Verona Pharma(US:VRNA)2022-05-03 16:47Financial Data and Key Metrics Changes - As of March 31, 2022, the company reported cash and equivalents of $132.8 million, which is expected to fund operations through at least the end of 2023 [21][22] - The loss after tax for Q1 2022 was $24.8 million, compared to a loss of $21.3 million in Q1 2021, representing a loss of $0.05 per ordinary share or $0.41 per ADS [23] - Research and development costs increased to $17.6 million in Q1 2022 from $13.6 million in Q1 2021, primarily due to costs associated with the Phase 3 ENHANCE program [24] - Selling, general and administrative expenses decreased to $7.4 million in Q1 2022 from $9.3 million in Q1 2021, driven by a reduction in share-based compensation charges [25] Business Line Data and Key Metrics Changes - The company is focused on the Phase 3 ENHANCE clinical program for ensifentrine, targeting the maintenance treatment of COPD, with enrollment nearing completion [7][10] - ENHANCE-1 trial is expected to be fully enrolled in Q2 2022, with approximately 90% of subjects already randomized [10] - ENHANCE-2 trial completed enrollment with over 800 subjects, with results expected in Q3 2022 [11][13] Market Data and Key Metrics Changes - COPD affects over 25 million patients in the U.S., with the maintenance COPD market generating over $10 billion in annual sales [16] - Despite existing treatments, over 1 million COPD patients remain symptomatic on maximum therapy, indicating a significant unmet need [17] Company Strategy and Development Direction - The company aims to submit a new drug application (NDA) to the U.S. FDA in the first half of 2023, contingent on positive trial results [14] - The addition of James Brady to the Board is expected to enhance the company's strategic and commercial expertise as it prepares for NDA submission and commercialization [15] Management's Comments on Operating Environment and Future Outlook - Management highlighted the ongoing challenges posed by the COVID-19 pandemic and the Russia-Ukraine conflict, which may impact clinical trial progress [3][14] - The company anticipates 2022 to be a productive year, with key milestones including data presentations and KOL events planned [18][19] Other Important Information - The U.K. R&D tax credit for Q1 2022 was $1.3 million, down from $2.1 million in Q1 2021 due to changes in the tax credit program [26] - The company plans to submit a claim for approximately $15 million related to its 2021 R&D spend, expected to be received later in 2022 [27] Q&A Session Summary Question: Background therapy and patient characteristics - Management confirmed that 55% to 65% of patients are expected to be on background therapy, with no significant differences observed in baseline demographics [30][32] Question: Phase 3 study and phenotypes - The study is not designed to evaluate exacerbations, but management is interested in capturing those events for future analysis [41][43] Question: R&D expenses and future cadence - R&D expenses are expected to remain around $17.6 million for Q2 2022, tapering off significantly in the latter half of the year [53] Question: Commercial structure post-NDA filing - The commercial build-out will begin following positive data from ENHANCE-2, focusing on payer discussions and market preparation [62][65] Question: IP strategy and commercialization - The company has a strong IP position for ensifentrine, with patents expected to provide protection into the mid-2030s [71][73]