Financial Data and Key Metrics Changes - In Q3 2024, Verona Pharma recorded net product sales of Ohtuvayre amounting to $5.6 million, marking the company's first sales since the product's launch [17] - The net loss after tax for Q3 2024 was $43 million, compared to a net loss of $14.7 million in Q3 2023, representing a loss of $0.07 per ordinary share [20] - Research and development costs increased to $10.6 million in Q3 2024 from $3 million in Q3 2023, primarily due to a rise in clinical trial costs [18] - Selling, general and administrative expenses rose to $35.2 million in Q3 2024 from $13.4 million in the same period last year, driven by increased personnel costs and marketing activities [19] Business Line Data and Key Metrics Changes - The launch of Ohtuvayre has seen over 5,000 prescriptions filled within 12 weeks, with more than 2,200 unique healthcare providers (HCPs) prescribing the medication [8][10] - Approximately 30% of Tier 1 HCPs have prescribed Ohtuvayre, indicating strong initial adoption among high-prescribing physicians [8] - The product is being utilized across a broad range of COPD patients, with nearly 50% of prescriptions for patients already on triple therapy [30] Market Data and Key Metrics Changes - The Centers for Medicare and Medicaid Services approved a permanent product-specific J-code for Ohtuvayre, effective January 2025, which is expected to facilitate reimbursement processes [14] - The company has reached over 90% of Tier 1 and Tier 2 HCPs through promotional efforts, indicating strong market engagement [11] Company Strategy and Development Direction - Verona Pharma aims to redefine the COPD treatment paradigm with Ohtuvayre, which offers both bronchodilation and non-steroidal anti-inflammatory effects [13] - The company has initiated two new Phase 2 clinical programs, focusing on a fixed-dose combination formulation for COPD and nebulized ensifentrine for bronchiectasis [14][15] - The global strategy includes collaboration with Nuance Pharma for ensifentrine's development in Greater China, with pivotal Phase 3 trial results expected in 2025 [16] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the continued acceleration of Ohtuvayre's use, citing strong demand and positive feedback from both patients and physicians [24] - The company is cautious about providing specific revenue guidance for Q4 2024 but remains confident in the ongoing interest and utilization of Ohtuvayre [31] - Management anticipates 2025 to be a significant growth year for Ohtuvayre, with plans to provide more detailed forecasts in future calls [31] Other Important Information - The balance sheet remains strong, with $336 million in cash and equivalents as of September 30, 2024, providing sufficient runway for operations through at least the end of 2026 [21] - The company has filed several patents related to Ohtuvayre, including one focused on COPD exacerbations, which is expected to enhance its commercial prospects [52] Q&A Session Summary Question: What is the expected revenue run rate for Q4 based on October sales? - Management did not provide specific guidance for Q4 but noted that October sales exceeded Q3, indicating a potential run rate of at least $17 million [22][23] Question: Can you disclose the number of unique patients prescribed Ohtuvayre? - Management indicated that the number of unique patients is fluid and increasing week-over-week, with a substantial number of patients being referred [25][26] Question: What are the prescribing trends for Ohtuvayre among different patient types? - Ohtuvayre is being prescribed broadly, with nearly 50% of prescriptions for patients on triple therapy, indicating a significant unmet medical need [30] Question: How is the reimbursement landscape for Ohtuvayre? - Over 80% of prescriptions are going through medical benefits, with low co-pays for patients, which is expected to support long-term brand growth [57][58] Question: How does the approval of Dupixent impact Ohtuvayre's market penetration? - Management believes Dupixent's approval highlights the need for additional treatments but does not foresee it impacting Ohtuvayre's commercialization due to the larger patient population with unmet needs [65][66] Question: What is the focus of the new Phase 2 study on ensifentrine? - The study aims to understand the pharmacology of ensifentrine and its effects on sputum inflammation in COPD patients, which may inform future clinical strategies [68][69]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Title of each classTrading Symbol(s) Name of each exchange on which registered Ordinary shares, nominal value £0.05 per share* VRNA The Nasdaq Stock Market LLC (Nasdaq Global Market) Large accelerated filer ☒ Accelerated filer ☐ Non-accelerated filer ☐ Smaller reporting company ☐ Emerging growth company ☐ For the quarterly period ended Se ...

Ohtuvayre™ (ensifentrine) launch recorded Q3 net sales of $5.6 million and October net sales exceeded Q3 Through October more than 2,200 unique prescribers and more than 5,000 prescriptions filled across a broad COPD population Pipeline expansion continues: Phase 2 programs enrolling Conference call today at 9:00 a.m. ET / 2:00 p.m. GMT LONDON and RALEIGH, N.C., Nov. 04, 2024 (GLOBE NEWSWIRE) -- Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma” or the “Company”), a biopharmaceutical company focused on respi ...

When it comes to short-term investing or trading, they say "the trend is your friend." And there's no denying that this is the most profitable strategy. But making sure of the sustainability of a trend to profit from it is easier said than done. Often, the direction of a stock's price movement reverses quickly after taking a position in it, making investors incur a short-term capital loss. So, it's important to ensure that there are enough factors -- such as sound fundamentals, positive earnings estimate re ...

LONDON and RALEIGH, N.C., Oct. 21, 2024 (GLOBE NEWSWIRE) -- Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma” or the “Company”) announces that it will report its financial results for the third quarter ended September 30, 2024 on Monday, November 4, 2024 and host an investment community conference call at 9:00 a.m. EDT / 2:00 p.m. GMT to discuss these financial results and provide a corporate update. To participate, please dial one of the following numbers and ask to join the Verona Pharma call: +1-833-816- ...

Most of us have heard the dictum "the trend is your friend." And this is undeniably the key to success when it comes to short-term investing or trading. But it isn't easy to ensure the sustainability of a trend and profit from it. Often, the direction of a stock's price movement reverses quickly after taking a position in it, making investors incur a short-term capital loss. So, it's important to ensure that there are enough factors -- such as sound fundamentals, positive earnings estimate revisions, etc. - ...

LONDON and RALEIGH, N.C., Sept. 30, 2024 (GLOBE NEWSWIRE) -- Verona Pharma plc (Nasdaq: VRNA) ("Verona Pharma" or the "Company") announces four oral presentations and two posters on analyses from its successful Phase 3 ENHANCE studies with Ohtuvayre (ensifentrine) for the treatment of chronic obstructive pulmonary disease ("COPD") will be presented at CHEST Annual Meeting ("CHEST") 2024. The analyses are published in the CHEST Annual Meeting on-line supplement. Ohtuvayre (ensifentrine) is a first-in-class s ...

Sneksy/E+ via Getty Images Introduction I last wrote on Verona Pharma plc (NASDAQ:VRNA) a year ago. My recommendation was "buy," noting the potential of their novel COPD treatment. Since then, its selective dual phosphodiesterase-3 (PDE3) and phosphodiesterase-4 (PDE4) inhibitor, Ohtuvayre (ensifentrine), was approved for the treatment of COPD. Subsequently, its stock has appreciated over 50% during this time. So I figure it's a good time to take another look at Verona as they begin launching Ohtuvayre. Ver ...

One oral presentation and three posters support Ohtuvayre™ (ensifentrine), as a first-in-class, selective, dual inhibitor of PDE3 and PDE4 LONDON and RALEIGH, N.C., Sept. 05, 2024 (GLOBE NEWSWIRE) -- Verona Pharma plc (Nasdaq: VRNA) ("Verona Pharma" or the "Company") announces one oral presentation and 3 posters on additional analyses from its successful Phase 3 ENHANCE studies with Ohtuvayre (ensifentrine) for the treatment of chronic obstructive pulmonary disease ("COPD") will be presented at the European ...

Verona Pharma plc (NASDAQ:VRNA) Q2 2024 Earnings Conference Call August 8, 2024 9:00 AM ET Company Participants David Zaccardelli - President and Chief Executive Officer Mark Hahn - Chief Financial Officer Christopher Martin - Chief Commercial Officer Tara Rheault - Chief Development Officer Conference Call Participants Andrew Tsai - Jefferies Group LLC Thomas Shrader - BTIG, LLC Raghuram Selvaraju - H.C. Wainwright & Co. Edward Thomason - Van Lanschot Kempen Operator Welcome to Verona Pharma’s Second Quart ...