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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

Third Quarter 2024 Financial Results

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:

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:

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  
         


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