PDUFA Target Action Date for ensifentrine of
Commercialization preparations advance
Strong balance sheet supports commercialization and Company's growth
Conference call today at
"2023 was a pivotal year for
"The NDA acceptance brings us closer to our goal of delivering ensifentrine to the millions of patients suffering from COPD. If approved, ensifentrine is expected to be the first novel inhaled mechanism available for the treatment of COPD in more than 20 years. Supported by the results from our ENHANCE ("Ensifentrine as a Novel inHAled Nebulized COPD thErapy") trials, we believe ensifentrine’s bronchodilator and non-steroidal anti-inflammatory activity has the potential to change the treatment paradigm for COPD.
"While we remain focused on the US commercialization efforts for ensifentrine, we progressed development of two new programs: a fixed-dose combination formulation with ensifentrine and glycopyrrolate, a long-acting muscarinic antagonist ("LAMA"), for the maintenance treatment of patients with COPD via a nebulizer and a potential second indication for nebulized ensifentrine for the treatment of non-cystic fibrosis bronchiectasis ("NCFBE").
"To support our commercialization activities and continued pipeline expansion, we enhanced our financial flexibility through a
"Alongside our progress in 2023, our development partner Nuance Pharma continued to enroll patients into a pivotal Phase 3 trial evaluating ensifentrine for the maintenance treatment of COPD in
"We expect 2024 to be a transformational year for
Program Updates and Key Milestones
The Company’s near-term milestones include:
- The FDA has assigned a PDUFA target action date of
June 26, 2024 and notified the Company that it is not currently planning to hold an advisory committee meeting to discuss the application. If approved, the Company intends to launch ensifentrine in the US market in the second half of 2024. - In the first half of 2024, the Company will work to finalize key launch activities including pricing, distribution and patient services, healthcare professional and patient engagement plans. Additionally, Verona's disease awareness campaign, titled "Unspoken COPD," will continue to highlight to key healthcare providers the burden of COPD for patients.
- The Company is developing a fixed-dose combination formulation with ensifentrine and glycopyrrolate, a LAMA, for the maintenance treatment of patients with COPD via delivery in a nebulizer. Following development activities to confirm a feasible formulation, in the second half of 2024, the Company plans to submit an investigational new drug application ("IND") to the FDA and, subject to clearance, initiate a Phase 2 clinical trial assessing the safety and efficacy of the fixed-dose combination formulation in COPD patients.
- In the second half of 2024, the Company plans to commence a Phase 2 clinical trial to assess the efficacy and safety of nebulized ensifentrine in patients with NCFBE, subject to clearance by the FDA.
Fourth Quarter and Recent Highlights
- In
October 2023 , the Company gave four presentations on pooled and subgroup post hoc analyses from the ENHANCE trials evaluating ensifentrine in COPD covering data related to exacerbations, lung function, symptoms and quality of life endpoints and use of daily rescue medication, at CHEST Annual Meeting 2023. Also at CHEST, the Company launched the "Unspoken COPD" disease awareness campaign, highlighting how many COPD patients struggle to talk about their condition. - Also in
October 2023 , the Company presented an update on key launch preparations including the overall market opportunity for ensifentrine, if approved, the finalization of sales force deployment strategy, Hub services and distribution pathway, as well as internal infrastructure needed to support the commercialization of ensifentrine. - In
December 2023 , the Company completed a debt facility providing access to up to$400 million from funds managed byOxford Finance and Hercules Capital. The debt facility provides non-dilutive capital and further financial flexibility to support Verona Pharma’s continued growth, including the commercialization of ensifentrine. The Company drew$50 million at closing, a portion of which was used to repay amounts outstanding under the previous$150 million debt facility with Oxford, and the remainder is available upon achievement of certain regulatory and commercial milestones and other conditions. - In
February 2024 ,Michael Austwick joined the board as a Non-Executive Director andRishi Gupta stepped down from the board after 7 years of service.Mr. Austwick brings a wealth of strategic and operational experience in the biopharmaceutical industry including more than 15 years of respiratory expertise in leadership roles across the US,China ,Europe andJapan . Most recently, he served as CEO at Vectura, and previously as Nordic General Manager and Head of the Global Respiratory Franchise at Novartis and as Head of US Respiratory and Vice President Global Inhaled Respiratory at AstraZeneca.Mr. Austwick has led the development and commercialization of more than 10 brands.
Fourth Quarter 2023 Financial Results
- Cash position: Cash and cash equivalents at
December 31, 2023 , were$271.8 million (December 31, 2022 :$227.8 million ). The Company believes cash and cash equivalents atDecember 31, 2023 , and funding expected to become available under the$400 million debt facility, will enableVerona Pharma to fund planned operating expenses and capital expenditure requirements through at least the end of 2026 including the commercial launch of ensifentrine in the US, if approved. - R&D Expenses: Research and development ("R&D") expenses were
$4.1 million for the fourth quarter endedDecember 31, 2023 (Q4 2022:$6.8 million ). This decrease of$2.7 million was primarily due to a$2.1 million decrease in clinical trial and other development costs as, in the prior year, the Company was incurring costs with the then ongoing Phase 3 ENHANCE program. - SG&A Expenses: Selling general and administrative expenses ("SG&A") were
$15.0 million for the fourth quarter endedDecember 31, 2023 (Q4 2022:$8.3 million ). The increase of$6.7 million was primarily due to a$3.2 million increase in people related costs, inclusive of share-based compensation, and an increase of$3.5 million related to the build-out of the commercial and information technology infrastructures in preparation for a potential commercial launch, marketing and market development expenses, travel and other corporate costs. - Net loss: Net loss was
$14.1 million for the fourth quarter endedDecember 31, 2023 (Q4 2022: net loss$10.5 million ).
Full Year 2023 Financial Results
- R&D Expenses: R&D expenses were
$17.2 million for the year endedDecember 31, 2023 (full year 2022:$49.3 million ), a decrease of$32.1 million . This decrease was primarily due to a$32.7 million decrease in clinical trial and other development costs as we incurred less costs under the Phase 3 ENHANCE program, which completed study conduct and analysis in 2023 whereas in 2022 significant costs were incurred associated with the then ongoing study conduct. - SG&A Expenses: SG&A expenses were
$50.4 million for the year endedDecember 31, 2023 (full year 2022:$26.6 million ), an increase of$23.8 million . This increase was driven primarily by a$15.6 million increase in people related costs, inclusive of share-based compensation, an increase of$9.7 million related to the build-out of the commercial and information technology infrastructures in preparation for a potential commercial launch, marketing and market development expenses, travel and other corporate costs. - Net loss: Net loss was
$54.4 million for the year endedDecember 31, 2023 (full year 2022:$68.7 million ).
Conference Call and Webcast Information
To participate, please dial one of the following numbers and ask to join the
- +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 fourth quarter and full year 2023 results press release will also be made available today on the Company’s website.
For further information please contact:
US Tel: +1-833-417-0262 | |
IR@veronapharma.com | |
Tel: +1-212-600-1902 verona@argotpartners.com | |
Ten | Tel: +1-312-523-5016 tbcverona@tenbridgecommunications.com |
About
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to, statements regarding our operational review, financial review, program updates and key milestones, the timing of the approval of the NDA for ensifentrine for the maintenance treatment of COPD, the development of ensifentrine in other formulations and for other indications and planned regulatory submissions and timing thereof, including the timing of submission of an IND for a fixed-dose combination formulation with ensifentrine and glycopyrrolate, a LAMA, for the maintenance treatment of patients with COPD and the timing of clinical studies to assess ensifentrine in patients with NCFBE, the planned US commercial launch of ensifentrine in 2024, the potential for ensifentrine to be the first therapy for the treatment of respiratory diseases to combine bronchodilator and non-steroidal anti-inflammatory benefits in one compound, the potential of ensifentrine to change the treatment paradigm for COPD patients, the potential of ensifentrine in the treatment of cystic fibrosis, NCFBE, asthma and other respiratory diseases, as well as the potential of the DPI and pMDI formulations of ensifentrine, the funding we expect to become available under our
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: our limited operating history; our ability to operate our business due to restrictions from our
Consolidated Financial Summary (unaudited) (in thousands, except share and per share amounts) |
Three months ended | Years ended | ||||||||||||||
2023 | 2022 | 2023 | 2022 | ||||||||||||
Revenue | $ | — | $ | 458 | $ | — | $ | 458 | |||||||
Cost of sales | — | (346 | ) | — | (346 | ) | |||||||||
Gross profit | — | 112 | — | 112 | |||||||||||
Operating expenses | |||||||||||||||
Research and development | 4,122 | 6,838 | 17,216 | 49,283 | |||||||||||
Selling, general and administrative | 14,972 | 8,323 | 50,343 | 26,579 | |||||||||||
Total operating expenses | 19,094 | 15,161 | 67,569 | 75,862 | |||||||||||
Operating loss | (19,094 | ) | (15,049 | ) | (67,569 | ) | (75,750 | ) | |||||||
Other income / (expense) | |||||||||||||||
Research & development tax credit | 1,034 | 796 | 1,104 | 9,634 | |||||||||||
Loss on extinguishment of debt | — | (815 | ) | — | (815 | ) | |||||||||
Interest income | 3,292 | 1,862 | 12,761 | 2,821 | |||||||||||
Interest expense | (623 | ) | (230 | ) | (2,057 | ) | (521 | ) | |||||||
Foreign exchange gain/(loss) | 1,206 | 3,013 | 1,866 | (3,817 | ) | ||||||||||
Total other income, net | 4,909 | 4,626 | 13,674 | 7,302 | |||||||||||
Loss before income taxes | (14,185 | ) | (10,423 | ) | (53,895 | ) | (68,448 | ) | |||||||
Income tax benefit/(expense) | 53 | (28 | ) | (474 | ) | (253 | ) | ||||||||
Net loss | $ | (14,132 | ) | $ | (10,451 | ) | $ | (54,369 | ) | $ | (68,701 | ) | |||
Weighted average shares outstanding – basic and diluted | 642,139,211 | 604,204,929 | 634,142,660 | 529,071,526 | |||||||||||
Loss per ordinary share - basic and diluted | $ | (0.02 | ) | $ | (0.02 | ) | $ | (0.09 | ) | $ | (0.13 | ) | |||
2023 | 2022 | ||||||||||||||
Cash and cash equivalents | $ | 271,772 | $ | 227,827 | |||||||||||
Total assets | 308,134 | 259,468 | |||||||||||||
Shareholders’ equity | $ | 249,283 | $ | 230,466 | |||||||||||
Source:
2024 GlobeNewswire, Inc., source