OPKO Health Q2 Earnings Call Highlights

Key Points

• OPKO Health narrowed its Q2 net loss to $8.4 million, or $0.01 per share, from $148.4 million a year earlier, while revenue rose to $163.6 million. The company ended the quarter with more than $300 million in cash and repurchased 9.7 million shares for approximately $13 million.
• Diagnostics profitability improved following the Labcorp transaction, with BioReference’s segment posting $4.8 million in operating income versus a $18.2 million loss a year earlier. Pharmaceutical revenue increased to $89 million, helped by a $29.4 million contribution from the China RAYALDEE commercialization agreement.
• OPKO raised its 2026 revenue outlook to $560 million–$585 million while lowering its total cost-and-expense forecast. The company is also advancing its pipeline, including a Phase I/IIa MASH study for OPKO-88006 and plans to begin first-in-human testing of its in vivo CAR-T candidate by late 2026 or early 2027.

OPKO Health NASDAQ: OPK reported a narrower second-quarter loss as gains tied to its diagnostics restructuring and a China commercialization agreement helped lift revenue, while the company continued to increase investment in clinical development programs.

Total revenue for the second quarter of 2026 was $163.6 million, compared with $156.8 million a year earlier. The company recorded a net loss of $8.4 million, or $0.01 per share, improving from a net loss of $148.4 million, or $0.19 per share, in the prior-year quarter. OPKO’s 2025 results included a $91.7 million expense associated with an exchange of convertible notes.

Consolidated operating loss narrowed to $7 million from $60 million in the prior-year period. Chief Financial Officer Adam Logal said the company ended the quarter with more than $300 million in cash, cash equivalents and restricted cash. OPKO also repurchased 9.7 million shares for approximately $13 million during the quarter and had about $94 million remaining under its repurchase authorization.

Diagnostics Results Improve Following Labcorp Transaction

BioReference Health generated $74.5 million in second-quarter diagnostic revenue, down from $101.1 million a year earlier. Logal said the decline was expected following the September 2025 sale of select oncology and oncology-related clinical testing assets to Labcorp.

Revenue from the retained diagnostics business declined approximately $1.7 million from the prior year, principally reflecting test-mix changes as OPKO shifted certain unprofitable, higher-priced esoteric testing to strategic partners. Revenue from the company’s 4Kscore prostate cancer test was $6.2 million in the quarter.

Diagnostics costs and expenses fell to $69.8 million from $119.3 million. The figure included an $18.1 million gain related to the final earn-out payment from the Labcorp transaction, which offset operating expenses. The diagnostics segment posted operating income of $4.8 million, compared with an operating loss of $18.2 million a year ago.

Management said BioReference is working toward breakeven and sustainable profitability through a more focused geographic footprint, lower headcount, a revised patient-service-center network and a shift toward higher-margin services. Logal said OPKO expects potential expansion of the 4Kscore opportunity in primary care to be more meaningful in 2027 and beyond, pending Medicare-related decisions.

Pharmaceutical Revenue Rises, Including China Agreement

Pharmaceutical revenue rose to $89 million from $55.7 million a year earlier. Product sales increased to $42.9 million from $40.7 million, driven by higher international sales volumes, foreign-exchange tailwinds and improved gross-to-net economics for RAYALDEE, partially offset by product-delivery timing in OPKO’s contract development and manufacturing business.

RAYALDEE revenue was $8.1 million, compared with $7.2 million in the prior-year period. OPKO’s Pfizer gross-profit share from the NGENLA long-acting pediatric growth hormone product was $6.4 million, up from $6.1 million.

The quarter also included $29.4 million in revenue related to Series A2 preferred shares received through OPKO’s partnership with Nicoya for commercialization of RAYALDEE in Greater China. As a result, IP and transfer-of-other revenue rose to $46.1 million from $15 million.

Pharmaceutical costs and expenses increased to $88.2 million from $84.4 million as research and development spending rose to $32.7 million from $29.8 million. The segment generated operating income of $8.8 million, compared with an operating loss of $28.7 million in the prior-year quarter.

Pipeline Updates Include MASH Study and In Vivo CAR-T Plans

Chairman and Chief Executive Officer Phillip Frost said OPKO continued to advance programs across ModeX Therapeutics and OPKO Biologics. The company opened enrollment for a Phase I/IIa trial of OPKO-88006, a once-weekly dual GLP-1/glucagon agonist. The study will assess ascending doses in healthy volunteers and then evaluate 16 weeks of treatment in participants with presumed metabolic dysfunction-associated steatohepatitis, or MASH.

Vice Chairman and President Elias Zerhouni said the initial MASH population is expected to focus on patients with F2 and F3 fibrosis, with an emphasis on F3 where possible. The company plans to evaluate weight loss, tolerability and biomarker changes, including FGF21 levels, before deciding whether to proceed to a larger Phase II program.

ModeX expects its in vivo CAR-T candidate, MDX-3001, to enter first-in-human studies by the end of 2026 or in early 2027. Gary Nabel, president and CEO of ModeX Therapeutics, said the company’s initial focus is expected to be autoimmune disease, using a CD19 CAR approach intended to deplete B cells. OPKO is discussing potential partnerships with larger pharmaceutical companies but said those discussions remain at an early stage.

• MDX-2001, a tetraspecific immuno-oncology candidate for solid tumors, has enrolled 39 patients in Phase I. The company expects dose escalation and regimen optimization to conclude in the third quarter or early fourth quarter of 2026, with early data targeted for late 2026 or early 2027.
• MDX-2003, an engager-expander candidate directed at CD19 and CD20 in B-cell cancers, is enrolling patients in Phase I. Management said oncology is the initial priority, followed by potential autoimmune development.
• MDX-2301, a BARDA-funded multispecific COVID-19 antibody program, is expected to complete Phase I enrollment during the third quarter, with early findings anticipated later this year or in early 2027.
• OPKO’s oral parathyroid hormone program with Entera Bio is advancing toward a planned investigational new drug filing later this year, while its long-acting growth hormone antagonist program for acromegaly is expected to enter clinical trials at the end of 2026.

Updated 2026 Outlook

OPKO raised its full-year revenue outlook to $560 million to $585 million. The company expects service revenue of $296 million to $306 million, pharmaceutical product revenue of $164 million to $174 million, and $100 million to $105 million of other revenue from collaborations, including $34 million to $37 million in Pfizer profit share.

The company lowered its full-year total cost-and-expense outlook to $710 million to $740 million, excluding future one-time items. It maintained expected R&D investment of $125 million to $135 million, partly offset by anticipated BARDA funding of $18 million to $22 million and reimbursement under its Regeneron collaboration.

For the third quarter, OPKO projected revenue of $131 million to $142 million and total costs and expenses of $180 million to $190 million. Third-quarter R&D expense is expected to range from $34 million to $38 million.

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.

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