Verona Pharma (VRNA) Q2 2024 earnings summary

Executive summary

• FDA approved Ohtuvayre (ensifentrine) for COPD maintenance in adults on June 26, 2024, with U.S. commercial launch beginning August 2024 and initial patient shipments underway.

• Ohtuvayre is the first inhaled COPD therapy with both bronchodilation and non-steroidal anti-inflammatory effects, and the first novel mechanism in over 20 years, delivered via standard jet nebulizer.

• Over 2,000 HCP visits and more than 100 unique prescribers since launch, with sales and reimbursement teams fully deployed.

• IND submitted for a fixed-dose combination with glycopyrrolate; Phase 2 trials for non-CF bronchiectasis and combination therapy planned for Q3 2024.

• Strategic collaboration with Nuance Pharma for Greater China, with Phase 3 trials ongoing in China.

Financial highlights

• Cash and cash equivalents were $404.6 million as of June 30, 2024, up from $271.8 million at year-end 2023, including $70 million from a debt facility and $100 million from RIPSA at approval.

• Net loss was $70.8 million for Q2 2024, compared to $8.8 million in Q2 2023, driven by launch, milestone, and commercialization costs.

• R&D expenses were $19.4 million in Q2 2024, up from a net reversal of $2.5 million in Q2 2023, due to milestone accruals, share-based compensation, inventory, and clinical trial costs.

• SG&A expenses rose to $49 million in Q2 2024 from $12.4 million year-over-year, mainly due to a $15 million milestone, marketing, commercial buildout, and RSU expenses.

• No product revenue recognized as commercial sales began in August 2024.

Outlook and guidance

• Cash and equivalents, plus expected funding from term loans and RIPSA, are projected to fund operations and the U.S. launch through at least the end of 2026.

• Permanent J-code for Ohtuvayre expected in January 2025.

• Metrics to track launch progress will evolve and be shared in future earnings updates.