Verona Pharma Reports Strong Ohtuvayre™ Launch and Provides Preliminary Fourth Quarter and Full Year 2024 Financial Highlights
Verona Pharma reports strong performance for their newly launched COPD treatment Ohtuvayre (ensifentrine), with approximately $36 million in net product sales for Q4 2024 and $42 million for full year 2024. The drug, launched after FDA approval in June 2024, has gained significant traction with over 3,500 unique healthcare professionals prescribing it and more than 16,000 prescriptions filled in 2024.
Key achievements include approximately 45% of Tier 1 HCPs prescribing Ohtuvayre, monthly prescription growth exceeding 35% in Q4, and about one-third of prescriptions being refills. The company maintains approximately two weeks of inventory at specialty pharmacies and reports strong cash position of approximately $400 million as of December 31, 2024.
Verona Pharma riporta una forte performance per il loro neonato trattamento per la COPD Ohtuvayre (ensifentrina), con circa 36 milioni di dollari in vendite nette di prodotto per il quarto trimestre del 2024 e 42 milioni di dollari per l'intero anno 2024. Il farmaco, lanciato dopo l'approvazione della FDA nel giugno 2024, ha guadagnato una notevole attenzione, con oltre 3.500 professionisti della salute unici che lo prescrivono e più di 16.000 prescrizioni compilate nel 2024.
Tra i risultati principali vi è circa il 45% dei HCP di Tier 1 che prescrivono Ohtuvayre, una crescita mensile delle prescrizioni che supera il 35% nel quarto trimestre, e circa un terzo delle prescrizioni sono ricariche. L'azienda mantiene circa due settimane di inventario presso le farmacie specializzate e riporta una solida posizione di cassa di circa 400 milioni di dollari al 31 dicembre 2024.
Verona Pharma informa sobre un fuerte rendimiento de su nuevo tratamiento para la COPD Ohtuvayre (ensifentrina), con aproximadamente 36 millones de dólares en ventas netas de productos para el cuarto trimestre de 2024 y 42 millones de dólares para el año completo 2024. El medicamento, lanzado tras la aprobación de la FDA en junio de 2024, ha ganado una tracción significativa con más de 3.500 profesionales de la salud únicos prescribiéndolo y más de 16.000 recetas cumplidas en 2024.
Los logros clave incluyen aproximadamente el 45% de los HCP de Nivel 1 que prescriben Ohtuvayre, un crecimiento mensual de recetas que supera el 35% en el cuarto trimestre y aproximadamente un tercio de las recetas son renovaciones. La empresa mantiene aproximadamente dos semanas de inventario en farmacias especializadas y reporta una sólida posición de efectivo de aproximadamente 400 millones de dólares al 31 de diciembre de 2024.
베로나 파마는 새로 출시된 COPD 치료제 오투베이르 (엔시펜트린)의 강력한 성과를 보고하며, 2024년 4분기에 약 3천6백만 달러의 순제품 판매와 2024년 전체 연도에 4천2백만 달러를 기록했다고 전합니다. 이 약물은 2024년 6월 FDA 승인을 받은 후 출시되어, 3,500명 이상의 독립적인 의료 전문가들이 처방하고, 2024년에는 16,000건 이상의 처방전이 발행되었습니다.
주요 성과로는 약 45%의 Tier 1 HCP들이 오투베이르를 처방하고, 4분기 동안 월 처방 성장률이 35%를 초과하며, 처방전의 약 삼분의 일이 재처방임을 포함합니다. 회사는 전문 약국에서 약 2주 분량의 재고를 유지하며, 2024년 12월 31일 기준으로 약 4억 달러의 강력한 현금 보유고를 보고합니다.
Verona Pharma annonce de solides performances pour son nouveau traitement de la BPCO Ohtuvayre (ensifentrine), avec environ 36 millions de dollars de ventes nettes de produits pour le quatrième trimestre 2024 et 42 millions de dollars pour l'année entière 2024. Ce médicament, lancé après l'approbation de la FDA en juin 2024, a gagné une traction significative avec plus de 3 500 professionnels de la santé uniques le prescrivant et plus de 16 000 prescriptions remplies en 2024.
Les réalisations clés incluent environ 45 % des HCP de niveau 1 qui prescrivent Ohtuvayre, une croissance mensuelle des prescriptions dépassant 35 % au quatrième trimestre, et environ un tiers des prescriptions étant des renouvellements. L'entreprise maintient environ deux semaines d'inventaire dans les pharmacies spécialisées et annonce une solide position de liquidités d'environ 400 millions de dollars au 31 décembre 2024.
Verona Pharma berichtet über eine starke Leistung ihres neu eingeführten COPD-Behandlungsprodukts Ohtuvayre (Ensifentrin), mit insgesamt ca. 36 Millionen Dollar an Nettoumsätzen im vierten Quartal 2024 und 42 Millionen Dollar für das gesamte Jahr 2024. Das Medikament, das im Juni 2024 nach der Genehmigung durch die FDA auf den Markt kam, hat signifikanten Zulauf erhalten, da über 3.500 einzigartige Gesundheitsfachkräfte es verschreiben und mehr als 16.000 Rezepte im Jahr 2024 eingelöst wurden.
Zu den wichtigsten Erfolgen gehört, dass etwa 45% der Tier 1 HCPs Ohtuvayre verschreiben, das monatliche Rezeptwachstum im vierten Quartal über 35% liegt und etwa ein Drittel der Rezepte Nachfüllungen sind. Das Unternehmen hält etwa zwei Wochen Inventar in Fachapotheken und berichtet zum 31. Dezember 2024 über eine starke Bargeldposition von etwa 400 Millionen Dollar.
- Strong Q4 2024 net product sales of $36 million
- Over 16,000 prescriptions filled in 2024
- 35%+ monthly prescription growth in Q4
- High refill rate at approximately one-third of prescriptions
- Robust cash position of $400 million
- 45% penetration among Tier 1 HCPs
- Over 150 HCPs prescribed to more than 20 patients each
- $100 million share offering causing potential dilution
Insights
The Q4 2024 results for VRNA demonstrate exceptional commercial execution with Ohtuvayre. The
The prescription metrics are particularly compelling - over 16,000 total prescriptions with
The J-code implementation effective January 2025 should further streamline reimbursement processes and drive adoption. The combination therapy development pipeline provides additional growth vectors beyond the current indication.
The clinical adoption patterns of Ohtuvayre reveal important insights about its therapeutic positioning. The broad prescribing across COPD patients on single, dual and triple therapy backgrounds indicates physicians are finding utility across the severity spectrum. The
The dual bronchodilator and anti-inflammatory mechanism appears to be resonating with prescribers. The Phase 2 dose-ranging study with glycopyrrolate could enable a fixed-dose LAMA combination, potentially offering a novel treatment option. The expansion into non-CF bronchiectasis demonstrates the platform potential in other inflammatory airway diseases.
Approximately
More than 3,500 unique prescribers and over 16,000 prescriptions filled in 2024 across a broad COPD population
Approximately
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
“We recorded net product sales of approximately
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.
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