Core Insights - Verona Pharma is a biopharmaceutical company focused on developing innovative therapies for chronic respiratory diseases with significant unmet medical needs [1] - The company's first commercial product, OhtuvayreTM (ensifentrine), is the first inhaled therapy for the maintenance treatment of COPD that combines bronchodilator and non-steroidal anti-inflammatory activities in one molecule [1] - Ensifentrine has potential applications in various respiratory diseases, including non-cystic fibrosis bronchiectasis, cystic fibrosis, and asthma [1] Company Overview - Verona Pharma plc will present a company overview at the 44th Annual Canaccord Growth Conference on August 13, 2024 [2] - A webcast of the event will be available on the company's website [4]

Company Overview - Verona Pharma plc is a biopharmaceutical company focused on developing and commercializing innovative therapies for chronic respiratory diseases with significant unmet medical needs [5] - The company's first commercial product, OhtuvayreTM (ensifentrine), is the first inhaled therapy for the maintenance treatment of COPD that combines bronchodilator and non-steroidal anti-inflammatory activities in one molecule [5] - Ensifentrine has potential applications in non-cystic fibrosis bronchiectasis, cystic fibrosis, asthma, and other respiratory diseases [5] Upcoming Financial Results - Verona Pharma will report its financial results for the second quarter ended June 30, 2024, on August 8, 2024 [1] - An investment community conference call will be hosted at 9:00 a.m. EDT / 2:00 p.m. BST to discuss these financial results and provide a corporate update [1] Communication and Participation - A live webcast of the conference call will be available on the company's website, and an audio replay will be accessible for 90 days [2] - For participation, callers can dial specific numbers provided for both U.S. and international callers [4]

Core Points - Verona Pharma is a biopharmaceutical company focused on developing therapies for chronic respiratory diseases with significant unmet medical needs [1] - The company's first commercial product, OhtuvayreTM (ensifentrine), is the first inhaled therapy for the maintenance treatment of COPD that combines bronchodilator and non-steroidal anti-inflammatory activities in one molecule [1] - Ensifentrine has potential applications in non-cystic fibrosis bronchiectasis, cystic fibrosis, asthma, and other respiratory diseases [1] Financial Results Announcement - Verona Pharma will report its financial results for the second quarter ended June 30, 2024, on August 8, 2024 [2] - An investment community conference call will be held at 9:00 a.m. EDT / 2:00 p.m. BST to discuss these financial results and provide a corporate update [2] Webcast Information - A live webcast will be available on the Events and Presentations link on the Investors page of the company's website [3] - An audio replay of the webcast will be available for 90 days [3]

PART I [Item 1. Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) The unaudited condensed consolidated financial statements for Q1 2024 are presented, showing a net loss of $25.8 million and $254.9 million in cash, alongside a significant post-quarter $400 million financing event [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheets as of March 31, 2024, show total assets at $289.9 million, a decrease from $308.1 million, and total liabilities increasing to $64.9 million Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $254,882 | $271,772 | | Total current assets | $271,840 | $289,708 | | Total assets | $289,912 | $308,124 | | **Liabilities & Equity** | | | | Total current liabilities | $14,774 | $8,692 | | Term loan | $48,546 | $48,374 | | Total liabilities | $64,924 | $58,841 | | Total shareholders' equity | $224,988 | $249,283 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) For the three months ended March 31, 2024, the company reported a net loss of $25.8 million, an increase from $16.7 million in the prior year, driven by higher SG&A expenses Condensed Consolidated Statements of Operations (in thousands) | Account | Three months ended March 31, 2024 | Three months ended March 31, 2023 | | :--- | :--- | :--- | | Research and development | $6,764 | $12,610 | | Selling, general and administrative | $20,434 | $9,589 | | **Total operating expenses** | **$27,198** | **$22,199** | | Operating loss | ($27,198) | ($22,199) | | Total other income/(expense), net | $2,158 | $5,629 | | **Net loss** | **($25,794)** | **($16,743)** | | Loss per ordinary share | ($0.04) | ($0.03) | [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities for Q1 2024 increased to $13.6 million from $5.8 million, with the company ending the quarter with $254.9 million in cash and cash equivalents Condensed Consolidated Statements of Cash Flows (in thousands) | Account | Three months ended March 31, 2024 | Three months ended March 31, 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | ($13,610) | ($5,782) | | Net cash used in investing activities | ($16) | $0 | | Net cash (used in)/provided by financing activities | ($3,123) | $68,685 | | **Net change in cash and cash equivalents** | **($16,890)** | **$63,588** | | Cash and cash equivalents at end of the period | $254,882 | $291,415 | [Notes to Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Key notes include the FDA's acceptance of the ensifentrine NDA with a PDUFA date of June 26, 2024, an accumulated deficit of $414.4 million, and a significant $400 million post-quarter financing event - The FDA accepted the company's New Drug Application (NDA) for ensifentrine for the maintenance treatment of COPD and assigned a PDUFA target action date of **June 26, 2024**[23](index=23&type=chunk) - The company has an accumulated deficit of **$414.4 million** as of March 31, 2024, but expects its cash and cash equivalents to be sufficient to fund operations for at least the **next 12 months**[24](index=24&type=chunk)[25](index=25&type=chunk) - Subsequent to the quarter's end, on May 9, 2024, the company entered into a new term loan facility of up to **$400.0 million** and a revenue interest purchase and sale agreement (RIPSA), using part of the proceeds to repay its existing 2023 term loan in full[48](index=48&type=chunk)[55](index=55&type=chunk)[56](index=56&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=14&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the development and commercialization of ensifentrine, highlighting increased SG&A costs for launch preparations, decreased R&D, and sufficient liquidity through at least 2026 [Overview](index=15&type=section&id=Overview) Verona Pharma focuses on ensifentrine for COPD, with an FDA PDUFA date of June 26, 2024, anticipating increased expenses for commercial launch and further clinical development - The company's product candidate, ensifentrine, has a PDUFA target action date of **June 26, 2024**, for the maintenance treatment of COPD[65](index=65&type=chunk) - The company anticipates **significant future expenses** related to establishing a sales and marketing infrastructure, scaling up manufacturing, and continuing clinical development of ensifentrine for other formulations and indications[69](index=69&type=chunk) - With cash on hand and new financing agreements, the company believes it can fund operations through at least the **end of 2026**, including the planned commercial launch of ensifentrine if approved[71](index=71&type=chunk) [Clinical Development Update](index=17&type=section&id=Clinical%20Development%20Update) The section summarizes positive Phase 3 ENHANCE program results for ensifentrine and outlines plans for Phase 2 trials for a fixed-dose combination and NCFBE in H2 2024 Top-line Results from ENHANCE Program vs Placebo | Top-line Measurement | ENHANCE-1 | ENHANCE-2 | | :--- | :--- | :--- | | Average FEV, AUC (0-12 hours) | +87 mL (p<0.0001) | +94 mL (p<0.0001) | | Exacerbation rate | 36% reduction (p=0.0503) | 43% reduction (p=0.0090) | | Pooled exacerbation rate | 40% reduction (p=0.0012) | N/A | - The company plans to submit an IND and initiate a **Phase 2 clinical trial** for a fixed-dose combination of ensifentrine and glycopyrrolate (a LAMA) in the **second half of 2024**[79](index=79&type=chunk)[80](index=80&type=chunk) - A **Phase 2 clinical trial** to assess nebulized ensifentrine in patients with non-cystic fibrosis bronchiectasis (NCFBE) is planned to commence in the **second half of 2024**[82](index=82&type=chunk) [Results of Operations](index=21&type=section&id=Results%20of%20Operations) The company's net loss increased to $25.8 million in Q1 2024, driven by a $10.8 million rise in SG&A costs, partially offset by a $5.8 million decrease in R&D expenses Comparison of Results of Operations (in thousands) | Account | Three months ended March 31, 2024 | Three months ended March 31, 2023 | | :--- | :--- | :--- | | Research and development | $6,764 | $12,610 | | Selling, general and administrative | $20,434 | $9,589 | | **Operating loss** | **($27,198)** | **($22,199)** | | **Net loss** | **($25,794)** | **($16,743)** | - The **$5.8 million decrease** in R&D costs was primarily due to the completion of the Phase 3 ENHANCE program in 2023[95](index=95&type=chunk) - The **$10.8 million increase** in SG&A costs was driven by a $4.6 million increase in marketing and pre-commercial activities and a $4.1 million increase in people-related costs in preparation for a potential commercial launch[96](index=96&type=chunk) [Liquidity and Capital Resources](index=23&type=section&id=Liquidity%20and%20Capital%20Resources) The company has an accumulated deficit of $414.4 million but believes its current cash and new financing will fund operations through at least the end of 2026 - The company has an accumulated deficit of **$414.4 million** as of March 31, 2024, and has never generated revenue from product sales[102](index=102&type=chunk)[103](index=103&type=chunk) - Management believes current cash and available funding from the 2024 Term Loan and RIPSA will fund planned operating expenses through **at least the end of 2026**[105](index=105&type=chunk) - The company may require **additional capital** for further clinical development of ensifentrine in other formulations or indications, or to in-license other product candidates[106](index=106&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=25&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company faces interest rate and foreign exchange risks, but management does not anticipate a material impact on its financial condition or results of operations from sudden changes - The company has exposure to interest rate risk on its **$254.9 million** of cash and cash equivalents and its floating-rate loan, but does not consider the potential impact to be material[112](index=112&type=chunk)[113](index=113&type=chunk) - Foreign exchange risk is present due to holdings and payables in foreign currencies (primarily pound sterling), but is **not considered material**[114](index=114&type=chunk) [Item 4. Controls and Procedures](index=25&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of March 31, 2024, with no material changes to internal control over financial reporting during the quarter - Management concluded that the company's disclosure controls and procedures were **effective** as of March 31, 2024[116](index=116&type=chunk) - **No material changes** to internal control over financial reporting occurred during the quarter ended March 31, 2024[117](index=117&type=chunk) PART II - OTHER INFORMATION [Item 1. Legal Proceedings](index=26&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings - The company is **not currently subject to any material legal proceedings**[118](index=118&type=chunk) [Item 1A. Risk Factors](index=26&type=section&id=Item%201A.%20Risk%20Factors) This section details significant risks, including complete dependence on ensifentrine, history of losses, funding needs, regulatory uncertainties, reliance on third parties, intense competition, and intellectual property challenges [Risks Related to Our Business and Industry](index=26&type=section&id=Risks%20Related%20to%20Our%20Business%20and%20Industry) The company faces substantial business risks due to its limited operating history, accumulated deficit of $414.4 million, complete dependence on ensifentrine, and restrictive debt covenants - The company has a limited operating history, has never generated product revenue, and had an accumulated deficit of **$414.4 million** as of March 31, 2024[120](index=120&type=chunk) - The company's success is **entirely dependent on ensifentrine**, its only product candidate, which has not yet received regulatory approval[131](index=131&type=chunk) - The company's credit facility and revenue interest purchase and sale agreement (RIPSA) impose **restrictive covenants and financial obligations** that could adversely affect business operations[137](index=137&type=chunk)[141](index=141&type=chunk) [Risks Related to Development, Clinical Testing and Regulatory Approval](index=32&type=section&id=Risks%20Related%20to%20Development%2C%20Clinical%20Testing%20and%20Regulatory%20Approval) This section highlights inherent risks in drug development, including lengthy, expensive, and uncertain clinical trials, potential for ensifentrine to not be safe or effective, and the impact of undesirable side effects - Clinical drug development is a **long, expensive, and uncertain process**, and there is no guarantee of a successful outcome for ensifentrine[146](index=146&type=chunk) - The regulatory approval process is **unpredictable**, and the FDA or other authorities **may not approve** ensifentrine even with positive clinical trial data, or may require additional, costly post-marketing studies[171](index=171&type=chunk)[173](index=173&type=chunk)[174](index=174&type=chunk) - **Serious or undesirable side effects** discovered during development or after approval could lead to delays, denial of approval, a more restrictive label, or market withdrawal[161](index=161&type=chunk) [Risks Related to Commercialization](index=48&type=section&id=Risks%20Related%20to%20Commercialization) The company faces significant commercialization risks, including intense competition, uncertainty in securing adequate reimbursement, challenges in market acceptance, and the need to build its own commercial infrastructure - The company operates in a **highly competitive industry** and will face **intense competition** from large pharmaceutical companies with greater resources[225](index=225&type=chunk)[226](index=226&type=chunk) - The ability to generate revenue depends on obtaining **adequate coverage and reimbursement** from payors like Medicare, which is a **significant uncertainty**[228](index=228&type=chunk) - The company is currently **building its commercial capabilities** and any failure or delay in developing its sales, marketing, and distribution infrastructure would **adversely impact** the commercialization of ensifentrine[240](index=240&type=chunk) [Risks Related to Intellectual Property](index=54&type=section&id=Risks%20Related%20to%20Intellectual%20Property) The company's commercial success relies on intellectual property, facing risks from expired composition of matter patents, potential challenges to remaining patents, and costly litigation for infringement claims - The issued patents covering the composition of matter for ensifentrine **expired in 2020**. The company's protection now relies on other patents expiring between **2031 and 2044**[284](index=284&type=chunk) - The company may be involved in **expensive and time-consuming lawsuits** to enforce its patents or defend against claims that it is infringing on the intellectual property rights of others[267](index=267&type=chunk)[271](index=271&type=chunk) - **Changes in patent law**, such as the America Invents Act (AIA) in the U.S. and the new Unified Patent Court (UPC) in Europe, could **diminish the value of patents** and impair the company's ability to protect its products[292](index=292&type=chunk)[298](index=298&type=chunk) [Risks Related to Taxation](index=65&type=section&id=Risks%20Related%20to%20Taxation) The company faces tax risks from potential adverse changes to the U.K.'s R&D tax relief regime and its status as a Passive Foreign Investment Company (PFIC) for 2023 - The company benefits from the U.K.'s SME R&D tax relief program, but proposed changes to this regime could have a **material adverse effect** on its financial position[327](index=327&type=chunk)[331](index=331&type=chunk)[333](index=333&type=chunk) - The company believes it was a **Passive Foreign Investment Company (PFIC)** for its 2023 taxable year, which could result in **adverse U.S. federal income tax consequences** for U.S. holders of its shares or ADSs[334](index=334&type=chunk) [Item 5. Other Information](index=69&type=section&id=Item%205.%20Other%20Information) This section discloses that the CEO and CFO terminated prior Rule 10b5-1 trading plans and adopted new ones during Q1 2024 Rule 10b5-1 Trading Plan Activity in Q1 2024 | Name and Title | Action | Date | Aggregate ADSs to be Sold | | :--- | :--- | :--- | :--- | | David Zaccardelli, CEO | Terminate | March 6, 2024 | 700,000 | | David Zaccardelli, CEO | Adopt | March 8, 2024 | 900,000 | | Mark Hahn, CFO | Terminate | March 5, 2024 | 700,000 | | Mark Hahn, CFO | Adopt | March 6, 2024 | 900,000 | [Item 6. Exhibits](index=71&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including key agreements dated May 9, 2024, and officer certifications

Verona Pharma plc (NASDAQ:VRNA) Q1 2024 Results Conference Call May 9, 2024 9:00 AM ET Company Participants David Zaccardelli - President, CEO & Executive Director Mark Hahn - Chief Financial Officer Christopher Martin - Chief Commercial Officer Tara Rheault - Chief Development Officer Conference Call Participants Andrew Tsai - Jefferies Tom Shrader - BTIG Ram Selvaraju - H.C. Wainwright Operator Hello, and welcome to Verona Pharma's First Quarter 2024 Financial Results and Operating Highlights Conference C ...

Verona Pharma Reports First Quarter 2024 Financial Results and Provides Corporate Update PDUFA Target Action Date for Ensifentrine of June 26, 2024 Finalizing commercial launch preparations 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., May 9, 2024 – Verona Pharma plc (Nasdaq: VRNA) ("Verona Pharma" or the "Company"), a biopharmaceutical company focused on respiratory diseases, announces its financial re ...

Verona Pharma plc (NASDAQ:VRNA) Q4 2023 Earnings Conference Call February 29, 2024 9:00 AM ET Company Participants David Zaccardelli - Chief Executive Officer Mark Hahn - Chief Financial Officer Chris Martin - Chief Commercial Officer Tara Rheault - Chief Development Officer Conference Call Participants Andrew Tsai - Jefferies Yasmeen Rahimi - Piper Sandler Caroline Pocher - Wedbush Securities Joon Lee - Truist Securities Tom Shrader - BTIG Operator Welcome to Verona Pharma's Fourth Quarter and Full Year Qu ...

March 2024 Ensifentrine is an investigational drug and has not been approved by the FDA (or any other regulatory authority). Nasdaq: VRNA | www.veronapharma.com Developing innovative therapies for the treatment of respiratory diseases 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 statemen ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 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) United Kingdom 98-1489389 (State or other ...

Financial Performance - The net loss for Q4 2023 was $14.1 million, compared to a net loss of $10.5 million in Q4 2022[10][15]. - Revenue for Q4 2023 was $0, unchanged from Q4 2022, while total revenue for the year was also $0, consistent with the previous year[21]. - Gross profit for Q4 2023 was $0, maintaining the same level as Q4 2022, with a gross profit of $112,000 for the year[21]. - The net loss for Q4 2023 was $14,132,000, compared to a net loss of $10,451,000 in Q4 2022, with a total net loss of $54,369,000 for the year versus $68,701,000 in 2022[21]. - Loss per ordinary share for Q4 2023 was $0.02, consistent with Q4 2022, while the annual loss per share was $0.09 compared to $0.13 in 2022[21]. Research and Development - R&D expenses for the fourth quarter of 2023 were $4.1 million, down from $6.8 million in Q4 2022, primarily due to reduced clinical trial costs[10][11]. - Full-year R&D expenses for 2023 totaled $17.2 million, significantly down from $49.3 million in 2022, reflecting the completion of the Phase 3 ENHANCE program[10][15]. - The company plans to submit an IND for a fixed-dose combination formulation of ensifentrine and glycopyrrolate in the second half of 2024[10][12]. Selling, General and Administrative Expenses - SG&A expenses for Q4 2023 were $15.0 million, up from $8.3 million in Q4 2022, driven by increased personnel and commercialization preparation costs[10][15]. - Full-year SG&A expenses for 2023 were $50.4 million, an increase from $26.6 million in 2022, largely due to costs associated with building commercial infrastructure[10][15]. - Selling, general and administrative expenses increased to $14,972,000 in Q4 2023 from $8,323,000 in Q4 2022, with total expenses for the year rising to $50,353,000 from $26,579,000[21]. Cash and Assets - Cash and cash equivalents at December 31, 2023, were $271.8 million, an increase from $227.8 million at the end of 2022[10]. - Cash and cash equivalents increased to $271,772,000 in Q4 2023 from $227,827,000 in Q4 2022[21]. - Total assets rose to $308,124,000 in Q4 2023, up from $259,468,000 in Q4 2022[21]. - Shareholders' equity increased to $249,283,000 in Q4 2023 from $230,466,000 in Q4 2022[21]. Debt Financing and Future Plans - The company completed a $400 million debt financing facility in December 2023 to support commercialization and pipeline expansion[5][10]. - The FDA has assigned a PDUFA target action date of June 26, 2024, for the NDA of ensifentrine, which is aimed at treating COPD[10]. - The company expects to launch ensifentrine in the US market in the second half of 2024, pending FDA approval[10][7]. - The weighted average shares outstanding for Q4 2023 was 642,139,211, compared to 604,204,929 in Q4 2022[21].