Valneva Reports Half Year 2024 Financial Results and Provides
Corporate Updates
First-Half Sales Performance in Line with
Full-Year 2024 Guidance
- Total revenues of
€70.8 million, including product sales of €68.3 million, in
line with anticipated supply and sales phasing
- Net Profit of €34.0 million,
including proceeds from PRV sale
- Operating profit of €46.7 million
compared to an operating loss of €35.0 million in the first half of
2023
- Cash position of €131.4
million
- Substantially
lower cash burn expected in the second half of 2024 as Valneva
completed its cost contributions to the agreed R&D budget for
its partnered Lyme disease program in the second quarter
- Significantly extended cash runway
with update of debt financing agreement1
Full-year 2024 Financial Guidance
Confirmed
- Expected total revenues between
€170 million and €190 million, including €160 million to
€180 million of product sales
- Expected R&D investments
between €60 million and €75 million
- Expected Other income between €100
million and €110 million, including €95 million from the PRV
sale
Strategic Pipeline Expansion, Strong
Clinical and Regulatory Execution
- Exclusive
worldwide license for S4V Shigella vaccine candidate,
adding an attractive Phase 2 clinical asset to Valneva’s R&D
pipeline without impacting full-year or mid-term financial
guidance2
- Additional marketing authorizations
for single-shot IXCHIQ® granted in Europe and Canada
ahead of initial guidance; Ongoing regulatory reviews in the UK and
Brazil; Recommended by ACIP and adopted by U.S. CDC3
- New CEPI grant4 of $41.3
million contributes significantly to Phase 4 costs and other
studies supporting broader access to the world’s first chikungunya
vaccine
- Reported positive six-month data
for Phase 3 adolescent study of IXCHIQ®5;
expects to submit label extensions for 12 to 17 years old in the
U.S., Europe and Canada in the second half of 2024
- IXCHIQ® two-year
antibody persistence data published in the Lancet Infectious
Diseases
- IXCHIQ® pediatric Phase
2 study fully enrolled
- Completed primary vaccinations
(three doses) of VALOR Lyme disease Phase 3 trial
participants6
- Initiated Phase 1 clinical trial
for second-generation Zika vaccine candidate7
Financial Information
(Unaudited results, consolidated per IFRS)
€ in million |
6 months ended June 30, |
|
2024 |
2023 |
Total revenues |
70.8 |
73.7 |
Product sales |
68.3 |
69.7 |
Net profit / loss |
34.0 |
(35.0) |
Adjusted EBITDA8 |
56.2 |
(28.3) |
Cash |
131.4 |
204.4 |
Saint-Herblain (France), August 13,
2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a
specialty vaccine company, today reported its consolidated
financial results for the first half of the year, ended June 30,
2024. The half year financial report, including the condensed
consolidated interim financial report and the half year management
report, is available on the Company’s website (Financial Reports –
Valneva).
Valneva will provide a live webcast beginning at
3 p.m. CEST / 9 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/mmuf83o5
Peter Bühler, Valneva’s Chief Financial
Officer, commented, “Our first half sales performance is
in line with our expectations. We aim to further capitalize on the
travel industry recovery as we focus on ramping up sales for
IXCHIQ® to support our commercial growth, while
continuing to execute on our key R&D and regulatory milestones.
The successful sale of our PRV and deferral of our loan
reimbursement allow us to maintain a solid cash position and, with
completion of our payments for the Lyme disease program in the
second quarter, we anticipate a significantly lower cash burn in
2024.”
Commercial Portfolio
Valneva’s commercial portfolio is composed of
three travel 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.
Valneva’s sales in the first half of 2024 were
€68.3 million compared to €69.7 million (€64.0 million
excluding final COVID-19 vaccine sales) in the first half of 2023.
While product sales grew meaningfully in the second quarter and
included first sales for IXCHIQ®, first half 2024 sales
were affected by previously reported supply constraints for
IXIARO® and third-party products.
JAPANESE ENCEPHALITIS VACCINE
IXIARO®/JESPECT®
In the first half of 2024,
IXIARO®/JESPECT® sales increased by 38% to
€41.9 million compared to €30.3 million in the first half of 2023.
The increase primarily reflects sales to the U.S. military, which
were minimal in the first half of 2023, as well as increased sales
to travelers.
CHOLERA / ETEC9-DIARRHEA
VACCINE DUKORAL®
In the first half of 2024, DUKORAL®
sales were €14.9 million compared to €17.1 million in the
first half of 2023. The decrease was due to reduced marketing
investments while Valneva’s new manufacturing site in Sweden
underwent regulatory evaluation and approval.
CHIKUNGUNYA VACCINE
IXCHIQ®
IXCHIQ® is the world’s first and only
licensed chikungunya vaccine available to address this significant
unmet medical need. The vaccine is now approved in the U.S.
10, Europe11, and Canada12 for the
prevention of disease caused by the chikungunya virus in
individuals 18 years of age and older. The U.S. launch is underway
while first sales in Canada and Europe are anticipated in the
fourth quarter of 2024.
Following adoption of the U.S. Advisory
Committee on Immunization Practices (ACIP)’s recommendations by the
U.S. Centers for Disease Control and Prevention (CDC)13
at the beginning of March 2024, Valneva recognized initial sales of
€1.0 million in the first half of 2024. Key launch metrics,
including stocking and re-stocking across all sales channels,
active customer accounts, as well as reimbursement for
IXCHIQ® by commercial and MediCare insurance plans
continue to track in line with expectations.
In addition to ramping up sales, Valneva is
focusing on expanding the vaccine’s label and access. The Company
expects marketing authorizations in the UK and Brazil in the second
half of 2024 and recently expanded its partnership with
CEPI14 to support broader access to the vaccine in Low
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 European
Union’s (EU) Horizon Europe program.
Based on positive pivotal six-month Phase 3 data
reported in May 202415, Valneva expects to file for
potential label extensions for use in adolescents aged 12 to 17
years in the second half of 2024. These data show that a
single-dose vaccination with IXCHIQ® induces a high and
sustained immune response in 99.1% of adolescents, and that the
vaccine was generally well tolerated. Conducted in Brazil in
collaboration with Instituto Butantan, the trial is also expected
to support licensure of the vaccine in Brazil, which would be the
first potential approval for use in endemic populations.
Additionally, Valneva recently completed
enrollment of a Phase 2 pediatric trial, VLA1553-221, in children
aged 1 to 11 years16, designed to support a Phase 3
pivotal pediatric study and potential future label extension to
this age group.
The peer-reviewed medical journal, The Lancet
Infectious Diseases, also just published the vaccine’s Phase 3
antibody persistence results two years after vaccination with a
single dose. The data show that IXCHIQ®’s robust immune
response was sustained for two years by 97% of participants and was
equally durable in younger and older adults17. These
data, which further support the anticipated long-term durability of
the immune response, will also be used to potentially expand the
vaccine’s current label. Valneva will continue to measure antibody
persistence for a period of at least five years and expects to
report three-year durability results later this year.
THIRD-PARTY
DISTRIBUTION
Valneva distributes certain third-party vaccines
in countries where it operates its own marketing and sales
infrastructure. During the first half of 2024, third-party sales
decreased by 37% to €10.5 million compared to €16.5 million in
the first half of 2023 as a result of anticipated supply
constraints.
Valneva expects third-party sales to gradually
wind down to less than 5% of overall product sales by 2026/2027,
allowing the Company to improve gross margins.
Clinical Vaccine Candidates
LYME DISEASE VACCINE CANDIDATE –
VLA15
Phase 3 primary vaccination completed
Valneva and Pfizer are developing VLA15, a Phase
3 vaccine candidate targeting Borrelia, the bacterium that causes
Lyme disease. VLA15 is the only Lyme disease program in late-stage
clinical development today and has received Fast Track designation
from the FDA. VLA15 is a multivalent recombinant protein vaccine
that targets six serotypes of Borrelia representing the most common
strains found in the United States and Europe.
Valneva and Pfizer reported results for the
Phase 2 clinical trials of VLA15 in both adult and pediatric
populations, in which high levels of antibodies against all six
serotypes were observed. Results of Phase 2 trials VLA15-201 and
VLA15-202 were published in the peer-reviewed medical journal, the
Lancet Infectious Diseases, in June 202418. Additional
18-month booster results from Study VLA15-202 were also published
in the same journal in July 202419.
In July 2024, Valneva and Pfizer announced
completion of primary vaccinations (three doses) of over 9,000
participants in the Phase 3 trial “Vaccine Against Lyme for Outdoor
Recreationists” (VALOR)20.
Completion of the VALOR trial is still expected
by the end of 2025, with the aim for Pfizer to submit a Biologic
License Application (BLA) to the FDA and a Marketing Authorization
Application (MAA) to the EMA in 2026, subject to positive data.
Based on the agreement with Pfizer, Valneva’s
agreed-upon cost contributions for the Lyme disease program were
completed in the second quarter of 2024, contributing to a
substantially lower expected cash burn in the second half of
2024.
SHIGELLA VACCINE CANDIDATE –
S4V
Valneva recently entered into a strategic
partnership and exclusive licensing agreement with LimmaTech
Biologics AG for the development, manufacturing and
commercialization of Shigella4V (S4V), a tetravalent bioconjugate
vaccine candidate against shigellosis21.
Shigellosis, caused by Shigella bacteria, 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 year22,
particularly among children in Low- and Middle-Income Countries
(LMICs). No approved Shigella vaccine is currently available and
the development of Shigella vaccines has been identified as a
priority by the World Health Organization (WHO)23.
Shigellosis also affects international travelers from high-income
countries and deployed military personnel in endemic regions. The
global market for a vaccine against Shigella is estimated to exceed
$500 million annually24.
Under the terms of the agreement with Valneva,
LimmaTech will receive an upfront payment of €10 million and
be eligible to receive additional regulatory, development and
sales-based milestone payments of up to €40 million as well as low
double-digit royalties on sales. LimmaTech will conduct a Phase 2
Controlled Human Infection Model study (CHIM) in the U.S. and a
Phase 2 pediatric study in LMICs. Both clinical trials are expected
to begin in the second half of 2024. 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 anticipated development path follows a
staggered and risk-mitigated strategy, allowing an efficient
capital allocation in line with Valneva’s communicated plan of
having a new R&D program in Phase 3 by 2027.
ZIKA VACCINE CANDIDATE –
VLA1601
Phase 1 ongoing with second-generation vaccine
candidate
VLA1601 is a second-generation 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 VLA160125. The randomized, placebo-controlled, Phase
1 trial, VLA1601-102, is planned to enroll 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. Topline data from the trial are expected in the first
half of 2025.
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. To date, a
total of 89 countries and territories have reported evidence of
mosquito transmitted Zika virus infection26; 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 Program27.
A vaccine against ZIKV could be a valuable
addition to Valneva’s portfolio against mosquito-borne diseases,
which already includes IXCHIQ® and
IXIARO®.
First Half 2024 Financial
Review
(Unaudited, consolidated under IFRS)
Revenues
Valneva’s total revenues were €70.8 million in the six months ended
June 30, 2024 compared to €73.7 million in the six months ended
June 30, 2023.
Valneva’s total product sales reached €68.3 million in the six
months ended June 30, 2024 compared to €69.7 million in the same
period of 2023. The impact of currency fluctuations of €0.1 million
was minimal.
Excluding final COVID-19 vaccine sales in the six months ended June
30, 2023, travel vaccine sales show a growth of €4.3 million or 7%
year-over-year.
IXIARO®/JESPECT® sales were €41.9 million in
the six months ended June 30, 2024 compared to €30.3 million in the
six months ended June 30, 2023. The 38% increase primarily reflects
sales to the U.S. military, which were minimal in the first half of
2023, as well as increased sales to travelers. The impact of
foreign currency movements in
IXIARO®/JESPECT® sales was negligible.
DUKORAL® sales were €14.9 million in
the six months ended June 30, 2024 compared to €17.1 million
in the comparative period of 2023. This 13% decrease was due to
reduced marketing investments while Valneva’s new manufacturing
site in Sweden underwent regulatory evaluation and approval.
Foreign currency fluctuations had an immaterial impact on
DUKORAL® sales.
Following adoption of the U.S. Advisory Committee on Immunization
Practices (ACIP)’s recommendations by the U.S. Centers for Disease
Control and Prevention (CDC) at the beginning of March 2024,
Valneva recognized initial sales for IXCHIQ® of €1.0
million in the first half of 2024.
Third Party product sales were €10.5 million in the six months
ended June 30, 2024 compared to €16.5 million in the six months
ended June 30, 2023. This 37% decrease was mainly driven by lower
sales of Rabipur®/RabAvert® and
Encepur®, under the distribution agreement with Bavarian
Nordic, due to supply shortages.
Other revenues, including revenues from collaborations, licensing
and services amounted to €2.5 million in the six months ended
June 30, 2024 compared to €4.1 million in the same period of 2023.
The reduction mainly resulted from lower revenue recognition
related to the R&D collaboration activities for chikungunya
with Instituto Butantan and the divestment of the CTM unit in
Sweden in July 2023.
Operating Result and adjusted
EBITDA
Costs of goods and services sold (COGS) were €45.6 million in the
six months ended June 30, 2024. The gross margin on commercial
product sales, excluding IXCHIQ®, amounted to 47.7%
compared to 40.0% in the six months ended June 30, 2023. COGS of
€17.8 million related to IXIARO® product sales, yielding
a product gross margin of 57.5%. COGS of €9.7 million related to
DUKORAL® product sales, yielding a product gross margin
of 34.8%. Product gross margins are expected to improve in the
second half of the year as the supply shortages during the first
half have been resolved. Of the remaining COGS in 2024, €7.7
million related to the third-party products distribution business,
€4.0 million to IXCHIQ®, €2.1 million to idle capacity
costs and €4.6 million to cost of services. In 2023, overall COGS
were €53.8 million, of which €48.4 million related to cost of goods
and €5.5 million related to cost of services.
Research and development expenses amounted to €29.7 million in the
six months ended June 30, 2024, compared to €26.0 million in the
six months ended June 30, 2023. This increase was mainly driven by
higher costs related to the ongoing transfer of operations into the
new Almeida manufacturing facility and higher R&D costs for
IXCHIQ®. Marketing and distribution expenses in the
first six months of 2024 amounted to €23.2 million compared to
€20.0 million in the first six months of 2023. The increase is
mainly related to €9.8 million of expenses associated with launch
activities for IXCHIQ® (first half of 2023: €7.8
million). In the six months ended June 30, 2024, general and
administrative expenses remained stable at €22.8 million after
€22.9 million in the same period of 2023. The largest expense
categories were employee-related expenses of €10.5 million and
consulting and other services of €9.6 million.
During the first half of 2024, a net gain of €90.8 million from the
sale of the PRV was recorded. 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 €6.4 million in
the six months ended June 30, 2024 from €14.0 million in the six
months ended June 30, 2023. In the first half of 2023, Valneva
recorded income from grants and tax credits for research and
development totaling €14.9 million, of which €8.7 million were
awarded by Scottish Enterprise (SE) for non-COVID-19 vaccine
development (IXCHIQ® and IXIARO®).
Valneva recorded an operating income of €46.7 million in the six
months ended June 30, 2024 compared to an operating loss of €35.0
million in the comparative period of 2023. The increase was mainly
the result of the PRV sale.
Adjusted EBITDA (as defined below) profit in the six months ended
June 30, 2024 was €56.2 million, whereas in the six months ended
June 30, 2023 an adjusted EBITDA loss of €28.3 million was
recorded.
Net Result
In the six months ended June 30, 2024, Valneva generated a net
profit of €34.0 million, mainly resulting from the sale of the PRV
in February 2024. This compared to a net loss of €35.0 million in
the first half of 2023.
Finance expense and currency effects in the first half of 2024
resulted in a net finance expense of €12.8 million, compared to a
net finance expense of €3.9 million in the first half of 2023. This
increase was mainly due to €5.7 million higher interest expenses on
loans resulting from the amendment of the Deerfield Management
Company and OrbiMed (D&O) loan facility. Additionally foreign
exchange losses of €1.7 million were recorded in the first half of
2024 compared to gains of €4.5 million observed in the first half
of 2023, primarily related to the development of the USD and GBP
exchange rates to the EUR.
Cash Flow and Liquidity
Net cash used in operating activities amounted to €66.3 million in
the six months ended June 30, 2024 compared to €65.4 million of
cash used in operating activities in the same period of 2023. Cash
outflows in the first half of 2024 were largely derived from the
operating loss for the period (net of gains from PRV sale)
amounting to €56.9 million and from working capital in the amount
of €31.2 million, which includes all payments to the Lyme disease
clinical program as per the R&D budget agreed between Pfizer
and Valneva. 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 €87.6 million in
the six months ended June 30, 2024 compared to cash outflows of
€6.6 million in the six months ended June 30, 2023. While both
years include outflows from construction activities across
production sites in Scotland and Sweden, the sale of the PRV
positively impacted 2024 by €90.8 million.
Net cash used in financing activities increased to €16.6 million in
the six months ended June 30, 2024 from €9.5 million in the six
months ended June 30, 2023. This increase was primarily due to €5.4
million higher interest payments resulting from the increase in the
D&O loan facility.
Cash and cash equivalents were €131.4 million as at June 30,
2024, compared to €126.1 million at 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 net profit / (loss) for the period before income tax,
finance income/expense, foreign exchange (gain)/loss, amortization,
depreciation, and impairment (excluding impairment loss of
disposal).
A reconciliation of Adjusted EBITDA to operating
loss, which is the most directly comparable IFRS measure, is set
forth below:
€ in million |
6 months ended June 30 |
(unaudited results, consolidated per IFRS) |
2024 |
2023 |
Net profit / (loss) |
34.0 |
(35.0) |
Add: |
|
|
Income tax benefit |
(0.2) |
(3.8) |
Total Finance income |
(0.8) |
(0.5) |
Total Finance expense |
12.0 |
8.9 |
Foreign exchange (gain)/ loss – net |
1.7 |
(4.5) |
Amortization |
2.5 |
3.2 |
Depreciation |
7.0 |
5.4 |
Impairment, excluding impairment loss of disposal |
- |
(1.9) |
Adjusted EBITDA |
56.2 |
(28.3) |
About Valneva
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, 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
Laetitia.bachelotfontaine@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
guidance for certain financial results in fiscal year 2024 and
mid-term outlook on financial results, cash position, and other
business developments, including results of ongoing clinical
trials, the timing and possible occurrence of further or initial
regulatory approvals of its product candidates, the anticipated
size of markets for approved products and sales of those products,
receipt of funding from external sources, supply of products sold
by Valneva, and relationships with current business partners. 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. These risks and uncertainties include those developed
or identified in any public documents filed with the French
financial markets authority (Autorité des marchés
financiers) and the U.S. Securities and Exchange Commission
made or to be made by Valneva. In particular, the expectations of
Valneva could be affected by, among other things, uncertainties
involved in the development and manufacture of vaccines (including
in relation to organic or strategic expansion of Valneva’s clinical
pipeline), unexpected clinical trial results, unexpected regulatory
actions or delays, competition in general, currency fluctuations,
the impact of the global and European financial crisis and other
global economic or political events, the ability to obtain or
maintain patent or other proprietary intellectual property
protection, the cancellation of existing contracts, the impact of a
pandemic, and changes in the regulatory environment in which
Valneva operates. The occurrence of any of these risks and
uncertainties 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 Extension of the Interest-Only
Period of Its Debt Facility with Deerfield and OrbiMed -
Valneva
2 Valneva and LimmaTech Enter into a Strategic
Partnership to Accelerate the Development of the World’s Most
Clinically Advanced Tetravalent Shigella Vaccine Candidate -
Valneva
3 ACIP Vaccine Recommendations and Schedules |
CDC
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 Reports Further Positive Pivotal Phase 3
Data in Adolescents for its Single-Shot Chikungunya Vaccine -
Valneva
6 Phase 3 VALOR Lyme Disease Trial: Valneva and Pfizer
Announce Primary Vaccination Series Completion - Valneva
7 Valneva Initiates Phase 1 Trial of Second-Generation
Zika Vaccine Candidate - Valneva
8 For additional information on Adjusted EBITDA, please refer
to the “Non-IFRS Financial Measures” section at the end of the
PR
9 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.
10 Valneva Announces U.S. FDA Approval of World’s
First Chikungunya Vaccine, IXCHIQ® - Valneva
11 Valneva Receives Marketing Authorization in Europe
for the World’s First Chikungunya Vaccine, IXCHIQ® -
Valneva
12 Valneva Announces Health Canada Approval of the
World’s First Chikungunya Vaccine, IXCHIQ® - Valneva
13 ACIP Vaccine Recommendations and Schedules |
CDC
14 CEPI Expands Partnership with Valneva with a $41.3
Million Grant to Support Broader Access to the World’s First
Chikungunya Vaccine - Valneva
15 Valneva Reports Further Positive Pivotal Phase 3
Data in Adolescents for its Single-Shot Chikungunya Vaccine -
Valneva
16 Valneva Vaccinates First Participant in Pediatric
Trial of Single-Shot Chikungunya Vaccine - Valneva
17
https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(24)00357-8/fulltext
18 Valneva Announces Publication of Lyme Disease Phase
2 Trials in the Lancet Infectious Diseases - Valneva
19 Immunogenicity and safety of an 18-month booster
dose of the VLA15 Lyme borreliosis vaccine candidate after primary
immunisation in healthy adults in the USA: results of the booster
phase of a randomised, controlled, phase 2 trial - The Lancet
Infectious Diseases
20 Phase 3 VALOR Lyme Disease Trial: Valneva and
Pfizer Announce Primary Vaccination Series Completion -
Valneva
21 LimmaTech Biologics AG
22 Shigellosis | CDC Yellow Book 2024
23 Immunization, Vaccines and Biologicals
(who.int)
24 Valneva’s Initial internal assessment
25 Valneva Initiates Phase 1 Trial of
Second-Generation Zika Vaccine Candidate - Valneva
26 Zika virus disease (who.int)
27 Tropical Disease Priority Review Voucher Program |
FDA
Full-year 2024 Financial Guidance Confirmed
- 2024_08_13_VLA_H1_Results_EN_Final
Valneva (EU:VLA)
Gráfica de Acción Histórica
De Ago 2024 a Sep 2024
Valneva (EU:VLA)
Gráfica de Acción Histórica
De Sep 2023 a Sep 2024