OPKO Health, Inc. Q4 FY2025 earnings call

• OPCO entered 2025 with momentum, focusing on diagnostics profitability, MODX pipeline, etc. - BioReference 2025 was transformative with oncology division sale, now focused on core clinical lab, correctional health, 4K score. - MODX has multiple clinical stage programs, collaboration with Regeneron. - BARDA-supported programs for multispecific COVID-19 and influenza antibodies moving forward. - In vivo CAR-T platform in late pre-IND stage. - OPCO 88006 and collaboration with Enterra on various products. - International pharmaceutical operations source of cash flow. - Diagnostic business after oncology sale has improved margins and 4K score growth

Diagnostics business: Q4 2025 revenue was $71.1 million, with $7 million from 4K score test (up over 16% from 2024). Diagnostic operating loss was $18.3 million. Pharmaceutical segment: Q4 2025 revenue was $77.4 million. Product sales revenue increased to $43.7 million. Pharmaceutical operating loss was $10.7 million. Consolidated: Total revenues Q4 2025 were $148.5 million, consolidated operating loss was $38.3 million, net loss was $31.3 million. Revenue contribution: Diagnostics around 48% ($71.1M of $148.5M), pharmaceutical around 52% ($77.4M of $148.5M)

First quarter 2026: Total revenue between $125 - $140M, services revenue $71 - $75M, pharmaceutical product revenue $38 - $45M, IP and other revenue $15 - $20M, costs and expenses $170 - $180M, R&D $30 - $32M, depreciation and amortization ~$24M. Full year 2026: Total revenue $530 - $560M, services $300 - $312M, pharmaceutical product $160 - $170M, other revenue $70 - $80M, costs and expenses $725 - $750M, R&D $125 - $135M, BARDA funding and Regeneron reimbursement $22 - $26M, depreciation and amortization ~$100M. Continue to accelerate share repurchase program

Q: Discuss timing of data disclosure for MDX-2001 and setting expectation for patients dosed.

A: Adjusting regimen, won't go to much higher dose, saw efficacy signs, will announce phase 1A results in upcoming conference, enter phase 1B for promising tumors by end of 2026.

Q: Drivers of NGINLA profit share increase and assumptions for 2026 guidance.

A: Regions moved up in tiering structure, Pfizer taking market share, 34 - 37M achievable at current growth rates.

Q: Bioreference 4K growth color.

A: Volume increases from urology, working with payers for primary care, expect high single-digit to low double-digit growth in 2026.

Q: Merck partnership EBV vaccine study timing.

A: Studies on EBD-naive patients, reducing age of inclusion, expect data by end of year, phase 2 start next year.

Q: GLP-1 glycogen combo asset status.

A: Oxyntamogenin at latest stages of IND submission, oral formulation with Enterra promising, injectable ready for phase 1.

Q: In vivo CAR T details.

A: Unique approach, conjugate targeting antibodies on lipid nanoparticle, versatile platform, advanced CMC and non-human primate experiments.

Q: MDX 2004 development.

A: Rejuvenates immune system, two-arm trials with PD-1 naives and previously exposed, testing tolerability and immune system response.

Q: Clinical milestones for 2001 and 2004 in 2026.

A: 2001 completion of dose regimen and entry into Phase 1B, 2004 phase 1 escalation, hope to complete Phase 1A within year.

Q: Bioreference expense bridge color.

A: Overall expense base to decline, expense expansion from R&D efforts