Verona Pharma Reports First Quarter 2025 Financial Results and Provides Corporate Update

Total net revenue of $76.3 million from Q1 2025 driven by Ohtuvayre$(R)$ net sales of $71.3 million (+95% vs Q4 2024)

25,000 prescriptions filled in Q1 2025

Q1 2025 revenue exceeds operating expenses excluding non-cash charges

Conference call today at 9:00 a.m. EDT / 2:00 p.m. BST

LONDON and RALEIGH, N.C., April 29, 2025 (GLOBE NEWSWIRE) -- Verona Pharma plc (Nasdaq: VRNA) ("Verona" or the "Company"), a biopharmaceutical company focused on respiratory diseases, announces its financial results for the first quarter ended March 31, 2025, and provides a corporate update.

"The remarkably strong US launch of Ohtuvayre (ensifentrine) for the maintenance treatment of chronic obstructive pulmonary disease ("COPD") continues to accelerate, with 95% net sales growth in the first quarter versus the fourth quarter of 2024, driven by significant increases in prescriptions, prescribers, new patients, and refills. The dramatic uptake of Ohtuvayre underscores the unmet need of patients with COPD. To continue to deepen the prescriber base and further accelerate the launch, we plan to add approximately 30 new sales representatives in the third quarter," said David Zaccardelli, Pharm. D., President and Chief Executive Officer.

"We continue to enroll our Phase 2 clinical study of ensifentrine in non-cystic fibrosis bronchiectasis ("bronchiectasis") and we plan to initiate the dose-ranging Phase 2b study of a fixed-dose combination of ensifentrine and glycopyrrolate for the maintenance treatment of COPD in the second half of 2025. We are extremely pleased to report that for the first time Verona's quarterly revenue exceeded our operating expenses, excluding non-cash charges. We believe we are in a robust financial position to continue commercializing Ohtuvayre, advance our clinical pipeline and implement our global strategy."

Ohtuvayre Q1 2025 Performance Metrics

   -- Approximately 25,000 prescriptions filled 
 
   -- New patient starts were over 25% greater than those in Q4 2024 
 
   -- Refills represented approximately 60% of overall dispenses 
 
   -- Prescribers grew about 50% to approximately 5,300 compared to the end of 
      Q4 2024 
 
   -- Approximately 60% of prescribers are in Verona's Tier 1 healthcare 
      professionals ("HCPs") 
 
   -- Over 425 HCPs have prescribed Ohtuvayre to more than 20 patients 

Program Updates and Key Milestones

Verona's near-term milestones include:

   -- At the American Thoracic Society International Conference 2025 in May, 
      Verona will present ten posters, including seven from the Phase 3 ENHANCE 
      studies of Ohtuvayre in COPD, two from nonclinical studies and one from a 
      real-world data analysis. The ENHANCE posters highlight subgroup analyses 
      of patients when used as monotherapy, in patients with COPD and comorbid 
      cardiac disorders and, separately, in patients with COPD and comorbid 
      type 2 diabetes. In addition, the Company will host an exhibition booth 
      with presentations led by clinical experts. 
 
   -- In the second half of 2025, Verona plans to initiate a dose-ranging Phase 
      2b trial to assess the safety and efficacy of a fixed-dose nebulized 
      combination of ensifentrine with glycopyrrolate for the treatment of 
      COPD. The Company has successfully completed a Phase 2 dose-ranging trial 
      with glycopyrrolate to support this program. 
 
   -- Verona continues to enroll subjects in a Phase 2 trial to assess the 
      efficacy and safety of nebulized ensifentrine for the treatment of 
      bronchiectasis. 
 
   -- Verona continues to progress the regulatory activities for potential 
      marketing authorization application submissions for Ohtuvayre for the 
      maintenance treatment of COPD in the European Union and in the UK in 
      2025. 
 
   -- In the second quarter of 2025, the Company's development partner in 
      Greater China, Nuance Pharma, is expected to report results from its 
      pivotal Phase 3 trial evaluating ensifentrine for the maintenance 
      treatment of COPD in China. 

First Quarter Highlights

   -- A newly granted patent (US Patent No. 12,251,384), expiring June 2044, 
      was listed in the FDA's Orange Book for Ohtuvayre, in addition to the 
      three original Orange Book listed patents. 
 
   -- In March 2025, Verona amended its strategic financing agreements by 
      repaying the revenue interest purchase and sales agreement and increasing 
      the debt facility to $450 million under more favorable terms with funds 
      managed by Oaktree Capital and OMERS Life Sciences. These changes 
      increased the Company's financial flexibility, reduced the cost of 
      capital and simplified the balance sheet. At March 31, 2025, the Company 
      had $250 million outstanding under this facility and $200 million 
      available in potential future draws. 
 
   -- In February 2025, Verona's development partner in Greater China, Nuance 
      Pharma, announced Ohtuvayre has been approved in Macau for the 
      maintenance treatment of COPD in adult patients. This is the first 
      regulatory approval for Ohtuvayre outside of the US. 
 
   -- On January 1, 2025, Ohtuvayre's product specific J-code became effective. 

First Quarter 2025 Financial Results

   -- Cash position: Cash and cash equivalents at March 31, 2025, were $401.4 
      million (December 31, 2024: $399.8 million). 
 
   -- Net revenue: Total net revenue was $76.3 million, driven by Ohtuvayre net 
      sales of $71.3 million, for the first quarter ended March 31, 2025 (Q1 
      2024: $0 million). Additionally, the Company recognized $5.0 million in a 
      clinical milestone from Nuance Pharma. 
 
   -- Cost of sales: Cost of sales was $3.4 million for the first quarter ended 
      March 31, 2025 (Q1 2024: $0 million), which included Ohtuvayre 
      manufacturing costs, inventory overhead costs and sales-based royalties. 
 
   -- R&D Expenses: Research and development ("R&D") expenses were $14.1 
      million for the first quarter ended March 31, 2025 (Q1 2024: $6.8 
      million). This increase of $7.3 million was primarily due to an increase 
      of $5.5 million in share-based compensation as well as an increase of 
      $1.9 million for clinical trial and other development costs related to 
      the two Phase 2 studies which were initiated in the third quarter of 2024 
      related to the combination of nebulized ensifentrine and glycopyrrolate 
      and for Ohtuvayre in patients with bronchiectasis. 
 
   -- SG&A Expenses: Selling general and administrative expenses ("SG&A") were 
      $69.1 million for the first quarter ended March 31, 2025 (Q1 2024: $20.4 
      million). The increase of $48.7 million was driven primarily by an 
      increase of $9.3 million in people-related costs and $27.1 million in 
      share-based compensation, each of which were impacted by the hiring of 
      our field sales team in mid-2024 in the lead-up to the launch of 
      Ohtuvayre. Additionally, our marketing and other commercial related 
      activities, including travel, increased by $7.8 million as we continue to 
      incur costs supporting the launch of Ohtuvayre. We also had an increase 
      of $2.7 million related to professional and consulting fees, information 
      technology costs and other support costs due to the continued buildout of 
      our commercial organization as well as an increase of $1.0 million 
      related to our RIPSA repayment and the amendment and draw of Tranche C of 
      the 2024 Term Loans. 
 
   -- Net loss and Adjusted Net Income*: Net loss was $16.3 million and 
      Adjusted Net Income was $20.5 million for the first quarter ended March 
      31, 2025 (Q1 2024: Net loss $25.8 million and Adjusted Net Loss $21.5 
      million). 

*See "Non-GAAP Financial Measures" below for further details and a reconciliation of this non-GAAP measure to its nearest comparable GAAP measure.

Conference Call and Webcast Information

Verona Pharma will host a live webcast and a conference call at 9:00 a.m. EDT / 2:00 p.m. BST on Tuesday, April 29, 2025, to discuss the first quarter 2025 financial results and corporate update.

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

   -- +1-800-715-9871 for callers in the United States 
 
   -- +1-646-307-1963 for international callers 

The webcast will be available under Events and Presentations on the Investors page of the Company's website, www.veronapharma.com/investors, and the audio replay will be available for 90 days.

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.

For further information please contact:

 
  Verona Pharma plc                       Tel: +1-844-341-9901 
--------------------------------------  -------------------------------------- 
  Victoria Stewart, Senior Director of    IR@veronapharma.com 
  Investor Relations and 
  Communications 
--------------------------------------  -------------------------------------- 
  Argot Partners                          Tel: +1-212-600-1902 
   US Investor Enquiries                   verona@argotpartners.com 
--------------------------------------  -------------------------------------- 
  Ten Bridge Communications               Tel: +1-781-316-4424 
   International / US Media Enquiries     tbcverona@tenbridgecommunications.co 
                                          m 
--------------------------------------  -------------------------------------- 
  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(R) (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 and prescriber growth, the ongoing commercialization of Ohtuvayre and the growth of our sales team, statements regarding our two recently initiated Phase 2 clinical trials, the Company's plans to initiate a Phase 2b clinical trial, potential regulatory approvals in the EU and UK, and Nuance Pharma's results from its pivotal Phase 3 trial, the amounts expected to become available and the conditions under the debt facility, our participation in the upcoming events and presentations, and the timing of any of the foregoing.

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 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 place restrictions on our operating and financial flexibility, and if we fail to comply with certain covenants, 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 quarter ended March 31, 2025, and our other reports filed 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 plc 
                   Consolidated Financial Summary 
                             (unaudited) 
         (in thousands, except share and per share amounts) 
 
                                    Three months ended March 31, 
                                       2025               2024 
 
Revenue 
Product sales, net               $       71,256       $        -- 
Other revenue                             5,000                -- 
                                    -----------        ---------- 
Total revenue, net                       76,256                -- 
                                    -----------        ---------- 
Operating expenses 
Cost of sales                             3,407                -- 
Research and development                 14,054             6,764 
Selling, general and 
 administrative                          69,112            20,434 
                                    -----------        ---------- 
Total operating expenses                 86,573            27,198 
                                    -----------        ---------- 
Operating loss                          (10,317)          (27,198) 
Other income/(expense) 
Research and development tax 
 credit                                      --               585 
Loss on extinguishment of debt             (407)               -- 
Interest income                           3,891             3,378 
Interest expense                        (10,195)           (1,586) 
Foreign exchange gain/(loss)                470              (219) 
                                    -----------        ---------- 
Total other (expense)/income, 
 net                                     (6,241)            2,158 
                                    -----------        ---------- 
Loss before income taxes                (16,558)          (25,040) 
Income tax benefit/(expense)                239              (754) 
                                    -----------        ---------- 
Net loss                         $      (16,319)      $   (25,794) 
                                    ===========        ========== 
 
Weighted-average shares 
 outstanding -- basic and 
 diluted                                    679,405       645,701 
Loss per ordinary share -- 
 basic and diluted               $            (0.02)  $     (0.04) 
                                    ===============    ========== 
 
                                       Mar-31             Dec-31 
                                         2025                2024 
                                    ---------------    ---------- 
Cash and cash equivalents        $          401,415   $   399,757 
Total assets                     $          525,936   $   474,242 
Shareholders' equity             $          226,595   $   204,559 
 
 
 

Non-GAAP Financial Measures

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