Verona Pharma Reports Strong Ohtuvayre™ Launch and Provides Preliminary Fourth Quarter and Full Year 2024 Financial Highlights

Approximately $36 million and $42 million net product sales of Ohtuvayre for the fourth quarter and full year 2024, respectively

More than 3,500 unique prescribers and over 16,000 prescriptions filled in 2024 across a broad COPD population

Approximately 45% of Tier 1 HCPs prescribed Ohtuvayre

LONDON and RALEIGH, N.C., Jan. 07, 2025 (GLOBE NEWSWIRE) — Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma” or the “Company”), a biopharmaceutical company focused on respiratory diseases, announces preliminary unaudited net product sales for the fourth quarter and full year ended December 31, 2024, and provides a corporate update.

“2024 was another transformational year for Verona with the approval and US launch of Ohtuvayre (ensifentrine) for the maintenance treatment of chronic obstructive pulmonary disease (“COPD”),” said David Zaccardelli, Pharm. D., President and Chief Executive Officer. “We are very pleased to report the exceptionally strong start to the launch of Ohtuvayre continues with more than 3,500 unique healthcare professionals (“HCPs”) prescribing Ohtuvayre and over 16,000 prescriptions filled of which approximately one-third were patient refills in 2024. During these initial 20 weeks, key metrics showed month over month growth including number of unique prescribers, new patient prescriptions, refill prescriptions, and net sales while maintaining approximately two weeks of inventory at the specialty pharmacies. Specifically, filled prescriptions increased by over 35% each month in the fourth quarter and physicians continued to prescribe Ohtuvayre across a broad COPD population including those receiving background single, dual and triple therapy.

“We recorded net product sales of approximately $36 million in the fourth quarter and $42 million for full year 2024. While it is still early in the launch, feedback from HCPs and patients is consistently positive including robust refill rates, and increasing prescriber depth with over 150 HCPs prescribing Ohtuvayre to more than 20 patients in their practice. These trends reinforce our belief that Ohtuvayre’s bronchodilator and non-steroidal anti-inflammatory activity can re-define the COPD treatment paradigm. We are excited by the initial impact of Ohtuvayre and look forward to building on this momentum in 2025.”

Program Updates and Key Milestones

  • Ohtuvayre’s product specific J-code, J7601, became effective on January 1, 2025.
  • In November 2024, the Company completed enrollment in a Phase 2 dose-ranging trial with glycopyrrolate, a long-acting muscarinic antagonist (“LAMA”), supporting a fixed-dose combination program for the maintenance treatment of COPD via a nebulizer. Results will support initiation of a Phase 2b trial with a fixed dose combination of ensifentrine with glycopyrrolate in the third quarter of 2025.
  • The Company continues to enroll subjects in a Phase 2 trial to assess the efficacy and safety of nebulized ensifentrine in patients with non-cystic fibrosis bronchiectasis (“NCFBE”).

Preliminary Fourth Quarter 2024 Financial Results

  • Cash position: Although the Company has not finalized its full financial results for the fourth quarter and fiscal year ended December 31, 2024, the Company expects to report that its cash and cash equivalents at December 31, 2024, were approximately $400 million (December 31, 2023: $271.8 million). The Company sold $100 million of its ordinary shares, in the form of ADSs, under its “at the market” equity offering program with Jefferies at an average price of $39.35 per ADS (equivalent to $4.92 per ordinary share) in the fourth quarter of 2024.
  • Product sales: The Company expects to report that net product sales were approximately $36 million for the fourth quarter ended December 31, 2024 (Q4 2023: $0 million) related to product sales of Ohtuvayre. The Company received FDA approval on June 26, 2024 and the product was commercially available beginning in August 2024.

Set forth in this release are certain estimated preliminary financial results for the fourth quarter and fiscal year ended December 31, 2024. These estimates are based on the information available to the Company at this time. The Company’s financial closing procedures for the fourth quarter and full year 2024 are not yet complete and, as a result, actual results may vary from the estimated preliminary results presented here due to the completion of the Company’s financial closing and review procedures, the execution of the Company’s internal control over financial reporting, final adjustments and other developments that may arise between now and the time the financial results for the fourth quarter and fiscal year ended December 31, 2024, are finalized. The estimated preliminary financial results have not been audited or reviewed by the Company’s independent registered public accounting firm. These estimates should not be viewed as a substitute for the Company’s full interim or annual financial statements. Accordingly, you should not place undue reliance on this preliminary data.

For further information please contact:

Verona Pharma plc Tel: +1-844-341-9901
Victoria Stewart, Senior Director of Investor Relations and Communications IR@veronapharma.com
Argot Partners
US Investor Enquiries
Tel: +1-212-600-1902
verona@argotpartners.com
Ten Bridge Communications
International / US Media Enquiries
Tel: +1-781-316-4424
tbcverona@tenbridgecommunications.com
Wendy Ryan  

About Verona Pharma

Verona Pharma is a biopharmaceutical company focused on developing and commercializing innovative therapies for the treatment of chronic respiratory diseases with significant unmet medical needs. OhtuvayreTM (ensifentrine) is the Company’s first commercial product and the first inhaled therapy for the maintenance treatment of COPD that combines bronchodilator and non-steroidal anti-inflammatory activities in one molecule. Ensifentrine has potential applications in non-cystic fibrosis bronchiectasis, cystic fibrosis, asthma and other respiratory diseases. For more information, please visit www.veronapharma.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. All statements contained in this press release other than statements of historical fact should be considered forward-looking statements. Words such as “anticipate,” “believe,” “plan,” “expect,” “intend,” “may,” “potential,” “prepare,” “possible” and similar words and expressions are intended to identify forward-looking statements. These forward-looking statements include, but are not limited to, statements regarding the potential benefits and efficacy of our drug Ohtuvayre to treat adult patients in the US with COPD, our anticipated financial results for the fourth quarter and full year ended December 31, 2024, the commercial growth of Ohtuvayre, and statements regarding our two recently initiated Phase 2 clinical trials.

These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from our expectations expressed or implied by the forward-looking statements, including, but not limited to, the following: risks related to the completion of closing and review procedures and the execution of our internal control of financial reporting; our limited operating history; our need for additional funding to complete development and commercialization of Ohtuvayre which may not be available and which may force us to delay, reduce or eliminate our development or commercialization efforts; our reliance on the success of Ohtuvayre, our only commercial product; our reliance on third-party manufacturers and suppliers; the efficacy of Ohtuvayre compared to competing drugs; our ability to successfully commercialize Ohtuvayre; serious adverse, undesirable or unacceptable side effects associated with Ohtuvayre which could adversely affect our ability to commercialize Ohtuvayre; failure to develop Ohtuvayre for additional indications, alternate delivery methods, or as a combination therapy; failure to obtain approval for and commercialize Ohtuvayre in multiple major pharmaceutical markets; our commercial capabilities and infrastructure, including sales, marketing, operations, distribution, and reimbursement infrastructure, may not be adequate to successfully commercialize Ohtuvayre; lawsuits related to patents covering Ohtuvayre and the potential for our patents to be found invalid or unenforceable; lawsuits related to our licensing of patents and know-how from third parties for the commercialization of Ohtuvayre; changes in our tax rates, unavailability of certain tax credits or reliefs or exposure to additional tax liabilities or assessments that could affect our profitability, and audits by tax authorities that could result in additional tax payments for prior periods; the terms of our credit agreement and the revenue interest purchase and sale agreement (“RIPSA”) place restrictions on our operating and financial flexibility, and if we fail to comply with certain covenants in the RIPSA, our results of operations and financial condition may be harmed; our vulnerability to natural disasters, global economic factors, geo-political actions and unexpected events, including health epidemics or pandemics; and the other important factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q for the period ended September 30, 2024, filed with the Securities and Exchange Commission (“SEC”) on November 4, 2024, as such factors may be updated from time to time in our other filings with the SEC. We disclaim any obligation to update or revise any forward-looking statement contained in this press release, even if subsequent events cause our views to change, except as required under applicable law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

Verona Pharma Announces December 2024 Investor Conference Participation

LONDON and RALEIGH, N.C., Nov. 19, 2024 (GLOBE NEWSWIRE) — Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma” or the “Company”) announces that senior management will present a company overview at the following conferences in December 2024:

Piper Sandler 36th Annual Healthcare Conference
Date: Tuesday, December 3, 2024
Time: 12:00 p.m. ET / 5:00 p.m. GMT
Location: New York, NY

7th Annual Evercore HealthCONx Conference
Date: Wednesday, December 4, 2024
Time: 3:00 p.m. ET / 8:00 p.m. GMT
Location: Miami, FL

A webcast of each conference presentation will be available on the Events and Presentations link on the Investors page of the Company’s website, www.veronapharma.com.

For further information please contact:

   
Verona Pharma plc Tel: +1-844-341-9901
Victoria Stewart, Senior Director of Investor
Relations and Communications
IR@veronapharma.com

Argot Partners
(US Investor Enquiries)
Tel: +1-212-600-1902
verona@argotpartners.com
Ten Bridge Communications
International / US Media Enquiries
Tel: +1-781-316-4424
tbcverona@tenbridgecommunications.com
Wendy Ryan  


About Verona Pharma

Verona Pharma is a biopharmaceutical company focused on developing and commercializing innovative therapies for the treatment of chronic respiratory diseases with significant unmet medical needs. Ohtuvayre™ (ensifentrine) is the Company’s first commercial product and the first inhaled therapy for the maintenance treatment of COPD that combines bronchodilator and non-steroidal anti-inflammatory activities in one molecule. Ensifentrine has potential applications in non-cystic fibrosis bronchiectasis, cystic fibrosis, asthma and other respiratory diseases. For more information, please visit www.veronapharma.com.

Verona Pharma to Present at Jefferies London Healthcare Conference

LONDON and RALEIGH, N.C., Nov. 05, 2024 (GLOBE NEWSWIRE) — Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma” or the “Company”) announces that senior management will present a company overview at the Jefferies London Healthcare Conference on Tuesday, November 19, 2024, at 6:30 a.m. ET / 11:30 a.m. GMT.

A webcast of the event will be available on the Events and Presentations link on the Investors page of the Company’s website, www.veronapharma.com.

For further information please contact:

Verona Pharma plc Tel: +1-844-341-9901
Victoria Stewart, Senior Director of Investor Relations and Communications IR@veronapharma.com
Argot Partners
(US Investor Enquiries)
Tel: +1-212-600-1902
verona@argotpartners.com
Ten Bridge Communications
International / US Media Enquiries
Tel: +1-781-316-4424
tbcverona@tenbridgecommunications.com
Wendy Ryan  
 

About Verona Pharma

Verona Pharma is a biopharmaceutical company focused on developing and commercializing innovative therapies for the treatment of chronic respiratory diseases with significant unmet medical needs. OhtuvayreTM (ensifentrine) is the Company’s first commercial product and the first inhaled therapy for the maintenance treatment of COPD that combines bronchodilator and non-steroidal anti-inflammatory activities in one molecule. Ensifentrine has potential applications in non-cystic fibrosis bronchiectasis, cystic fibrosis, asthma and other respiratory diseases. For more information, please visit www.veronapharma.com.

Verona Pharma Reports Third Quarter 2024 Financial Results and Provides Corporate Update

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 respiratory diseases, announces its financial results for the third quarter ended September 30, 2024, and provides a corporate update.

“We are pleased to report an exceptionally strong start to the US launch of Ohtuvayre (ensifentrine) with healthcare professionals (HCPs) prescribing treatment across a broad range of chronic obstructive pulmonary disease (“COPD”) patients including background single, dual and nearly 50% on triple therapy,” said David Zaccardelli, Pharm. D., President and Chief Executive Officer. “While it is still very early in the launch, we are extremely encouraged from the initial patient and HCP reports about Ohtuvayre’s potential to improve COPD symptoms regardless of COPD severity. This broad utilization across all patient types is consistent with market research and supports our belief that Ohtuvayre’s bronchodilator and non-steroidal anti-inflammatory activity is a significant advancement for COPD patients and can re-define the treatment paradigm.

“In the third quarter, through the first seven weeks of launch, we recorded $5.6 million of net sales. We are excited by the continued acceleration as net sales for October exceeded the third quarter. More than 5,000 Ohtuvayre prescriptions were filled and more than 2,200 unique HCPs prescribed Ohtuvayre in just 12 weeks.

“Alongside our successful Ohtuvayre launch, in the third quarter we initiated two Phase 2 clinical trials: a dose-ranging trial with glycopyrrolate, a long-acting muscarinic antagonist (“LAMA”), supporting a nebulized fixed-dose combination program with ensifentrine for the maintenance treatment of COPD, and a trial assessing the efficacy and safety of nebulized ensifentrine in patients with non-cystic fibrosis bronchiectasis (“NCFBE”).”

Third Quarter and Recent Highlights

  • In August 2024, the Company launched Ohtuvayre for the maintenance treatment of COPD in the US.
  • During the third quarter of 2024, the Company began enrollment in two new clinical programs:
    • Phase 2 dose-ranging trial with glycopyrrolate, a LAMA, supporting a fixed-dose combination program for the maintenance treatment of COPD via a nebulizer.
    • Phase 2 trial to assess the efficacy and safety of nebulized ensifentrine in patients with NCFBE.
  • Following the end of the third quarter, the Company received notification from the Centers for Medicare & Medicaid Services that its permanent, product-specific J-code for Ohtuvayre, J7601, has been accepted and will be effective January 1, 2025.
  • The Company recently presented additional analyses of data from the Phase 3 ENHANCE trials with ensifentrine for the maintenance treatment of COPD at the European Respiratory Society International Congress 2024 and at CHEST Annual Meeting 2024 (“CHEST”). Approximately 1,500 HCPs visited Verona Pharma’s medical and commercial booths for Ohtuvayre at CHEST.
  • In September 2024, the Company’s development partner in Greater China, Nuance Pharma, completed enrollment in its pivotal Phase 3 clinical trial evaluating ensifentrine for the maintenance treatment of COPD in China. Results from the trial are expected in 2025.

Third Quarter 2024 Financial Results

  • Cash position: Cash and cash equivalents at September 30, 2024 were $336.0 million (December 31, 2023: $271.8 million). The Company believes cash and cash equivalents at September 30, 2024, along with product sales and funding expected to become available under the $650 million strategic financings completed in May 2024, will enable Verona Pharma to fund planned operating expenses and capital expenditure requirements through at least the end of 2026.
  • Product sales: Net sales were $5.6 million for the third quarter ended September 30, 2024 (Q3 2023: $0 million) related to product sales of Ohtuvayre. The Company received FDA approval on June 26, 2024 and the product was commercially available beginning in August 2024.
  • Cost of sales: Cost of sales was $0.5 million for the third quarter ended September 30, 2024 (Q3 2023: $0 million), which included Ohtuvayre manufacturing costs incurred after US approval, inventory overhead costs and sales-based royalties due to Ligand.
  • R&D Expenses: Research and development (“R&D”) expenses were $10.6 million for the third quarter ended September 30, 2024 (Q3 2023: $3.0 million). This increase of $7.6 million was primarily due to an $7.8 million increase in clinical trial and other development costs as we initiated two Phase 2 trials in the quarter.
  • SG&A Expenses: Selling general and administrative expenses (“SG&A”) were $35.2 million for the third quarter ended September 30, 2024 (Q3 2023: $13.4 million). This increase of $21.8 million was driven primarily by a $9.7 million increase in people-related costs and $2.8 million in share-based compensation primarily related to our field sales team, which was hired in the lead up to the launch of Ohtuvayre. Additionally, marketing and other commercial related activities, including travel, increased by $7.5 million due to the launch. We also had an increase of $1.6 million related to professional and consulting fees, information technology costs and other support costs due to the continued build-out of our commercial organization.
  • Net loss: Net loss was $43.0 million for the third quarter ended September 30, 2024 (Q3 2023: $14.7 million).

Conference Call and Webcast Information
Verona Pharma will host an investment community webcast and conference call at 9:00 a.m. ET / 2:00 p.m. GMT on Monday, November 4, 2024, to discuss the third quarter 2024 financial results and provide a corporate update.

To participate, please dial one of the following numbers and ask to join the Verona Pharma call:

  • +1-833-816-1396 for callers in the United States
  • +1-412-317-0489 for international callers

A live webcast will be available on the Events and Presentations link on the Investors page of the Company’s website, www.veronapharma.com, and the audio replay will be available for 90 days. An electronic copy of the third quarter 2024 results press release will also be made available today on the Company’s website.

For further information please contact:

Verona Pharma plc Tel: +1-844-341-9901
Victoria Stewart, Senior Director of Investor Relations and Communications IR@veronapharma.com
Argot Partners
US Investor Enquiries
Tel: +1-212-600-1902
verona@argotpartners.com
Ten Bridge Communications
International / US Media Enquiries
Tel: +1-781-316-4424
tbcverona@tenbridgecommunications.com
Wendy Ryan  

About Verona Pharma

Verona Pharma is a biopharmaceutical company focused on developing and commercializing innovative therapies for the treatment of chronic respiratory diseases with significant unmet medical needs. Ohtuvayre™ (ensifentrine) is the Company’s first commercial product and the first inhaled therapy for the maintenance treatment of COPD that combines bronchodilator and non-steroidal anti-inflammatory activities in one molecule. Ensifentrine has potential applications in non-cystic fibrosis bronchiectasis, cystic fibrosis, asthma and other respiratory diseases. For more information, please visit www.veronapharma.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. All statements contained in this press release other than statements of historical fact should be considered forward-looking statements. Words such as “anticipate,” “believe,” “plan,” “expect,” “intend,” “may,” “potential,” “prepare,” “possible” and similar words and expressions are intended to identify forward-looking statements. These forward-looking statements include, but are not limited to, statements regarding the potential benefits and efficacy of our drug Ohtuvayre to treat adult patients in the US with COPD, as well as the continued growth of sales and adoption by HCPs of Ohtuvayre, and statements regarding our two recently initiated Phase 2 clinical trials.

These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from our expectations expressed or implied by the forward-looking statements, including, but not limited to, the efficacy of Ohtuvayre compared to competing drugs and the other important factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q for the period ended September 30, 2024 filed with the Securities and Exchange Commission (“SEC”) on November 4, 2024, as such factors may be updated from time to time in our other filings with the SEC. We disclaim any obligation to update or revise any forward-looking statement contained in this press release, even if subsequent events cause our views to change, except as required under applicable law.

Verona Pharma plc

Consolidated Financial Summary

(unaudited)

(in thousands, except share and per share amounts)

    Three months ended September 30,
      2024       2023  
Revenue   $                 5,624     $                        –  
Operating expenses        
Cost of sales     543        
Research and development             10,552                  2,958  
Selling, general and administrative             35,196       13,353  
Total operating expenses             46,291               16,311  
Operating loss             (40,667 )             (16,311 )
Other income/(expense)        
Research and development tax credit     1,612       (309 )
Interest income     4,750       3,390  
Interest expense     (9,882 )             (401 )
Foreign exchange gain/(loss)     1,475               (1,012 )
Total other (expense)/income, net     (2,045 )             1,668  
Loss before income taxes     (42,712 )             (14,643 )
Income tax expense     (250 )     (44 )
Net loss   $          (42,962 )   $                    (14,687 )
         
Weighted-average shares outstanding – basic and diluted     651,944       638,239  
Loss per ordinary share – basic and diluted   $         (0.07 )   $         (0.02 )

 

 

Sep-30

 

Jun-30

      2024       2024  
Cash and cash equivalents   $         336,040     $         404,599  
Total assets   $         381,818     $         434,123  
Shareholders’ equity   $         130,491     $         168,274  
         

Verona Pharma to Report Third Quarter 2024 Financial Results and Provide Corporate Update

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. EST / 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:

  • +1-833-816-1396 for callers in the United States
  • +1-412-317-0489 for international callers

A live webcast will be available on the Events and Presentations link on the Investors page of the Company’s website, www.veronapharma.com, and the audio replay will be available for 90 days.

For further information please contact:

Verona Pharma plc Tel: +1-844-341-9901
Victoria Stewart, Senior Director of Investor Relations and Communications IR@veronapharma.com
Argot Partners
US Investor Enquiries
Tel: +1-212-600-1902
verona@argotpartners.com
Ten Bridge Communications
International / US Media Enquiries
Tel: +1-312-523-5016
tbcverona@tenbridgecommunications.com
Leslie Humbel  

About Verona Pharma

Verona Pharma is a biopharmaceutical company focused on developing and commercializing innovative therapies for the treatment of chronic respiratory diseases with significant unmet medical needs. Ohtuvayre™ (ensifentrine) is the Company’s first commercial product and the first inhaled therapy for the maintenance treatment of COPD that combines bronchodilator and non-steroidal anti-inflammatory activities in one molecule. Ensifentrine has potential applications in non-cystic fibrosis bronchiectasis, cystic fibrosis, asthma and other respiratory diseases. For more information, please visit www.veronapharma.com.

Verona Pharma Reports Second Quarter 2024 Financial Results and Provides Corporate Update

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 pleased today to announce that Ohtuvayre (ensifentrine) is now available in the US for the maintenance treatment of chronic obstructive pulmonary disease (“COPD”) in adults,” said David Zaccardelli, Pharm. D., President and Chief Executive Officer. “Ohtuvayre is the first novel inhaled product available for the treatment of COPD in more than 20 years. Healthcare professionals (“HCPs”) and patients are excited about Ohtuvayre’s potential to relieve COPD symptoms and we believe its bronchodilator and non-steroidal anti-inflammatory activity will redefine the treatment paradigm for COPD.

“Our field sales force began interacting with HCPs in late July and, to date, we have conducted over 2,000 HCP visits and more than 100 unique HCPs have prescribed Ohtuvayre through our exclusive network of specialty pharmacies. We are confident in the launch of Ohtuvayre and look forward to updating you on our progress.”

Program Updates and Key Milestones

The Company’s near-term milestones include:

  • In July 2024, the Company submitted an investigational new drug application (“IND”) to the FDA to allow initiation of the clinical program for development of a fixed-dose combination of ensifentrine and glycopyrrolate, a long-acting muscarinic antagonist (“LAMA”), for the maintenance treatment of COPD via a nebulizer. Subject to clearance of the IND, the Company intends to initiate a Phase 2 dose-ranging trial in the third quarter of 2024.
  • Also in the third quarter of 2024, the Company plans to initiate a Phase 2 clinical trial to assess the efficacy and safety of nebulized ensifentrine in patients with non-cystic fibrosis bronchiectasis (“NCFBE”).
  • In the second half of 2024, the Company plans to present further analyses from the Phase 3 ENHANCE trials at the European Respiratory Society International Congress 2024 and at CHEST Annual Meeting 2024.

Second Quarter Highlights

  • On June 26, 2024, the FDA approved Ohtuvayre (ensifentrine) for the maintenance treatment of COPD and the product is now available in the US.
  • In June 2024, the Company submitted the J-code application and local coverage determination documents to support the launch and expects to receive a permanent, product-specific J-code for Ohtuvayre effective January 2025.
  • In May 2024, the Company refinanced its $400 million debt facility and entered into a $250 million capped revenue interest purchase and sales agreement (“RIPSA”) with Oaktree Capital and OMERS Life Sciences (collectively the “$650 million strategic financing”).
  • Also in May 2024, the Company presented eight posters including two oral presentations, at the American Thoracic Society International Conference (“ATS”) 2024. The posters highlighted additional pooled analyses of the Phase 3 ENHANCE trials with ensifentrine for the treatment of COPD. The abstracts are published on the ATS website and in the American Journal of Respiratory and Critical Care Medicine.

Second Quarter 2024 Financial Results

  • Cash position: Cash and cash equivalents at June 30, 2024 were $404.6 million (December 31, 2023: $271.8 million). Following the approval of Ohtuvayre, the Company drew $70 million under the debt facility and $100 million under the RIPSA leading to the $404.6 million cash balance. The Company believes cash and cash equivalents at June 30, 2024, along with the funding expected to become available under the $650 million strategic financings will enable Verona Pharma to fund planned operating expenses and capital expenditure requirements beyond 2026 including the commercial launch of Ohtuvayre in the US.
  • R&D Expenses: Research and development (“R&D”) expenses were $19.4 million for the second quarter ended June 30, 2024 (Q2 2023: a net reversal of costs of $2.5 million). This increase of $21.9 million was primarily driven by the accrual of the $6.3 million approval milestone due to Ligand, $2.5 million increase in share-based compensation largely driven by the recognition of performance restricted stock units (“PRSU”) expense and $1.7 million of expense related to pre-launch inventory production. Further, we had $2.5 million in clinical trial and other development costs in the three months ended June 30, 2024 while in the three months ended June 30, 2023, we recorded a reversal of costs of $6.3 million related to the resolution of a supplier matter, which resulted in net negative research and development expense for the three months ended June 30, 2023.
  • SG&A Expenses: Selling general and administrative expenses (“SG&A”) were $49.0 million for the second quarter ended June 30, 2024 (Q2 2023: $12.4 million). This increase of $36.6 million was driven primarily by an accrual of the $15.0 million first sale milestone payment due to Ligand, an increase of $7.4 million for marketing and other commercial launch related activities and an increase of $2.3 million in other support costs including travel, professional and consulting fees and information technology costs. Additionally, share-based compensation increased by $8.0 million largely driven by the recognition of PRSU expense as well as an increase of $4.3 million in people-related costs as we built out our commercial organization including much of the field sales team.
  • Net loss: Net loss was $70.8 million for the second quarter ended June 30, 2024 (Q2 2023: net loss $8.8 million).

Conference Call and Webcast Information
Verona Pharma will host an investment community webcast and conference call at 9:00 a.m. EDT / 2:00 p.m. BST on Thursday, August 8, 2024, to discuss the second quarter 2024 financial results and the corporate update.

To participate, please dial one of the following numbers and ask to join the Verona Pharma call:

  • +1-833-816-1396 for callers in the United States
  • +1-412-317-0489 for international callers

A live webcast will be available on the Events and Presentations link on the Investors page of the Company’s website, www.veronapharma.com, and the audio replay will be available for 90 days. An electronic copy of the second quarter 2024 results press release will also be made available today on the Company’s website.

For further information please contact:

Verona Pharma plc Tel: +1-844-341-9901
Victoria Stewart, Senior Director of Investor Relations and Communications IR@veronapharma.com
Argot Partners
US Investor Enquiries
Tel: +1-212-600-1902
verona@argotpartners.com
Ten Bridge Communications
International / US Media Enquiries
Tel: +1-312-523-5016
tbcverona@tenbridgecommunications.com
Leslie Humbel  


About Verona Pharma

Verona Pharma is a biopharmaceutical company focused on developing and commercializing innovative therapies for the treatment of chronic respiratory diseases with significant unmet medical needs. OhtuvayreTM (ensifentrine) is the Company’s first commercial product and the first inhaled therapy for the maintenance treatment of COPD that combines bronchodilator and non-steroidal anti-inflammatory activities in one molecule. Ensifentrine has potential applications in non-cystic fibrosis bronchiectasis, cystic fibrosis, asthma and other respiratory diseases. For more information, please visit www.veronapharma.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release other than statements of historical fact should be considered forward-looking statements. Words such as “anticipate,” “believe,” “plan,” “expect,” “intend,” “may,” “potential,” “prepare,” “possible” and similar words and expressions are intended to identify forward-looking statements. These forward-looking statements include, but are not limited to, statements regarding the potential benefits, efficacy and commercial strategy for Ohtuvayre, including, but not limited to, statements relating to the potential to change the treatment paradigm for adult COPD patients, the Company’s ability to successfully market and sell Ohtuvayre, the timing of the Company’s Phase 2 trial for the development of a fixed-dose combination of ensifentrine and glycopyrrolate for the maintenance treatment of COPD via delivery in a nebulizer and the Phase 2 clinical trial to assess the efficacy and safety of nebulized ensifentrine in patients with non-cystic fibrosis bronchiectasis, the potential applications of ensifentrine, the Company’s participation in upcoming events and presentations, and the Company’s cash runway.

These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from our expectations expressed or implied by the forward-looking statements, including, but not limited to, the following: our limited operating history; our need for additional funding to complete development and commercialization of Ohtuvayre which may not be available and which may force us to delay, reduce or eliminate our development or commercialization efforts; our reliance on the success of Ohtuvayre, our only commercial product; our reliance on third-party manufacturers and suppliers; the efficacy of Ohtuvayre compared to competing drugs; our ability to successfully commercialize Ohtuvayre; serious adverse, undesirable or unacceptable side effects associated with Ohtuvayre which could adversely affect our ability to commercialize Ohtuvayre; failure to develop Ohtuvayre for additional indications, alternate delivery methods, or as a combination therapy; failure to obtain approval for and commercialize Ohtuvayre in multiple major pharmaceutical markets; our commercial capabilities and infrastructure, including sales, marketing, operations, distribution, and reimbursement infrastructure, may not be adequate to successfully commercialize Ohtuvayre; lawsuits related to patents covering Ohtuvayre and the potential for our patents to be found invalid or unenforceable; lawsuits related to our licensing of patents and know-how from third parties for the commercialization of Ohtuvayre; changes in our tax rates, unavailability of certain tax credits or reliefs or exposure to additional tax liabilities or assessments that could affect our profitability, and audits by tax authorities that could result in additional tax payments for prior periods; the terms of our credit agreement and the revenue interest purchase and sale agreement (“RIPSA”) place restrictions on our operating and financial flexibility, and if we fail to comply with certain covenants in the RIPSA, our results of operations and financial condition may be harmed; and our vulnerability to natural disasters, global economic factors, geo-political actions and unexpected events, including health epidemics or pandemics. These and other important factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q for the period ended June 30, 2024 filed with the Securities and Exchange Commission (“SEC”) on August 8, 2024, and our other reports filed with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change, except as required under applicable law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

 
Verona Pharma plc
Consolidated Financial Summary
(unaudited)
(in thousands, except share and per share amounts)
 
    Three months ended June 30,
      2024       2023  
Operating expenses        
Research and development   $ 19,388     $ (2,474 )
Selling, general and administrative     49,035       12,439  
Total operating expenses     68,423       9,965  
Operating loss     (68,423 )     (9,965 )
Other income/(expense)        
Research and development tax credit     847       (1,934 )
Loss on extinguishment of debt     (3,653 )      
Interest income     3,140       3,402  
Interest expense     (1,757 )     (740 )
Foreign exchange gain     25       740  
Total other (expense)/income, net     (1,398 )     1,468  
Loss before income taxes     (69,821 )     (8,497 )
Income tax expense     (1,014 )     (310 )
Net loss   $ (70,835 )   $ (8,807 )
         
Weighted-average shares outstanding – basic and diluted     648,217,411       634,469,423  
Loss per ordinary share – basic and diluted   $ (0.11 )   $ (0.01 )
         
    Jun-30   Mar-31
      2024       2024  
Cash and cash equivalents   $ 404,599     $ 254,882  
Total assets   $ 434,123     $ 289,912  
Shareholders’ equity   $ 168,274     $ 224,988  
         

Verona Pharma to Present at 44th Annual Canaccord Growth Conference

LONDON and RALEIGH, N.C., July 30, 2024 (GLOBE NEWSWIRE) — Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma” or the “Company”) announces that senior management will present a company overview at the 44th Annual Canaccord Growth Conference on Tuesday, August 13, 2024, at 1:30 p.m. EDT / 6:30 p.m. BST.

A webcast of the event will be available on the Events and Presentations link on the Investors page of the Company’s website, www.veronapharma.com.

For further information please contact:

   
Verona Pharma plc Tel: +1-844-341-9901
Victoria Stewart, Senior Director of Investor Relations and Communications IR@veronapharma.com
Argot Partners
(US Investor Enquiries)
Tel: +1-212-600-1902
verona@argotpartners.com
Ten Bridge Communications
International / US Media Enquiries
Tel: +1-312-523-5016
tbcverona@tenbridgecommunications.com 
Leslie Humbel  

About Verona Pharma

Verona Pharma is a biopharmaceutical company focused on developing and commercializing innovative therapies for the treatment of chronic respiratory diseases with significant unmet medical needs. OhtuvayreTM (ensifentrine) is the Company’s first commercial product and the first inhaled therapy for the maintenance treatment of COPD that combines bronchodilator and non-steroidal anti-inflammatory activities in one molecule. Ensifentrine has potential applications in non-cystic fibrosis bronchiectasis, cystic fibrosis, asthma and other respiratory diseases. For more information, please visit www.veronapharma.com.

Verona Pharma to Report Second Quarter 2024 Financial Results and Provide Corporate Update

LONDON and RALEIGH, N.C., July 25, 2024 (GLOBE NEWSWIRE) — Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma” or the “Company”) announces that it will report its financial results for the second quarter ended June 30, 2024 on Thursday, August 8, 2024 and host an investment community conference call at 9:00 a.m. EDT / 2:00 p.m. BST 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:

  • +1-833-816-1396 for callers in the United States
  • +1-412-317-0489 for international callers

A live webcast will be available on the Events and Presentations link on the Investors page of the Company’s website, www.veronapharma.com, and the audio replay will be available for 90 days.

For further information please contact:

Verona Pharma plc Tel: +1-844-341-9901
Victoria Stewart, Senior Director of Investor Relations and Communications IR@veronapharma.com
Argot Partners
US Investor Enquiries
Tel: +1-212-600-1902
verona@argotpartners.com
Ten Bridge Communications
International / US Media Enquiries
Tel: +1-312-523-5016
tbcverona@tenbridgecommunications.com 
Leslie Humbel  
   

About Verona Pharma

Verona Pharma is a biopharmaceutical company focused on developing and commercializing innovative therapies for the treatment of chronic respiratory diseases with significant unmet medical needs. OhtuvayreTM (ensifentrine) is the Company’s first commercial product and the first inhaled therapy for the maintenance treatment of COPD that combines bronchodilator and non-steroidal anti-inflammatory activities in one molecule. Ensifentrine has potential applications in non-cystic fibrosis bronchiectasis, cystic fibrosis, asthma and other respiratory diseases. For more information, please visit www.veronapharma.com.

Verona Pharma Announces US FDA Approval of Ohtuvayre™ (ensifentrine)

Ohtuvayre is indicated for the maintenance treatment of COPD allowing for broad use in COPD patients

First inhaled COPD treatment providing bronchodilation and non-steroidal anti-inflammatory effects

Conference call tomorrow at 8:30 a.m. EDT / 1:30 p.m. BST

LONDON and RALEIGH, N.C., June 26, 2024 (GLOBE NEWSWIRE) — Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma” or the “Company”), announces the US Food and Drug Administration (“FDA”) approved Ohtuvayre (ensifentrine) for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients. Ohtuvayre is the first inhaled product with a novel mechanism of action available for the maintenance treatment of COPD in more than 20 years.

Ohtuvayre is a first-in-class selective dual inhibitor of the enzymes phosphodiesterase 3 and phosphodiesterase 4 (“PDE3 and PDE4”) that combines bronchodilator and non-steroidal anti-inflammatory effects in one molecule. Ohtuvayre is delivered directly to the lungs through a standard jet nebulizer without the need for high inspiratory flow rates or complex hand-breath coordination.

“The approval of Ohtuvayre is a significant advance in COPD care, and we believe Ohtuvayre’s novel profile can change the treatment paradigm for COPD,” said David Zaccardelli, Pharm. D., President and Chief Executive Officer of Verona Pharma. “We plan to launch Ohtuvayre in the third quarter 2024, ensuring Ohtuvayre is available to help the millions of patients who still experience daily COPD symptoms.”

Michael Wells, MD, Associate Professor in the Division of Pulmonary, Allergy, and Critical Care Medicine at the University of Alabama Birmingham, commented: “In my experience, despite maintenance therapy, most patients report grappling with daily symptoms, including breathlessness and persistent coughing. COPD has a significant impact on both mortality and morbidity in the US, and until today, innovation in inhaled treatment modalities has been limited to combinations of existing treatment classes for over two decades. Ohtuvayre, as a first-in-class PDE3 and PDE4 inhibitor, offers a needed, unique approach and is an important advance in the treatment of COPD.”

The US approval of Ohtuvayre was based on extensive data including the Phase 3 ENHANCE trials, the results of which were published in the American Journal of Respiratory and Critical Care Medicine. In the ENHANCE trials, Ohtuvayre demonstrated clinical benefits both alone and when used with other maintenance therapies. Ohtuvayre was well-tolerated in a broad population of subjects with moderate to severe COPD.

The Company is fully staffed to launch and expects Ohtuvayre to be available in the third quarter 2024 through an exclusive network of accredited specialty pharmacies.

Conference Call
Verona Pharma will host an investment community conference call at 8:30 a.m. EDT / 1:30 p.m. BST on Thursday, June 27, 2024 to discuss the US approval of Ohtuvayre. To participate, please dial one of the following numbers and ask to join the Verona Pharma call:

  • +1-833-816-1396 for callers in the United States
  • +1-412-317-0489 for international callers

A live webcast will be available on the Events and Presentations link on the Investors page of the Company’s website, www.veronapharma.com, and the audio replay will be available for 90 days.

About Ohtuvayre (ensifentrine)

Ohtuvayre is the first inhaled therapy for the maintenance treatment of COPD that combines bronchodilator and non-steroidal anti-inflammatory activities in one molecule. Verona has evaluated nebulized Ohtuvayre in its Phase 3 clinical program ENHANCE (“Ensifentrine as a Novel inHAled Nebulized COPD thErapy”) for COPD maintenance treatment. Ohtuvayre met the primary endpoint in both ENHANCE-1 and ENHANCE-2, demonstrating statistically significant and clinically meaningful improvements in lung function. A fixed-dose combination of ensifentrine and glycopyrrolate, a LAMA, is currently under development for the maintenance treatment of COPD. Ensifentrine has potential applications for development in non-cystic fibrosis bronchiectasis, cystic fibrosis, asthma and other respiratory diseases.

Important Safety Information

Indication

Ohtuvayre is a prescription medicine used to treat COPD in adults. COPD is a chronic (long-term) lung disease that includes chronic bronchitis, emphysema, or both.

What is the most important information I should know about Ohtuvayre?

Ohtuvayre can cause serious side effects, including:

  • Sudden breathing problems immediately after inhaling your medicine. If you have sudden breathing problems immediately after inhaling your medicine, stop using Ohtuvayre and call your healthcare provider right away or go to the nearest hospital emergency room right away.
  • Mental health problems including suicidal thoughts and behavior. You may experience mood or behavior changes when taking Ohtuvayre. Call your healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you: thoughts of suicide or dying, attempt to commit suicide, trouble sleeping (insomnia), new or worse anxiety, new or worse depression, acting on dangerous impulses, and/or other unusual changes in your behavior or mood.

Do not use Ohtuvayre to treat sudden breathing problems. Always have a rescue inhaler with you.

Who Should Not use Ohtuvayre?

Do not use Ohtuvayre if you have had an allergic reaction to ensifentrine or any of the ingredients in Ohtuvayre.

What should I tell my healthcare provider before using Ohtuvayre?

Before you use Ohtuvayre, tell your healthcare professional if you have or have had a history of mental health problems including depression and suicidal behavior; have liver problems; are pregnant or plan to become pregnant; are breastfeeding. It is not known if Ohtuvayre may harm your unborn baby. It is not known if the medicine in Ohtuvayre passes into your breast milk and if it can harm your baby.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What are the most common side effects of Ohtuvayre?

The most common side effects of Ohtuvayre include back pain, high blood pressure, bladder infection and diarrhea.

These are not all the possible side effects of Ohtuvayre. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This summary does not include all the information about Ohtuvayre and is not meant to take the place of a discussion with your healthcare provider about your treatment.

For further information, please see the full Prescribing Information, including the Patient Information Leaflet.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

About COPD

Chronic obstructive pulmonary disease (“COPD”) refers to a group of diseases that cause airflow blockage and breathing-related problems, such as emphysema and chronic bronchitis. More than 390 million people worldwide are living with COPD, and more than 8.6 million Americans are treated chronically1-2. Symptoms include increased shortness of breath, frequent coughing (with and without mucus), wheezing, tightness in the chest and unusual tiredness. Approximately 50% of COPD patients experience almost daily symptoms3. There is no cure for COPD and despite available treatment options, it is the third leading cause of death globally.

1Adeloye D, et al. Lancet Respir Med. 2022;10(5):447-458

2Verona IQVIA Ensifentrine Market Research

3Phreesia 2022 COPD Patient Survey

About Verona Pharma

Verona Pharma is a biopharmaceutical company focused on developing and commercializing innovative therapies for the treatment of chronic respiratory diseases with significant unmet medical needs, including COPD, non-cystic fibrosis bronchiectasis, cystic fibrosis, asthma and other respiratory diseases. For more information, please visit www.veronapharma.com.

For further information please contact:

Verona Pharma plc Tel: +1-844-341-9901
Victoria Stewart, Senior Director of Investor Relations and Communications IR@veronapharma.com
Argot Partners
US Investor Enquiries
Tel: +1-212-600-1902
verona@argotpartners.com
Ten Bridge Communications
International / US Media Enquiries
Tel: +1-774-278-8273
tbcverona@tenbridgecommunications.com
Nichole Bobbyn  
   

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release other than statements of historical fact should be considered forward-looking statements. Words such as “anticipate,” “believe,” “plan,” “expect,” “intend,” “may,” “potential,” “prepare,” “possible” and similar words and expressions are intended to identify forward-looking statements. These forward-looking statements include, but are not limited to, statements regarding the potential benefits, efficacy, and approval of our drug Ohtuvayre, including, but not limited to, statements relating to the potential to change the treatment paradigm for COPD patients, the anticipated timing of commercial availability and our ability to successfully market and sell Ohtuvayre.

These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from our expectations expressed or implied by the forward-looking statements, including, but not limited to, the following: our limited operating history; our need for additional funding to complete development and commercialization of Ohtuvayre which may not be available and which may force us to delay, reduce or eliminate our development or commercialization efforts; our reliance on the success of Ohtuvayre, our only commercial product; our reliance on third-party manufacturers and suppliers; the efficacy of Ohtuvayre compared to competing drugs; our ability to successfully commercialize Ohtuvayre; serious adverse, undesirable or unacceptable side effects associated with Ohtuvayre which could adversely affect our ability to commercialize Ohtuvayre; failure to develop Ohtuvayre for additional indications, alternate delivery methods, or as a combination therapy; failure to obtain approval for and commercialize Ohtuvayre in multiple major pharmaceutical markets; lawsuits related to patents covering Ohtuvayre and the potential for our patents to be found invalid or unenforceable; lawsuits related to our licensing of patents and know-how from third parties for the commercialization of Ohtuvayre; changes in our tax rates, unavailability of certain tax credits or reliefs or exposure to additional tax liabilities or assessments that could affect our profitability, and audits by tax authorities that could result in additional tax payments for prior periods; and our vulnerability to natural disasters, global economic factors, geo-political actions and unexpected events, including health epidemics or pandemics. These and other important factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q for the period ended March 31, 2024 filed with the Securities and Exchange Commission (“SEC”) on May 10, 2024, and our other reports filed with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change, except as required under applicable law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

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 09, 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 first quarter ended March 31, 2024, and provides a corporate update.

“As we approach the PDUFA target action date for ensifentrine of June 26, we are finalizing our preparations for a potential US launch in the third quarter of 2024,” said David Zaccardelli, Pharm. D., President and Chief Executive Officer. “If approved, ensifentrine is expected to be the first novel inhaled mechanism available for the treatment of COPD in more than 20 years, and we continue to work with the US Food and Drug Administration during their review. Our goal is to address the significant unmet need in COPD and provide a novel and effective treatment for patients that continue to experience symptoms, despite existing therapies.

“We believe ensifentrine’s bronchodilator and non-steroidal anti-inflammatory activity has the potential to change the treatment paradigm for COPD and we look forward to providing updates later this year on our planned clinical programs for a fixed-dose combination of ensifentrine and glycopyrrolate in COPD and ensifentrine in non-cystic fibrosis bronchiectasis.

“With the financing announced this morning, we are pleased to have further strengthened our balance sheet and enhanced our financial flexibility as we prepare for the potential launch of ensifentrine with access to up to $650 million in addition to our existing cash of $255 million. We refinanced our $400 million debt facility to one with a lower overall cost of capital and favorable financial covenants. In addition, we have entered into a $250 million capped revenue interest sales transaction with repayment based on a percentage of future ensifentrine revenues. We expect these funds, along with existing cash, to support the Company’s growth through the planned commercialization beyond 2026.”

Program Updates and Key Milestones

The Company’s near-term milestones include:

  • The FDA has assigned a Prescription Drug User Fee Act (“PDUFA”) target action date for ensifentrine of June 26, 2024 and notified the Company that it is not currently planning to hold an advisory committee meeting to discuss the application. If approved, the Company intends to launch ensifentrine in the US market in the third quarter of 2024.
  • In the second quarter of 2024, the Company continues to finalize key launch preparations including sales force deployment strategy, pricing, distribution and patient services, healthcare professional and patient engagement plans.
  • In the second quarter of 2024, the Company will continue to highlight the burden of chronic obstructive pulmonary disease (“COPD”) through the “Unspoken COPD” disease awareness campaign. Through the first quarter of 2024, 85% of targeted healthcare professionals (“HCPs”) were reached with the campaign and over 2,000 HCPs engaged with the website.
  • In May 2024, the Company will present eight posters including two mini oral symposia, at the American Thoracic Society International Conference (“ATS”) 2024. The posters will highlight additional pooled analyses of the Phase 3 ENHANCE studies with ensifentrine for the treatment of COPD. A pooled analysis demonstrating reductions in the rate and risk of exacerbations with ensifentrine will be presented as part of the ‘Late Breaking Mini Symposium’ designed to highlight new breakthroughs. In addition, the Company will host an exhibition booth exploring the role of phosphodiesterase (“PDE”) in inflammation and lung function impairment in COPD as well as three innovation hub presentations led by clinical experts.
  • In the second half of 2024, the Company intends to submit an investigational new drug application (“IND”) to the FDA and, subject to clearance, initiate a Phase 2 clinical trial assessing the safety and efficacy of a fixed-dose combination formulation of ensifentrine and glycopyrrolate, a long-acting muscarinic antagonist (“LAMA”), for the maintenance treatment of patients with COPD via delivery in a nebulizer.
  • Also in the second half of 2024, the Company plans to initiate a Phase 2 clinical trial to assess the efficacy and safety of nebulized ensifentrine in patients with non-cystic fibrosis bronchiectasis (“NCFBE”), subject to clearance by the FDA.

Financing and Recent Highlights

  • In May 2024, the Company refinanced its $400 million debt facility and entered into a $250 million capped revenue interest sales transaction with Oaktree Capital and OMERS Life Sciences (collectively “the $650 million strategic financing”).
  • Also in May 2024, the Company presented posters at the International Society for Pharmacoeconomics and Outcomes Research (“ISPOR”) Annual International Conference 2024. Posters at ISPOR included claims data demonstrating exacerbations persist for patients even when they are receiving treatment regimens containing inhaled corticosteroids, resulting in a significant burden to the healthcare system.

First Quarter 2024 Financial Results

  • Cash position: Cash and cash equivalents at March 31, 2024, were $254.9 million (December 31, 2023: $271.8 million). The Company believes cash and cash equivalents at March 31, 2024, and funding expected to become available under the $650 million strategic financing facility, will enable Verona Pharma to fund planned operating expenses and capital expenditure requirements beyond 2026 including the commercial launch of ensifentrine in the US, if approved.
  • R&D Expenses: Research and development (“R&D”) expenses were $6.8 million for the first quarter ended March 31, 2024 (Q1 2023: $12.6 million). This decrease of $5.8 million was primarily due to expense of $7.2 million in the three months ended March 31, 2023 for finalizing all matters related to the Phase 3 ENHANCE program. As the program completed in 2023, no similar costs were incurred in 2024. This decrease was partially offset by $1.5 million of pre-approval active pharmaceutical ingredient manufacturing-related costs as well as an increase of $0.7 million in people related costs including share-based compensation.
  • SG&A Expenses: Selling general and administrative expenses (“SG&A”) were $20.4 million for the first quarter ended March 31, 2024 (Q1 2023: $9.6 million). The increase of $10.8 million was primarily due to an increase of $4.6 million related to marketing, commercial preparation and other pre-commercial activities, $1.1 million related to professional fees, consulting costs and other administrative expenses, which support our continued growth and evolution of our business, and $0.7 million related to the continued build-out of our information technology infrastructure. Additionally, people related costs increased by $4.1 million including share-based compensation as we increased our headcount in our commercial and support functions in preparation for the planned commercial launch.
  • Net loss: Net loss was $25.8 million for the first quarter ended March 31, 2024 (Q1 2023: net loss $16.7 million).

Conference Call and Webcast Information
Verona Pharma will host an investment community webcast and conference call at 9:00 a.m. EDT / 2:00 p.m. BST on Thursday, May 9, 2024, to discuss the first quarter 2024 financial results and the corporate update.

To participate, please dial one of the following numbers and ask to join the Verona Pharma call:

  • +1-833-816-1396 for callers in the United States
  • +1-412-317-0489 for international callers

A live webcast will be available on the Events and Presentations link on the Investors page of the Company’s website, www.veronapharma.com, and the audio replay will be available for 90 days. An electronic copy of the first quarter 2024 results press release will also be made available today on the Company’s website.

For further information please contact:

Verona Pharma plc US Tel: +1-833-417-0262
UK Tel: +44 (0)203 283 4200
Victoria Stewart, Senior Director of Investor Relations and Communications IR@veronapharma.com
Argot Partners US Investor Enquiries Tel: +1-212-600-1902
verona@argotpartners.com
Ten Bridge Communications International / US Media Enquiries Tel: +1-312-523-5016
tbcverona@tenbridgecommunications.com
Leslie Humbel

About Verona Pharma

Verona Pharma is a biopharmaceutical company focused on developing and commercializing innovative therapies for the treatment of chronic respiratory diseases with significant unmet medical needs. In the third quarter of 2023, the US Food and Drug Administration accepted for review the Company’s NDA for ensifentrine for the maintenance treatment of patients with COPD and assigned a PDUFA target action date of June 26, 2024. If approved, ensifentrine has the potential to become the first inhaled non-steroidal therapy for the treatment of respiratory diseases that combines bronchodilator and anti-inflammatory activities in one molecule. The Company has evaluated nebulized ensifentrine in its Phase 3 clinical program ENHANCE (“Ensifentrine as a Novel inHAled Nebulized COPD thErapy”) for COPD maintenance treatment. Ensifentrine met the primary endpoint in both ENHANCE-1 and ENHANCE-2 trials demonstrating statistically significant and clinically meaningful improvements in lung function. In addition, ensifentrine substantially reduced the rate and risk of COPD exacerbations in pooled analysis from ENHANCE-1 and ENHANCE-2. Two additional formulations of ensifentrine have been evaluated in Phase 2 trials for the treatment of COPD: dry powder inhaler (“DPI”) and pressurized metered-dose inhaler (“pMDI”) and a fixed-dose combination formulation with ensifentrine and glycopyrrolate, a LAMA, is currently under development, also for the treatment of COPD. Ensifentrine also has potential applications in cystic fibrosis, non-cystic fibrosis bronchiectasis, asthma and other respiratory diseases. For more information, please visit www.veronapharma.com

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to, statements regarding our operational review, financial review, program updates and key milestones, the timing of the approval of the NDA for ensifentrine for the maintenance treatment of COPD, the development of ensifentrine in other formulations and for other indications and planned regulatory submissions and timing thereof, including the timing of submission of an IND for a fixed-dose combination formulation with ensifentrine and glycopyrrolate, a LAMA, for the maintenance treatment of patients with COPD and the timing of clinical studies to assess ensifentrine in patients with NCFBE, the planned US commercial launch of ensifentrine in 2024, the potential for ensifentrine to be the first therapy for the treatment of respiratory diseases to combine bronchodilator and non-steroidal anti-inflammatory benefits in one compound, the potential of ensifentrine to change the treatment paradigm for COPD patients, the potential of ensifentrine in the treatment of cystic fibrosis, NCFBE, asthma and other respiratory diseases, as well as the potential of the DPI and pMDI formulations of ensifentrine, the funding we expect to become available under our $650 million strategic financing facility, and the sufficiency of cash and cash equivalents, and the cash runway period provided by the sources of financing to fund planned operating expenses and capital expenditure requirements beyond 2026 including the commercial launch of ensifentrine in the US, if approved.

These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from our expectations expressed or implied by the forward-looking statements, including, but not limited to, the following: our limited operating history; our ability to operate our business due to restrictions from our $400 million debt financing facility and any other existing or future indebtedness; our need for additional funding to complete development and commercialization of any future product candidates or development and commercialization of other formulations or target indications of ensifentrine, which may not be available and which may force us to delay, reduce or eliminate our product development programs or commercialization efforts; the reliance of our business on the success of ensifentrine, our only product candidate under development; economic, political, regulatory and other risks involved with international operations; the lengthy and expensive process of clinical drug development, which has an uncertain outcome; serious adverse, undesirable or unacceptable side effects associated with ensifentrine, which could adversely affect our ability to develop or commercialize ensifentrine; we may not be successful in developing ensifentrine in other formulations or for multiple indications; our ability to obtain approval for and commercialize ensifentrine in multiple major pharmaceutical markets; misconduct or other improper activities by our employees, consultants, principal investigators, third-party service providers and licensees; our inability to realize the anticipated benefits under licenses granted by us to third parties to develop and commercialize ensifentrine, our future growth and ability to compete depends on retaining our key personnel and recruiting additional qualified personnel; material differences between our “top-line” data and final data; our reliance on third parties, including clinical research organizations, clinical investigators, manufacturers and suppliers, and the risks related to these parties’ ability to successfully develop and commercialize ensifentrine; lawsuits related to patents covering ensifentrine and the potential for our patents to be found invalid or unenforceable; lawsuits related to our licensing of patents and know-how with third parties for the development and commercialization of ensifentrine; changes in our tax rates, unavailability of certain tax credits or reliefs or exposure to additional tax liabilities or assessments could affect our profitability, and audits by tax authorities could result in additional tax payments for prior periods; and our vulnerability to natural disasters, global economic factors, geo-political actions and unexpected events, including health epidemics or pandemics, and conflicts such as the Russia-Ukraine conflict, which has and may continue to adversely impact our business. These and other important factors under the caption “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2023, as updated in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2024, and our other reports filed with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Although management believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee future results, levels of activity, performance or achievements. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change, except as required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

Verona Pharma plc
Consolidated Financial Summary
(unaudited)
(in thousands, except share and per share amounts)
Three months ended March 31,
2024 2023
Operating expenses
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 )
Other income/(expense)
Research and development tax credit 585 2,313
Interest income 3,378 2,677
Interest expense (1,586 ) (293 )
Foreign exchange (loss)/gain (219 ) 932
Total other income, net 2,158 5,629
Loss before income taxes (25,040 ) (16,570 )
Income tax expense (754 ) (173 )
Net loss $ (25,794 ) $ (16,743 )
Weighted-average shares outstanding – basic and diluted 645,701,197 621,450,900
Loss per ordinary share – basic and diluted $ (0.04 ) $ (0.03 )
Mar-31 Mar-31
2024 2023
Cash and cash equivalents $ 254,882 $ 291,415
Total assets $ 289,912 $ 323,146
Shareholders’ equity $ 224,988 $ 276,749