OPK 10-K & 10-Q changes, risk factors and insider trading
Opko Health, Inc. · Nasdaq · Pharmaceutical Preparations · CIK 944809 · All filings on SEC.gov
At a glance
What changed in the latest 10-K
Risk Factors
Removed heading “Our business depends on our ability to generate profits and cash flow from our laboratory operations.”
Removed heading “The ongoing Russia-Ukraine conflict and the recent Israel-Hamas conflict may adversely impact our business operations and financial performance.”
Largest changes
“United States and global markets have experienced volatility and disruption following the geopolitical instability resulting from the ongoing Russia-Ukraine conflict and the Israel-Hamas conflict. …”see in full comparison
“The ongoing Russia-Ukraine conflict and the recent Israel-Hamas conflict may adversely impact our business operations and financial performance.”see in full comparison
“Although the Company has security measures implemented, cyber-attacks and threats against us and our third-party providers continue to evolve and are often not recognized until such attacks are launched against a potential target. Such attacks also may be further enhanced in frequency or effectiveness through threat actors' use of artificial intelligence ("AI"). As with many innovations, AI presents risks, challenges, and unintended consequences that could affect its adoption, and therefore our business. AI algorithms and training methodologies may be flawed, ineffective or inadequate. …”see in full comparison
“("EirGen") and Rayaldee), could be impacted by changing global trade policies and the imposition of new tariffs. Based on the current financial performance of our diagnostics segment and our Ireland reporting unit, we could be subject to such charges if their future performance deviates from our current estimates and assumptions. For reference, the goodwill of our diagnostics segment totaled $163.4 million and $219.7 million at December 31, 2025 and 2024, respectively. …”see in full comparison
“Based on the current financial performance of our diagnostics segment and our Ireland reporting unit, which includes EirGen and Rayaldee, if future results are not consistent with our estimates and assumptions, then we may be exposed to impairment charges, which could be material. At December 31, 2024, the goodwill of our diagnostics segment totaled $219.7 million and the goodwill of our Ireland reporting unit totaled $79.4 million. There can be no assurance that future reviews of our goodwill and other intangible assets will not result in impairment charges. …”see in full comparison
“Our business depends on our ability to generate profits and cash flow from our laboratory operations.”see in full comparison
Full comparison: every changed paragraph (90)
Other than for the fiscal years ended December 31, 2020 and 2021, during which time BioReference conducted a substantial number of COVID-19 tests, our consolidated operations have not historically been profitable. Our pharmaceutical business has historically generated only limited revenue from operations and we may not generate substantial revenue from the sale of proprietary pharmaceutical products or certain of our diagnostic products for some time, if at all. Other than NGENLA® (Somatrogon), which has been approved in many territories including the U.S., EU, Japan, Canada and Australia, Rayaldee is our only other proprietary pharmaceutical product that has been approved for marketing in the U.S. or elsewhere. We continue to incur substantial research and development and general and administrative expenses related to our operations including our pre-clinical development activities and clinical trials. We may continue to incur losses from our operations in the future and these losses could increase as we continue our research activities and conduct development of, and seek regulatory approvals and clearances for, our product candidates, particularly if we are unable to generate or sustain profits and cash flow from sales of Rayaldee, NGENLA,NGENLA®, or our operations at BioReference. If we are unable to generate or sustain profits and cash flow from our operations, our product candidates fail in clinical trials or do not gain regulatory approval or clearance, or if our approved products and product candidates do not achieve market acceptance, we may not achieve profitability. In particular, if we are unable to successfully commercialize Rayaldee or NGENLA,NGENLA®, we may never generate substantial revenues from Rayaldee or NGENLA.NGENLA®.
be found to be ineffective, unreliable, or otherwise inadequate or otherwise fail to receive regulatory approval;
be difficult or impossible to manufacture on a commercial scale;
be uneconomical to market or otherwise not be effectively marketed;
fail to be successfully commercialized if adequate reimbursement from government health administration authorities, private health insurers, and other organizations for the costs of these products is unavailable;
be impossible to commercialize because they infringe on the proprietary rights of others or compete with products marketed by others that are superior; or fail to be commercialized prior to the successful marketing of similar products by competitors.
Positive results from pre-clinical studies and early clinical trial experience should not be relied upon as evidence that later-stage or large-scale clinical trials will succeed. Likewise, there can be no assurance that the results of studies conducted by collaborators or other third parties will be viewed favorably or are indicative of our own future study results. We may be required to demonstrate with substantial evidence through well-controlled clinical trials that our product candidates are either (i) with respect to drugs [or Class III devices,] safe and effective for use in a diverse population for their intended uses or [(ii) with respect to Class I or Class II devices, are substantially equivalent in terms of safety and effectiveness to devices that are already marketed under section 510(k) of the Food, Drug and Cosmetic Act.Act]. Success in early clinical trials does not mean that future clinical trials will be successful because product candidates in later-stage clinical trials may fail to demonstrate sufficient safety and efficacy to the satisfaction of the FDA and other non-U.S. regulatory authorities despite having progressed through initial clinical trials.
In May 2016, EirGen, our wholly-owned subsidiary, partnered with VFMCRP through a Development and License Agreement for the development and marketing of Rayaldee in Europe, Canada, Mexico, Australia, South Korea and certain other international markets. The license to VFMCRP potentially covers all therapeutic and prophylactic uses of the product in human patients, provided that initially the license is for the use of the product for the treatment or prevention of secondary hyperparathyroidism related to patients with stage 3 or 4 chronic kidney disease and vitamin D insufficiency/deficiency. Effective May 5, 2020, we entered into the VFMCRP Amendment, pursuant to which the parties agreed to exclude Mexico, South Korea, the Middle East and all of the countries of Africa from the VFMCRP Territory (as defined in the VFMCRP Agreement). In May 2021, we further amended the VFMCRP Agreement for VFMCRP to assume all the rights to Rayaldee in Japan that had been previously granted to Japan Tobacco. In addition, the parties agreed to certain amendments to the milestone structure and to reduce minimum royalties payable. As revised, the Company is eligible to receive up to $15 million in regulatory milestones and $200 million in milestone payments tied to launch, pricing and sales of Rayaldee, and tiered, double-digit royalties. The success of the Development and License Agreement with VFMCRP is dependent in part on, among other things, the skills, experience and efforts of VFMCRP’s employees responsible for the project, VFMCRP’s commitment to the arrangement, including following its restructuring, and the financial condition of VFMCRP, all of which are beyond our control. In the event that VFMCRP, for any reason, including but not limited to early termination of the agreement, fails to devote sufficient resources to successfully develop and market Rayaldee internationally, our ability to earn milestone payments or receive royalty payments would be adversely affected, which wouldcould have a material adverse effect on our financial condition and prospects.
On June 18, 2021, EirGen and Nicoya entered into the Nicoya Agreement granting Nicoya the exclusive rights for the development and commercialization of the Nicoya Product in the Nicoya Territory. The license grant to Nicoya covers the therapeutic and preventative use of the Nicoya Product for SHPT in non-dialysis and hemodialysis chronic kidney disease patients. EirGen received an initial upfront payment of $5 million and was eligible to receive an additional $5 million upon the first to occur of (A) a predetermined milestone and (B) the first anniversary of the effective date (the “First Milestone”). However, the parties amended the Nicoya Agreement to provide that Nicoya pay $2.5 million plus accrued interest by October 31, 2022 in partial satisfaction of the First Milestone, and $2.5 million upon the earlier of (i) submission of the investigational new drug application by Nicoya or its affiliated party, and (ii) February 15, 2023. EirGen received the additional $2.5 million upon Nicoya's submission of an investigation new drug (IND) application to the center for drug evaluation of China in March 2023. EirGen is also eligible to receive up to an additional aggregate amount of $115 million upon the achievement of certain development, regulatory and sales-based milestones by Nicoya for the Nicoya Product in the Nicoya Territory. EirGen will also receive tiered, double digit royalty payments at rates in the low double digits on net product sales within the Nicoya Territory and in the Nicoya Field. Nicoya will, at its sole cost and expense, be responsible for performing all development activities necessary to obtain all regulatory approvals for the Nicoya Product in the Nicoya Territory and for all commercial activities pertaining to the Nicoya Product in the Nicoya Territory. The success of the Nicoya Agreement is dependent in part on, Nicoya's financial condition, Nicoya’s commitment to the product and our collaboration, as well as the experience of its employees, all of which are beyond our control.
Our exclusive worldwide agreement with Pfizer is important to our business. If we do not successfully develop Somatrogon (hGH- CTP) and/or Pfizer does not successfully commercialize Somatrogon (hGH-CTP ), our business could be adversely affected.
In December 2014, we entered into a development and commercialization agreement with Pfizer relating to our long-acting hGH-CTP for the treatment of GHD in adults and children (the “Original Pfizer Agreement”). Under the Restated Pfizer Agreement,Agreement (defined below), we are eligible to receive an aggregate of up to $275 million upon the achievement of certain regulatory milestones, of which the Company has received $175 million to date. We are also we are eligible to receive a regional, tiered gross profit share based upon sales of both Somatrogon (hGH-CTP) and Pfizer’s Genotropin® (somatropin) following the launch of Somatrogon (hGH-CTP) for pediatric GHD and contingent upon certain other sales criteria. We are responsible for the development program and are obligated to pay for the development up to an agreed cap, which has been exceeded. In May 2020, we entered into an Amended and Restated Development and Commercialization License Agreement (the “Restated Pfizer Agreement”) with Pfizer, effective January 1, 2020, pursuant to which the parties agreed, among other things, to share all costs for Manufacturing Activities, as defined in the Restated Pfizer Agreement, for developing a licensed product for the three indications included in the Restated Pfizer Agreement. The Restated Pfizer Agreement did not change the milestone payments, royalties and profit share provisions under the Original Pfizer Agreement. hGH-CTP has been approved in the U.S., EU, Japan, Canada and Australia under the name NGENLA.NGENLA®. We are substantially dependent on Pfizer for the successful commercialization of such product. The success of the collaboration arrangement with Pfizer is dependent in part on, among other things, the skills, experience and efforts of Pfizer’s employees responsible for the project and Pfizer’s commitment to the arrangement. The Restated Pfizer Agreement is terminable for any reason by Pfizer upon ninety days written notice to OPKO. In the event that Pfizer terminates the Restated Pfizer Agreement or fails to devote sufficient resources to continue to successfully develop and commercialize any product resulting from the collaboration arrangement, our ability to earn milestone payments or receive royalty or profit sharing payments would be adversely affected, which would have a material adverse effect on our financial condition and prospects and the trading prices of our securities.
On October 21, 2019, we and Pfizer announced that the global phase 3 trial evaluating Somatrogon (hGH-CTP) dosed once-weekly in pre-pubertal children with GHD met its primary endpoint of non-inferiority to daily Genotropin® (somatropin) for injection, as measured by annual height velocity at 12 months. In addition, change in height standard deviation scores at six and 12 months, key secondary endpoints, were higher in the hGH-CTP dosed once-weekly cohort in comparison to the Genotropin® (somatropin) dosed once-daily cohort. hGH-CTP was generally well tolerated in this study and comparable to Genotropin® (somatropin) dosed once-daily with respect to the types, numbers and severity of the adverse events observed between the treatment arms. Although the primary endpoint and key secondary endpoints were met and the safety profile for hGH-CTP was consistent with that observed with those treated with Genotropin® (somatropin), further testing and analysis, other clinical trials or patient use may undermine those determinations or unexpected side effects may arise. We previously announced topline data from an earlier phase 3, double blind, placebo controlled study of hGH-CTP in adults with GHD. Although there was no statistically significant difference between hGH-CTP and placebo on the primary endpoint of change in trunk fat mass from baseline to 26 weeks, after unblinding the study, we identified an exceptional value of trunk fat mass reduction in the placebo group that may have affected the primary outcome. We completed post-hoc sensitivity analyses for the adult study to evaluate the influence of outliers on the primary endpoint results using multiple statistical approaches. Analyses that excluded outliers showed a statistically significant difference between hGH-CTP and placebo on the change in trunk fat mass. Additional analyses that did not exclude outliers showed mixed results. There can be no assurance that the FDA or regulatory agencies in other countries will consider the sensitivity analysis or consider the product for approval for adults with GHD.
In June 2023, the FDA approved NGENLA® (Somatrogon (hGH-CTP)) for the treatment of pediatric GHD in the United States. However, there can be no assurance that NGENLA® (Somatrogon (hGH-CTP)) for the treatment of pediatric GHD will be commercially successful in the United States or that we will obtain marketing approval for the adult indication. Before it can be marketed, Somatrogon (hGH-CTP) for the adult indication must be approved by the FDA or similar foreign governmental agencies. The process for obtaining FDA marketing approval is both time-consuming and costly, with no certainty of a successful outcome. If we are unable to successfully commercialize NGENLA® (Somatrogon (hGH-CTP)) to treat pediatric GHD and/or receive regulatory approval for hGH-CTP to treat adults with GHD, our business could be significantly adversely impacted.
NGENLA® has been approved in over 50 territories for the long-term treatment of pediatric patients with growth disturbance. NGENLA® may nevertheless fail to be successfully commercialized in these territories which would adversely impact our anticipated milestone payments under the Restated Pfizer Agreement and negatively affect our business, financial condition and results of operations.
Our business depends on our ability to generate profits and cash flow from our laboratory operations.
We compete in the clinical laboratory market through BioReference, primarily on the basis of the quality of testing, reporting and information systems, reputation in the medical community, the pricing of services and ability to employ qualified personnel. Our failure to successfully compete on any of these factors could result in the loss of clients and a reduction in our revenues and profits. To offset efforts by payors to reduce the cost and utilization of clinical laboratory services, we will need to obtain and retain new clients and business partners. Our laboratory operations have not been profitable, and our sale of certain assets to Labcorp in September 2024 in the BioReference Transaction has significantly reduced our diagnostic revenues.
While, in addition to the BioReference Transaction, we have engaged in significant cost reduction efforts, including reducing our workforce, in an effort to make the diagnostic business profitable and align our core business testing needs with the size of our operations we may not be able to return to and maintain adequate growth in our remaining testing business or client base, which could have a material adverse impact on our ability to generate profits and cash flow from the laboratory operations in the future.
a limited number of, and competition for, suitable patients with the particular types of disease required for enrollment in our clinical trials or that otherwise meet the protocol’s inclusion criteria and do not meet any of the exclusion criteria;
a limited number of, and competition for, suitable serum or other samples from patients with particular types of disease required for our validation studies;
a limited number of, and competition for, suitable sites to conduct our clinical trials;
delay or failure to obtain FDA or other non-U.S. regulatory authorities’ approval or agreement to commence a clinical trial;
delay or failure to obtain sufficient supplies of the product candidate for our clinical trials;
requirements to provide the drugs, diagnostic tests, or medical devices required in our clinical trial protocols or clinical trials at no cost or cost, which may require significant expenditures that we are unable or unwilling to make;
delay or failure to reach agreement on acceptable clinical trial agreement terms or clinical trial protocols with prospective sites or investigators;
delay or failure to obtain institutional review board (“IRB”) approval to conduct or renew a clinical trial at a prospective site; and insufficient liquidity to fund our preclinical and clinical studies.
slower than expected rates of patient recruitment and enrollment;
failure of patients to complete the clinical trial;
unforeseen safety issues;
lack of efficacy evidenced during clinical trials;
termination of our clinical trials by one or more clinical trial sites;
inability or unwillingness of patients or medical investigators to follow our clinical trial protocols;
inability to monitor patients adequately during or after treatment; and insufficient liquidity to fund ongoing studies.
timing of market introduction of competitive products;
safety and efficacy of our product compared to other products;
prevalence and severity of any side effects;
potential advantages or disadvantages over alternative treatments;
strength of marketing and distribution support;
price of our products, both in absolute terms and relative to alternative treatments;
availability of coverage and reimbursement from government and other third-party payors;
potential product liability claims;
limitations or warnings contained in a product’s regulatory authority-approved labeling; and changes in the standard of care for the targeted indications for any of our products or product candidates, which could reduce the marketing impact of any claims that we could make following applicable regulatory authority approval.
Although the Company has security measures implemented, cyber-attacks and threats against us and our third-party providers continue to evolve and are often not recognized until such attacks are launched against a potential target. Such attacks also may be further enhanced in frequency or effectiveness through threat actors' use of artificial intelligence ("AI"). As with many innovations, AI presents risks, challenges, and unintended consequences that could affect its adoption, and therefore our business. AI algorithms and training methodologies may be flawed, ineffective or inadequate. The rapid evolution of AI, particularly the anticipated government regulation of AI, could require significant resources for compliance, whether in the development, testing, or maintenance of such systems or software. AI development or deployment practices by us or third -party providers could increase vulnerability to cybersecurity risks and require additional resources to implement heightened cybersecurity measures to protect the security of our data.
Although the Company has security measures implemented, cyber-attacks and threats against us and our third-party providers continue to evolve and are often not recognized until such attacks are launched against a potential target. A successful cybersecurity attack or other data security incident could result in the misappropriation and/or loss of confidential or personal information, create system interruptions, or deploy malicious software that attacks our systems. The unauthorized dissemination of sensitive personal information or proprietary or confidential information due to a breach of these IT systems could expose us or other third-parties to regulatory fines or penalties, litigation and potential liability, or otherwise harm our business. Any mitigation or remediation efforts that we undertake may require expenditures of significant resources and the diversion of the attention of management. In addition, we have taken, and continue to take, precautionary measures to reduce the risk of, and detect and respond to, future cyber threats, and prevent or minimize vulnerabilities in our IT systems. We have also taken, and will continue to take, measures to assess the cybersecurity protections implemented by our third-party providers. There can be no assurances that our precautionary measures or measures used by our third-party providers will prevent, contain or successfully defend against cyber or information security threats that could have a significant impact on our business, results of operations and reputation and subject us to liability.
The ongoing Russia-Ukraine conflict and the recent Israel-Hamas conflict may adversely impact our business operations and financial performance.
United States and global markets have experienced volatility and disruption following the geopolitical instability resulting from the ongoing Russia-Ukraine conflict and the Israel-Hamas conflict. In response to the ongoing Russia-Ukraine conflict, the North Atlantic Treaty Organization (“NATO”) deployed additional military forces to eastern Europe, and the United States, the United Kingdom, the European Union and other countries have announced various sanctions and restrictive actions against Russia, Belarus and related individuals and entities, including the removal of certain financial institutions from the Society for Worldwide Interbank Financial Telecommunication (SWIFT) payment system. Certain countries, including the United States, have also provided and may continue to provide military aid or other assistance to Ukraine and to Israel, increasing geopolitical tensions among a number of nations. The foregoing conflicts and the resulting measures that have been taken, and could be taken in the future, by NATO, the United States, the United Kingdom, the European Union, Israel and its neighboring states and other countries have created global security concerns that could have a lasting impact on regional and global economies. Although the length and impact of the foregoing conflicts are highly unpredictable, they could lead to market disruptions, including significant volatility in commodity prices, and the credit and capital markets, as well as supply chain interruptions and increased cyber-attacks against U.S. companies. Additionally, any resulting sanctions could adversely affect the global economy and financial markets and lead to instability and lack of liquidity in the capital markets. These ongoing conflicts and the resulting geopolitical instability can adversely impact our business operations and financial performance.
The research, testing, manufacturing, labeling, approval, selling, marketing, and distribution of drug products, diagnostic products, or medical devices are subject to extensive regulation by the FDA and other non-U.S. regulatory authorities, which regulations differ from country to country. In general, we are not permitted to market our product candidates in the U.S. until we receive approval of a BLA, an approval of an NDA, a clearance letter under the premarket notification process, or 510(k) process, or an approval of a PMA from the FDA. To date, we have only submitted one NDA which was approved in June 2016, and one BLA which was approved for filing in January 2021. We have received FDA approval for our 4Kscore test for use in men age 45 and older who have not had a prior prostate biopsy or are biopsy negative and have an age-specific abnormal total PSA and/or abnormal digital rectal exam, but we have not received marketing approval or clearance from FDA for any of our other diagnostic product candidates that we currently plan to market. Obtaining approval of an NDA or PMA can be a lengthy, expensive, and uncertain process. [With respect to medical devices, while the FDA reviews and clears a premarket notification in as little as three months, there is no guarantee that our products will qualify for this more expeditious regulatory process, which is reserved for Class I and II devices, nor is there any assurance that even if a device is reviewed under the 510(k) process that the FDA will review it expeditiously or determine that the device is substantially equivalent to a lawfully marketed non-PMA device. If the FDA fails to make this finding, then we cannot market the device. In lieu of acting on a premarket notification, the FDA may seek additional information or additional data which would further delay our ability to market the product. Furthermore, we are not permitted to make changes to a device approved through the PMA or 510(k) which affects the safety or efficacy of the device without first submitting a supplement application to the PMA and obtaining FDA approval or cleared premarket notification for that supplement. ] In some cases, the FDA may require clinical trials to support a supplement application. In addition, failure to comply with FDA, non-U.S. regulatory authorities, or other applicable U.S. and non-U.S. regulatory requirements may, either before or after product approval or clearance, if any, subject our company to administrative or judicially imposed sanctions, including, but not limited to the following:
restrictions on the products, manufacturers, or manufacturing process;
adverse inspectional observations (Form 483), warning letters, or non-warning letters incorporating inspectional observations;
civil and criminal penalties;
injunctions;
suspension or withdrawal of regulatory approvals or clearances;
product seizures, detentions, or import bans;
voluntary or mandatory product recalls and publicity requirements;
total or partial suspension of production;
imposition of restrictions on operations, including costly new manufacturing requirements; and refusal to approve or clear pending NDAs or supplements to approved NDAs, applications or pre-market notifications.
a drug candidate may not be deemed safe or effective;
a medical device candidate may not be deemed to be substantially equivalent to a lawfully marketed non-PMA device, in the case of a premarket notification;
the FDA may not find the data from pre-clinical studies and clinical trials sufficient;
the FDA may not approve our or our third-party manufacturer’s processes or facilities; or the FDA may change its approval or clearance policies or adopt new regulations.
federal and state laws applicable to billing and claims payment;
Management's Discussion & Analysis (MD&A)
New heading “RECENT DEVELOPMENTS”
New heading “Entera Collaboration Agreements”
New heading “For The Years Ended December 31, 2025 and 2024”
New heading “Merck Agreement:”
New heading “Restated Pfizer Agreement:”
New heading “VFMCRP Agreement:”
New heading “Nicoya Agreement:”
New heading “Eli Lilly Agreement:”
New heading “Recently adopted accounting standards.”
Removed heading “For The Years Ended December 31, 2023 and 2022”
Removed heading “Recently adopted accounting standards”
Largest changes
“In connection with our agreements with Merck, Pfizer, VFMCRP, and Nicoya, we are eligible to receive various milestone payments and royalty considerations. Under the terms of the Merck Agreement, we received an initial payment of $50.0 million and are also eligible to receive up to an additional $860.0 million upon the achievement of certain commercial and development milestones under several indications. …”see in full comparison
“While we believe our estimates and assumptions used in impairment testing (including for goodwill and IPR&D) are reasonable and reflect those used by market participants, there is a potential risk of material impairment charges. Our future performance, particularly for our Ireland reporting unit, which includes EirGen and Rayaldee, could be impacted by changing global trade policies and the imposition of new tariffs. …”see in full comparison
“Upon obtaining regulatory approval, IPR&D assets are then accounted for as a finite-lived intangible asset and amortized on a straight-line basis over its estimated useful life. If the project is abandoned, the IPR&D asset is charged to expense. Finite lived intangible assets are tested for impairment when events or changes in circumstances indicate it is more likely than not that the carrying amount of such assets may not be recoverable. The testing includes a comparison of the carrying amount of the asset to its estimated undiscounted future cash flows expected to be generated by the asset. …”see in full comparison
“BARDA Contract: $28.5 million recognized for ongoing performance Pfizer:$31.9 million in royalty revenue, consisting of gross profit share and royalty payments for NGENLA® and Genotropin® Regeneron:$7.2 million which includes $7.0 million upfront payment Eli Lilly: $4.3 million in royalty revenue following the commercial launch of Mazdutide in China Contract Manufacturers: …”see in full comparison
“Revenue from transfer of intellectual property and other. For the years ended December 31, 2023 and 2022, revenue from transfer of intellectual property and other principally reflects $90.0 million from Pfizer triggered by the FDA approval of NGENLA (Somatrogon) in 2023, and, in 2022, a $85.0 million regulatory milestone payment based on the commencement of sales from NGENLA (Somatrogon) in Europe and Japan, as well as gross profit share and royalty payments for both NGENLA (Somatrogon) and Pfizer’s Genotropin® (Somatropin) of $22.6 million and $4.4 million for the years ended December 31 …”see in full comparison
“For the year ended December 31, 2023, revenue from the transfer of intellectual property included $116.7 million from Pfizer, which included a $90.0 million milestone payment triggered by the FDA approval of NGENLA (Somatrogon), $22.6 million from gross profit share and royalty payments for both NGENLA (Somatrogon) and Pfizer's Genotropin® (Somatropin), $50.0 million from Merck in consideration for the rights granted under the Merck Agreement, $7.0 million from VFMCRP triggered by the German price approval for Rayaldee, $2.5 million from Nicoya due to Nicoya's submission of the …”see in full comparison
Full comparison: every changed paragraph (150)
We are a diversified healthcare company that seeks to establish industry leadingindustry-leading positions in large and rapidly growing medical markets. Our pharmaceutical business features Somatrogon (hGH-CTP), a once-weekly human growth hormone injection. We have partnered with Pfizer Inc. (“Pfizer”) for thefurther development and commercialization of Somatrogon (hGH-CTP). Regulatory approvals for Somatrogon (hGH-CTP) for the treatment of growth hormone deficiency in children and adolescentsadolescents, 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,markets worldwide, including in the United States, European Union (“EU”) Member States, Japan, Canada, and Australia, where it is marketedAustralia under the brand name NGENLA®. WeAlso, alsothrough our pharmaceutical business, we manufacture and sell Rayaldee, an FDA approved treatment for secondary hyperparathyroidism (“SHPT”) in adults with stage 3 or 4 chronic kidney disease (“CKD”) and vitamin D insufficiency, through our pharmaceutical division. We have also expanded our pharmaceutical pipeline with early-stage immune therapies targeting cancer and infectious diseases through our 2022 acquisition of ModeX Therapeutics, Inc. (“ModeX”).insufficiency.
Our subsidiary, ModeX Therapeutics, Inc. (“ModeX”), is a biotechnology company focused on developing innovative multi-specific immune therapies for cancer and infectious disease candidates. ModeX has a robust early-stage pipeline with assets in key areas of immuno-oncology and infectious diseases, and we intend to further expand our pharmaceutical product pipeline through ModeX’s portfolio of development candidates.
Our diagnostics business, BioReference Health, LLC (“BioReference”), is a highly specialized laboratory in the United States, with a sales and marketing team focused on growth and new product integration, including the 4Kscore® test which is designed to assesses a patient's probability for prostate cancer test.cancer. BioReference® offers a broad spectrum of diagnostic testing services for oncology, urology (4Kscore), and corrections nationwide, setting new standards with ourits industry-leading turnaround times. BioReference also provides comprehensive clinical and women’s health testing in New York and New Jersey. Our test offerings are backed by a team of board-certified medical professionals and driven by the latest healthcare guidelines and standards-standards. marketedWe market our laboratory testing services directly to physicians, geneticists, hospitals, clinics, correctional facilities, and other healthcarehealth providers.facilities. OnAs Septemberdescribed 16, 2024below, we consummated the sale ofsold certain BioReference assets of BioReference to Laboratory Corporation of America Holdings (“Labcorp”), asin described2024 below.and 2025.
TheWe Companyoperate maintainsseveral established, revenue-generating pharmaceutical platforms internationally, with our principal operations located in Spain, Ireland, Chile, and Mexico,Mexico. ourThese mostkey significantplatforms such platforms, contributingcontribute to positive cash flow and facilitatingfacilitate future market entry for our developmentproducts pipeline.currently Inin additiondevelopment. toBeyond these platforms, weour operateoperations include a global pharmaceutical development and commercial supply pharmaceutical company, as well as a global supply chain operation, and manufacture specialty active pharmaceutical ingredients (API) in Israel through our subsidiary, FineTech.operation.
On September 15, 2025, we consummated the sale of certain assets of BioReference to Labcorp (the “Oncology Transaction”), pursuant to an agreement entered into on March 10, 2025 (the “Labcorp Oncology Purchase Agreement”). Labcorp acquired BioReference's oncology diagnostics business and related clinical testing services assets, which were part of our diagnostics segment. Upon closing, Labcorp paid an aggregate of $192.5 million in cash consideration, of which $19.2 million was deposited in escrow. The escrow is to be released to us on the 12-month anniversary of the closing date, net of any outstanding or liquidated indemnity claims. The Company may also receive up to $32.5 million in performance-based cash contingent consideration in accordance with the terms of a post-closing earnout based upon revenue generated by certain customer accounts. We recognized a gain of $101.6 million from the Oncology Transaction for the year ended December 31, 2025.
On September 16, 2024, we consummated the sale of certain assets of BioReference to Labcorp pursuant to an agreement entered into on March 27, 2024, the Company entered into a definitive agreement with Labcorp2024 (the “Labcorp Asset Purchase Agreement”), pursuant to which. Labcorp agreed to acquireacquired select assets of BioReference (the “BioReference Transaction”)., The BioReference Transaction closed on September 16, 2024, and upon closing, Labcorp paid to the Company aggregate consideration of $237.5 million in cash, subject to certain adjustments as set forth in the Labcorp Asset Purchase Agreement. These assetswhich were part of our diagnostics segment and included BioReference's laboratory testing businesses focused on clinical diagnostics, reproductive health, and women's health across the United States, excluding BioReference's New York and New Jersey operations. Upon closing, Labcorp paid us aggregate consideration of $237.5 million, in cash, net of $23.75 million deposited in escrow. We received $24.6 million of escrow funds, including accrued interest. We recognized a gain of $121.5 million from the BioReference Transaction for the year ended December 31, 2024.
RECENT DEVELOPMENTS
Entera Collaboration Agreements
On February 4, 2026, we and our wholly owned subsidiary, OPKO Biologics, entered into an amendment to our 2025 collaboration and license agreement with Entera Bio Ltd. (“Entera”) to expand the partnership to include the development of a first-in-class oral long-acting parathyroid hormone (LA-PTH) analog for the treatment of hypoparathyroidism. This program combines the Company's proprietary long-acting PTH variants with Entera's proprietary N-Tab® oral peptide delivery technology to create a once-daily tablet intended to replace daily or weekly injections.
Under the terms of the expanded agreement, the Company and Entera will each hold a 50% pro-rata ownership interest in the LA-PTH hypoparathyroidism program and will each be responsible for 50% of the associated development costs. The companies expect to file an investigational new drug (IND) application with the FDA for the LA-PTH program in late 2026.
This expansion builds upon the existing collaboration between the parties, which includes the development of an oral oxyntomodulin (OXM) dual GLP-1/glucagon analog for metabolic and fibrotic disorders and an oral GLP-2 tablet for the treatment of short bowel syndrome. For the oral OXM program, the Company and Entera maintain a 60% and 40% ownership structure, respectively, with development costs shared on a pro-rata basis. Initial Phase 1 clinical data for the injectable formulation of OXM is expected in late 2026, with an IND filing for the oral tablet formulation to follow thereafter.
Pursuant to the Labcorp Asset Purchase Agreement, a total of approximately $23.7 million was withheld at closing and deposited by Labcorp into an escrow account to satisfy potential indemnity claims. The escrow will be released to the Company on the twelve-month anniversary of the closing date, subject to any outstanding or liquidated indemnity claims. The Company recorded the escrow within other current assets on the Condensed Consolidated Balance Sheet.
We recognized a gain of $121.5 million from the BioReference Transaction for the year ended December 31, 2024.
For the years ended December 31, 2025, 2024, and 2023, andapproximately 2022, approximately28.0%, 23.1%, 29.6%, and 21.6%29.6% of revenue, respectively, was denominated in currencies other than the U.S. Dollar (USD). Our financial statements are reported in USD; therefore,and, accordingly, fluctuations in exchange rates affect the translation of revenues and expenses denominated in foreign currencies into USD for purposes of reporting our consolidated financial results. During the years ended December 31, 2024,2025, 20232024 and 2022,2023, the most significant currency exchange rate exposures were to the Chilean Peso and Euro. Gross accumulated currency translation adjustments recorded as a separate component of shareholders’ equity were $52.7$17.6 million and $34.6$52.7 million at December 31, 20242025 and 2023,2024, respectively.
We are subject to foreign currency translation risk for fluctuations in exchange rates during the period of time between the consummation and cash settlement of transactions. We limit foreign currency transaction risk through hedge transactions with foreign currency forward contracts. Under these forward contracts, for any rate above or below the rate fixed by the contract,rate, we receive or pay the difference between the spot rate and the fixed rate for the given amount at the settlement date. AtAs of December 31, 2024,2025, we held no$13.6 openmillion foreign exchange forward contracts. At December 31, 2023, we held 52in open foreign exchange forward contracts related to inventory purchases on letters of credit.credit, Thesecompared to zero open contracts matured monthly through January 2024 with a total notional valueas of approximatelyDecember $2.931, million.2024.
For The Years Ended December 31, 2025 and 2024
Our consolidated loss from operations for the years ended December 31, 2025 and 2024 was as follows:
Revenue. Revenue from services for the year ended December 31, 2025 decreased by approximately $110.4 million, or 23.0%, compared to the year ended December 31, 2024. The decrease was driven by total reductions of $119.8 million, composed of $109.6 million reflecting the sale of BioReference's lab and oncology operations, and $10.2 million from lower clinical test volume in continuing operations, which were partially offset by a $9.4 million increase from higher clinical test reimbursement rates. In addition, revenue benefited from increased demand for the 4Kscore test, with test revenue rising approximately 13%, or $3.2 million, year over year.
Estimated collection amounts are subject to the complexities and ambiguities of billing, reimbursement regulations and claims processing, as well as considerations unique to Medicare and Medicaid programs, and require us to consider the potential for retroactive adjustments when estimating variable consideration in the recognition of revenue for the period in which the related services are rendered. For the years ended December 31, 2025 and 2024, we recorded $1.3 million and $1.5 million, respectively, of negative revenue adjustments due to changes in estimates of implicit price concessions for performance obligations satisfied in prior periods mainly due to the composition of patient payer mix.
The composition of revenue from services by payor for the years ended December 31, 2025 and 2024 was as follows:
Cost of revenue. Cost of revenue for the year ended December 31, 2025 decreased $94.8 million, or 23.6% compared to the year ended December 31, 2024. This decrease was predominantly driven by the absence of costs associated with divested operations following the sale of BioReference assets to Labcorp. The reduction in expenses was characterized by a significant decrease in personnel costs due to headcount reductions, as well as lower clinical activity expenses resulting from decreased consumption of materials and lower testing volumes. Furthermore, the decrease was supported by ongoing cost-reduction initiatives at BioReference and lower expenditures for freight, raw materials, and reference lab testing.
Selling, general and administrative expenses. Selling, general and administrative expenses for the years ended December 31, 2025 and 2024 were $129.3 million and $205.2 million, respectively, representing a decrease of 37.0% from the prior year. The decrease was primarily driven by lower employee-related expenses resulting from headcount reductions, as well as decreases in professional fees, technology and communication costs, and facility rental expenses. These reductions were largely attributable to costs associated with divested operations, as well as the successful execution of continued cost-reduction initiatives across the remaining ongoing operations.
Research and development expenses for the years ended December 31, 2025 and 2024 were $1.6 million and $2.1 million, respectively, representing a decrease of 21.1% from the prior year. The decrease in research and development expenses was primarily due to lower employee-related expenses reflecting continued cost-reduction initiatives implemented at BioReference.
Amortization of intangible assets. Amortization of intangible assets was $12.3 million and $16.9 million for the years ended December 31, 2025 and 2024, respectively. The decrease is primarily attributable to divested operations.
Gain on sale of assets. Gain on sale of assets for the year ended December 31, 2025 and 2024 was $101.6 million and $121.5 million, respectively. These gains were due to the Oncology Transaction, which closed during the third quarter of 2025, and the BioReference Transaction, which closed during the third quarter of 2024.
Revenue from products. Revenue from products for the year ended December 31, 2025 increased $1.8 million, or 1%, compared to the year ended December 31, 2024. This increase was primarily driven by a positive net foreign exchange impact of $2.9 million, resulting from a $5.0 million favorable movement in the Euro that was partially offset by a combined $2.1 million negative impact from the Mexican Peso and Chilean Peso. These gains were moderated by lower sales volumes in our international operations, specifically within our Chilean and Ireland operating companies, which were impacted by the timing of customer orders and product mix. This overall increase was also supported by a $0.8 million increase in revenue from Rayaldee, which grew to $29.8 million compared to $29.0 million in the 2024 period.
Revenue from transfer of intellectual property and other. Revenue from intellectual property and other increased by $2.3 million to $79.7 million for the year ended December 31, 2025, from $77.4 million in the same period last year. The increase was primarily driven by a $4.8 million increase from the BARDA Contract, with revenue recognized under the contract totaling $28.5 million for the year ended December 31, 2025, compared to $23.8 million for the 2024 period. Performance was further bolstered by $4.3 million in royalty revenue from Eli Lilly following the commercial launch of Mazdutide in China and a $7.2 million upfront payment from Regeneron during the 2025 period. Additionally, we saw an increase of $3.5 million in gross profit share and royalty payments from NGENLA® and Pfizer’s Genotropin® (Somatropin). These positive factors were partially offset by the absence of $12.5 million milestone payment from Merck in the 2024 period and a $2.8 million decrease in contract manufacturers’ commercial milestones.
Cost of revenue. Cost of revenue for the year ended December 31, 2025 increased by 1% to $93.6 million compared to $92.5 million for the year ended December 31, 2024. This was primarily driven by shifts in product mix due to the timing of customer orders from our international operating companies, which included an inventory reserve expense of $4.1 million for 2025 compared to $2.1 million for 2024. These factors were partially offset by a decrease in product costs resulting from lower sales volumes across our international operations, specifically within our Chilean and Ireland operations.
Selling, general and administrative expenses. Selling, general and administrative expenses for the years ended December 31, 2025 and 2024 were $53.9 million and $58.0 million, respectively, representing a decrease of 7% from the prior year. The decrease in selling, general and administrative expenses was primarily driven by lower employee-related expenses resulting from operational efficiencies, particularly impacting the Rayaldee commercial operations. This was further aided by a reduction in costs from international operations, which reflected lower professional fees, primarily related to tax litigation.
Research and development expenses. Research and development expenses for the years ended December 31, 2025 and 2024 were $121.9 million and $103.0 million, respectively, representing an increase of 18% from the prior year. Research and development expenses include external and internal expenses, partially offset by third-party grants and funding arising from collaboration agreements. External expenses include clinical and non-clinical activities performed by contract research organizations, lab services, purchases of drug and diagnostic product materials and manufacturing development costs. We track external research and development expenses by individual program for phase 3 clinical trials for drug approval and premarket approval for diagnostics tests, if any. Internal expenses include employee-related expenses such as salaries, benefits and equity-based compensation expense. Other internal research and development expenses are incurred to support overall research and development activities and include expenses related to general overhead and facilities.
Research and development expenses for the year ended December 31, 2025 increased primarily due to higher manufacturing expenses for biological products, including costs incurred under the BARDA Contract, and higher employee‑related expenses due to an increase in headcount, primarily at ModeX. Additionally, the increase reflected lower third-party grants and funding from collaboration agreements compared to the prior year. These funds consist primarily of reimbursements from Merck for development costs related to the Epstein-Barr Virus (EBV) program. Much of the Phase 1 work for this program was done in 2024 and successfully completed in 2025. These increases were partially offset by a modest decrease in spending on earlier-stage programs as resources were prioritized toward advancing these key clinical initiatives.
Amortization of intangible assets. Amortization of intangible assets was $65.6 million and $65.7 million, respectively, for the years ended December 31, 2025 and 2024. Amortization expense reflects the amortization of acquired intangible assets with defined useful lives. Our indefinite lived IPR&D assets will not be amortized until the underlying development programs are completed. Upon obtaining regulatory approval, IPR&D assets will be accounted for as a finite-lived intangible asset and amortized on a straight-line basis over its estimated useful life of approximately 12 years.
Operating loss for our unallocated corporate operations for the years ended December 31, 2025 and 2024 was $40.3 million and $41.1 million, respectively, and principally reflects general and administrative expenses incurred in connection with our corporate operations. The decrease in operating loss was primarily due to lower employee-related expenses.
Interest income. Interest income for the years ended December 31, 2025 and 2024 was $14.8 million and $8.4 million, respectively. The increase in interest income is driven by interest earned on our larger cash investment.
Interest expense. Interest expense for the years ended December 31, 2025 and 2024 was $108.5 million and $47.5 million, respectively. The increase was primarily attributable to $59.1 million from the amortization of $54.7 million in unamortized debt discount and $4.4 million in debt issuance costs related to the Note Exchange Transactions (as defined in Note 7 of the Consolidated Financial Statements). In addition, interest expense was impacted by interest incurred on the 2029 Convertible Notes and the 2044 Notes (both as defined in Note 7 of the Consolidated Financial Statements), including amortization of deferred financing and debt issuance costs.
Fair value changes of derivative instruments, net. Fair value changes of derivative instruments, net for the years ended December 31, 2025 and 2024 were $0.4 million of expense and $26.2 million reversal of expense, respectively. Derivative expense was principally related to the change in fair value of the 2029 Convertible Notes and of foreign currency forward exchange contracts at OPKO Chile.
Other income (expense), net. Other income (expense), net for the years ended December 31, 2025 and 2024, was ($29.9) million of expense and $206.9 million of income, respectively. The decrease was primarily related to our GeneDx (as defined in Note 5 to the Consolidated Financial Statements) investment; we recognized $204.5 million of income for the year ended December 31, 2024, which included $140.0 million reflecting an increase in the fair value of our investment (primarily unrealized gains) and $64.5 million from the sale of GeneDx shares. The decrease was also caused by the inclusion of $32.6 million in inducement expense related to the Note Exchange Transactions for the year ended December 31, 2025. Furthermore, a foreign currency loss of $2.0 million was recorded in the 2025, compared with a loss of $3.8 million recorded in 2024 and were further impacted by a net increase from other non-operating income and expense items.
Income tax benefit (provision). Our income tax benefit (provision) for the years ended December 31, 2025 and 2024 was $15.7 million and ($42.8 million), respectively. The $58.6 million increase in income tax benefit was primarily a result of the discrete, non-recurring tax expenses related to the BioReference Transaction and the Oncology Transaction. While the U.S. federal statutory income tax rate is 21%, our consolidated effective tax rate for both periods differed from this rate primarily due to the relative mix of earnings and losses generated in the U.S. versus foreign tax jurisdictions, as well as the operating results in tax jurisdictions which do not result in a tax benefit.
Loss from investments in investees. We have invested in certain early stage companies that we believe have valuable proprietary technology and significant potential to create value for us as an equity holder. We account for these investments under the equity method of accounting, resulting in the recording of our proportionate share of their losses until our share of their loss exceeds our investment. Until the investees’ technologies are commercialized, if ever, we anticipate they will report net losses. Loss from investments in investees was $29.0 thousand and $18.0 thousand for the years ended December 31, 2025 and 2024, respectively.
Our consolidated income (loss) from operations for the years ended December 31, 2024 and 2023 wasis as follows:
Revenue from transfer of intellectual property and other. For the year ended December 31, 2024, we recorded $77.4 million in revenue from the transfer of intellectual property and other. Revenue for the year ended December 31, 2024 principally reflects $30.0 million from Pfizer, which includes $28.3 million from gross profit share and royalty payments for both NGENLA (somatrogon) and Pfizer's Genotropin® (somatropin). Revenue in 2024 also included $23.8 million from the BARDA Contract, a $12.5 million milestone payment from Merck, and $10.2 million from contract manufacturers' commercial milestones.
Revenue from transfer of intellectual property and other. For the year ended December 31, 2024, we recorded $77.4 million in revenue from the transfer of intellectual property and other. Revenue for the year ended December 31, 2024 principally reflects $30.0 million from Pfizer, which includes $28.3 million from gross profit share and royalty payments for both NGENLA® and Pfizer's Genotropin®. Revenue in 2024 also included $23.8 million from the BARDA Contract, a $12.5 million milestone payment from Merck, and $10.2 million from contract manufacturers' commercial milestones. In comparison, for the year ended December 31, 2023, we recorded $180.7 million in revenue from the transfer of intellectual property and other. This was primarily driven by a $90.0 million milestone payment, triggered by the FDA approval of NGENLA (somatrogon)®, and $26.7 million in revenue that included $22.6 million from gross profit share and royalty payments for both NGENLA (somatrogon)® and Pfizer's Genotropin® (somatropin). In 2023, revenue also included $50.0 million from Merck in consideration for the rights granted to Merck under the Merck Agreement, $7.0 million from VFMCRP triggered by the German price approval for Rayaldee, $2.5 million from Nicoya due to Nicoya's submission of the investigational new drug application to China's Center for Drug Evaluation, $2.4 million from contract manufacturers' commercial milestones and $1.2 million from the BARDA Contract.
Loss from investments in investees. We have invested in certain early stage companies that we believe have valuable proprietary technology and significant potential to create value for us as an equityholder.equity holder. We account for these investments under the equity method of accounting, resulting in the recording of our proportionate share of their losses until our share of their loss exceeds our investment. Until the investees’ technologies are commercialized, if ever, we anticipate they will report net losses. Loss from investments in investees was $18.0 thousand and $107.0 thousand for the years ended December 31, 2024 and 2023, respectively.
For The Years Ended December 31, 2023 and 2022
Our consolidated income (loss) from operations for the years ended December 31, 2023 and 2022 is as follows:
Revenue. Revenue from services for the year ended December 31, 2023 decreased by approximately $240.4 million, or 32%, compared to the year ended December 31, 2022. The decrease in revenue for the year ended December 31, 2023 primarily reflected lower demand for COVID-19 testing and lower COVID-19 reimbursement of $189.7 million and $5.1 million, respectively. The reduction in reimbursement reflects an increase in utilization of antigen point of care diagnostic tests as well as a change in the mix of customers, which pay varying contract prices depending on the level of services we provide. For the year ended December 31, 2023, clinical test volume increased $31.1 million, while clinical test reimbursement decreased $28.4 million, respectively, as a result of the mix of testing ordered. Furthermore, as a result of our sale of GeneDx in April 2022, genomic test revenues decreased by $48.3 million for the year ended December 31, 2023.
Estimated collection amounts are subject to the complexities and ambiguities of billing, reimbursement regulations and claims processing, as well as considerations unique to Medicare and Medicaid programs, and require us to consider the potential for retroactive adjustments when estimating variable consideration in the recognition of revenue for the period in which the related services are rendered. For the years ended December 31, 2023, and 2022, negative revenue adjustments due to changes in estimates of implicit price concessions for performance obligations satisfied in prior periods of $19.2 million and $21.5 million, respectively, were recognized. Revenue adjustments for the year ended December 31, 2023 were primarily due to lower reimbursements from Medicare payors and for the year ended December 31, 2022 were primarily due to lower COVID-19 test reimbursement estimates.
The composition of revenue from services by payor for the years ended December 31, 2023 and 2022 was as follows:
Client payors include cities, states and companies for which BioReference provides COVID-19 testing services.
Revenue from transfer of intellectual property and other for the year ended December 31, 2022 represents grants received under the CARES Act totaling $16.2 million.
Cost of revenue. Cost of revenue for the year ended December 31, 2023 decreased $181.7 million, a decrease of 29% compared to the year ended December 31, 2022. Cost of revenue decreased primarily due to continued cost-reduction initiatives implemented at BioReference, a decline in the volume of COVID-19 tests performed during the year ended December 31, 2023 compared to 2022, and changes in the mix of testing ordered during the period. Furthermore, cost of revenue decreased by $34.9 million as a result of our sale of GeneDx in 2022.
Selling, general and administrative expenses. Selling, general and administrative expenses for the years ended December 31, 2023 and 2022 were $202.3 million and $284.4 million, respectively, respresenting a decrease of 29% from the prior period. Selling, general and administrative expenses in our diagnostics segment decreased primarily due to continued cost-reduction initiatives implemented at BioReference as we strive to return to profitability, as well as decreased expenses due to our sale of GeneDx in 2022.
The decrease in research and development expenses for the year ended December 31, 2023 was primarily due to the continued cost-reduction initiatives implemented at BioReference and partly as a result of the disposition of GeneDx.
Amortization of intangible assets. Amortization of intangible assets was $20.2 million and $23.9 million for the years ended December 31, 2023 and 2022, respectively. Amortization expense reflects the amortization of acquired intangible assets with defined useful lives. Amortization expense declined for the year ended December 31, 2023 due to the disposition of GeneDx and as a result of the full amortization of certain acquired intangible assets.
Gain on sale of assets. Gain on sale of assets for the year ended December 31, 2022 was $18.6 million due to the disposition of GeneDx. There was no comparable transaction for the year ended December 31, 2023.
Revenue from products. Revenue from products for the year ended December 31, 2023 increased $24.7 million, or 17%, compared to the year ended December 31, 2022. The increase in revenue was driven by growing sales from our international operations, which were positively impacted by foreign exchange fluctuations of approximately $6.3 million, as well as increased sales of Rayaldee. Revenue from sales of Rayaldee for the years ended December 31, 2023, and 2022, was $31.0 million and $27.2 million, respectively, an increase of 14%.
Revenue from transfer of intellectual property and other. For the years ended December 31, 2023 and 2022, revenue from transfer of intellectual property and other principally reflects $90.0 million from Pfizer triggered by the FDA approval of NGENLA (Somatrogon) in 2023, and, in 2022, a $85.0 million regulatory milestone payment based on the commencement of sales from NGENLA (Somatrogon) in Europe and Japan, as well as gross profit share and royalty payments for both NGENLA (Somatrogon) and Pfizer’s Genotropin® (Somatropin) of $22.6 million and $4.4 million for the years ended December 31, 2023 and 2022, respectively. For the years ended December 31, 2023 and 2022, revenue from transfer of intellectual property and other principally reflects $4.1 million and $9.3 million, respectively, of revenue related to the Pfizer Transaction. For the year ended December 31, 2023, revenue from transfer of intellectual property and other included $50.0 million from Merck in consideration for the rights granted to Merck under the Merck Agreement, $7.0 million from VFMCRP triggered by German price approval for Rayaldee, and $2.5 million from Nicoya due to Nicoya’s submission of the investigational new drug application to China's Center for Drug Evaluation. For the year ended December 31, 2022, revenue from transfer of intellectual property and other included $3.0 million related to the achievement of a sales milestone pursuant to the VFMCRP Agreement, and $2.5 million from Nicoya tied to the first anniversary of the effective date of the Nicoya agreement.
Cost of revenue. Cost of revenue for the year ended December 31, 2023 increased by 13% to $99.5 million compared to the year ended December 31, 2022, which was driven by growing sales in our international operations due primarily to changes in product mix during the period and higher inventory costs compared to the prior period partially impacted by unfavorable foreign exchange fluctuations of $4.4 million.
Selling, general and administrative expenses. Selling, general and administrative expenses for the years ended December 31, 2023 and 2022 were $55.7 million and $49.2 million, respectively, representing an increase of 13% from the prior year period. The increase in selling, general and administrative expenses was due to higher employee-related expenses from our international operations and from higher employee-related expenses from Rayaldee.
Research and development expenses. Research and development expenses for the years ended December 31, 2023 and 2022 were $87.0 million and $61.3 million, respectively, representing an increase of 42% from the prior year. Research and development expenses include external and internal expenses, partially offset by third-party grants and funding arising from collaboration agreements. External expenses include clinical and non-clinical activities performed by contract research organizations, lab services, purchases of drug and diagnostic product materials and manufacturing development costs. We track external research and development expenses by individual program for phase 3 clinical trials for drug approval and premarket approval for diagnostics tests, if any. Internal expenses include employee-related expenses such as salaries, benefits and equity-based compensation expense. Other internal research and development expenses are incurred to support overall research and development activities and include expenses related to general overhead and facilities.
What changed in the latest 10-Q
Risk Factors
There have been no material changes to our risk factors as previously disclosed in our Form 10-K.
No wording changes found in this section.
Full comparison: every changed paragraph (0)
Management's Discussion & Analysis (MD&A)
New heading “Nicoya Amendment”
New heading “FOR THE SIX MONTHS ENDED JUNE 30, 2026 AND 2025”
New heading “Pharmaceuticals”
Removed heading “Entera Collaboration and License Agreement”
Largest changes
“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). …”see in full comparison
“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). …”see in full comparison
“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. …”see in full comparison
“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). …”see in full comparison
Full comparison: every changed paragraph (75)
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 theits developmentcommercialization in mainland China through our strategic partner.
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.
Entera Collaboration and License Agreement
In February 2026, the Company and its subsidiary, OPKO Biologics, entered into an amended and restated collaboration and license agreement with Entera Bio Ltd. (“Entera”), expanding our existing partnership to include the preclinical and clinical development of a daily long-acting PTH tablet (“LA-PTH”) for the treatment of hypoparathyroidism and other indications. This program is in addition to our existing collaboration for an oral dual agonist GLP-1/glucagon peptide. Under the terms of the amended agreement, the ownership and cost-sharing structures are as follows:
Oral GLP-1/Glucagon Program: the Company and Entera maintain their 60% and 40% pro-rata ownership interests, respectively, and remain responsible for 60% and 40% of the program's development costs, respectively; and LA-PTH Program: the Company and Entera each hold a 50% pro-rata ownership interest and will share development costs equally (50/50). We expect to file an investigational new drug application with the FDA for the LA-PTH program in late 2026.
In February 2026, Steven D. Rubin, the Company’s Executive Vice President, Administration and a member of our Board of Directors, was appointed to the Board of Directors of Entera. We continue to provide Entera with certain licenses to our technology, including our proprietary long-acting oxyntomodulin analog (OPK-88006), to support development efforts. Our equity investment in Entera remains subject to the standstill and lock-up provisions established in the initial March 2025 agreement.
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 MarchJune 31,30, 2026,2026 are not directly comparable to the prior year period,periods, which included the operations of the divested assets. WeUnder remainthe eligiblepurchase 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 performance-basedcash, contingentrepresenting the total earnout amount earned and payable under such purchase agreement. No further earnout consideration underis theexpected termsto ofbe the agreement.received.
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 threesix months ended MarchJune 31,30, 2026, the Company repurchased an additional 3,950,0009,835,105 shares of Common Stock at an average price of $1.21$1.39 per share, for an aggregate cost of approximately $4.8$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 MarchJune 31,30, 2026, the total cost of repurchases under the program was approximately $92.0$105.3 million.
These new measures did not have a material impact on our results of operations for the threesix months ended MarchJune 31,30, 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.
Approximately 32.7%33.3% of our revenue for the threesix months ended MarchJune 31,30, 2026, was denominated in currencies other than the U.S. Dollar (USD). This compares to 22.3%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 threesix months ended MarchJune 31,30, 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 $24.1$25.0 million and $17.6 million at MarchJune 31,30, 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 MarchJune 31,30, 2026, we held $25.4$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.
FOR THE THREE MONTHS ENDED MARCHJUNE 31,30, 2026 AND 2025
Our consolidated income from operations for the three months ended MarchJune 31,30, 2026 and 2025 was as follows:
Revenue. Revenue from services for the three months ended MarchJune 31,30, 2026 decreased by approximately $30.7$26.6 million, a decrease of 29.8%26.3% compared to the same period in 2025. This decline was primarily attributable to a $25.9$24.9 million reduction in revenue resulting from consummationthe completion of the Oncology Transaction in September 2025. The remaining $4.8$1.7 million decreasedecreased wasprimarily drivendue by lower clinicalto test volumesmix andchanges clinicalas testwe reimbursementcontinued ratesto withinsee the impact of shifting certain unprofitable but higher priced esoteric testing to our continuingstrategic operations.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 MarchJune 31,30, 2026, we recorded $1.0 million of positive revenue adjustments due to changes in estimates of implicit price concessions for performance obligations satisfied in prior periods, primarily due to favorable shifts in the composition of our client mix. For the three months ended March 31, 2025, we recorded $1.5$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.
The composition of revenue from services by payor for the three months ended MarchJune 31,30, 2026 and 2025 was as follows:
Cost of revenue. Cost of revenue for the three months ended MarchJune 31,30, 2026 decreased $28.4$23.9 million, a decrease of 33.6%29.0% compared to the three months ended MarchJune 31,30, 2025. Of this decrease, $24.8$23.1 million was due to the divestiture ofeffected certainby laboratorythe assetsOncology 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 MarchJune 31,30, 2026 and 2025 were $26.2$26.6 million and $38.0$33.4 million, respectively, representing a decrease of 31.1%20.4% from the prior period. This decrease was primarily driven by a $6.5$6.8 million reduction in costs associated with divested operations and a $5.3 million decrease resulting from continued cost-reduction initiatives, particularly in lease-related expenses.operations.
The decrease in research and development expenses for the three months ended MarchJune 31,30, 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 $3.8$3.0 million, respectively, for the three months ended MarchJune 31,30, 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.
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 products. Revenue from products for the three months ended March 31, 2026 increased $3.2 million or 9.2%, compared to the three months ended March 31, 2025. This increase was primarily driven by a $2.4 million favorable impact from foreign currency exchange rates and strong performance in our Spanish operations. Higher sales volumes in Spain more than offset slight decreases in our other international platforms, resulting in an additional $0.8 million net increase in product revenue. Revenue from Rayaldee remained consistent at $6.3 million for both the three months ended March 31, 2026 and 2025.
Revenue from transfer of intellectual property and other. Revenue from intellectual property and other increased by $1.7$31.1 million to $14.0$46.1 million for the three months ended MarchJune 31,30, 2026,2026 from $12.3$15.0 million for the same period last year. ThisThe 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 $4.5$6.1 million in the 2025 period, and $1.4$3.2 million from Eli Lilly. Additionally, we recognized $0.9$1.1 million in collaboration revenue from Regeneron duringfor the currentthree period.months ended June 30, 2026. These gainsincreases were partially offset by a decrease in revenue recognized under the BARDA contract, which totaled $4.1$5.0 million infor the currentthree periodmonths ended June 30, 2026 compared to $7.0$6.5 million for the same period in 2025.2025, as well as a $1.3 million decrease in contract manufacturers’ commercial milestones.
Cost of revenue. Cost of revenue for the three months ended MarchJune 31,30, 2026 decreasedincreased $0.5$0.1 million, or 2.3%,0.3%, compared to the three months ended MarchJune 31,30, 2025. ThisThe decreasenet increase was primarily driven by lower production costs and operational efficiencies within our international manufacturing platforms. These savings were largely offset by a $1.6$1.1 million unfavorable impact from foreign currency exchange rates.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 MarchJune 31,30, 2026 and 2025 were $14.2$13.9 million and $12.7$13.2 million, respectively, an increase of 11.8%5.4% from the prior year period. This increase was primarily driven by a $1.0$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 MarchJune 31,30, 2026 and 2025 were $28.8$32.7 million and $30.2$29.8 million, respectively, aan decreaseincrease of 4.9%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.
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.
The decrease in research and development expenses was primarily driven by a $2.1 million reduction in spending associated with the BARDA COVID and BARDA FLU programs, which was discontinued. The decrease was partially offset by an increase in expenditures related to our earlier stage programs. The overall reduction reflects the timing of activities under the BARDA contract, even as we continue to invest in our earlier-stage clinical pipeline.
Amortization of intangible assets. Amortization of intangible assets was $16.4 million and $16.1 million for the three months ended MarchJune 31,30, 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.
Operating loss for our unallocated corporate operations was $8.4$12.6 million for the three months ended MarchJune 31,30, 2026, compared to $8.5$13.1 million for the same period in 2025. TheseWhile these results primarily reflect general and administrative expenses incurred in connection with our corporate operationsoperations, andthe remainedslight consistentdecrease within the loss was primarily driven by lower employee-related expenses compared to the prior year period.
Interest income. Interest income for the three months ended MarchJune 31,30, 2026 and 2025 was $3.0$3.2 million and $4.7$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).
Interest expense. Interest expense decreased to $10.9 million for the three months ended March 31, 2026, compared to $15.5 million for the same period of 2025. The decrease was primarily attributable to lower interest incurred on the 2029 Notes, which accounted for $4.0 million of the reduction. Additionally, interest expense related to our HCRx royalty financing and other international credit facilities decreased by approximately $0.5 million in the aggregate compared to the prior year period. These decreases include the impact of lower principal balances and the related amortization of deferred financing and debt issuance costs.
Fair value changes of derivative instruments, net. Fair value changes of derivative instruments, net for the three months ended MarchJune 31,30, 2026 and 2025, was $298.0$65.0 thousand of expense and $273.0$16.0 thousand of income, respectively. Derivative expenseThis 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.
Other expense, net. Other expense, net changed by $6.6 million to a $1.7 million expense for the three months ended March 31, 2026, compared to $4.9 million of income for the prior year period. This was primarily driven by the non-recurrence of a $3.9 million gain from the sale of our remaining investment in GeneDx Holdings Corp. recognized in the 2025 period and a $2.1 million fair value adjustment expense related to our investment in Entera during the current period. These decreases were partially offset by a $1.4 million increase in foreign currency gains, which totaled $1.5 million for the current period compared with $0.1 million in the 2025 period.
Income tax benefit. Our income tax benefit for the three months ended MarchJune 31,30, 2026 and 2025 was $6.1$5.0 million and $5.8$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:
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.
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:
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:
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.
Pharmaceuticals
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:
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.
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.
OPK insider buying and selling (Form 4)
Since 2026-04-11, insiders reported open-market purchases in 0 Form 4 filings and open-market sales in 0 filings. Totals add up every open-market (code P and S) line in those filings, using the prices reported in the filings. Awards, option exercises, tax withholding and gifts are listed below but not counted.
| Trade date | Insider | Transaction | Shares | Price | Value |
|---|---|---|---|---|---|
| 2026-07-24 | Logal Adam |
Shares withheld for tax | 53,266 | $1.22 | $65.0K |
| 2026-07-24 | Rubin Steven D |
Shares withheld for tax | 53,266 | $1.22 | $65.0K |
Well-known investors holding OPK (13F)
| Investor | Quarter | Shares | Reported value | % of their 13F | Change vs prior quarter |
|---|---|---|---|---|---|
| Citadel Advisors (Ken Griffin) | 2026-06-30 | 1,420,922 | $2.1M | 0.0% | Reduced 32% |
| AQR Capital Management (Cliff Asness) | 2026-06-30 | 1,239,399 | $1.9M | 0.0% | Added 62% |
| Two Sigma Investments | 2026-06-30 | 175,801 | $263.7K | 0.0% | Added 3% |
| Point72 Asset Management (Steve Cohen) | 2026-06-30 | 145,234 | $217.9K | 0.0% | Added 56% |
| Renaissance Technologies | 2026-06-30 | 109,543 | $124.9K | — | Sold out |
| Millennium Management (Israel Englander) | 2026-06-30 | 72,301 | $108.5K | 0.0% | New position |