On February 26, 2026 OPKO Health, Inc. (NASDAQ: OPK) (OPKO) reported business highlights and financial results for the three and 12 months ended December 31, 2025, and introduces financial guidance for the first quarter and full year 2026.
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Highlights from the fourth quarter of 2025 and recent weeks include the following:
Entered into a research collaboration with Regeneron Pharmaceuticals to develop multispecific antibodies. This new partnership leverages ModeX’s MSTAR technology platform with Regeneron’s proprietary binders to develop single molecule candidates that target multiple distinct biological pathways in several clinical indications. ModeX received an upfront payment and is entitled to potential milestone payments exceeding $200 million for each program. The overall potential value of the collaboration exceeds $1 billion if multiple products from the collaboration are successful. In addition, ModeX is eligible to receive tiered royalties on global net sales, reaching low double digits at the highest tier. Regeneron is responsible for funding all preclinical and clinical development, as well as all commercialization activities.
Merck completed the Phase 1 Epstein-Barr virus vaccine trial (NCT06655324). This investigational vaccine candidate is being developed in collaboration with Merck. The Phase 1 trial evaluating safety and tolerability in over 200 healthy adults was completed in the fourth quarter of 2025. Additional studies are in progress to inform dose and adjuvant selection for potential Phase 2 studies.
MDX2003, a first-in-class trispecific T-cell engager-expander for the treatment of leukemia and lymphoma, was approved for Phase 1 studies in Australia, which are expected to begin in the first half of 2026. Also, an abstract was presented at 2025 ASH (Free ASH Whitepaper) Annual Meeting. In November, an abstract titled "MDX2003, a novel tetraspecific T cell engager-expander targeting CD19xCD20xCD3xCD28, demonstrates potent preclinical activity against B cell malignancies" was presented at the American Society of Hematology (ASH) (Free ASH Whitepaper)’s 67th ASH (Free ASH Whitepaper) Annual Meeting and Exposition. In an animal model, MDX2003 prevented further tumor growth at low doses and was well-tolerated with low levels of cytokines in the blood and no observable toxicity.
Abstract for MDX2004, a first-in-class trispecific antibody-fusion protein immune rejuvenator, was presented at SITC (Free SITC Whitepaper) 2025. In November, an abstract titled "MDX2004, a novel immune rejuvenator targeting CD3, CD28, and 4–1BB, augments tumor immunity in preclinical animal models" was presented at SITC (Free SITC Whitepaper) 2025, the annual meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper). The ongoing Phase 1/2a study (NCT07110584) is designed to evaluate the safety, tolerability and biologic activity of MDX2004 as an immunotherapy for advanced cancers.
Abstract for MDX2001 cMet-Trop2/CD3-CD28, a first-in-class tetraspecific T-cell engager, was presented at ESMO (Free ESMO Whitepaper) 2025. In October, an abstract titled "A phase I/IIa, multicenter, first-in-human, open-label clinical trial evaluating MDX2001, a tetraspecific T cell engager-expander in patients with advanced solid tumors" was presented at ESMO (Free ESMO Whitepaper) Congress 2025, the annual meeting of the European Society for Medical Oncology. The MDX2001 cMet-Trop2/CD3-CD28 tetraspecific antibody has advanced to the fifth dose level in its Phase 1 clinical trial, with Phase 1b studies in select solid tumors expected to begin in the first half of 2026.
FDA permission to proceed to Phase 1 granted to MDX2301, a tetravalent bispecific antibody that neutralizes all known strains of SARS-CoV2, for the prevention and treatment of COVID-19 infection. Supported by non-dilutive funding from BARDA, the clinical trial in healthy volunteers is scheduled to begin in the second quarter of 2026, with pharmacokinetic and immunogenicity data expected later this year.
Expanded partnership with Entera Bio to advance first-in-class oral long-acting PTH tablet for patients with hypoparathyroidism. This third program under the collaboration combines OPKO’s proprietary long-acting PTH variants with Entera’s proprietary N-Tab technology. Following favorable pharmacodynamic and pharmacokinetic data reported in December 2025, the companies have jointly decided to accelerate development and expect to file an investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA) in late 2026. OPKO and Entera Bio each hold a 50% pro-rata ownership interest in the long-acting PTH hypoparathyroidism program and each is responsible for 50% of the program’s development costs.
Fourth Quarter Financial Results
Consolidated: Consolidated total revenues for the fourth quarter of 2025 were $148.5 million compared with $183.6 million for the 2024 period, with the decrease principally resulting from the sale of certain BioReference assets in 2025. Operating loss for the fourth quarter of 2025 was $38.3 million compared with operating loss of $33.1 million for the 2024 quarter. Net loss for the fourth quarter of 2025 was $31.3 million, or $0.04 per share, compared with net income of $14.0 million, or $0.01 per diluted share, for the 2024 quarter. Net income for the fourth quarter of 2024 included a realized gain of $54.1 million from the sale of shares of GeneDx, as well as non-cash other income of $21.4 million.
Pharmaceuticals: Revenue from products in the fourth quarter of 2025 was $43.7 million compared with $37.4 million in the fourth quarter of 2024, driven by a positive net foreign exchange impact of $4.0 million and by higher sales volumes in our international operations. Revenue from Rayaldee was $8.8 million compared with $9.1 million in the comparable prior-year quarter. Revenue from the transfer of intellectual property and other was $33.7 million in the fourth quarter of 2025 compared with $43.1 million in the 2024 period. Gross profit share payments for NGENLA, which totaled $12.5 million in the 2025 period compared with $9.6 million in the 2024 period, reflect the global commercial progress by Pfizer. In addition, the fourth quarter of 2025 included $4.3 million in royalty revenue from Eli Lilly following the commercial launch of mazdutide in China by their partner Innovent Biologics and a $7.0 million upfront payment from Regeneron. The comparable period of 2024 included a $12.5 million milestone payment from Merck, as well as a $7.0 million decrease in commercial milestones at our Eirgen business and a $4.1 million decrease in revenue from our contract with BARDA. Total costs and expenses increased to $88.0 million in the fourth quarter of 2025 from $82.6 million in the prior-year period, primarily due to higher cost of revenue related to higher sales volume, higher research and development expenses driven by advancements in early-stage programs and employee-related expenses reflecting an increase in headcount to support ongoing clinical activities. Operating loss was $10.7 million in the fourth quarter of 2025, which included $18.3 million in depreciation and amortization expense, compared with operating loss of $2.1 million in the fourth quarter of 2024, which included $18.1 million of depreciation and amortization expense.
Diagnostics: Revenue from services in the fourth quarter of 2025 was $71.1 million compared with $103.1 million in the prior-year period. The decrease was principally a result of the sale of certain BioReference assets in 2025 and the resulting decline in clinical test volume, and lower clinical test reimbursement rates, partially offset by increased demand and higher average reimbursement for the 4Kscore test, resulting in a 16% increase in revenue to $7.0 million in the 2025 quarter compared with $6.0 million in revenue in the 2024 quarter. Total costs and expenses were $89.4 million in the fourth quarter of 2025 compared with $124.8 million in the fourth quarter of 2024. The decrease was primarily attributable to the assets sold and to continued cost-reduction initiatives at BioReference. Operating loss was $18.3 million in the fourth quarter of 2025, which included $4.1 million of depreciation and amortization expense, compared with operating loss of $21.7 million in the 2024 period, which included $6.0 million of depreciation and amortization expense. The fourth quarter of 2025 was impacted by non-recurring transition-related adjustments of $5.8 million, primarily from severance, asset write-offs, third-party revenue adjustments, and capital tax expense. The fourth quarter of 2024 included revenue of $26.3 million and costs and expenses of $32.9 million from the oncology assets that were sold to Labcorp on September 15, 2025.
Cash, cash equivalents, marketable securities and restricted cash: Cash, cash equivalents and restricted cash were $369.1 million as of December 31, 2025. As of December 31, 2025, approximately $87.3 million of OPKO’s common stock had been repurchased, including $13.5 million in the fourth quarter of 2025, under the program since its authorization in July 2024. Approximately $112.7 million remained authorized and available for future repurchases.
2026 Financial Guidance: The table below reflects financial guidance for the first quarter and full year 2026 (in millions):
For the three months ended March 31, 2026 For the year ended December 31, 2026
Low High Low High
Revenue
Services revenue $ 71 $ 75 $ 300 $ 312
Product revenue 38 45 160 170
IP and other revenue 15 20 70 80
Total revenues 125 140 530 560
Included in revenue
Pfizer profit share 5 6 34 37
BARDA contract 7 9 18 22
Total costs and expenses 170 180 725 750
R&D included in costs and expenses 30 32 125 135
Conference Call and Webcast Information
OPKO’s senior management will provide a business update, discuss fourth quarter financial results, provide financial guidance and answer questions during a conference call and live audio webcast today beginning at 4:30 p.m. Eastern time. Participants are encouraged to pre-register for the conference call here. Callers who pre-register will receive a unique PIN to gain immediate access to the call and bypass the live operator. Participants may register at any time, including up to and after the call start time. Those unable to pre-register may participate by dialing 833-630-0584 (U.S.) or 412-317-1815 (International). A webcast of the call can also be accessed at OPKO’s Investor Relations page and here.
A telephone replay will be available until March 5, 2026, by dialing 855-669-9658 (U.S.) or 412-317-0088 (International) and providing the passcode 2367034. A webcast replay will be available beginning approximately one hour after the completion of the live conference call here.
(Press release, Opko Health, FEB 26, 2026, View Source [SID1234663084])