Valneva Provides Updated 2023 Financial Guidance
December 29 2023 - 3:30PM
Valneva Provides Updated 2023 Financial Guidance
Saint-Herblain (France), December 29,
2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a
specialty vaccine company, today announced that the Company is
modifying its financial guidance for 2023. Product sales guidance
remains unchanged, as do anticipated R&D expenses. The €90
million to €110 million of other income related to proceeds from
potential sale of the Company’s priority review voucher (PRV),
which was previously expected before year-end, is now expected in
early 2024.
The Company’s previous guidance included
expected total revenues and other income between €220 million and
€260 million1. The modified 2023 guidance now includes the
previously stated product sales revenue of €130 million to €150
million, which the Company remains on track to achieve, as well as
R&D expenses between €60 million and €70 million, which were
recently reduced2, primarily driven by lower than anticipated costs
related to the closeout of the Company’s COVID-19 activities.
Peter Bühler, Chief Financial
Officer of Valneva, said, “We remain confident in our
ability to sell our priority review voucher successfully at a price
within the previously suggested range. As we continue to work
actively toward a potential sale agreement, we look forward to
providing an update in the new year.”
The Company was awarded a tropical disease PRV
in November 20233 following U.S. FDA approval of IXCHIQ®, Valneva’s
single-dose, live-attenuated vaccine indicated for the prevention
of disease caused by chikungunya virus (CHIKV) in individuals 18
years of age and older who are at increased risk of exposure to
CHIKV. With this approval, IXCHIQ® became the world’s first
licensed chikungunya vaccine available to address this unmet
medical need. Valneva expects to launch the vaccine in the U.S. in
early 2024.
The Company has also drawn down the remaining
$50 million made available under its debt financing agreement with
funds managed by U.S. investment firms Deerfield Management Company
and OrbiMed4.
About Valneva SEWe are a
specialty vaccine company that develops, manufactures, and
commercializes prophylactic vaccines for infectious diseases
addressing unmet medical needs. We take a highly specialized and
targeted approach, applying our deep expertise across multiple
vaccine modalities, focused on providing either first-, best- or
only-in-class vaccine solutions.
We have a strong track record, having advanced
multiple vaccines from early R&D to approvals, and currently
market two proprietary travel vaccines as well as certain
third-party vaccines leveraging our established commercial
infrastructure.
Revenues from our growing commercial business
help fuel the continued advancement of our vaccine pipeline. This
includes the world’s first vaccine against the chikungunya virus
and the only Lyme disease vaccine candidate in advanced clinical
development, which is partnered with Pfizer, as well as vaccine
candidates against the Zika virus and other global public health
threats.
About
IXCHIQ®In the U.S.,
IXCHIQ® is a live-attenuated vaccine indicated for
the prevention of disease caused by chikungunya virus (CHIKV) in
individuals 18 years of age and older who are at increased risk of
exposure to CHIKV. As for all products approved under FDA’s
accelerated approval pathway, continued approval for this
indication is contingent upon verification and description of
clinical benefit in confirmatory studies.
Please click here for
full Prescribing Information for
IXCHIQ®.
Valneva
Investor and Media ContactsLaetitia Bachelot-FontaineVP
Global Communications & European Investor RelationsM +33 (0)6
4516
7099laetitia.bachelot-fontaine@valneva.com |
Joshua
Drumm, Ph.D.VP Global Investor RelationsM +001 917 815
4520joshua.drumm@valneva.com |
Forward-Looking Statements
This press release contains certain
forward-looking statements relating to the business of Valneva,
including with respect to its financial results for 2023 and the
sale of its priority review voucher. In addition, even if the
actual results or development of Valneva are consistent with the
forward-looking statements contained in this press release, those
results or developments of Valneva may not be sustained in the
future. In some cases, you can identify forward-looking statements
by words such as “could,” “should,” “may,” “expects,”
“anticipates,” “believes,” “intends,” “estimates,” “aims,”
“targets,” or similar words. These forward-looking statements are
based largely on the current expectations of Valneva as of the date
of this press release and are subject to a number of known and
unknown risks and uncertainties and other factors that may cause
actual results, performance or achievements to be materially
different from any future results, performance or achievement
expressed or implied by these forward-looking statements. In
particular, the expectations of Valneva could be affected by, among
other things, uncertainties and delays involved in the development
and manufacture of vaccines, unexpected clinical trial results,
unexpected regulatory actions or delays, competition in general,
currency fluctuations, the impact of the global and European credit
crisis, and the ability to obtain or maintain patent or other
proprietary intellectual property protection. Success in
preclinical studies or earlier clinical trials may not be
indicative of results in future clinical trials. In light of these
risks and uncertainties, there can be no assurance that the
forward-looking statements made during this presentation will in
fact be realized. Valneva is providing the information in these
materials as of this press release and disclaim any intention or
obligation to publicly update or revise any forward-looking
statements, whether as a result of new information, future events,
or otherwise.
1 Valneva Reports Nine-Month 2023 Financial Results and Provides
Corporate Updates2 Valneva Reports Nine-Month 2023 Financial
Results and Provides Corporate Updates3 Valneva Announces U.S.
FDA Approval of World’s First Chikungunya Vaccine, IXCHIQ® -
Valneva4 Valneva Reports Nine-Month 2023 Financial Results and
Provides Corporate Updates - Valneva
- 2023_12_29_VLA_Guidance_Update_PR_EN_Final
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