Vir Biotechnology (VIR) Q4 2025 earnings summary

Executive summary

• Announced a global strategic collaboration with Astellas to co-develop and commercialize VIR-5500, a dual-masked PSMA-targeting T-cell engager for prostate cancer, leveraging the PRO-XTEN platform and Astellas' commercial leadership.

• Positive phase I data for VIR-5500 in metastatic castration-resistant prostate cancer (mCRPC) show compelling safety and efficacy, with deep and durable PSA and radiographic responses, especially at higher doses, validating the PRO-XTEN platform.

• The collaboration includes $335 million in upfront and near-term payments, up to $1.37 billion in milestones, a 50/50 U.S. profit split, and tiered, double-digit ex-U.S. royalties.

• The PRO-XTEN platform's dual-masking approach reduces toxicity, enables higher dosing, and supports a wider therapeutic window, with potential applications in other solid tumors.

• Also signed a licensing agreement with Norgine for hepatitis delta therapy, expanding global reach.

Financial highlights

• Total potential combined upfront and milestone payments from Astellas reach $1.7 billion, including $335 million in upfront and near-term payments.

• 2025 R&D expenses were $456 million, down 10% from 2024; SG&A expenses fell 23% to $92 million.

• Net loss for 2025 was $438 million, improved from $522 million in 2024.

• Year-end 2025 cash, cash equivalents, and investments stood at $782 million, with cash runway expected to extend into Q2 2028, factoring in the Astellas deal.

• Q4 2025 revenue was $64.1 million, driven by $64.3 million license revenue from Norgine.

Outlook and guidance

• Expansion cohorts for VIR-5500 in late-line mCRPC monotherapy, first-line mCRPC in combination, and metastatic hormone-sensitive prostate cancer are set to begin in Q2 2026.

• Pivotal Phase 3 trials for VIR-5500 are planned for 2027, with topline data from ECLIPSE 1 expected in Q4 2026 and ECLIPSE 2 and 3 in Q1 2027.

• Ongoing development of masked TCEs for HER2 and EGFR tumors, with multiple preclinical programs advancing toward candidate selection by early 2027.