- **Revenue Breakthrough**: Q1 2025 marks first quarter where revenue exceeded operating expenses, with $71.3M in Ohtuvayre sales.
- **Rapid Adoption**: 25,000 prescriptions, 5,300 prescribers, and 60% refill rate highlight strong patient engagement.
- **Financial Strength**: $401.4M cash, amended $450M debt facility, and gross to net ratio below 20% support long-term growth.
- **Global Expansion**: Macau approval and China Phase III results expected Q2, with EU/UK regulatory filings underway.
- **Strategic Flexibility**: $200M available for in-licensing, targeting pulmonology assets to complement Ohtuvayre.

**【CEO Summary Section】**
- Q1 2025 revenue exceeded quarterly operating expenses (excluding non-cash charges), marking a significant milestone. Net product sales reached $71.3 million, nearly doubling from Q4 2024.
- Ohtuvayre prescriptions grew to 25,000 filled in Q1, with 25% new patient starts YoY and 60% refill rate. Prescribers expanded to 5,300 (60% Tier 1 HCPs), with 425 HCPs prescribing to ≥20 patients.
- Ohtuvayre adoption spans 50% of COPD patients on triple therapy, highlighting its broad applicability. A new Orange Book patent (2044 expiry) adds to the portfolio of four listed patents.
- Field sales team to expand to 120 representatives by Q3 to support growth. Global strategy includes Macau approval and China Phase III trial results expected Q2.

**【CFO Financial Commentary】**
- Total net revenue $76.3 million (including $5M clinical milestone). Operating loss $10.3 million, net loss $16.3 million, but adjusted net income $20.5 million (excluding $36.8M share-based comp).
- Cash balance $401.4M, up from $399.8M. Debt facility amended to $450M with favorable terms, $250M drawn, $200M available. Gross to net ratio improved to below 20%.
- Financial flexibility to support U.S. launch and potential in-licensing/acquisition of complementary products.

**【Q&A Key Highlights】**
- **Sales Momentum**: Q1 growth driven by early launch phase; Q2+ trends indicate accelerating refill rates and new patient adds. Gross to net ratio expected to stabilize near 20%.
- **Competitive Landscape**: Ohtuvayre's unique bronchodilator + anti-inflammatory profile positions it as a broad COPD treatment, complementary to biologics. Physicians see low discontinuation rates due to favorable tolerability.
- **Global Strategy**: EU/UK MAA submissions in progress; China Phase III results expected Q2. No plans to repurchase China rights; collaboration with Nuance Pharma continues.
- **Strategic Flexibility**: Debt facility provides $200M for potential in-licensing/acquisition of pulmonology-focused assets.


Verona Pharma plc (VRNA) Q1 2025 Earnings Call Transcript

- **Q4 Sales Surge**: $36.6M in Q4, $42.3M annual, with Q1 2025 prescriptions up 2x Q4.
- **Global Expansion**: Macau approval and China trial completion mid-2025.
- **Breakeven Vision**: $250-300M annual sales target for 2025 cash flow breakeven.
- **Cost Control**: 80%+ patients pay <$10, minimal gross-to-net impact.
- **Safety Assurance**: No unexpected side effects; profile as labeled.


**【CEO Opening Remarks】**
- Ohtuvayre achieved $36.6M in Q4 2024 sales, with full-year sales of $42.3M.
- Q1 2025 prescriptions surpassed Q4 2024 levels, with 4,600+ prescribers (55% of Tier 1 targets).
- Expansion into global markets: Macau approval and China Phase III trial completion expected in mid-2025.

**【CFO Financial Highlights】**
- Q4 2024 net loss: $33.8M ($0.05/share), full-year loss: $173.4M ($0.27/share).
- R&D expenses: $7.9M (Q4) / $44.6M (FY), up due to pipeline trials and milestones.
- SG&A expenses: $45.1M (Q4) / $149.8M (FY), driven by commercial launch costs.
- Cash balance: $400M, with $425M available via Oaktree facilities.

**【Q&A Key Takeaways】**
- **Sales Momentum**: Q1 2025 prescriptions outpace Q4 2024, despite deductible resets.
- **Gross-to-Net Impact**: Minimal effect from high-deductible plans, <10% co-pays for 80%+ patients.
- **Breakeven Outlook**: Targeting $250-300M annual sales for cash flow breakeven by end-2025.
- **Global Strategy**: Europe filings in progress; Greater China pricing aligns with U.S. via Nuance Pharma partnership.
- **Side Effects**: No unexpected safety signals; profile consistent with FDA label.


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