Verona Pharma plc (NASDAQ:VRNA) Q3 2023 Results Conference Call November 2, 2023 9:00 AM ET Company Participants Dr. David Zaccardelli - CEO Mark Hahn - CFO Dr. Kathy Rickard - Chief Medical Officer Chris Martin - SVP, Commercial Conference Call Participants Andrew Tsai - Jefferies Yasmeen Rahimi - Piper Sandler Andreas Argyrides - Wedbush Securities Tom Shrader - BTIG Dipesh Patel - H.C. Wainwright Operator Welcome to Verona Pharma's Third Quarter 2023 Financial Results and Operating Highlights Conference ...

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 For the quarterly period ended September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM __________ TO __________ Commission File Number: 001-38067 Verona Pharma plc (Exact name of Registrant as specified in its Charter) (State or other jurisdiction of i ...

Verona Pharma plc. (NASDAQ:VRNA) Q2 2023 Earnings Conference Call August 3, 2023 9:00 AM ET Company Participants David Zaccardelli - Chief Executive Officer Mark Hahn - Chief Financial Officer Kathy Rickard - Chief Medical Officer Christopher Martin - Senior Vice President of Commercial Conference Call Participants Andreas Argyrides - Wedbush Andrew Tsai - Jefferies Edward Nash - Canaccord Genuity Thomas Shrader - BTIG Boobalan Pachaiyappan - H.C. Wainwright Operator Welcome to Verona Pharma Second Quarter ...

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 For the quarterly period ended June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM __________ TO __________ Commission File Number: 001-38067 3 More London Riverside London SE1 2RE United Kingdom Not Applicable (Address of principal executive offices) ( ...

Verona Pharma plc (NASDAQ:VRNA) Q1 2023 Earnings Conference Call May 9, 2023 9:00 AM ET Company Participants David Zaccardelli - President and Chief Executive Officer Mark Hahn - Chief Financial Officer Kathleen Rickard - Chief Medical Officer Christopher Martin - Senior Vice President Commercial Conference Call Participants Andreas Argyrides - Wedbush David Risinger - SVB Securities Thomas Shrader - BTIG Boobalan Pachaiyappan - H.C. Wainwright Joon Lee - Truist Securities Operator Good morning. Welcome to ...

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 For the quarterly period ended March 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM __________ TO __________ Commission File Number: 001-38067 Verona Pharma plc (Exact name of Registrant as specified in its Charter) (State or other jurisdiction of incor ...

Verona Pharma plc (NASDAQ:VRNA) Q4 2022 Earnings Conference Call March 7, 2023 9:00 AM ET Company Participants David Zaccardelli - President and Chief Executive Officer Mark Hahn - Chief Financial Officer Kathleen Rickard - Chief Medical Officer Christopher Martin - Senior Vice President Commercial Conference Call Participants Andreas Argyrides - Wedbush Joon Lee - Truist Securities Thomas Shrader - BTIG Boobalan Pachaiyappan - H.C. Wainwright Operator Welcome to Verona Pharma's, Fourth Quarter and Full Yea ...

Developing innovative therapies for the treatment of respiratory diseases March 2023 Breath of Innovation™ Nasdaq: VRNA | www.veronapharma.com Forward-looking statements This presentation contains "forward‐looking" statements that are based on the beliefs and assumptions and on information currently available to management of Verona Pharma plc (together with its consolidated subsidiaries, the "Company"). All statements other than statements of historical fact contained in this presentation are forward-looki ...

Clinical Trials and Efficacy - Ensifentrine met primary endpoints in both Phase 3 ENHANCE trials, demonstrating statistically significant improvements in lung function for moderate to severe COPD patients [38]. - Approximately 1,600 subjects were enrolled across the ENHANCE-1 and ENHANCE-2 trials, with both trials showing significant reductions in the rate and risk of moderate to severe COPD exacerbations [40]. - The ENHANCE-1 trial reported a statistically significant improvement in quality of life measures, while ENHANCE-2 also showed clinically meaningful improvements [38]. - Ensifentrine demonstrated improvements in lung function and quality of life in Phase 2b trials, with significant results in both monotherapy and background therapy settings [36]. - Ensifentrine demonstrated a placebo-corrected increase in average FEV area under the curve of 87 mL (p<0.0001) in ENHANCE-1 and 94 mL (p<0.0001) in ENHANCE-2 [6]. - The treatment resulted in a 36% reduction in moderate to severe COPD exacerbations in ENHANCE-1 (p=0.0503) and a 43% reduction in ENHANCE-2 (p=0.0090) [47]. - In pooled data, ensifentrine showed a 40% reduction in the rate of moderate to severe COPD exacerbations over 24 weeks (p=0.0012) compared to placebo [48]. - The average morning trough FEV increased by 35 mL (p=0.0413) in ENHANCE-1 and 49 mL (p=0.0016) in ENHANCE-2, supporting a twice-daily dosing regimen [6]. - Quality of Life (SGRQ Total Score) improved by -2.3 units (p=0.0253) in ENHANCE-1, exceeding the minimal clinically important difference [52]. - Ensifentrine has shown potential applications in other respiratory diseases, including cystic fibrosis and asthma [62]. Safety and Tolerability - Ensifentrine has been well tolerated in clinical trials involving approximately 3,000 subjects, with no significant adverse effects reported [32]. - Ensifentrine was well tolerated, with low incidence of adverse events occurring in more than 1% of subjects [53]. - Ensifentrine's development has demonstrated statistically significant improvements in lung function and safety profiles similar to placebo across all formulations [59]. Market Opportunity and Collaboration - Approximately 384 million people worldwide are affected by COPD, making it the third leading cause of death globally [26]. - 45% of COPD patients continue to experience symptoms more than 24 days a month, indicating a significant opportunity for new inhaled therapies [30]. - The U.S. COPD maintenance treatment market generates approximately $10 billion in sales, with around 8.5 million patients receiving treatment [74]. - Approximately 50% of COPD patients report symptoms for more than 24 days a month, indicating a significant unmet need for new therapies [74]. - The company has entered a strategic collaboration with Nuance Pharma to develop and commercialize ensifentrine in Greater China [24]. - A strategic collaboration with Nuance Pharma was established, valued at up to $219 million, to develop and commercialize ensifentrine in Greater China, including a $40 million upfront payment [78]. - Nuance Pharma is responsible for all costs related to clinical development and commercialization in Greater China, with Phase 1 and Phase 3 studies of ensifentrine already cleared to begin [79]. Regulatory and Development Plans - The company plans to submit a New Drug Application (NDA) to the FDA in Q2 2023 for inhaled ensifentrine for COPD maintenance treatment [23]. - The company plans to submit a New Drug Application (NDA) to the FDA in Q2 2023 based on the positive results from the ENHANCE program [55]. - The FDA requires submission of an IND, which includes non-clinical test results, manufacturing information, and clinical data, to authorize the shipment and administration of investigational new drugs [97]. - Human clinical trials are conducted in three phases, with Phase 1 focusing on safety and dosage, Phase 2 on efficacy and safety risks, and Phase 3 on generating data for approval [100]. - The FDA aims to review and act on standard NDAs for new molecular entities within ten months from the filing date, with a typical review duration of twelve months [106]. - Fast track designation allows for expedited review of drugs intended for serious conditions, with a goal of six months for priority review applications [115]. Financial Performance and Projections - The company reported net losses of $68.7 million and $55.6 million for the years ended December 31, 2022 and 2021, respectively, with an accumulated deficit of $333.1 million as of December 31, 2022 [189]. - The company has devoted substantially all financial resources to the research and development of ensifentrine, its only product candidate, and has not completed development of any product candidate or drugs [191]. - The company expects to incur significant operating losses for the foreseeable future as it expands research and development efforts and seeks regulatory approval for ensifentrine [189]. - The company anticipates that expenses will increase substantially due to ongoing clinical trials and potential regulatory challenges [190]. - The company will need additional funding to complete development and commercialization of ensifentrine and any future product candidates [196]. - The company expects ongoing costs associated with operating as a public company in the United States and maintaining a listing on the Nasdaq Global Market [196]. - The company estimates that existing cash resources, UK tax credit receipts, and a $150.0 million debt facility will fund operations through at least the end of 2025, including the commercial launch of ensifentrine [197]. - The company has not generated any revenue from product sales and relies solely on the success of ensifentrine, which is its only product candidate under development [201]. Risks and Challenges - The company faces significant risks and uncertainties associated with pharmaceutical product development, impacting the predictability of expenses and profitability [194]. - The company may never achieve significant revenue or profitability, which could depress the market price of its ADSs [195]. - The company may face significant delays or inability to commercialize ensifentrine due to various regulatory and operational challenges [204]. - The company’s existing debt obligations could limit operational flexibility and increase vulnerability to adverse market conditions [212]. - The company faces risks associated with international operations, including economic weakness and differing regulatory requirements in non-U.S. markets [215]. - The clinical development of the product candidate, ensifentrine, is lengthy and expensive, with uncertain outcomes that may lead to additional costs or delays [218]. - Regulatory approvals for ensifentrine require extensive pre-clinical studies and clinical trials, which are costly and time-consuming [219].

Financial Data and Key Metrics Changes - The company ended Q3 2022 with $231.7 million in cash and equivalents, significantly strengthening its financial position [15] - The net loss after tax for Q3 2022 was $15.6 million, compared to a net profit of $11.1 million in Q3 2021, representing a loss of $0.03 per ordinary share [16] - Research and development costs decreased to $9.8 million in Q3 2022 from $22.6 million in Q3 2021, primarily due to reduced clinical trial costs [16] - Selling, general and administrative expenses were $5.3 million in Q3 2022, down from $10.9 million in Q3 2021, mainly due to a non-recurring expense in 2021 [17] Business Line Data and Key Metrics Changes - The ENHANCE-2 trial met primary and secondary endpoints, showing a 42% reduction in the rate of moderate and severe COPD exacerbations compared to placebo [9] - The company is preparing for the potential commercial launch of ensifentrine in the U.S. in 2024, contingent on positive results from the ENHANCE-1 trial [11] Market Data and Key Metrics Changes - Over 380 million patients suffer from COPD worldwide, highlighting the urgent need for novel treatments [13] - The company has engaged with over 35 payers covering over 200 million lives, with over 85% expected to cover ensifentrine at launch [31] Company Strategy and Development Direction - The company plans to submit a new drug application to the U.S. FDA in the first half of 2023, conditional on positive ENHANCE-1 results [11] - The global partnering strategy includes Nuance Pharma, which received clearance to begin Phase 1 and Phase 3 studies of ensifentrine for COPD in China [12] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming ENHANCE-1 data readout and the potential for ensifentrine to address unmet needs in COPD treatment [13] - The company is evaluating the potential impact of the Inflation Reduction Act on its operations and product formulations [66] Other Important Information - The company has access to approximately $400 million, including a $150 million equity offering and a $150 million debt financing facility [6] - The company expects to extend its cash runway through at least the end of 2025, supporting ongoing pre-commercialization activities [6] Q&A Session Summary Question: When is the last patient visit for the ENHANCE-1 trial expected? - Management indicated that they are tracking towards a November completion but cannot guarantee the exact timing due to variables [22] Question: What is the European commercialization strategy? - Management has not yet discussed with the EMA but plans to do so after reviewing ENHANCE-1 and ENHANCE-2 data [23] Question: What commercial activities will occur post-ENHANCE-1 data? - Management has engaged with payers and plans to continue discussions to ensure coverage for ensifentrine [30] Question: Is there an option to retain rights from Nuance in the China market? - There are clawback rights in the agreement with Nuance, allowing the company to reclaim rights under certain conditions [39] Question: What is the manufacturing progress for ensifentrine? - Management reported that they are well progressed in manufacturing validation processes and stability data [37] Question: What is the impact of ensifentrine on CRP levels? - Initial data shows a trend towards decreased CRP levels, but results are not yet conclusive [44] Question: Are there any differences in efficacy between smokers and non-smokers? - Management cautioned against drawing conclusions from subgroup analyses, emphasizing that positive effects were observed across all groups [46]