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Jun 30, 2023
Verona Pharma Q2 2023 Earnings Report
Reported financial results for the second quarter ended June 30, 2023 and provided a corporate update.
Key Takeaways
Verona Pharma reported a net loss of $8.8 million for the second quarter ended June 30, 2023. The company's cash and cash equivalents were $270.7 million as of June 30, 2023. A New Drug Application (NDA) was submitted to the US FDA for ensifentrine for maintenance treatment of COPD.
NDA submitted to US FDA for ensifentrine for maintenance treatment of COPD.
Phase 3 ENHANCE data published in the American Journal of Respiratory and Critical Care Medicine.
Cash and cash equivalents at June 30, 2023, were $270.7 million.
Expects SG&A expenses to continue to be the main driver of expense as Verona Pharma prepares for a potential commercial launch in 2024.
Verona Pharma
Verona Pharma
Forward Guidance
Verona Pharma plans to continue to advance its commercialization efforts across medical affairs, marketing, commercial operations, IT and CMC as well as other departments to support the planned launch of ensifentrine in 2024, subject to the approval of the NDA.
Positive Outlook
- US FDA is expected to make a decision on acceptance of the Company's NDA for inhaled ensifentrine for the maintenance treatment of patients with COPD in the third quarter of 2023.
- The Company plans to continue to advance its commercialization efforts across medical affairs, marketing, commercial operations, IT and CMC as well as other departments to support the planned launch of ensifentrine in 2024, subject to the approval of the NDA in the third quarter of 2023.
- The Company plans to present further analyses from the Phase 3 ENHANCE trials at the European Respiratory Society International Congress 2023 and at CHEST Annual Meeting 2023 in the second half of 2023.
- The Company plans to host an analyst meeting providing an overview of its commercial launch plans in the second half of 2023.
- Submitted a NDA to the US FDA for ensifentrine for the maintenance treatment of patients with COPD in June 2023.
Challenges Ahead
- The lengthy and expensive process of clinical drug development, which has an uncertain outcome.
- Serious adverse, undesirable or unacceptable side effects associated with ensifentrine, which could adversely affect our ability to develop or commercialize ensifentrine.
- Reliance on third parties, including clinical research organizations, clinical investigators, manufacturers and suppliers, and the risks related to these parties’ ability to successfully develop and commercialize ensifentrine.
- Lawsuits related to patents covering ensifentrine and the potential for our patents to be found invalid or unenforceable.
- Vulnerability to natural disasters, global economic factors, geo-political actions and unexpected events, including health epidemics or pandemics like the COVID-19 pandemic, and conflicts such as the Russia-Ukraine conflict, which has and may continue to adversely impact our business.