Verona Pharma plc (Nasdaq: VRNA) ("Verona Pharma" or the
"Company"), a clinical-stage biopharmaceutical company focused on
respiratory diseases, announces its financial results for the
fourth quarter and full year ended December 31, 2023, and provides
a corporate update.
"2023 was a pivotal year for Verona Pharma with
the acceptance of our New Drug Application ("NDA") for review by
the US Food and Drug Administration ("FDA") and continued
advancement of our commercialization strategy in preparation for
the US launch of ensifentrine, if approved," said David
Zaccardelli, Pharm. D., President and Chief Executive Officer. "In
August, the FDA accepted for review our NDA seeking approval of
ensifentrine for the maintenance treatment of patients with chronic
obstructive pulmonary disease ("COPD") and assigned a Prescription
Drug User Fee Act ("PDUFA") target action date of June 26,
2024.
"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 $400 million debt financing facility in December. We
expect this facility, along with our existing cash, to support
Verona Pharma's growth including the commercialization of
ensifentrine, if approved, through at least 2026.
"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 China. Nuance Pharma are developing and, if approved,
will commercialize ensifentrine in Greater China and we look
forward to providing future updates.
"We expect 2024 to be a transformational year
for Verona Pharma. We are finalizing our US launch preparations and
look forward to commercializing ensifentrine in the second half of
2024, if approved. We also look forward to continued progress on
our development programs as we work to build-out our pipeline."
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 by Oxford 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
and Rishi 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 and Japan. 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 at December 31, 2023,
and funding expected to become available under the $400 million
debt facility, will enable Verona 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 ended December 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 ended December 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
ended December 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
ended December 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 ended December 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 ended
December 31, 2023 (full year 2022: $68.7 million).
Conference Call and Webcast
InformationVerona Pharma will host an investment community
webcast and conference call at 9:00 a.m. EST / 2:00 p.m. GMT on
Thursday, February 29, 2024, to discuss the fourth quarter and full
year 2023 financial results and the 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 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:
Verona Pharma plc |
US Tel: +1-833-417-0262UK Tel: +44 (0)203 283 4200 |
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:
+1-312-523-5016 tbcverona@tenbridgecommunications.com |
Leslie Humbel |
|
About Verona Pharma
Verona Pharma is a clinical-stage
biopharmaceutical company focused on developing and commercializing
innovative therapies for the treatment of chronic respiratory
diseases with significant unmet medical needs. In the third quarter
of 2023, the US Food and Drug Administration accepted for review
the Company’s NDA for ensifentrine for the maintenance treatment of
patients with COPD and assigned a PDUFA target action date of June
26, 2024. If approved, ensifentrine has the potential
to become the first inhaled non-steroidal therapy for the treatment
of respiratory diseases that combines bronchodilator and
anti-inflammatory activities in one molecule. The Company has
evaluated nebulized ensifentrine in its Phase 3 clinical program
ENHANCE ("Ensifentrine as a Novel inHAled Nebulized COPD thErapy")
for COPD maintenance treatment. Ensifentrine met the primary
endpoint in both ENHANCE-1 and ENHANCE-2 trials demonstrating
statistically significant and clinically meaningful improvements in
lung function. In addition, ensifentrine substantially reduced the
rate and risk of COPD exacerbations in pooled analysis from
ENHANCE-1 and ENHANCE-2. Two additional formulations of
ensifentrine have been evaluated in Phase 2 trials for the
treatment of COPD: dry powder inhaler ("DPI") and pressurized
metered-dose inhaler ("pMDI"). Ensifentrine also has potential
applications in cystic fibrosis, non-cystic fibrosis
bronchiectasis, 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. 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 $400 million debt
financing facility and from cash receipts from UK tax credits, and
the sufficiency of cash and cash equivalents, and the cash runway
period provided by the sources of financing through to at least the
end of 2026 and expected to fully fund the planned
commercialization of ensifentrine.
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 $400 million debt financing facility and
any other existing or future indebtedness; our need for additional
funding to complete development and commercialization of any future
product candidates or development and commercialization of other
formulations or target indications of ensifentrine, which may not
be available and which may force us to delay, reduce or eliminate
our product development programs or commercialization efforts; the
reliance of our business on the success of ensifentrine, our only
product candidate under development; economic, political,
regulatory and other risks involved with international operations;
the lengthy and expensive process of clinical drug development,
which has an uncertain outcome; serious adverse, undesirable or
unacceptable side effects associated with ensifentrine, which could
adversely affect our ability to develop or commercialize
ensifentrine; we may not be successful in developing ensifentrine
in other formulations or for multiple indications; our ability to
obtain approval for and commercialize ensifentrine in multiple
major pharmaceutical markets; misconduct or other improper
activities by our employees, consultants, principal investigators,
third-party service providers and licensees; our inability to
realize the anticipated benefits under licenses granted by us to
third parties to develop and commercialize ensifentrine, our future
growth and ability to compete depends on retaining our key
personnel and recruiting additional qualified personnel; material
differences between our "top-line" data and final data; our
reliance on third parties, including clinical research
organizations, clinical investigators, manufacturers and suppliers,
and the risks related to these parties’ ability to successfully
develop and commercialize ensifentrine; lawsuits related to patents
covering ensifentrine and the potential for our patents to be found
invalid or unenforceable; lawsuits related to our licensing of
patents and know-how with third parties for the development and
commercialization of ensifentrine; changes in our tax rates,
unavailability of certain tax credits or reliefs or exposure to
additional tax liabilities or assessments could affect our
profitability, and audits by tax authorities could result in
additional tax payments for prior periods; and our vulnerability to
natural disasters, global economic factors, geo-political actions
and unexpected events, including health epidemics or pandemics like
the COVID-19 pandemic, and conflicts such as the Russia-Ukraine
conflict, which has and may continue to adversely impact our
business. These and other important factors under the caption "Risk
Factors" in our Annual Report on Form 10-K for the year ended
December 31, 2023, and our other reports filed with the SEC, could
cause actual results to differ materially from those indicated by
the forward-looking statements made in this press release. Although
management believes that the expectations reflected in the
forward-looking statements are reasonable, it cannot guarantee
future results, levels of activity, performance or achievements.
Any such forward-looking statements represent management's
estimates as of the date of this press release. While we may elect
to update such forward-looking statements at some point in the
future, we disclaim any obligation to do so, even if subsequent
events cause our views to change, except as required by 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 plcConsolidated Financial
Summary(unaudited)(in thousands,
except share and per share amounts) |
|
Three months ended December 31, |
|
Years ended December 31, |
|
|
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 |
|
|
|
|
|
|
|
|
|
|
|
|
|
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