What changed in this filing

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Item 8. Financial Statements and Supplementary Data

2024-03-01 compared with 2023-02-27 · 643 added, 476 removed, 1227 unchanged (48% of the section changed)

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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, 2022 and 2021, 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, 2022, and the related notes and financial statement schedule included at Item 15(a)(1) (collectively referred to as the “consolidated 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”).

In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company at December 31, 2023 and 2022, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2023, in conformity with U.S.

generally accepted accounting principles.

We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the Company's internal control over financial reporting as of December 31, 2022, based on criteria established in Internal Control-Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework) and our report dated February 27, 2023 expressed an unqualified opinion thereon.

Adoption of ASU No.

As discussed in Note 3 to the consolidated financial statements, the Company changed its method of accounting for convertible debt instruments in 2022 due to the adoption of ASU 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).

We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the Company's internal control over financial reporting as of December 31, 2023, based on criteria established in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework), and our report dated March 1, 2024 expressed an unqualified opinion thereon.

Basis for Opinion

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Critical Audit Matter

The critical audit matter communicated below is a matter arising from the current period audit of the financial statements that was communicated or required to be communicated to the audit committee and that (1) relates to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective, or complex judgments.

(1) relates to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective or complex judgments.

The communication of the critical audit matter does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.

Variable Consideration in Determining Revenue from Services

Description of the Matter For the year ended December 31, 2022, the Company recorded revenue from services of $755.6 million.

Description of the Matter

For the year ended December 31, 2023, the Company recorded revenue from services of $515.3 million.

As discussed in Note 15 to the consolidated financial statements, revenue from services includes amounts due under third-party and government payer programs, net of estimates for explicit and implicit price concessions and other elements of variable consideration.

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This resulted in significant auditor judgment in the performance of our procedures.

How We Addressed the Matter in Our Audit We obtained an understanding, evaluated the design, and tested the operating effectiveness of controls over the Company’s variable consideration estimation process, including controls over management’s review of collections experience and the evaluation of factors that would affect the amount of variable consideration described above.

To test the estimate of variable consideration, we performed audit procedures that included, among others, assessing the methodology used and testing the underlying data used by the Company in its analysis.

We compared the collection rates used by management to historical collection trends and evaluated whether changes in the regulatory environment or the Company’s business model, customer base, mix of services and other factors would affect the estimate of variable consideration.

We assessed the historical accuracy of management’s estimate and performed sensitivity analyses to evaluate the changes in variable consideration that would result from changes in the expected collection rates used and the corresponding effect on revenue from services.

How We Addressed the

Matter in Our Audit

We obtained an understanding, evaluated the design, and tested the operating effectiveness of controls over the Company’s variable consideration estimation process, including management’s review of collections experience and the evaluation of factors that would affect the amount of variable consideration described above.

To test the variable consideration estimate, we performed audit procedures that included, among others, assessing the methodology used and testing the underlying data used by the Company in its analysis.

We assessed the historical accuracy of management’s estimate and reviewed management’s sensitivity analyses to evaluate the changes in variable consideration that would result from changes in the expected collection rates used and the corresponding effect on revenue from services.

/s/ Ernst & Young LLP

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Miami, Florida

February 27, 2023

March 1, 2024

Report of Independent Registered Public Accounting Firm

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and subsidiaries’ internal control over financial reporting as of December 31, 2023, based on criteria established in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework) (the COSO criteria).

In our opinion, OPKO Health, Inc, and subsidiaries (the Company) maintained, in all material respects, effective internal control over financial reporting as of December 31, 2022, based on the COSO criteria.

We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the 2022 consolidated financial statements of the Company and our report dated February 27, 2023, expressed an unqualified opinion thereon.

In our opinion, OPKO Health, Inc.

and subsidiaries (the Company) maintained, in all material respects, effective internal control over financial reporting as of December 31, 2023, based on the COSO criteria.

We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the 2023 consolidated financial statements of the Company and our report dated March 1, 2024 expressed an unqualified opinion thereon.

Basis for Opinion

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Miami, Florida

February 27, 2023

March 1, 2024

OPKO Health, Inc.

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Cash and cash equivalents

$ 95,881 $ 153,191

Accounts receivable, net

123,379 127,312

Inventory, net

65,697 74,060

Other current assets and prepaid expenses

Assets held for sale — 314,994

24,519 39,962

Total current assets

309,476 394,525

Property, plant and equipment, net

75,429 82,879

Intangible assets, net

740,283 823,520

In-process research and development

Goodwill 595,851 520,601

Investments 28,080 10,729

195,000 195,000

598,260 595,851

16,082 28,080

Operating lease right-of-use assets

Other assets 8,679 9,534

Total assets $ 2,167,259 $ 2,399,715

68,088 38,725

$ 2,011,698 $ 2,167,259

LIABILITIES AND EQUITY

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Accounts payable

$ 69,677 $ 66,993

Accrued expenses

90,086 98,269

Current maturities of operating leases

12,996 11,628

Current portion of convertible notes

Liabilities associated with assets held for sale — 28,156

Current portion of lines of credit and notes payable

27,293 33,540

Total current liabilities

200,052 213,480

Operating lease liabilities

54,140 27,963

Convertible notes

214,325 210,371

Deferred tax liabilities

126,773 126,426

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

27,189 27,371

Total long-term liabilities

422,427 392,131

Total liabilities

622,479 605,611

Common Stock - $ 0.01 par value, 1,000,000,000 shares authorized;

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Additional paid-in capital

3,433,006 3,421,872

Accumulated other comprehensive loss

( 38,030 ) ( 43,323 )

Accumulated deficit

( 2,011,786 ) ( 1,822,923 )

Total shareholders’ equity

1,389,219 1,561,648

Total liabilities and equity

$ 2,011,698 $ 2,167,259

The accompanying Notes to Consolidated Financial Statements are an integral part of these statements.

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For the years ended December 31,

2022 2021 2020

Revenue from services

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Other income (expense), net

Other income and (expense), net ( 165,268 ) ( 32,775 ) ( 9,031 )

Income (loss) before income taxes and investment losses ( 391,521 ) ( 14,025 ) 48,683

Other expense, net

Loss before income taxes and investment losses

Income tax benefit (provision)

Net income (loss) before investment losses ( 328,022 ) ( 29,514 ) 31,066

Net loss before investment losses

Loss from investments in investees

Net income (loss) $ ( 328,405 ) $ ( 30,143 ) $ 30,586

Income (loss) per share basic and diluted:

Income (loss) per share $ ( 0.46 ) $ ( 0.05 ) $ 0.05

Weighted average number of common shares

outstanding, basic and diluted 719,060,942 648,077,716 640,655,290

Loss per share basic and diluted:

Loss per share

Weighted average number of common shares outstanding, basic and diluted

The accompanying Notes to Consolidated Financial Statements are an integral part of these statements.

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For the years ended December 31,

2022 2021 2020

Net income (loss) $ ( 328,405 ) $ ( 30,143 ) $ 30,586

Other comprehensive income (loss), net of tax:

Change in foreign currency translation and other comprehensive income (loss)

Comprehensive income (loss) $ ( 341,233 ) $ ( 56,413 ) $ 48,431

Comprehensive loss

The accompanying Notes to Consolidated Financial Statements are an integral part of these statements.

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For the years ended December 31, 2023, 2022, 2021

Common Stock Treasury Additional

Capital Accumulated Other

Accumulated Other

Comprehensive

Loss Accumulated

Deficit Total

Shares Dollars Shares Dollars

Balance at December 31, 2020

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Exercise of common stock options and warrants

Adoption of ASC 326 — — — — — — ( 1,342 ) ( 1,342 )

Net income — — — — — — 30,586 30,586

Other comprehensive income — — — — — 17,845 — 17,845

Conversion of 2025 convertible notes

Other comprehensive loss

Balance at December 31, 2021

Common Stock Treasury Additional

Capital Accumulated Other

Accumulated Other

Comprehensive

Loss Accumulated

Deficit Total

Shares Dollars Shares Dollars

Balance at December 31, 2021

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Exercise of common stock options and warrants

Conversion of 2025 convertible notes 19,051,270 190 ( 8,105,175 ) — 55,085 — — 55,275

Net loss — — — — — — ( 30,143 ) ( 30,143 )

Adoption of ASU 2020-06

ModeX Acquisition

Other comprehensive loss

Balance at December 31, 2022

Common Stock Treasury Additional

Capital Accumulated Other

Accumulated Other

Comprehensive

Loss Accumulated

Deficit Total

Shares Dollars Shares Dollars

Balance at December 31, 2022

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Exercise of common stock options and warrants

Adoption of ASU 2020-06 — — — — ( 39,100 ) — 17,458 ( 21,642 )

ModeX Acquisition 90,594,044 906 — — 220,756 — — 221,662

Net loss — — — — — — ( 328,405 ) ( 328,405 )

Other comprehensive loss — — — — — ( 12,828 ) — ( 12,828 )

Other comprehensive income

Balance at December 31, 2023

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For the years ended December 31,

2022 2021 2020

Cash flows from operating activities:

Net income (loss) $ ( 328,405 ) $ ( 30,143 ) $ 30,586

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

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Other current assets and prepaid expenses

Other assets 1,935 260 ( 447 )

Accounts payable

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Repayments of lines of credit

Redemption of 2033 Senior Notes

Net cash (used in) provided by financing activities

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2025 convertible Notes

$ — $ 68,775 $ —

Common Stock options and warrants, surrendered in net exercise

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Note 1 Business and Organization

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

Our diagnostics business includes BioReference Health, LLC (“BioReference”), one of the nation’s largest full service laboratories with a 180 -person sales and marketing team to drive growth and leverage new products, and we offer our 4Kscore prostate cancer test through BioReference.

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 completed a successful phase 3 study in August 2019 and is partnered with Pfizer Inc.

Regulatory applications for Somatrogon (hGH-CTP) have been submitted to the applicable regulatory bodies for review in several countries around the world.

In February 2022, the European Commission granted marketing authorization in the European Union for Somatrogon (hGH-CTP) under the brand name NGENLA® to treat children and adolescents from as young as 3 years of age with growth disturbance due to insufficient secretion of growth hormone and has been granted pricing approval in Germany.

NGENLA® has also been approved in Japan, Canada, and Australia.

We also submitted the initial Biologics License Application (“BLA”) with the FDA for approval of Somatrogon (hGH-CTP) in the United States and Pfizer received a complete response letter in January 2022.

Pfizer and OPKO have evaluated the FDA’s comments and will work with the agency to determine an appropriate path forward for the advancement of Somatrogon (hGH-CTP).

In May 2022, we acquired ModeX Therapeutics, Inc.

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

(“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.

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

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.

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

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

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, which we expect will facilitate the development of our pipeline of molecules and compounds for our proprietary molecular diagnostic and therapeutic products.

Our research and development activities are primarily performed at facilities in Woburn, MA, Waterford, Ireland, Kiryat

Gat, Israel, and Barcelona, Spain.

On May 9, 2022 (the “Closing Date”), the Company entered into an Agreement and Plan of Merger (the “ModeX Merger Agreement”), in accordance with which we acquired ModeX pursuant to a merger in which ModeX survived as a wholly owned subsidiary of the Company.

The Company paid the entirety of the $ 300.0 million purchase price pursuant to the issuance of an aggregate of 89,907,310 shares (the “Consideration Shares”) of the Company’s common stock, par value $ 0.01 per share (“Common Stock”), of which 10 % were deposited in a twelve-month escrow for purposes of satisfying the potential indemnity obligations of the sellers under the ModeX Merger Agreement.

Additionally, the Company issued equity awards to ModeX employees in an amount equal to $ 12.4 million, which was deducted from the consideration payable on the Closing Date.

If any of such awards are forfeited or otherwise remain unvested on the four-year anniversary of the Closing Date, up to 812,792 shares of Common Stock may be distributed pro rata to ModeX’s former stockholders in respect of such forfeited or unvested awards.

Shares of Common Stock with respect to such potential distribution have been escrowed and will remain escrowed for such four-year period.

For accounting purposes, the Consideration 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 Global Select Market (“NASDAQ”) on the Closing Date.

Included in the total fair value of consideration transferred of $ 221.7 million were $ 2.3 million of fully vested equity awards.

On January 14, 2022, the Company entered into an Agreement and Plan of Merger and Reorganization (the “GeneDx Merger Agreement”) with Sema4 Holdings Corp., a Delaware corporation (“Sema4”), pursuant to which Sema4 acquired the Company’s former subsidiary, GeneDx LLC, (f/k/a GeneDx, Inc.

“GeneDx”), in a transaction (the “GeneDx Transaction”) that closed on April 29, 2022 (the “GeneDx Closing”).

Upon the GeneDx 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”).

Additionally, subject to GeneDx achieving certain revenue targets for the fiscal years ending December 31, 2022 and 2023, we are eligible to receive an earnout payment in cash or stock (at GeneDx Holdings’ discretion) equal to a maximum of 30.9 million shares of GeneDx Holdings’ Class A common stock if paid in stock.

Based on the closing price of GeneDx Holdings Common Stock on April 29, 2022, the total upfront consideration was approximately $ 322 million, and the total aggregate consideration, including the potential Milestone Consideration, was approximately $ 447 million.

In connection with the transactions contemplated by the GeneDx Merger Agreement, on January 14, 2022, the Company entered into a Shareholder Agreement (the “GeneDx Holdings Shareholder Agreement”) with GeneDx Holdings, pursuant to which the Company has agreed to, among other things, be subject to a lock-up period with respect to its shares of GeneDx Holdings Common Stock, which expires on April 29, 2023 with respect to the Closing Shares, and, if earned and received, would extend for periods of one-year and six-months from the date of issuance of such shares in respect of the first and second potential Milestone Consideration payments, respectively.

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.

In addition, 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.

The Company has also agreed to vote its shares of GeneDx Holdings Common Stock in accordance with the recommendations of GeneDx Holdings’s board of directors for so long as it continues to hold at least 5 % of the outstanding shares of GeneDx Holdings Common Stock.

Further, GeneDx Holdings has also granted the Company certain customary shelf, piggyback and demand registration rights that require GeneDx Holdings to register the shares of the Company’s shares of GeneDx Holdings Common Stock for resale under the Securities Act.

OPKO intends to have a designee serving on GeneDx Holdings’s board of directors through the lock-up period applicable to the Company’s shares of GeneDx Holdings Common Stock.

Such designee may continue to sit on the GeneDx Holdings board if elected by the GeneDx Holdings stockholders.

Therefore, OPKO is not actively participating in the policy-making process of GeneDx Holdings.

We recognized a $ 18.6 million gain on the sale of GeneDx during the year ended December 31, 2022.

As of December 31, 2021, GeneDx met the held-for-sale accounting criteria and the related assets and liabilities are classified as held for sale in the consolidated balance sheet.

GeneDx was included in our diagnostics segment as of December 31, 2021.

In June 2021, EirGen Pharma Limited (“EirGen”), our wholly owned subsidiary, entered into a definitive agreement to sell one of its facilities in Waterford, Ireland to Horizon Therapeutics plc for $ 65 million in cash less certain assumed and accrued liabilities relating to transferred employees.

The facility, which was formerly included in our pharmaceutical segment, housed EirGen’s sterile-fill-finish business and was no longer a core component of our ongoing operations and business strategy.

The transaction closed in the third quarter of 2021.

We recognized a $ 31.5 million gain on the sale of the facility during the year ended December 31, 2021.

Note 2 Impact of COVID-19 and foreign exchange rates

Impact of COVID-19

We continue to be a part of the coordinated public and private sector response to the COVID-19 pandemic.

There continues to be a high level of uncertainty relating to the pandemic’s continuing evolution, including how governments and consumers will react to new developments, and whether the pandemic will have a longer-term effect on the healthcare industry and patient habits.

BioReference has been providing COVID-19 solutions, including diagnostic molecular testing and serology antibody testing, to meet the testing needs of its customers, including physicians, health systems, long-term care facilities, governments, schools, employers, professional sports teams and entertainment venues, as well as the general public through relationships with retail pharmacy chains.

Throughout the pandemic, we have managed our company-wide lab operations specimen acquisition, logistics, procurement, customer service, and initiatives to manage our cost structure to match the ever changing COVID-19 testing volumes and to identify and capitalize on efficiencies in our core clinical lines of business.

While BioReference benefitted from significant COVID-19 testing volumes in 2020 and 2021, demand declined in 2022 and we expect COVID-19 test demand to continue to decline in 2023 as compared to 2022.

Revenue from services for the year ended December 31, 2022 decreased by $ 851.5 million as compared to 2021 due to COVID-19 testing volumes.

Excluding COVID-19 test volumes, for the year ended December 31, 2022, routine clinical test volume decreased 2.0 % as compared to volumes for the year ended December 31, 2021.

Foreign Currency Exchange Rates

For the years ended December 31, 2022, 2021, and 2020, approximately 21.6 %, 7.4 %, and 5.7 % of revenue were denominated in currencies other than the U.S.

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.

Note 2 Foreign exchange rates

For the years ended December 31, 2023 , 2022 , and 2021 , approximately 29.6 %, 21.6 %, and 7.4 % of revenue was denominated in currencies other than the U.S.

Dollar (USD).

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 the consolidated financial results.

During the years ended December 31, 2022, 2021 and 2020, the most significant currency exchange rate exposures were to the Euro and Chilean Peso.

Gross accumulated currency translation adjustments recorded as a separate component of shareholders’ equity were $ 39.9 million and $ 27.1 million on December 31, 2022 and 2021, respectively.

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.

Gross accumulated currency translation adjustments recorded as a separate component of shareholders’ equity were $ 34.6 million and $ 39.9 million at December 31, 2023 and 2022 , 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.

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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, 2021, we had 33 open foreign exchange forward contracts relating to inventory purchases on letters of credit with various amounts maturing monthly through January 2022 with a notional value totaling approximately $ 2.6 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.

Note 3 Summary of Significant Accounting Policies

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Goodwill was $ 598.3 million and $ 595.9 million, respectively, at December 31, 2023 and 2022 .

At December 31, 2021, Assets held for sale include $ 151.8 million of goodwill related to GeneDx.

Net intangible assets other than goodwill was $ 1.0 billion and $ 1.1 billion at December 31, 2022 and 2021, respectively, including IPR&D of $ 195.0 million and $ 590.2 million at December 31, 2022 and 2021, respectively.

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 .

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

Considering the high risk nature of research and development and the industry’s success rate of bringing developmental compounds to market, IPR&D impairment charges may occur in future periods.

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

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

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

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.

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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.

No impairment charges were recognized for the years ended December 31 2022, 2021, and 2020.

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 segment, if future results are not consistent with our estimates and assumptions, then we may be exposed to impairment charges, which could be material.

In our pharmaceutical segment, Pfizer submitted the initial BLA with the FDA for approval of Somatrogon (hGH-CTP) in the United States, and Pfizer received a Complete Response Letter in January 2022.

Pfizer and OPKO have evaluated the FDA’s comments and will work with the agency to determine the best path forward for Somatrogon (hGH-CTP) in the United States.

If we are unable to get approval for Somatrogon (hGH-CTP) in the United States, then we may be exposed to impairment charges, which could be material.

During the year ended December 31, 2022, we reclassified $ 590.2 million of IPR&D related to Somatrogon (hGH-CTP) from IPR&D in our Consolidated Balance Sheet upon the approval of NGENLA (Somatrogon) in Europe and Japan.

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

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.

No impairment charges were recognized for the years ended December 31, 2023, 2022, or 2021.

During the year ended December 31, 2022 , upon the approval of NGENLA (Somatrogon) in Europe and Japan, we reclassified $ 590.2 million of IPR&D related to Somatrogon (hGH-CTP) from IPR&D in our Consolidated Balance Sheet to finite-lived intangible assets.

We are amortizing the assets on a straight-line basis over their estimated useful lives of approximately 12 years.

We amortize intangible assets with definite lives on a straight-line basis over their estimated useful lives, ranging from 3 to 20 years.

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Investments that are considered equity securities as of December 31, 2023 and 2022 are predominately carried at fair value.

Our debt under the credit agreement with JPMorgan Chase Bank, N.A.

approximates fair value due to the variable rate of interest applicable to such debt.

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.

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

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Included in Other long-term liabilities is an accrual of $ 9.9 million related to uncertain tax positions involving income recognition.

In connection with an examination of foreign tax returns for the 2014 through 2020 tax years, a foreign taxing

authority has issued an income tax assessment of approximately $ 246 million (including interest).

In connection with an examination of foreign tax returns for the 2015 through 2021 tax years, a foreign taxing authority has issued an income tax assessment of approximately $ 246 million (including interest).

We are appealing this assessment, as we believe, other than for uncertain tax positions for which we have reserved, the issues are without technical merit.

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At December 31, 2023 and 2022 , receivable balances (net of explicit and implicit price concessions) from Medicare and Medicaid were 6.7 % and 14.2 %, respectively, of our consolidated Accounts receivable, net.

At December 31, 2021, receivable balances (net of explicit and implicit price concessions) due directly from states, cities and other municipalities, specifically related to our real-time reverse-transcription polymerase chain reaction (real-time RT-PCR) assay to detect COVID-19 were 4.1 % of our consolidated accounts receivable, net.

The portion of our accounts receivable due from individual patients comprises the largest portion of credit risk.

At December 31, 2022 and 2021, receivables due from patients represent approximately 2.9 % and 1.7 %, respectively, of our consolidated Accounts receivable, net.

At December 31, 2023 and 2022 , receivables due from patients represented approximately 2.0 % and 2.9 %, respectively, of our consolidated Accounts receivable, net.

We assess the collectability of accounts receivable balances by considering factors such as historical collection experience, customer credit worthiness, the age of accounts receivable balances, regulatory changes and current economic conditions and trends that may affect a customer’s ability to pay.

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The credit loss expense for the years ended December 31, 2023, 2022 and 2021 was $ 0.3 million, $ 0.3 million and $ 0.4 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 ).

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

Equity-based compensation.

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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, 2022, 2021 and 2020, we recorded $( 1.8 ) million, $( 1.4 ) million and $ 1.6 million, respectively of transaction gains (losses).

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.

Variable interest entities.

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Refer to Note 5.

Recently adopted accounting pronouncements .

Accounting standards yet to be adopted .

In December 2023, the FASB issued ASU No.

2023 - 09, “Income Taxes (Topic 740 ):

Improvements to Income Tax Disclosures” (“ ASU 2023 - 09 ”), which modifies the rules on income tax disclosures to require entities to disclose (i) specific categories in the rate reconciliation, (ii) the income or loss from continuing operations before income tax expense or benefit (separated between domestic and foreign) and (iii) income tax expense or benefit from continuing operations (separated by federal, state and foreign).

ASU 2023 - 09 also requires entities to disclose their income tax payments to international, federal, state, and local jurisdictions, among other changes.

The guidance is effective for annual periods beginning after December 15, 2024.

Early adoption is permitted for annual financial statements that have not yet been issued or made available for issuance.

ASU 2023 - 09 should be applied on a prospective basis, but retrospective application is permitted.

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

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

Improvements to Reportable Segment Disclosures ("ASU 2023 - 07" ).

ASU 2023 - 07 enhances disclosures for significant segment expenses for all public entities required to report segment information in accordance with ASC 280.

ASC 280 requires a public entity to report for each reportable segment a measure of segment profit or loss that its 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 .

In August 2020, the FASB issued ASU No.

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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 under the share lending arrangement 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 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.

Refer to Note 7.

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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 be antidilutive, no effect is given to Common Stock issuable under outstanding options or 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.

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.

A total of 82,843,173 , 55,580,089 and 62,204,391 potential shares of Common Stock have been excluded from the calculation of diluted net income (loss) per share for the years ended December 31, 2023, 2022 and 2021 , 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, 2023 , 18,750 options were exercised and 549,680 restricted stock units vested, resulting in the issuance of 405,721 shares of Common Stock.

Of the 549,680 restricted stock units settled, 162,709 shares of Common Stock were surrendered in lieu of a cash payment via the net exercise feature of the agreements.

During the year ended December 31, 2022 , an aggregate of 211,187 options were exercised and 1,599,212 restricted stock units were settled, resulting in the issuance of 1,316,570 shares of Common Stock.

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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.

During the year ended December 31, 2020, 206,875 Common Stock options to purchase shares of our Common Stock were exercised, resulting in the issuance of 206,875 shares of Common Stock.

Of the 206,875 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 and acquired ModeX in a merger, pursuant to which ModeX survived as a wholly owned subsidiary of the Company.

The Company paid the entirety of the $ 300.0 million purchase price pursuant to the issuance of the Consideration Shares to the former stockholders of ModeX.

The Consideration 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.

Included in the total fair value of consideration transferred of $ 221.7 million were $ 2.3 million of fully vested equity awards.

The following table summarizes the preliminary purchase price allocation and the estimated fair value of the net assets acquired and liabilities assumed at the date of acquisition.

The purchase price allocation for the ModeX transaction is preliminary, pending completion of the fair value analysis of acquired assets and liabilities:

(in thousands) ModeX

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

Other assets 554

Property, plant and equipment

IPR&D assets 195,000

Goodwill 80,432

Accounts payable

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Total purchase price

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

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.

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

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 $ 10.6 million of net loss of ModeX from the date of acquisition.

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.

The following table reflects the accounting method, carrying value and underlying equity in net assets of our unconsolidated investments as of December 31, 2023 and 2022 :

(in thousands) As of December 31, 2022 As of December 31, 2021

Investment type Investment Carrying Value Underlying Equity in Net Assets Investment Carrying Value Underlying Equity in Net Assets

(in thousands)

As of December 31, 2023

As of December 31, 2022

Investment type

Investment Carrying Value

Underlying Equity in Net Assets

Investment Carrying Value

Underlying Equity in Net Assets

Equity method investments

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

(“NIMS”) ( 1 %), Neovasc

(“Neovasc”) ( 0 %), BioCardia, Inc.

(“NIMS”) ( 0.5 %), BioCardia, Inc.

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

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

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

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.

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Equity method investments - Fair value option

On April 29, 2022, the Company sold GeneDx to Sema4 (now 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.

As of December 31, 2022, we held 80.0 million shares of GeneDx Holdings Common Stock, representing an approximate 21 % ownership interest in GeneDx Holdings.

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.

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

We hold one of eleven seats on GeneDx Holdings board of directors, and it is anticipated that our designee will serve until GeneDx Holdings 2024 annual meeting of stockholders or otherwise in accordance with the applicable lock-up period.

The 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.

As such, OPKO is not actively participating in the policy-making process of GeneDx Holdings.

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 Consolidated Statements of Operations.

For the year ended December 31, 2022 we recognized $ 150.9 million in net losses for fair value changes in our shares of GeneDx Holdings Common Stock.

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.

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.

Investments in Equity securities

Our equity securities consist of investments in Phio Pharmaceuticals (“Phio”) (ownership 0.01 %), VBI ( 1 %), ChromaDex Corporation (“ChromaDex”) ( 0.1 %), Eloxx Pharmaceuticals, Inc.

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.

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Warrants and options

In addition to our equity method investments and equity securities, we hold options to purchase 47 thousand additional shares of BioCardia, all of which were vested as of December 31, 2022 and 2021, and 33 thousand and 0.7 million warrants to purchase additional shares of COCP and InCellDx, Inc., respectively.

We recorded the changes in the fair value of the options and warrants in Fair value changes of derivative instruments, net in our Consolidated Statement of Operations.

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.

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We have determined that we hold variable interests in LeaderMed and Zebra Biologics, Inc.

We made this determination as a result of our assessment that they do not have sufficient resources to carry out their principal activities without additional financial support.

(“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.

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Accounts receivable

$ 125,379 $ 131,474

allowance for doubtful accounts

( 2,000 ) ( 4,162 )

$ 123,379 $ 127,312

Inventories, net

Finished products

$ 35,582 $ 37,139

Consumable supplies

25,864 31,275

Work in-process

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( 6,461 ) ( 3,574 )

$ 65,697 $ 74,060

Other current assets and prepaid expenses

Prepaid supplies

$ 6,177 $ 7,918

Prepaid insurance

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Other receivables

Other 6,252 6,195

$ 24,519 $ 39,962

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Machinery, medical and other equipment

$ 138,776 $ 136,048

Leasehold improvements

28,058 25,516

Furniture and fixtures

12,046 11,271

18,885 18,314

14,410 14,218

Automobiles and aircraft

Software 14,218 14,507

Building 18,314 10,661

Land 2,317 2,421

12,701 12,808

Construction in process

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( 157,127 ) ( 142,406 )

$ 75,429 $ 82,879

Intangible assets, net:

Technologies $ 826,282 $ 246,101

$ 831,509 $ 826,282

Customer relationships

Trade names 49,752 49,770

315,799 314,854

49,758 49,752

Covenants not to compete

Licenses 5,988 5,766

12,916 12,911

Product registrations

Other 5,861 6,128

accumulated amortization

( 488,694 ) ( 398,959 )

$ 740,283 $ 823,520

For the years ended December 31,

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Employee benefits

$ 28,952 $ 33,765

Gross to net provision

Inventory received but not invoiced

Taxes payable

Commitments and contingencies

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Contract liabilities

Other 42,988 69,299

23,302 27,366

$ 90,086 $ 98,269

Other long-term liabilities:

Mortgages and other debts payable

$ 7,709 $ 9,098

Finance leases long-term

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Contract liabilities

Other 10,072 7,356

12,199 10,072

$ 27,189 $ 27,371

Our intangible assets and goodwill relate principally to our completed acquisitions of OPKO Renal, OPKO Biologics, EirGen, BioReference and ModeX.

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The estimated useful lives by asset class are as follows:

technologies - 7 - 17 years, customer relationships - 5 - 20 years, product registrations - 7 - 10 years, covenants not to compete - 5 years, trade names - 5 - 10 years, other 9 - 13 years.

technologies - 7 - 17 years;

customer relationships - 5 - 20 years;

product registrations - 7 - 10 years;

covenants not to compete - 5 years;

trade names - 5 - 10 years;

and other 9 - 13 years.

We do not anticipate capitalizing the cost of product registration renewals, rather we expect to expense these costs, as incurred.

Our goodwill is not tax deductible for income tax purposes in any jurisdiction in which we operate.

As of December 31, 2021, GeneDx met the held-for-sale accounting criteria and its related assets and liabilities were recognized at the lower of carrying value or fair value less costs to sell in the consolidated balance sheet.

In addition, on December 31, 2021, assets held for sale included $ 151.8 million of goodwill related to GeneDx.

During the year ended December 31, 2022 , upon the approval of NGENLA (Somatrogon (hGH-CTP)) in Europe and Japan, we reclassified $ 590.2 million of IPR&D related to Somatrogon (hGH-CTP) from IPR&D in our Consolidated Balance Sheet.

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

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

(In thousands) Beginning

balance Charged

expense Written-off Charged

to other Ending

(In thousands)

Allowance for doubtful accounts

$ ( 4,162 ) ( 247 ) 2,408 — $ ( 2,000 )

Inventory reserve

$ ( 3,574 ) ( 8,100 ) 5,213 — $ ( 6,461 )

Tax valuation allowance

$ ( 279,212 ) ( 11,128 ) — ( 4,223 ) $ ( 294,563 )

Allowance for doubtful accounts

$ ( 1,839 ) ( 304 ) ( 2,019 ) — $ ( 4,162 )

Inventory reserve

$ ( 4,779 ) ( 4,059 ) 5,264 — $ ( 3,574 )

Tax valuation allowance

$ ( 260,397 ) ( 24,579 ) — 5,764 $ ( 279,212 )

The following table summarizes the changes in Goodwill by reporting unit during the years ended December 31, 2023 and 2022 .

(In thousands) Gross goodwill at January 1 Cumulative impairment at January 1 Acquisition and dispositions Foreign exchange and other Balance at December 31st Gross goodwill at January 1 Cumulative impairment at January 1 Foreign exchange and other Balance at December 31st

(In thousands)

Gross goodwill at January 1

Cumulative impairment at January 1

Acquisitions, dispositions and other

Foreign exchange and other

Balance at December 31st

Gross goodwill at January 1

Cumulative impairment at January 1

Acquisitions, dispositions and other

Foreign exchange and other

Balance at December 31st

Pharmaceuticals

CURNA $ 4,827 $ ( 4,827 ) $ — $ — $ — $ 4,827 $ ( 4,827 ) $ — $ —

Rayaldee 86,554 — — ( 4,768 ) 81,786 93,418 — ( 6,865 ) 86,554

FineTech 11,698 ( 11,698 ) — — — 11,698 ( 11,698 ) — —

ModeX — 80,432 — 80,432 — — — —

$ 4,827 $ ( 4,827 ) $ — $ — $ — $ 4,827 $ ( 4,827 ) $ — $ — $ —

81,786 — — 2,485 84,273 86,554 — — ( 4,768 ) 81,786

11,698 ( 11,698 ) — — — 11,698 ( 11,698 ) — — —

80,432 — ( 172 ) — 80,260 — — 80,432 — 80,432

OPKO Biologics

OPKO Chile 3,760 — — 7 3,767 4,505 — ( 745 ) 3,760

139,784 — — — 139,784 139,784 — — — 139,784

3,767 — — ( 125 ) 3,642 3,760 — — 7 3,767

OPKO Health Europe

OPKO Mexico 100 ( 100 ) — — — 100 ( 100 ) — —

7,057 — — 219 7,276 7,478 — — ( 421 ) 7,057

100 ( 100 ) — — — 100 ( 100 ) — — —

Transition Therapeutics

BioReference 434,809 — ( 151,784 ) — 283,025 434,809 — ( 151,784 ) 283,025

3,421 ( 3,421 ) — — — 3,421 ( 3,421 ) — — —

283,025 — — — 283,025 434,809 — ( 151,784 ) — 283,025

OPKO Diagnostics

17,977 ( 17,977 ) — — — 17,977 ( 17,977 ) — — —

Foreign exchange and other amounts for the year ended December 31, 2021 includes amounts related to GeneDx which is included as Assets held for sale at December 31, 2021.

$ 633,874 $ ( 38,023 ) $ ( 172 ) $ 2,579 $ 598,260 $ 710,408 $ ( 38,023 ) $ ( 71,352 ) $ ( 5,182 ) $ 595,851

As of December 31, 2023 and 2022 , our debt consisted of the following:

(In thousands) As of December 31, 2022 As of December 31, 2021

2025 Notes $ 142,096 $ 119,360

(In thousands)

As of December 31, 2023

As of December 31, 2022

$ 143,250 $ 142,096

2023 Convertible Notes

71,025 68,275

2033 Senior Notes

JP Morgan Chase 18,080 —

JP Morgan line of credit

12,671 18,080

Chilean and Spanish lines of credit

12,629 13,740

Current portion of notes payable

Long term portion of notes payable

Total $ 256,251 $ 205,271

$ 249,345 $ 256,251

Balance sheet captions

1 unchanged sentence

Long term portion of convertible notes

214,325 210,371

Current portion of lines of credit and notes payable

27,293 33,540

LT notes payable included in other long-term liabilities

Total $ 256,251 $ 205,271

In February 2019, we issued $ 200.0 million aggregate principal amount of Senior Convertible Notes due 2025 (the “2025 Notes”) in an underwritten public offering.

$ 249,345 $ 256,251

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.

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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 notes, at our option, on or after February 15, 2022, 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.

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.

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

In May 2021, we entered into exchange agreements 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”).

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, 2022 and 2021, a total of 21,144,825 and 21,144,825 shares remained outstanding under the share lending arrangement, respectively.

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 :

(In thousands) 2025 Senior Notes Discount Debt Issuance Costs Total

(In thousands)

2025 Senior Notes

Debt Issuance Costs

Balance at December 31, 2022

$ 144,580 $ — $ ( 2,484 ) $ 142,096

Amortization of debt discount and debt issuance costs

Adoption of ASU 2020-06 — 22,747 ( 1,105 ) 21,642

— — 1,154 1,154

Balance at December 31, 2023

$ 144,580 $ — $ ( 1,330 ) $ 143,250

In August 2020, the FASB issued ASU No.

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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 2023 Convertible Notes mature 5 years from the date of issuance.

Each holder of a 2023 Convertible Note has 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.

We may redeem all or any part of the then issued and outstanding 2023 Convertible Notes, together with accrued and unpaid interest thereon, pro rata among the holders, upon no fewer than 30 days, and no more than 60 days, notice to the holders.

The 2023 Convertible Notes contain customary events of default and representations and warranties of OPKO.

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.

In January 2013, we entered into note purchase agreements with respect to the issuance and sale of our 3.0 % Senior Notes due 2033 (the “2033 Senior Notes”) in a private placement exempt from registration under the Securities Act.

We issued the 2033 Senior Notes on January 30, 2013.

The 2033 Senior Notes, which totaled $ 175.0 million in original principal amount, bear interest at the rate of 3.0 % per year, payable semiannually on February 1 and August 1 of each year.

The 2033 Senior Notes mature on February 1, 2033, unless earlier repurchased, redeemed or converted.

Upon a fundamental change as defined in the indenture, governing the 2033 Senior Notes, subject to certain exceptions, the holders may require us to repurchase all or any portion of their 2033 Senior Notes for cash at a repurchase price equal to 100 % of the principal amount of the 2033 Senior Notes being repurchased, plus any accrued and unpaid interest to but not including the related fundamental change repurchase date.

From 2013 to 2016, holders of the 2033 Senior Notes converted $ 143.2 million in aggregate principal amount into an aggregate of 21,539,873 shares of Common Stock.

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 as set forth in the indenture, governing the 2033 Senior Notes, following which repurchase only $ 3.0 million aggregate principal amount of the 2033 Senior Notes remained outstanding.

Holders of the remaining $ 3.0 million principal amount of the 2033 Senior Notes may require us to repurchase such notes for 100 % of their principal amount, plus accrued and unpaid interest, on February 1, 2023, on February 1, 2028, or following the occurrence of a fundamental change as described above.

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.

In January 2013, we issued an aggregate of $ 175.0 million of our 3.0 % Senior Notes due 2033 (the “2033 Senior Notes”) in a private placement.

The 2033 Senior Notes bear interest at the rate of 3.0 % per year, payable semiannually on February 1 and August 1 of each year and mature on February 1, 2033, unless earlier repurchased, redeemed or converted.

From 2013 to 2016, holders of the 2033 Senior Notes converted $ 143.2 million in aggregate principal amount into Common Stock, and, on February 1, 2019, approximately $ 28.8 million aggregate principal amount of 2033 Senior Notes were tendered by holders pursuant to such holders’ option to require us to repurchase the 2033 Senior Notes.

During the 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:

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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.

For accounting and financial reporting purposes, we combined these embedded derivatives and valued them together as one unit of accounting.

In 2017, certain terms of the embedded derivatives expired pursuant to the original agreement and the embedded derivatives no longer met the criteria to be separated from the host contract and, as a result, the embedded derivatives were no longer required to be valued separate and apart from the 2033 Senior Notes and were reclassified to additional paid in capital.

In November 2015, BioReference and certain of its subsidiaries entered into the Credit Agreement.

As amended, the Credit Agreement provides for a $ 75.0 million secured revolving credit facility and includes a $ 20.0 million sub-facility for swingline loans and a $ 20.0 million sub-facility for the issuance of letters of credit.

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.

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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 (a) the prime rate and (b) the LIBOR rate (adjusted for statutory reserve requirements for Eurocurrency liabilities) for an interest period of one month plus 2.50 %) plus an applicable margin of 0.75 % or (ii) the LIBOR rate (adjusted for statutory reserve requirements for Eurocurrency liabilities) plus an applicable margin of 1.75 %.

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, 2022 and 2021, $ 18.1 million amount and no amount, 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.

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

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.

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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.

On April 29, 2022, we amended the Credit Agreement to, among other things, (i) waive specified defaults under the Credit Agreement resulting from certain internal reorganization transactions that resulted in both BioReference and GeneDx changing their respective forms of organization from New Jersey corporations to Delaware limited liability companies, (ii) provide for the disposition of GeneDx pursuant to the transactions contemplated by the GeneDx Merger Agreement, (iii) amend certain reporting requirements under the Credit Agreement and (iv) provide that the borrowers under the Credit Agreement may effect certain restricted payments to the extent necessary for their parent entities to pay income tax in respect of income earned by the borrowers.

In addition to the Credit Agreement, we had line of credit agreements with thirteen other financial institutions as of December 31, 2022 and eleven other financial institutions as of December 31, 2021 in the U.S., Chile and Spain.

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.

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

The following table summarizes the amounts outstanding under the BioReference, Chilean and Spanish lines of credit:

(Dollars in thousands) Balance Outstanding

Lender Interest rate on

borrowings at December 31, 2022 Credit line

capacity December 31,

2022 December 31,

JP Morgan Chase 5.50 % $ 75,000 $ 18,080 $ —

Itau Bank 5.50 % 2,378 2,378 1,603

(Dollars in thousands)

Balance Outstanding

Interest rate on

borrowings at December 31, 2023

JPMorgan Chase

9.50 % $ 50,000 $ 12,671 $ 18,080

5.50 % 2,363 1,264 2,378

Bank of Chile

BICE Bank 5.50 % 2,500 1,661 850

BBVA Bank 5.50 % 1,500 599 —

Security Bank 5.50 % 1,400 755 1,111

Estado Bank 5.50 % 4,000 1,621 2,540

6.60 % 2,500 1,728 817

5.50 % 2,500 1,734 1,661

5.00 % 5,500 981 1,646

Santander Bank

Scotiabank 5.00 % 5,500 1,646 567

BCI Bank 5.00 % 2,500 2,100 2,515

Corpbanca 5.00 % — — 2,935

5.50 % 5,000 450 1,238

Security Bank

5.50 % 1,400 — 755

5.50 % 4,000 3,303 1,621

5.00 % 2,500 1,626 2,100

Internacional Bank

5.50 % 1,500 1,197 599

Consorcio Bank

5.00 % 2,000 346 925

Banco De Sabadell

Banco Bilbao Vizcaya 2.15 % 535 — —

Total $ 105,348 $ 31,820 $ 13,672

1.75 % 552 — —

Santander Bank

1.95 % 552 — —

$ 80,367 $ 25,300 $ 31,820

At December 31, 2023 and 2022 , the weighted average interest rate on our lines of credit was approximately 7.52 % and 5.5 %, 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:

(In thousands) December 31,

2022 December 31,

(In thousands)

Current portion of notes payable

$ 1,993 $ 1,720

Other long-term liabilities

Total $ 11,010 $ 3,664

$ 9,720 $ 11,010

The notes and other debt mature at various dates ranging from 2024 through 2032 bearing variable interest rates from 0.7 % up to 5.1 %.

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For the year ended December 31, 2023 , changes in Accumulated other comprehensive income (loss), net of tax, were as follows:

(In thousands) Foreign

(In thousands)

currency translation

Balance at December 31, 2022

Other comprehensive loss ( 12,828 )

Other comprehensive income

Balance at December 31, 2023

For the year ended December 31, 2022 , changes in Accumulated other comprehensive income, net of tax, were as follows:

(In thousands) Foreign

(In thousands)

currency translation

Balance at December 31, 2021

Other comprehensive income ( 26,270 )

Other comprehensive loss

Balance at December 31, 2022

Note 10 Equity-Based Compensation

We maintain three equity-based incentive compensation plans, the 2016 Equity Incentive Plan, the 2007 Equity Incentive Plan, and the Modigene Inc.

2007 Equity Incentive Plan that provide for grants of stock options and restricted stock to our directors, officers, key employees and certain outside consultants.

We maintain two equity-based incentive compensation plans, the 2016 Equity Incentive Plan and the 2007 Equity Incentive Plan that provide for grants of stock options and restricted stock to our directors, officers, key employees and certain outside consultants.

Equity awards granted under our 2016 Equity Incentive Plan are exercisable for a period of up to 10 years from the date of grant.

Equity awards granted under our 2007 Equity Incentive Plan are exercisable for a period of either 7 years or 10 years from the date of grant.

Equity awards granted under the Modigene plan are exercisable for a period of up to 10 years from date of grant.

Vesting periods range from immediate to 5 years.

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We account for forfeitures as they occur and apply the following assumptions in our Black-Scholes-Merton Model option-pricing formula:

2022 Year Ended

2021 Year Ended

Expected term (in years)

Risk-free interest rate 1.71 % - 4.02 %

3.74 - 10.0 3.74 - 10.0 3.75 - 10.0

Risk-free interest rate

3.61 % - 4.72 % 1.71 % - 4.02 % 0.34 % - 1.34 %

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We intend to issue new shares upon the exercise of stock options.

Stock options granted under these plans were granted at an option exercise price equal to the closing market value of the Common Stock on

the applicable date of the grant.

Stock options granted under these plans were granted at an option exercise price equal to the closing market value of the Common Stock on the applicable date of the grant.

Stock options granted under these plans to employees typically become exercisable over four years in equal annual installments after the date of grant, and stock options granted to non-employee directors become exercisable in full one -year after the grant date, subject to, in each case, continuous service with us during the applicable vesting period.

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A summary of option activity under our stock option plans as of December 31, 2023 , and the change during the year is presented below:

Options Number of

options Weighted

price Weighted

term (years) Aggregate

intrinsic value

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Outstanding at December 31, 2022

Granted 4,125,176 $ 2.99

Exercised ( 211,187 ) $ 2.34

Forfeited ( 2,501,698 ) $ 4.01

Expired ( 2,130,416 ) $ 7.80

46,087,641 $ 5.90 5.32 $ —

11,873,258 $ 1.60

( 18,750 ) $ 2.12

( 886,007 ) $ 3.13

( 5,199,136 ) $ 6.18

Outstanding at December 31, 2023

51,857,006 $ 4.94 5.32 $ 63

Vested and expected to vest at December 31, 2023

51,857,006 $ 4.94 5.32 $ 63

Exercisable at December 31, 2023

33,681,791 $ 6.34 3.80 $ 63

A summary of restricted stock unit activity as of December 31, 2023 , and the change during the year is presented below:

Restricted stock units Number of

shares Weighted

fair value Weighted

term (years) Aggregate

intrinsic value

Restricted stock units

(in thousands)

Unvested at December 31, 2022

Granted 3,386,579 $ 3.11

2,448,743 $ 3.07 9.39 $ 3,061

( 25,000 ) $ —

Actual vested

( 549,680 ) $ —

Unvested and expected to vest at December 31, 2023

1,874,063 $ 3.05 8.41 $ 2,830

The total intrinsic value of stock options exercised for the years ended December 31, 2023 , 2022 , and 2021 was $ 0.0 million, $ 0.2 million and $ 0.8 million, respectively.

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(In thousands)

Federal $ — $ — $ ( 234 )

State ( 394 ) ( 2,536 ) 351

Foreign ( 10,512 ) ( 2,794 ) ( 2,094 )

$ ( 487 ) $ — $ —

Federal 40,750 ( 10,901 ) ( 254 )

State 12,078 1,280 933

Foreign 21,577 ( 538 ) ( 16,319 )

946 ( 394 ) ( 2,536 )

Total, net $ 63,499 $ ( 15,489 ) $ ( 17,617 )

Deferred income tax assets and liabilities as of December 31, 2022 and 2021 are comprised of the following:

(In thousands) December 31, 2022 December 31, 2021

( 4,750 ) ( 10,512 ) ( 2,794 )

( 4,291 ) ( 10,906 ) ( 5,330 )

( 52 ) 40,750 ( 10,901 )

298 12,078 1,280

( 392 ) 21,577 ( 538 )

( 146 ) 74,405 ( 10,159 )

$ ( 4,437 ) $ 63,499 $ ( 15,489 )

Deferred income tax assets and liabilities as of December 31, 2023 and 2022 were comprised of the following:

(In thousands)

December 31, 2023

December 31, 2022

Deferred income tax assets:

Federal net operating loss

$ 70,779 $ 68,022

State net operating loss

59,650 55,134

Foreign net operating loss

13,315 16,947

Research and development expense

Tax credits 22,488 22,938

21,431 14,349

20,827 22,488

Stock options

Accruals 2,724 10,692

30,431 33,558

Equity investments

Bad debts 265 265

25,718 17,309

Lease liability

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Operating lease asset

Other 5,263 6,493

17,141 10,919

Investment in subsidiaries

Deferred income tax assets

282,132 264,757

Deferred income tax liabilities:

Intangible assets

Convertible debt — ( 6,286 )

( 91,020 ) ( 94,856 )

Operating lease liability

Investment in subsidiaries — ( 42,140 )

Fixed assets ( 180 ) ( 2,592 )

Other ( 3,097 ) ( 1,638 )

( 16,773 ) ( 10,675 )

( 3,067 ) ( 3,097 )

Deferred income tax liabilities

Net deferred income tax assets (liabilities) 155,949 117,688

( 110,860 ) ( 108,808 )

Net deferred income tax assets

171,272 155,949

Valuation allowance

Net deferred income tax liabilities $ ( 123,263 ) $ ( 142,709 )

( 294,563 ) ( 279,212 )

Net deferred income tax assets (liabilities)

$ ( 123,291 ) $ ( 123,263 )

Net deferred income tax liability balances at December 31, 2023 and 2022 include $ 3.5 million and $ 3.2 million, respectively, recorded to Other assets on the Consolidated Balance Sheets.

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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.

In 2020 we completed the transfer of certain assets to an OPKO affiliate.

The transaction gave rise to a deferred tax asset of approximately $ 148.9 million.

Realizability of a deferred tax asset ultimately depends on the existence of sufficient taxable income in the carryback and carryforward periods as permitted by tax law.

The Company evaluated the realizability of the deferred tax asset as required by ASC 740-10-30-18.

The Company has determined that the deferred tax asset is not more-likely-than-not to be realized as of December 31, 2020.

As a result, the Company has recorded a full valuation allowance against the deferred tax asset.

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.

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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.

We were required to recognize the effect of the tax

law changes in the period of enactment, such as remeasuring our U.S.

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.

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Unrecognized tax benefits at beginning of period

$ 14,843 $ 11,497

Gross increases – tax positions in current period

Gross decreases – tax positions in prior period

Gross decreases – settlements with taxing authorities — ( 1,952 )

( 348 ) ( 271 )

Lapse of Statute of Limitations

( 195 ) ( 96 )

Unrecognized tax benefits at end of period

$ 16,931 $ 14,843

Other Income Tax Disclosures

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For the years ended December 31,

2022 2021 2020

Federal statutory rate

21.0 % 21.0 % 21.0 %

State income taxes, net of federal benefit

4.7 % 4.0 % ( 7.9 )%

Foreign income tax

( 2.5 )% ( 2.0 )% 21.6 %

Income Tax Refunds

( 0.4 )% — % 6.1 %

Research and development tax credits

0.7 % 0.2 % 2.3 %

GeneDx Disposition

— % 0.8 % — %

Valuation allowance

( 7.0 )% ( 6.3 )% 235.4 %

Rate change effect

0.4 % 5.2 % ( 40.5 )%

Non-deductible items

( 0.6 )% 0.6 % ( 67.0 )%

Unrecognized tax benefits

GILTI ( 4.9 ) % — % — %

IPR&D benefit — % — % ( 309.6 ) %

Stock options excess tax benefit ( 0.3 ) % ( 3.8 ) % 10.6 %

0.7 % ( 0.7 )% 11.3 %

( 14.8 )% ( 4.9 )% — %

Stock options excess tax benefit, cancellations & expirations

( 2.3 )% ( 0.3 )% ( 3.8 )%

Imputed interest

( 0.8 )% ( 0.4 )% ( 6.3 )%

Investment in subsidiaries

Other ( 1.0 ) % 9.7 % 3.2 %

Total 16.2 % ( 105.7 ) % 36.5 %

— % — % ( 287.6 )%

Tax on deemed dividend

— % ( 1.0 )% — %

True-Up to Adjustments

( 2.3 )% — % — %

0.8 % — % 9.7 %

( 2.4 )% 16.2 % ( 105.7 )%

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.

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$ ( 198,394 ) $ ( 389,439 ) $ ( 2,965 )

Foreign ( 2,465 ) ( 11,689 ) ( 33,531 )

Total $ ( 391,904 ) $ ( 14,654 ) $ 48,203

13,968 ( 2,465 ) ( 11,689 )

$ ( 184,426 ) $ ( 391,904 ) $ ( 14,654 )

In 2021, we revised our position regarding unrepatriated foreign earnings to a partially reinvested assertion.

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Note 12 Related Party Transactions

In August 2020, GeneDx entered into an agreement with Mednax Services, Inc.

(“Mednax Services”), a subsidiary of MEDNAX, Inc., (“MEDNAX”) pursuant to which the parties formed a joint venture under the brand Detect Genomix.

GeneDx’s initial capital investment in Detect Genomix was $ 245,000 for which GeneDx received a 49 % ownership interest in Detect Genomix, and Mednax Services contributed $ 255,000 in exchange for a 51 % ownership interest in Detect Genomix.

Adam Logal, the Company’s Chief Financial Officer, was the chair and sat on the Board of Managers of the joint venture.

Mednax Services provided administrative services to the joint venture pursuant to an administrative services agreement.

GeneDx provided laboratory services to the joint venture.

Roger Medel, a director of the Company, is the former Chief Executive Officer of MEDNAX and Mednax Services.

Medel continues to serve on the board of MEDNAX.

The joint venture was dissolved in January 2022.

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 December 31, 2022, including human resources, information technology support, and finance and accounting.

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.

See Note 22 for additional information.

On October 12, 2023, the Company entered into an E-Commerce Distribution Agreement with NextPlat Corp ("NextPlat"), a global e-commerce provider, in which Dr.

Frost owns more than a 20% interest.

Under the terms of the agreement, NextPlat has agreed to launch an OPKO Health-branded online storefront on the Alibaba Group Holding Limited Tmall Global e-commerce platform in China, featuring an assortment of nutraceutical and veterinary products sold and distributed by OPKO Health Europe SLU, our wholly-owned subsidiary.

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 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.

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.

In August 2020, we paid a $ 125,000 filing fee to the Federal Trade Commission (the “FTC”) in connection with filings made by us and Dr.

Jane Hsiao, our Vice Chairman and Chief Technical Officer, under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (“HSR Act”) relating to her percentage equity ownership interest in OPKO and potential future purchases of our Common Stock.

In August 2020, Dr.

Phillip Frost, our Chairman and Chief Executive Officer, paid a filing fee of $ 280,000 to the FTC under the HSR Act in connection with filings made by us and Dr.

Frost, relating to his percentage equity ownership interest in OPKO and potential future purchases of our Common Stock.

We reimbursed Dr.

Frost for the HSR filing fee.

On February 25, 2020, we entered into a credit agreement with an affiliate of Dr.

Frost, pursuant to which the lender committed to provide us with an unsecured line of credit in the amount of $ 100 million.

This line of credit called for a commitment fee equal to 0.25 % per annum of the unused portion of the line.

We terminated this line of credit in June 2021 and as of December 31, 2021, no amount was outstanding thereunder.

We hold investments in Zebra (ownership 29 %), Neovasc ( 0 %), ChromaDex Corporation ( 0.1 %), COCP ( 3 %), NIMS ( 1 %), Eloxx ( 1 %), BioCardia ( 1 %) and LeaderMed Health Group Limited ( 47 %).

We hold investments in Zebra (ownership 28.5 %), ChromaDex Corporation ( 0.05 %), COCP ( 2 %), NIMS ( 0.5 %), Eloxx ( 1.2 %), BioCardia ( 1.0 %) 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.

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

We also hold an investment in GeneDx of 21 % in connection with our sale of GeneDx, Inc.

and subsequent participation in an underwritten offering.

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

We also hold an investment in GeneDx Holdings (Nasdaq:

WGS) representing an 13.7 % ownership interest as a result of our sale of GeneDx, Inc.

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.

See further discussion of our investments in Note 5.

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The discretionary company match for employee contributions to the Plan is 100 % up to the first 4 % of the participant’s earnings contributed to the Plan.

Our matching contributions to our plans, including predecessor plans for BioReference, were approximately $ 10.6 million, $ 9.6 million and $ 8.3 million for the years ended December 31, 2022, 2021, and 2020 respectively.

Our matching contributions to our plans, including the Plan and predecessor plans for BioReference, were approximately $ 7.3 million, $ 10.6 million and $ 9.6 million for the years ended December 31, 2023 , 2022 , and 2021 , respectively.

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 determined whether there is any merit to the TX OAG claims nor can it determine the extent of any potential liability.

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.

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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 a result, as of December 31, 2022, we recorded $ 1.0 million as contingent consideration, which is recorded within Other long-term liabilities in the accompanying Consolidated Balance Sheets.

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.

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The Company’s or BioReference’s failure to comply with its obligations under the CIA could result in monetary penalties and the exclusion from participation in Federal Health Care Programs.

and any actual source or recipient of health care business or referrals and involves, directly or indirectly, the offer, payment, or provision of anything of value, or (ii) is between BioReference and any physician (or a physician’s immediate family member).

The CIA does not apply to any of the Company’s subsidiaries other than BioReference, and its scope is generally limited to “focus arrangements”, which are those “arrangements” (as defined in the CIA) (i) between BioReference and any actual source or recipient of health care business or referrals and involves, directly or indirectly, the offer, payment, or provision of anything of value, or (ii) is between BioReference and any physician (or a physician’s immediate family member).

Most of these measures have already been implemented at BioReference.

Following its acquisition of BioReference, the Company and BioReference implemented robust compliance measures that substantially align with those actions required under the CIA.

GeneDx, Inc., the Company’s former subsidiary, received a letter dated May 26, 2022 from the Texas Medicaid Office of the Inspector General stating that certain testing provided by GeneDx was not eligible for reimbursement by the Texas Medicaid program, because the testing was considered non-covered by the Texas Medicaid program at the time the tests were performed and/or GeneDx did not hold the requisite CLIA subspecialty classifications for the testing.

The Company is working with GeneDx Holdings to investigate these issues.

Following recent communication, it appears the CLIA subspecialty classification issue has been addressed to the satisfaction of the Texas Medicaid Office of the Inspector General.

The potential non-covered testing issue, however, remains under investigation.

The Texas Medicaid Office has expressed in writing a potential repayment liability of approximately $ 784 thousand.

At this time, the Company can express no opinion as to the likelihood of an unfavorable outcome or the range of potential loss in this matter.

GeneDx, the Company’s former subsidiary, received a letter dated May 26, 2022 from the Texas Medicaid Office of the Inspector General stating that certain testing provided by GeneDx was not eligible for reimbursement by the Texas Medicaid program, because the testing was considered non-covered by the Texas Medicaid program at the time the tests were performed and/or GeneDx did not hold the requisite CLIA subspecialty classifications for the testing.

This matter was settled in November 2023 for approximately $ 231 thousand.

On March 1, 2019, the Company received a Civil Investigative Demand (“CID”) from the U.S.

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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 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.

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 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 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.

Briefing on the motion to dismiss is complete.

The court has not decided the motion.

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.

On November 26, 2019, BioReference received a CID from the DOJ.

The CID stated that the DOJ was investigating whether BioReference paid unlawful remuneration to health care practitioners in violation of the Anti-Kickback Statute or Stark law and thus submitted or caused to be submitted false claims to government health care programs in violation of the False Claims Act.

The time period covered by the DOJ’s requests was January 1, 2011 through November 26, 2019.

BioReference has fully cooperated with the DOJ by submitting the requested information and making current employees available for interviews, and the DOJ made a presentation to BioReference regarding its position.

The parties have reached an agreement on the settlement amount, which is approximately $ 10 million, excluding attorney fees.

As of December 31, 2021, $ 10.0 million was recorded in Accrued expenses, respectively, which the Company paid in full during the year ended December 31, 2022.

The matter was dismissed with prejudice in January 2024.

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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It’s reasonably possible the ultimate liability could exceed amounts currently estimated and we review established accruals and adjust them to reflect ongoing negotiations, settlements, rulings, advice of legal counsel and other relevant information.

To the extent new information is obtained and our views on the probable outcomes of claims, suits, assessments, investigations or legal proceedings change, changes in our accrued liabilities

would be recorded in the period in which such determination is made.

To the extent new information is obtained and our views on the probable outcomes of claims, suits, assessments, investigations or legal proceedings change, changes in our accrued liabilities would be recorded in the period in which such determination is made.

Because of the high degree of judgment involved in establishing loss estimates, the ultimate outcome of such matters will differ from our estimates and such differences may be material to our business, financial condition, results of operations, and cash flows.

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Actual amounts are adjusted in the period those adjustments become known.

For the year ended December 31, 2022, negative revenue adjustments due to changes in estimates of implicit price concessions for performance obligations satisfied in prior periods of $ 21.5 million were recognized.

For the years ended December 31, 2021 and 2020, positive revenue adjustments due to changes in estimates of implicit price concessions for performance obligations satisfied in prior periods of $ 40.4 million and $ 0.3 million were recognized, respectively.

For the year ended December 31, 2023 , and 2022, negative revenue adjustments due to changes in estimates of implicit price concessions for performance obligations satisfied in prior periods of $ 19.2 million and $ 21.5 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.

Third-party payors, including government programs, may decide to deny payment or recoup payments for testing they contend were improperly billed or not medically necessary, against their coverage determinations, or for which they believe they have otherwise overpaid (including as a result of their own error), and we may be required to refund payments already received.

Our revenues may be subject to retroactive adjustment as a result of these factors among others, including without limitation, differing interpretations of billing and coding guidance and changes by government agencies and payors in

interpretations, requirements, and “conditions of participation” in various programs.

We have processed requests for recoupment from third -party payors in the ordinary course of our business, and it is likely that we will continue to do so in the future.

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As of December 31, 2023 and 2022 , we have liabilities of approximately $ 3.1 million and $ 1.8 million within Accrued expenses and Other long-term liabilities related to reimbursements for payor overpayments.

The composition of Revenue from services by payor for the years ended December 31, 2022, 2021 and 2020 is as follows:

The composition of Revenue from services by payor for the years ended December 31, 2023, 2022 and 2021 was as follows:

For the years ended December 31,

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Healthcare insurers

$ 315,560 $ 326,144 $ 520,244

Government payors

82,502 97,191 222,242

Client payors

Patients 15,986 21,215 50,666

Total $ 755,630 $ 1,607,106 $ 1,262,242

100,171 316,309 843,405

17,042 15,986 21,215

$ 515,275 $ 755,630 $ 1,607,106

Revenue from products

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The following table presents an analysis of product sales allowances and accruals as contract liabilities for the years ended December 31, 2023, 2022 and 2021 :

(In thousands) Chargebacks, discounts, rebates and fees Governmental Returns Total

(In thousands)

Chargebacks, discounts, rebates and fees

Balance at December 31, 2022

$ 1,532 $ 5,063 $ 1,683 $ 8,278

Provision related to current period sales

14,606 20,589 1,351 36,546

Credits or payments made

( 13,560 ) ( 19,502 ) ( 842 ) ( 33,904 )

Balance at December 31, 2023

$ 2,578 $ 6,150 $ 2,192 $ 10,920

Total gross Rayaldee sales

Provision for Rayaldee sales allowances and accruals as a percentage of gross Rayaldee sales

(In thousands) Chargebacks, discounts, rebates and fees Governmental Returns Total

(In thousands)

Chargebacks, discounts, rebates and fees

Balance at December 31, 2021

$ 2,014 $ 5,499 $ 2,639 $ 10,152

Provision related to current period sales

12,995 18,165 1,170 32,330

Credits or payments made

( 13,477 ) ( 18,601 ) ( 2,126 ) ( 34,204 )

Balance at December 31, 2022

$ 1,532 $ 5,063 $ 1,683 $ 8,278

Total gross Rayaldee sales

Provision for Rayaldee sales allowances and accruals as a percentage of gross Rayaldee sales

(In thousands) Chargebacks, discounts, rebates and fees Governmental Returns Total

(In thousands)

Chargebacks, discounts, rebates and fees

Balance at December 31, 2020

$ 2,332 $ 5,812 $ 3,593 $ 11,737

Provision related to current period sales

14,426 21,553 1,286 37,265

Credits or payments made

( 14,744 ) ( 21,866 ) ( 2,240 ) ( 38,850 )

Balance at December 31, 2021

$ 2,014 $ 5,499 $ 2,639 $ 10,152

Total gross Rayaldee sales

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We constrain (reduce) our estimates of variable consideration such that it is probable that a significant reversal of previously recognized revenue will not occur throughout the life of the contract.

determining if variable consideration should be constrained, we consider whether there are factors outside of our control that could result in a significant reversal of revenue.

When determining if variable consideration should be constrained, we consider whether there are factors outside of our control that could result in a significant reversal of revenue.

In making these assessments, we consider the likelihood and magnitude of a potential reversal of revenue.

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The corresponding revenues or offset to research and development expenses are recognized as the related performance obligations are satisfied.

BARDA Contract:

Revenue from the BARDA contract is generated under terms that are cost plus fee.

We recognize revenue using the incurred costs output method to measure progress.

Revenue will only be recognized when research and development services are performed to the extent of actual costs incurred.

Sales-based Milestone and Royalty Payments:

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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 year ended December 31, 2022, revenue from transfer of intellectual property and other principally reflects $ 85.0 million regulatory milestone payments from Pfizer based on the commencement of sales from NGENLA (Somatrogon) in Europe and Japan, as well as royalty payments and gross profit share 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 the agreement.

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

Furthermore, For the year ended December 31, 2021, revenue from transfer of intellectual property and other principally includes $ 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).

For the year ended December 31, 2020, revenue from transfer of intellectual property and other principally reflects

$ 28.7 million of revenue related to the Pfizer Transaction (as defined in Note 16), $ 16.2 million of grants received by BioReference under the Coronavirus Aid, Relief, and Economic Security (CARES) Act and a $ 3 million milestone payment triggered by the first marketing approval of Rayaldee in Europe.

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.

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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.

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.

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 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.

The Company concluded that research and development services performed under the BARDA Contract would be recognized as revenue when research and development services are performed to the extent of actual costs incurred including a fixed fee and will be reimbursed by BARDA.

Costs incurred represent work performed, which corresponds with, and thereby best depicts, the transfer of control of the research and development to BARDA.

Types of contract costs include labor, material, and third -party services.

As such, the related BARDA revenue is recognized as revenue from transfer of intellectual property and other within the Company’s Consolidated Statements of Operations.

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

As of December 31, 2023 , the aggregate amount of transaction price allocated to remaining performance obligations, excluding unexercised contract options, was $ 57.8 million.

We expect to recognize this amount as revenue through February 2028.

On March 8, 2023, ModeX, the Company (with respect to certain sections), and Merck Sharp & Dohme LLC (“Merck”) entered into a License and Research Collaboration Agreement (the “Merck Agreement”) pursuant to which ModeX granted to Merck a license to certain patent rights and know-how in connection with the development of ModeX’s preclinical nanoparticle vaccine candidate targeting the Epstein-Barr Virus.

Under the terms of the Merck Agreement, ModeX granted to Merck an exclusive, sublicensable, royalty-bearing license to certain intellectual property to develop, manufacture, use and commercialize (i) a multivalent or monovalent vaccine assembled using our platform for Epstein-Barr Virus (“Vaccine”), and (ii) any pharmaceutical or biological preparation in final form containing a Vaccine for sale or for administration to human patients in a clinical trial for all uses (“Product”).

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.

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.

As part of their strategic collaboration, ModeX and Merck have put in place a research plan to manage research and other development activities related to the development of a Vaccine or Product including a joint steering committee to facilitate the research program.

As part of the research plan, they will use a third -party contract development and manufacturing organization (“CDMO”) to carry out such activities unless otherwise agreed.

Development costs incurred by ModeX in furtherance of these development activities will be reimbursed by Merck.

To date, we have spent $ 14.2 million of development costs related to the Epstein -Barr Virus, for which Merck has provided or will provide reimbursement.

The Merck Agreement will remain in effect until one or more Products receive marketing authorization, and, thereafter, until the expiration of all royalty obligations unless earlier terminated as permitted under the Merck Agreement.

In addition to termination rights for material breach and bankruptcy, Merck is permitted to terminate the Merck Agreement in its entirety without cause after a specified notice period.

If Merck terminates the Merck Agreement for convenience or by us for Merck’s uncured material breach, we may elect to receive a reversion license such that we can continue its work with Vaccines and Products which have not been terminated due to a material safety issue.

On September 14, 2021, we and LeaderMed announced the formation of a joint venture to develop, manufacture and commercialize two of OPKO’s clinical stage, long-acting drug products in Greater China and eight other Asian territories.

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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 Agreement after a specified notice period.

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 received an initial upfront payment of $ 5 million and is eligible to receive an aggregate additional amount of $ 5 million tied to the first anniversary of the effective date of the Nicoya Agreement, as amended, of which EirGen has received $ 2.5 million plus accrued interest for the delayed payment.

Furthermore, EirGen is eligible to receive the additional $ 2.5 million upon Nicoya’s submission of an investigational new drug (IND) application to the Center for Drug Evaluation (CDE) of China.

Furthermore, EirGen received the additional $ 2.5 million upon Nicoya’s submission of an investigational new drug (IND) application to the Center for Drug Evaluation (CDE) of China in March 2023.

EirGen is also eligible to receive up to an additional aggregate amount of $ 115 million upon the achievement of certain development, regulatory and sales-based milestones by Nicoya for the Nicoya Product in the Nicoya Territory.

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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.

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In addition, the parties agreed to certain amendments to the milestone structure and to reduce minimum royalties payable.

As revised, the Company has received a $ 3 million payment triggered by the first marketing approval of Rayaldee in Europe and is eligible to receive up to an additional $ 17 million in regulatory milestones and $ 207 million in milestone payments tied to launch, pricing and sales of Rayaldee , and tiered, double-digit royalties.

As revised, the Company has received a $ 3 million payment triggered by the first marketing approval of Rayaldee in Europe, $ 7.0 million payment triggered by the Germany price approval by the local sick fund association, and is eligible to receive up to an additional $ 15 million in regulatory milestones and $ 200 million in milestone payments tied to launch, pricing and sales of Rayaldee, and tiered, double-digit royalties.

We plan to share responsibility with VFMCRP for the conduct of trials specified within an agreed-upon development plan, with each company leading certain activities within the plan.

EirGen will lead the manufacturing activities within and outside the VFMCRP Territory and the commercialization activities outside the VFMCRP Territory and outside the VFMCRP

Field in the VFMCRP Territory and VFMCRP will lead the commercialization activities in the VFMCRP Territory and the VFMCRP Field.

EirGen will lead the manufacturing activities within and outside the VFMCRP Territory and the commercialization activities outside the VFMCRP Territory and outside the VFMCRP Field in the VFMCRP Territory and VFMCRP will lead the commercialization activities in the VFMCRP Territory and the VFMCRP Field.

For the initial development plan, the companies have agreed to certain cost sharing arrangements.

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We account for the sales milestones as royalties and sales milestones payments will be recognized as revenue in the period in which the associated milestone is achieved or sales occur, assuming all other revenue recognition criteria are met.

In December 2014, we entered into an exclusive worldwide agreement (the “Pfizer Agreement”) with Pfizer for the development and commercialization of our long-acting Somatrogon (hGH-CTP) for the treatment of growth hormone deficiency (“GHD”) in adults and children, as well as for the treatment of growth failure in children born small for gestational age (the “Pfizer Transaction”).

In early 2022, the European Commission and Ministry of Health, Labour and Welfare in Japan approved the next-generation long-acting recombinant human growth hormone NGENLA (Somatrogon), a once-weekly injection to treat pediatric growth hormone deficiency, and we received pricing approvals in Germany and Japan.

With the achievement of these milestones, we received $ 85.0 million in milestone payments during the year ended December 31, 2022.

Further, Canada and Australia approved NGENLA during the year ended December 31, 2021.

In January 2022, the FDA issued a Complete Response Letter for the BLA for Somatrogon (hGH-CTP).

Pfizer and OPKO have evaluated the FDA’s comments and will work with the agency to determine the best path forward for Somatrogon (hGH-CTP) in the United States.

In May 2020, we entered into an Amended and Restated Development and Commercialization License Agreement (the “Restated Pfizer Agreement”) with Pfizer, effective January 1, 2020, pursuant to which the parties agreed, among other things, to share all costs for Manufacturing Activities, as defined in the Restated Pfizer Agreement, for developing a licensed product for the three indications included in the Restated Pfizer Agreement.

In December 2014, we entered into an exclusive worldwide agreement with Pfizer for the development and commercialization of our long-acting Somatrogon (hGH-CTP) for the treatment of growth hormone deficiency (“GHD”) in adults and children, as well as for the treatment of growth failure in children born small for gestational age (the “Pfizer Transaction”).

In May 2020, we entered into an amended and restated development and commercialization license with Pfizer, effective January 1, 2020 ( the “Restated Pfizer Agreement”), pursuant to which the parties agreed, among other things, to share all costs for Manufacturing Activities, as defined in the Restated Pfizer Agreement, for developing a licensed product for the three indications included in the Restated Pfizer Agreement.

In June 2023, the FDA approved NGENLA (Somatrogon (hGH-CTP)) a once-weekly injection to treat pediatric growth hormone deficiency in the United States.

In early 2022, the European Commission and Ministry of Health, Labour and Welfare in Japan approved NGENLA (Somatrogon).

We have also received pricing approvals in Germany and Japan.

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.

On October 21, 2019, we and Pfizer announced that the global phase 3 trial evaluating Somatrogon dosed once-weekly in prepubertal children with GHD met its primary endpoint of non-inferiority to daily Genotropin® (somatropin) for injection, as measured by annual height velocity at 12 months.

Under the terms of the Pfizer Transaction, as restated, we received non-refundable and non-creditable upfront payments of $ 295.0 million and are eligible to receive up to an additional $ 275.0 million upon the achievement of certain regulatory milestones, $ 85 million of which we received during the second quarter of 2022.

Under the terms of the Restated Pfizer Agreement, we received non-refundable and non-creditable upfront payments of $ 295.0 million and are eligible to receive up to an additional $ 275.0 million upon the achievement of certain regulatory milestones.

Pfizer received the exclusive license to commercialize Somatrogon worldwide.

In addition, we are eligible to receive initial tiered royalty payments associated with the commercialization of Somatrogon for adult GHD with percentage rates ranging from the high teens to mid-twenties.

Upon the launch of Somatrogon for pediatric GHD in certain major markets, the royalties will transition to regional, tiered gross profit sharing for both Somatrogon and Pfizer’s Genotropin® (somatropin).

The agreement with Pfizer will remain in effect until the last sale of the licensed product, unless earlier terminated as permitted under the Pfizer Agreement.

In addition to termination rights for material breach and bankruptcy, Pfizer is permitted to terminate the Pfizer Agreement in its entirety, or with respect to one or more world regions, without cause after a specified notice period.

If the Pfizer Agreement is terminated by us for Pfizer’s uncured material breach, or by Pfizer without cause,

provision has been made for transition of product and product responsibilities to us for the terminated regions, as well as continued supply of product by Pfizer or transfer of supply to us in order to support the terminated regions.

In addition, we are eligible to receive regional, tiered gross profit sharing for both Somatrogon and Pfizer’s Genotropin® (somatropin) in all global markets, with the U.S.

region commencing gross profit sharing in August 2023.

The Restated Pfizer Agreement will remain in effect until the last sale of the licensed product, unless earlier terminated in accordance with its terms.

In addition to termination rights for material breach and bankruptcy, Pfizer is permitted to terminate the Restated Pfizer Agreement in its entirety, or with respect to one or more world regions, without cause after a specified notice period.

If the Restated Pfizer Agreement is terminated by us for Pfizer’s uncured material breach, or by Pfizer without cause, provision has been made for transition of product and product responsibilities to us for the terminated regions, as well as continued supply of product by Pfizer or transfer of supply to us in order to support the terminated regions.

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

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

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

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.

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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.

ModeX was previously located in Natick, Massachusetts and relocated to Weston, Massachusetts, upon lease commencement.

The new location is approximately 33,056 square feet of office space.

ModeX has two options to extend the lease term for an additional five years per extension, which would commence upon the expiration of the term in October 2033.

Straight-line monthly expense for the lease is $ 243.5 thousand.

The following table presents the lease balances within the Consolidated Balance Sheet as of December 31, 2023 and 2022 :

(in thousands) Classification on the Balance Sheet December 31, 2022 December 31, 2021

Operating lease assets Operating lease right-of-use assets $ 38,725 $ 44,228

Finance lease assets Property, plant and equipment, net 9,898 5,181

Operating lease liabilities Current maturities of operating leases 11,628 11,624

Accrued expenses Current maturities of finance leases 2,809 2,257

Operating lease liabilities Operating lease liabilities 27,963 33,097

Other long-term liabilities Finance lease liabilities $ 7,089 $ 2,924

(in thousands)

Classification on the Balance Sheet

December 31, 2023

December 31, 2022

Operating lease assets

Operating lease right-of-use assets

$ 68,088 $ 38,725

Finance lease assets

Property, plant and equipment, net

Operating lease liabilities

Current maturities of operating leases

12,996 11,628

Accrued expenses

Current maturities of finance leases

Operating lease liabilities

54,140 27,963

Other long-term liabilities

Finance lease liabilities

$ 7,274 $ 7,089

Weighted average remaining lease term

Operating leases 6.0 years 7.2 years

Finance leases 6.5 years 2.4 years

Operating leases (years)

Finance leases (years)

Weighted average discount rate

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The following table reconciles the undiscounted future minimum lease payments (displayed by year and in the aggregate) under noncancelable operating leases with terms of more than one year to the total operating lease liabilities recognized on our Consolidated Balance Sheet as of December 31, 2023 :

(in thousands) Operating Finance

2023 $ 11,999 $ 2,919

2024 7,900 2,401

2025 5,136 1,729

2026 3,984 1,059

(in thousands)

$ 13,433 $ 3,135

Thereafter 11,908 1,926

Total undiscounted future minimum lease payments

82,002 10,485

Difference between lease payments and discounted lease liabilities

Total lease liabilities

$ 67,136 $ 10,101

Expense under operating leases and finance leases was $ 16.6 million and $ 2.9 million, respectively, for the year ended December 31, 2023 , which includes $ 1.4 million of variable lease costs.

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Supplemental cash flow information is as follows:

(in thousands) For the years ended December 31,

(in thousands)

For the years ended December 31,

Operating cash out flows from operating leases

$ 16,112 $ 16,271

Operating cash out flows from finance leases

Financing cash out flows from finance leases

Total $ 17,765 $ 18,754

$ 18,742 $ 17,765

Note 18 Segments

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Pharmaceutical

Diagnostics 755,630 1,607,106 1,262,242

Corporate — — —

515,275 755,630 1,607,106

$ 515,275 $ 755,630 $ 1,607,106

Revenue from products:

Pharmaceutical

Diagnostics — — —

Corporate — — —

$ 167,557 $ 142,845 $ 141,770

Revenue from transfer of intellectual property and other:

Pharmaceutical

Diagnostics — — 16,240

Corporate — — —

$ 180,663 $ 105,721 $ 25,842

Operating income (loss):

Pharmaceutical

Diagnostics ( 173,652 ) 98,067 138,922

Corporate ( 39,640 ) ( 60,266 ) ( 37,689 )

$ 41,184 $ ( 12,961 ) $ ( 19,051 )

( 155,596 ) ( 173,652 ) 98,067

( 42,609 ) ( 39,640 ) ( 60,266 )

$ ( 157,021 ) $ ( 226,253 ) $ 18,750

Depreciation and amortization:

Pharmaceutical

Diagnostics 40,037 52,289 56,361

Corporate — — —

$ 71,548 $ 68,618 $ 26,427

33,749 40,037 52,289

$ 105,297 $ 108,655 $ 78,716

Loss from investment in investees:

Pharmaceutical

Diagnostics — — —

Corporate — — —

$ ( 107 ) $ ( 383 ) $ ( 629 )

Ireland 117,214 32,809 43,920

Chile 62,044 63,798 44,153

Spain 22,477 22,682 16,932

Israel 3,845 3,563 4,251

Mexico 14,546 11,005 7,865

Other 863 507 526

$ 597,822 $ 783,207 $ 1,640,354

(In thousands) December 31,

141,465 117,214 32,809

68,491 62,044 63,798

23,517 22,477 22,682

9,738 3,845 3,563

20,216 14,546 11,005

2,246 863 507

$ 863,495 $ 1,004,196 $ 1,774,718

(In thousands)

December 31, 2023

December 31, 2022

Pharmaceutical

Diagnostics 690,504 1,238,583

Corporate 154,224 46,672

$ 1,331,764 $ 1,322,531

630,753 690,504

49,181 154,224

$ 2,011,698 $ 2,167,259

Pharmaceutical

Diagnostics 283,025 283,025

$ 315,235 $ 312,826

283,025 283,025

$ 598,260 $ 595,851

No customer represented more than 10% of our total consolidated revenue during the years ended December 31, 2023, 2022 and 2021 .

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and foreign jurisdictions:

(In thousands) December 31, 2022 December 31, 2021

(In thousands)

December 31, 2023

December 31, 2022

$ 39,852 $ 52,795

Foreign 30,084 29,168

Total $ 82,879 $ 79,727

35,577 30,084

$ 75,429 $ 82,879

Note 19 Fair Value Measurements

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Fair value measurements as of December 31, 2023

(In thousands) Quoted

(Level 1) Significant

(Level 2) Significant

(Level 3) Total

(In thousands)

Money market funds

$ 32,404 $ — $ — $ 32,404

Equity securities

Equity Method - fair value option

9,786 — — 9,786

Common stock options/warrants

Total assets $ 124,541 $ 28 $ — $ 124,569

$ 42,306 $ 2 $ — $ 42,308

Forward contracts

Contingent consideration:

$ — $ 29 $ — $ 29

Total liabilities

$ — $ 29 $ — $ 29

Fair value measurements as of December 31, 2022

(In thousands) Quoted

(Level 1) Significant

(Level 2) Significant

(Level 3) Total

(In thousands)

Money market funds

$ 102,773 $ — $ — $ 102,773

Equity securities

Equity Method - fair value option

21,120 — — 21,120

Common stock options/warrants

$ 124,541 $ 28 $ — $ 124,569

Forward contracts

Total assets $ 4,226 $ 138 $ — $ 4,364

$ — $ 1,123 $ — $ 1,123

Contingent consideration:

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Total liabilities

$ — $ 1,123 $ 1,036 $ 2,159

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.

1 unchanged sentence

December 31, 2023

(In thousands) Carrying

Fair Value Level 1 Level 2 Level 3

2025 Notes $ 142,096 $ 125,495 $ — $ 125,495 $ —

(In thousands)

$ 143,250 $ 142,411 $ — $ 142,411 $ —

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

2 unchanged sentences

December 31, 2023

(In thousands) Contingent

consideration

(In thousands)

Contingent consideration

Balance at December 31, 2022

4 unchanged sentences

December 31, 2022

(In thousands) Contingent

consideration

(In thousands)

Contingent consideration

Balance at December 31, 2021

2 unchanged sentences

Foreign currency impact

Payments ( 1,162 )

Balance at December 31, 2022

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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.

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The following table summarizes the fair values and the presentation of our derivative financial instruments in the Consolidated Balance Sheets:

(In thousands) Balance Sheet Component December 31, 2022 December 31,

(In thousands)

Balance Sheet Component

December 31, 2023

December 31, 2022

Derivative financial instruments:

Common stock options/warrants Investments, net $ 28 $ 16

Forward contracts Unrealized gains on forward contracts are recorded in Other current assets and prepaid expenses.

Common stock options/warrants

Investments, net

Forward contracts

Unrealized gains on forward contracts are recorded in Other current assets and prepaid expenses.

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

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Common stock options/warrants

$ ( 25 ) $ 12 $ ( 58 )

Forward contracts

Total $ 649 $ 846 $ 50

$ ( 756 ) $ 637 $ 904

$ ( 781 ) $ 649 $ 846

Note 21 Selected Quarterly Financial Data (Unaudited)

For the 2023 Quarters Ended

(In thousands, except per share data) March 31 June 30 September 30 December 31

(In thousands, except per share data)

Total revenues

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For the 2022 Quarters Ended

(In thousands, except per share data) March 31 June 30 September 30 December 31

(In thousands, except per share data)

Total revenues

3 unchanged sentences

Note 22 Subsequent Events

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

In addition, under the terms of the 2023 Convertible Note, interest will accrue 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.

The remaining provisions of the original note are unchanged.

In January 2023, Nicoya submitted the investigational new drug application to China's Center for Drug Evaluation (“CDE”).

Under the terms of the Nicoya Agreement, we are eligible to receive $ 2.5 million upon Nicoya’s submission of the IND, of which we received in February 2023 and will be recognized as license revenue in the first quarter of 2023.

In January 2023, in conjunction with a underwritten public offering, we invested $ 5.0 million for 14,285,714 shares of GeneDx Holdings Class A common stock at a public offering price of $ 0.35 per share.

As of January 26th, 2023, our beneficial ownership in GeneDx Holdings decreased to 11.6 % as a result of their public offering.

Effective January 2, 2023, ModeX entered into a 10-year office lease agreement commencing on August 1, 2023.

ModeX is currently located in Natick, Massachusetts and will relocate to Weston, Massachusetts, upon lease commencement.

The new location will have approximately 33,056 square feet of office space.

Under the new lease, ModeX has two options to extend the lease term for an additional five years per extension, which would commence upon the expiration of the term on August 1, 2033.

Straight-line monthly rent expense for the lease is approximately $ 241 thousand.

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”).

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.

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.

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 is initially equal to 869.5652 shares of Common Stock per $1,000 principal amount of notes (equivalent to an initial conversion price of approximately $ 1.15 per share of Common Stock).

The conversion rate for the 2029 Convertible Notes will be subject to adjustment upon the occurrence of certain events, but will not be adjusted for any accrued and unpaid interest.

In addition, following certain corporate events that occur prior to the maturity date of the notes, in certain circumstances we will increase the conversion rate of the 2029 Convertible Notes for a holder who elects to convert its notes in connection with such a corporate event.

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

If we undergo a fundamental change, holders may require us to purchase the notes in whole or in part for cash at a fundamental change purchase price equal to 100 % of the principal amount of the notes to be purchased, plus accrued and unpaid interest, if any, to, but excluding, the fundamental change purchase date.

The 2029 Convertible Notes are our senior unsecured obligations and rank senior in right of payment to any indebtedness that is expressly subordinated in right of payment to the notes, and equal in right of payment with all of our existing and future unsecured indebtedness that is not so subordinated.

The notes are effectively subordinated to all of our existing and future secured indebtedness to the extent of the value of the assets securing such indebtedness and structurally subordinated to all existing and future liabilities (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.

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.

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.

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