Verona Pharma plc (Nasdaq: VRNA) announced its third-quarter 2024 financial results, highlighting a strong start to the US launch of Ohtuvayre™ (ensifentrine) and continued pipeline expansion. The company reported net sales of $5.6 million for Ohtuvayre™ in Q3, with October sales exceeding this figure, signaling an accelerating uptake of the drug.
Ohtuvayre™ Launch and Market Reception
According to David Zaccardelli, Pharm. D., President and Chief Executive Officer, healthcare professionals are prescribing Ohtuvayre across a broad range of COPD patients, including those 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. He added that this broad utilization aligns with market research, reinforcing the belief that Ohtuvayre's bronchodilator and non-steroidal anti-inflammatory activity represents a significant advancement in COPD treatment.
Within the first 12 weeks of launch, more than 5,000 Ohtuvayre prescriptions were filled by over 2,200 unique healthcare providers.
Pipeline Expansion
Verona Pharma has also been actively expanding its pipeline. In Q3 2024, the company initiated two Phase 2 clinical trials:
- A dose-ranging trial evaluating glycopyrrolate, a long-acting muscarinic antagonist (LAMA), in combination with nebulized ensifentrine for COPD maintenance treatment.
- A trial assessing the efficacy and safety of nebulized ensifentrine in patients with non-cystic fibrosis bronchiectasis (NCFBE).
Financial Highlights
Verona Pharma's financial results for Q3 2024 include:
- Cash Position: Cash and cash equivalents totaled $336.0 million as of September 30, 2024.
- Product Sales: Net sales of Ohtuvayre were $5.6 million for the third quarter.
- R&D Expenses: Research and development expenses increased to $10.6 million, driven by the initiation of the two Phase 2 trials.
- SG&A Expenses: Selling, general, and administrative expenses rose to $35.2 million, primarily due to costs associated with the Ohtuvayre launch.
- Net Loss: The company reported a net loss of $43.0 million for the quarter.
Other Developments
Following the end of Q3, Verona Pharma received notification from the Centers for Medicare & Medicaid Services that its permanent, product-specific J-code for Ohtuvayre, J7601, has been accepted and will be effective January 1, 2025. The company also presented additional analyses of Phase 3 ENHANCE trial data at the European Respiratory Society International Congress 2024 and CHEST Annual Meeting 2024.
Nuance Pharma, Verona's development partner in Greater China, completed enrollment in its pivotal Phase 3 clinical trial evaluating ensifentrine for COPD maintenance treatment in China, with results expected in 2025.
