Verona Pharma plc (NASDAQ: VRNA) announced its third-quarter 2024 financial results, highlighting a successful initial launch of Ohtuvayre™ (ensifentrine) for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in the United States. The company reported net sales of $5.6 million for Ohtuvayre in the third quarter, with October sales exceeding the entire third-quarter figure, signaling continued growth.
Ohtuvayre Launch and Market Penetration
According to David Zaccardelli, Pharm. D., President and Chief Executive Officer, Ohtuvayre has seen prescriptions from over 2,200 unique healthcare professionals (HCPs), with more than 5,000 prescriptions filled across a diverse COPD patient group. This includes patients on single, dual, and triple therapies. "We are extremely encouraged from the initial patient and HCP reports about Ohtuvayre's potential to improve COPD symptoms regardless of COPD severity," Zaccardelli stated, emphasizing the drug's potential to redefine the COPD treatment landscape due to its bronchodilator and non-steroidal anti-inflammatory activities.
Clinical Development Programs
Verona Pharma is expanding its clinical pipeline with two Phase 2 trials initiated in the third quarter:
- Fixed-Dose Combination Trial: A dose-ranging trial evaluating glycopyrrolate, a long-acting muscarinic antagonist (LAMA), in combination with ensifentrine for COPD maintenance treatment, delivered via nebulizer.
- Non-Cystic Fibrosis Bronchiectasis (NCFBE) Trial: Assessing the efficacy and safety of nebulized ensifentrine in patients with NCFBE.
Financial Highlights
As of September 30, 2024, Verona Pharma's cash and cash equivalents stood at $336.0 million. The company believes these funds, along with product sales and expected funding from strategic financings, will sustain operations through at least the end of 2026. Key financial details include:
- Product Sales: $5.6 million in net sales for Ohtuvayre in Q3 2024, following FDA approval on June 26, 2024, and commercial availability in August 2024.
- Research and Development (R&D) Expenses: Increased to $10.6 million in Q3 2024, driven by the initiation of the two Phase 2 trials.
- Selling, General, and Administrative (SG&A) Expenses: Increased to $35.2 million, primarily due to costs associated with the Ohtuvayre launch, including the expansion of the field sales team and marketing activities.
- Net Loss: $43.0 million for the third quarter ended September 30, 2024.
Additional Highlights
- The Centers for Medicare & Medicaid Services accepted a permanent, product-specific J-code (J7601) for Ohtuvayre, effective January 1, 2025.
- Additional analyses from the Phase 3 ENHANCE trials were presented at the European Respiratory Society International Congress 2024 and CHEST Annual Meeting 2024.
- Nuance Pharma, Verona Pharma's development partner in Greater China, completed enrollment in a pivotal Phase 3 trial evaluating ensifentrine for COPD maintenance treatment in China, with results expected in 2025.
