Verona Pharma Reports Third Quarter 2024 Financial Results and Provides Corporate Update
Verona Pharma reported strong Q3 2024 results, with Ohtuvayre™ (ensifentrine) launch generating $5.6 million in net sales during its first seven weeks. October sales exceeded Q3 performance, with over 5,000 prescriptions filled and 2,200 unique prescribers across COPD patients. The company initiated two Phase 2 trials: a dose-ranging trial with glycopyrrolate and a trial for non-cystic fibrosis bronchiectasis. Cash position stood at $336.0 million, expected to fund operations through 2026. Q3 expenses increased with R&D at $10.6 million and SG&A at $35.2 million, resulting in a net loss of $43.0 million.
Verona Pharma ha riportato risultati solidi per il terzo trimestre del 2024, con il lancio di Ohtuvayre™ (ensifentrina) che ha generato 5,6 milioni di dollari in vendite nette durante le prime sette settimane. Le vendite di ottobre hanno superato le performance del terzo trimestre, con oltre 5.000 ricette compilate e 2.200 prescrittori unici tra i pazienti affetti da BPCO. La società ha avviato due studi di Fase 2: uno studio sulle dosi con glicopirronio e un trial per la bronchiectasia non fibrosica cistica. La posizione di cassa è stata di 336,0 milioni di dollari, si prevede che sia sufficiente a finanziare le operazioni fino al 2026. Le spese del terzo trimestre sono aumentate, con R&S a 10,6 milioni di dollari e SG&A a 35,2 milioni di dollari, risultando in una perdita netta di 43,0 milioni di dollari.
Verona Pharma reportó resultados sólidos para el tercer trimestre de 2024, con el lanzamiento de Ohtuvayre™ (ensifentrina) generando 5,6 millones de dólares en ventas netas durante sus primeras siete semanas. Las ventas de octubre superaron el rendimiento del tercer trimestre, con más de 5.000 recetas llenadas y 2.200 prescriptores únicos entre pacientes con EPOC. La compañía inició dos ensayos de Fase 2: un ensayo de rango de dosis con glicopirrolato y un ensayo para bronquiectasia no relacionada con fibrosis quística. La posición de efectivo se situó en 336,0 millones de dólares, y se espera que financie operaciones hasta 2026. Los gastos del tercer trimestre aumentaron, con I+D a 10,6 millones de dólares y SG&A a 35,2 millones de dólares, resultando en una pérdida neta de 43,0 millones de dólares.
Verona Pharma는 2024년 3분기에 강력한 실적을 보고했으며, Ohtuvayre™ (ensifentrine) 출시로 처음 7주 동안 560만 달러의 순매출을 기록했습니다. 10월의 매출은 3분기 성과를 초과하며 5,000건 이상의 처방이 채워졌고 2,200명의 독립 처방자가 COPD 환자들 사이에서 활동했습니다. 회사는 글리코피롤레이트에 대한 용량 범위 시험과 비낭포성 섬유증 기관지 확장증에 대한 시험을 포함하여 두 개의 2상 시험을 시작했습니다. 현금 보유액은 3억 3,600만 달러로 2026년까지 운영 자금을 지원할 것으로 예상됩니다. 3분기 지출은 R&D가 1,060만 달러, SG&A가 3,520만 달러로 증가하면서 순손실이 4,300만 달러에 달했습니다.
Verona Pharma a rapporté des résultats solides pour le troisième trimestre 2024, avec le lancement de Ohtuvayre™ (ensifentrine) générant 5,6 millions de dollars de ventes nettes durant les sept premières semaines. Les ventes d'octobre ont dépassé les performances du troisième trimestre, avec plus de 5 000 prescriptions complétées et 2 200 prescripteurs uniques parmi les patients atteints de BPCO. L'entreprise a lancé deux essais de phase 2 : un essai à dosage échelonné avec le glycopyrrolate et un essai pour la bronchiectasie non fibrose kystique. La position de liquidité était de 336,0 millions de dollars, ce qui devrait financer les opérations jusqu'en 2026. Les dépenses du troisième trimestre ont augmenté, avec une R&D à 10,6 millions de dollars et des SG&A à 35,2 millions de dollars, entraînant une perte nette de 43,0 millions de dollars.
Verona Pharma berichtete über starke Ergebnisse im 3. Quartal 2024, wobei die Einführung von Ohtuvayre™ (ensifentrine) in den ersten sieben Wochen einen Nettoumsatz von 5,6 Millionen Dollar generierte. Die Verkaufszahlen im Oktober übertrafen die Leistungen des 3. Quartals, mit über 5.000 ausgefüllten Rezepten und 2.200 einzigartigen Verschreibern unter COPD-Patienten. Das Unternehmen hat zwei Phase-2-Studien begonnen: eine Dosisbereichsstudie mit Glycopyrrolat und eine Studie zur nicht-zystischen Fibrose-Bronchiektasie. Die Liquiditätsposition lag bei 336,0 Millionen Dollar, was voraussichtlich ausreicht, um den Betrieb bis 2026 zu finanzieren. Die Ausgaben im 3. Quartal stiegen mit F&E bei 10,6 Millionen Dollar und SG&A bei 35,2 Millionen Dollar, was zu einem Nettoverlust von 43,0 Millionen Dollar führte.
- Strong initial Ohtuvayre launch with $5.6M net sales in Q3
- October sales exceeded entire Q3 performance
- Over 5,000 prescriptions filled and 2,200 unique prescribers in 12 weeks
- Strong cash position of $336.0M, funded through 2026
- Permanent J-code secured for Medicare/Medicaid, effective January 2025
- Increased net loss of $43.0M compared to $14.7M in Q3 2023
- SG&A expenses increased by $21.8M to $35.2M
- R&D expenses increased by $7.6M to $10.6M
Insights
Verona Pharma's Q3 results demonstrate strong early commercial traction for Ohtuvayre.
Key metrics show promising market penetration with over 2,200 unique prescribers and 5,000 prescriptions filled across broad COPD patient segments. However, operating expenses increased significantly, with SG&A up by
The secured J-code effective January 2025 should improve reimbursement efficiency. Pipeline expansion into fixed-dose combinations and new indications could provide additional growth catalysts.
The early adoption patterns of Ohtuvayre reveal significant clinical implications. The drug's utilization across patients on single, dual and triple therapy (
The expansion into non-cystic fibrosis bronchiectasis (NCFBE) through Phase 2 trials represents a strategic move into an underserved market. The development of a fixed-dose combination with glycopyrrolate could further enhance treatment convenience and potentially improve patient compliance.
Ohtuvayre™ (ensifentrine) launch recorded Q3 net sales of
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
“In the third quarter, through the first seven weeks of launch, we recorded
“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 | ||||
FAQ
What were Verona Pharma's (VRNA) Q3 2024 net sales for Ohtuvayre?
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When will VRNA's Ohtuvayre J-code for Medicare/Medicaid become effective?
