Valneva Reports Preliminary Unaudited 2024 Revenue and Cash and Provides 2025 Outlook
18 Fevereiro 2025 - 3:00AM
- Met 2024 growth targets for sales revenue (+13% vs
2023) and total revenues (+10% vs 2023)
- Strong
year-end cash position of €168.3 million
-
Substantial clinical and regulatory progress in 2024,
leading to multiple anticipated data readouts, product approvals
and label extensions in 2025
- 2025 outlook reflects solid
revenue growth and positive commercial cash flows to support
strategic R&D investments with lower operating cash
burn
Saint-Herblain (France), February 18,
2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) a
specialty vaccine company, today reported its preliminary unaudited
full-year 2024 revenue and cash results1 and provided a 2025
outlook. The Company will publish its 2024 audited consolidated
financial statements and host an analyst call on March 20,
2025.
2024 Performance
- Total revenues were €169.6 million
for the year ended December 31, 2024 compared to €153.7 million in
the year ended December 31, 2023, an increase of 10%
- Product sales revenue reached
€163.3 million for the year ended December 31, 2024 compared to
€144.6 million in the same period of 2023, an increase of 13%
- Cash and cash equivalents were
€168.3 million as at December 31, 2024, compared to €126.1 million
at December 31, 2023. Year-end cash of €168.3 million,
significantly augmented by the sale of the Priority Review Voucher2
and successful Private Placement3
2025 Financial Outlook
- Sales revenues expected to grow to
€170-180 million, driving positive cash-flows for the overall
commercial business
- Total revenues expected to reach
€180-190 million
- Total R&D investments expected
between €90 - €100 million, which will be partially offset by grant
funding and anticipated R&D tax credits
- Continued stringent focus on cash
management supporting sufficient cash runway to reach key
inflection points; substantially lower operating cash burn expected
in 2025, less than 30 million compared to over €60.0 million in
2024
Peter Bühler, Valneva’s Chief Financial
Officer, commented, “Once again, we successfully delivered
double digit sales growth, despite lower than anticipated
launch-year IXCHIQ® sales in the U.S. We made significant clinical
and regulatory progress last year, setting the stage for several
important catalysts to drive value in 2025, most notably with the
first Phase 3 study results for our lead Lyme disease vaccine
candidate, VLA15. In 2025, we will continue to focus on commercial
execution while investing strategically in advancing our
science-driven pipeline to generate substantial future value. With
over €168 million of cash at the end of 2024, we are entering 2025
in a good financial position to support these objectives.”
Regulatory, R&D and Strategic
Highlights
- Continued to progress Lyme disease
program according to plan, including completion of primary
vaccination in ongoing Phase 3 study, reporting of further positive
Phase 2 booster results, and publication of Phase 2 data in the
Lancet
- Secured three additional regulatory
approvals for world’s first chikungunya vaccine, IXCHIQ® (Canada,
Europe, UK); filed adolescent label extension submissions; awarded
new $41.3 million grant from the Coalition for Epidemic
Preparedness (CEPI)4
- Augmented clinical pipeline with a
leading tetravalent Shigella vaccine candidate5 and initiated Phase
2b trial; Granted Fast Track Designation by the United States Food
and Drug Administration (FDA)
- Advanced novel Zika vaccine
candidate into Phase 1 clinical development
- Finalized new $32.8 million IXIARO®
supply contract with the U.S. Department of Defense in January
20256
Key Upcoming Catalysts:
- Lyme disease Phase 3 first data
readout by the end of 2025
- Further chikungunya vaccine
approvals, including the first endemic country (Brazil) and
adolescent label extensions for IXCHIQ® in major travel
markets
- Initiation of Phase 3 pediatric
trial of IXCHIQ® to support further potential label expansion
- Phase 2b efficacy data from Human
Challenge Study (CHIM) of tetravalent Shigella vaccine candidate in
mid-2025 and launch of pediatric study
- Phase 1 results for Zika vaccine
candidate in the first half of 2025
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 three proprietary travel vaccines, including
the world’s first chikungunya vaccine, as well as certain
third-party vaccines.Revenues from our growing commercial business
help fuel the continued advancement of our vaccine pipeline. This
includes the only Lyme disease vaccine candidate in advanced
clinical development, which is partnered with Pfizer, the world’s
most clinically advanced Shigella vaccine candidate, as well as
vaccine candidates against the Zika virus and other global public
health threats. More information is available at
www.valneva.com.
Valneva
Investor and Media ContactsLaetitia Bachelot-FontaineVP,
Global Communications and European Investor RelationsM +33 (0)6
4516
7099investors@valneva.com |
Joshua
Drumm, Ph.D.VP, Global Investor Relations M +001 917 815
4520joshua.drumm@valneva.com |
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Forward-Looking Statements
This press release contains certain
forward-looking statements relating to the business of Valneva,
including with respect to business partnerships and the progress,
timing, results and completion of technology transfer and
regulatory approvals in additional markets. 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 in this press release will in fact
be realized. Valneva is providing this information as of the date
of this press release and disclaims 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 The financial figures presented in this release are
preliminary and unaudited. The final audited financial results,
which remain subject to approval by the Board of Directors, are
expected to be published on March 20.2 Valneva Announces Sale of
Priority Review Voucher for $103 Million - Valneva3 Valneva
Announces the Success of its Private Placement Raising
approximately €60 Million - Valneva4 CEPI Expands Partnership with
Valneva with a $41.3 Million Grant to Support Broader Access to the
World’s First Chikungunya Vaccine - Valneva5 Valneva and LimmaTech
Enter into a Strategic Partnership to Accelerate the Development of
the World’s Most Clinically Advanced Tetravalent Shigella Vaccine
Candidate - Valneva6 Valneva Announces New IXIARO® Supply Contract
with the U.S. Government Worth a Minimum of $32.8 Million -
Valneva
- 2025_02_18_FY2024_RevCash_PR_EN_Final
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