Verona Pharma plc

Good morning, everyone, and welcome to Verona Pharma's third quarter 2024 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 ended September 30th, 2024. 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. 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 conference call is being recorded and will remain available for 90 days. I now like to turn the floor over to Dr. David Zecardelli, Chief Executive Officer. Sir, you may begin.

Thank you, and welcome everyone to today's call. We are extremely pleased to be with you today to share our remarkable achievement in the third quarter, highlighted by the launch of O2Ver. 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 Rowe, our Chief Development Officer. The third quarter was exceptional for Verona Pharma, marked by the US launch of O2Ver for the maintenance treatment of COPD and continued progress on our clinical development programs. First, let's review the outstanding launch of O2Ver, which is grounded in its broad COPD indication and the compelling benefits O2Ver provides to COPD patients. After just seven weeks, net product sales were $5.6 million for the third quarter. We are excited as demand for O2Ver continues to escalate, with net sales for October exceeding the third quarter. Now let's review some key launch metrics. Through the end of October, only 12 weeks after fully launching O2Ver, more than 5,000 O2Ver prescriptions have been filled, with more than 2,200 unique HCPs prescribing O2Ver. Our launch efforts continue to focus on promoting O2Ver to the highest prescribing 14,500 HCPs. In 12 weeks, approximately 30% of our 2,500 Tier 1 HCPs have prescribed O2Ver. As a reminder, Tier 1 HCPs write on average 150 COPD maintenance treatment prescriptions per month. We also continue to see that once an HCP prescribes O2-ver, they increase their prescribing to more patients in their practice. We are impressed by the breadth and depth of prescribers and prescriptions this early in the launch. Importantly, HCPs are prescribing O2-ver across a broad range of COPD patients, including background single, dual, and approximately 50% on triple therapy. This broad utilization across all patient types is consistent with our market research and continues to highlight the significant unmet need across the COPD patient population. Initial feedback from both patients and healthcare providers about the potential of O2Ver to deliver a meaningful impact against COPD, regardless of disease severity and background therapy, is extremely encouraging and is all supported by the early refill data. Our commercial activities to engage HCPs continue to increase month over month. Through the first 12 weeks of launch, we have reached more than 90% of our Tier 1 and Tier 2 HCPs through in-person or digital promotion. Our speaker programs with HCPs continue to accelerate. and we expect to have approximately 120 programs completed by the end of 2024. We recently presented new analyses from the Phase III enhanced studies evaluating O2-VeR in COPD. Presentations at CHEST and ERS conferences highlighted subgroup and pooled efficacy and safety analyses from the enhanced trial, as well as the impact of O2-VeR on COPD-related healthcare resource utilization and the unmet need in COPD based on real-world claims data. At CHEST, our team interacted with approximately 1,500 HCPs at our medical and commercial booths for O2Ver, highlighting the high level of interest in O2Ver from HCPs. While it is still very early in the launch, we are extremely encouraged by the strong start to the U.S. commercialization of O2Ver. Otuver is the first inhaled COPD treatment to provide both bronchodilation and non-steroidal anti-inflammatory effects, and we are confident that it can redefine the COPD treatment paradigm. We are also pleased to report the Centers for Medicare and Medicaid Services recently approved a permanent product-specific J-code for Otuver, which will be effective in January 2025. Alongside our successful O2-VeR launch, we initiated two new Phase II clinical programs during the third quarter. In September, enrollment began in a Phase II dose-ranging trial supporting a fixed-dose combination formulation with Ncfentrin and glycoparylate, ALAMA, for the maintenance treatment of COPD delivered via a standard jet nebulizer. The dose-ranging trial is a randomized, double-blind, placebo-controlled, one-week crossover trial to assess lung function, safety, and the pharmacokinetic profile of glycopyrrolate delivered via nebulizer in approximately 40 subjects with DOPD. Following identification of an appropriate glycopyrrolate dose range, a Phase II trial assessing the fixed-dose combination of encipentrin and glycopyrrolate will be conducted. Also in September, Enrollment began in the Phase II trial to assess nebulized Ncfentrin in patients with non-cystic fibrosis bronchiectasis. The randomized double-blind placebo-controlled parallel group trial will enroll 180 subjects with a recent history of pulmonary exacerbations. The trial will assess the effect of Ncfentrin 3 mg twice daily on the rate and risk of pulmonary exacerbations, symptoms, and quality of life. To ensure robust powering, the trial is event-driven with all subjects treated for at least 24 weeks and until the required number of exacerbation events are observed. Finally, turning to our global strategy, Nuance Pharma, our development partner for NC-Fentron in Greater China, announced it has completed enrollment in its pivotal phase three clinical trial, evaluating NC-Fentron for the maintenance treatment of COPD in China. Nuance Pharma expects to provide results from the pivotal phase three clinical trial in 2025, and we look forward to providing an update next year.

I will now turn the call over to Mark to review our financial results for the third quarter.