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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 its commercialization 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
Nicoya Amendment
On April 30, 2026, EirGen entered into a second amendment to its license agreement with NICOYA Macau Limited ("Nicoya") relating to the development and commercialization of Rayaldee® in Greater China. Under the amended agreement, the parties expanded the scope of the licensed field and revised certain commercial terms. As partial consideration for the reduction in future royalty rates, EirGen received a 15% equity interest in Nicoya Therapeutics Cayman, Nicoya's parent company. We believe the transaction enhances our long-term participation in the potential value of the Rayaldee franchise in Greater China while maintaining our strategic relationship with Nicoya as it progresses toward broader commercialization in the region.
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 and six months ended June 30, 2026 are not directly comparable to the prior year periods, which included the operations of the divested assets. Under the purchase agreement in respect of the Oncology Transaction, we had been entitled
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to receive up to $32.5 million of performance based earnout consideration, and, during the second quarter of 2026, we received $18.4 million in cash, representing the total earnout amount earned and payable under such purchase agreement. No further earnout consideration is expected to be received.
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 six months ended June 30, 2026, the Company repurchased an additional 9,835,105 shares of Common Stock at an average price of $1.39 per share, for an aggregate cost of approximately $13.2 million. Of these repurchased shares, 9,310,105 were retired prior to June 30, 2026, and 525,000 were retired in July 2026. As of June 30, 2026, the total cost of repurchases under the program was approximately $105.3 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 six months ended June 30, 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 33.3% of our revenue for the six months ended June 30, 2026, was denominated in currencies other than the U.S. Dollar (USD). This compares to 24.5% 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 six months ended June 30, 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 $25.0 million and $17.6 million at June 30, 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 June 30, 2026, we held $6.8 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 JUNE 30, 2026 AND 2025
Our consolidated income from operations for the three months ended June 30, 2026 and 2025 was as follows:
For the three months ended June 30,
(In thousands) 2026 2025 Change % Change
Revenues:
Revenue from services $ 74,549 $ 101,101 $ (26,552 ) (26 )%
Revenue from products 42,941 40,743 2,198 5 %
Revenue from transfer of intellectual property and other 46,090 14,963 31,127 208 %
Total revenues 163,580 156,807 6,773 4 %
Costs and expenses:
Cost of revenue 83,563 107,405 (23,842 ) (22 )%
Selling, general and administrative 52,924 59,597 (6,673 ) (11 )%
Research and development 33,166 30,342 2,824 9 %
Amortization of intangible assets 18,969 19,444 (475 ) (2 )%
Gain on sale of assets (18,070 ) — (18,070 ) (100 )%
Total costs and expenses 170,552 216,788 (46,236 ) (21 )%
Loss from operations $ (6,972 ) $ (59,981 ) $ 53,009 88 %
Diagnostics
For the three months ended June 30,
(In thousands) 2026 2025 Change % Change
Revenues
Revenue from services $ 74,549 $ 101,101 $ (26,552 ) (26 )%
Total revenues 74,549 101,101 (26,552 ) (26 )%
Costs and expenses:
Cost of revenue 58,462 82,383 (23,921 ) (29 )%
Selling, general and administrative 26,574 33,369 (6,795 ) (20 )%
Research and development 294 484 (190 ) (39 )%
Amortization of intangible assets 2,533 3,029 (496 ) (16 )%
Gain on sale of assets (18,070 ) — (18,070 ) (100 )%
Total costs and expenses 69,793 119,265 (49,472 ) (41 )%
Loss from operations $ 4,756 $ (18,164 ) $ 22,920 126 %
Revenue. Revenue from services for the three months ended June 30, 2026 decreased by approximately $26.6 million, a decrease of 26.3% compared to the same period in 2025. This decline was primarily attributable to a $24.9 million reduction in revenue resulting from the completion of the Oncology Transaction in September 2025. The remaining $1.7 million decreased primarily due to test mix changes as we continued to see the impact of shifting certain unprofitable but higher priced esoteric testing to our strategic partners.
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 June 30, 2026, we recorded $0.9 million of negative revenue adjustments due to changes in estimates of implicit price concessions for performance obligations satisfied in prior periods, primarily due to shifts in the composition of our client and patient pay mix. For the three months ended June 30, 2025, we recorded $0.8 million of positive revenue adjustments due to changes in estimates of implicit price concessions for performance obligations satisfied in prior periods, mainly due to the composition of client pay mix.
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The composition of revenue from services by payor for the three months ended June 30, 2026 and 2025 was as follows:
Three months ended June 30,
(In thousands) 2026 2025
Healthcare insurers $ 49,990 $ 58,478
Government payers 9,169 17,102
Client payers 13,132 23,168
Patients 2,258 2,353
Total $ 74,549 $ 101,101
Cost of revenue. Cost of revenue for the three months ended June 30, 2026 decreased $23.9 million, a decrease of 29.0% compared to the three months ended June 30, 2025. Of this decrease, $23.1 million was due to the divestiture effected by the Oncology Transaction in September 2025. The remaining decrease was primarily attributable to a reduction in clinical activity costs driven by lower testing volumes.
Selling, general and administrative expenses. Selling, general and administrative expenses for the three months ended June 30, 2026 and 2025 were $26.6 million and $33.4 million, respectively, representing a decrease of 20.4% from the prior period. This decrease was driven by a $6.8 million reduction in costs associated with divested operations.
Research and development expenses. The following table summarizes the components of our research and development expenses:
Research and Development Expenses Three months ended June 30,
(In thousands) 2026 2025
Research and development employee-related expenses $ 144 $ 310
Other internal research and development expenses 150 174
Total research and development expenses $ 294 $ 484
The decrease in research and development expenses for the three months ended June 30, 2026 as compared to 2025 was primarily due to continued cost-reduction initiatives implemented at BioReference.
Amortization of intangible assets. Amortization of intangible assets was $2.5 million and $3.0 million, respectively, for the three months ended June 30, 2026 and 2025. This decrease was primarily due to the removal of amortizable intangible assets associated with the Oncology Transaction that closed during September 2025.
Gain on sale of assets. Gain on sale of assets for the three months ended June 30, 2026 was $18.1 million. This net gain comprised of $18.4 million representing the full amount of earnout consideration payable in connection with the Oncology Transaction, partially offset by approximately $0.3 million in related transaction costs.
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Pharmaceuticals
For the three months ended June 30,
(In thousands) 2026 2025 Change % Change
Revenues:
Revenue from products $ 42,941 $ 40,743 $ 2,198 5 %
Revenue from transfer of intellectual property and other 46,090 14,963 31,127 208 %
Total revenues 89,031 55,706 33,325 60 %
Costs and expenses:
Cost of revenue 25,101 25,022 79 0 %
Selling, general and administrative 13,916 13,197 719 5 %
Research and development 32,739 29,778 2,961 10 %
Amortization of intangible assets 16,436 16,415 21 0 %
Total costs and expenses 88,192 84,412 3,780 4 %
Loss from operations $ 839 $ (28,706 ) $ 29,545 103 %
Revenue from products. Revenue from products for the three months ended June 30, 2026 increased $2.2 million, or 5.4%, compared to the three months ended June 30, 2025. The increase was primarily driven by higher revenue within our Spanish and Mexican operations, as well as higher revenue from Rayaldee, which increased to $8.1 million for the three months ended June 30, 2026, compared to $7.2 million for the same period in 2025, primarily due to favorable gross-to-net adjustments. Revenue from our international operations benefited from a $1.8 million favorable impact from foreign currency exchange rates, predominantly related to our operations in Chile and Mexico, which was partially offset by a decrease of approximately $1.7 million in product revenue from other international operations, primarily related to our Ireland CDMO business.
Revenue from transfer of intellectual property and other. Revenue from intellectual property and other increased by $31.1 million to $46.1 million for the three months ended June 30, 2026 from $15.0 million for the same period last year. The increase was primarily driven by $29.4 million in revenue recognized from Series A-2 Preferred Shares received in connection with our investment in Nicoya (refer to Note 14 to our consolidated financial statements contained in this Quarterly Report on Form 10-Q), alongside higher royalty income and collaboration revenue. Royalty revenue included $6.4 million from NGENLA®, compared to $6.1 million in the 2025 period, and $3.2 million from Eli Lilly. Additionally, we recognized $1.1 million in collaboration revenue from Regeneron for the three months ended June 30, 2026. These increases were partially offset by a decrease in revenue recognized under the BARDA contract, which totaled $5.0 million for the three months ended June 30, 2026 compared to $6.5 million for the same period in 2025, as well as a $1.3 million decrease in contract manufacturers’ commercial milestones.
Cost of revenue. Cost of revenue for the three months ended June 30, 2026 increased $0.1 million, or 0.3%, compared to the three months ended June 30, 2025. The net increase was primarily driven by a $1.1 million unfavorable impact from foreign currency exchange rates, along with higher costs associated with our operations in Mexico and Spain resulting from higher sales volumes. These increases were offset by lower costs within our operations in Chile and Finetech, primarily driven by lower sales volumes.
Selling, general and administrative expenses. Selling, general and administrative expenses for the three months ended June 30, 2026 and 2025 were $13.9 million and $13.2 million, respectively, an increase of 5.4% from the prior year period. This increase was primarily driven by a $0.4 million unfavorable impact from foreign currency exchange rates and slightly higher employee-related costs across our pharmaceutical operations.
Research and development expenses. Research and development expenses for the three months ended June 30, 2026 and 2025 were $32.7 million and $29.8 million, respectively, an increase of 9.9% from the prior year period. 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 Three months ended June 30,
(In thousands) 2026 2025
External expenses:
Manufacturing expense for biological products $ 10,173 $ 10,999
Phase 3 studies — 15
Post-marketing studies 2 6
Earlier-stage programs 9,307 8,524
Research and development employee-related expenses 11,131 10,173
Other internal research and development expenses 2,214 1,848
Third-party grants and funding from collaboration agreements (88 ) (1,787 )
Total research and development expenses $ 32,739 $ 29,778
This overall increase reflects our continued strategic investment in our pre-clinical pipeline, partially offset by the timing of activities and program discontinuations under the BARDA contract. This increase was primarily driven by a $1.7 million reduction in third-party grants and funding from collaboration agreements compared to the prior year period. Additionally, the net increase was driven by a $1.0 million increase in employee-related expenses, an $0.8 million increase in external expenditures related to our earlier-stage programs, and a $0.4 million increase in other internal research and development expenses. These increases were partially offset by an $0.8 million decrease in manufacturing expenses for biological products, which was largely associated with the timing of activities and program discontinuations under the BARDA COVID and BARDA FLU contract.
Amortization of intangible assets. Amortization of intangible assets was $16.4 million and $16.1 million for the three months ended June 30, 2026 and 2025. The 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 by the FDA, the 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. The assets will be amortized on a straight-line basis over their estimated useful life of approximately 12 years.
Corporate
For the three months ended June 30,
(In thousands) 2026 2025 Change % Change
Costs and expenses:
Selling, general and administrative $ 12,434 $ 13,031 $ (597 ) (5 )%
Research and development 133 80 53 66 %
Total costs and expenses 12,567 13,111 (544 ) (4 )%
Loss from operations $ (12,567 ) $ (13,111 ) $ 544 4 %
Operating loss for our unallocated corporate operations was $12.6 million for the three months ended June 30, 2026, compared to $13.1 million for the same period in 2025. While these results primarily reflect general and administrative expenses incurred in connection with our corporate operations, the slight decrease in the loss was primarily driven by lower employee-related expenses compared to the prior year period.
Other
Interest income. Interest income for the three months ended June 30, 2026 and 2025 was $3.2 million and $3.3 million, respectively. The decrease in interest income was primarily driven by lower average interest rates and a lower average balance of cash and cash equivalents invested during the 2026 period compared to the prior year period.
Interest expense. Interest expense decreased to $11.4 million for the three months ended June 30, 2026, compared to $70.3 million for the same period of 2025. The decrease was primarily attributable to the absence of $59.1 million in charges recorded in the 2025 period, which consisted of 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 to our condensed consolidated financial statements contained in this Quarterly Report on Form 10-Q).
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Fair value changes of derivative instruments, net. Fair value changes of derivative instruments, net for the three months ended June 30, 2026 and 2025, was $65.0 thousand of expense and $16.0 thousand of income, respectively. This was principally related to foreign currency forward exchange contracts at OPKO Chile.
Other income (expense), net. Other income (expense), net changed by $37.3 million to a $1.8 million income for the three months ended June 30, 2026 compared to $35.5 million of expense for the prior year period. This was primarily driven by the absence of a $32.6 million inducement expense recorded in the 2025 period related to the Note Exchange Transactions (as defined in Note 7 to our condensed consolidated financial statements contained in this Quarterly Report on Form 10-Q). In addition, foreign currency impacts improved by $2.7 million, moving from a $2.6 million expense in the prior year period to $0.1 million of income in the current period.
Income tax benefit. Our income tax benefit for the three months ended June 30, 2026 and 2025 was $5.0 million and $14.1 million, respectively. 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.
FOR THE SIX MONTHS ENDED JUNE 30, 2026 AND 2025
Our consolidated income from operations for the six months ended June 30, 2026 and 2025 was as follows:
For the six months ended June 30,
(In thousands) 2026 2025 Change % Change
Revenues:
Revenue from services $ 146,735 $ 203,945 $ (57,210 ) (28 )%
Revenue from products 80,984 75,585 5,399 7 %
Revenue from transfer of intellectual property and other 60,058 27,229 32,829 121 %
Total revenues 287,777 306,759 (18,982 ) (6 )%
Costs and expenses:
Cost of revenue 162,003 214,737 (52,734 ) (25 )%
Selling, general and administrative 101,531 118,683 (17,152 ) (14 )%
Research and development 62,365 61,183 1,182 2 %
Amortization of intangible assets 37,935 39,304 (1,369 ) (3 )%
Gain on sale of assets (18,070 ) — (18,070 ) (100 )%
Total costs and expenses 345,764 433,907 (88,143 ) (20 )%
Loss from operations $ (57,987 ) $ (127,148 ) $ 69,161 54 %
Diagnostics
For the six months ended June 30,
(In thousands) 2026 2025 Change % Change
Revenues
Revenue from services $ 146,735 $ 203,945 $ (57,210 ) (28 )%
Total revenues 146,735 203,945 (57,210 ) (28 )%
Costs and expenses:
Cost of revenue 114,604 166,901 (52,297 ) (31 )%
Selling, general and administrative 52,725 71,325 (18,600 ) (26 )%
Research and development 606 1,022 (416 ) (41 )%
Amortization of intangible assets 5,066 6,779 (1,713 ) (25 )%
Gain on sale of assets (18,070 ) — (18,070 ) (100 )%
Total costs and expenses 154,931 246,027 (91,096 ) (37 )%
Loss from operations $ (8,196 ) $ (42,082 ) $ 33,886 81 %
Revenue. Revenue from services for the six months ended June 30, 2026 decreased by approximately $57.2 million, a decrease of 28.1% compared to the same period in 2025. This decline was primarily attributable to a $50.8 million reduction in revenue resulting from the completion of the Oncology Transaction in September 2025. The remaining $6.4 million decreased
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primarily due to test mix changes as we continued to see the impact of shifting certain unprofitable but higher priced esoteric testing to our strategic partners.
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 six months ended June 30, 2026, we recorded $0.1 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 six months ended June 30, 2025, we recorded $0.7 million of negative revenue adjustments due to changes in estimated implicit price concessions for services provided in prior periods, primarily due to shifts in the composition of our client mix.
The composition of revenue from services by payor for the six months ended June 30, 2026 and 2025 was as follows:
Six months ended June 30,
(In thousands) 2026 2025
Healthcare insurers $ 94,566 $ 116,130
Government payers 18,824 34,257
Client payers 28,790 48,448
Patients 4,555 5,110
Total $ 146,735 $ 203,945
Cost of revenue. Cost of revenue for the six months ended June 30, 2026 decreased $52.3 million, a decrease of 31.3% compared to the six months ended June 30, 2025. Of this decrease, $47.9 million was due to the divestiture of effected by the Oncology Transaction in September 2025. The remaining $4.4 million decrease was primarily attributable to a reduction in clinical activity costs driven by lower testing volumes and from continued cost-reduction initiatives.
Selling, general and administrative expenses. Selling, general and administrative expenses for the six months ended June 30, 2026 and 2025 were $52.7 million and $71.3 million, respectively, representing a decrease of 26.1% from the prior period. This decrease was primarily driven by a $12.7 million reduction in costs associated with divested operations and a $5.9 million decrease resulting from continued cost-reduction initiatives, particularly in lease-related expenses.
Research and development expenses. The following table summarizes the components of our research and development expenses:
Research and Development Expenses Six months ended June 30,
2026 2025
Research and development employee-related expenses $ 288 $ 630
Other internal research and development expenses 318 392
Total research and development expenses $ 606 $ 1,022
The decrease in research and development expenses for the six months ended June 30, 2026 as compared to 2025 was primarily due to continued cost-reduction initiatives implemented at BioReference.
Amortization of intangible assets. Amortization of intangible assets was $5.1 million and $6.8 million, respectively, for the six months ended June 30, 2026 and 2025. This decrease was primarily due to the removal of amortizable intangible assets associated with the Oncology Transaction that closed during September 2025.
Gain on sale of assets. Gain on sale of assets for the six months ended June 30, 2026 was $18.1 million. This net gain was comprised of $18.4 million representing the full amount of earnout consideration under the Oncology Transaction, partially offset by approximately $0.3 million in related transaction costs.
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Pharmaceuticals
For the six months ended June 30,
(In thousands) 2026 2025 Change % Change
Revenues:
Revenue from products $ 80,984 $ 75,585 $ 5,399 7 %
Revenue from transfer of intellectual property and other 60,058 27,229 32,829 121 %
Total revenues 141,042 102,814 38,228 37 %
Costs and expenses:
Cost of revenue 47,399 47,836 (437 ) (1 )%
Selling, general and administrative 28,121 25,907 2,214 9 %
Research and development 61,492 60,016 1,476 2 %
Amortization of intangible assets 32,869 32,525 344 1 %
Total costs and expenses 169,881 166,284 3,597 2 %
Loss from operations $ (28,839 ) $ (63,470 ) $ 34,631 55 %
Revenue from products. Revenue from products for the six months ended June 30, 2026 increased $5.4 million, or 7.1%, compared to the six months ended June 30, 2025. The increase was primarily driven by higher sales volumes in our Spanish and Mexican operations, as well as higher revenue from Rayaldee, which increased $0.9 million to $14.4 million for the six months ended June 30, 2026, compared to $13.5 million for the same period in 2025, primarily due to favorable gross-to-net adjustments. Revenue from our international operations benefited from a $4.9 million favorable impact from foreign currency exchange rates, predominantly related to our operations in Chile and Mexico. These positive factors were partially offset by lower product revenue from other international operations, primarily related to our Ireland CDMO business.
Revenue from transfer of intellectual property and other. Revenue from intellectual property and other increased by $32.8 million to $60.1 million for the six months ended June 30, 2026, from $27.2 million for the same period last year. The increase was primarily driven by $29.4 million in revenue recognized from shares received in connection with our investment in Nicoya (refer to Note 6 and Note 14 to our consolidated financial statements in this Quarterly Report on Form 10-Q), alongside higher royalty income and collaboration revenue. Royalty revenue included $12.8 million from NGENLA®, compared to $10.6 million in the 2025 period, and $4.6 million from Eli Lilly. Additionally, we recognized $2.1 million in collaboration revenue from Regeneron during the six months ended June 30, 2026. These increases were partially offset by a decrease in revenue recognized under the BARDA contract, which totaled $9.0 million in the six months ended June 30, 2026 compared to $13.5 million for the same period in 2025, as well as a $0.8 million decrease in contract manufacturers’ commercial milestones.
Cost of revenue. Cost of revenue for the six months ended June 30, 2026 decreased $0.4 million, or 0.9%, compared to the six months ended June 30, 2025. This decrease was primarily driven by lower production costs and operational efficiencies within our international manufacturing platforms. These savings were largely offset by a $3.4 million unfavorable impact from foreign currency exchange rates.
Selling, general and administrative expenses. Selling, general and administrative expenses for the six months ended June 30, 2026 and 2025 were $28.1 million and $25.9 million, respectively, an increase of 8.5% from the prior year period. This increase was primarily driven by a $1.5 million unfavorable impact from foreign currency exchange rates and slightly higher employee-related costs across our pharmaceutical operations.
Research and development expenses. Research and development expenses for the six months ended June 30, 2026 and 2025 were $61.5 million and $60.0 million, respectively, an increase of 2.5% from the prior year period. 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 Six months ended June 30,
(In thousands) 2026 2025
External expenses:
Manufacturing expense for biological products $ 15,092 $ 23,901
Phase III studies 1,735 49
Post-marketing studies 146 38
Earlier-stage programs 18,805 15,164
Research and development employee-related expenses 21,611 19,792
Other internal research and development expenses 4,377 3,933
Third-party grants and funding from collaboration agreements (274 ) (2,861 )
Total research and development expenses $ 61,492 $ 60,016
The increase in research and development expenses reflects our continued strategic investment in our clinical and pre-clinical pipeline. This increase was primarily driven by a $3.6 million increase in external expenditures related to our earlier-stage programs, a $1.8 million increase in employee-related expenses, and a $1.7 million increase related to Phase III studies. Additionally, net expenses increased due to a $2.6 million reduction in third-party grants and funding from collaboration agreements compared to the prior year period. These increases were partially offset by an $8.8 million decrease in manufacturing expenses for biological products, which was largely driven by the timing of activities and a reduction in expenditures associated with the discontinuations under the BARDA COVID and BARDA FLU programs.
Amortization of intangible assets. Amortization of intangible assets was $32.9 million and $32.5 million for the six months ended June 30, 2026 and 2025, respectively. The 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 by the FDA, the 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. The assets will be amortized on a straight-line basis over their estimated useful life of approximately 12 years.
Corporate
For the six months ended June 30,
(In thousands) 2026 2025 Change % Change
Costs and expenses:
Selling, general and administrative $ 20,685 $ 21,451 $ (766 ) (4 )%
Research and development 267 145 122 84 %
Total costs and expenses 20,952 21,596 (644 ) (3 )%
Loss from operations $ (20,952 ) $ (21,596 ) $ 644 3 %
Operating loss for our unallocated corporate operations was $21.0 million for the six months ended June 30, 2026, compared to $21.6 million for the same period in 2025. While these results primarily reflect general and administrative expenses incurred in connection with our corporate operations, the slight decrease in the loss was primarily driven by lower employee-related expenses compared to the prior year period.
Other
Interest income. Interest income for the six months ended June 30, 2026 and 2025 was $6.2 million and $8.0 million, respectively. The decrease in interest income was primarily driven by lower average interest rates and a lower average balance of cash and cash equivalents invested during the 2026 period compared to the prior year period.
Interest expense. Interest expense decreased to $22.3 million for the six months ended June 30, 2026, compared to $85.8 million for the same period of 2025. The decrease was primarily attributable to the absence of $59.1 million in charges recorded in the 2025 period, which consisted of 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 to our condensed consolidated financial statements contained in this Quarterly Report on Form 10-Q). The overall decrease was further driven by a $3.6 million reduction in regular interest expense incurred on the 2029 Notes. Additionally, interest expense related to our 2044 Royalty Financing Notes and other international credit facilities decreased by approximately $0.7 million in the aggregate compared to the prior year period, primarily reflecting the impact of lower principal balances and the related amortization of deferred financing and debt issuance costs.
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Fair value changes of derivative instruments, net. Fair value changes of derivative instruments, net for the six months ended June 30, 2026 and 2025, was $0.4 million and $0.3 million of expense, respectively. Derivative expense was principally related to foreign currency forward exchange contracts at OPKO Chile.
Other income (expense), net. Other income (expense), net changed by $30.7 million to $0.1 million of income for the six months ended June 30, 2026, compared to $30.7 million of expense for the prior year period. This was primarily driven by the absence of a $32.6 million inducement expense recorded in the 2025 period related to the Note Exchange Transactions (as defined in Note 7 to our condensed consolidated financial statements contained in this Quarterly Report on Form 10-Q). Additionally, there was a $3.4 million positive shift in foreign currency impacts, which moved from a $2.0 million loss in the 2025 period to a $1.4 million gain in the current period. These favorable changes were partially offset by the non-recurrence of a $3.9 million gain from the sale of our remaining investment in GeneDx Holdings Corp. which we recognized in the 2025 period.
Income tax benefit. Our income tax benefit for the six months ended June 30, 2026 and 2025 was $11.1 million and $19.8 million, respectively. 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.
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LIQUIDITY AND CAPITAL RESOURCES
On June 30, 2026, we had cash, cash equivalents and restricted cash of approximately $314.4 million. Cash used in operations of $62.8 million for the six months ended June 30, 2026 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 $13.7 million for the six months ended June 30, 2026,which primarily included $18.4 million in earnout consideration received from Labcorp in connection with the Oncology Transaction, partially offset by capital expenditures of $4.8 million. Cash used in financing activities for the six months ended June 30, 2026 was $18.2 million, which primarily reflected the repurchase of Common Stock for $17.8 million, partially offset by net borrowings on our lines of credit of $0.1 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, sale of assets, as well as credit facilities available to us.
On September 15, 2025, we consummated the Oncology Transaction, pursuant to which Labcorp acquired BioReference’s oncology diagnostics and related clinical testing services assets for total consideration of $192.5 million, consisting of $173.3 million in cash and $19.2 million held in escrow. As of June 30, 2026, the escrow balance was $19.7 million, including accrued interest, and is scheduled to be released to the Company on September 15, 2026, net of any indemnification obligations.
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. Approximately $105.3 million of Common Stock had been repurchased under the existing 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, pursuant to which 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. This debt retirement significantly reduced our long-term debt obligations and resulted in lower ongoing interest expense for the current period.
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 June 30, 2026, the aggregate amount remaining to be funded by BARDA, which is subject to performance obligations and excluding unexercised contract options, was $40.9 million.
On July 17, 2024, the Company completed a private offering of $250.0 million aggregate principal amount of the 2044 Royalty Financing Notes. The 2044 Royalty Financing Notes are secured by the Company’s profit share payments from Pfizer under the Restated Pfizer Agreement. The 2044 Royalty Financing Notes bear interest at the three-month SOFR subject to a 4.0% per annum floor, plus 7.5% per annum. The 2044 Royalty Financing Notes mature in July 2044, with interest-only payments required for the first four years of the term.
As of June 30, 2026, the total commitments under our lines of credit with financial institutions in Chile and Spain were $30.4 million, of which $9.6 million was drawn as of June 30, 2026. On June 30, 2026, the weighted 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 six months ended June 30, 2026 was $9.9 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 will be impacted by the successful achievement of various milestones and the generation of royalty revenues under our existing collaboration and licensing agreements. As of June 30, 2026, the potential payments from these agreements are as follows:
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Merck Agreement:
•Milestone Potential: Eligible for up to an additional $860.0 million upon achieving certain commercial and development milestones under several indications.
•Royalties: 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)
•Historical Milestone: In January 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:
•Milestone Potential: Eligible to receive $50.0 million in regulatory milestones.
•Profit Sharing: Eligible to receive regional, tiered gross profit sharing for both NGENLA® and Pfizer’s Genotropin®.
VFMCRP Agreement:
•Milestone Potential: Eligible to receive up to an additional $15 million in regulatory milestones and $200 million in payments tied to the launch, pricing, and sales of Rayaldee.
•Royalties: Eligible to receive tiered, double-digit royalty payments on future sales.
•Historical Milestones: Received a $7 million regulatory milestone payment in the first quarter of 2023, triggered by the German price approval for Rayaldee and received a $3 million regulatory milestone payment in 2022 following the first sale of Rayaldee in Europe.
Nicoya Agreement:
•Milestone Potential: 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.
•Remaining Payments: Of the $5 million tied to the first anniversary of the effective date of the Nicoya Agreement, $2.5 million remains eligible to be received.
•Royalties: Following the April 2026 Second Amendment, EirGen remains eligible to receive tiered royalty payments on net product sales of the Nicoya Product in the Nicoya Territory.
•Historical Activity: Received a $5.0 million upfront payment and an additional $2.5 million in March 2023 upon Nicoya’s submission of an IND application in China.
Eli Lilly Agreement:
•Royalties: Eligible to receive 3% royalty of Mazdutide world wide net sales.
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” of the Form 10-K.
We believe that the cash, cash equivalents and restricted cash on hand on June 30, 2026 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
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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 June 30, 2026, with respect to the amounts and timing of our known contractual obligation payments due by period.
Contractual obligations Remaining six months ending
(In thousands) December 31, 2026 2027 2028 2029 2030 Thereafter Total
Open purchase orders $ 40,163 $ 717 $ — $ — $ — $ — $ 40,880
Operating leases 5,771 9,978 8,202 6,456 5,075 9,507 44,989
Finance leases 739 1,063 208 205 205 1,623 4,043
2029 and 2033 Convertible Notes — — — 89,807 — 50 89,857
2044 Royalty Financing — — — — — 246,854 246,854
Mortgages and other debts payable 495 838 854 506 — — 2,693
Lines of credit 10,558 — — — — — 10,558
Interest commitments 2,351 4,651 4,647 193 — — 11,842
Total $ 60,077 $ 17,247 $ 13,911 $ 97,167 $ 5,280 $ 258,034 $ 451,716
The preceding table does not include information with respect to the amounts of obligations that 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
There were no material changes to our critical accounting policies and estimates described in our Form 10-K that have had a material impact on our Quarterly Financials and related notes.
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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 November 2024, the FASB issued ASU 2024-04, Debt (Subtopic 470-20): Debt with Conversion and Other Options. (“ASU 2024-04”) clarifies the assessment of whether a transaction should be accounted for as an induced conversion or extinguishment of convertible debt when changes are made to conversion features as part of an offer to settle the instrument. ASU 2024-04 is effective for reporting periods beginning after December 15, 2025, and interim periods within those annual reporting periods. Early adoption is permitted for entities that have adopted ASU 2020-06. We adopted ASU 2024-04 prospectively effective January 1, 2025. The adoption of ASU 2024-04 did not have a material impact on our Condensed Consolidated Financial Statements.
In December 2023, the FASB issued ASU No. 2023-09, “Income Taxes (Topic 740): Improvements to Income Tax Disclosures” (“ASU 2023-09”), which modifies the rules on income tax disclosures to require entities to disclose (i) specific categories in the rate reconciliation, (ii) the income or loss from continuing operations before income tax expense or benefit (separated between domestic and foreign) and (iii) income tax expense or benefit from continuing operations (separated by federal, state and foreign). ASU 2023-09 also requires entities to disclose their income tax payments to international, federal, state, and local jurisdictions, among other changes. The guidance is effective for annual periods beginning after December 15, 2024. Early adoption is permitted for annual financial statements that have not yet been issued or made available for issuance. ASU 2023-09 should be applied on a prospective basis, but retrospective application is permitted. The Company adopted ASU 2023-09 in the fourth quarter of fiscal year 2025. This guidance was applied prospectively.
In November 2023, the FASB issued ASU No 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures (“ASU 2023-07”). ASU 2023-07 enhances disclosures for significant segment expenses for all public entities required to report segment information in accordance with ASC 280. ASC 280 requires a public entity to report for each reportable segment a measure of segment profit or loss that its CODM uses to assess segment performance and to make decisions about resource allocations. The Company adopted ASU 2023-07 in the fourth quarter of fiscal year 2024. This guidance was applied prospectively. The adoption of ASU 2023-07 did not have a material impact on our Condensed Consolidated Financial Statements.
In 2021, the Organization for Economic Co-operation and Development (“OECD”) established an inclusive framework on base erosion and profit shifting and agreed on a two-pillar solution (“Pillar Two”) to global taxation, focusing on global profit allocation and a 15% global minimum effective tax rate. On December 15, 2022, the EU member states agreed to implement the OECD’s global minimum tax rate of 15%. The OECD issued Pillar Two model rules and continues to release guidance on these rules. Various participating countries have enacted or have announced plans to enact new tax laws to implement the global minimum tax, some effective beginning in 2024. We considered the applicable tax law changes on Pillar Two implementation in the relevant countries, and there is no material impact to our tax results for the period. We anticipate further legislative activity and administrative guidance, and will continue to evaluate the impacts of enacted legislation and pending legislation to enact Pillar Two Model Rules in the non-US tax jurisdictions we operate in.
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