Verona Pharma (VRNA) Q1 2025 earnings summary

Executive summary

• Ohtuvayre (ensifentrine) received FDA approval for COPD maintenance in June 2024 and launched in the U.S. in August 2024, marking the first new inhaled therapy for COPD in over 20 years.

• Q1 2025 net revenue reached $76.3 million, primarily from Ohtuvayre sales, up 95% from Q4 2024, with $5 million milestone revenue from Nuance Pharma.

• Ohtuvayre prescriptions filled totaled approximately 25,000 in Q1, with new patient starts up over 25% and prescribers up 50% to about 5,300.

• For the first time, quarterly revenue exceeded operating expenses (excluding non-cash charges), driven by Ohtuvayre's accelerating US launch.

• Regulatory progress included a new Orange Book patent (expiring 2044), first approval outside the US in Macau, and ongoing EU/UK submissions.

Financial highlights

• Q1 2025 net product sales of Ohtuvayre reached $71.3 million, with total net revenue of $76.3 million (Q1 2024: $0 million).

• Cost of sales was $3.4 million; R&D expenses were $14.1 million, and SG&A expenses were $69.1 million, reflecting commercialization investments.

• Operating loss was $10.3 million; net loss after tax was $16.3 million, improved from $25.8 million in Q1 2024.

• Adjusted net income (excluding share-based compensation) was $20.5 million, with a margin of 26.9%.

• Cash and equivalents stood at $401.4 million as of March 31, 2025.

Outlook and guidance

• Management expects substantial growth to continue, citing strong refill rates, persistency, and a large addressable market.

• Plans to add approximately 30 new sales representatives in Q3 2025 to accelerate Ohtuvayre launch.

• Initiation of Phase 2b study for fixed-dose ensifentrine/glycopyrrolate in COPD expected in H2 2025.

• Cash, anticipated product sales, and available term loan funding are expected to cover operating and capital needs for at least the next 12 months.

• Gross-to-net discounts improved to well below 20% in Q1, with price stability for Ohtuvayre anticipated through 2025.