OPKO HEALTH Q2 FY26 earnings call OPK

ModeX is advancing five clinical trial programs in oncology, immunology, and vaccines, with a sixth asset, an in vivo CAR-T program (MDX3001), expected to begin first-in-human trials by the end of 2026 or early 2027. The MDX3001 program is highly differentiated, leveraging multi-specific antibody expertise and targeted lipid nanoparticles to generate engineered T cells directly inside the patient's body. Preclinical data for MDX3001 demonstrated in vivo CAR T cell generation with B-cell depletion in humanized mouse and nonhuman primate models, supporting its potential in cancer and autoimmunity.

The collaboration with Merck for MDX2201, an Epstein-Barr virus vaccine, is fully funded by Merck and is in the late stages of Phase I data analysis, with potential progression to Phase II in 2027. OPKO's partnership with Regeneron combines their extensive library of monoclonal antibody binders with ModeX's multi-specific architecture, advancing four initial discovery programs across immunology, oncology, and metabolic diseases. This collaboration offers potential milestones exceeding $1 billion and tiered royalties up to low double digits on global sales.

OPKO Biologics is making steady progress across its portfolio, including the initiation of a Phase I/IIa clinical study in the U.S. for its GLP-1 glucagon candidate (OPK-88006) for MASH patients. The human growth hormone antagonist (OPK8801001) for acromegaly, designed as a once-weekly injection, is expected to advance to clinical trials by the end of 2026. Additionally, the oral PTH program for hypoparathyroidism, in collaboration with Entera Bio, reported excellent preclinical results and intends to file an IND later this year.

NGENLA, OPKO's long-acting human growth hormone partnered with Pfizer, continues to increase market penetration globally and contributes meaningfully to recurrent cash flow, with ongoing clinical trials for label expansion. RAYALDEE, an innovative vitamin D product, is performing to plan, with gross-to-net improvements realized last year resulting in meaningful cash flow from operations in 2026 while maintaining overall revenue levels. Global pharmaceutical product sales grew 7% year-to-date as of June 30, driven by favorable demand and foreign currency tailwinds.

Following the sale of select oncology assets to Labcorp in 2025, BioReference Health received an additional $18.4 million earn-out payment in Q2 FY26. The diagnostics business is strengthening its core platform by leveraging regional lab operations and the proprietary 4Kscore test. Management is focused on achieving breakeven and sustainable profitability in 2026 through significant cost rationalization, including a reduction in headcount from 3,300 to approximately 1,400, and strategic partnerships for unprofitable esoteric testing.

OPKO continues to make meaningful investments in its R&D programs, with Q2 FY26 spending totaling $32.7 million, up from $29.8 million in Q2 FY25, reflecting increased activity in early-stage clinical trials. The company adjusted its full-year 2026 guidance, increasing total revenue expectations to $560 million-$585 million and reducing total costs and expenses to $710 million-$740 million, excluding one-time items^📎, reflecting ongoing efforts to improve financial performance.