Total net revenue of $76.3 million from Q1 2025 driven by Ohtuvayre® 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
“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.
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