OPKO Health (NASDAQ:OPK) executives said the company exited 2025 with “tremendous momentum,” citing efforts to reposition its diagnostics business for a return to profitability, advance its ModeX therapeutic pipeline, use non-dilutive partnership funding to support R&D, and strengthen the balance sheet.
BioReference reshaped after oncology divestiture
Management described 2025 as a transformative year for BioReference following the sale of its oncology division and related testing services to Labcorp in September. According to Chairman and CEO Dr. Phillip Frost, the divestiture enabled the company to focus BioReference on its core clinical laboratory business in the New York and New Jersey region, correctional health, and the 4Kscore Test nationally. Executives said the transaction streamlined infrastructure, reduced fixed costs, and freed capital for broader strategic objectives.
On the 4Kscore Test, Zerhouni said fourth-quarter volume increased more than 6% year-over-year and pointed to an FDA-approved labeling change that removes the requirement for a digital rectal exam. He said the updated label is expected to support continued momentum and eventual entry into primary care, noting that most PSA screening is performed by primary care physicians.
In the Q&A, CFO Adam Logal said OPKO has not yet made “meaningful” efforts into primary care for 4Kscore and is still working with payers on coverage. He said recent volume increases have been driven by the urology market and suggested growth could accelerate as payer coverage expands. Logal added that overall revenue growth also benefited from improved revenue cycle management and a better payer mix, and he said the company expects 4Kscore growth at a high single-digit to low double-digit pace into 2026.
ModeX pipeline updates and partnership activity
Zerhouni said ModeX is now a clinical-stage platform spanning vaccines, oncology, and immunology, with three programs in the clinic and two more expected to enter clinical trials in the coming months.
- EBV vaccine (partnered with Merck): Management said Merck has enrolled more than 200 subjects in a Phase 1 trial evaluating safety, tolerability, and immunogenicity using OPKO antigens combined with Merck adjuvants. In the Q&A, Merck collaboration leader Dr. Gary Nabel said ongoing work is intended to generate more data in EBV-seronegative patients (the target population for Phase 2) and to potentially reduce the age of inclusion from 18+ to 12+. Nabel said he expects most of the data needed for decisions by the end of the year, with Phase 2 potentially starting next year.
- MDX-2001: OPKO’s lead immuno-oncology program is a tetraspecific T-cell engager targeting c-Met and TROP-2 with CD3 and CD28. Zerhouni said more than 25 patients have been dosed in Phase 1 dose escalation across multiple solid tumors, reaching dose levels about 10 times higher than the starting dose with acceptable safety. In the Q&A, management said it is adjusting the regimen and does not plan to move to a “much higher” dose level based on current information. Executives said they see “signs of efficacy” but said it is too early to formally report; they expect to announce Phase 1A results at an upcoming conference and then move into Phase 1B expansion cohorts in tumor types showing the most promising signs, with results they can share by the end of 2026.
- MDX-2004: Described as a first-in-class multispecific “immune rejuvenator” for advanced cancers, MDX-2004 engages CD3, CD28, and 4-1BB. Zerhouni said the program entered Phase 1 late last year in Australia and subsequently in Israel. In the Q&A, he characterized MDX-2004 as an “accelerator” intended to reinvigorate T-cell activity in settings where immune function is exhausted, including patients with multiple prior cancer treatments. He said the Phase 1 study includes two arms (PD-1 naïve and previously exposed) and that, at the time of the call, eight patients had been treated.
- MDX-2003: A tetraspecific antibody binding CD19 and CD20 on B cells and CD3 and CD28 on T cells. Zerhouni said OPKO presented preclinical findings at ASH in December, received IND approval in Australia, and expects to begin a first-in-human cancer trial in “a few weeks.” He said OPKO is also considering an autoimmune indication separately.
OPKO also highlighted its Regeneron collaboration, which Zerhouni said combines Regeneron’s monoclonal antibody resources with ModeX’s multispecific platform across four initial programs in metabolism, oncology, and immunology, with potential expansion. Management said Regeneron will fund preclinical and clinical development and commercialization for selected assets, while OPKO is eligible for milestones exceeding $1 billion plus up to low- to double-digit royalties.
Infectious disease programs and in vivo CAR-T platform
Zerhouni said OPKO’s BARDA-supported multispecific antibody programs for COVID-19 and influenza continue to advance. He said the company recently received FDA IND clearance for MDX-2301, a COVID multispecific antibody aimed at high-risk immunocompromised populations, with plans to enter the clinic in the first half of 2026. He said the influenza program is in pre-IND and that OPKO is evaluating lead candidates in challenge models to prioritize for additional clinical work and potential incremental BARDA funding.
Management said OPKO received $28.5 million in BARDA non-dilutive funding for the two programs in 2025 and $54 million since inception, and that BARDA will assume the cost of clinical trials.
On its in vivo CAR-T platform, Zerhouni said OPKO uses targeted lipid nanoparticles carrying mRNA or DNA, with covalent conjugation of targeting antibodies to the nanoparticle surface, enabling targeting of multiple cell types. He said non-human primate studies showed B-cell depletion and safety, and that the company is in late-stage pre-IND work with hopes to enter the clinic late 2026 or in early 2027.
Financial results, capital returns, and 2026 guidance
CFO Adam Logal said OPKO ended the quarter with $369 million in cash, cash equivalents, and restricted cash. He said the company repurchased 9.8 million shares during the fourth quarter and 34.6 million shares during 2025 for approximately $47 million, with about $113 million remaining under its authorization. Logal also said OPKO deployed more than $109 million in convertible note and common stock repurchases in 2025, and nearly $230 million since the start of 2024.
In diagnostics, OPKO reported fourth-quarter 2025 revenue of $71.1 million, including $7 million from 4Kscore, compared with $103.1 million in the prior-year quarter. Logal attributed the decline primarily to the September 2025 Labcorp transaction, while also noting retained business revenue declined mainly due to test mix changes, partially offset by slight volume increases. Diagnostics costs and expenses were $89.4 million, down from $124.8 million, and included $5.8 million of non-recurring expenses tied to headcount reductions and asset write-offs. The diagnostics operating loss was $18.3 million versus $21.7 million a year earlier.
Pharmaceutical segment revenue was $77.4 million in the fourth quarter of 2025 compared with $80.5 million in the prior-year period. Product sales rose to $43.7 million from $37.4 million, which management attributed to foreign exchange tailwinds and higher international volumes. Rayaldee contributed $8.8 million versus $9.1 million, reflecting lower government rebates partially offset by a roughly 17% decline in volumes. OPKO’s Pfizer gross profit share was $12.5 million, up from $9.6 million, which management said was the highest to date and reflects Pfizer’s progress commercializing NGENLA.
Logal also said OPKO recorded $7.2 million of revenue from its new Regeneron collaboration in the quarter, compared with $12.5 million of Merck milestone payments in the year-ago quarter related to the EBV collaboration. BARDA funding was $6.9 million compared with $11.0 million, reflecting differences in activity levels. The company recorded $4.3 million of royalties from Eli Lilly tied to mazdutide sales in China from July through December 2025.
On a consolidated basis, OPKO reported fourth-quarter 2025 revenue of $148.5 million, compared with $183.6 million in the fourth quarter of 2024, and an operating loss of $38.3 million compared with $33.1 million. Net loss was $31.3 million, or $0.04 per share, compared with net income of $14.0 million, or $0.01 per diluted share, in the prior-year quarter.
For the first quarter of 2026, OPKO guided total revenue of $125 million to $140 million and said weather in the Northeast had already impacted volumes by an estimated $3 million to $5 million. For full-year 2026, management guided total revenue of $530 million to $560 million, with total costs and expenses expected between $725 million and $750 million. Logal said expense growth is expected primarily from R&D, while the company anticipates stable to declining costs in other operating areas, including continued efficiency improvements at BioReference.
About OPKO Health (NASDAQ:OPK)
OPKO Health, Inc (NASDAQ:OPK) is a diversified, global healthcare company headquartered in Miami, Florida, with a focus on diagnostics, pharmaceuticals and biologics development. The company operates two main business segments—Laboratory Services and Pharma Services & Products—driven by its mission to advance patient care through innovation in testing and targeted therapies.
In its Laboratory Services segment, OPKO leverages BioReference Laboratories, one of the largest full-service commercial labs in the United States.
