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]

Financial Performance - Product sales for the three months ended September 30, 2024, were $5.6 million, compared to $0 for the same period in 2023, marking a significant revenue generation milestone[12]. - The net loss for the three months ended September 30, 2024, was $43.0 million, compared to a net loss of $14.7 million for the same period in 2023, indicating a 192.5% increase in losses[12]. - The company reported a net loss of $139,591,000 for the nine months ended September 30, 2024, compared to a net loss of $40,237,000 for the same period in 2023[19]. - The net loss for the three months ended September 30, 2024, was $42.96 million, compared to a net loss of $14.69 million for the same period in 2023, representing an increase of 192%[50]. - The company reported a net cash used in operating activities of $93,367,000 for the nine months ended September 30, 2024, compared to $39,820,000 for the same period in 2023[19]. Assets and Liabilities - Total assets increased to $381.8 million as of September 30, 2024, up from $308.1 million at December 31, 2023, representing a 23.8% growth[10]. - Cash and cash equivalents rose to $336.0 million, compared to $271.8 million at the end of 2023, indicating a 23.6% increase[10]. - Total current assets increased to $364.25 million as of September 30, 2024, from $289.71 million at December 31, 2023, marking a growth of 25.7%[10]. - Total liabilities surged to $251.33 million as of September 30, 2024, compared to $58.84 million at December 31, 2023, indicating a significant increase of 326%[10]. - The accumulated deficit grew to $528.5 million as of September 30, 2024, compared to $388.4 million at the end of 2023, indicating a 36.1% increase[10]. Shareholder Information - The company reported a weighted-average share count of 651,944 for the three months ended September 30, 2024, compared to 638,239 for the same period in 2023[11]. - The company had a total of 667,659,630 ordinary shares outstanding as of September 30, 2024[16]. - The total shareholders' equity decreased to $130,491,000 as of September 30, 2024, down from $263,533,000 at the end of September 2023[16]. Research and Development - Research and development expenses for the three months ended September 30, 2024, were $10.6 million, up from $3.0 million in the same period last year, reflecting a 256.8% increase[12]. - The company recognized $6.3 million in research and development costs related to a milestone payment for the first regulatory approval of ensifentrine and $15.0 million for the first commercial sale of ensifentrine[35]. - The Company initiated a Phase 2 dose-ranging trial for a fixed-dose combination formulation with ensifentrine and glycopyrrolate in Q3 2024[22]. Product Launch and Sales - The company launched its first commercial product, Ohtuvayre, in the U.S. in August 2024, following FDA approval on June 26, 2024[21]. - Ohtuvayre is the first inhaled therapy for COPD with a novel mechanism of action available in over 20 years, combining bronchodilator and anti-inflammatory effects[21]. - Ohtuvayre's net product sales were entirely supplied through four specialty pharmacies, which accounted for 100% of sales in the three and nine months ended September 30, 2024[25]. Financing and Funding - The term loan increased significantly to $120.0 million from $48.4 million, reflecting a 148.5% rise in non-current liabilities[10]. - The company raised $122,500,000 from term loans and $100,000,000 from RIPSA during the nine months ended September 30, 2024[19]. - The company entered into a term loan facility of up to $400.0 million, with an initial advance of $50.0 million, which was fully repaid by May 9, 2024[37]. - The effective interest rate for the 2024 Term Loans was approximately 13% per annum as of September 30, 2024[40]. - The company may need to secure substantial additional funds to advance clinical activities and commercialize Ohtuvayre[23]. Operational Challenges - The company is heavily reliant on the success of ensifentrine, recently approved by the FDA as Ohtuvayre, for future revenue generation[6]. - The company faces significant risks including the need for additional funding for product development and commercialization, which could impact its financial condition[6]. - The Company has an accumulated deficit of $528.5 million as of September 30, 2024, and expects to incur additional losses until products reach commercial profitability[23].

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 ...

Core Viewpoint - The article emphasizes the importance of identifying sustainable trends in short-term investing, highlighting that a stock's price movement can quickly reverse, leading to potential losses. A screening strategy based on recent price strength can help investors find stocks with solid fundamentals to maintain upward momentum. Group 1: Stock Performance - Verona Pharma PLC (VRNA) has shown a significant price increase of 52.3% over the past 12 weeks, indicating strong investor interest [2] - In the last four weeks, VRNA's price has increased by 24.6%, suggesting that the upward trend is still intact [2] - VRNA is currently trading at 95.1% of its 52-week high-low range, indicating a potential breakout [2] Group 2: Fundamental Strength - VRNA holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate revisions and EPS surprises [3] - The Zacks Rank system has a strong historical performance, with Rank 1 stocks averaging a +25% annual return since 1988 [3] - The Average Broker Recommendation for VRNA is 1 (Strong Buy), reflecting high optimism from the brokerage community regarding its near-term price performance [3] Group 3: Investment Strategy - The article suggests that VRNA may continue its price trend without reversal in the near future [4] - Investors are encouraged to explore other stocks that meet the criteria of the "Recent Price Strength" screen for potential investment opportunities [4] - The Zacks Research Wizard tool is recommended for backtesting stock-picking strategies and identifying successful investment opportunities [4]

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. - ...

Core Viewpoint - Verona Pharma's Ohtuvayre, a novel treatment for COPD, has been approved and is expected to significantly impact the market despite its high pricing and associated risks [3][9]. Product Overview - Ohtuvayre is the first inhaled product with a new mechanism of action for COPD in over 20 years, approved in June 2024 after successful Phase 3 trials [3]. - The drug is priced at $2,950 per month, leading to an annual cost of $35,400, which exceeds the benchmark of $12,700 set by ICER [3]. Market Potential - Approximately 40% of the 11.7 million COPD patients in the US experience exacerbations despite existing therapies, indicating a potential market of about 4.6 million patients seeking alternatives [3]. - Ohtuvayre is particularly recommended for patients resistant to triple therapy (LABA-LAMA-ICS), which represents a significant patient population [3]. Financial Projections - A discounted cash flow analysis estimates a suitable US population for Ohtuvayre at 1.15 million, with an anticipated market penetration rate of 10% [3][6]. - The projected peak sales year is 2034, with a risk-adjusted net present value of $3.974 billion calculated based on future cash flows [6]. Sales Forecast - Sales projections indicate a gradual increase in market share from 0% in 2024 to 10% by 2034, with estimated sales reaching $2.0355 billion in the peak sales year [7]. - Previous peak annual sales estimates for Ohtuvayre ranged between $500 million and $1.1 billion, which are considered conservative given the unmet need in the COPD market [9]. Financial Health - As of June 30, Verona held $404.599 million in cash, with total current assets of $416.292 million against current liabilities of $46.346 million, indicating a strong short-term financial position [8]. - Operating expenses have increased significantly, with Q2 R&D and SG&A expenses reported at $19.388 million and $49.035 million, respectively, leading to a net loss of $70.835 million [8]. Competitive Landscape - The COPD market is highly competitive, and Ohtuvayre will face challenges in marketing against established therapies [10]. - Verona's partner, Ligand, is entitled to a low single-digit royalty on worldwide net sales of Ohtuvayre, which may impact overall profitability [8].

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 ...

Core Viewpoint - Verona Pharma has launched Ohtuvayre (ensifentrine) for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adults, marking the first novel inhaled product for COPD in over 20 years, with expectations to redefine treatment paradigms [2][4]. Company Updates - The company has initiated patient shipments of Ohtuvayre and has conducted over 2,000 healthcare professional (HCP) visits, with more than 100 unique HCPs prescribing the product [3]. - Near-term milestones include the submission of an investigational new drug application (IND) for a fixed-dose combination of ensifentrine and glycopyrrolate, with plans to start a Phase 2 trial in Q3 2024 [3]. - A Phase 2 clinical trial for nebulized ensifentrine in patients with non-cystic fibrosis bronchiectasis is also planned for Q3 2024 [3]. Financial Highlights - As of June 30, 2024, the company reported cash and cash equivalents of $404.6 million, a significant increase from $271.8 million at the end of 2023, supported by a $70 million draw from the debt facility and $100 million from a revenue interest purchase and sales agreement [5][6]. - Research and development (R&D) expenses for Q2 2024 were $19.4 million, compared to a net reversal of costs of $2.5 million in Q2 2023, reflecting increased costs related to milestone payments and pre-launch inventory production [6]. - Selling, general and administrative (SG&A) expenses rose to $49.0 million in Q2 2024 from $12.4 million in Q2 2023, driven by milestone payments, marketing activities, and increased personnel costs [6]. - The net loss for Q2 2024 was $70.8 million, compared to a net loss of $8.8 million in Q2 2023 [7]. Product and Market Context - Ohtuvayre is positioned as a significant advancement in COPD treatment, combining bronchodilator and non-steroidal anti-inflammatory activities in one molecule, with potential applications in other respiratory diseases [10].

OhtuvayreTM (ensifentrine) now available; patient shipments started Strong balance sheet supports commercialization and pipeline expansion Conference call today at 9:00 a.m. EDT / 2:00 p.m. BST LONDON and RALEIGH, N.C., Aug. 08, 2024 (GLOBE NEWSWIRE) -- Verona Pharma plc (Nasdaq: VRNA) ("Verona Pharma" or the "Company"), a biopharmaceutical company focused on respiratory diseases, announces its financial results for the second quarter ended June 30, 2024, and provides a corporate update. "We are very please ...