OPKO HEALTH, INC.
For the period ended Sep 30, 2026. Filed Nov 4, 2026.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2026 · Filed Nov 4, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2026-06-30; filed 2026-07-27.
0001193125-26-318090
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-09-30; filed 2026-11-04.
0001193125-26-447364
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 123 previous paragraphs and 121 current paragraphs.
42 unchanged; 34 reworded; 45 added; 46 removed; 1 previous and 0 current paragraphs rearranged.
Tables are not compared: 15 previous and 13 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (45)
Current report
We are a biopharmaceutical company focused on two complementary business platforms: Global Products and Innovative Biotech. Through our Global Products platform, we develop, manufacture and commercialize pharmaceutical products and services through established operations in the United States, Ireland, Spain, Chile and Mexico. Through our Innovative Biotech platform, we advance proprietary therapeutic programs, intellectual property assets and strategic collaborations intended to address significant unmet medical needs. We seek to create long-term shareholder value through a balanced business model that combines revenue-generating pharmaceutical operations with a portfolio of innovative biotechnology opportunities. Consistent with this strategy, management evaluates and manages the business through these two platforms.
Current report
Our Innovative Biotech platform includes proprietary development programs, intellectual property assets, strategic collaborations, royalty interests and next-generation therapeutic technologies. We have partnered with Pfizer Inc. (“Pfizer”) for the development and commercialization of NGENLA® (somatrogon-ghla), a once-weekly human growth hormone therapy that has received regulatory approvals in more than 50 countries worldwide. Through our subsidiary, ModeX Therapeutics, Inc. (“ModeX”), we are advancing a portfolio of multispecific antibody and immunotherapy candidates focused on oncology and infectious diseases. Our Innovative Biotech platform also includes biologics research, development-stage therapeutic programs and other opportunities intended to create future value through innovation, strategic partnerships and potential commercialization.
Current report
Planned Sale of Remaining BioReference Diagnostic Operations
Current report
On September 30, 2026, our Board of Directors approved a plan to sell substantially all of the remaining diagnostic operations of BioReference Health, LLC ("BioReference") to Laboratory Corporation of America Holdings (“Labcorp”). On October 14, 2026, we entered into an Asset Purchase Agreement with Labcorp relating to the transaction. The planned disposition includes certain assets of BioReference's clinical and anatomic pathology laboratory testing business, including assets associated with clinical and women's health testing services, urology, corrections and BioReference's proprietary 4Kscore® prostate cancer test, together with certain liabilities related to those operations. The transaction excludes specified assets and liabilities that will remain with us following completion of the sale. Accordingly, the results of our diagnostic operations have been classified as discontinued operations and are presented separately from continuing operations in the accompanying condensed consolidated financial statements for all periods presented. See Note 2 to our condensed consolidated financial statements contained in this Quarterly Report on Form 10-Q for additional information regarding the transaction and discontinued operations presentation.
Current report
2044 Royalty Financing Notes Amendment
Current report
On August 13, 2026, we entered into a First Amendment to the Note Purchase Agreement governing our senior secured royalty notes (the "2044 Royalty Financing Notes"). Pursuant to the amendment, the purchasers acquired an additional $125.0 million aggregate principal amount of senior secured royalty notes, increasing the aggregate principal amount of the facility to $375.0 million. The amendment also expanded the repayment and collateral framework to include certain royalty payments receivable under our license agreement with Eli Lilly and Company ("Eli Lilly") related to Mazdutide. We believe the net proceeds from the issuance and sale of the additional notes enhance our liquidity and financial flexibility while supporting the continued advancement of our product portfolio.
Current report
During the second quarter of 2026, we received $18.4 million of earnout consideration related to the September 2025 sale of BioReference's oncology diagnostics business to Labcorp. During the third quarter of 2026, we received approximately $19.8 million from the release of escrow funds retained in connection with that transaction. No additional earnout consideration is expected to be received.
Current report
The U.S. trade environment has experienced changes in 2026, including changes in tariffs applicable to certain imported pharmaceutical products. In April 2026, the U.S. government issued a presidential proclamation establishing tariffs on certain patented pharmaceutical products and related pharmaceutical ingredients imported into the United States. Under the current framework, certain qualifying imports from the European Union are generally subject to a 15% tariff rate.
Current report
Total Revenue. Total revenue increased approximately $9.0 million, or 16%, to $65.4 million for the three months ended September 30, 2026, compared to $56.4 million for the same period in 2025. The increase was primarily attributable to higher royalty revenue from Eli Lilly, increased sales of Rayaldee and growth in our international operations.
Current report
Loss from operations. Loss from operations decreased $2.1 million, or 6%, to $31.4 million for the three months ended September 30, 2026, compared with $33.6 million for the same period in 2025. The improvement was primarily attributable to stronger operating results within our Global Products segment, partially offset by increased research and development expenditures associated with our innovative pipeline programs.
Current report
Operating Income. Operating income from Global Products increased to $6.0 million for the three months ended September 30, 2026, as compared to an operating loss of $1.2 million for the same period in 2025. The improvement was primarily attributable to stronger operating results within our Global Products segment, driven by higher royalty revenue from Eli Lilly, increased sales of Rayaldee and growth in our international operations. Operating income included approximately $1.9 million of depreciation expense, $4.2 million of amortization expense and $0.2 million of equity-based compensation expense. Foreign currency fluctuations had an approximately $0.1 million unfavorable impact on operating results during the period.
Current report
Licensing, collaboration and other revenue. Licensing, collaboration and other revenue increased by $4.9 million to $6.6 million for the three months ended September 30, 2026 from $1.8 million for the same period in 2025. The increase was primarily attributable to $5.8 million of royalty revenue recognized from Eli Lilly. This increase was partially offset by lower contract manufacturers' commercial milestone revenue recognized by EirGen compared to the same period in 2025.
Current report
Cost of revenue. Cost of revenue increased by $2.0 million, or 9%, for the three months ended September 30, 2026, as compared to the same period in 2025. The increase was primarily attributable to higher costs at EirGen resulting from increased sales volumes, changes in product mix, and higher services, repairs and maintenance expenses. The increase also reflected higher product costs associated with increased Rayaldee sales. Included in the increase was an approximately $0.5 million unfavorable impact from foreign currency fluctuations, primarily due to the appreciation of the Chilean peso and Mexican peso relative to USD.
Current report
Selling, general and administrative expenses. Selling, general and administrative expenses for the three months ended September 30, 2026 and 2025 were $13.3 million and $11.7 million, respectively, representing an increase of $1.6 million, or 14%, from the prior-year period. The increase was primarily attributable to higher personnel-related expenses and increased commercial and administrative spending, including higher freight and distribution costs. These increases were partially offset by lower personnel-related costs associated with reduced headcount in certain operations.
Current report
Research and development expenses. Research and development expenses for the three months ended September 30, 2026 and 2025 were $1.6 million and $3.3 million, respectively, representing a decrease of $1.7 million, or 51%, from the prior-year period. The decrease was primarily attributable to the recognition of a $1.4 million Irish research and development tax credit by EirGen during the three months ended September 30, 2026, which offset research and development expense for the period.
Current report
Amortization of intangible assets. Amortization of intangible assets was $4.2 million and $4.3 million for the three months ended September 30, 2026 and 2025, respectively. Amortization expense remained relatively consistent period over period. The slight decrease was primarily attributable to the impact of foreign currency fluctuations on intangible assets denominated in foreign currencies.
Current report
Loss from operations. Loss from operations increased $4.3 million for the three months ended September 30, 2026 compared to the same period in 2025, primarily due to increased investment in our ModeX development programs. Operating results included approximately $0.6 million of depreciation expense, $12.3 million of amortization expense, primarily related to the human growth hormone intangible asset, and $0.6 million of equity-based compensation expense. Foreign currency fluctuations had an immaterial favorable impact on operating results during the period.
Current report
Licensing, collaboration and other revenue. Licensing, collaboration and other revenue for the three months ended September 30, 2026 and 2025 was $17.0 million for both periods. Lower revenue recognized under the contract awarded to ModeX by the Biomedical Advanced Research and Development Authority (“BARDA”) (as amended, the “BARDA Contract”) was substantially offset by collaboration revenue recognized under our agreement with Regeneron Pharmaceuticals Inc. (“Regeneron”). Royalty revenue recognized from Pfizer remained relatively consistent with the prior-year period.
Current report
Cost of revenue. Cost of revenue for the three months ended September 30, 2026 and 2025 was immaterial.
Current report
Selling, general and administrative expenses. Selling, general and administrative expenses for the three months ended September 30, 2026 and 2025 were $1.1 million and $0.9 million, respectively, representing an increase of $0.2 million, or 27%, from the prior-year period. The increase was primarily driven by higher employee-related costs.
Current report
Research and development expenses. Research and development expenses for the three months ended September 30, 2026 and 2025 were $30.4 million and $26.3 million, respectively, representing an increase of $4.1 million, or 16%, from the prior-year period. The increase was primarily attributable to increased investment in our ModeX development programs as these programs continued to advance through preclinical and clinical development activities, as well as higher employee-related expenses supporting these programs. These increases were partially offset by lower manufacturing expenses for biological products.
Current report
Research and development expenses include external and internal expenses, partially offset by third-party grants and funding. External expenses include clinical and non-clinical activities performed by contract research organizations, lab services, manufacturing activities and other development costs. 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.
Current report
Amortization of intangible assets. Amortization of intangible assets was $12.3 million for both the three months ended September 30, 2026 and 2025. Amortization expense remained consistent period over period and primarily relates to the amortization of our human growth hormone ("hGH") intangible asset.
Current report
Interest expense. Interest expense increased to$13.5 million for the three months ended September 30, 2026, compared to$11.3 million for the same period of 2025. The increase was primarily attributable to higher interest expense associated with the 2044 Royalty Financing Notes and our 3.75% Convertible Senior Notes due 2029 (the “2029 Convertible 144A Notes”).
Current report
Other income, net. Other income (expense), net was income of $3.9 million for the three months ended September 30, 2026, as compared to income of $1.2 million for the same period in 2025. The increase was primarily attributable to a $4.2 million gain recognized on our investment in EnteraBio Bio Ltd. ("Entera"). This increase was partially offset by unfavorable foreign currency fluctuations, which resulted in foreign currency losses of $0.1 million during the three months ended September 30, 2026 compared to foreign currency gains of $1.1 million during the same period in 2025.
Current report
Loss from investments in investees. We have invested in certain early-stage companies that we believe have valuable proprietary technology and the potential to create long-term value as an equity holder. We account for these investments under the equity method of accounting. Loss from investments in investees was $5.0 million and an immaterial amount for the three months ended September 30, 2026 and 2025, respectively. The increase was primarily attributable to the recognition of $5.0 million of previously suspended equity method losses associated with our investment in Cocrystal Pharma, Inc. (“Cocrystal”) following our July 2026 purchase of additional shares of Cocrystal common stock. See Note 7 to our condensed consolidated financial statements contained in this Quarterly Report on Form 10-Q for further information.
Current report
FOR THE NINE MONTHS ENDED SEPTEMBER 30, 2026 AND 2025
Current report
Total revenue. Total revenue increased $47.2 million, or 30%, to $206.5 million for the nine months ended September 30, 2026, as compared with $159.2 million for the same period in 2025. The increase was primarily attributable to revenue recognized from shares received in connection with our investment in Nicoya, higher royalty revenue from Eli Lilly, increased sales of Rayaldee and growth in our international operations.
Current report
Loss from operations. Loss from operations decreased $37.5 million, or 32%, to $81.4 million for the nine months ended September 30, 2026, compared with $118.9 million for the same period in 2025. The improvement was primarily attributable to revenue recognized from shares received in connection with our investment in Nicoya and higher royalty revenue from Eli Lilly, partially offset by increased research and development expenditures associated with our innovative pipeline programs.
Current report
Operating income (loss). Operating income (loss) increased $44.3 million to $35.6 million for the nine months ended September 30, 2026, as compared with an operating loss of $8.6 million for the same period in 2025. The improvement was primarily attributable to revenue recognized from shares received in connection with our investment in Nicoya, increased royalty revenue from Eli Lilly, higher sales of Rayaldee and growth in our international operations. Operating income included approximately $4.7 million of depreciation expense, $12.5 million of amortization expense and $0.7 million of equity-based compensation expense. Foreign currency fluctuations had an approximately $1.1 million favorable impact on operating results during the period.
Current report
Revenue from products. Revenue from products increased $9.5 million, or 8%, to $122.8 million for the nine months ended September 30, 2026, compared with $113.3 million for the same period in 2025. The increase was primarily driven by higher sales of Rayaldee of approximately $2.0 million and increased revenue from our international operations of approximately $7.5 million. International revenue growth reflected stronger performance in certain markets, including Spain, Chile and Mexico, as well as a favorable product mix. International revenue growth also benefited from approximately $5.7 million of favorable foreign currency impact, primarily due to the appreciation of the Chilean peso and Mexican peso relative to USD.
Current report
Selling, general and administrative expenses. Selling, general and administrative expenses for the nine months ended September 30, 2026 and 2025 were $38.6 million and $34.5 million, respectively, representing an increase of $4.1 million, or 12%, from the prior year period. The increase was primarily attributable to higher personnel costs, commercial spending and freight expenses within our international operations, as well as increased commercial expenses at EirGen. Included in the increase was an approximately $0.9 million unfavorable impact from foreign currency fluctuations, primarily due to the appreciation of the Chilean peso and Mexican peso relative to USD.
Current report
Research and development expenses. Research and development expenses for the nine months ended September 30, 2026 and 2025 were $8.5 million and $10.9 million, respectively, representing a decrease of $2.4 million, or 22%, from the prior-year period. The decrease was primarily attributable to lower spending on earlier-stage programs, including reduced product development activities at EirGen, and lower employee-related expenses.
Current report
Loss from operations. Loss from operations increased $6.9 million, or 9%, to $84.3 million for the nine months ended September 30, 2026, as compared with $77.4 million for the same period in 2025. The increase was primarily attributable to increased expenditures on certain ModeX therapeutic development programs and growth hormone-related development activities, partially offset by lower spending on BARDA-supported programs and certain other research and development initiatives. Operating results included approximately $1.6 million of depreciation expense, $36.8 million of amortization expense, primarily related to the human growth hormone intangible asset, and $2.6 million of equity-based compensation expense. Foreign currency fluctuations had an immaterial unfavorable impact on operating results during the period.
Current report
Licensing, collaboration and other revenue. Licensing, collaboration and other revenue decreased by $0.5 million to $40.6 million for the nine months ended September 30, 2026, from $41.1 million for the same period in 2025. The decrease was primarily attributable to lower revenue recognized under the BARDA contract. The decrease was partially offset by higher royalty revenue from NGENLA and collaboration revenue recognized under ModeX's agreement with Regeneron.
Current report
Cost of revenue. Cost of revenue for the nine months ended September 30, 2026 and 2025 was immaterial.
Current report
Selling, general and administrative expenses. Selling, general and administrative expenses for the nine months ended September 30, 2026 and 2025 were $3.1 million and $3.0 million, respectively, representing an increase of $0.1 million, or 2%, from the prior-year period. The increase was primarily driven by higher employee-related costs.
Current report
Research and development expenses. Research and development expenses for the nine months ended September 30, 2026 and 2025 were $84.9 million and $78.6 million, respectively, representing an increase of $6.3 million, or 8%, from the prior-year period. The increase was primarily attributable to increased investment in our ModeX development programs, including higher spending on earlier-stage and Phase 3 programs, as these programs continued to advance through preclinical and clinical development activities, as well as higher employee-related expenses. These increases were partially offset by lower manufacturing expenses for biological products and other internal research and development expenses.
Current report
Research and development expenses include external and internal expenses, partially offset by third-party grants and funding. External expenses include clinical and non-clinical activities performed by contract research organizations, lab services, manufacturing activities and other development costs. 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.
Current report
Amortization of intangible assets. Amortization of intangible assets was $36.8 million for both the nine months ended September 30, 2026 and 2025. Amortization expense remained consistent period over period and primarily relates to the amortization of our hGH intangible asset.
Showing the first 40 of 45 passages. Open the source sections for the rest.
Removed paragraphs (46)
Previous report
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®.
Previous report
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.
Previous report
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.
Previous report
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 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.
Previous report
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.
Previous report
Diagnostics
Previous report
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.
Previous report
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.
Previous report
The composition of revenue from services by payor for the three months ended June 30, 2026 and 2025 was as follows:
Previous report
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.
Previous report
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.
Previous report
Research and development expenses. The following table summarizes the components of our research and development expenses:
Previous report
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.
Previous report
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.
Previous report
Pharmaceuticals
Previous report
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.
Previous report
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.
Previous report
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.
Previous report
The following table summarizes the components of our research and development expenses:
Previous report
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.
Previous report
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.
Previous report
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.
Previous report
FOR THE SIX MONTHS ENDED JUNE 30, 2026 AND 2025
Previous report
Diagnostics
Previous report
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 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.
Previous report
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.
Previous report
The composition of revenue from services by payor for the six months ended June 30, 2026 and 2025 was as follows:
Previous report
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.
Previous report
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.
Previous report
Research and development expenses. The following table summarizes the components of our research and development expenses:
Previous report
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.
Previous report
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.
Previous report
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.
Previous report
Pharmaceuticals
Previous report
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.
Previous report
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.
Previous report
The following table summarizes the components of our research and development expenses:
Previous report
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.
Previous report
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.
Previous report
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.
Showing the first 40 of 46 passages. Open the source sections for the rest.
Reworded paragraphs (34)
Previous wording
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.
Current wording
Our Global Products platform includes the development, manufacture and commercialization of pharmaceutical products and services, as well as certain commercial arrangements generally associated with the commercialization of pharmaceutical products. Our portfolio includes 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 received marketing authorizations in multiple international markets, and we continue to pursue additional commercialization opportunities through strategic partnerships. Our Global Products platform also includes established pharmaceutical operations that provide manufacturing, development and commercialization capabilities across multiple international markets.
Previous wording
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.
Current wording
We operate established pharmaceutical businesses internationally, with principal operations in Ireland, Spain, Chile and Mexico. These businesses generate revenue and cash flow while providing development, manufacturing, regulatory and commercial capabilities that support our broader operations. Our Irish subsidiary, EirGen Pharma Ltd. (“EirGen”), specializes in the development and commercial supply of high-potency oral solid-dose pharmaceutical products and exports products to more than 60 countries worldwide. Research and development activities are primarily conducted in facilities located in Weston, Massachusetts; Waterford, Ireland; Kiryat Gat, Israel; and Barcelona, Spain.
Previous wording
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.
Current wording
On April 30, 2026, EirGen entered into a second amendment (the "Second Amendment") to its Development and License Agreement (the "Nicoya Agreement") with NICOYA Macau Limited ("Nicoya") relating to the development and commercialization of Rayaldee® in Greater China, which includes mainland China, Hong Kong, Macau and Taiwan. 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.
Previous wording
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.
Current wording
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, $0.01 par value per share ("Common Stock") repurchase program, originally established on July 18, 2024, increasing the program’s aggregate capacity to $200.0 million. As of December 31, 2025, the Company had repurchased 60,383,629 shares of Common Stock for an aggregate cost of approximately $87.2 million. During the nine months ended September 30, 2026, the Company repurchased an additional 20,835,105 shares of Common Stock at an average price of $1.37 per share, for an aggregate cost of approximately $28.4 million.
Previous wording
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.
Current wording
These new measures did not have a material impact on our results of operations for the nine months ended September 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.
Previous wording
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.
Current wording
Approximately 79.2% of our revenue for the nine months ended September 30, 2026, was denominated in currencies other than the U.S. Dollar (USD). This compares to 72.7% 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 nine months ended September 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 $29.9 million and $17.6 million at September 30, 2026 and December 31, 2025, respectively.
Previous wording
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.
Current wording
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 September 30, 2026, we held $9.5 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.
Previous wording
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.
Current wording
Revenue from products. Revenue from Global Products increased $4.1 million, or 11%, to $41.8 million for the three months ended September 30, 2026, as compared with $37.7 million for the same period in 2025. The increase was primarily attributable to higher sales of Rayaldee, which increased to $8.6 million for the three months ended September 30, 2026, as compared to $7.5 million for the same period in 2025, primarily due to favorable gross-to-net adjustments as a result of changes to our Medicare Coverage. In addition, revenue from our international operations increased approximately $3.0 million, reflecting stronger performance in certain international markets, including our animal health business, as well as higher revenue from EirGen driven by increased sales volumes and a favorable product mix. The increase in international revenue included an approximately $0.7 million favorable impact from foreign currency fluctuations, primarily due to the appreciation of the Chilean peso and Mexican peso relative to USD.
Previous wording
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.
Current wording
Research and development expenses include external and internal expenses, partially offset by third-party grants and funding from collaboration agreements. External expenses include clinical and non-clinical activities performed by contract research organizations, lab services, purchases of drug and product materials and manufacturing development costs. 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.
Previous wording
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.
Current wording
Operating loss for our unallocated corporate operations was $10.6 million for the three months ended September 30, 2026, compared to $9.9 million for the same period in 2025. These results primarily reflect employee-related and general administrative expenses incurred in connection with our corporate operations that are not allocated to our operating segments. Operating results included approximately $0.9 million of equity-based compensation expense and an insignificant amount of depreciation expense and benefited from a favorable foreign currency impact of approximately $0.2 million. The increase in operating loss was primarily attributable to higher employee-related expenses.
Previous wording
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.
Current wording
Interest income. Interest income for the three months ended September 30, 2026 and 2025 was$2.9 million and$2.7 million, respectively. The increase was primarily due to higher average cash and cash equivalents balances during the 2026 period compared to the prior year period.
Previous wording
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.
Current wording
Fair value changes of derivative instruments, net. Fair value changes of derivative instruments, net for the three months ended September 30, 2026 and 2025, were income of approximately$0.3 million and an immaterial expense, respectively. This was principally related to foreign currency forward exchange contracts at OPKO Chile.
Previous wording
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.
Current wording
Income tax benefit. Our income tax benefit for the three months ended September 30, 2026 and 2025 was$7.3 million and$8.1 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.
Previous wording
Our consolidated income from operations for the six months ended June 30, 2026 and 2025 was as follows:
Current wording
Our consolidated income from operations for the nine months ended September 30, 2026 and 2025 was as follows:
Previous wording
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.
Current wording
Licensing, collaboration and other revenue. Licensing, collaboration and other revenue increased $38.2 million to $43.1 million for the nine months ended September 30, 2026, from $4.9 million for the same period in 2025. 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 7 and Note 15 to our consolidated financial statements in this Quarterly Report on Form 10-Q) and $10.3 million of royalty revenue from Eli Lilly. These increases were partially offset by a $1.7 million decrease in contract manufacturers' commercial milestones from our Ireland operations.
Previous wording
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.
Current wording
Cost of revenue. Cost of revenue increased by $1.5 million, or 2%, for the nine months ended September 30, 2026 as compared to the same period in 2025. The increase was primarily driven by higher product costs associated with increased product sales. Included in the increase was an approximately $3.2 million unfavorable impact from foreign currency exchange rates, primarily due to the appreciation of the Chilean peso and Mexican peso relative to USD. These increases were partially offset by lower production costs and operational efficiencies within our international manufacturing platforms.
Previous wording
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.
Current wording
Research and development expenses include external and internal expenses, partially offset by third-party grants and funding. External expenses include clinical and non-clinical activities performed by contract research organizations, lab services, purchases of drug and product materials and other development costs. 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.
Previous wording
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.
Current wording
Amortization of intangible assets. Amortization of intangible assets was $12.5 million and $12.2 million, respectively, for the nine months ended September 30, 2026 and 2025. Amortization expense primarily reflects the amortization of the Rayaldee intangible asset and intangible assets associated with our commercial pharmaceutical operations. The increase compared to the prior-year period was primarily due to foreign currency fluctuations.
Previous wording
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.
Current wording
Operating loss for our unallocated corporate operations was $32.8 million for the nine months ended September 30, 2026, compared to $32.9 million for the same period in 2025. These results primarily reflect employee-related and general administrative expenses incurred in connection with our corporate operations that are not allocated to our operating segments. The decrease in operating loss was primarily attributable to lower selling, general and administrative expenses, including lower professional fees, partially offset by higher employee-related expenses. Operating results benefited from a favorable foreign currency impact of approximately $0.6 million and included approximately $2.8 million of equity-based compensation expense. Depreciation expense was not material during the period.
Previous wording
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.
Current wording
Interest income. Interest income for the nine months ended September 30, 2026 and 2025 was $8.4 million and $10.1 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.
Previous wording
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.
Current wording
Interest expense. Interest expense decreased to $35.7 million for the nine months ended September 30, 2026, compared with $97.0 million for the same period in 2025. The decrease was primarily attributable to the absence of $59.1 million of charges recorded in the 2025 period related to the Note Exchange Transactions (as defined in Note 8 to our condensed consolidated financial statements contained in this Quarterly Report on Form 10-Q), consisting of the amortization of $54.7 million of unamortized debt discount and $4.4 million of debt issuance costs. . The decrease was also driven by a $3.3 million reduction in interest expense associated with the 2029 Convertible 144A Notes. These decreases were partially offset by a $1.3 million increase in interest expense related to our 2044 Royalty Financing Notes. In addition, interest expense associated with our international credit facilities decreased modestly compared with the prior-year period, primarily reflecting lower outstanding borrowings.
Previous wording
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.
Current wording
Fair value changes of derivative instruments, net. Fair value changes of derivative instruments, net for the nine months ended September 30, 2026 and 2025, was $0.1 million and $0.3 million of expense, respectively. The activity was principally related to foreign currency forward exchange contracts at OPKO Chile.
Previous wording
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.
Current wording
Other income (expense), net. Other income (expense), net changed by $36.0 million to $4.1 million of income for the nine months ended September 30, 2026, compared to $31.9 million of expense for the prior year period. The change was primarily attributable to the absence of a $32.6 million inducement expense recorded during the 2025 period related to the Note Exchange Transactions (as defined in Note 8 to our condensed consolidated financial statements contained in this Quarterly Report on Form 10-Q). In addition, we recognized a $4.2 million gain related to our investment in Entera, and foreign currency transactions resulted in a $1.6 million gain during the 2026 period, compared with a $1.5 million loss during the prior-year period. These favorable changes were partially offset by the absence of a $3.9 million gain recognized during the 2025 period from the sale of our remaining investment in GeneDx Holdings Corp.
Previous wording
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.
Current wording
Income tax benefit. Our income tax benefit for the nine months ended September 30, 2026 and 2025 was $18.7 million and $29.0 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.
Previous wording
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 thesix 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.
Current wording
On September 30, 2026, we had cash, cash equivalents and restricted cash of approximately$403.2 million. Cash used in operating activities was$99.1 million for the nine months ended September 30, 2026, primarily reflecting research and development expenditures associated with our innovative pipeline programs, employee-related and general administrative expenses, and sales and marketing activities supporting our pharmaceutical operations. Cash provided by investing activities was$25.0 million for the nine months ended September 30, 2026, primarily reflecting $38.1 million of proceeds from the Oncology Transaction, including $18.4 million of earnout consideration received during the second quarter of 2026 and the release of approximately $19.8 million of escrow funds, including accrued interest during the third quarter of 2026. These inflows were partially offset by capital expenditures of $7.6 million and investments in investees of $5.2 million. Cash provided by financing activities was$96.3 million for the nine months ended September 30, 2026, primarily reflecting net proceeds of approximately $123.1 million from the issuance of an additional $125.0 million aggregate principal amount of 2044 Royalty Financing Notes and $2.8 million of net borrowings under lines of credit, partially offset by $28.4 million of share repurchases. We have historically not generated sustained positive cash flow sufficient to offset our operating and other expenses, and our primary sources of liquidity have been public and private issuances of equity and debt securities, asset dispositions, royalty financing arrangements and available credit facilities.
Previous wording
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.
Current wording
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, with approximately $19.8 million subsequently received including accrued interest. During September 2026, substantially all of the escrow funds, together with accrued interest, were released to the Company, net of any indemnification obligations.
Previous wording
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.
Current wording
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 $115.7 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 Securities Exchange Act of 1934, as amended (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.
Previous wording
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.
Current wording
In September 2024, ModeX entered into two amendments (the “BARDA Amendments”) to modify the scope and funding of the BARDA Contract. The BARDA Amendments structured the funding thereunder as cost-plus-fixed-fee, which included a $26.9 million supplement to further advance the development of COVID-19 multispecific antibodies and provided $24.1 million for the development of a multispecific protein antibody for influenza or another pathogen. In December 2025, the Company entered into a further bilateral modification to de-scope all mRNA development-related efforts using SARS-CoV-2 as an antigen model, as these activities were no longer a priority for the U.S. Department of Health and Human Services. As a result, the total value of the BARDA Contract decreased from $110.0 million to $103.5 million, and the total potential value of the overall contract, inclusive of all options, decreased from $205.0 million to $198.5 million. As of September 30, 2026, the aggregate amount remaining to be funded by BARDA, which is subject to performance obligations and excluding unexercised contract options, was $33.5 million.
Previous wording
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 thesix 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.
Current wording
As of September 30, 2026, the total commitments under our lines of credit with financial institutions in Chile and Spain were$29.8 million, of which$12.0 million was drawn as of September 30, 2026. On September 30, 2026, the weighted average interest rate on these lines of credit was approximately 5.3%. 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 thenine months ended September 30, 2026 was $12.7 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.
Previous wording
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:
Current wording
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 September 30, 2026, the potential payments from these agreements (each as defined in Note 15 to our condensed consolidated financial statements contained in this Quarterly Report on Form 10-Q) were as follows:
Previous wording
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 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.
Current wording
We believe that the cash, cash equivalents and restricted cash on hand on September 30, 2026, together with anticipated cash flows from operations, available borrowings under our credit facilities and other sources of liquidity, will be 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 may 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, 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 litigation with the Israel Tax Authority) 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.
Previous wording
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.
Current wording
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 condensed consolidated financial statements contained in this Quarterly Report on Form 10-Q and related notes.
Previous wording
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.
Current wording
In November 2024, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“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.
Previous wording
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.
Current wording
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 contained in this Quarterly Report on Form 10-Q.
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
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).