Verona Pharma (VRNA) Q4 2024 earnings summary

Executive summary

• Achieved FDA approval and commercial launch of Ohtuvayre for COPD, the first novel inhaled therapy in over 20 years, with strong initial sales and rapid uptake continuing into Q1 2025.

• Expanded prescriber base to over 4,600 unique HCPs, with ~55% of Tier 1 HCPs prescribing by February 2025 and broad adoption across patient types.

• Advanced pipeline with completion of Phase 2 dose-ranging trial for glycopyrrolate LAMA, ongoing bronchiectasis trial, and plans for a Phase 2b fixed-dose combination trial in H2 2025.

• Secured first ex-US approval in Macau, with regulatory filings progressing in EU and UK, and pivotal Phase 3 results in China expected mid-2025.

• Ohtuvayre added to the 2025 GOLD COPD treatment algorithm and received a product-specific J-code effective January 2025.

Financial highlights

• Q4 2024 net sales of Ohtuvayre reached $36.6 million; full year 2024 sales totaled $42.3 million.

• Cost of sales for Ohtuvayre was $2 million in Q4 and $2.6 million for the year, resulting in a gross margin of ~94%.

• R&D expenses rose to $7.9 million in Q4 and $44.6 million for the year, driven by clinical trial and development costs.

• SG&A expenses increased to $45.1 million in Q4 and $149.8 million for the year, reflecting launch-related investments.

• Net loss after tax was $33.8 million in Q4 and $173.4 million for 2024; loss per share was $0.27 (ordinary) for the year.

• Cash and equivalents stood at $400 million at year-end, with access to $425 million in additional capital.

Outlook and guidance

• Expect continued growth in prescriptions, new patient starts, and refills in 2025, with management targeting cash flow break-even at a $250–$300 million annualized sales run rate.

• Plans to initiate a Phase 2b trial for fixed-dose ensifentrine/glycopyrrolate in H2 2025 and regulatory submissions in the EU and UK.

• No significant impact from Q1 insurance deductible resets anticipated due to strong launch momentum.

• Ongoing regulatory and partnering activities in Europe and other global markets, with China Phase 3 results expected mid-2025.