Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma”), announces it
and its wholly-owned subsidiary, Verona Pharma, Inc. (“VPI” and
together with Verona Pharma, the “Company”), have entered into
strategic financing agreements providing access to up to $650
million from funds managed by Oaktree Capital Management, L.P.
(“Oaktree”) and OMERS Life Sciences (“OMERS”).
The agreements provide non-dilutive capital and
additional financial flexibility ahead of Verona Pharma’s planned
US launch of ensifentrine and will support the Company’s continued
growth. Ensifentrine is currently under review by the US Food and
Drug Administration (“FDA”), and, if approved, is expected to be
the first novel inhaled mechanism for the maintenance treatment of
chronic obstructive pulmonary disease in more than 20 years.
The strategic financing was led by Oaktree and
is comprised of the following:
- Debt
facility: Up to $400 million in term loans available in
five separate tranches via a term loan facility (“debt
facility”).
- Revenue
interest purchase and sale agreement (“RIPSA”): Up to $250
million in funding from the sale of a redeemable interest in future
ensifentrine-related revenue, which is capped at 1.75x of the
amount funded.
The debt facility replaces the existing facility
of up to $400 million with funds managed by Oxford Finance LLC and
Hercules Capital, Inc. (NYSE: HTGC).
Under the terms of the debt facility, VPI is
drawing $55 million at closing, and may draw, subject to certain
conditions, an additional $70 million upon FDA approval of
ensifentrine, $175 million in two separate tranches upon
achievement of certain net sales milestones and, subject to the
approval of the Lenders, $100 million to support strategic
initiatives. VPI will pay only interest on the outstanding loans
under the five-year debt facility on a quarterly basis with all
amounts outstanding due at maturity. Approximately $52 million of
the loans drawn at closing will be used to repay in full the
existing facility, including to pay fees and associated costs
thereunder.
Under the terms of the RIPSA, VPI will receive
$100 million upon FDA approval of ensifentrine and will be eligible
to draw an additional $150 million upon the achievement of certain
net sales milestones. The revenue interest financing rate is 5% and
6.5% of certain proceeds the Company receives from licensees that
the Company may engage during the term of the RIPSA outside of the
US and in the US, respectively, and 6.5% of global net sales of
ensifentrine by the Company. The total revenue interest financing
payable by the Company to Oaktree and OMERS is capped at 1.75x of
the amount actually funded, with the ability to redeem the RIPSA at
lower multiples within the first three years from funding.
“As we finalize preparations for the potential
US approval and commercial launch of ensifentrine, we are pleased
to be working with Oaktree and OMERS who are aligned with our view
of ensifentrine’s importance to the COPD community and its
commercial opportunity. This strategic agreement, with access to up
to $650 million, allows us to further strengthen our cash position
and improve our financial flexibility,” said David Zaccardelli,
Pharm. D., President and Chief Executive Officer of Verona
Pharma. “These funds, together with our existing cash of $255
million, are expected to support the Company through
commercialization and growth beyond 2026.”
“We believe ensifentrine’s impressive clinical
data generated to date and unique mechanism of action position it
well to become a paradigm-shifting advancement in the maintenance
treatment of COPD, a condition with continued unmet need,” said
Aman Kumar, Co-Portfolio Manager for Oaktree’s Life Sciences
Lending platform. “This strategic investment in Verona Pharma
underscores Oaktree’s commitment to provide flexible capital
solutions to innovative life sciences companies that are working on
bringing important therapies to patients and providers
worldwide.”
Morgan Stanley & Co. LLC acted as sole
structuring agent on the transaction. Latham & Watkins
LLP served as legal counsel to Verona Pharma. Sullivan
& Cromwell LLP served as legal counsel to Oaktree.
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 PartnersUS Investor Enquiries |
Tel: +1-212-600-1902verona@argotpartners.com |
Ten Bridge CommunicationsInternational / US Media
Enquiries |
Tel: +1-312-523-5016tbcverona@tenbridgecommunications.com |
Leslie Humbel |
|
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. 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”); and a
fixed-dose combination formulation with ensifentrine and
glycopyrrolate, a LAMA, is currently under development, also for
the treatment of COPD. 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.
About Oaktree
Oaktree is a leader among global investment
managers specializing in alternative investments, with $192 billion
in assets under management as of March 31, 2024. The firm
emphasizes an opportunistic, value-oriented and risk-controlled
approach to investments in credit, private equity, real assets and
listed equities. The firm has over 1,200 employees and offices in
23 cities worldwide. For additional information, please visit
Oaktree’s website at http://www.oaktreecapital.com/.
About OMERS Life Sciences and
OMERS
OMERS Life Sciences provides royalty financings
and other non-dilutive solutions to biopharma companies and
academic institutions, supporting their efforts to address unmet
medical needs and improve the quality of life of patients around
the world.
OMERS is a jointly sponsored, defined benefit
pension plan, with 1,000 participating employers ranging from large
cities to local agencies, and over 600,000 active, deferred and
retired members. Our members include union and non-union employees
of municipalities, school boards, local boards, transit systems,
electrical utilities, emergency services and children’s aid
societies across Ontario. OMERS teams work in Toronto, London, New
York, Amsterdam, Luxembourg, Singapore, Sydney and other major
cities across North America and Europe – serving members and
employers, and originating and managing a diversified portfolio of
high-quality investments in bonds, public and private credit,
public and private equity, infrastructure and real estate.
Forward-Looking Statements
This press release contains forward-looking
statements. 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 the debt facility providing non-dilutive
capital and further financial flexibility to support Verona
Pharma’s continued growth, including the planned commercial launch
of ensifentrine, statements regarding the future availability of
future draws under the debt facility, the timing of repayment and
termination of the existing facility, the ability of Verona Pharma
to reach certain net sales milestones, 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 for
ensifentrine to be the first novel inhaled mechanism for the
maintenance treatment of chronic obstructive pulmonary disease in
more than 20 years and the potential of ensifentrine in the
treatment of cystic fibrosis, non-cystic fibrosis bronchiectasis,
asthma and other respiratory diseases, as well as the potential of
the DPI and pMDI formulations 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 need for additional funding to
complete development and commercialization of ensifentrine, which
may not be available and which may force us to delay, reduce or
eliminate our development 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
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, 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, as updated in our Quarterly Report on
Form 10-Q for the quarter ended March 31, 2024 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. 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.
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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