OPKO HEALTH, INC. (OPK)

CIK: 0000944809. SIC: 2834 Pharmaceutical Preparations. Latest 10-K as of: 2026-02-26.

SIC breadcrumb: Manufacturing > Chemicals And Allied Products > SIC 2834 Pharmaceutical Preparations

SEC company page: https://www.sec.gov/edgar/browse/?CIK=944809. Latest filing source: 0001193125-26-076596.

Selected Fundamentals

Financials

Annual standardized facts from SEC companyfacts as of latest extracted filing date 2026-02-26. Source: https://data.sec.gov/api/xbrl/companyfacts/CIK0000944809.json. Derived margins, ratios, and free cash flow are computed from the extracted annual SEC facts.

Flow metrics use full-year FY periods from 10-K/10-K/A filings; balance-sheet metrics use FY-end instants. Free cash flow = operating cash flow - capital expenditures. Missing metrics are omitted rather than fabricated.

Ratios

ROE and ROA use period-end equity/assets. Liabilities / equity uses total liabilities divided by stockholders' equity. Current ratio uses current assets divided by current liabilities when both are reported.

Financial Charts

Quarterly

Quarterly standardized facts from SEC companyfacts as of latest extracted filing date 2026-04-28. Source: https://data.sec.gov/api/xbrl/companyfacts/CIK0000944809.json.

Flow metrics use discrete quarter-length periods from 10-Q/10-Q/A filings. Q4 revenue and net income are derived only when annual FY and nine-month YTD facts exist for the same fiscal year; derived Q4 values are labeled. EPS Q4 is not derived.

Quarterly Charts

Macro Cross-References

• CPIAUCSL - Consumer Price Index for All Urban Consumers: All Items in U.S. City Average
• UNRATE - Unemployment Rate
• FEDFUNDS - Federal Funds Effective Rate
• CES0500000003 - Average Hourly Earnings of All Employees, Total Private
• DFEDTARU - Federal Funds Target Range - Upper Limit
• DFEDTARL - Federal Funds Target Range - Lower Limit
• DGS3MO - Market Yield on U.S. Treasury Securities at 3-Month Constant Maturity
• DGS2 - Market Yield on U.S. Treasury Securities at 2-Year Constant Maturity
• DGS10 - Market Yield on U.S. Treasury Securities at 10-Year Constant Maturity
• DGS30 - Market Yield on U.S. Treasury Securities at 30-Year Constant Maturity
• T10Y2Y - 10-Year Treasury Constant Maturity Minus 2-Year Treasury Constant Maturity
• CPILFESL - Consumer Price Index for All Urban Consumers: All Items Less Food and Energy
• CPIUFDSL - Consumer Price Index for All Urban Consumers: Food
• CPIENGSL - Consumer Price Index for All Urban Consumers: Energy
• CUSR0000SAH1 - Consumer Price Index for All Urban Consumers: Shelter
• PCEPI - Personal Consumption Expenditures: Chain-type Price Index
• PCEPILFE - Personal Consumption Expenditures Excluding Food and Energy: Chain-type Price Index
• PPIACO - Producer Price Index by Commodity: All Commodities
• T10YIE - 10-Year Breakeven Inflation Rate
• U6RATE - Total Unemployed, Plus All Marginally Attached Workers Plus Total Employed Part Time for Economic Reasons
• PAYEMS - All Employees, Total Nonfarm
• CIVPART - Labor Force Participation Rate
• EMRATIO - Employment-Population Ratio
• UNEMPLOY - Unemployed
• CE16OV - Employment Level
• ICSA - Initial Claims
• JTSJOL - Job Openings: Total Nonfarm
• JTSQUR - Quits: Total Nonfarm
• GDPC1 - Real Gross Domestic Product
• A191RL1Q225SBEA - Real Gross Domestic Product: Percent Change from Preceding Period
• INDPRO - Industrial Production: Total Index
• TCU - Capacity Utilization: Total Index
• HOUST - New Privately-Owned Housing Units Started: Total Units
• PERMIT - New Privately-Owned Housing Units Authorized in Permit-Issuing Places: Total Units
• RSAFS - Advance Retail Sales: Retail Trade
• PCE - Personal Consumption Expenditures
• DSPIC96 - Real Disposable Personal Income
• PSAVERT - Personal Saving Rate
• M2SL - M2
• BOPGSTB - U.S. International Trade in Goods and Services: Balance
• MSPUS - Median Sales Price of Houses Sold for the United States
• HSN1F - New One Family Houses Sold: United States
• RHORUSQ156N - Homeownership Rate in the United States
• TTLCONS - Total Construction Spending: Total Construction in the United States
• RRVRUSQ156N - Rental Vacancy Rate in the United States
• TOTALSL - Total Consumer Credit Owned and Securitized
• REVOLSL - Revolving Consumer Credit Owned and Securitized
• DRCCLACBS - Delinquency Rate on Credit Card Loans, All Commercial Banks
• GDP - Gross Domestic Product
• GPDI - Gross Private Domestic Investment
• GCE - Government Consumption Expenditures and Gross Investment
• PCEC - Personal Consumption Expenditures
• NETEXP - Net Exports of Goods and Services
• GFDEBTN - Federal Debt: Total Public Debt
• GFDEGDQ188S - Federal Debt: Total Public Debt as Percent of Gross Domestic Product
• FYFSD - Federal Surplus or Deficit
• FGRECPT - Federal Government Current Receipts
• FGEXPND - Federal Government: Current Expenditures
• MANEMP - All Employees, Manufacturing
• USCONS - All Employees, Construction
• USTRADE - All Employees, Retail Trade
• USFIRE - All Employees, Financial Activities
• USGOVT - All Employees, Government
• AWHAETP - Average Weekly Hours of All Employees, Total Private
• DGORDER - Manufacturers' New Orders: Durable Goods
• NEWORDER - Manufacturers' New Orders: Nondefense Capital Goods Excluding Aircraft
• BUSINV - Total Business Inventories
• EXPGS - Exports of Goods and Services
• IMPGS - Imports of Goods and Services
• IR - Import Price Index (End Use): All Commodities
• PPIFIS - Producer Price Index by Commodity: Final Demand

Latest quarter (10-Q)

Latest 10-Q source: 0001193125-26-187007.

Extracted structurally from real Item 2 body heading to real Item 3/4 boundary. Confidence: high. Filing date: 2026-04-28. Report date: 2026-03-31.

ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.

OVERVIEW

You should read this discussion together with the unaudited Condensed Consolidated Financial Statements, related notes, and other financial information included elsewhere in this Quarterly Report on Form 10-Q together with our audited consolidated financial statements, related notes, and other information contained in our Annual Report on Form 10-K for the year ended December 31, 2025 (the “Form 10-K”). The following discussion contains assumptions, estimates and other forward-looking statements that involve a number of risks and uncertainties, including those discussed under “Risk Factors,” in Part I, Item 1A of the Form 10-K and as described from time to time in our other filings with the Securities and Exchange Commission. These risks could cause our actual results to differ materially from those anticipated in these forward-looking statements.

We are a diversified healthcare company that seeks to establish industry-leading positions in large and rapidly growing medical markets. Our pharmaceutical business features NGENLA® (somatrogon-ghla), also referred to as Somatrogon (hGH-CTP), a once-weekly human growth hormone injection. We have partnered with Pfizer Inc. (“Pfizer”) for further development and commercialization of Somatrogon (hGH-CTP). Regulatory approvals for Somatrogon (hGH-CTP) for the treatment of children and adolescents, as young as three years of age, with growth disturbance due to insufficient secretion of growth hormone, have been secured in more than 50 markets worldwide, including in the United States, European Union Member States, Japan, Canada, and Australia under the brand name NGENLA®.

Through our pharmaceutical business, we also manufacture and sell Rayaldee, a U.S. Food and Drug Administration (“FDA”) approved treatment for secondary hyperparathyroidism (“SHPT”) in adults with stage 3 or 4 chronic kidney disease (“CKD”) and vitamin D insufficiency. Rayaldee has secured marketing authorizations in 11 European countries, and we are advancing the development in mainland China through our strategic partner.

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

We operate established, revenue-generating pharmaceutical platforms internationally, with our principal operations located in Spain, Ireland, Chile, and Mexico. These key platforms contribute to positive cash flow and may facilitate future market entry for our products currently in development. Our Irish subsidiary, EirGen Pharma Ltd. (“EirGen”), specializes in the development and commercial supply of high-potency oral solid dose pharmaceutical products and exports to more than 60 countries. Research and development activities are primarily conducted in facilities located in Weston, Massachusetts; Waterford, Ireland; Kiryat Gat, Israel; and Barcelona, Spain.

Our diagnostics business, BioReference Health, LLC (“BioReference”), is a highly specialized laboratory in the United States. Following the strategic divestitures of certain of its assets to Labcorp in 2024 and 2025, BioReference focuses on its core clinical and women’s health testing operations in the New York and New Jersey regions and its national specialty urology franchise, including our proprietary 4Kscore® prostate cancer test. We market our laboratory testing services directly to physicians, geneticists, hospitals, clinics, correctional and other health facilities.

RECENT DEVELOPMENTS

Entera Collaboration and License Agreement

In February 2026, the Company and its subsidiary, OPKO Biologics, entered into an amended and restated collaboration and license agreement with Entera Bio Ltd. (“Entera”), expanding our existing partnership to include the preclinical and clinical development of a daily long-acting PTH tablet (“LA-PTH”) for the treatment of hypoparathyroidism and other indications. This program is in addition to our existing collaboration for an oral dual agonist GLP-1/glucagon peptide. Under the terms of the amended agreement, the ownership and cost-sharing structures are as follows:

•
Oral GLP-1/Glucagon Program: the Company and Entera maintain their 60% and 40% pro-rata ownership interests, respectively, and remain responsible for 60% and 40% of the program's development costs, respectively; and

•
LA-PTH Program: the Company and Entera each hold a 50% pro-rata ownership interest and will share development costs equally (50/50). We expect to file an investigational new drug application with the FDA for the LA-PTH program in late 2026.

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In February 2026, Steven D. Rubin, the Company’s Executive Vice President, Administration and a member of our Board of Directors, was appointed to the Board of Directors of Entera. We continue to provide Entera with certain licenses to our technology, including our proprietary long-acting oxyntomodulin analog (OPK-88006), to support development efforts. Our equity investment in Entera remains subject to the standstill and lock-up provisions established in the initial March 2025 agreement.

Completion of the Oncology Transaction

In September 2025, we completed the sale of BioReference’s oncology diagnostics business and related clinical testing services to Labcorp for $192.5 million in cash (the “Oncology Transaction”). As a result of this divestiture, our results of operations for the three months ended March 31, 2026, are not directly comparable to the prior year period, which included the operations of the divested assets. We remain eligible to receive up to $32.5 million in performance-based contingent consideration under the terms of the agreement.

Stock Repurchase Program

On April 4, 2025, the Company announced that its Board of Directors authorized an increase of $100.0 million to the Company’s existing Common Stock repurchase program, originally established on July 18, 2024, increasing the program’s aggregate capacity to $200.0 million. As previously reported in the Company’s Form 10‑K, the Company had repurchased 60,383,629 shares of Common Stock for an aggregate cost of approximately $87.2 million as of December 31, 2025. During the three months ended March 31, 2026, the Company repurchased an additional 3,950,000 shares of Common Stock at an average price of $1.21 per share, for an aggregate cost of approximately $4.8 million. As of March 31, 2026, the total cost of repurchases under the program was approximately $92.0 million.

Tariffs and Trading Relationships

The U.S. trade environment has seen significant regulatory shifts following a February 2026 U.S. Supreme Court ruling that invalidated several previous tariff actions. In response, the U.S. government has transitioned to a new tariff framework, which includes a presidential proclamation issued in April 2026 regarding patented pharmaceutical products. This new framework currently provides for a 15% tariff rate on qualifying imports from the European Union, where our principal international pharmaceutical manufacturing platforms are located.

These new measures did not have a material impact on our results of operations for the three months ended March 31, 2026. We are continuing to monitor the implementation of these trade policies and evaluate their potential effect on our global supply chain and future financial results.

RESULTS OF OPERATIONS

Foreign Currency Exchange Rates

Approximately 32.7% of our revenue for the three months ended March 31, 2026, was denominated in currencies other than the U.S. Dollar (USD). This compares to 22.3% for the same period in 2025. Our financial statements are reported in USD; therefore, fluctuations in exchange rates affect the translation of foreign-denominated revenue and expenses. During the three months ended March 31, 2026 and the year ended December 31, 2025, our most significant currency exchange rate exposures were to the Chilean Peso and Euro. Gross accumulated currency translation adjustments, recorded as a separate component of shareholders’ equity, totaled $24.1 million and $17.6 million at March 31, 2026 and December 31, 2025, respectively.

We are subject to foreign currency transaction risk due to fluctuations in exchange rates between the time a transaction is initiated and settled. To mitigate this risk, we use foreign currency forward contracts. These contracts fix an exchange rate, allowing us to offset potential losses (or gains) caused by exchange rate changes at the settlement date. As of March 31, 2026, we held $25.4 million in open foreign exchange forward contracts related to inventory purchases on letters of credit, compared to $13.6 million in open contracts as of December 31, 2025.

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FOR THE THREE MONTHS ENDED MARCH 31, 2026 AND 2025

Our consolidated income from operations for the three months ended March 31, 2026 and 2025 was as follows:

For the three months ended

March 31,

(In thousands)

2026

2025

Change

% Change

Revenues:

Revenue from services

$

72,186

$

102,844

$

(30,658

)

(30

)%

Revenue from products

38,042

34,842

3,200

9

%

Revenue from transfer of intellectual property and other

13,968

12,266

1,702

14

%

Total revenues

124,196

149,952

(25,756

)

(17

)%

Costs and expenses:

Cost of revenue

78,441

107,332

(28,891

)

(27

)%

Selling, general and administrative

48,607

59,086

(10,479

)

(18

)%

Research and development

29,199

30,841

(1,642

)

(5

)%

Amortization of intangible assets

18,966

19,861

(895

)

(5

)%

Total costs and expenses

175,213

217,120

(41,907

)

(19

)%

Loss from operations

$

(51,017

)

$

(67,168

)

$

16,151

(24

)%

Diagnostics

For the three months ended

March 31,

(In thousands)

2026

2025

Change

% Change

Revenues

Revenue from services

$

72,186

$

102,844

$

(30,658

)

(30

)%

Total revenues

72,186

102,844

(30,658

)

(30

)%

Costs and expenses:

Cost of revenue

56,143

84,518

(28,375

)

(34

)%

Selling, general and administrative

26,151

37,956

(11,805

)

(31

)%

Research and development

312

538

(226

)

(42

)%

Amortization of intangible assets

2,533

3,750

(1,217

)

(32

)%

Total costs and expenses

85,139

126,762

(41,623

)

(33

)%

Loss from operations

$

(12,953

)

$

(23,918

)

$

10,965

(46

)%

Revenue. Revenue from services for the three months ended March 31, 2026 decreased by approximately $30.7 million, a decrease of 29.8% compared to the same period in 2025. This decline was primarily attributable to a $25.9 million reduction in revenue resulting from consummation of the Oncology Transaction in September 2025. The remaining $4.8 million decrease was driven by lower clinical test volumes and clinical test reimbursement rates within our continuing operations.

Estimated collection amounts are subject to the complexities and ambiguities of billing, reimbursement regulations and claims processing, as well as considerations unique to Medicare and Medicaid programs, and require us to consider the potential for retroactive adjustments when estimating variable consideration in the recognition of revenue for the period during which the related services are rendered. For the three months ended March 31, 2026, we recorded $1.0 million of positive revenue adjustments due to changes in estimates of implicit price concessions for performance obligations satisfied in prior periods, primarily due to favorable shifts in the composition of our client mix. For the three months ended March 31, 2025, we recorded $1.5 million of negative revenue adjustments due to changes in estimates of implicit price concessions for p

[Excerpt truncated for page length; source filing is linked above.]

Latest 10-K MD&A

Extracted structurally from real Item 7 body heading to real Item 7A/8 boundary. Confidence: high. Filing date: 2026-02-26. Report date: 2025-12-31.

ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.

This Annual Report on Form 10-K contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (“PSLRA”), Section 27A of the Securities Act of 1933, as amended, (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended, (the “Exchange Act”), about our expectations, beliefs, or intentions regarding our product development efforts, business, financial condition, results of operations, strategies and prospects. You can identify forward-looking statements by the fact that these statements do not relate to historical or current matters. Rather, forward-looking statements relate to anticipated or expected events, activities, trends or results and otherwise reflect our views related thereto only as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause our actual results to differ materially from any future results expressed or implied by the forward-looking statements. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those contained in “Item 1A — Risk Factors” of this Annual Report on Form 10-K. We do not undertake any obligation to update forward-looking statements except as required by applicable law. We intend that all forward-looking statements be subject to the safe harbor provisions of PSLRA.

OVERVIEW

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

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

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

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

Our management team possesses extensive industry experience in development, regulatory affairs, and commercialization. Their industry relationships support the identification and pursuit of commercial opportunities. Research and development activities are primarily conducted in facilities located in Weston, Massachusetts, Waterford, Ireland, Kiryat Gat, Israel, and Barcelona, Spain.

On September 15, 2025, we consummated the sale of certain assets of BioReference to Labcorp (the “Oncology Transaction”), pursuant to an agreement entered into on March 10, 2025 (the “Labcorp Oncology Purchase Agreement”). Labcorp acquired BioReference's oncology diagnostics business and related clinical testing services assets, which were part of our diagnostics segment. Upon closing, Labcorp paid an aggregate of $192.5 million in cash consideration, of which $19.2 million was deposited in escrow. The escrow is to be released to us on the 12-month anniversary of the closing date, net of any outstanding or liquidated indemnity claims. The Company may also receive up to $32.5 million in performance-based cash contingent consideration in accordance with the terms of a post-closing earnout based upon revenue generated by certain customer accounts. We recognized a gain of $101.6 million from the Oncology Transaction for the year ended December 31,

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2025.

On September 16, 2024, we consummated the sale of certain assets of BioReference to Labcorp pursuant to an agreement entered into on March 27, 2024 (the “Labcorp Asset Purchase Agreement”). Labcorp acquired select assets of BioReference (the “BioReference Transaction”), which were part of our diagnostics segment and included BioReference's laboratory testing businesses focused on clinical diagnostics, reproductive health, and women's health across the United States, excluding BioReference's New York and New Jersey operations. Upon closing, Labcorp paid us aggregate consideration of $237.5 million, in cash, net of $23.75 million deposited in escrow. We received $24.6 million of escrow funds, including accrued interest. We recognized a gain of $121.5 million from the BioReference Transaction for the year ended December 31, 2024.

RECENT DEVELOPMENTS

Entera Collaboration Agreements

On February 4, 2026, we and our wholly owned subsidiary, OPKO Biologics, entered into an amendment to our 2025 collaboration and license agreement with Entera Bio Ltd. (“Entera”) to expand the partnership to include the development of a first-in-class oral long-acting parathyroid hormone (LA-PTH) analog for the treatment of hypoparathyroidism. This program combines the Company's proprietary long-acting PTH variants with Entera's proprietary N-Tab® oral peptide delivery technology to create a once-daily tablet intended to replace daily or weekly injections.

Under the terms of the expanded agreement, the Company and Entera will each hold a 50% pro-rata ownership interest in the LA-PTH hypoparathyroidism program and will each be responsible for 50% of the associated development costs. The companies expect to file an investigational new drug (IND) application with the FDA for the LA-PTH program in late 2026.

This expansion builds upon the existing collaboration between the parties, which includes the development of an oral oxyntomodulin (OXM) dual GLP-1/glucagon analog for metabolic and fibrotic disorders and an oral GLP-2 tablet for the treatment of short bowel syndrome. For the oral OXM program, the Company and Entera maintain a 60% and 40% ownership structure, respectively, with development costs shared on a pro-rata basis. Initial Phase 1 clinical data for the injectable formulation of OXM is expected in late 2026, with an IND filing for the oral tablet formulation to follow thereafter.

RESULTS OF OPERATIONS

Foreign Currency Exchange Rates

For the years ended December 31, 2025, 2024, and 2023, approximately 28.0%, 23.1%, and 29.6% of revenue, respectively, 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 our consolidated financial results. During the years ended December 31, 2025, 2024 and 2023, the most significant currency exchange rate exposures were to the Chilean Peso and Euro. Gross accumulated currency translation adjustments recorded as a separate component of shareholders’ equity were $17.6 million and $52.7 million at December 31, 2025 and 2024, respectively.

We are subject to foreign currency translation risk for fluctuations in exchange rates during the period of time between the consummation and cash settlement of transactions. We limit foreign currency transaction risk through hedge transactions with foreign currency forward contracts. Under these forward contracts, for any rate above or below the fixed rate, we receive or pay the difference between the spot rate and the fixed rate for the given amount at the settlement date. As of December 31, 2025, we held $13.6 million in open foreign exchange forward contracts related to inventory purchases on letters of credit, compared to zero open contracts as of December 31, 2024.

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For The Years Ended December 31, 2025 and 2024

Our consolidated loss from operations for the years ended December 31, 2025 and 2024 was as follows:

For the years ended

December 31,

(In thousands)

2025

2024

Change

% Change

Revenues:

Revenue from services

$

370,275

$

480,667

$

(110,392

)

(23

)%

Revenue from products

156,924

155,111

1,813

1

%

Revenue from transfer of intellectual property and other

79,680

77,364

2,316

3

%

Total revenues

606,879

713,142

(106,263

)

(15

)%

Costs and expenses:

Cost of revenue

400,939

494,632

(93,693

)

(19

)%

Selling, general and administrative

223,002

304,220

(81,218

)

(27

)%

Research and development

124,033

105,214

18,819

18

%

Amortization of intangible assets

77,890

82,634

(4,744

)

(6

)%

Gain on sale of assets

(101,576

)

(121,493

)

19,917

(16

)%

Total costs and expenses

724,288

865,207

(140,919

)

(16

)%

Loss from operations

(117,409

)

(152,065

)

34,656

23

%

Diagnostics

For the years ended

December 31,

(In thousands)

2025

2024

Change

% Change

Revenues

Revenue from services

$

370,275

$

480,667

$

(110,392

)

(23

)%

Total revenues

370,275

480,667

(110,392

)

(23

)%

Costs and expenses:

Cost of revenue

307,350

402,109

(94,759

)

(24

)%

Selling, general and administrative

129,301

205,185

(75,884

)

(37

)%

Research and development

1,637

2,075

(438

)

(21

)%

Amortization of intangible assets

12,304

16,916

(4,612

)

(27

)%

Gain on sale of assets

(101,576

)

(121,493

)

19,917

(16

)%

Total costs and expenses

349,016

504,792

(155,776

)

(31

)%

Income (loss) from operations

21,259

(24,125

)

45,384

188

%

Revenue. Revenue from services for the year ended December 31, 2025 decreased by approximately $110.4 million, or 23.0%, compared to the year ended December 31, 2024. The decrease was driven by total reductions of $119.8 million, composed of $109.6 million reflecting the sale of BioReference's lab and oncology operations, and $10.2 million from lower clinical test volume in continuing operations, which were partially offset by a $9.4 million increase from higher clinical test reimbursement rates. In addition, revenue benefited from increased demand for the 4Kscore test, with test revenue rising approximately 13%, or $3.2 million, year over year.

Estimated collection amounts are subject to the complexities and ambiguities of billing, reimbursement regulations and claims processing, as well as considerations unique to Medicare and Medicaid programs, and require us to consider the potential for retroactive adjustments when estimating variable consideration in the recognition of revenue for the period in which the related services are rendered. For the years ended December 31, 2025 and 2024, we recorded $1.3 million and $1.5 million, respectively, of negative revenue adjustments due to changes in estimates of implicit price concessions for performance obligations satisfied in prior periods mainly due to the composition of patient payer mix.

The composition of revenue from services by payor for the years ended December 31, 2025 and 2024 was as follows:

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For the years ended December 31,

(In thousands)

2025

2024

Healthcare insurers

$

213,603

$

289,158

Government payers

59,925

82,421

Client payers

87,608

93,310

Patients

9,139

15,778

Total

$

370,275

$

480,667

Cost of revenue. Cost of revenue for the year ended December 31, 2025 decreased $94.8 million, or 23.6% compared to the year ended December 31, 2024. This decrease was predominantly driven by the absence of costs associated with divested operations following the sale of BioReference assets to Labcorp. The reduction in expenses was characterized by a significant decrease in personnel costs due to headcount reductions, as well as lower clinical activity expenses resulting from decreased consumption of materials and lower testing volumes. Furthermore, the decrease was supported by ongoing cost-reduction initiatives at BioReference and lower expenditures for freight, raw materials, and reference lab testing.

Selling, general and administrative expenses. Selling, general and administrative expenses for the years ended December 31, 2025 and 2024 were $129.3 million and $205.2 million, respectively, representing a decrease of 37.0% from the prior year. The decrease was primarily driven by lower employee-related expenses resulting from headcount reductions, as well as decreases in professional fees, technology and communication costs, and facility rental expenses. These reductions were largely attributable to costs associated with divested operations, as well as the successful execution of continued cost-reduction initiatives across the remaining ongoing operations.

Research and development expenses. The following table summarizes the components of our research and development expenses:

Research and Development Expenses

For the years ended December 31,

2025

2024

External expenses:

Research and development employee-related expenses

$

1,059

$

1,333

Other internal research and development expenses

578

742

Total research and development expenses

$

1,637

$

2,075

Research and development expenses for the years ended December 31, 2025 and 2024 were $1.6 million and $2.1 million, respectively, representing a decrease of 21.1% from the prior year. The decrease in research and development expenses was primarily due to lower employee-related expenses reflecting continued cost-reduction initiatives implemented at BioReference.

Amortization of intangible assets. Amortization of intangible assets was $12.3 million and $16.9 million for the years ended December 31, 2025 and 2024, respectively. The decrease is primarily attributable to divested operations.

Gain on sale of assets. Gain on sale of assets for the year ended December 31, 2025 and 2024 was $101.6 million and $121.5 million, respectively. These gains were due to the Oncology Transaction, which closed during the third quarter of 2025, and the BioReference Transaction, which closed during the third quarter of 2024.

Pharmaceuticals

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For the years ended

December 31,

(In thousands)

2025

2024

Change

% Change

Revenues:

Revenue from products

$

156,924

$

155,111

$

1,813

1

%

Revenue from transfer of intellectual property and other

79,680

77,364

2,316

3

%

Total revenues

236,604

232,475

4,129

2

%

Costs and expenses:

Cost of revenue

93,589

92,523

1,066

1

%

Selling, general and administrative

53,866

58,007

(4,141

)

(7

)%

Research and development

121,905

103,022

18,883

18

%

Amortization of intangible assets

65,586

65,718

(132

)

(0

)%

Total costs and expenses

334,946

319,270

15,676

5

%

Loss from operations

(98,342

)

(86,795

)

(11,547

)

(13

)%

Revenue from products. Revenue from products for the year ended December 31, 2025 increased $1.8 million, or 1%, compared to the year ended December 31, 2024. This increase was primarily driven by a positive net foreign exchange impact of $2.9 million, resulting from a $5.0 million favorable movement in the Euro that was partially offset by a combined $2.1 million negative impact from the Mexican Peso and Chilean Peso. These gains were moderated by lower sales volumes in our international operations, specifically within our Chilean and Ireland operating companies, which were impacted by the timing of customer orders and product mix. This overall increase was also supported by a $0.8 million increase in revenue from Rayaldee, which grew to $29.8 million compared to $29.0 million in the 2024 period.

Revenue from transfer of intellectual property and other. Revenue from intellectual property and other increased by $2.3 million to $79.7 million for the year ended December 31, 2025, from $77.4 million in the same period last year. The increase was primarily driven by a $4.8 million increase from the BARDA Contract, with revenue recognized under the contract totaling $28.5 million for the year ended December 31, 2025, compared to $23.8 million for the 2024 period. Performance was further bolstered by $4.3 million in royalty revenue from Eli Lilly following the commercial launch of Mazdutide in China and a $7.2 million upfront payment from Regeneron during the 2025 period. Additionally, we saw an increase of $3.5 million in gross profit share and royalty payments from NGENLA® and Pfizer’s Genotropin® (Somatropin). These positive factors were partially offset by the absence of $12.5 million milestone payment from Merck in the 2024 period and a $2.8 million decrease in contract manufacturers’ commercial milestones.

Cost of revenue. Cost of revenue for the year ended December 31, 2025 increased by 1% to $93.6 million compared to $92.5 million for the year ended December 31, 2024. This was primarily driven by shifts in product mix due to the timing of customer orders from our international operating companies, which included an inventory reserve expense of $4.1 million for 2025 compared to $2.1 million for 2024. These factors were partially offset by a decrease in product costs resulting from lower sales volumes across our international operations, specifically within our Chilean and Ireland operations.

Selling, general and administrative expenses. Selling, general and administrative expenses for the years ended December 31, 2025 and 2024 were $53.9 million and $58.0 million, respectively, representing a decrease of 7% from the prior year. The decrease in selling, general and administrative expenses was primarily driven by lower employee-related expenses resulting from operational efficiencies, particularly impacting the Rayaldee commercial operations. This was further aided by a reduction in costs from international operations, which reflected lower professional fees, primarily related to tax litigation.

Research and development expenses. Research and development expenses for the years ended December 31, 2025 and 2024 were $121.9 million and $103.0 million, respectively, representing an increase of 18% from the prior year. Research and development expenses include external and internal expenses, partially offset by third-party grants and funding arising from collaboration agreements. External expenses include clinical and non-clinical activities performed by contract research organizations, lab services, purchases of drug and diagnostic product materials and manufacturing development costs. We track external research and development expenses by individual program for phase 3 clinical trials for drug approval and premarket approval for diagnostics tests, if any. Internal expenses include employee-related expenses such as salaries, benefits and equity-based compensation expense. Other internal research and development expenses are incurred to support overall research and development activities and include expenses related to general overhead and facilities.

The following table summarizes the components of our research and development expenses:

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Research and Development Expenses

For the years ended December 31,

2025

2024

External expenses:

Manufacturing expense for biological products

$

46,439

$

37,394

Phase 3 studies

13

1,239

Post-marketing studies

95

713

Earlier-stage programs

29,528

29,882

Research and development employee-related expenses

40,784

37,650

Other internal research and development expenses

8,133

8,036

Third-party grants and funding from collaboration agreements

(3,087

)

(11,892

)

Total research and development expenses

$

121,905

$

103,022

Research and development expenses for the year ended December 31, 2025 increased primarily due to higher manufacturing expenses for biological products, including costs incurred under the BARDA Contract, and higher employee‑related expenses due to an increase in headcount, primarily at ModeX. Additionally, the increase reflected lower third-party grants and funding from collaboration agreements compared to the prior year. These funds consist primarily of reimbursements from Merck for development costs related to the Epstein-Barr Virus (EBV) program. Much of the Phase 1 work for this program was done in 2024 and successfully completed in 2025. These increases were partially offset by a modest decrease in spending on earlier-stage programs as resources were prioritized toward advancing these key clinical initiatives.

Amortization of intangible assets. Amortization of intangible assets was $65.6 million and $65.7 million, respectively, for the years ended December 31, 2025 and 2024. Amortization expense reflects the amortization of acquired intangible assets with defined useful lives. Our indefinite lived IPR&D assets will not be amortized until the underlying development programs are completed. Upon obtaining regulatory approval, IPR&D assets will be accounted for as a finite-lived intangible asset and amortized on a straight-line basis over its estimated useful life of approximately 12 years.

Corporate

For the years ended

December 31,

(In thousands)

2025

2024

Change

% Change

Costs and expenses:

Selling, general and administrative

$

39,835

$

41,028

$

(1,193

)

(3

)%

Research and development

491

117

374

320

%

Total costs and expenses

40,326

41,145

(819

)

(2

)%

Loss from operations

$

(40,326

)

$

(41,145

)

$

819

2

%

Operating loss for our unallocated corporate operations for the years ended December 31, 2025 and 2024 was $40.3 million and $41.1 million, respectively, and principally reflects general and administrative expenses incurred in connection with our corporate operations. The decrease in operating loss was primarily due to lower employee-related expenses.

Other

Interest income. Interest income for the years ended December 31, 2025 and 2024 was $14.8 million and $8.4 million, respectively. The increase in interest income is driven by interest earned on our larger cash investment.

Interest expense. Interest expense for the years ended December 31, 2025 and 2024 was $108.5 million and $47.5 million, respectively. The increase was primarily attributable to $59.1 million from the amortization of $54.7 million in unamortized debt discount and $4.4 million in debt issuance costs related to the Note Exchange Transactions (as defined in Note 7 of the Consolidated Financial Statements). In addition, interest expense was impacted by interest incurred on the 2029 Convertible Notes and the 2044 Notes (both as defined in Note 7 of the Consolidated Financial Statements), including amortization of deferred financing and debt issuance costs.

Fair value changes of derivative instruments, net. Fair value changes of derivative instruments, net for the years ended December 31, 2025 and 2024 were $0.4 million of expense and $26.2 million reversal of expense, respectively. Derivative

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expense was principally related to the change in fair value of the 2029 Convertible Notes and of foreign currency forward exchange contracts at OPKO Chile.

Other income (expense), net. Other income (expense), net for the years ended December 31, 2025 and 2024, was ($29.9) million of expense and $206.9 million of income, respectively. The decrease was primarily related to our GeneDx (as defined in Note 5 to the Consolidated Financial Statements) investment; we recognized $204.5 million of income for the year ended December 31, 2024, which included $140.0 million reflecting an increase in the fair value of our investment (primarily unrealized gains) and $64.5 million from the sale of GeneDx shares. The decrease was also caused by the inclusion of $32.6 million in inducement expense related to the Note Exchange Transactions for the year ended December 31, 2025. Furthermore, a foreign currency loss of $2.0 million was recorded in the 2025, compared with a loss of $3.8 million recorded in 2024 and were further impacted by a net increase from other non-operating income and expense items.

Income tax benefit (provision). Our income tax benefit (provision) for the years ended December 31, 2025 and 2024 was $15.7 million and ($42.8 million), respectively. The $58.6 million increase in income tax benefit was primarily a result of the discrete, non-recurring tax expenses related to the BioReference Transaction and the Oncology Transaction. While the U.S. federal statutory income tax rate is 21%, our consolidated effective tax rate for both periods differed from this rate primarily due to the relative mix of earnings and losses generated in the U.S. versus foreign tax jurisdictions, as well as the operating results in tax jurisdictions which do not result in a tax benefit.

Loss from investments in investees. We have invested in certain early stage companies that we believe have valuable proprietary technology and significant potential to create value for us as an equity holder. We account for these investments under the equity method of accounting, resulting in the recording of our proportionate share of their losses until our share of their loss exceeds our investment. Until the investees’ technologies are commercialized, if ever, we anticipate they will report net losses. Loss from investments in investees was $29.0 thousand and $18.0 thousand for the years ended December 31, 2025 and 2024, respectively.

For The Years Ended December 31, 2024 and 2023

Our consolidated income (loss) from operations for the years ended December 31, 2024 and 2023 is as follows:

For the years ended

December 31,

(In thousands)

2024

2023

Change

% Change

Revenues:

Revenue from services

$

480,667

$

515,275

$

(34,608

)

(7

)%

Revenue from products

155,111

167,557

(12,446

)

(7

)%

Revenue from transfer of intellectual property and other

77,364

180,663

(103,299

)

(57

)%

Total revenues

713,142

863,495

(150,353

)

(17

)%

Costs and expenses:

Cost of revenue

494,632

545,368

(50,736

)

(9

)%

Selling, general and administrative

304,220

300,559

3,661

1

%

Research and development

105,214

89,593

15,621

17

%

Contingent consideration

—

(1,036

)

1,036

100

%

Amortization of intangible assets

82,634

86,032

(3,398

)

(4

)%

Gain on sale of assets

(121,493

)

—

(121,493

)

(100

)%

Total costs and expenses

865,207

1,020,516

(155,309

)

(15

)%

Loss from operations

(152,065

)

(157,021

)

4,956

(3

)%

Diagnostics

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Table of Contents

For the years ended

December 31,

(In thousands)

2024

2023

Change

% Change

Revenues

Revenue from services

$

480,667

$

515,275

(34,608

)

(7

)%

Total revenues

480,667

515,275

(34,608

)

(7

)%

Costs and expenses:

Cost of revenue

402,109

445,827

(43,718

)

(10

)%

Selling, general and administrative

205,185

202,341

2,844

1

%

Research and development

2,075

2,508

(433

)

(17

)%

Amortization of intangible assets

16,916

20,195

(3,279

)

(16

)%

Gain on sale of assets

(121,493

)

—

(121,493

)

(100

)%

Total costs and expenses

504,792

670,871

(166,079

)

(25

)%

Loss from operations

(24,125

)

(155,596

)

131,471

84

%

Revenue. Revenue from services for the year ended December 31, 2024 decreased by approximately $34.6 million, or 7%, compared to the year ended December 31, 2023. This decrease was primarily due to a $42.5 million decrease in clinical test volume, largely attributable to the BioReference Transaction, offset by a $7.9 million increase in clinical test reimbursement rates.

Estimated collection amounts are subject to the complexities and ambiguities of billing, reimbursement regulations and claims processing, as well as considerations unique to Medicare and Medicaid programs, and require us to consider the potential for retroactive adjustments when estimating variable consideration in the recognition of revenue for the period in which the related services are rendered. For the years ended December 31, 2024 and 2023, we recorded $1.5 million and $19.2 million, respectively, of negative revenue adjustments due to changes in estimates of implicit price concessions for performance obligations satisfied in prior periods mainly due to the composition of patient payer mix.

The composition of revenue from services by payor for the years ended December 31, 2024 and 2023 was as follows:

For the years ended December 31,

(In thousands)

2024

2023

Healthcare insurers

$

289,158

$

315,560

Government payers

82,421

82,502

Client payers

93,310

100,171

Patients

15,778

17,042

Total

$

480,667

$

515,275

Cost of revenue. Cost of revenue for the year ended December 31, 2024 decreased $43.7 million, a decrease of 10% compared to the year ended December 31, 2023. Cost of revenue decreased primarily due to lower employee headcount, reflecting our continued cost-reduction initiatives implemented at BioReference, changes in the mix of testing ordered during the period, and by a decrease in consumption reflecting the timing of the BioReference Transaction.

Selling, general and administrative expenses. Selling, general and administrative expenses for the years ended December 31, 2024 and 2023 were $205.2 million and $202.3 million, respectively, representing an increase of 1% from the prior period. The increase in expense is primarily related to $26.3 million in severance charges associated with cost reduction initiatives and $9.7 million in adjustments to the life of certain leases. This was partially offset by continued cost-reduction initiatives at BioReference, which included a reduction in employee headcount and the streamlining of certain smaller operations, resulting in an overall decrease in employee-related expenses and other operating efficiencies. The divestiture of certain laboratory operations also contributed to the reduction in employee-related expenses.

Research and development expenses. The following table summarizes the components of our research and development expenses:

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Table of Contents

Research and Development Expenses

For the years ended December 31,

2024

2023

External expenses:

Research and development employee-related expenses

$

1,333

$

1,729

Other internal research and development expenses

742

779

Total research and development expenses

$

2,075

$

2,508

The decrease in research and development expenses for the year ended December 31, 2024 was primarily due to a decrease in employee-related expenses as a result of the continued cost-reduction initiatives implemented at BioReference and the BioReference Transaction.

Amortization of intangible assets. Amortization of intangible assets was $16.9 million and $20.2 million for the years ended December 31, 2024 and 2023, respectively. The decrease is primarily attributable to the BioReference Transaction, which impacted the amount of amortizable intangible assets.

Gain on sale of assets. Gain on sale of assets for the year ended December 31, 2024 was $121.5 million due to the BioReference Transaction which closed during the third quarter of 2024.

Pharmaceuticals

For the years ended

December 31,

(In thousands)

2024

2023

Change

% Change

Revenues:

Revenue from products

$

155,111

$

167,557

$

(12,446

)

(7

)%

Revenue from transfer of intellectual property and other

77,364

180,663

(103,299

)

(57

)%

Total revenues

232,475

348,220

(115,745

)

(33

)%

Costs and expenses:

Cost of revenue

92,523

99,541

(7,018

)

(7

)%

Selling, general and administrative

58,007

55,687

2,320

4

%

Research and development

103,022

87,007

16,015

18

%

Contingent consideration

—

(1,036

)

1,036

100

%

Amortization of intangible assets

65,718

65,837

(119

)

(0

)%

Total costs and expenses

319,270

307,036

12,234

4

%

(Loss) income from operations

(86,795

)

41,184

(127,979

)

311

%

Revenue from products. Revenue from products for the year ended December 31, 2024 decreased $12.5 million, or 7%, compared to the year ended December 31, 2023. The decrease in product revenue was primarily driven by unfavorable foreign exchange fluctuations of approximately $8.9 million from our international operations and a $2.0 million decrease in Rayaldee sales. While we experienced higher sales volumes in 2024 compared to 2023, this increase was more than offset by unfavorable foreign exchange fluctuations. Revenue from sales of Rayaldee for the year ended December 31, 2024, was $29.0 million compared to $31.0 million for the year ended December 31, 2023.

Revenue from transfer of intellectual property and other. For the year ended December 31, 2024, we recorded $77.4 million in revenue from the transfer of intellectual property and other. Revenue for the year ended December 31, 2024 principally reflects $30.0 million from Pfizer, which includes $28.3 million from gross profit share and royalty payments for both NGENLA® and Pfizer's Genotropin®. Revenue in 2024 also included $23.8 million from the BARDA Contract, a $12.5 million milestone payment from Merck, and $10.2 million from contract manufacturers' commercial milestones. In comparison, for the year ended December 31, 2023, we recorded $180.7 million in revenue from the transfer of intellectual property and other. This was primarily driven by a $90.0 million milestone payment, triggered by the FDA approval of NGENLA®, and $26.7 million in revenue that included $22.6 million from gross profit share and royalty payments for both NGENLA® and Pfizer's Genotropin®. In 2023, revenue also included $50.0 million from Merck in consideration for the rights granted to Merck under the Merck Agreement, $7.0 million from VFMCRP triggered by the German price approval for Rayaldee, $2.5 million from Nicoya due to Nicoya's submission of the investigational new drug application to China's Center for Drug Evaluation, $2.4 million from contract manufacturers' commercial milestones and $1.2 million from the BARDA Contract.

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Cost of revenue. Cost of revenue for the year ended December 31, 2024 decreased by 7% to $92.5 million compared to $99.5 million for the year ended December 31, 2023, which was primarily driven by favorable foreign exchange fluctuations. Despite increased sales volumes during 2024, which typically increases cost of revenue, we were able to limit this increase due to a combination of factors, including favorable foreign currency fluctuations and a reduction in Rayaldee's cost of revenue. Favorable foreign currency fluctuations positively impacted cost of revenue by approximately $6.1 million. The reduction in Rayaldee's cost of revenue resulted from a lower standard cost per bottle, achieved through ongoing process improvements and favorable raw material pricing.

Selling, general and administrative expenses. Selling, general and administrative expenses for the years ended December 31, 2024 and 2023 were $58.0 million and $55.7 million, respectively, representing an increase of 4% from the prior year period. The increase in selling, general and administrative expenses was due to higher employee-related, professional, and legal expenses related to our international operations.

Research and development expenses. Research and development expenses for the years ended December 31, 2024 and 2023 were $103.0 million and $87.0 million, respectively, representing an increase of 18% from the prior year. Research and development expenses include external and internal expenses, partially offset by third-party grants and funding arising from collaboration agreements. External expenses include clinical and non-clinical activities performed by contract research organizations, lab services, purchases of drug and diagnostic product materials and manufacturing development costs. We track external research and development expenses by individual program for phase 3 clinical trials for drug approval and premarket approval for diagnostics tests, if any. Internal expenses include employee-related expenses such as salaries, benefits and equity-based compensation expense. Other internal research and development expenses are incurred to support overall research and development activities and include expenses related to general overhead and facilities.

The following table summarizes the components of our research and development expenses:

Research and Development Expenses

For the years ended December 31,

2024

2023

External expenses:

Manufacturing expense for biological products

$

37,394

$

14,687

Phase 3 studies

1,239

4,414

Post-marketing studies

713

591

Earlier-stage programs

29,882

45,476

Research and development employee-related expenses

37,650

33,719

Other internal research and development expenses

8,036

4,894

Third-party grants and funding from collaboration agreements

(11,892

)

(16,774

)

Total research and development expenses

$

103,022

$

87,007

Research and development expenses for the year ended December 31, 2024, increased primarily due to growth in our BARDA collaboration and higher employee-related expenses. These increases were partially offset by a one-time payment to Sanofi of $12.5 million made in 2023 pursuant to the Sanofi In-License Agreement, which was triggered as a result of the Merck Agreement, and lower costs related to Somatrogon (hGH-CTP) following the closure of open-label extension studies in countries where it has received marketing authorization.

Contingent consideration. Contingent consideration for the year ended December 31, 2023 reflected a reversal of expense of $1.0 million. This was primarily attributable to changes in assumptions regarding the timing of achievement of future milestones for OPKO Renal, and potential amounts payable to former stockholders of OPKO Renal in connection therewith, pursuant to our acquisition agreement in March 2013. We recorded no contingent consideration for the year ended December 31, 2024.

Amortization of intangible assets. Amortization of intangible assets was $65.7 million and $65.8 million, respectively, for the years ended December 31, 2024 and 2023. Amortization expense reflects the amortization of acquired intangible assets with defined useful lives. Our indefinite lived IPR&D assets will not be amortized until the underlying development programs are completed. Upon obtaining regulatory approval, IPR&D assets will be accounted for as a finite-lived intangible asset and amortized on a straight-line basis over its estimated useful life of approximately 12 years.

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Corporate

For the years ended

December 31,

(In thousands)

2024

2023

Change

% Change

Costs and expenses:

Selling, general and administrative

$

41,028

$

42,531

$

(1,503

)

(4

)%

Research and development

117

78

39

50

%

Total costs and expenses

41,145

42,609

(1,464

)

(3

)%

Loss from operations

$

(41,145

)

$

(42,609

)

$

1,464

3

%

Operating loss for our unallocated corporate operations for the years ended December 31, 2024 and 2023 was $41.4 million and $42.6 million, respectively, and principally reflect general and administrative expenses incurred in connection with our corporate operations.

Other

Interest income. Interest income for the years ended December 31, 2024 and 2023 was $8.4 million and $4.0 million, respectively. The increase reflects higher average cash and investment balances as a result of the cash received from the BioReference Transaction, the issuance of the 2044 Notes, and the sale of common stock of GeneDx Holdings Corp. (formerly, Sema4 Holdings Corp., (“GeneDx Holdings”). We originally acquired shares of GeneDx Holdings in the 2022 disposition of our former subsidiary, GeneDx LLC (“GeneDx”) and subsequently acquired additional shares in an underwritten offering by GeneDx Holdings.

Interest expense. Interest expense for the years ended December 31, 2024 and 2023 was $47.5 million and $13.5 million, respectively. The increase was primarily driven by interest incurred on the 2029 Convertible Notes (as defined below) and the 2044 Notes, including amortization of deferred financing and debt issuance costs. This increase was partially offset by the extinguishment of our outstanding 2023 Convertible Notes (as defined below) in connection with their exchange for 2029 Convertible Notes and the repurchase of a significant portion of the outstanding 2025 Notes (as defined in Note 7 of the Consolidated Financial Statements) using a portion of the net proceeds from the issuance of 2029 Convertible Notes.

Fair value changes of derivative instruments, net. Fair value changes of derivative instruments, net for the years ended December 31, 2024 and 2023 were $26.2 million of expense and $0.8 million reversal of expense, respectively. Derivative expense for the years ended December 31, 2024 and 2023 was principally related to the change in fair value of the 2029 Convertible Notes and of foreign currency forward exchange contracts at OPKO Chile.

Other income (expense), net. Other income (expense), net for the years ended December 31, 2024 and 2023, was $206.9 million and ($17.0 million), respectively. The increase in 2024 was primarily driven by a $140.0 million gain related to the change in fair value of our investment in GeneDx Holdings and a $64.5 million gain from the sale of 2,937,762 shares of GeneDx Holdings. In 2023, the expense was primarily due to a $23.0 million loss related to the change in fair value of our investment in GeneDx Holdings, partially offset by a $6.7 million gain resulting from GeneDx Holdings achieving specific revenue target milestones. Foreign currency fluctuations resulted in a $3.8 million loss in 2024 and a $1.2 million gain in 2023.

Income tax benefit (provision). Our income tax benefit (provision) for the years ended December 31, 2024 and 2023 was ($42.8 million) and ($4.4 million), respectively. For the year ended December 31, 2024, the tax rate differed from the U.S. federal statutory rate of 21% primarily due to the relative mix in earnings and losses in the U.S. versus foreign tax jurisdictions, impact related to the BioReference Transaction, the impact of the payments under Merck Agreement, the impact of sales of the GeneDx investment, and operating results in tax jurisdictions which do not result in a tax benefit.

Loss from investments in investees. We have invested in certain early stage companies that we believe have valuable proprietary technology and significant potential to create value for us as an equity holder. We account for these investments under the equity method of accounting, resulting in the recording of our proportionate share of their losses until our share of their loss exceeds our investment. Until the investees’ technologies are commercialized, if ever, we anticipate they will report net losses. Loss from investments in investees was $18.0 thousand and $107.0 thousand for the years ended December 31, 2024 and 2023, respectively.

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LIQUIDITY AND CAPITAL RESOURCES

At December 31, 2025, we had cash, cash equivalents and restricted cash of approximately $382.7 million. Cash used in operations of $178.5 million for year ended December 31, 2025 principally reflected general and administrative expenses related to our corporate operations, research and development activities and sales and marketing activities related to our pharmaceutical and diagnostic business. Cash provided by investing activities was $230.3 million for the year ended December 31, 2025, primarily reflecting $197.8 million in total proceeds from the BioReference Transaction and Oncology Transaction, inclusive of escrow released, and $52.2 million from the sale of equity securities, offset by a $7.7 million investment in Entera and $13.0 million in capital expenditures. Cash used in financing activities of $118.1 million primarily reflected both the repurchase of Common Stock for $47.0 million and the 2029 Convertible 144A Notes for $62.2 million, as well as net repayments on our lines of credit of $7.9 million. We have historically not generated sustained positive cash flow sufficient to offset our operating and other expenses, and our primary sources of cash have been from the public and private placement of equity and debt, as well as credit facilities available to us.

On September 15, 2025, the Company consummated the Oncology Transaction, pursuant to which Labcorp acquired BioReference's oncology diagnostics and related clinical testing services assets. Labcorp paid to the Company aggregate consideration of $192.5 million, consisting of $173.3 million in cash and an escrow of $19.2 million, subject to certain adjustments as set forth in the Labcorp Oncology Purchase Agreement.

On April 4, 2025, the Company announced that its Board of Directors has authorized an increase of $100.0 million to the Company’s existing Common Stock repurchase program, bringing the aggregate capacity of the program to $200.0 million. As of December 31, 2025, approximately $50.6 million shares of Common Stock had been repurchased under the program since its authorization in July 2024. Under this program, the Company may repurchase shares from time to time through various methods, including open market purchases, block trades, privately negotiated transactions, accelerated share repurchases, as well as pursuant to pre-set trading plans meeting the requirements of Rule 10b5-1(c) of the Exchange Act, and otherwise in compliance with applicable laws. The timing and amount of any repurchases is subject to general market conditions, the Company's capital management, investment opportunities, and other factors. The repurchase program does not obligate the Company to repurchase any specific number of shares, has no time limit, and may be modified, suspended, or discontinued at any time at the Company's discretion.

On April 1, 2025, the Company consummated the Note Exchange Transactions related to its 2029 Convertible 144A Notes. In total, the Company exchanged $159,221,000 aggregate principal amount of the 2029 Convertible 144A Notes for 121,437,998 shares of Common Stock and cash payments totaling approximately $63.5 million, inclusive of accrued and unpaid interest. The exchanged 2029 Convertible 144A Notes were subsequently retired. As of December 31,2025, approximately $85.0 million aggregate principal amount of our 2029 Convertible Notes, which bear interest at 3.75% per annum, remained outstanding. See Note 7 to our Consolidated Financial Statements.

During the first quarter of 2025, the Company sold its entire holding of 620 thousand shares of GeneDx common stock at various prices per share for approximately $51.7 million in aggregate proceeds. As a result of these sales, the Company no longer holds shares in GeneDx.

In September 2024, ModeX entered into two amendments to modify the scope and funding of the BARDA Contract. The BARDA Amendments structured the funding thereunder as cost-plus-fixed-fee, which included a $26.9 million supplement to further advance the development of COVID-19 multispecific antibodies and provided $24.1 million for the development of a multispecific protein antibody for influenza or another pathogen. In December 2025, the Company entered into a further bilateral modification to de-scope all mRNA development-related efforts using SARS-CoV-2 as an antigen model, as these activities were no longer a priority for the U.S. Department of Health and Human Services. As a result, the total value of the BARDA Contract decreased from $110.0 million to $103.5 million, and the total potential value of the overall contract, inclusive of all options, decreased from $205.0 million to $198.5 million. As of December 31, 2025, the aggregate amount of transaction price allocated to remaining performance obligations, excluding unexercised contract options, was $49.9 million.

On July 17, 2024, we completed a private offering of $250 million aggregate principal amount of the 2044 Notes in accordance with the terms of the 2044 Note Purchase Agreement. The 2044 Notes are secured by the Company’s profit share payments from Pfizer under the Restated Pfizer Agreement. The 2044 Notes bear interest at the 3-month SOFR plus 7.5%, subject to a minimum interest rate of 4.0% per annum. The 2044 Notes mature in July 2044, with interest-only payments required for the first four years.

As of December 31, 2025, the total commitments under our lines of credit with financial institutions in Chile and Spain were $30.4 million, of which $8.5 million was drawn as of December 31, 2025. On December 31, 2025, the weighted

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average interest rate on these lines of credit was approximately 5.5%. These lines of credit are short-term and are used primarily as a source of working capital. The highest aggregate principal balance at any time outstanding during the year ended December 31, 2025 was $14.3 million. We intend to continue to draw under these lines of credit as needed. There is no assurance that these lines of credit or other funding sources will be available to us on acceptable terms, or at all, in the future.

Our liquidity would be impacted by the successful achievement of various milestones and the generation of royalty revenues under our existing collaboration and licensing agreements. We can provide no assurance that any of the following milestones or royalties will be achieved or earned. As of December 31, 2025, the historical and potential payments from these agreements were as follows:

Merck Agreement:

•
Received an initial payment of $50.0 million.

•
Eligible for up to an additional $860.0 million upon achieving certain commercial and development milestones under several indications.

•
Potential for tiered royalty payments ranging from high single digits to low double digits upon achieving certain sales targets of the Product. (as defined in the Merck Agreement)

•
On January 7, 2025, a $12.5 million milestone payment was triggered by the dosing of the first participant in a Phase 1 study for an EBV vaccine candidate.

Restated Pfizer Agreement:

•
Eligible to receive an additional $50.0 million in regulatory milestones.

•
Eligible to receive regional, tiered gross profit sharing for both NGENLA® and Pfizer’s Genotropin®.

VFMCRP Agreement:

•
Entitled to receive up to an additional $15 million in regulatory milestones.

•
Entitled to receive $200 million in milestone payments tied to the launch, pricing, and sales of Rayaldee.

•
Received a $7 million regulatory milestone payment in the first quarter of 2023, triggered by the German price approval for Rayaldee.

•
Recognized a $3 million regulatory milestone payment in 2022 following the first sale of Rayaldee in Europe.

•
Eligible to receive tiered, double-digit royalty payments.

Nicoya Agreement:

•
Received an initial upfront payment of $5 million.

•
Eligible to receive an aggregate of $5 million tied to the first anniversary of the effective date of the Nicoya Agreement, of which $2.5 million has been received.

•
Received an additional $2.5 million upon Nicoya’s submission of the investigational new drug application to the Center for Drug Evaluation of China in March 2023.

•
Eligible to receive up to an additional aggregate amount of $115 million upon achieving certain development, regulatory, and sales-based milestones by Nicoya for the Nicoya Product in the Nicoya Territory.

•
Eligible to receive tiered, double-digit royalty payments at rates in the low double digits on net product sales within the Nicoya Territory and in the Nicoya Field.

Eli Lilly Agreement:

•
Eligible to receive 3% royalty of Mazdutide world wide net sales.

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•
Recognized approximately $4.3 million in royalty revenue during the year ended December 31, 2025, following the commercial launch of Mazdutide in China.

The timing and ultimate receipt of these milestone and royalty payments are subject to the achievement of the specified events and certain risks and uncertainties inherent in drug development and commercialization. For further discussion of these risks, please refer to “Item 1A – Risk Factors”.

We believe that the cash, cash equivalents and restricted cash on hand on December 31, 2025 are sufficient to meet our anticipated cash requirements for operations and debt service beyond the next 12 months. We based this estimate on assumptions that may prove to be wrong or are subject to change, and we may be required to use our available cash resources sooner than we currently expect. If we acquire additional assets or companies, accelerate our product development programs or initiate additional clinical trials, we will need additional funds. Our future cash requirements, and the timing of those requirements, will depend on a number of factors, including the approval and success of our products and products in development, particularly our long acting Somatrogon (hGH-CTP) for which we have received approval in over 50 markets, including the United States, Europe, Japan, Australia and Canada, the commercial success of Rayaldee, the commercial launch of Mazdutide by our partners, BioReference’s financial performance, possible acquisitions and dispositions, the continued progress of research and development of our product candidates, the timing and outcome of clinical trials and regulatory approvals, the costs involved in preparing, filing, prosecuting, maintaining, defending, and enforcing patent claims and other intellectual property rights, the status of competitive products, the availability of financing, our success in developing markets for our product candidates and results of government investigations, payor claims, existing legal proceedings (including the ITA litigation) and those that may arise in the future. We have historically not generated sustained positive cash flow and if we are not able to secure additional funding when needed, we may have to delay, reduce the scope of, or eliminate one or more of our clinical trials or research and development programs or possible acquisitions or reduce our marketing or sales efforts or cease operations.

The following table provides information as of December 31, 2025, with respect to the amounts and timing of our known contractual obligation payments due by period.

Contractual obligations

(In thousands)

2026

2027

2028

2029

2030

Thereafter

Total

Open purchase orders

$

32,953

$

108

$

—

$

—

$

—

$

—

$

33,061

Operating leases

10,917

9,075

7,593

6,099

4,832

9,216

47,732

Finance leases

1,690

1,172

214

211

211

1,585

5,083

2029 and 2033 Convertible Notes

—

—

—

84,970

—

50

85,020

2044 Notes

—

—

—

—

—

246,433

246,433

Mortgages and other debts payable

1,736

862

879

521

—

—

3,998

Lines of credit

10,251

—

—

—

—

—

10,251

Interest commitments

4,670

4,652

4,647

193

—

—

14,162

Total

$

62,217

$

15,869

$

13,333

$

91,994

$

5,043

$

257,284

$

445,740

The preceding table does not include information where the amounts of the obligations are not currently determinable, including the following:

•
Contractual obligations in connection with clinical trials, which span over two years, and that depend on patient enrollment. The total amount of expenditures is dependent on the actual number of patients enrolled and as such, the contracts do not specify the maximum amount we may owe.

•
Product license agreements effective during the lesser of 15 years or patent expiration whereby payments and amounts are determined by applying a royalty rate on uncapped future sales.

CRITICAL ACCOUNTING POLICIES AND ESTIMATES

Use of estimates. The preparation of financial statements in conformity with accounting principles generally accepted in the U.S. requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ significantly from these estimates.

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Goodwill and intangible assets. Goodwill, in-process research and development (“IPR&D”) and other intangible assets acquired in business combinations, licensing and other transactions was $1.2 billion and $1.3 billion at December 31, 2025 and 2024, respectively.

Assets acquired and liabilities assumed in business combinations, licensing and other transactions are generally recognized at the date of acquisition at their respective fair values. Any excess of the purchase price over the estimated fair values of the net assets acquired is recognized as goodwill. At acquisition, we generally determine the fair value of intangible assets, including IPR&D, using the “income method.”

Subsequent to acquisition, goodwill and indefinite lived intangible assets are tested at least annually as of October 1 for impairment, or when events or changes in circumstances indicate it is more likely than not that the carrying amount of such assets may not be recoverable. Our annual assessment may consist of a qualitative or quantitative analysis to determine whether it is more likely than not that its fair value exceeds the carrying value. When performing qualitative analysis, the factors we consider include our share price, our financial performance compared to budgets, long-term financial plans, the timing and cost of development plans, macroeconomic, industry and market conditions as well as the excess of fair value over the carrying value of net assets from the annual impairment test previously performed.

When performing quantitative analysis, we use a combination of income and market valuation methods and may weigh the outcomes of valuation approaches when estimating fair value. Inputs and assumptions used to determine fair value are determined from a market participant view, which might be different than our specific views. The valuation process is complex and requires significant input and judgment using internal and external sources. Market approaches depend on the availability of guideline companies and representative transactions. When using the income approach, complex and judgmental matters applicable to the valuation process may include the following:

•
Estimated useful life – The asset life expected to contribute meaningful cash flows is determined after considering expected regulatory approval dates (if unapproved), exclusivity periods and other legal, regulatory or contractual provisions.

•
Projections – Future revenues are estimated after considering many factors such as historical results, market opportunity, pricing, sales trajectories to peak sales levels, competitive environment and product evolution. Future costs and expenses are estimated after considering historical factors such as the timing and level of development costs to obtain regulatory approvals, maintain or further enhance the product. For IPR&D projects, we generally assume initial positive cash flows to commence shortly after the receipt of expected regulatory approvals which typically may not occur for a number of years. Actual cash flows attributed to the project are likely to be different than those assumed since projections are subjected to multiple factors including trial results and regulatory matters which could materially change the ultimate commercial success of the asset as well as significantly alter the costs to develop the respective asset into commercially viable products.

•
Tax rates – The expected future income is tax effected using a market participant tax rate. In determining the tax rate, we consider the jurisdiction in which the intellectual property is held and the location of the research and manufacturing infrastructure.

•
Discount rate – Discount rates are selected after considering the risks inherent in the future cash flows; the assessment of the asset’s life cycle and the competitive trends impacting the asset, including consideration of any Company specific technical, legal, regulatory, or economic barriers to entry.

Goodwill was $484.3 million and $529.3 million at December 31, 2025 and 2024, respectively. Estimating the fair value of a reporting unit for goodwill impairment is highly sensitive to changes in projections and assumptions and changes in assumptions could potentially lead to impairment. We perform sensitivity analyses around our assumptions in order to assess the reasonableness of the assumptions and the results of our testing. Ultimately, potential changes in these assumptions may impact the estimated fair value of a reporting unit and result in an impairment if the fair value of such reporting unit is less than its carrying value.

Net intangible assets other than goodwill were $711.3 million and $811.6 million at December 31, 2025 and 2024, respectively, including IPR&D of $195.0 million at December 31, 2025 and 2024. For the year ended December 31, 2025, $30.5 million of intangible assets were de-recognized as part of the consummation of the Oncology Transaction, which was included in the sale of assets for the year ended December 31, 2025. Considering the high risk nature of research and development and the industry’s success rate of bringing developmental compounds to market, IPR&D impairment charges

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

Upon regulatory approval, IPR&D assets are classified as finite-lived intangible assets. These assets are then amortized on a straight-line basis over their estimated useful lives. If a project is abandoned, the associated IPR&D costs are immediately expensed. We also regularly assess finite-lived intangible assets for impairment. This assessment involves comparing the carrying amount of an asset, which is its cost minus accumulated amortization, to its estimated future undiscounted cash flows. If an asset's carrying amount exceeds its estimated future cash flows, then an impairment charge is recognized to reflect the difference between the asset's carrying amount and its fair value.

While we believe our estimates and assumptions used in impairment testing (including for goodwill and IPR&D) are reasonable and reflect those used by market participants, there is a potential risk of material impairment charges. Our future performance, particularly for our Ireland reporting unit, which includes EirGen and Rayaldee, could be impacted by changing global trade policies and the imposition of new tariffs. Based on the current financial performance of our diagnostics segment and our Ireland reporting unit, we could be subject to such charges if their future performance deviates from our current estimates and assumptions. For reference, the goodwill of our diagnostics segment totaled $163.4 million and $219.7 million at December 31, 2025 and 2024, respectively. The decrease reflects the derecognition of $56.3 million of goodwill as part of the Oncology Transaction, which was included in the sale of assets. Separately, the goodwill of our Ireland reporting unit totaled $89.5 million and $79.4 million at December 31, 2025 and 2024, respectively. The $10.1 million increase was entirely attributable to the impact of foreign currency exchange rate fluctuations. No impairment charges were recognized for the years ended December 31, 2025, 2024, or 2023.

We amortize intangible assets with definite lives on a straight-line basis over their estimated useful lives, ranging from 3 to 20 years. We use the straight-line method of amortization as there is no reliably determinable pattern in which the economic benefits of our intangible assets are consumed or otherwise used up. Amortization expense was $77.9 million, $82.6 million and $86.0 million for the years ended December 31, 2025, 2024 and 2023, respectively.

Revenue recognition. We generate revenues from services, products and intellectual property as follows:

Revenue from services. Revenue for laboratory services is recognized at the time test results are reported, which approximates when services are provided and the performance obligations are satisfied. Services are provided to patients covered by various third-party payor programs including various managed care organizations, as well as the Medicare and Medicaid programs. Billings for services are included in revenue net of allowances for contractual discounts, allowances for differences between the amounts billed and estimated program payment amounts, and implicit price concessions provided to uninsured patients which are all elements of variable consideration.

The following are descriptions of our payors for laboratory services:

Healthcare Insurers. Reimbursements from healthcare insurers are based on negotiated fee-for-service schedules. Revenues consist of amounts billed, net of contractual allowances for differences between amounts billed and the estimated consideration we expect to receive from such payors, which considers historical denial and collection experience and the terms of our contractual arrangements. Adjustments to the allowances, based on actual receipts from the third-party payors, are recorded upon settlement.

Government Payors. Reimbursements from government payors are based on fee-for-service schedules set by governmental authorities, including traditional Medicare and Medicaid. Revenues consist of amounts billed, net of contractual allowances for differences between amounts billed and the estimated consideration we expect to receive from such payors, which considers historical denial and collection experience and the terms of our contractual arrangements. Adjustments to the allowances, based on actual receipts from the government payors, are recorded upon settlement.

Client Payors. Client payors include physicians, hospitals, employers, and other institutions for which services are performed on a wholesale basis, and are billed and recognized as revenue based on negotiated fee schedules.

Patients. Uninsured patients are billed based on established patient fee schedules or fees negotiated with physicians on behalf of their patients. Insured patients (including amounts for coinsurance and deductible responsibilities) are billed based on fees negotiated with healthcare insurers. Collection of billings from patients is subject to credit risk and ability of the patients to pay. Revenues consist of amounts billed net of discounts provided to uninsured patients in accordance with our policies and implicit price concessions. Implicit price concessions represent differences between amounts billed and the estimated consideration that we expect to receive from patients, which considers historical collection experience and other

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factors including current market conditions. Adjustments to the estimated allowances, based on actual receipts from the patients, are recorded upon settlement.

The complexities and ambiguities of billing, reimbursement regulations and claims processing, as well as considerations unique to Medicare and Medicaid programs, require us to estimate the potential for retroactive adjustments as an element of variable consideration in the recognition of revenue in the period the related services are rendered. Actual amounts are adjusted in the period those adjustments become known. For the years ended December 31, 2025 and 2024, we recorded $1.3 million and $1.5 million, respectively, of negative revenue adjustments due to changes in estimates of implicit price concessions for performance obligations satisfied in prior periods mainly due to the composition of patient payer mix.

Third-party payors, including government programs, may decide to deny payment or recoup payments for testing they contend were improperly billed or not medically necessary, against their coverage determinations, or for which they believe they have otherwise overpaid (including as a result of their own error), and we may be required to refund payments already received. Our revenues may be subject to retroactive adjustment as a result of these factors among others, including without limitation, differing interpretations of billing and coding guidance and changes by government agencies and payors in interpretations, requirements, and “conditions of participation” in various programs. We have processed requests for recoupment from third-party payors in the ordinary course of our business, and it is likely that we will continue to do so in the future. If a third-party payor denies payment for testing or recoups money from us in a later period, reimbursement for our testing could decline.

As an integral part of our billing compliance program, we periodically assess our billing and coding practices, respond to payor audits on a routine basis, and investigate reported failures or suspected failures to comply with federal and state healthcare reimbursement requirements, as well as overpayment claims which may arise from time to time without fault on the part of the Company. We may have an obligation to reimburse Medicare, Medicaid, and third-party payors for overpayments regardless of fault. We have periodically identified and reported overpayments, reimbursed payors for overpayments and taken appropriate corrective action.

Settlements with third-party payors for retroactive adjustments due to audits, reviews or investigations are also considered variable consideration and are included in the determination of the estimated transaction price for providing services. These settlements are estimated based on the terms of the payment agreement with the payor, correspondence from the payor and our historical settlement activity, including an assessment of the probability a significant reversal of cumulative revenue recognized will occur when the uncertainty is subsequently resolved. Estimated settlements are adjusted in future periods as adjustments become known (that is, new information becomes available), or as years are settled or are no longer subject to such audits, reviews, and investigations. As of December 31, 2025 and 2024, we have liabilities of approximately $2.1 million and $2.0 million, respectively, within Accrued expenses and Other long-term liabilities related to reimbursements for payor overpayments.

Revenue from products. We recognize revenue from product sales when a customer obtains control of promised goods or services. The amount of revenue that is recorded reflects the consideration that we expect to receive in exchange for those goods or services. Our estimates for sales returns and allowances are based upon the historical patterns of product returns and allowances taken, matched against the sales from which they originated, and our evaluation of specific factors that may increase or decrease the risk of product returns. Product revenues are recorded net of estimated rebates, chargebacks, discounts, co-pay assistance and other deductions (collectively, “Sales Deductions”) as well as estimated product returns which are all elements of variable consideration. Allowances are recorded as a reduction of revenue at the time product revenues are recognized. The actual amounts of consideration ultimately received may differ from our estimates. If actual results in the future vary from our estimates, we will adjust these estimates, which would affect Revenue from products in the period such variances become known.

Rayaldee is distributed in the U.S. principally through the retail pharmacy channel, which initiates with the largest wholesalers in the U.S. (collectively, “Rayaldee Customers”). In addition to distribution agreements with Rayaldee Customers, we have entered into arrangements with many healthcare providers and payors that provide for government-mandated and/or privately-negotiated rebates, chargebacks and discounts with respect to the purchase of Rayaldee.

We recognize revenue for shipments of Rayaldee at the time of delivery to customers after estimating Sales Deductions and product returns as elements of variable consideration utilizing historical information and market research projections. For the years ended December 31, 2025, 2024 and 2023, we recognized $29.8 million, $29.0 million and $31.0 million, respectively, in net product revenue from sales of Rayaldee.

Taxes collected from customers related to revenues from services and revenues from products are excluded from revenues.

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Revenue from intellectual property. We recognize revenues from the transfer of intellectual property generated through license, development, collaboration and/or commercialization agreements. The terms of these agreements typically include payment to us for one or more of the following: non-refundable, up-front license fees; development and commercialization milestone payments; funding of research and/or development activities; and royalties on sales of licensed products. Revenue is recognized upon satisfaction of a performance obligation by transferring control of a good or service to the customer.

For research, development and/or commercialization agreements that result in revenues, we identify all material performance obligations, which may include a license to intellectual property and know-how, and research and development activities. In order to determine the transaction price, in addition to any upfront payment, we estimate the amount of variable consideration at the outset of the contract either utilizing the expected value or most likely amount method, depending on the facts and circumstances relative to the contract. We constrain (reduce) our estimates of variable consideration such that it is probable that a significant reversal of previously recognized revenue will not occur throughout the life of the contract. When determining if variable consideration should be constrained, we consider whether there are factors outside of our control that could result in a significant reversal of revenue. In making these assessments, we consider the likelihood and magnitude of a potential reversal of revenue. These estimates are re-assessed each reporting period as required.

Upfront License Fees: If a license to our intellectual property is determined to be functional intellectual property distinct from the other performance obligations identified in the arrangement, we recognize revenue from nonrefundable, upfront license fees based on the relative value prescribed to the license compared to the total value of the arrangement. The revenue is recognized when the license is transferred to the customer and the customer is able to use and benefit from the license. For licenses that are not distinct from other obligations identified in the arrangement, we utilize judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time. If the combined performance obligation is satisfied over time, we apply an appropriate method of measuring progress for purposes of recognizing revenue from nonrefundable, upfront license fees. We evaluate the measure of progress each reporting period and, if necessary, adjust the measure of performance and related revenue recognition.

Development and Regulatory Milestone Payments: Depending on facts and circumstances, we may conclude that it is appropriate to include the milestone in the estimated transaction price or that it is appropriate to fully constrain the milestone. A milestone payment is included in the transaction price in the reporting period that we conclude that it is probable that recording revenue in the period will not result in a significant reversal in amounts recognized in future periods. We may record revenues from certain milestones in a reporting period before the milestone is achieved if we conclude that achievement of the milestone is probable and that recognition of revenue related to the milestone will not result in a significant reversal in amounts recognized in future periods. We record a corresponding contract asset when this conclusion is reached. Milestone payments that have been fully constrained are not included in the transaction price to date. These milestones remain fully constrained until we conclude that achievement of the milestone is probable and that recognition of revenue related to the milestone will not result in a significant reversal in amounts recognized in future periods. We re-evaluate the probability of achievement of such development milestones and any related constraint each reporting period. We adjust our estimate of the overall transaction price, including the amount of revenue recorded, if necessary.

Research and Development Activities: If we are entitled to reimbursement from our collaborators for specified research and development expenses, we account for them as separate performance obligations if distinct. We also determine whether the research and development funding would result in revenues or an offset to research and development expenses in accordance with provisions of gross or net revenue presentation. The corresponding revenues or offset to research and development expenses are recognized as the related performance obligations are satisfied.

BARDA Contract (as defined in Note 16 of the Consolidated Financial Statements): Revenue from the BARDA Contract is generated under terms that are cost plus fee. We recognize revenue using the incurred costs output method to measure progress. Revenue will only be recognized when research and development services are performed to the extent of actual costs incurred.

Sales-based Milestone and Royalty Payments: Our collaborators may be required to pay us sales-based milestone payments or royalties on future sales of commercial products. We recognize revenues related to sales-based milestone and royalty payments upon the later to occur of (i) achievement of the customer’s underlying sales or (ii) satisfaction of any performance obligation(s) related to these sales, in each case assuming the license to our intellectual property is deemed to be the predominant item to which the sales-based milestones and/or royalties relate.

Other Potential Products and Services: Arrangements may include an option for license rights, future supply of drug substance or drug product for either clinical development or commercial supply at the licensee’s election. We assess if these options provide a material right to the licensee and if so, they are accounted for as separate performance obligations at the

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inception of the contract and revenue is recognized only if the option is exercised and products or services are subsequently delivered or when the rights expire. If the promise is based on market terms and not considered a material right, the option is accounted for if and when exercised. If we are entitled to additional payments when the licensee exercises these options, any additional payments are generally recorded in license or other revenues when the licensee obtains control of the goods, which is upon delivery.

The following summarize the components of revenue from the transfer of intellectual property and other for the periods presented, highlighting the impact of significant milestones, royalties, and upfront payments on our results of operations:

Year Ended December 31, 2025

•
BARDA Contract: $28.5 million recognized for ongoing performance

•
Pfizer:$31.9 million in royalty revenue, consisting of gross profit share and royalty payments for NGENLA® and Genotropin®

•
Regeneron:$7.2 million which includes $7.0 million upfront payment

•
Eli Lilly: $4.3 million in royalty revenue following the commercial launch of Mazdutide in China

•
Contract Manufacturers: $7.4 million from commercial milestones

Year Ended December 31, 2024

•
Pfizer:$30.0 million, inclusive of $28.3 million from gross profit share and royalty payments for both NGENLA® and Pfizer's Genotropin® (Somatropin)

•
BARDA Contract: $23.8 million recognized under the agreement

•
Merck:$12.5 million milestone payment under the Merck Agreement

•
Contract Manufacturers: $10.2 million from commercial milestones

Year Ended December 31, 2023

•
Pfizer:$116.7 million, which included a $90.0 million milestone payment triggered by the FDA approval of NGENLA® and $22.6 million from gross profit share and royalty payments for both NGENLA® and Pfizer's Genotropin®

•
Merck:$50.0 million in consideration for the rights granted under the Merck Agreement

•
VFMCRP:$7.0 million triggered by the German price approval for Rayaldee

•
Nicoya:$2.5 million due to the submission of the investigational new drug application to China's Center for Drug Evaluation

•
BARDA Contract: $1.2 million recognized under the agreement

•
Contract Manufacturers: $2.4 million from commercial milestones

Concentration of credit risk and allowance for doubtful accounts. Financial instruments that potentially subject us to concentrations of credit risk consist primarily of accounts receivable. Substantially all of our accounts receivable are with either companies in the health care industry or patients. However, credit risk is limited due to the number of our clients as well as their dispersion across many different geographic regions.

While we have receivables due from federal and state governmental agencies, such receivables are not a credit risk because federal and state governments fund the related healthcare programs. Payment is primarily dependent upon submitting appropriate documentation. At December 31, 2025 and 2024, receivable balances (net of explicit and implicit price concessions) from Medicare and Medicaid were 5.2% and 4.8%, respectively, of our consolidated Accounts receivable, net.

The portion of our accounts receivable due from individual patients comprises the largest portion of credit risk. At December 31, 2025 and 2024, receivables due from patients represented approximately 1.5% and 1.7%, respectively, of our consolidated accounts receivable, net.

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We assess the collectability of accounts receivable balances by considering factors such as historical collection experience, customer credit worthiness, the age of accounts receivable balances, regulatory changes and current economic conditions and trends that may affect a customer’s ability to pay. Actual results could differ from those estimates. The allowance for credit losses was $2.1 million and $1.3 million at December 31, 2025 and 2024, respectively. The credit loss expense for the years ended December 31, 2025, 2024 and 2023 was $0.8 million, $0.1 million and $0.3 million, respectively.

Accounts receivable as of December 31, 2025 and 2024 included $2.3 million and $3.6 million, respectively, of government contract revenue earned under the BARDA Contract.

Income taxes. Income taxes are accounted for under the asset-and-liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and the respective tax bases and for operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in operations in the period that includes the enactment date. We periodically evaluate the realizability of our net deferred tax assets. Our tax accruals are analyzed periodically and adjustments are made as events occur to warrant such adjustment. Valuation allowances on certain U.S. deferred tax assets and non-U.S. deferred tax assets are established, because realization of these tax benefits through future taxable income does not meet the more-likely-than-not threshold.

Equity-based compensation. We measure the cost of services received in exchange for an award of equity instruments based on the grant-date fair value of the award. That cost is recognized in the Consolidated Statements of Operations over the period during which an employee is required to provide service in exchange for the award. We record excess tax benefits, realized from the exercise of stock options, as cash flows from operations. We estimate the grant-date fair value of our stock option grants using a valuation model known as the Black-Scholes-Merton formula or the “Black-Scholes Model.” The Black-Scholes Model requires the use of several variables to estimate the grant-date fair value of stock options including expected term, expected volatility, expected dividends and risk-free interest rate. We perform analyses to calculate and select the appropriate variable assumptions used in the Black-Scholes Model. The selection of assumptions is subject to significant judgment and future changes to our assumptions and estimates which may have a material impact on our Consolidated Financial Statements.

Inventories. Inventories are valued at the lower of cost and net realizable value. Cost is determined by the first-in, first-out method. We consider such factors as the amount of inventory on hand, estimated time required to sell such inventories, remaining shelf-life, and current market conditions to determine whether inventories are stated at the lower of cost and net realizable value. Inventories at our diagnostics segment consist primarily of purchased laboratory supplies, which are used in our testing laboratories. Inventory obsolescence expense for the years ended December 31, 2025, 2024 and 2023 was $4.1 million, $2.1 million and $8.1 million, respectively.

RECENT ACCOUNTING PRONOUNCEMENTS

Accounting standards yet to be adopted.

In November 2024, the FASB issued ASU 2024-03, Income Statement (Subtopic 220-40): Disaggregation of Income Statement Expenses is effective prospectively to financial statements issued for reporting period after the effective date or retrospectively to any or all prior periods presented in the financial statements, for annual periods beginning after December 15, 2026 and interim reporting periods beginning after December 15, 2027. Early adoption is permitted. We are currently evaluating the potential impact of adopting this new guidance on our consolidated financial statements and related disclosures.

Recently adopted accounting standards.

In 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.

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In November 2024, the FASB issued ASU 2024-04, Debt (Subtopic 470-20): Debt with Conversion and Other Options. (“ASU 2024-04”) clarifies the assessment of whether a transaction should be accounted for as an induced conversion or extinguishment of convertible debt when changes are made to conversion features as part of an offer to settle the instrument. ASU 2024-04 is effective for reporting periods beginning after December 15, 2025, and interim periods within those annual reporting periods. Early adoption is permitted for entities that have adopted ASU 2020-06. We adopted ASU 2024-04 prospectively effective January 1, 2025. The adoption of ASU 2024-04 did not have a material impact on our Condensed Consolidated Financial Statements.

In November 2023, the FASB issued ASU No 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures (“ASU 2023-07”). ASU 2023-07 enhances disclosures for significant segment expenses for all public entities required to report segment information in accordance with ASC 280. ASC 280 requires a public entity to report for each reportable segment a measure of segment profit or loss that its CODM uses to assess segment performance and to make decisions about resource allocations. The Company adopted ASU 2023-07 in the fourth quarter of fiscal year 2024. This guidance was applied prospectively.

In 2021, the Organization for Economic Co-operation and Development (“OECD”) established an inclusive framework on base erosion and profit shifting and agreed on a two-pillar solution (“Pillar Two”) to global taxation, focusing on global profit allocation and a 15% global minimum effective tax rate. On December 15, 2022, the EU member states agreed to implement the OECD’s global minimum tax rate of 15%. The OECD issued Pillar Two model rules and continues to release guidance on these rules. Various participating countries have enacted or have announced plans to enact new tax laws to implement the global minimum tax, some effective beginning in 2024. We considered the applicable tax law changes on Pillar Two implementation in the relevant countries, and there is no material impact to our tax results for the period. We anticipate further legislative activity and administrative guidance, and will continue to evaluate the impacts of enacted legislation and pending legislation to enact Pillar Two Model Rules in the non-US tax jurisdictions we operate in.

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