Verona Pharma Announces Q1 2024 Financial Results and Corporate Update

Verona Pharma plc, a biopharmaceutical company specializing in respiratory diseases, has released its financial results for the first quarter ending March 31, 2024, along with a corporate update. The company is gearing up for the potential U.S. launch of its novel respiratory therapy, ensifentrine, targeting chronic obstructive pulmonary disease (COPD). The company's CEO, David Zaccardelli, emphasized the significance of the upcoming PDUFA Target Action Date for Ensifentrine of June 26, 2024. If approved, ensifentrine will be the first new inhaled treatment for COPD in over two decades.

The company has been collaborating closely with the U.S. Food and Drug Administration (FDA) during the review process. Zaccardelli highlighted the dual-function nature of ensifentrine, combining bronchodilator and non-steroidal anti-inflammatory properties, which could revolutionize COPD treatment. Verona Pharma is also planning further clinical programs for a fixed-dose combination of ensifentrine and glycopyrrolate in COPD and ensifentrine in non-cystic fibrosis bronchiectasis later this year.

Financially, Verona Pharma strengthened its balance sheet with a newly announced financing plan, providing access to up to $650 million in addition to the existing $255 million in cash. The company refinanced its $400 million debt facility, achieving a lower cost of capital and better financial covenants. Additionally, a $250 million capped revenue interest sales transaction was executed, anticipated to support the company's growth and commercialization endeavors through 2026.

Key milestones for Verona Pharma in the near future include the expected FDA approval and subsequent U.S. launch of ensifentrine in the third quarter of 2024. In the second quarter of 2024, the company will finalize its launch preparations, including sales strategies, pricing, distribution, and patient services. The "Unspoken COPD" disease awareness campaign will continue to highlight the burden of COPD, having already reached 85% of targeted healthcare professionals in the first quarter of 2024.

Verona Pharma plans to present at the American Thoracic Society International Conference in May 2024, showcasing additional analyses of the Phase 3 ENHANCE studies with ensifentrine. The company will also highlight the role of PDE in inflammation and lung function impairment in COPD, with an exhibition booth and presentations by clinical experts.

In the latter half of 2024, Verona Pharma intends to submit an investigational new drug application (IND) for a fixed-dose combination of ensifentrine and glycopyrrolate, targeting COPD. Additionally, the company plans to initiate a Phase 2 clinical trial for nebulized ensifentrine in patients with non-cystic fibrosis bronchiectasis, pending FDA clearance.

Financial results for the first quarter of 2024 indicate a cash position of $254.9 million, slightly down from $271.8 million at the end of 2023. The company reported research and development expenses of $6.8 million, a decrease from $12.6 million in the previous year, primarily due to the completion of the Phase 3 ENHANCE program. Selling, general, and administrative expenses rose to $20.4 million from $9.6 million, driven by increased marketing and commercial preparation costs, professional fees, and personnel expenses as the company ramps up for the commercial launch.

Verona Pharma experienced a net loss of $25.8 million for the first quarter of 2024, compared to a net loss of $16.7 million in the same period last year. Despite the increased expenses, the company believes its current financial position and the new financing arrangements will support its operational and capital expenditure needs beyond 2026, including the potential U.S. launch of ensifentrine.

Verona Pharma scheduled a conference call and webcast for investors on May 9, 2024, to discuss these financial results and corporate updates in more detail. The company continues to focus on addressing significant unmet medical needs in respiratory diseases through innovative treatments like ensifentrine.