Valneva Reports Full Year 2024 Results and Provides Business
Updates and Outlook
- Met 2024
growth targets for product sales (+13% vs 2023) and total revenues
(+10% vs 2023)
- Strong
year-end cash position of €168.3 million including sale of Priority
Review Voucher1, successful private
placement and 67% reduction in operating cash burn
-
Substantial clinical and regulatory progress in 2024;
further data readouts, product approvals and label extensions
anticipated 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), March 20,
2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a
specialty vaccine company, today reported its consolidated
financial results for the year ended December 31, 2024 and provided
key corporate updates and guidance for its future results. The
consolidated financial results2 are available on the
Company’s website (Financial Reports – Valneva).
Valneva will provide a live webcast of its
full-year 2024 results conference call beginning at 3 p.m. CET/10
a.m. EDT today. This webcast will also be available on the
Company’s website. Please refer to this link:
https://edge.media-server.com/mmc/p/4n8iegdt
2024 Financial Performance
- Product sales 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%
- Total revenues were €169.6 million
for the year ended December 31, 2024 compared to
€153.7 million for the year ended December 31, 2023, an increase of
10%
- Net loss of €12.2 million compared
to a 2023 net loss of €101.4 million, including proceeds from the
Priority Review Voucher (PRV) sale
- 67% reduction in operating cash
burn (€67.2 million in 2024 compared to €202.7 million in
2023)
- 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 was
significantly augmented by the sale of the PRV and successful
private placement3.
Financial Outlook
The Company provides the following guidance on its future
results:
- Product sales expected to grow to
€170-180 million in 2025, driving positive cash-flows for the
overall commercial business
- Total revenues expected to reach
€180-190 million in 2025
- Total R&D investments expected
between €90 - €100 million in 2025, which will be partially offset
by grant fundings and anticipated R&D tax credits
- Continued stringent focus on cash
management supporting sufficient cash runway to reach key
inflection points; targeting more than 50% lower operating cash
burn in 2025
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 advancements to potentially 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.”
R&D, Regulatory, and Strategic
Highlights
- Continued to progress Lyme disease
program according to plan, including completion of primary
vaccination series (three doses) in ongoing Phase 3 study VALOR,
reporting of further positive Phase 2 booster results, and
publication of Phase 2 data in the Lancet
- Secured three additional regulatory
approvals (Canada, Europe, UK) for world’s first chikungunya
vaccine, IXCHIQ®; filed adolescent label extension
submissions and received positive opinion from the European
Medicines Agency (EMA); awarded new $41.3 million grant from the
Coalition for Epidemic Preparedness (CEPI)4 and signed
exclusive license agreement with the Serum Institute of India
(SII)5 for Asia
- Augmented clinical pipeline with a
leading tetravalent Shigella vaccine candidate6 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 (DoD) in January 20257
Key Upcoming Milestones:
- First data readout for Lyme disease
Phase 3 VALOR study expected at 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
- Launch of Phase 2 pediatric study
of tetravalent Shigella vaccine candidate in the first half of 2025
and Phase 2b efficacy data from Human Challenge Study (CHIM)
- Phase 1 results for Zika vaccine
candidate
Financial Information
€ in million |
12 months ending December 31, |
|
2024 |
2023 |
Total Revenues |
169.6 |
153.7 |
Product Sales |
163.3 |
144.6 |
Net profit/(loss) |
(12.2) |
(101.4) |
Adjusted EBITDA8 |
32.9 |
(65.2) |
Cash |
168.3 |
126.1 |
Commercial Portfolio
Valneva’s commercial portfolio is composed of
three vaccines, IXIARO®/JESPECT®,
DUKORAL® and recently launched IXCHIQ®. The
Company also distributes certain third-party products in countries
where it operates its own marketing and sales infrastructure.
JAPANESE ENCEPHALITIS VACCINE
IXIARO®/JESPECT®
In 2024, IXIARO®/JESPECT®
sales increased by 28% to €94.1 million, showing double-digit sales
growth to both travelers and the DoD compared to 2023.
In 2024, Valneva supplied additional doses of
IXIARO® to the DoD under the contract signed in
September 2023, which allowed the DoD to purchase additional doses
during the following twelve months.
In January 2025, Valneva secured a new
$32.8 million contract with the DoD9. Similar to
previous contracts, it includes the possibility to purchase
additional doses during the following twelve months.
CHOLERA /
ETEC10-DIARRHEA
VACCINE DUKORAL®
In 2024, DUKORAL® sales grew 8%
reaching €32.3 million supported by increased sales in Canada, the
biggest travel market for DUKORAL®, as well as improved
product availability resulting in replenishment orders from
indirect markets.
CHIKUNGUNYA VACCINE
IXCHIQ®
IXCHIQ® is the world’s first licensed
chikungunya vaccine available to address this significant unmet
medical need. It is approved in the U.S.11,
Europe12, Canada13 and the United
Kingdom14 for the prevention of disease caused by the
chikungunya virus in individuals 18 years of age and older.
IXCHIQ® was launched in the U.S.,
Canada and France in March, October and November 2024,
respectively. Considering IXCHIQ® is the first vaccine
worldwide against this unmet need, Valneva’s commercial teams
focused in 2024 on raising awareness on the disease, shaping the
market and booking first sales. The Company recognized initial
sales of €3.7 million in 2024.
Since the start of 2025, Valneva has focused on
ramping up sales and launching the vaccine in additional countries,
including the Nordics and Austria. A marketing application is under
review in Brazil, which would represent the first approval in an
endemic country. Label extension applications are also under review
in the U.S., Europe and Canada to potentially extend the use of
IXCHIQ®, which is currently approved in adults, to
adolescents 12 to 17 years of age. In February 2025, the Committee
for Medicinal Products for Human Use (CHMP) of EMA adopted a
positive opinion recommending authorization of a label extension
for IXCHIQ® in adolescents 12 years of age and
older15.
Additionally, Valneva recently expanded its
partnership with CEPI16 to support broader access to the
vaccine in Low-and-Middle-Income Countries (LMICs), post-marketing
trials and potential label extensions in children, adolescents and
pregnant women. CEPI will provide Valneva up to $41.3 million of
additional funding over the next five years, with support from the
EU’s Horizon Europe program.
Within the framework of its CEPI agreement,
Valneva also announced an exclusive license agreement with the
Serum Institute of India (SII)17 to enable supply of its
chikungunya vaccine in Asia.
In parallel, Valneva is continuing to generate
additional clinical data to support label extensions and further
establish IXCHIQ® as a differentiated brand. The Company
notably reported positive three-year Phase 3 persistence data
demonstrating antibody persistence in 96% of study participants,
positive twelve-month Phase 3 data in adolescents and the world’s
first positive Phase 2 pediatric data for a chikungunya
vaccine.
These data supporting potential label
extensions, combined with anticipated ex-U.S. and endemic product
launches are expected to significantly expand access of
IXCHIQ® and contribute to its future revenues.
THIRD-PARTY DISTRIBUTION
Valneva distributes certain third-party vaccines
in countries where it operates its own marketing and sales
infrastructure. In 2024, third-party sales decreased by €2.5
million to €33.2 million compared to €35.7 million in
2023, as a result of third parties’ supply constraints in the first
half of the year.
As previously communicated, Valneva expects to
gradually wind down third-party sales to less than 5% of overall
product sales by 2026 / 2027, resulting in overall gross margin
improvement.
Clinical Vaccine Candidates
LYME DISEASE VACCINE CANDIDATE – VLA15
Phase 3 primary vaccination completed; booster
vaccinations ongoing
VLA15 is the Lyme disease vaccine candidate
which has advanced the furthest along the clinical development
timeline, with two Phase 3 trials in progress. It leverages an
established mechanism of action of antibodies to Borrelia outer
surface protein A (OspA) preventing tick-borne Lyme borreliosis
transmission and the vaccine antigens target the six most prevalent
serotypes.
Pfizer is currently executing the Phase 3 field
efficacy study, VALOR (Vaccine Against Lyme for Outdoor
Recreationists). Enrollment in the trial was completed in December
2023, and primary vaccination series was completed in July
202418. Participants will be monitored for the
occurrence of Lyme disease cases and first results are expected at
the end of 2025.
Pfizer aims to submit a Biologics License
Application (BLA) to the U.S. FDA and Marketing Authorization
Application (MAA) to the European Medicines Agency in 2026, subject
to positive Phase 3 data. If VLA15 is approved and commercialized,
Valneva will be eligible to receive $143 million in initial
milestones from Pfizer, plus ongoing sales royalties ranging from
14% to 22% and an additional $100 million in cumulative sales
milestones.
Based on the agreement with Pfizer, Valneva’s
expected cost contributions for the Lyme disease program were
completed in the second quarter of 2024, contributing to a
substantially lower cash burn in the second half of the year.
Additionally, Valneva and Pfizer reported
further positive Phase 2 results after a second booster dose in
September 202419 and announced publication of Lyme
disease Phase 2 trials, VLA15-201 and VLA15-202 trial, in the
peer-reviewed medical journal, The Lancet Infectious
Diseases in June 202420.
SHIGELLA VACCINE CANDIDATE –
S4V2
The world’s most clinically advanced
tetravalent Shigella vaccine candidate
S4V2 is a tetravalent bioconjugate vaccine
candidate against shigellosis, a diarrheal infection caused by
Shigella bacteria, under development in collaboration with
LimmaTech Biologics AG.
Shigellosis is the second leading cause of fatal
diarrheal disease worldwide. It is estimated that up to 165 million
cases of disease and an estimated 600,000 deaths are attributed to
Shigella each year21, particularly among children in
LMICs. No approved Shigella vaccine is currently available outside
of Russia or China, where two vaccines exist for limited use. The
development of Shigella vaccines has been identified as a priority
by the World Health Organization (WHO)22. In October
2024, the U.S. FDA granted Fast Track designation to S4V2,
recognizing its potential to address a serious condition and fill
an unmet medical need23.
In November 2024, Valneva and LimmaTech
announced the launch of a Phase 2b controlled human infection model
(CHIM) study to assess the safety and preliminary efficacy in
approximately 120 healthy Shigella-naïve participants aged 18 to 50
years at three sites in the United States24. In addition
to the CHIM study, LimmaTech is planning to initiate a Phase 2
pediatric study in LMICs in the first half of 2025. Subject to
positive results, Valneva will assume all further development,
including CMC (chemistry, manufacturing and controls) and
regulatory activities, and be responsible for its commercialization
worldwide, if approved. The global market for a vaccine against
Shigella is estimated to exceed $500 million
annually25.
ZIKA VACCINE CANDIDATE –
VLA1601
Phase 1 ongoing with novel vaccine
candidate
VLA1601 is a novel adjuvanted inactivated
vaccine candidate against the mosquito-borne disease caused by the
Zika virus (ZIKV). In March 2024, Valneva initiated a Phase 1
clinical trial to investigate the safety and immunogenicity of
VLA160126. The randomized, placebo-controlled, Phase 1
trial, VLA1601-102, is enrolling approximately 150 participants
aged 18 to 49 years in the United States. Participants will receive
a low, medium or high dose of VLA1601. In addition, the low dose of
VLA1601 will be evaluated with an additional adjuvant. Sentinel
recruitment and vaccinations have been completed and data from the
trial are expected this year.
Zika disease outbreaks have been reported in
tropical Africa, Southeast Asia, the Pacific Islands, and, since
2015, in the Americas. Zika virus transmission persists in several
countries in the Americas and in other endemic regions, such as
India. To date, a total of 89 countries and territories have
reported evidence of mosquito transmitted Zika virus
infection27; however, surveillance remains limited
globally. There are no preventive vaccines or effective treatments
available and, as such, Zika remains a public health threat and is
included in the FDA’s Tropical Disease Priority Review Voucher
Program28.
A vaccine against ZIKV could be a valuable
addition to Valneva’s portfolio against mosquito-borne diseases,
which already includes IXCHIQ® and
IXIARO®.
Full Year 2024 Financial
Review
(Audited29, consolidated under IFRS)
Revenues
Valneva’s total revenues were €169.6 million in 2024 compared to
€153.7 million in 2023.
Valneva’s total product sales reached €163.3
million in 2024 compared to €144.6 million in 2023. Currency
fluctuations of €0.5 million positively impacted product sales.
Excluding 2023 COVID-19 vaccine sales, 2024 vaccine sales grew by
€24.3 million or 18% year-over-year.
IXIARO/JESPECT® sales were €94.1
million in 2024 compared to €73.5 million in 2023. The 28% increase
reflects double digit growth in sales to both travelers (19%) and
the US Military. Currency fluctuations of €0.4 million positively
impacted sales of IXIARO/JESPECT® in 2024.
DUKORAL® sales were €32.3 million in
2024 compared to €29.8 million in 2023. This 8% increase was due to
sales growth achieved in Canada, the biggest travel market for
DUKORAL® as well as improved product availability
resulting in replenishment orders from indirect markets.
Following adoption by the U.S. Centers for
Disease Control of the recommendations of the U.S. Advisory
Committee for Immunization Practice (ACIP) at the beginning of
March 2024, Valneva recognized initial sales for IXCHIQ®
of €3.7 million in 2024.
Third Party product sales were €33.2 million in
2024 compared to €35.7 million in 2023. This 7% decrease was mainly
driven by lower sales of Rabipur®/RabAvert®
and Encepur® under the distribution agreement with
Bavarian Nordic, as a result of external supply constraints in the
first half of 2024.
Other revenues, including revenues from
collaborations, licensing and services amounted to €6.3 million in
2024 compared to €9.1 million in 2023. The reduction mainly
resulted from lower revenue recognition related to the R&D
collaboration activities for chikungunya with Instituto Butantan as
well as recognition of the final settlement related to the COVID-19
supply agreement with the Kingdom of Bahrain in the fourth quarter
of 2023.
Operating Result and adjusted
EBITDA
Costs of goods and services sold (COGS) were €98.5 million in 2024.
The gross margin on commercial product sales, excluding
IXCHIQ®, amounted to 50.6% compared to 46.0% in 2023.
Product gross margins continued recovering during the second half
of 2024 as the first-half supply shortages were resolved. COGS of
€36.7 million related to IXIARO® product sales, yielding
a product gross margin of 61.0%. COGS of €19.8 million related to
DUKORAL® product sales, yielding a product gross margin
of 38.7%. Of the remaining COGS in 2024, €22.3 million related to
the third-party products distribution business, €7.2 million to
IXCHIQ® and €8.6 million to cost of services. In 2023,
overall COGS were €100.9 million, of which €90.7 million related to
cost of goods and €10.2 million related to cost of services.
Research and development expenses amounted to
€74.1 million in 2024, compared to €59.9 million in 2023. This
increase was mainly driven by higher costs related to the ongoing
transfer of operations into the new Almeida manufacturing
facility.
Marketing and distribution expenses in 2024
amounted to €52.4 million compared to €48.8 million in 2023. The
increase was mainly related to higher staff costs to support
product sales growth across the direct markets.
In 2024, general and administrative expenses
decreased to €42.8 million from €47.8 million in 2023. The main
driver was a strategic reduction in expenses relating to consulting
and professional services.
During 2024, Valneva recorded a net gain of
€90.8 million from the sale of the PRV. The gross proceeds of $103
million were reduced by transaction costs as well as contractual
payment obligations related to the sale of the PRV.
Other income, net of other expenses, decreased
to €20.7 million in 2024 from €21.5 million in 2023. In 2024,
activities related to the first chikungunya-related grant awarded
by CEPI in 2019 were completed and spending related to the second
grant obtained in 2024 ramped up during the second half of 2024,
resulting in a net decrease. Additionally, 2023 was positively
impacted by a one-time income from a one-time settlement payment
from a COVID-19 supplier.
Valneva recorded an operating profit of €13.3
million in 2024 compared to an operating loss of €82.1 million in
2023. The 2024 profit was mainly the result of the one-time PRV
sale.
Adjusted EBITDA (as defined below) profit in
2024 was €32.9 million, whereas in 2023 an adjusted EBITDA loss of
€65.2 million was recorded.
Net Result
In 2024, Valneva generated a net loss of €12.2 million compared to
a net loss of €101.4 million in 2023. The improvement resulted from
the one-time sale of the PRV in February 2024.
Finance expense and currency effects in 2024
resulted in a net finance expense of €24.8 million, compared to a
net finance expense of €16.5 million in 2023. This increase was
mainly due to foreign exchange losses of €3.2 million in 2024
compared to a foreign exchange profit of €5.6 million in 2023
primarily related to the development of the USD exchange rate.
Higher interest expenses on loans resulting from the amendment of
the Deerfield Management Company and OrbiMed (D&O) loan
facility were largely offset by no longer incurring interest
charges on Pfizer refund liabilities following fulfillment of all
agreed-upon Lyme-related refund liabilities.
Cash Flow and Liquidity
Net cash used in operating activities amounted to €67.2 million in
2024 compared to €202.7 million in 2023. Cash outflows in 2024 were
largely derived from the operating loss for the period (excluding
gains from PRV sale) amounting to €77.5 million and from working
capital in the amount of €11.4 million, which includes Valneva’s
final agreed-upon payments for the Lyme disease clinical program.
In 2023, changes in working capital were higher, mainly related to
higher payments to Pfizer in conjunction with the Lyme disease
program, reducing the refund liability.
Cash inflows from investing activities amounted
to €76.9 million in 2024 compared to cash outflows of €20.6 million
in 2023. Cash outflows from construction activities across
production sites in Scotland and Sweden amounting to €13.9 million
in 2024 and €14.2 million in 2023 were included. The sale of the
PRV positively impacted 2024 by €90.8 million.
Net cash generated from financing activities
decreased to €30.7 million in 2024 from €63.1 million in 2023. This
increase was primarily due to €57.1 million of net proceeds from
the private placement completed in the third quarter of 2024, while
2023 included proceeds from the increase of the D&O loan
facility.
Cash and cash equivalents were €168.3 million as
of December 31, 2024 compared to €126.1 million as of December 31,
2023.
Non-IFRS Financial Measures
Management uses and presents IFRS results as
well as the non-IFRS measure of Adjusted EBITDA to evaluate and
communicate its performance. While non-IFRS measures should not be
construed as alternatives to IFRS measures, management believes
non-IFRS measures are useful to further understand Valneva’s
current performance, performance trends, and financial
condition.
Adjusted EBITDA is a common supplemental measure
of performance used by investors and financial analysts. Management
believes this measure provide additional analytical tools. Adjusted
EBITDA is defined as earnings (loss) for the period before income
tax, finance income/expense, foreign exchange gain/(loss), results
from investments in associates, amortization, depreciation, and
impairment (excluding impairment loss of disposal).
A reconciliation of Adjusted EBITDA to net loss
for the period, which is the most directly comparable IFRS measure,
is set forth below:
€ in million |
Twelve months ending December 31 |
(consolidated per IFRS) |
2024 |
2023 |
Loss for the period |
(12.2) |
(101.4) |
Add: |
|
|
Income tax expense |
0.8 |
2.8 |
Total Finance income |
(2.4) |
(1.2) |
Total Finance expense |
24.0 |
23.3 |
Foreign exchange (gain)/loss – net |
3.2 |
(5.6) |
Result from investments in associates |
- |
- |
Amortization |
4.9 |
5.8 |
Depreciation |
14.7 |
11.8 |
Impairment |
- |
(0.7) |
Adjusted EBITDA |
32.9 |
(65.2) |
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
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 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 business partnerships, clinical trials,
technology transfer, regulatory approvals, sales and spending. 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 (including in connection with changes in leadership at the
national or agency level), competition in general, currency
fluctuations, the impact of global economic and political events,
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 Valneva Announces Sale of Priority Review Voucher
for $103 Million - Valneva
2 The audit procedures on the consolidated financial statements
have been performed. The audit report will be issued upon
finalization of procedures regarding the filing.
3 Valneva Announces the Success of its Private Placement
Raising approximately €60 Million - Valneva
4 CEPI Expands Partnership with Valneva with a $41.3
Million Grant to Support Broader Access to the World’s First
Chikungunya Vaccine - Valneva
5 Valneva Successfully Expands Access to Asia for its
Chikungunya Vaccine with Serum Institute of India -
Valneva
6 Valneva and LimmaTech Enter into a Strategic
Partnership to Accelerate the Development of the World’s Most
Clinically Advanced Tetravalent Shigella Vaccine Candidate -
Valneva
7 Valneva Announces New
IXIARO® Supply Contract with the U.S.
Government Worth a Minimum of $32.8 Million - Valneva
8 For additional information on Adjusted EBITDA, please refer
to the “Non-IFRS Financial Measures” section at the end of the
PR
9 Valneva Announces New
IXIARO® Supply Contract with the U.S.
Government Worth a Minimum of $32.8 Million - Valneva
10 Indications differ by country - Please refer to Product /
Prescribing Information (PI) / Medication Guide approved in your
respective countries for complete information, incl. dosing, safety
and age groups in which this vaccine is licensed, ETEC =
Enterotoxigenic Escherichia coli (E. Coli) bacterium.
11 Valneva Announces U.S. FDA Approval of World’s
First Chikungunya Vaccine, IXCHIQ® -
Valneva
12 Valneva Receives Marketing Authorization in Europe
for the World’s First Chikungunya Vaccine,
IXCHIQ® - Valneva
13 Valneva Announces Health Canada Approval of the
World’s First Chikungunya Vaccine, IXCHIQ®
- Valneva
14 Valneva Receives Marketing Authorization in the UK
for the World’s First Chikungunya Vaccine,
IXCHIQ® - Valneva
15 Valneva Receives EMA’s Positive CHMP Opinion for
Adolescent Label Extension for Chikungunya Vaccine
IXCHIQ® - Valneva
16 CEPI Expands Partnership with Valneva with a $41.3
Million Grant to Support Broader Access to the World’s First
Chikungunya Vaccine - Valneva
17 Valneva Successfully Expands Access to Asia for its
Chikungunya Vaccine with Serum Institute of India -
Valneva
18 Phase 3 VALOR Lyme Disease Trial: Valneva and
Pfizer Announce Primary Vaccination Series Completion -
Valneva
19
https://valneva.com/press-release/valneva-and-pfizer-report-further-positive-phase-2-booster-results-for-lyme-disease-vaccine-candidate/
20 Valneva Announces Publication of Lyme Disease Phase
2 Trials in the Lancet Infectious Diseases
21 Shigellosis | CDC Yellow Book 2024
22 Immunization, Vaccines and Biologicals
(who.int)
23 Valneva and LimmaTech Awarded FDA Fast Track
Designation for Tetravalent Shigella Vaccine Candidate S4V -
Valneva
24 Valneva and LimmaTech Announce First Vaccination in
Phase 2b Human Challenge Study of Tetravalent Shigella Vaccine
Candidate S4V2
25 LEK analysis
26 Valneva Initiates Phase 1 Trial of
Second-Generation Zika Vaccine Candidate - Valneva
27 Zika virus disease (who.int)
28 Tropical Disease Priority Review Voucher Program |
FDA
29 The audit procedures on the consolidated financial
statements have been performed. The audit report will be issued
upon finalization of procedures regarding the filing.
- 2025_03_20_FY_2024_Results_PR_EN_Final
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