Savara (SVRA) Q4 2025 earnings summary

Executive summary

• Achieved key regulatory milestones for MOLBREEVI in autoimmune PAP, including FDA BLA filing and Priority Review with a PDUFA date set for August 22, 2026.

• Submitted marketing applications to EMA and UK MHRA; no FDA Advisory Committee planned.

• U.S. commercial planning underway with market development team onboarding to complete in Q2 2026.

Financial highlights

• Net loss for Q4 2025 was $32.2M ($0.13/share), compared to $29.0M ($0.13/share) in Q4 2024.

• Full-year 2025 net loss was $118.8M ($0.53/share), up from $95.9M ($0.48/share) in 2024.

• R&D expenses for 2025 increased 4.3% to $81.4M, mainly due to regulatory and quality assurance costs for MOLBREEVI.

• General and administrative expenses rose 68% to $42.1M in 2025, driven by workforce expansion and commercial activities.

• Cash, cash equivalents, and short-term investments totaled $235.7M as of December 31, 2025.

Outlook and guidance

• Access to up to $150M in non-dilutive capital upon FDA approval of MOLBREEVI.

• Well capitalized to fund global commercial launch activities and enter 2026 with strong financial flexibility.