays, as well as Pap smear, anatomic pathology (biopsies) and other types of tissue analysis, as well as testing for COVID- 19.

We market our laboratory testing services directly to physicians, geneticists, hospitals, clinics, correctional and other health facilities.

We operate established, revenue-generating pharmaceutical platforms in Spain, Ireland, Chile, and Mexico, from which we expect to generate positive cash flow and facilitate future market entry for our products currently in development.

We have a development and commercial supply pharmaceutical company as well as a global supply chain operation.

We also own a specialty active pharmaceutical ingredients (“APIs”) manufacturer in Israel.

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

Our research and development activities are primarily performed at facilities in Weston, Massachusetts, Waterford, Ireland, Kiryat Gat, Israel, and Barcelona, Spain.

On May 9, 2022, the Company entered into an Agreement and Plan of Merger (the “ModeX Merger Agreement”), pursuant to which the Company acquired ModeX.

The Company paid the entirety of the $ 300.0 million purchase price pursuant to the issuance of an aggregate of 89,907,310 shares of the Company’s common stock, par value $ 0.01 per share (“Common Stock”), to the former stockholders of ModeX.

Please see Note 5 for additional information.

On January 14, 2022, the Company entered into an Agreement and Plan of Merger and Reorganization (the “GeneDx Merger Agreement”) with GeneDx Holdings Corp.

(f/k/a Sema4 Holdings Corp.), a Delaware corporation (“GeneDx Holdings”), pursuant to which, on April 28, 2022, GeneDx Holdings acquired the Company’s former subsidiary, GeneDx LLC, (f/k/a GeneDx, Inc.

At closing, GeneDx Holdings paid to the Company aggregate consideration of $ 150 million in cash (before deduction of transaction expenses and other customary purchase price adjustments), together with 80.0 million shares (the “Closing Shares”) of GeneDx Holdings’ Class A common stock, par value $ 0.0001 per share (“GeneDx Holdings Common Stock”).

Based on the closing price of GeneDx Holdings Common Stock as of April 29, 2022, the total upfront consideration represented approximately $ 322 million.

Additionally, subject to GeneDx achieving certain revenue targets for the fiscal years ended December 31, 2022 and 2023, we were eligible to receive an earnout payment (“GeneDx Milestone Consideration”) in cash or stock (at GeneDx Holdings’ discretion) equal to a maximum of 30.9 million shares of GeneDx Holdings’ Common Stock if paid in stock.

We received 23.1 million shares of Class A Common Stock as a result of GeneDx satisfactorily achieving targets as of December 31, 2022;

however, we do not currently expect to receive any GeneDx Milestone Consideration with respect to the year ended December 31, 2023.

In connection with the transactions contemplated by the GeneDx Merger Agreement, on January 14, 2022, the Company entered into a shareholder agreement with GeneDx Holdings, pursuant to which the Company agreed to certain lockup restrictions in respect the shares of GeneDx Holdings Common Stock held by the Company.

Additionally, pursuant to the GeneDx Merger Agreement, the Company designated, and GeneDx Holdings nominated for election, an individual to serve on the board of directors of GeneDx Holdings, and such nominee was elected by GeneDx Holdings’ stockholders to serve as a director at least until GeneDx Holdings’ 2024 annual meeting of stockholders.

The Company has further agreed to certain standstill provisions whereby, subject to certain exceptions, it is obligated to refrain from taking certain actions with respect to the GeneDx Holdings Common Stock, and the Company has also agreed to vote its shares of GeneDx Holdings Common Stock in accordance with the recommendations of GeneDx Holdings’ board of directors for so long as it continues to hold at least 5 % of the outstanding shares of GeneDx Holdings Common Stock.

Please see Note 5 for additional information.

We are a diversified healthcare company that seeks to establish industry leading positions in large and rapidly growing medical markets.

Our pharmaceutical business features Somatrogon (hGH-CTP), a once-weekly human growth hormone injection.

We have partnered with Pfizer Inc.

(“Pfizer”) for the development and commercialization of Somatrogon (hGH-CTP).

Regulatory approvals for Somatrogon (hGH-CTP) for the treatment of growth hormone deficiency in children and adolescents have been secured in more than 50 markets, including the United States, European Union (“EU”) Member States, Japan, Canada, and Australia, where it is marketed under the brand name NGENLA®.

Through our pharmaceutical business, we also 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.

Through our 2022 acquisition of ModeX Therapeutics, Inc.

(“ModeX”), we have expanded our pharmaceutical pipeline with early-stage immune therapies targeting cancer and infectious diseases.

Our diagnostics business, BioReference Health, LLC (“BioReference”), is a highly specialized laboratory in the United States, with a sales and marketing team focused on growth and new product integration, including the 4Kscore ® prostate cancer test.

BioReference® offers a broad spectrum of diagnostic testing services for oncology, urology ( 4Kscore ), and corrections nationwide, setting new standards with our industry-leading turnaround times.

BioReference also provides comprehensive clinical and women’s health testing in New York and New Jersey.

Our test offerings are backed by a team of board-certified medical professionals and driven by the latest healthcare guidelines and standards- marketed directly to physicians, geneticists, hospitals, clinics, correctional facilities, and other healthcare providers.

On September 16, 2024 we consummated the sale of certain assets of BioReference to Laboratory Corporation of America Holdings (“Labcorp”), as described below.

The Company maintains established, revenue-generating pharmaceutical platforms in Spain, Ireland, Chile, and Mexico, contributing to positive cash flow and facilitating market entry for our development pipeline.

In addition to these platforms, we operate a global pharmaceutical development and commercial supply company, a global supply chain operation, and manufacture specialty active pharmaceutical ingredients (API) in Israel through our subsidiary, FineTech.

Our management team possesses extensive industry experience in development, regulatory affairs, and commercialization.

Their industry relationships support the identification and pursuit of commercial opportunities.

Research and development activities are primarily conducted in facilities located in Weston, Massachusetts, Waterford, Ireland, Kiryat Gat, Israel, and Barcelona, Spain.

On March 27, 2024, the Company entered into a definitive agreement with Labcorp (the “Labcorp Asset Purchase Agreement”), pursuant to which Labcorp agreed to acquire select assets of BioReference (the “BioReference Transaction”).

The BioReference Transaction closed on September 16, 2024, and upon closing, Labcorp paid to the Company aggregate consideration of $ 237.5 million in cash, which is subject to certain adjustments as set forth in the Labcorp Asset Purchase Agreement.

These assets were part of our diagnostics segment and include 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.

Pursuant to the Labcorp Asset Purchase Agreement, a total of approximately $ 23.7 million was withheld at closing and deposited by us into an escrow account to satisfy potential indemnity claims under the Labcorp Asset Purchase Agreement.

The escrow will be released to the Company on the twelve -month anniversary of the closing date, subject to any outstanding or liquidated indemnity claims.

The Company recorded the escrow within other current assets on the Condensed Consolidated Balance Sheet as of December 31, 2024.

We recognized a gain of $ 121.5 million from the BioReference Transaction for the year ended December 31, 2024.

Note 2 Foreign exchange rates

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Our financial statements are reported in USD and, accordingly, fluctuations in 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, 2023, 2022 and 2021 , the most significant currency exchange rate exposures were to the Euro and the Chilean Peso.

During the years ended December 31, 2024, 2023 and 2022 , 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 $ 52.7 million and $ 34.6 million at December 31, 2024 and 2023 , respectively.

We are subject to foreign currency transaction risk for fluctuations in exchange rates during the period of time between the consummation and cash settlement of transactions.

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.

At December 31, 2023 , we had 52 open foreign exchange forward contracts relating to inventory purchases on letters of credit with various amounts maturing monthly through January 2024 with a notional value totaling approximately $ 2.9 million.

At December 31, 2022 , we had 194 open foreign exchange forward contracts relating to inventory purchases on letters of credit with various amounts that matured monthly through January 2023 with a notional value totaling approximately $ 11.9 million.

As of December 31, 2024 , we held no open foreign exchange forward contracts relating to inventory purchases on letters of credit.

At December 31, 2023 , we had 52 open foreign exchange forward contracts relating to inventory purchases on letters of credit.

These contracts matured monthly through January 2024 with a notional value totaling approximately $ 2.9 million.

Note 3 Summary of Significant Accounting Policies

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Actual results could differ significantly from these estimates.

Cash and cash equivalents.

Cash and cash equivalents include short-term, interest-bearing instruments with original maturities of 90 days or less at the date of purchase.

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.

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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, 2024

December 31, 2023

Cash and cash equivalents

$ 426,582 $ 95,881

Restricted cash, current

Restricted cash, long-term

Total cash, cash equivalents, and restricted cash shown in the Condensed Consolidated Statements of Cash Flows

$ 445,615 $ 95,881

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 are valued at the lower of cost and net realizable value.

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Goodwill was $ 529.3 million and $ 598.3 million, respectively, at December 31, 2024 and 2023 .

Net intangible assets other than goodwill were $ 0.9 billion and $ 1.0 billion at December 31, 2023 and 2022 , respectively, including IPR&D of $ 195.0 million at December 31, 2023 and 2022 .

Net intangible assets other than goodwill were $ 811.6 million and $ 935.3 million at December 31, 2024 and 2023 , respectively, including IPR&D of $ 195.0 million at December 31, 2024 and 2023 .

Intangible assets are highly vulnerable to impairment charges, particularly newly acquired assets for recently launched products and IPR&D.

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Estimating the fair value of IPR&D for potential impairment is highly sensitive to changes in estimates and assumptions, and changes in such estimates or assumptions could potentially lead to impairment.

Upon obtaining regulatory approval, IPR&D assets are accounted for as finite-lived intangible assets and amortized on a straight-line basis over their respective estimated useful lives.

If a project is abandoned, the IPR&D asset is charged to expense.

Finite lived intangible assets are tested for impairment when events or changes in circumstances indicate it is more likely than not that the carrying amount of such assets may not be recoverable.

The testing includes a comparison of the carrying amount of the asset to its estimated undiscounted future cash flows expected to be generated by the asset.

If the carrying amount of an asset exceeds its estimated undiscounted 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.

We believe that our estimates and assumptions in testing goodwill and other intangible assets, including IPR&D, for impairment are reasonable and otherwise consistent with assumptions that marketplace participants would use in their estimates of fair value.

Based on the current financial performance of our diagnostic segement and our Ireland reporting unit, which includes Eirgen and Rayaldee , if future results are not consistent with our estimates and assumptions, then we may be exposed to impairment charges, which could be material.

At December 31, 2023 , the combined goodwill of our diagnotics segment and our Ireland reporting unit was $ 367.3 million.

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.

Based on the current financial performance of our diagnostics segment and our Ireland reporting unit (which includes Eirgen and Rayaldee), we could be subject to such charges if their future performance deviates from our current estimates and assumptions as recently experienced.

For reference, the goodwill of our diagnostics segment totaled $ 219.7 million and $ 283.0 million at December 31, 2024 and 2023, respectively, while the goodwill of our Ireland reporting unit totaled $ 79.4 million and $ 84.3 million at December 31, 2024 and 2023, respectively.

No impairment charges were recognized for the years ended December 31, 2024, 2023, or 2022.

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Fair value measurements .

The carrying amounts of our cash and cash equivalents, accounts receivable, accounts payable and short-term debt approximate their fair value due to the short-term maturities of these instruments.

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, 2024 and 2023 are predominately carried at fair value.

Our debt under the Credit Agreement (as defined in Note 7 ) approximates fair value due to the variable rate of interest applicable to such debt.

Our debt under the BioReference Credit Agreement (as defined in Note 7 ) approximated fair value due to the variable rate of interest applicable to such debt.

In evaluating the fair value information, considerable judgment is required to interpret the market data used to develop the estimates.

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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 an impairment charge of $ 1.2 million related to these assets included in our pharmaceutical segment.

Income taxes.

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The credit loss expense for the years ended December 31, 2024, 2023 and 2022 was $ 0.1 million, $ 0.3 million and $ 0.3 million, respectively.

Accounts receivable as of December 31, 2023 included $ 0.6 million of government contract revenue earned under the BARDA Contract (as defined in Note 16 ).

As of December 31, 2024 , accounts receivable included $ 3.6 million of revenue earned under the BARDA Contract (as defined in Note 16 ).

As of December 31, 2023, accounts receivable included $ 0.6 million under this contract.

Refer to Note 15, Government Contract Revenue for further information government contracts and to Note 16, Strategic Alliances for further information.

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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).

During the years ended December 31, 2023, 2022 and 2021 , we recorded $ 1.2 million in transaction gains and $( 1.8 ) million and $( 1.4 ) million in transaction losses, respectively.

We recorded foreign currency transaction gains and losses of ($ 3.8 million), $ 1.2 million, and ($ 1.8 million) for the years ended December 31, 2024, 2023 and 2022 , respectively.

Variable interest entities.

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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 2023, the FASB issued ASU No 2023 - 07, Segment Reporting (Topic 280 ):

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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 chief operating decision maker (“CODM”) uses to assess segment performance and to make decisions about resource allocations.

The amendments in ASU 2023 - 07 improve financial reporting by requiring all public entities to disclose incremental segment information on an annual and interim basis to enable investors to develop more useful financial analyses.

Topic 280 requires that a public entity disclose certain information about its reportable segments, for example, a public entity is required to report a measure of segment profit or loss that the CODM uses to assess segment performance and make decisions about allocating resources.

ASC 280 also requires other specified segment items and amounts, such as depreciation, amortization, and depletion expense, to be disclosed under certain circumstances.

The ASU 2023 - 07 amendments do not change or remove those disclosure requirements.

The amendments in ASU 2023 - 07 also do not change how a public entity identifies its operating segments, aggregates those operating segments, or applies the quantitative thresholds to determine its reportable segments.

Upon adoption, a public entity must retrospectively apply ASU 2023 - 07 amendments to all prior periods presented in the financial statements.

The amendments in ASU 2023 - 07 are effective for all public entities for fiscal years beginning after December 15, 2023 ( e.g., for calendar-year-end public entities, annual periods beginning on January 1, 2024 — i.e., December 31, 2024, Form 10 -K), and interim periods within fiscal years beginning after December 15, 2024 ( e.g., for calendar-year-end public entities, interim periods beginning on January 1, 2025 — i.e., Form 10 -Q for the first quarter of 2025 ).

Early adoption is permitted.

We are currently evaluating the potential impact of adopting this new guidance on our consolidated financial statements and related disclosures.

In December 2022, the European Union member states voted unanimously to adopt a Directive implementing the Pillar 2 (global minimum tax) rules, giving member states until December 31, 2023, to implement the Directive into national legislation.

Further details regarding implementing these rules are expected, and if implemented, such reform may increase our tax liabilities, compliance costs and reduce our profitability.

Pillar 2 is effective from January 1, 2024, and will be treated as a period cost in future years and does not impact operating results in 2023.

Recently adopted accounting standards .

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.

ASU 2023 - 07 is effective for the Company beginning with the fiscal year ended December 31, 2024.

This guidance is being applied prospectively.

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.

The inclusive framework calls for tax law changes by participating countries to take effect in 2025.

Various countries have enacted or have announced plans to enact new tax laws to implement the global minimum tax.

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 in 2025, 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.

In August 2020, the FASB issued ASU No.

2020 - 06, “Debt—Debt with Conversion and Other Options (Subtopic 470 - 20 ) and Derivatives and Hedging—Contracts in Entity's Own Equity (Subtopic 815 - 40 ).” ASU 2020 - 06 simplifies the accounting for convertible instruments by reducing the number of accounting models for convertible debt instruments and convertible preferred stock.

The ASU is effective for public entities for fiscal years beginning after December 15, 2021, with early adoption permitted.

As required, we adopted ASU 2020 - 06 on January 1, 2022 and used the modified retrospective approach for all convertible debt instruments at the beginning of the period of adoptions.

Results for reporting periods beginning January 1, 2022 are presented under ASU 2020 - 06, while prior period amounts were not adjusted and continue to be reported in accordance with historic accounting guidance.

Under the modified approach, entities applied the guidance to all financial instruments that are outstanding as of the beginning of the year of adoption with the cumulative effect recognized as an adjustment to the opening balance of retained earnings.

ASU 2020 - 06 eliminates the cash conversion and beneficial conversion feature models in ASC 470 - 20 that require an issuer of certain convertible debt and preferred stock to separately account for embedded conversion features as a component of equity.

The adoption of ASU 2020 - 06 at January 1, 2022 resulted in an increase of the 2025 Convertible notes of $ 21.6 million, a reduction of the Accumulated deficit of $ 17.5 million and a reduction of Additional paid-in capital of $ 39.1 million.

2020 - 06, “Debt—Debt with Conversion and Other Options (Subtopic 470 - 20 ) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815 - 40 ).” This standard simplified the accounting for convertible instruments.

We adopted ASU 2020 - 06 on January 1, 2022, using the modified retrospective approach.

This resulted in an increase of $ 21.6 million to the 2025 Convertible Notes, a reduction of $ 17.5 million to the Accumulated deficit, and a reduction of $ 39.1 million to Additional paid-in capital.

Note 4 Income (loss) Per Share

Basic income (loss) per share is computed by dividing our net income (loss) by the weighted average number of shares of our Common Stock outstanding during the period.

Shares of Common Stock outstanding pursuant to the share lending arrangement (the "Share Lending Arrangement") under the Share Lending Agreement (as defined in Note 22 ) entered into in conjunction with the 2025 Notes (as defined in Note 7 ) are excluded from the calculation of basic and diluted earnings per share because the borrower of the shares is required under the Share Lending Arrangement to refund any dividends paid on the shares lent.

Shares of Common Stock outstanding under the share lending arrangement entered into in conjunction with the 2025 Notes (as defined in Note 7 ) have been excluded from the calculation of basic and diluted earnings per share because the borrower of the shares is required under the share lending arrangement to refund any dividends paid on the shares lent.

We terminated the share lending arrangement on January 22, 2024.

Refer to Note 7.

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 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 to Common Stock issuable under outstanding options, warrants or the potentially dilutive shares issuable pursuant to the 2033 Senior Notes, the 2023 Convertible Notes and the 2025 Notes in the dilutive computation.

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 291,185,409 , 82,843,173 and 55,582,089 potential shares of Common Stock have been excluded from the calculation of diluted net income (loss) per share for the years ended December 31, 2024, 2023 and 2022 , 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, 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.

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Of the 1,810,399 exercised and restricted stock units settled, 493,829 shares of Common Stock were surrendered in lieu of a cash payment via the net exercise feature of the related agreements.

During the year ended December 31, 2021 , 445,437 Common Stock options to purchase shares of our Common Stock were exercised, resulting in the issuance of 445,437 shares of Common Stock.

Of the 445,437 Common Stock options exercised, 0 shares of Common Stock were surrendered in lieu of a cash payment via the net exercise feature of the agreements.

Note 5 Acquisitions and Investments

ModeX Acquisition

On May 9, 2022, the Company entered into the ModeX Merger Agreement, pursuant to which the Company acquired ModeX.

The Company paid the entirety of the $ 300.0 million purchase price pursuant to the issuance of shares of Common Stock to the former stockholders of ModeX.

Such shares were valued at $ 219.4 million, based on the closing price per share of our Common Stock of $ 2.44 as reported by NASDAQ on the closing date of the acquisition.

Included in the total purchase price of $ 221.7 million were $ 2.3 million of fully vested equity awards.

The following table summarizes the final purchase price allocation and the fair value of the net assets acquired and liabilities assumed at the Modex acquisition date:

(in thousands)

Cash and cash equivalents

Property, plant and equipment

Accounts payable

Deferred tax liability

Total purchase price

Goodwill from the acquisition of ModeX principally related to intangible assets that did not qualify for separate recognition (for instance, ModeX's assembled workforce) and the deferred tax liability generated as a result of the transaction.

Goodwill is not tax deductible for income tax purposes and was assigned to the pharmaceutical reporting segment.

IPR&D assets from the acquisition of ModeX will not be amortized until the underlying development programs are completed and we obtain regulatory approval.

The IPR&D asset is then accounted for as a finite-lived intangible asset and amortized depending on pattern of future use.

Intangible assets are tested for impairment whenever events or changes in circumstances indicate that the carrying amount of such assets may not be recoverable, although IPR&D is required to be tested at least annually until the project is completed or abandoned.

Net loss in the Consolidated Statement of Operations for the year ended December 31, 2022, includes ModeX net loss from the date of acquisition to December 31, 2022 of $ 10.6 million.

Revenue and net loss in the Consolidated Statement of Operations for the year ended December 31, 2023, includes ModeX revenue and net income of $ 51.2 million and $ 5.4 million, respectively.

Note 5 Investments

The following table reflects the accounting method, carrying value and underlying equity in net assets of our unconsolidated investments as of December 31, 2024 and 2023 :

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Underlying Equity in Net Assets

Equity securities

$ 49,655 1,329 $ 116 2,942

Equity securities with no readily determinable fair value

4,139 — 5,382 420

Equity method investments

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Equity method investments - FV option

Equity securities

Equity securities with no readily determinable fair value

Warrants and options

Total carrying value of investments

Equity method investments

Our equity method investments, other than GeneDx Holdings disclosed below, consist of investments in Pharmsynthez (ownership 8.5 %), Cocrystal Pharma, Inc.

(“COCP”) ( 2.2 %), Non-Invasive Monitoring Systems, Inc.

(“NIMS”) ( 0.5 %), BioCardia, Inc.

(“BioCardia”) ( 1.0 %), Xenetic Biosciences, Inc.

(“Xenetic”) ( 2.9 %), and LeaderMed Health Group Limited (“LeaderMed”) ( 47.0 %).

Neovasc, Inc., in which we owned a 0.5 % interest was acquired by Shockwave Medical, Inc.

in April 2023, and during the year ended December 31, 2023, we received $ 363 thousand in merger consideration in exchange for our shares.

The aggregate amount of assets, liabilities, and net losses of these equity method investees as of and for the year ended December 31, 2023 was $ 85.5 million, $ 20.8 million, and $ 37.7 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, 2022 was $ 167.1 million, $ 46.5 million, and $ 101.5 million, respectively.

We have determined that we or our related parties have the ability to exercise significant influence over our equity method investments through our board representation or voting power.

Accordingly, we account for our investment in these entities under the equity method and record our proportionate share of their losses in Loss from investments in investees in our Consolidated Statement of Operations.

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, 2023 and 2022 was $ 0.7 million and 1.3 million, respectively.

Equity method investments - Fair value option

On April 29, 2022, the Company sold GeneDx to GeneDx Holdings in accordance with the terms of the GeneDx Merger Agreement, pursuant to which GeneDx Holdings paid to the Company aggregate consideration of $ 150 million in cash (before deduction of transaction expenses and other customary purchase price adjustments), together with the Closing Shares.

In January 2023, we purchased 14,285,714 shares of GeneDx Holdings Common Stock for an aggregate of $ 5.0 million in GeneDx Holdings’ underwritten public offering.

Additionally, subject to GeneDx having achieved certain revenue targets for the year ended December 31, 2022 and 2023, we were eligible to receive the GeneDx Milestone Consideration in cash or stock (at GeneDx Holdings’ discretion) equal to a maximum of 30.9 million shares of GeneDx Holdings’ Common Stock if paid in stock.

We received 23.1 million shares of Class A Common Stock as a result of GeneDx satisfactorily achieving targets as of December 31, 2022;

however, we do not expect to receive any GeneDx Milestone Consideration with respect to the year ended December 31, 2023.

In April 2023, GeneDx Holdings announced a 1 -for- 33 reverse stock split of the GeneDx Holdings Common Stock which automatically converted every 33 outstanding shares of GeneDx Common Stock into one new share of GeneDx Common Stock.

As of December 31, 2023 , we held 3,558,602 shares of GeneDx Holdings Common Stock, representing an approximate 13.7 % ownership interest in GeneDx Holdings.

Pursuant to the GeneDx Merger Agreement, the Company designated, and GeneDx Holdings nominated for election an individual to serve on the board of directors of GeneDx Holdings, and such nominee was elected by GeneDx Holdings stockholders to serve as a director until GeneDx Holdings 2024 annual meeting of stockholders.

As a result, we have determined that the Company or our related parties can exercise significant influence over the investee through our board representation or voting power.

However, our influence is restricted by the GeneDx Holdings Shareholder Agreement, pursuant to which we have agreed to vote our shares of GeneDx Holdings Common Stock in accordance with the recommendation of GeneDx Holdings’s board of directors for so long as we continue to hold at least 5 % of the outstanding shares of GeneDx Holdings Common Stock.

Other than through our sole board seat, we are unable to influence GeneDx Holdings’s policy-making process.

We hold one of seven seats on GeneDx Holdings board of directors, and our designee may continue to serve following the expiration of the lock-up period if the GeneDx Holdings stockholders elect him to continue serving on the board.

We elected to account for our investment in GeneDx Holdings under the equity method fair value option and record gains and losses from changes in fair value in other income (expense), net in our Condensed Consolidated Statements of Operations.

For the years ended December 31, 2023 , and 2022, we recognized $ 23.0 million and $ 150.9 million of expense related to the change in fair value of our GeneDx Holdings investment, respectively.

As of December 31, 2023 , the aggregate value of our GeneDx Holdings investment based on the quoted market price of the GeneDx Holdings Common Stock was $ 9.8 million.

$ 54,584 $ 16,082

Investments in Equity securities

Our equity securities consist of investments in VBI ( 0.2 %), ChromaDex Corporation (“ChromaDex”) ( 0.05 %), Eloxx Pharmaceuticals, Inc.

(“Eloxx”) ( 1.2 %), CAMP4 Therapeutics Corporation ( “CAMP4” ) ( 2.4 %), and HealthSnap, Inc.

We have determined that our ownership, along with that of our related parties, does not provide us with significant influence over the operations of these investments.

Accordingly, we account for our investment in these entities as equity securities, and we record changes in the fair value of these investments in Other income (expense) each reporting period when they have readily determinable fair value.

Equity securities without a readily determinable fair value are adjusted to fair value when there is an observable price change.

Net gains and losses on our equity securities for the year ended December 31, 2023, 2022 and 2021 are as follows:

We hold investments in various equity securities, which are accounted for based on the Company's level of influence over the investee and whether the 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 value 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, 2024, we sold 2,937,762 shares of GeneDx common stock at various prices per share for an aggregate of $ 166.6 million.

As a result, our ownership in GeneDx had decreased to 2.2 % as of December 31, 2024.

This reduction, coupled with the absence of a contractual agreement for continued board representation, led to us concluding we could no longer exercise significant influence over GeneDx Holdings.

Accordingly, we changed our accounting method for our investment in GeneDx Holdings from the equity method to the fair value method for equity securities.

For the year ended December 31, 2024, we recognized $ 140.0 million in net income related to the change in fair value of our GeneDx Holdings investment.

For the years ended December 31, 2023 and 2022, we recognized $ 23.0 million and $ 150.9 million, respectively, of expense related to the change in fair value of our GeneDx Holdings investment.

As of December 31, 2024, the aggregate value of our GeneDx Holdings investment was $ 47.7 million based on the quoted market price of GeneDx Holdings common stock.

Xenetic Biosciences, Inc.

During the fourth quarter of 2024, our investment in Xenetic Biosciences, Inc.

(“Xenetic”), representing a 2.9 % interest was reclassified from an equity method investment to an equity security with a readily determinable fair value.

This reclassification resulted from the loss of purported influence over Xenetic due to loss in board representation.

CAMP4 Therapeutics Corporation

During 2024, CAMP4 Therapeutics Corporation ( “CAMP4” ), in which we hold a 1.5 % interest, completed an initial public offering, resulting in its common stock now having a readily determinable fair value.

Accordingly, we changed our accounting method for our investment in CAMP4 from the measurement alternative for equity securities without readily determinable fair values to the fair value method for equity securities.

Other Equity Securities

We hold equity securities in ChromaDex Corporation (“ChromaDex”) ( 0.05 %), and Eloxx Pharmaceuticals, Inc.

(“Eloxx”) ( 1.0 %).

Our investment in HealthSnap, Inc.

( 3.8 %) is accounted for under the measurement alternative for equity securities without readily determinable fair values.

We also held equity securities in VBI Vaccines Inc.

( 0.2 %) prior to that company filing for bankruptcy, as a result of which we no longer hold any interest in such company.

During the year ended December 31, 2024, we recorded a $ 30 thousand impairment loss from our investment in VBI Vaccines Inc.

due to that company's bankruptcy.

Net gains and losses on our equity securities for the year ended December 31, 2024, 2023 and 2022 were as follows:

For the year ended December 31

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Net gains and (losses) recognized during the period on equity securities

$ 73,873 $ ( 532 ) $ ( 3,578 )

Net gains realized during the period on equity securities

( 54,026 ) — —

Unrealized net gains and losses recognized during the period on equity securities still held at the reporting date

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 hold options to purchase 47 thousand shares of BioCardia, all of which were vested as of December 31, 2023 and 2022 , and warrants to purchase 33 thousand and 0.7 million shares of COCP and InCellDx, Inc., respectively.

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.

$ 19,847 $ ( 532 ) $ ( 3,578 )

Investments in variable interest entities

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(“Zebra”) based on our assessment that they do not have sufficient resources to carry out their principal activities without additional financial support.

On September 14, 2021, we and LeaderMed, a pharmaceutical development company with operations based in Asia, 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 being developed to treat hemophilia, in exchange for 4,703 shares 47 % ownership interest in the joint venture.

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 being developed to treat hemophilia, in exchange for 4,703 shares 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.

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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 hold options to purchase 47 thousand shares of BioCardia, all of which were vested as of December 31, 2024 and 2023 .

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 consist of investments in Pharmsynthez (ownership 5.8 %), Cocrystal Pharma, Inc.

(“COCP”) ( 2.2 %), Non-Invasive Monitoring Systems, Inc.

(“NIMS”) ( 0.5 %), BioCardia, Inc.

(“BioCardia”) ( 0.3 %), and LeaderMed Health Group Limited (“LeaderMed”) ( 47.0 %).

Neovasc, Inc., in which we owned 0.0 % as of December 31, 2023, was acquired by Shockwave Medical, Inc.

in April 2023.

We received $ 363 thousand in merger consideration in exchange for its shares.

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, 2024 and 2023 was $ 0.5 million and 0.7 million, respectively.

Note 6 Composition of Certain Financial Statement Captions

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Other current assets and prepaid expenses

Escrow receivable

Prepaid supplies

$ 6,177 $ 7,918

Prepaid insurance

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14,171 14,410

14,410 14,218

Automobiles and aircraft

12,701 12,808

Construction in process

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Accrued expenses:

Employee benefits

Employee benefits and severance

$ 34,167 $ 28,952

Gross to net provision

Accrued interest

Inventory received but not invoiced

4 unchanged sentences

Professional fees

Contingent consideration

Contract liabilities

22,385 20,701

1 unchanged sentence

Other long-term liabilities:

Employee severance

Mortgages and other debts payable

$ 7,709 $ 9,098

Finance leases long-term

Contingent consideration

Contract liabilities

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The assets will be amortized on a straight-line basis over their estimated useful life of approximately 12 years.

Other changes in value of the intangible assets and goodwill on December 31, 2023 and 2022 , were primarily due to foreign currency fluctuations between the Chilean Peso, and the Euro against the U.S.

Other changes in value of the intangible assets and goodwill on December 31, 2024 and 2023 , were primarily due to foreign currency fluctuations between the Euro, and the Chilean Peso against the U.S.

The following table reflects the changes in the allowance for doubtful accounts, provision for inventory reserve and tax valuation allowance accounts:

47 unchanged sentences

2029 Convertible Notes

71,025 68,275

2033 Senior Notes

JP Morgan line of credit

12,671 18,080

2023 Convertible Notes

JPMorgan Chase Bank line of credit

Chilean and Spanish lines of credit

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14,849 27,293

LT notes payable included in other long-term liabilities

Long Term notes payable included in long-term liabilities

248,578 7,727

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 bear interest at a rate of 4.50 % per year, payable semiannually in arrears on February 15 and August 15 of each year.

The 2025 Notes mature on February 15, 2025, unless earlier repurchased, redeemed or converted.

Holders may convert their 2025 Notes into shares of Common Stock at their option at any time prior to the close of business on the business day immediately preceding November 15, 2024 only under the following circumstances:

( 1 ) during any calendar quarter commencing after the calendar quarter ended March 31, 2019 ( 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 a period of 30 consecutive trading days ending on the last trading day of the immediately preceding calendar quarter is greater than or equal to 130 % of the conversion price on each applicable trading day;

( 2 ) during the five business day period after any five consecutive trading day period (the “measurement period”) in which the trading price per $1,000 principal amount of 2025 Notes for each trading day of the measurement period was less than 98 % of the product of the last reported sale price of our Common Stock and the conversion rate on each such trading day;

( 3 ) if we call any or all of the 2025 Notes for redemption, at any time prior to the close of business on the scheduled trading day immediately preceding the redemption date;

or ( 4 ) upon the occurrence of specified corporate events set forth in the indenture governing the 2025 Notes.

On or after November 15, 2024, until the close of business on the business day immediately preceding the maturity date, holders of the 2025 Notes may convert their notes at any time, regardless of the foregoing conditions.

Upon conversion, 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 initial and current conversion rate for the 2025 Notes is 236.7424 shares of Common Stock per $1,000 principal amount of 2025 Notes (equivalent to a conversion price of approximately $ 4.22 per share of Common Stock).

The conversion rate for the 2025 Notes is subject to adjustment in 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 2025 Notes or if we deliver a notice of redemption, in certain circumstances the indenture governing the 2025 Notes requires an increase in the conversion rate of the 2025 Notes for a holder who elects to convert its notes in connection with such a corporate event or notice of redemption, as the case may be.

We may redeem for cash any or all of the 2025 Notes, at our option, if the last reported sale price of our Common Stock has been at least 130 % of the then current conversion price for the notes for at least 20 trading days (whether or not consecutive) during any 30 consecutive trading day period (including the last trading day of such period) ending on, and including, the trading day immediately preceding the date on which we provide notice of redemption at a redemption price equal to 100 % of the principal amount of the notes to be redeemed, plus accrued and unpaid interest to, but excluding, the redemption date.

No sinking fund is provided for the 2025 Notes.

If we undergo a fundamental change, as defined in the indenture governing the 2025 Notes, prior to the maturity date of the 2025 Notes, holders may require us to repurchase for cash all or any portion of their notes at a repurchase price equal to 100 % of the principal amount of the notes to be repurchased, plus accrued and unpaid interest to, but excluding, the fundamental change repurchase date.

The 2025 Notes are our senior unsecured obligations and rank senior in right of payment to any of our indebtedness that is expressly subordinated in right of payment to the 2025 Notes;

equal in right of payment to any of our existing and future liabilities that are not so subordinated;

effectively junior in right of payment to any of our secured indebtedness to the extent of the value of the assets securing such indebtedness;

and structurally junior to all indebtedness and other liabilities (including trade payables) of our current or future subsidiaries.

In May 2021, we entered into the Exchange with certain holders of the 2025 Notes pursuant to which the holders exchanged $ 55.4 million in aggregate principal amount of the outstanding 2025 Notes for 19,051,270 shares of our Common Stock (the “Exchange”).

We recorded an $ 11.1 million non-cash loss related to the Exchange during 2021.

Contemporaneously with the closing of our offering of the 2029 Convertible Notes (as defined in Note 22 ) on January 9, 2024, we repurchased approximately $ 144.4 million aggregate principal amount of the 2025 Notes for cash, using $ 146.3 million of the net proceeds from our issuance and sale of the 2029 Convertible 144A Notes, following which only $ 170 thousand aggregate principal amount of the 2025 Notes remained outstanding.

See Note 22 for additional information.

In conjunction with the issuance of the 2025 Notes, we agreed to loan up to 30,000,000 shares of our Common Stock to affiliates of the underwriter in order to assist investors in the 2025 Notes to hedge their position.

Following the consummation of the Exchange, the number of outstanding borrowed shares of Common Stock was reduced by 8,105,175 shares.

As of December 31, 2023 and 2022 , a total of 21,144,825 shares remained outstanding under the Share Lending Arrangement.

We will not receive any of the proceeds from the sale of the borrowed shares, but we received a one -time nominal fee of $ 0.3 million for the newly issued shares.

Shares of our Common Stock outstanding under the Share Lending Arrangement are excluded from the calculation of basic and diluted earnings per share.

The Share Lending Arrangement was terminated in connection with the closing of the offering of the 2029 Convertible Notes.

The following table sets forth information related to the 2025 Notes which is included in our Consolidated Balance Sheet as of December 31, 2023 :

$ 437,203 $ 249,345

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 Secured Overnight Financing Rate (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 amount of 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 (the “Initial Purchaser”).

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 effected with or through the Initial Purchaser or its affiliate.

The purchase price per share of the Common Stock in these transactions equaled the closing sale price of $ 0.9067 per share of Common Stock on January 4, 2024.

Contemporaneously with the closing of the offering of the 2029 Convertible 144A Notes on January 9, 2024, 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 ( the “Affiliate Note Purchase Agreement”) by and among the Company and certain investors, Frost Gamma Investments Trust, a trust controlled by Dr.

Phillip Frost, and Dr.

Hsiao (collectively, the “Affiliate Purchasers”).

Pursuant to the Affiliate Note Purchase 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 2023 Convertible Notes held by the Affiliate Purchasers, together with approximately $ 16.1 million of accrued but unpaid interest thereon.

On January 9th, 2024, we recorded the $ 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 Notes.

From the date the Notes were issued through March 31, 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.

Effective April 1, 2024, the conversion option contained in the 2029 Convertible Notes met the requirements for classification as an equity component.

As a result, we reclassified $ 151.9 million of the embedded derivative liability from debt, non-current, to additional paid-in capital in stockholders' equity on our Condensed Consolidated Balance Sheet as of December 31, 2024.

As of December 31, 2024 the 2029 Convertible 144A Notes were 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 ended 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 the five consecutive business day period after any ten consecutive trading day period (the “measurement period”) in which the trading price per $1,000 principal amount of notes for each trading day of the 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 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, 2024 :

(In thousands)

2025 Senior Notes

2029 convertible notes

Embedded conversion option

Debt Issuance Costs

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$ — $ — $ — $ — $ —

Issuance of 3.75 % 2029 Convertible Notes

301,054 125,620 ( 125,620 ) ( 8,562 ) 292,492

Amortization of debt discount and debt issuance costs

— 17,210 1,771 18,981

Change in fair value of embedded derivative

— 26,250 — — 26,250

Reclassification of embedded derivative to equity

— ( 151,870 ) — — ( 151,870 )

( 20,460 ) — 7,531 632 ( 12,297 )

Balance at December 31, 2024

$ 280,594 $ — $ ( 100,879 ) $ ( 6,159 ) $ 173,556

During the year ended December 31, 2024, the Company repurchased $ 20.5 million in aggregate principal amount of the 2029 Convertible 144A Notes for $ 29.8 million in cash.

Such convertible debt repurchase resulted in a gain of $ 7.6 million, which included unamortized discount of $ 7.5 million and debt issuance costs of $ 0.6 million.

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 bear interest at a rate of 4.50 % per year, payable semiannually in arrears on February 15 and August 15 of each year.

The 2025 Notes mature on February 15, 2025, unless earlier repurchased, redeemed or converted.

In May 2021, we entered into an agreement with certain holders of the 2025 Notes pursuant to which the holders exchanged $ 55.4 million in aggregate principal amount of the outstanding 2025 Notes for 19,051,270 shares of our Common Stock (the “Exchange”).

Contemporaneously with the closing of our offering of the 2029 Convertible Notes, we repurchased approximately $ 144.4 million aggregate principal amount of the 2025 Notes for cash, using $ 146.3 million of the net proceeds from our issuance and sale of the 2029 Convertible 144A Notes, following which only $ 170 thousand aggregate principal amount of the 2025 Notes remained outstanding.

On January 22, 2024, we terminated our share lending agreement, dated February 4, 2019, with Jefferies Capital Services, LLC (“Share Borrower”).

Through this agreement, we had lent the Share Borrower approximately 30 million shares of our Common Stock related to our 2019 issuance of the 2025 Notes.

With the termination of this agreement, all remaining borrowed shares of Common Stock have been returned to us and are now held as treasury shares.

In August 2020, the FASB issued ASU No.

The ASU is effective for public entities for fiscal years beginning after December 15, 2021, with early adoption permitted.

As required, we adopted ASU 2020 - 06 on January 1, 2022 and used the modified retrospective approach for all convertible debt instruments at the beginning of the period of adoptions.

We adopted ASU 2020 - 06 on January 1, 2022, using the modified retrospective approach.

This resulted in an increase of $ 21.6 million to the 2025 Convertible notes, a reduction of $ 17.5 million to the Accumulated deficit, and a reduction of $ 39.1 million to Additional paid-in capital.

2023 Convertible Notes

In February 2018, we issued a series of 5 % Convertible Promissory Notes (the “2023 Convertible Notes”) in the aggregate principal amount of $ 55.0 million.

The original maturity of the 2023 Convertible Notes was five years following the date of issuance and each holder of a 2023 Convertible Note originally had the option, from time to time, to convert all or any portion of the outstanding principal balance of such 2023 Convertible Note, together with accrued and unpaid interest thereon, into shares of our Common Stock at a conversion price of $ 5.00 per share.

On February 10, 2023, we amended the 2023 Convertible Notes to extend their maturity to January 31, 2025 and reset the conversion price to the 10 day volume weighted average price immediately preceding the date of the amended notes, plus a 25 % conversion premium, or $ 1.66 per share.

Interest under the 2023 Convertible Notes accrues from the most recent date to which interest has been paid or, if no interest has been paid, from the date of issuance, until the principal and accrued and unpaid interest, are paid in full.

Purchasers of the 2023 Convertible Notes included an affiliate of Dr.

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Hsiao, Ph.D., MBA, our Vice-Chairman and Chief Technical Officer.

Contemporaneously with the closing of the offering of the 2029 Convertible Notes (as defined in Note 22 ) on January 9, 2024, we issued and sold approximately $ 71.1 million aggregate principal amount of the 2029 Convertible Affiliate Notes (as defined in Note 22 ) in exchange for all $ 55.0 million aggregate principal amount of the outstanding 2023 Convertible Notes, including approximately $ 16.1 million of accrued but unpaid interest thereon, following which no 2023 Convertible Notes remained outstanding.

See Note 22 for additional information.

The original maturity of the 2023 Convertible Notes was five years following the date of issuance.

Each holder of a 2023 Convertible Note originally had the option to convert all or any portion of the outstanding principal balance of such 2023 Convertible Note, together with accrued and unpaid interest thereon, into shares of our Common Stock at a conversion price of $ 5.00 per share.

On February 10, 2023, we amended the 2023 Convertible Notes to extend the maturity to January 31, 2025 and reset the conversion price to $ 1.66 per share.

In connection with the closing of the 2029 Convertible Notes offering, the Company issued approximately $ 71.1 million aggregate principal amount of its 2029 Convertible Affiliate Notes in exchange for all issued and outstanding 2023 Convertible notes, following which no 2023 Convertible Notes remained outstanding.

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.

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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 year ended December 31, 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.

The terms of the 2033 Senior Notes, include, among others:

(i) rights to convert the notes into shares of our Common Stock, including upon a fundamental change;

and (ii) a coupon make-whole payment in the event of a conversion by the holders of the 2033 Senior Notes on or after February 1, 2017 but prior to February 1, 2019.

We determined that these specific terms were embedded derivatives.

Embedded derivatives are required to be separated from the host contract, the 2033 Senior Notes, and carried at fair value when:

(a) the embedded derivative possesses economic characteristics that are not clearly and closely related to the economic characteristics of the host contract;

and (b) a separate, stand-alone instrument with the same terms would qualify as a derivative instrument.

We concluded that the embedded derivatives within the 2033 Senior Notes met these criteria and, as such, were valued separate and apart from the 2033 Senior Notes and recorded at fair value each reporting period.

In November 2015, BioReference and certain of its subsidiaries entered into a credit agreement (as amended (the “Credit Agreement”) with JPMorgan Chase Bank, N.A.

(“CB”), as lender and administrative agent.

The Credit Agreement originally provided for a $ 75.0 million secured revolving credit facility and currently includes a $ 20.0 million sub-facility for swingline loans and a $ 20.0 million sub-facility for the issuance of letters of credit.

On June 29, 2023, the Company entered into an amendment to the Credit Agreement (the "Credit Agreement Amendment"), which, among other things, (i) replaced the London interbank offered rate (LIBOR) with the forward-looking term rate based on the secured overnight financing rate (the "SOFR Rate") as the interest rate benchmark, (ii) reduced the aggregate revolving commitment from $ 75,000,000 to $ 50,000,000 , (iii) provided a revised commitment fee rate, and (iv) extended the maturity date from August 2024 to the earlier of August 2025, and 90 days prior to the maturity date of any indebtedness of the Company in an aggregate principal amount exceeding $7,500,000.

The Credit Agreement is guaranteed by all of BioReference’s domestic subsidiaries and is also secured by substantially all assets of BioReference and its domestic subsidiaries, as well as a non-recourse pledge by us of our equity interest in BioReference.

Availability under the Credit Agreement is based on a borrowing base composed of eligible accounts receivables of BioReference and certain of its subsidiaries, as specified therein.

As of December 31, 2023 , $ 7.5 million remained available for borrowing under the Credit Agreement.

Principal under the Credit Agreement is due upon maturity on August 30, 2025.

At BioReference’s option, borrowings under the Credit Agreement (other than swingline loans) bear interest at (i) the CB floating rate (defined as the higher of ( x ) the prime rate and (y) the SOFR Rate for an interest period of one month plus 2.50 % and a benchmark spread adjustment of 0.10 %) plus an applicable margin of 1.00%;

or (ii) the SOFR Rate plus a benchmark spread adjustment of 0.10 % and an applicable margin of 2.00 %.

Swingline loans will bear interest at the CB floating rate plus the applicable margin.

The Credit Agreement also calls for other customary fees and charges, including an unused commitment fee of 0.400 % if the average quarterly availability is 50% or more of the revolving commitment, or 0.275 % if the average quarterly availability is less than or equal to 50% of the revolving commitments.

As of December 31, 2023 and 2022 , $ 12.7 million and $ 18.1 million, respectively, was outstanding under the Credit Agreement.

The Credit Agreement contains customary covenants and restrictions, including, without limitation, covenants that require BioReference and its subsidiaries to maintain a minimum fixed charge coverage ratio if availability under the new credit facility falls below a specified amount and to comply with laws and restrictions on the ability of BioReference and its subsidiaries to incur additional indebtedness or to pay dividends and make certain other distributions to the Company, subject to certain exceptions as specified therein.

Failure to comply with these covenants would constitute an event of default under the Credit Agreement, notwithstanding the ability of BioReference to meet its debt service obligations.

The Credit Agreement also includes various customary remedies for the lenders following an event of default, including the acceleration of repayment of outstanding amounts under the Credit Agreement and execution upon the collateral securing obligations under the Credit Agreement.

Substantially all the assets of BioReference and its subsidiaries are restricted from sale, transfer, lease, disposal or distributions to the Company, subject to certain exceptions.

As of December 31, 2023 , BioReference and its subsidiaries had net assets of approximately $ 488.3 million, which included goodwill of $ 283.0 million and intangible assets of $ 167.8 million.

In addition to the Credit Agreement, we had line of credit agreements with twelve other financial institutions as of December 31, 2023 and December 31, 2022 in the U.S., Chile and Spain.

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.

BioReference Credit Agreement

In November 2015, BioReference and certain subsidiaries established a credit agreement with JPMorgan Chase Bank, N.A.

(“CB”) as lender and administrative agent (the “BioReference Credit Agreement”).

As amended, the BioReference Credit Agreement provided for a $ 50.0 million secured revolving credit facility, including a $ 20.0 million sub-facility for swingline loans and a $ 20.0 million sub-facility for letters of credit.

On September 16, 2024, BioReference fully repaid its obligations and terminated the BioReference Credit Agreement.

BioReference paid approximately $ 9.7 million to settle its obligations, incurring no prepayment premium or penalty.

International Line of Credit Agreements

The Company had line of credit agreements with twelve other financial institutions as of December 31, 2024 and December 31, 2023 in the U.S., Chile and Spain.

These lines of credit are used primarily as a source of working capital for inventory purchases.

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borrowings at December 31, 2024

JPMorgan Chase

5.50 % $ 2,363 $ 200 $ 1,264

5.50 % 2,363 1,264 2,378

Bank of Chile

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5.36 % 519 — —

La Caixa Bank

4.09 % 519 — —

JPMorgan Chase

$ 30,820 $ 13,466 $ 25,300

At December 31, 2024 and 2023 , the weighted average interest rate on our lines of credit was approximately 5.52 % and 7.5 %, respectively.

At December 31, 2023 and 2022 , we had notes payable and other debt (excluding the 2033 Senior Notes, the 2023 Convertible Notes, the 2025 Notes, the Credit Agreement and amounts outstanding under lines of credit described above) as follows:

At December 31, 2024 and 2023 , 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:

(In thousands)

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As of December 31, 2024 and 2023 , there were no 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 up to $ 100 million of shares of Common Stock.

Under this program, the Company may repurchase shares through various methods, including open market purchases, block trades, privately negotiated transactions, and accelerated share repurchases, as well as pursuant to pre-set trading plans meeting the requirements of Rule 10b5 - 1 (c) of the Exchange Act, and otherwise in compliance with applicable laws.

The timing and volume of repurchases will depend on market conditions, the Company's 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 the Company's discretion.

The Company repurchased 25,825,785 shares at an average price per share of $ 1.56 for approximately $ 40.2 million during the year ended December 31, 2024 under this repurchase program.

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, facilitated by the Initial Purchaser or its affiliate.

The purchase price per share was $ 0.9067 , equivalent to the closing sale price of our Common Stock on January 4, 2024.

Note 9 Accumulated Other Comprehensive Income (Loss)

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Balance at December 31, 2023

Other comprehensive income

Other comprehensive loss

Balance at December 31, 2024

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Balance at December 31, 2022

Other comprehensive loss

Other comprehensive income

Balance at December 31, 2023

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( 5,780,625 ) $ 7.24

( 5,199,136 ) $ 6.18

Outstanding at December 31, 2024

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9,679,250 $ 1.36

( 60,223 ) $ 1.68

Actual vested

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Equity investments

25,718 17,309

Lease liability

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17,588 17,141

Investment in subsidiaries

Deferred income tax assets

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Net deferred income tax liability balances at December 31, 2024 and 2023 include $ 2.4 million and $ 3.5 million, respectively, recorded to Other assets on the Consolidated Balance Sheets.

As of December 31, 2023 , we have federal, state and foreign net operating loss carryforwards of approximately $ 430.2 million, $ 797.3 million and $ 49.9 million, respectively, that expire at various dates through 2039 unless indefinite in nature.

As of December 31, 2024 , we had federal, state and foreign net operating loss carryforwards of approximately $ 51.6 million, $ 438.1 million and $ 77.3 million, respectively, that expire at various dates through 2040 unless indefinite in nature.

As of December 31, 2024 , we have research and development tax credit carryforwards of approximately $ 16.1 million that expire in varying amounts through 2043.

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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, 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.

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).

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During 2020, we conducted a study to determine whether any ownership changes occurred from 2009 through 2020.

In 2023, the study has been updated and we have concluded that the annual utilization of our NOLs and tax credits is not subject to a limitation pursuant to Internal Revenue Code Section 382.

In 2024, the study was updated 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.

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Tax audits by their very nature are often complex and can require several years to complete.

It is reasonably possible that some audits will close within the next twelve months, which we do not believe would result in a material change to our accrued uncertain tax positions.

Other than the Israeli tax matter, we did not have any U.S.

or foreign audits as of December 31, 2024.

Under the tax statute of limitations applicable to the Internal Revenue Code, we are no longer subject to U.S.

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Tax Cuts and Jobs Act

On December 22, 2017, the 2017 Tax Act was enacted into law and the new legislation contains 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.

On December 22, 2017, the 2017 Tax Cuts and Jobs Act (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.

Effective January 1, 2018, the Tax Act provides for a new Global Intangible Low Taxed Income provision (“GILTI”).

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.

Unrecognized Tax Benefits

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Gross decreases – tax positions in prior period

( 348 ) ( 271 )

Lapse of Statute of Limitations

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( 441.7 )% ( 14.8 )% ( 4.9 )%

Convertible Debt

( 71.8 )% — % — %

Stock options excess tax benefit, cancellations & expirations

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( 19.7 )% ( 0.8 )% ( 0.4 )%

Investment in subsidiaries

— % — % ( 287.6 )%

Tax on deemed dividend

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( 12.3 )% ( 2.3 )% — %

BioReference Asset Sale

( 133.9 )% — % — %

6.3 % 0.8 % — %

( 412.8 )% ( 2.4 )% 16.2 %

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.

The impact of the tax holiday on a per share basis for the year ended December 31, 2023 was a benefit of $ 0.00 per share.

For the year ended December 31, 2024 the tax holiday had expired.

The following table reconciles our income (loss) before income taxes between U.S.

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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.

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.

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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.

We maintain an accrued withholding tax estimate of $ 1.1 million related to earnings that are not deemed to be permanently reinvested.

As of December 31, 2024, we do not maintain any accrued withholding tax related to earnings that are not deemed to be permanently reinvested.

Note 12 Related Party Transactions

In January 2024, in connection with the closing of the offering of the 2029 Convertible Notes (as defined in Note 22 ), we issued and sold approximately $ 71.1 million aggregate principal amount of the 2029 Convertible Affiliate Notes (as defined in Note 22 ) to the Affiliate Purchasers (as defined in Note 22 ), 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.

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.

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.

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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 an upfront payment of $ 150,000 , a number of potential milestone payments up to $ 1 million, commercial milestones ranging from low to double digit millions, and royalty payments.

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 the GeneDx Transaction, the Company entered into a Transition Services Agreement (the “Transition Services Agreement”), with GeneDx (now a wholly owned subsidiary of GeneDx Holdings), pursuant to which the Company agreed to provide, at cost, certain customary support services in respect of GeneDx’s business through October 31, 2023, including human resources, information technology support, and finance and accounting.

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 year ended December 31, 2023 , the Company incurred expenses of $ 1.2 million for services rendered under the Transaction Services Agreement.

As of December 31, 2023 , the company has a receivable of $ 11,262 thousand payable to the Company by GeneDx in accordance with the terms of the Transition Services Agreement.

For the year ended December 31, 2024, the Company did not incur expenses for services rendered under the Transition Services Agreement.

As of December 31, 2024, GeneDx had no 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 2.9 % ownership interest as of December 31, 2024 .

See further discussion of our Xenetic investment in Note 5

We hold investments in Zebra (ownership 28.5 %), ChromaDex Corporation ( 0.05 %), COCP ( 2 %), NIMS ( 0.5 %), Eloxx ( 1.0 %), BioCardia ( 0.3 %) and LeaderMed Health Group Limited ( 47.0 %).

Neovasc, Inc., in which we owned a 0.5 % interest, was acquired by Shockwave Medical, Inc.

in April 2023, and during the year ended December 31, 2023 , we received $ 363 thousand in merger consideration in exchange for our shares.

Neovasc, Inc., in which we owned 0.0 % as of December 31, 2023, was acquired by Shockwave Medical, Inc.

in April 2023.

We received $ 363 thousand in merger consideration in exchange for its shares.

These investments were considered related party transactions as a result of our executive management’s ownership interests and/or board representation in these entities.

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and subsequent participation in an underwritten offering by GeneDx Holdings.

Richard Pfenniger who sits on our Board also sits on the GeneDx Board as a result of the acquisition.

Richard Pfenniger who sits on our Board also sits on the GeneDx Board.

See further discussion of our investments in Note 5.

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, 2019, we entered into an amendment to our lease agreement with Frost Holdings.

The lease, as amended, is for approximately 29,500 square feet of space.

The lease provides for payments of approximately $ 89 thousand per month in the first year increasing annually to $ 101 thousand per month in the fifth year, plus applicable sales tax.

The rent is inclusive of operating expenses, property taxes and parking.

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 $ 3.2 million, $ 4.7 million, and $ 0.3 million, respectively, during the year ended December 31, 2024 .

BioReference purchases and uses certain products acquired from InCellDx, a company in which we hold a 29 % minority interest.

BioReference purchases and uses certain products acquired from InCellDx, a company in which we hold a 29 % interest.

We reimburse Dr.

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Note 14 Commitments and Contingencies

In February 2023, the Office of the Attorney General for the State of Texas (“TX OAG”) informed BioReference that it believes that, from 2005 to the present, BioReference may have violated the Texas Medicaid Fraud Prevention Act with respect to claims it presented to Texas Medicaid for reimbursement.

BioReference has not yet determine the extent of any potential liability.

While management cannot predict the outcome of these matters at this time, the ultimate outcome could be material to our business, financial condition, results of operations, and cash flows.

In February 2023, the Office of the Attorney General for the State of Texas (“TX OAG”) informed BioReference that it believes that, from 2005 to 2023, BioReference may have violated the Texas Medicaid Fraud Prevention Act with respect to claims it presented to Texas Medicaid for reimbursement.

BioReference and the TX OAG entered into a settlement agreement in February 2025 for $ 4.2 million, under which BioReference did not admit any wrongdoing

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 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.

We recognize that local tax law is inherently complex and the local taxing authorities may not agree with certain tax positions taken.

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.

The matter is currently before the courts.

The trial has concluded;

however, 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 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.

In connection with our acquisitions of CURNA, OPKO Diagnostics and OPKO Renal, we agreed to pay future consideration to the sellers upon the achievement of certain events.

As of December 31, 2023 , we had no contingent consideration recorded in accrued expenses and other long-term liabilities in the accompanying Condensed Consolidated Balance Sheets.

As of December 31, 2022 , $ 1.0 million of contingent consideration was recorded in accrued expenses and other long-term liabilities in the accompanying Consolidated Balance Sheets.

Refer to Note 6.

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”).

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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 agreed to pay 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 consists 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 paid on July 18, 2022.

Conditioned upon payment of the Settlement Amount, the United States, Massachusetts and Connecticut have 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 has agreed to release 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 has agreed to release and refrain 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.

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”).

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 5 years, BioReference is required to, among other things:

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The CID sets forth document requests and interrogatories in connection with allegations that the Company and certain of its affiliates violated the False Claims Act and/or the Anti-Kickback Statute.

On January 13, 2022, the Federal Government notified the U.S.D.C., Middle District Florida, Jacksonville Division, that it declined to intervene in the matter but retained the right, via the Attorney General, to consent to any proposed dismissal of the action by the Court.

On February 9, 2022, the States of Florida, and Georgia, and the Commonwealth of Massachusetts notified the U.S.D.C., Middle District Florida, Jacksonville Division, that they declined to intervene in the matter.

Notwithstanding the above declinations, on February 17, 2022, the Company was served with the Relator’s Summons and Complaint (“Complaint”), which had been previously sealed.

The Complaint alleged violations of the False Claims Act, the California Fraud Preventions Act, the Florida False Claims Act, the Massachusetts False Claims Act, the Georgia False Medicaid Claims Act, and illegal kickbacks.

A motion to dismiss the Complaint was filed on April 25, 2022.

The matter was dismissed with prejudice in January 2024.

On January 13, 2022, the Federal Government notified the U.S.D.C., Middle District Florida, Jacksonville Division, that it is declining to intervene in the matter but retains the right, via the Attorney General, to consent to any proposed dismissal of the action by the Court.

On February 9, 2022, the States of Florida, Georgia, and Commonwealth of Massachusetts notified the U.S.D.C., Middle District Florida, Jacksonville Division, that they are declining to intervene in the matter.

Notwithstanding the above declinations, on February 17, 2022, the Company was served with the Relator’s Summons and Complaint which alleges violations of the False Claims Act, the California Fraud Preventions Act, the Florida False Claims Act, the Massachusetts False Claims Act, the Georgia False Medicaid Claims Act, and illegal kickbacks.

The case was dismissed in March 2023.

However, the Relator filed an amended complaint in April 2023, which was subsequently dismissed, and a second amended complaint which was dismissed in January 2024.

Relator then filed an appeal in the U.S.

Eleventh Circuit Court of Appeals.

On November 18, 2024, the Eleventh Circuit Court of Appeals issued an order affirming the Federal District Court’s Dismissal with prejudice.

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.

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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.

Client payors also include cities, states and companies for which BioReference provides COVID- 19 testing services.

Uninsured patients are billed based on established patient fee schedules or fees negotiated with physicians on behalf of their patients.

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For the year ended December 31, 2024 , and 2023, negative revenue adjustments due to changes in estimates of implicit price concessions for performance obligations satisfied in prior periods of $ 1.5 million and $ 19.2 million, respectively, were recognized.

Revenue adjustments for the year ended December 31, 2023 were primarily due to lower reimbursements from Medicare payors and for the year ended December 31, 2022 were primarily due to lower COVID- 19 test reimbursement estimates.

Revenue adjustments for the year ended December 31, 2024 were primarily due to the composition of patient pay mix and for the year ended December 31, 2023 were primarily due to lower reimbursements from Medicare payors.

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.

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We evaluate the measure of progress each reporting period and, if necessary, adjust the measure of performance and related revenue recognition.

Development and Regulatory Milestone Payments:

Depending on facts and circumstances, we may conclude that it is appropriate to include the milestone in the estimated transaction price or that it is appropriate to fully constrain the milestone.

A milestone payment is included in the transaction price in the reporting period that we conclude that it is probable that recording revenue in the period will not result in a significant reversal in amounts recognized in future periods.

We may record revenues from certain milestones in a reporting period before the milestone is achieved if we conclude that achievement of the milestone is probable and that recognition of revenue related to the milestone will not result in a significant reversal in amounts recognized in future periods.

We record a corresponding contract asset when this conclusion is reached.

Milestone payments that have been fully constrained are not included in the transaction price to date.

These milestones remain fully constrained until we conclude that achievement of the milestone is probable and that recognition of revenue related to the milestone will not result in a significant reversal in amounts recognized in future periods.

We re-evaluate the probability of achievement of such development milestones and any related constraint each reporting period.

We adjust our estimate of the overall transaction price, including the amount of revenue recorded, if necessary.

Research and Development Activities:

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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.

For the years ended December 31, 2023, 2022 and 2021 , we recorded $ 180.7 million, $ 105.7 million and $ 25.8 million of revenue from the transfer of intellectual property and other, respectively.

For the years ended December 31, 2023 , and 2022, revenue from transfer of intellectual property and other principally reflects $ 90.0 million from Pfizer triggered by the FDA approval of NGENLA (Somatrogon), and in 2022, an $ 85.0 million regulatory milestone payments based on the commencement of sales from NGENLA (Somatrogon) in Europe and Japan, as well as gross profit share and royalty payments for both NGENLA (Somatrogon) and Pfizer’s Genotropin® (Somatropin) of $ 22.6 million and $ 4.4 million, respectively, for the years ended December 31, 2023, and 2022.

For the years ended December 31, 2023, 2022, and 2021, revenue from transfer of intellectual property and other principally reflects $ 4.1 million, $ 9.3 million and $ 10.8 million, respectively, of revenue related to the Pfizer Transaction (as defined below).

For the year ended December 31, 2023 , revenue from transfer of intellectual property and other included $ 50.0 million from Merck in consideration for the rights granted to Merck under the Merck Agreement (as defined below), $ 7.0 million from VFMCRP (as defined below) triggered by the German price approval for Rayaldee and $ 2.5 million from Nicoya due to Nicoya’s submission of the investigational new drug application to China's Center for Drug Evaluation.

For the year ended December 31, 2022, revenue from transfer of intellectual property and other included $ 3.0 million related to a sales milestone pursuant to the VFMCRP Agreement, and $ 2.5 million from Nicoya tied to the first anniversary of the effective date of the agreement.

For the year ended December 31, 2021 , revenue from transfer of intellectual property and other principally included $ 1.0 million related to the LeaderMed joint venture (as defined below), $ 4.9 million related to the CAMP4 Agreement (as defined below) and a $ 5.0 million non-refundable upfront payment received under the Nicoya Agreement (as defined below).

Contract liabilities relate to cash consideration that OPKO receives in advance of satisfying the related performance obligations.

Changes in the contractual liabilities balance for the year ended December 31, 2023 are as follows:

(In thousands)

Balance at December 31, 2022

Balance at December 31, 2023

Revenue recognized in the period from:

Amounts included in contracts liability at the beginning of the period

Revenue from the transfer of intellectual property and other:

includes milestone payments, royalties, and other collaboration revenues, which totaled $ 77.4 million, $ 180.7 million, and $ 105.7 million for the years ended December 31, 2024, 2023, and 2022, respectively.

For the year ended December 31, 2024, such revenue 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 (Somatrogon) and Pfizer's Genotropin® (Somatropin), $ 23.8 million from the BARDA Contract, a $ 12.5 million milestone payment from Merck under the Merck Agreement, $ 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 (Somatrogon), $ 22.6 million from gross profit share and royalty payments for both NGENLA (Somatrogon) and Pfizer's Genotropin® (Somatropin), $ 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.

For the year ended December 31, 2022, revenue from the transfer of intellectual property and other totaled $ 105.7 million, which included $ 98.7 million from Pfizer, inclusive of an $ 85.0 million regulatory milestone payment based on the commencement of sales of NGENLA (Somatrogon) in Europe and Japan and $ 4.4 million from gross profit share and royalty payments for both NGENLA (Somatrogon) and Pfizer's Genotropin® (Somatropin), $ 3.0 million related to a sales milestone pursuant to the VFMCRP Agreement and $ 2.5 million from Nicoya tied to the first anniversary of the effective date of that agreement.

Note 16 Strategic Alliances

Biomedical Advanced Research and Development Authority

On September 28, 2023, ModeX was awarded a contract (the "BARDA Contract") from 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, to advance a platform and specific product candidates designed to address a range of public health threats in viral infectious diseases.

The awarded funding will enable research, development and clinical evaluation of potent multispecific antibodies, based on ModeX's proprietary MSTAR technology.

MSTAR is a flexible plug-and-play platform able to incorporate four to six independent antibody binding sites into a single molecule, dramatically expanding its therapeutic potential while enabling rapid responses to emerging infections and their viral variants, including COVID- 19, influenza, and other pathogens.

The BARDA Contract is cost plus fixed fee, pursuant to which we will receive an initial $ 59.0 million payment over a five -year period from September 2023 to February 2028 for the development, manufacturing, and execution of a Phase 1 clinical trial for a next-generation MSTAR multispecific antibody with broad neutralizing activity against known variants of SARS-CoV- 2.

We are eligible to receive up to an additional $ 109.6 million from BARDA upon achieving particular milestones to develop multispecific antibodies targeting other viral pathogens, such as influenza.

On September 28, 2023 , ModeX was awarded a contract (as amended as decribed 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 includes a $ 26.9 million supplement to further advance the development of COVID- 19 multispecific antibodies.

This increased funding supports the ongoing development, manufacturing, and execution of a Phase 1 clinical trial for a next-generation MSTAR multispecific antibody with broad neutralizing activity against known SARS-CoV- 2 variants.

The BARDA Amendments also provided for BARDA's exercise of the option for the development of a multispecific protein antibody for influenza or another pathogen, with $ 24.1 million allocated to cover the expanded work under this exercised option.

These modifications increased the total value of the BARDA Contract from $ 59.0 million to $ 110.0 million, with the potential value if BARDA exercises all options thereunder to expand ModeX's services, increasing from $ 168.6 million to $ 205 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 assessments of progress, and the continuation of the BARDA Contract is based on ModeX’s performance thereunder, the timeliness and quality of deliverables, and certain other factors.

The BARDA Contract contains a number of terms and conditions that are customary for government contracts of this nature, including provisions giving BARDA the right to terminate the BARDA Contract at any time in its sole discretion.

The Company evaluated the BARDA Contract under ASC, Topic 606, Revenue from Contracts with Customers, or ASC 606, and concluded that the BARDA Contract is in scope of ASC 606 as the U.S.

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 and development activities that fall into the following areas:

non-clinical efficacy studies, clinical activities;

manufacturing activities;

and all associated regulatory, quality assurance, management and administrative activities.

The R&D effort for the development of these multispecific antibodies will progress in specific stages that cover the base performance segment, and option segments.

ModeX will complete specific tasks required in each of the discrete work segments.

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 tetravalent trispecific antibody for COVID- 19;

(ii) development of multispecific protein Ab for Influenza or other pathogen;

and (iii) nucleic acid delivery of a mutltispecific influenza Ab or other pathogen.

The Company determined that the promise to develop a tetravalent trispecific antibody for COVID- 19, is a separate performance obligation because it is distinct within the context of the contract, as the services have a standalone value and are separately identifiable from other promises within the contract.

The Company evaluated the material promises that contained option rights (ii) development of multispecific protein Ab for influenza or other pathogen and (iii) nucleic acid delivery of a mutltispecific influenza Ab or other pathogen and determined (ii) and (iii) were not offered at a discount that is incremental to the range of discounts typically given for these goods and services, and as such, do not represent material rights.

Therefore, options for additional services in (ii) and (iii) were not considered performance obligations at the outset of 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.

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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 year ended December 31, 2023 , we recorded $ 1.2 million in revenue under the BARDA Contract.

For the years ended December 31, 2024 and 2023, we recorded $ 23.8 million and $ 1.2 million in revenue under the BARDA Contract.

As of December 31, 2024 , the aggregate amount of transaction price allocated to remaining performance obligations, excluding unexercised contract options, was $ 85.0 million.

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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”).

We received an initial payment of $ 50.0 million and are eligible to receive up to an additional $ 872.5 million upon the achievement of certain commercial and development milestones under several indications.

We are also eligible to receive tiered royalty payments ranging from high single digits to low double digits upon 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, milestones and royalties received by us under the Merck Agreement may be payable to Sanofi under the terms of the Sanofi In-License Agreement.

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 a result of such obligations under the Sanofi In-License Agreement, we paid $ 12.5 million to Sanofi during the year ended December 31, 2023.

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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 being developed to treat hemophilia, in exchange for a 47 % ownership interest in the joint venture.

In addition, we received an upfront payment of $ 1 million and will be reimbursed for clinical trial material and technical support we provide the joint venture.

We recognized the upfront payment of $ 1 million as revenue from transfer of intellectual property and other during the year ended December 31, 2022 .

LeaderMed has agreed to be 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.

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.

CAMP4 Therapeutics

On July 6, 2021, we entered into an exclusive license agreement (the “CAMP4 Agreement”) with CAMP4, pursuant to which we granted to CAMP4 an exclusive license to develop, manufacture, commercialize or improve therapeutics utilizing the AntagoNAT technology, an oligonucleotide platform developed under OPKO CURNA, which includes the molecule for the treatment of Dravet syndrome, together with any derivative or modification thereof (the “Licensed Compound”) and any pharmaceutical product that comprises or contains the Licensed Compound, alone or in combination with one or more other active ingredients (“Licensed Product”), worldwide.

The CAMP4 Agreement grant covers human pharmaceutical, prophylactic, and therapeutic and certain diagnostic uses.

We received an initial upfront payment of $ 1.5 million and 3,373,008 shares of CAMP4’s Series A Prime Preferred Stock (“Preferred Stock”), which equates to approximately 9 % of the outstanding shares of CAMP4, and we are eligible to receive up to $ 3.5 million in development milestone payments for Dravet syndrome products, and $ 4 million for non-Dravet syndrome products, as well as sales milestones of up to $ 90 million for Dravet syndrome products and up to $ 90 million for non-Dravet syndrome products.

We may also receive double digit royalty payments on the net sales of royalty bearing products, subject to adjustment.

In addition, upon achievement of certain development milestones, we will be eligible to receive equity consideration of up to 5,782,299 shares of Preferred Stock in connection with Dravet syndrome products and up to 1,082,248 shares of Preferred Stock in connection with non-Dravet syndrome products.

In connection with our acquisition of CURNA, we agreed to pay future consideration to the sellers upon the achievement of certain events.

As a result of our execution of the CAMP4 Agreement, we will have to pay a percentage of any payments received under the CAMP4 Agreement to the former CURNA stockholders.

For the year ended December 31, 2021, we recognized the fair value of the upfront payments of cash and shares of Preferred Stock totaling $ 4.9 million in revenue from transfer of intellectual property and other.

Unless earlier terminated, the CAMP4 Agreement will remain in effect on a Licensed Product-by-Licensed Product and country by-country basis until such time as the royalty term expires for a Licensed Product in a country, and expires in its entirety upon the expiration of the royalty term for the last Licensed Product in the last country.

CAMP4’s royalty obligations expire on the later of (i) the expiration, invalidation or abandonment date of the last patent right in connection with the royalty bearing product, or (ii) ten ( 10 ) years after a royalty bearing product’s first commercial sale in a country.

In addition to termination rights for material breach and bankruptcy, CAMP4 is permitted to terminate the CAMP4 Agreement after a specified notice period.

CAMP4 has informed the Company that the FDA has placed the Dravet clinical trials on hold as CAMP4 is pursuing strategies to potentially advance to clinical trials.

NICOYA Macau Limited

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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 will also 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 will, at its sole cost and expense, be responsible for performing all development activities necessary to obtain all regulatory approvals for the Nicoya Product in the Nicoya Territory and for all commercial activities pertaining to 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.

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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 price approval for Rayaldee was granted by the German Association of Statutory Health Insurance funds (GKV-SV), which triggered a milestone payment of $ 7.0 million for the year ended December 31, 2023.

For the year ended December 31, 2022 we recognized a milestone payment of $ 3.0 million in revenue from transfer of intellectual property and other for the first sale of Rayaldee in Europe.

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.

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NGENLA (Somatrogon (hGH-CTP)) 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, during the year ended December 31, 2023 , we recorded revenue of $ 90 million and during the year ended December 31, 2022 , we recorded $ 85.0 million, in each case under the Restated Pfizer Agreement.

With the achievement of these milestones, in 2023 we recorded revenue of $ 90 million, and in 2022 we recorded $ 85.0 million, in each case 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.

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We recognized the non-refundable $ 295.0 million upfront payments as revenue as the research and development services were completed.

As of December 31, 2023 and 2022 , we had no contract liabilities related to the Pfizer Transaction.

The Restated Pfizer Agreement includes milestone payments of $ 275.0 million upon the achievement of certain milestones.

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.

To date, $ 175.0 million revenue has been recognized related to the achievement of the milestones.

As of December 31, 2024, we had no contract liabilities related to the Pfizer Transaction.

The Restated Pfizer Agreement outlines up to $ 275.0 million in potential milestone payments.

These payments are structured to include $ 175 million for the achievement of milestones in Pediatric GHD and $ 50 million for milestones in SGA.

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.

Individual milestone amounts within these allocations range from $ 20.0 million to $ 90.0 million and are triggered by regulatory approval in the U.S., as well as regulatory and price approvals in other major markets.

Milestone payments are recognized as revenue in the period of achievement, provided all other revenue recognition criteria are met.

To date, $ 175.0 million in milestone revenue has been recognized, attributable to the Pediatric GHD indication.

We have completed strategic deals with numerous institutions and commercial partners.

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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 commencing in October 2023.

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.

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Total undiscounted future minimum lease payments

82,002 10,485

Difference between lease payments and discounted lease liabilities

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Note 18 Segments

We manage our operations in two reportable segments, pharmaceuticals and diagnostics.

The pharmaceuticals 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 our clinical laboratory operations through BioReference and our point-of-care operations.

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 and income taxes.

Information regarding our operations and assets for our operating segments and the unallocated corporate operations as well as geographic information are as follows:

We manage our operations in two 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.

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 are no 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, 2024, 2023 and 2022 .

For the years ended December 31,

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$ 77,364 $ 180,663 $ 105,721

Operating income (loss):

Cost of revenue:

Pharmaceutical

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$ 494,632 $ 545,368 $ 715,977

Gross margin:

Pharmaceutical

$ 139,953 $ 248,682 $ 160,137

Depreciation and amortization:

78,558 69,445 128,082

$ 218,511 $ 318,127 $ 288,219

Selling, general and administrative:

Pharmaceutical

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41,028 42,531 39,052

Loss from investment in investees:

$ 304,220 $ 300,559 $ 372,672

Research and development:

Pharmaceutical

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$ 105,214 $ 89,593 $ 73,887

Amortization of intangible assets:

Pharmaceutical

$ 65,718 $ 65,837 $ 63,914

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$ 82,634 $ 86,032 $ 87,784

Other segment items:

Pharmaceutical

$ — $ ( 1,036 ) $ ( 1,312 )

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$ ( 121,493 ) $ ( 1,036 ) $ ( 19,871 )

Segment operating income (loss):

Pharmaceutical

$ ( 86,795 ) $ 41,184 $ ( 12,961 )

( 24,125 ) ( 155,596 ) ( 173,652 )

( 41,145 ) ( 42,609 ) ( 39,640 )

$ ( 152,065 ) $ ( 157,021 ) $ ( 226,253 )

For the years ended December 31,

(In thousands)

Depreciation and amortization:

Pharmaceutical

$ 71,958 $ 71,548 $ 68,618

26,218 33,749 40,037

$ 98,176 $ 105,297 $ 108,655

$ 546,300 $ 597,822 $ 783,207

48,397 141,465 117,214

65,049 68,491 62,044

24,634 23,517 22,477

1,772 9,738 3,845

23,867 20,216 14,546

3,123 2,246 863

$ 713,142 $ 863,495 $ 1,004,196

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, 2024

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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, 2023 , we have equity securities and an equity method fair value option (refer to Note 5 ), forward foreign currency exchange contracts for inventory purchases (refer to Note 20 ) and contingent consideration related to the acquisitions of CURNA, OPKO Diagnostics and OPKO Renal that are required to be measured at fair value on a recurring basis.

In addition, in connection with our investment and our consulting agreement with BioCardia, we record the related BioCardia options at fair value as well as the warrants from COCP.

As of December 31, 2024 , we have equity securities and an equity method fair value option (refer to Note 5 ), forward foreign currency exchange contracts for inventory purchases (refer to Note 20 ).

In connection with our investment and our consulting agreement with BioCardia, we record the related BioCardia options at fair value as well as the warrants from COCP.

In addition, restricted cash collateralized by money market funds is a financial asset measured at fair value as a Level 1 financial instrument under the fair value hierarchy.

Our financial assets and liabilities measured at fair value on a recurring basis are as follows:

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Equity securities

Equity Method - fair value option

49,655 — — 49,655

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$ 331,776 $ 3 $ — $ 331,779

Forward contracts

$ — $ 29 $ — $ 29

Total liabilities

$ — $ 29 $ — $ 29

Fair value measurements as of December 31, 2023

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$ — $ 29 $ — $ 29

Contingent consideration:

— — 1,036 1,036

Total liabilities

$ — $ 29 $ — $ 29

The carrying amount and estimated fair value of our 2025 Notes, as well as the applicable fair value hierarchy tiers, are contained in the table below.

The fair value of the 2025 Notes is determined using inputs other than quoted prices in active markets that are directly observable.

The carrying amount and estimated fair value of our 2029 Convertible Notes and 2025 Notes, as well as the applicable fair value hierarchy tiers, are contained in the table below.

Additionally, the fair value of the 2029 Convertible Notes and 2025 Notes is determined using inputs other than quoted prices in active markets that are directly observable.

December 31, 2024

(In thousands)

2029 Convertible Notes

$ 173,556 $ 394,207 $ — $ 394,207 $ —

$ 170 $ 170 $ — $ 170 $ —

There have been no transfers between Level 1 and Level 2 and no transfers to or from Level 3 of the fair value hierarchy.

As of December 31, 2023 and 2022 , the carrying value of our other financial instrument assets approximates their fair value due to their short-term nature or variable rate of interest.

The following tables reconcile the beginning and ending balances of our Level 3 assets and liabilities as of December 31, 2023 and 2022 :

December 31, 2023

(In thousands)

Contingent consideration

Balance at December 31, 2022

Change in fair value:

Included in results of operations

Foreign currency impact

Balance at December 31, 2023

December 31, 2022

The following tables reconcile the beginning and ending balances of our Level 3 assets and liabilities as of December 31, 2024:

Embedded conversion

(In thousands)

Contingent consideration

Balance at December 31, 2023

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Included in results of operations

Foreign currency impact

Reclassification of embedded derivatives to equity

Balance at December 31, 2024

The estimated fair values of our financial instruments have been determined by using available market information and what we believe to be appropriate valuation methodologies.

We use the following methods and assumptions in estimating fair value:

Contingent consideration – We estimate the fair value of the contingent consideration utilizing a discounted cash flow model for the expected payments based on estimated timing and expected revenues.

We use several discount rates depending on each type of contingent consideration related to OPKO Diagnostics, CURNA and OPKO Renal transactions.

As of December 31, 2023, we had no contingent consideration balance recorded in accrued expenses and other long-term liabilities.

As of December 31, 2022, $ 1.0 million of contingent consideration was recorded in accrued expenses and other long-term liabilities.

As of December 31, 2021, of the $ 2.8 million of contingent consideration, $ 0.5 million is recorded in Accrued expenses and $ 2.3 million is recorded in Other long-term liabilities.

As a result of our execution of the CAMP4 Agreement (as defined in Note 16 ), we will have to pay a percentage of any payments received under the CAMP4 Agreement to the former CURNA stockholders.

Note 20 Derivative Contracts

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Unrealized (losses) on forward contracts are recorded in Accrued expenses.

$ ( 29 ) $ ( 1,123 )

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.

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Derivative gain (loss):

Common stock options/warrants

$ ( 26,250 ) $ — $ —

Common stock options/warrants

Forward contracts

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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)

Earnings (loss) per share, basic and diluted

( 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

For the 2023 Quarters Ended

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Total revenues

$ 237,577 $ 265,418 $ 178,595 $ 181,905

Total costs and expenses

268,171 258,393 243,002 250,949

Net income (loss)

( 18,267 ) ( 19,640 ) ( 84,473 ) ( 66,483 )

Earnings (loss) per share, basic and diluted

Note 22 Subsequent Events

Morgan Securities LLC (the “Initial Purchaser”).

The $ 230.0 million aggregate principal amount of 2029 Convertible 144A Notes included $ 30.0 million aggregate principal amount of 2029 Convertible 144A Notes purchased on the Closing Date by the Initial Purchaser in accordance with its exercise in full of its option to purchase additional 2029 Convertible 144A Notes under the 144A Note Purchase Agreement.

We received net proceeds from the issuance of the 2029 Convertible 144A Notes of approximately $ 222.0 million, after deducting fees and estimated offering expenses payable by us.

We used approximately $ 50.0 million of the net proceeds from the offering of the 2029 Convertible 144A Notes to repurchase shares of our Common Stock from purchasers of the 2029 Convertible 144A Notes in privately negotiated transactions effected with or through the Initial Purchaser or its affiliate.

The purchase price per share of the Common Stock repurchased in such transactions equaled the closing sale price of the Common Stock on January 4, 2024, which was $ 0.9067 per share.

Also, contemporaneously with the pricing of the 2029 Convertible 144A Notes, we entered into separate, privately negotiated transactions with certain holders of our outstanding 2025 Notes to repurchase, on the closing date, approximately $ 144.4 million aggregate principal amount of such notes.

We effected such repurchases for cash, using $ 146.3 million of the net proceeds from the offering of the 2029 Convertible 144A Notes.

Additionally, 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” of the "notes") pursuant to the terms of a note purchase agreement entered into on January 4, 2024 ( the “Affiliate Note Purchase Agreement”) by and among the Company and certain investors including, Frost Gamma Investments Trust, a trust controlled by Phillip Frost, M.D., our Chairman and Chief Executive Officer, and Jane H.

Hsiao, Ph.D., MBA, our Vice-Chairman and Chief Technical Officer (collectively, the “Affiliate Purchasers”).

Pursuant to the Affiliate Note Purchase 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 2023 Convertible Notes, together with approximately $ 16.1 million of accrued but unpaid interest thereon, held by the Affiliate Purchasers.

Following such exchange, no 2023 Convertible Notes remained outstanding.

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 the five consecutive business day period after any ten 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.

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.

However, we will be required to elect to deliver solely cash or, subject to certain limitations, a combination of cash and shares of our Common Stock upon conversion, unless and until we have duly authorized and reserved for issuance (by all necessary corporate action and arrangements with the transfer agent for our Common Stock) upon conversion of the notes a number of authorized shares of our Common Stock that have not been issued or reserved for any other purpose, and/or a number of treasury shares of our Common Stock that have not been reserved for any other purpose, equal to the maximum number of underlying shares.

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.

We may not redeem the notes prior to the maturity date, and no sinking fund is provided for the notes.

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 (including trade payables) of our subsidiaries (including, without limitation, liabilities of our subsidiaries under the Credit Agreement).

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.

Effective January 22, 2024, the Company terminated its share lending agreement, dated as of February 4, 2019 ( the “Share Lending Agreement”), entered into with Jefferies Capital Services, LLC (the “Share Borrower”), pursuant to which the Company lent to the Share Borrower approximately 30 million shares of its Common Stock in connection with the 2019 issuance of its $ 200.0 million aggregate principal amount of the 2025 Notes.

The amount of outstanding borrowed shares was subsequently reduced by approximately 8,313,000 shares and concurrent with the termination of the Share Lending Agreement, all shares have been returned to the Company to be held as treasury shares.

$ ( 0.02 ) $ ( 0.03 ) $ ( 0.11 ) $ ( 0.09 )

CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 8. Financial Statements and Supplementary Data