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Verona Pharma(VRNA) - 2022 Q3 - Quarterly Report
2022-11-09 13:09
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, 2022 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 | Title ...
Verona Pharma(VRNA) - 2022 Q2 - Earnings Call Presentation
2022-08-17 18:26
ENHANCE-2 Phase 3 data August 2022 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-looking statements. Forward‐looking statements include information concerning ...
Verona Pharma(VRNA) - 2022 Q2 - Quarterly Report
2022-08-09 11:53
[PART I - FINANCIAL INFORMATION](index=4&type=section&id=PART%20I%20-%20FINANCIAL%20INFORMATION) This section presents Verona Pharma's financial statements, including balance sheets, statements of operations, and cash flows, along with accompanying notes [Financial Statements](index=4&type=section&id=Item%201%20Financial%20Statements) For the six months ended June 30, 2022, Verona Pharma reported a net loss of $42.6 million, with total assets of $154.9 million and cash and cash equivalents decreasing to $111.5 million [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) This section provides a summary of the company's financial position at June 30, 2022, compared to December 31, 2021 Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2022 | December 31, 2021 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $111,510 | $148,380 | | Total current assets | $138,632 | $170,063 | | Total assets | $154,856 | $186,587 | | **Liabilities & Equity** | | | | Total current liabilities | $38,863 | $33,422 | | Total liabilities | $43,976 | $38,582 | | Total shareholders' equity | $110,880 | $148,005 | | Total liabilities and shareholders' equity | $154,856 | $186,587 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) This section details the company's financial performance, including operating loss and net loss, for the three and six months ended June 30, 2022 and 2021 Statement of Operations Summary (in thousands) | Metric | Q2 2022 | Q2 2021 | H1 2022 | H1 2021 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $14,982 | $20,563 | $32,607 | $34,137 | | Selling, general and administrative | $5,526 | $7,985 | $12,966 | $17,267 | | **Operating loss** | **($20,508)** | **($28,548)** | **($45,573)** | **($51,404)** | | **Net loss** | **($17,766)** | **($22,068)** | **($42,603)** | **($43,358)** | | Loss per ordinary share | ($0.04) | ($0.05) | ($0.09) | ($0.09) | [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This section summarizes the cash inflows and outflows from operating, investing, and financing activities for the six months ended June 30, 2022 and 2021 Cash Flow Summary for the Six Months Ended June 30 (in thousands) | Activity | 2022 | 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | ($34,029) | ($38,756) | | Net cash used in investing activities | ($29) | $0 | | Net cash used in financing activities | ($1,415) | ($3,399) | | **Net change in cash and cash equivalents** | **($36,870)** | **($41,951)** | | Cash and cash equivalents at end of period | $111,510 | $146,035 | [Notes to Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) This section provides additional information and details supporting the condensed consolidated financial statements - The company is a clinical-stage biopharmaceutical firm focused on respiratory diseases, with an accumulated deficit of **$306.7 million** as of June 30, 2022, due to recurring losses since inception[25](index=25&type=chunk)[26](index=26&type=chunk) - Management believes existing cash and cash equivalents are sufficient to fund operations for at least the next 12 months from the report's issuance date[27](index=27&type=chunk) - The company has a term loan facility of up to **$30.0 million** with Silicon Valley Bank, with **$5.0 million** principal outstanding as of June 30, 2022, and additional tranches contingent on clinical milestones[43](index=43&type=chunk) - In June 2021, the company entered a collaboration and license agreement with Nuance Pharma for ensifentrine in Greater China, receiving **$25.0 million** in cash and a **$15.0 million** equity interest, with eligibility for up to **$179.0 million** in future milestone payments[62](index=62&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=18&type=section&id=Item%202%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the positive top-line results from the Phase 3 ENHANCE-2 trial for ensifentrine and plans to submit an NDA in the first half of 2023, contingent on ENHANCE-1 results, while operating expenses decreased primarily due to lower share-based compensation [Overview and Clinical Development Update](index=19&type=section&id=Overview%20and%20Clinical%20Development%20Update) This section provides an overview of Verona Pharma's focus on ensifentrine and updates on its Phase 3 clinical trials - Verona Pharma is a clinical-stage biopharmaceutical company focused on developing ensifentrine, a first-in-class inhaled dual inhibitor of PDE3 and PDE4 for respiratory diseases[83](index=83&type=chunk) - The Phase 3 ENHANCE-2 trial for nebulized ensifentrine in COPD met its primary and secondary endpoints, showing significant improvements in lung function and a **42% reduction** in the rate of moderate to severe exacerbations over 24 weeks[84](index=84&type=chunk)[90](index=90&type=chunk) - Top-line data from the second Phase 3 trial, ENHANCE-1, is expected around the end of 2022, with a New Drug Application (NDA) submission to the FDA planned for the first half of 2023, pending positive results[85](index=85&type=chunk)[94](index=94&type=chunk) - The company is monitoring potential impacts from the COVID-19 pandemic and the Russia-Ukraine conflict on its clinical trial operations, timelines, and costs[99](index=99&type=chunk)[102](index=102&type=chunk) [Results of Operations](index=26&type=section&id=Results%20of%20Operations) This section analyzes the company's financial performance, highlighting changes in research and development and selling, general and administrative expenses Comparison of Results for the Three Months Ended June 30 (in thousands) | Item | 2022 | 2021 | Change | | :--- | :--- | :--- | :--- | | Research and development | $14,982 | $20,563 | ($5,581) | | Selling, general and administrative | $5,526 | $7,985 | ($2,459) | | **Net loss** | **$17,766** | **$22,068** | **$4,302** | - The decrease in Q2 2022 R&D costs was primarily due to a **$4.2 million** decrease in clinical trial costs as the ENHANCE program progressed and a **$1.9 million** decrease in share-based compensation[134](index=134&type=chunk) Comparison of Results for the Six Months Ended June 30 (in thousands) | Item | 2022 | 2021 | Change | | :--- | :--- | :--- | :--- | | Research and development | $32,607 | $34,137 | ($1,530) | | Selling, general and administrative | $12,966 | $17,267 | ($4,301) | | **Net loss** | **$42,603** | **$43,358** | **$755** | - The decrease in H1 2022 SG&A costs was primarily driven by a **$5.7 million** decrease in share-based compensation, partially offset by a **$2.0 million** charge related to the Ligand Agreement modification[141](index=141&type=chunk) [Liquidity and Capital Resources](index=28&type=section&id=Liquidity%20and%20Capital%20Resources) This section discusses the company's cash position, funding needs, and available capital resources - As of June 30, 2022, the company had cash and cash equivalents of **$111.5 million** and an accumulated deficit of **$306.7 million**[11](index=11&type=chunk)[150](index=150&type=chunk) - The company believes its current cash, expected UK tax credits, and available funding from its Term Loan will be sufficient to fund operations through at least the end of 2023[155](index=155&type=chunk) - Significant additional capital will be required to advance clinical activities, fund pre-launch and launch costs, and establish a sales and marketing organization for ensifentrine[156](index=156&type=chunk) - The company has an "at the market" (ATM) equity offering program with up to **$100.0 million**, with **$99.2 million** remaining available for sale as of June 30, 2022[152](index=152&type=chunk)[153](index=153&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=31&type=section&id=Item%203%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company is a smaller reporting company and is not required to provide the information for this item - As a smaller reporting company defined in Rule 12b-2 of the Exchange Act, Verona Pharma is not required to provide quantitative and qualitative disclosures about market risk[162](index=162&type=chunk) [Controls and Procedures](index=31&type=section&id=Item%204%20Controls%20and%20Procedures) Management, including the CEO and CFO, evaluated the company's disclosure controls and procedures and concluded they were effective at a reasonable assurance level as of June 30, 2022, with no material changes to internal control over financial reporting during the quarter - Based on an evaluation as of the end of the quarter, the principal executive officer and principal financial officer concluded that the company's disclosure controls and procedures were effective at the reasonable assurance level[164](index=164&type=chunk) - There were no changes in the company's internal control over financial reporting during the quarter ended June 30, 2022, that have materially affected, or are reasonably likely to materially affect, internal controls[165](index=165&type=chunk) [PART II - OTHER INFORMATION](index=32&type=section&id=PART%20II%20-%20OTHER%20INFORMATION) This section covers other information not included in the financial statements, such as legal proceedings, risk factors, and exhibits [Legal Proceedings](index=32&type=section&id=Item%201%20Legal%20Proceedings) The company is not currently subject to any material legal proceedings - The company reports that it is not currently subject to any material legal proceedings[166](index=166&type=chunk) [Risk Factors](index=32&type=section&id=Item%201A.%20Risk%20Factors) There have been no material changes to the company's risk factors from those described in its Annual Report on Form 10-K for the year ended December 31, 2021 - The company's risk factors have not materially changed from those disclosed in the 2021 Form 10-K[167](index=167&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=32&type=section&id=Item%202%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) There were no unregistered sales of equity securities during the period - None[168](index=168&type=chunk) [Exhibits](index=33&type=section&id=Item%206%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including CEO and CFO certifications and Inline XBRL documents - The report includes CEO and CFO certifications under Rule 13a-14(a)/15d-14(a) and Section 1350, as well as Inline XBRL documents, filed or furnished herewith[173](index=173&type=chunk)
Verona Pharma(VRNA) - 2022 Q1 - Earnings Call Presentation
2022-05-09 19:49
Developing innovative therapies for the treatment of respiratory diseases March 2022 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 ...
Verona Pharma(VRNA) - 2022 Q1 - Earnings Call Transcript
2022-05-03 16:47
Financial 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]
Verona Pharma(VRNA) - 2022 Q1 - Quarterly Report
2022-05-03 12:24
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, 2022 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 o ...
Verona Pharma(VRNA) - 2021 Q4 - Earnings Call Presentation
2022-03-04 19:42
Developing innovative therapies for the treatment of respiratory diseases March 2022 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 ...
Verona Pharma(VRNA) - 2021 Q4 - Earnings Call Transcript
2022-03-03 20:33
Call Start: 09:00 January 1, 0000 9:33 AM ET Verona Pharma plc (NASDAQ:VRNA) Q4 2021 Earnings Conference Call March 3, 2022 09:00 ET Company Participants David Zaccardelli - President & Chief Executive Officer Mark Hahn - Chief Financial Officer Chris Martin - Senior Vice President of Commercial Kathleen Rickard - Chief Medical Officer Conference Call Participants Andreas Argyrides - Wedbush Securities Suji Jeong - Jefferies Tom Shrader - BTIG Operator Welcome to Verona Pharma's Fourth Quarter and Year End ...
Verona Pharma(VRNA) - 2021 Q4 - Annual Report
2022-03-03 13:58
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, 2021 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) Registrant's telephone number, including a ...
Verona Pharma(VRNA) - 2021 Q3 - Earnings Call Transcript
2021-11-09 19:32
Verona Pharma plc (NASDAQ:VRNA) Q3 2021 Earnings Conference Call November 9, 2021 9:00 AM ET Company Participants David Zaccardelli - President and Chief Executive Officer Mark Hahn - Chief Financial Officer Kathy Rickard - Chief Medical Officer Conference Call Participants Andreas Argyrides - Wedbush Securities Boobalan Pachaiyappan - H.C. Wainwright Tom Shrader - BTIG Operator Welcome to Verona Pharma's Third Quarter 2021 Financial Results and Operating Highlights Conference Call. At this time, all partic ...