Valneva Reports Full Year 2023 Revenue and Cash, Provides First
2024 Guidance
Valneva Reports Full Year 2023 Revenue
and Cash,
Provides First 2024 Guidance
Total revenues of €153.7 million,
including product sales of €144.6 million
- Product sales surpassed
pre-pandemic (2019) sales by 12% and 2022 sales by 26%
- Excluding COVID-19 vaccine sales,
product sales grew by 63% compared to 2022
Cash position of €126.1 million at
December 31, 2023
- Excludes recent sale of the
Priority Review Voucher (PRV) for $103 million (€95
million)1
- Reflects significant payments
related to the Phase 3 Lyme disease study, for which Valneva’s cost
contributions are expected to be completed in the first half
20242
First full year 2024
guidance
- Product sales expected between €150
million and €180 million, reflecting continued revenue growth for
proprietary products and IXCHIQ®’s launch-year sales,
despite anticipated supply constraints for third-party products and
IXIARO®
- Other income anticipated between
€95 million and €105 million, including the PRV sold in early 2024
for €95 million
- Expected R&D expenses between
€65 million and €90 million
Saint-Herblain (France), February 15,
2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) a
specialty vaccine company, today reported its revenue and cash
balance for the full year 2023 and provided first full year 2024
sales and R&D expense guidance. The Company will publish its
2023 audited consolidated financial statements on March 20,
2024.
Peter Bühler, Valneva’s Chief Financial
Officer, commented, “In 2023, Valneva successfully
executed on key strategic objectives despite a difficult economic
environment. Our chikungunya vaccine IXCHIQ® became the
world’s first licensed chikungunya vaccine available to address
this unmet medical need and we also managed to surpass our
pre-pandemic product sales. Our objective for 2024 is to continue
capitalizing on the travel industry recovery to deliver further
commercial growth for our existing proprietary products and
generate first sales from our chikungunya vaccine
IXCHIQ®. With the recent successful sale of our PRV, we
are entering 2024 in a good financial position to support our
commercial and R&D objectives.”
Revenues
Valneva’s total revenues were €153.7 million in 2023 compared
to €361.3 million in 2022. Total revenues in 2022 included
€280.0 million of revenue recognition mainly related to the
COVID-19 supply agreements in the prior year.
Valneva’s total product sales reached €144.6
million in 2023 compared to €114.8 million in 2022. Currency
fluctuations of €2.8 million adversely impacted product sales.
COVID-19 vaccine sales in 2023 amounted to €7.7 million
compared to €29.6 million in 2022. Excluding COVID-19, product
sales reached €138.9 million in 2023 compared to €85.2 million
during the comparator period of 2022, an increase of 63%.
IXIARO®/JESPECT® sales
were €73.5 million in 2023 compared to €41.3 million in 2022. The
78% increase in sales is primarily the result of the continued
travel market recovery, as well as price increases. The increase in
IXIARO®/JESPECT® product sales included an
adverse €1.5 million foreign currency impact.
DUKORAL® sales were
€29.8 million in 2023 compared to €17.3 million in 2022.
This 72% increase is also a result of the significant recovery in
the private travel markets and price increases. Foreign currency
fluctuations reduced DUKORAL® sales by
€0.9 million.
Third Party product sales were €35.7 million in
2023 compared to €26.5 million in 2022, a 34% increase which
was mainly driven by sales of
Rabipur®/RabAvert® and Encepur®
under the distribution agreement with Bavarian Nordic.
Other revenues, including revenues from
collaborations, licensing and services amounted to
€9.1 million in 2023 compared to €246.5 million in 2022.
Other revenues in 2022 included COVID-related one-time effects of
€280.0 million consisting of released refund liability as a result
of the settlement with the UK government, as well as released
non-refundable advance payments from European Member States,
partially offset by €45.9 million of negative revenue
resulting from an increase in the refund liability linked to the
amended VLA15 collaboration and license agreement with Pfizer.
Liquidity
Cash and cash equivalents were €126.1 million as of December 31,
2023, compared to €289.4 million as of December 31, 2022. Cash
and Cash equivalents in 2023 included the drawing of a total of
$100 million from the Deerfield & OrbiMed loan agreement as
well as significant payments made to Pfizer related to the
companies’ Phase 3 Lyme disease study “VALOR”. They, however,
excluded $103 million of proceeds from the PRV which Valneva sold
in February 2024.
2024 Guidance
Product sales in 2024 are expected between €150 million and €180
million, subject to availability of IXIARO® and
third-party products, as well as IXCHIQ®’s launch-year
sales performance in the United States. 2024 product sales are
expected to reflect further growth of the Company’s existing
proprietary product sales (IXIARO®,
DUKORAL®), lower third-party product sales due to supply
constraints as well as first IXCHIQ® sales. Other
revenues are expected at similar levels as compared to 2023. Other
income is anticipated between €95 million and €105 million,
including the PRV sold in early 2024 for €95 million. The Company
expects R&D expenses between €65 million and €90 million,
mainly driven by investments in earlier stage R&D pipeline
programs and ongoing clinical development activities for the
Company’s chikungunya vaccine.
About Valneva SE
We 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 and only 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, 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 Contacts
Laetitia Bachelot-Fontaine
VP, Global Communications and European Investor Relations
M +33 (0)6 4516 7099
investors@valneva.com
|
Joshua Drumm, Ph.D.
VP, Global Investor Relations
M +001 917 815 4520
joshua.drumm@valneva.com
|
|
|
Forward-Looking Statements
This press release contains certain forward-looking statements
relating to the business of Valneva, including with respect to
expected total revenues and product sales for full fiscal year 2023
and guidance for certain financial results in fiscal year 2024. 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
indicative of future results. 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 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 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 other global events, the ability to
obtain or maintain patent or other proprietary intellectual
property protection, the cancellation of existing contracts, and
the impact of a pandemic, the occurrence of any of which could
substantially harm Valneva’s business, financial condition,
prospects and results of operations. 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 this press release as of
the date hereof 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 Valneva Announces Sale of Priority Review Voucher
for $103 Million - Valneva
2 Valneva and Pfizer Enter into an Equity Subscription
Agreement and Update Terms of Collaboration Agreement for Lyme
Disease Vaccine Candidate VLA15
- 2024_02_15_VLA_2023_RevCash_PR_EN_Final
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