Verona Pharma plc (NASDAQ:VRNA) Q4 2023 Earnings Conference Call February 29, 2024 9:00 AM ET

Company Participants

David Zaccardelli - Chief Executive Officer

Mark Hahn - Chief Financial Officer

Chris Martin - Chief Commercial Officer

Tara Rheault - Chief Development Officer

Conference Call Participants

Andrew Tsai - Jefferies

Yasmeen Rahimi - Piper Sandler

Caroline Pocher - Wedbush Securities

Joon Lee - Truist Securities

Tom Shrader - BTIG

Operator

Welcome to Verona Pharma's Fourth Quarter and Full Year Quarter 2023 Financial Results and Operating Highlights Conference Call. At this time, all participants are in a listen-only mode. Earlier this morning, Verona Pharma issued a press release announcing its financial results for the three months and full year ended December 31, 2023. A copy can be found in the Investor Relations tab on the corporate website, www.veronapharma.com.

Before we begin, I'd like to remind you that during today's call, statements about the company's future expectations, plans and prospects are forward-looking statements. These forward-looking statements are based on management's current expectations. These statements are neither promises nor guarantees and involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from our expectations expressed or implied by the forward-looking statements.

Any such forward-looking statements represent management's estimates as of the date of this conference call. While the company may elect to update such forward-looking statements at some point in the future, it disclaims any obligation to do so even if subsequent events cause its views to change. As a reminder, this call is being recorded and will remain available for 90 days.

I'd now like to turn the call over to Dr. David Zaccardelli, Chief Executive Officer. Please go ahead.

David Zaccardelli

Thank you, and welcome, everyone, to today's call. With me today are Mark Hahn, our Chief Financial Officer; Dr. Kathy Rickard, our Chief Medical Officer; Chris Martin, our Chief Commercial Officer; and Dr. Tara Rheault, our Chief Development Officer.

2023 was a pivotal year for Verona Pharma and importantly, for millions of patients suffering from COPD. Following a very positive data from our Phase 3 ENHANCE program, we submitted a new drug application to the FDA seeking U.S. approval of ensifentrine for the maintenance treatment of patients with COPD.

As you know, the FDA accepted our NDA for review and assigned a PDUFA target action date of June 26, 2024, and indicated they are not planning to hold an advisory committee meeting to discuss the NDA. We continue to advance our preparations for the planned commercial launch of ensifentrine in the U.S. and look forward to continuing our work with the FDA during their review. If approved, ensifentrine is expected to be the first novel inhaled mechanism available for the treatment of COPD in over 20 years.