OPKO Health, Inc. Q1 FY2026 earnings call

Biopharma: MODX has five programs in clinic. Collaboration with Merck on EBV vaccine, MDX2001 phase one study ongoing, MDX2004 in dose escalation, MDX2003 in phase one trial. Collaboration with Regeneron progressing. Infectious diseases: MDX2301 phase one trial initiated. BARDA supports influenza program. In vivo CAR-T platform: IND enabling studies ongoing. Endocrine and metabolic: APCO 88006 phase one/2A trial planned. International pharmaceutical: Global product sales grew about 9% in Q1. Diagnostics: BioReference streamlined business with volume increase, 4K score test label update positions for broader adoption.

Diagnostics business: Q1 2026 revenue was $72.2 million, including $6.5 million from the 4K score test. Revenue in Q1 2025 was $102.8 million. Total costs and expenses were $85.1 million, down from $126.8 million last year. Diagnostic operating loss was $13 million, compared to $23.9 million in Q1 2025. Pharmaceutical business: Revenue was $52 million in Q1 2026 compared to $47.1 million in the prior year. Product sales revenue increased to $38 million. Costs and expenses for pharmaceutical business were $81.7 million. R&D for Q1 2026 totaled $28.8 million. Pharmaceutical operating loss was $30 million in Q1 2026 compared to last year's operating loss of $34.8 million.

Expect total revenue for Q2 2026 to be between 127 to $132 million. Revenue of services from 72 to $76 million. Pharmaceutical product revenue of $38 to $42 million. IP and other revenue to be between $15 to $19 million. Total costs and expenses for Q2 expected to come in between $180 and $190 million. R&D to be between $32 and $38 million. BARDA funding $5 to $7 million. Depreciation and amortization expense of approximately $24 million. Affirm full-year guidance. Approximately $108 million authorized to repurchase shares.

Q: Maury Raycroft asked about 4K score payer policies, growth expectations, and IngenLa with Pfizer.

A: Working on payer policies, waiting for LCD update for primary care, seeing growth in 4K and Pfizer's progress with IngenLa.

Q: Brian Chang inquired about MDX2003 lymphoma trial and Merck's EBV vaccine.

A: MDX2003 trial focuses on safety and efficacy, Merck's EBV vaccine trial ongoing with plans for phase two.

Q: Yi Chen asked about first quarter revenue shortfall and MBX 2301 commercialization.

A: Shortfall related to delayed CMC activities, MBX 2301 to be developed with partner for immune impaired population.

Q: Kevin DeGida asked about in vivo CAR-T platform differentiation and milestones.

A: Differentiation in targeting, lower doses, and multi-applications; key milestones include completing CMC and entering clinic by end 2026.

Q: Neil Jen asked about diagnostics growth factors and MDX2001 target selection.

A: Drivers beyond 4K in New York, New Jersey markets, MDX2001 targeting triple negative breast cancer.

Q: Edward Tenthoff asked about in vivo trial in China and immune rejuvenator regulatory path.

A: Planning trial in China, immune rejuvenator trial as monotherapy with potential combination.

Q: Michael Patowski asked about diagnostics new business opportunities and cost control.

A: Line of sight to traditional business growth, continuing operating efficiency for cost control.