Q3 milestones included
- Major COVID-19 vaccine partnership with U.K.
government
- Pre-clinical and industrialization activities on
track
- Positive top-line results for Lyme Phase 2
studies
- First company to initiate Phase 3 study for chikungunya
vaccine; EMA PRIME Designation granted
- New US military / DoD contract for
IXIARO®
Cash position of €156 million at end of
Q3, year-end outlook expected to exceed €180 million
Operating financial results impacted by
second wave of COVID-19 pandemic
- Limited product sales in Q3
- Gross Margin impacted
- US military orders and supply rephased into
Q4
Thomas Lingelbach, Chief Executive
Officer, commented “We have seen a quarter marked by
excellent progress for the Company – positive results from our Lyme
Phase 2 studies, the start of a potentially pivotal Phase 3 trial
for chikungunya and we signed a very important agreement to provide
COVID-19 vaccines to the U.K. government. It is also true, however,
that our commercial business has continued to suffer from the
ongoing COVID-19 impact on the travel industry. Nonetheless,
we continue to focus on building shareholder value, as reflected in
our share price performance in 2020 to date, and to build on our
strengths.”
Financial highlights
- Cash position of €156 million at end of September; FY
2020 cash outlook expected at between €180 million and €200
million.
- UK COVID vaccine partnership deal executed in September,
advance payments invoiced in September create high Q3 receivables
position
- In excess of €100 million of receivables paid in October
- UK Government COVID-19 vaccine partnership will continue to
provide funding for the Livingston site capacity expansion and the
UK VLA2001 clinical trials
- No further drawing from $85 million debt financing arrangement
with leading US funds expected for the rest of 2020 ($60 million
drawn in Q1 and Q2 2020)
- Total revenues of €58.8 million in the first nine
months of 2020 compared to €81.4 million in the first nine
months of 2019; Overall FY 2020 revenue guidance now expected at
around €120 million
- Product sales revenue of €45.9 million in the first nine months
of 2020 adversely affected by the COVID-19 pandemic (€86.4 million
in the first nine months of 2019) and the US military phasing in
Q4.
- FY 2020 product sales revenue now expected at around €70
million
- FY 2020 total revenue to include €35 million to €40 million
resulting from the Lyme vaccine partnership with Pfizer and
approximately €10 million of Service and Technology revenues.
- No revenue associated with the UK COVID-19 partnership booked
in Q3; IFRS accounting treatment being assessed during Q4.
- EBITDA1 loss of €45.2 million in the first nine months
of 2020 compared to an EBITDA profit of €3.0 million in the first
nine months of 2019;
- Nine-month EBITDA includes planned increase in R&D
investment of €51.7 million in the first nine months of 2020
compared to €23.2 million in the first nine months of 2019
- Notwithstanding potential revenue recognition, €5.2 million of
COVID-19 R&D investment were included in the nine-month 2020
results
- Lyme, chikungunya and COVID-19 vaccine programs progressed well
as reflected in the level of R&D investments
- Gross margin adversely affected by inventory provisions and
idle capacity costs in manufacturing plants caused by the impact of
the ongoing COVID-19 pandemic
- G&A costs include additional share option costs given share
price appreciation during 2020 as well as one-off costs related to
corporate partnership deal expenses
- FY EBITDA guidance remains highly dependent on the
ongoing impact of the COVID-19 pandemic on the travel industry
including demand for travel vaccines, revenue recognition of the
Pfizer collaboration, the UK COVID vaccine partnership, the
chikungunya-CEPI agreement as well as on other non-cash related
items, and is therefore subject to significant variance.
- FY EBITDA loss currently is expected to be in the range of
minus €40 million to minus €50 million
David Lawrence, Valneva’s Chief
Financial Officer, commented, “During these first nine
months, Valneva has managed to deliver strong returns to its
shareholders despite the adverse impact of the COVID-19 pandemic on
our commercial business. The ongoing excellent execution in R&D
combined with the important partnerships that we have struck this
year ensure that the Company is in a strong financial position as
we look forward.”
Nine-month 2020 Financial
Information (unaudited, consolidated under IFRS)
€million |
9 months ending September 30 |
|
2020 |
2019 |
Total revenues |
58.8 |
81.4 |
Product sales |
45.9 |
86.4 |
Net profit / (loss) |
(62.3) |
(2.4) |
EBITDA |
(45.2) |
3.0 |
Cash |
156.2 |
67.4 |
Saint Herblain (France), November 3,
2020 – Valneva SE (“Valneva” or “the Company”), a
specialty vaccine company focused on prevention against diseases
with major unmet needs, reported today its nine-month financial
results ending September 30, 2020. The condensed and consolidated
interim financial results are available on the Company’s website
www.valneva.com.
Valneva will provide a live webcast of its
nine-month 2020 results conference call beginning at 3 p.m. CET
today. This webcast will also be available on the Company’s
website. Please refer to this link:
https://edge.media-server.com/mmc/p/6xazaoyo
Commercial Vaccines
JAPANESE ENCEPHALITIS VACCINE
(IXIARO®/JESPECT®) In the first nine months of 2020,
revenues from IXIARO®/JESPECT® product sales reached
€30.8 million compared to €64.2 million in the first nine
months of 2019. Sales were affected by the impact of the COVID-19
pandemic on the travel market and the phasing of the US Department
of Defense (DoD) contract.
At the beginning of September 2020, Valneva
announced the signing of a new contract with the US DoD for the
supply of its Japanese encephalitis (JE) vaccine, IXIARO®2. This
new contract spans a total of three years (one base year, plus two
option years) with a base-year value of $61 million. The DoD has
the possibility to purchase a total of $76 million – $105
million worth of IXIARO® across the two option years. Deliveries
for the base-year will commence in the fourth quarter of 2020.
CHOLERA / ETEC3-DIARRHEA VACCINE
(DUKORAL®)
In the first nine months of 2020, revenues from
DUKORAL® sales reached €13.2 million compared to €19.8 million in
the first nine months of 2019. DUKORAL® sales were also adversely
impacted by the COVID-19 pandemic effect on the travel
market.
OVERALL SALES OUTLOOKTaking
into account the ongoing COVID-19 situation, Valneva’s sales could
return to 2019 levels in 2023 with the expected sales recovery of
its two commercial products and the marketing and distribution
partnership with Bavarian Nordic announced in June 20204. The
successful development of a SARS-CoV-2 vaccine could accelerate
that timeline.
Clinical Stage Vaccine
Candidates
LYME DISEASE VACCINE CANDIDATE –
VLA15 Partnering deal with Pfizer;
Positive initial results reported for the two Phase 2
studies
Valneva has developed a multivalent vaccine
candidate, VLA15, which is currently the only active vaccine
program in clinical development against Lyme disease. The program
was granted Fast Track designation by the US Food and Drug
Administration (FDA) in July 20175 and, in April 2020, the Company
signed an exclusive, worldwide partnering deal with Pfizer Inc. for
the late stage development and future commercialization of
VLA156.
During the first nine months of the year,
Valneva reported positive initial results for the two Phase 2
studies of its Lyme disease vaccine candidate (VLA12-201 in July
20207 and VLA15-202 in October 20208). Both studies met their
endpoints.
The two studies, conducted in the EU and US,
were investigating similar doses of the vaccine but with two
different vaccination schedules (Month 0-1-2 for VLA15-201 and
Month 0-2-6 for VLA15-202) in a total of approximately 800 healthy
adults aged 18 to 65 years.
In both studies, the vaccine was generally safe
across all doses and age groups tested and no related Serious
Adverse Events (SAEs) were observed in any treatment group.
Reactogenicity decreased following the first vaccination.
Compared to study VLA15-201, immunogenicity was
further enhanced in VLA15-202 using a Month 0-2-6 schedule. SCRs
(Seroconversion Rates) after completion of primary vaccination
series, were equally distributed and ranged from 93.8% (Serotype 1)
to 98.8% (Serotypes 2 and 3). Antibody responses were comparable in
the two dose groups tested in both studies.
The immunological response in older adults, one
of the main target groups for a Lyme disease vaccine, was
particularly encouraging in the two studies. Results in both
studies did not indicate that prior exposure to Borrelia
spirochetes (sero-positivity) has an impact on immunogenicity or
safety, as observed in VLA15-201.
A Serum Bactericidal Assay (SBA), assessing the
functional immune response against Lyme disease after vaccination
with VLA15, was conducted for the first time in VLA15-202 and
demonstrated functionality of antibodies against all OspA
serotypes. Assays, such as SBAs, are commonly used to enable a
potential prediction of vaccine efficacy via the measurement of
vaccine-induced functional immune responses.
VLA15-202 safety and immunogenicity data at Day
208 support advancing the program with the Month 0-2-6 schedule.
Valneva and Pfizer will finalize dosage analysis and prepare for
the next development steps in the coming months.
According to the US Centers for Disease Control
and Prevention (CDC), approximately 300,000 Americans4 are infected
with Lyme disease annually with at least an additional further
200,000 cases in Europe9.
VLA15 is a multivalent, protein subunit vaccine
that targets the outer surface protein A (OspA) of Borrelia and is
intended to protect against the majority of human pathogenic
Borrelia species. VLA15 is designed to confer protection by raising
antibodies that prevent Borrelia from migrating from ticks to
humans after a bite.
Peak revenue potential for a Lyme disease
vaccine in the US and EU is estimated at more than $1 billion10
annually.
CHIKUNGUNYA VACCINE CANDIDATE –
VLA1553Phase 3 initiated; EMA PRIME designation
granted
Valneva has developed VLA1553, a single-shot
vaccine candidate against chikungunya. The program entered Phase 3
in September 202011 and is currently the most advanced chikungunya
vaccine program worldwide. The sponsor of the first chikungunya
vaccine Biologics License Application (BLA) to be approved in the
US will be eligible to receive a Priority Review Voucher (PRV)12.
VLA1553 was granted Fast Track designation by the FDA in December
201813 and received PRIME designation by the European Medicine
Agency (EMA) in October 202014. Valneva plans to take VLA1553 to
market with the prospect of leveraging major manufacturing and
commercial synergies, primarily focusing on the traveler vaccine
market.
In September 2020, Valneva initiated a pivotal
Phase 3 study, VLA1553-301. Conducted in the US, VLA1553-301 is a
double-blinded, placebo-controlled, multi-center study in
approximately 4,000 healthy adults aged 18 or above. Participants
will be randomized into two study groups to receive either vaccine
or placebo. The primary endpoint will be to demonstrate safety and
immunogenicity 28 days after a single-shot vaccination with
VLA1553. A subset of participants will be tested for
sero-protection based on an immunological surrogate under the
Accelerated Approval pathway. Participants will be followed for a
total of six months. The total duration of the study is expected to
be nine to twelve months and the outcome, if positive, shall
provide the basis for licensure of the vaccine. Seroprotection
threshold is subject to FDA approval and the Phase 3 study duration
is subject to COVID-19 pandemic related impact on clinical
operations.
To make VLA1553 also accessible to Low and
Middle Income Countries, Valneva and the Butantan Institute in
Brazil signed a binding term sheet in May 2020 for the development,
manufacturing and marketing of VLA155315. The collaboration will be
effective upon the signing of definitive agreements and will fall
within the framework of the $23.4 million funding which Valneva
received from the Coalition for Epidemic Preparedness Innovations
(CEPI) in July 201916.
Chikungunya is considered a major public health
threat with no preventive vaccines or effective treatments
available. Chikungunya is a mosquito-borne viral disease caused by
the chikungunya virus (CHIKV), a Togaviridae virus, transmitted by
Aedes mosquitoes. As of September 2020, there have been more than 3
million reported cases in the Americas17 and the economic impact is
considered to be significant (e.g. Colombia outbreak 2014: $73.6
million18). The medical burden is expected to grow as the
distribution of the CHIKV primary mosquito vectors continues to
spread further geographically.
The global market for vaccines against
chikungunya is estimated to exceed $500 million annually by
203219.
SARS-CoV-2 VACCINE CANDIDATE – VLA2001
Major COVID-19 Vaccine Partnership with
U.K. Government
In April 2020, Valneva initiated a program
aiming to rapidly develop a vaccine against SARS-CoV-2, the
pathogen that causes COVID-1920.
In September 2020, Valneva announced a major
COVID-19 vaccine partnership with the U.K. government potentially
worth up to €1.4 billion. Under the agreement, if vaccine
development is successful, Valneva will provide the UK government
with 60 million doses in the second half of 2021, representing €470
million in revenues. UK Government then has options over 40 million
doses in 2022 and a further 30 million to 90 million doses, in
aggregate, across 2023 to 2025. Revenue from these options could
amount to almost €900 million. Valneva’s inactivated SARS-CoV-2
vaccine is expected to have a two dose regimen. UK government is
also investing up-front in the scale up and development of the
vaccine, with the investment being recouped against the vaccine
supply under the partnership. The agreement follows the initial
intent to participate in the UK Government’s COVID-19 vaccine
response announced in July 202021.
As part of its broader COVID-19 response,
Valneva plans to further invest in its manufacturing facility in
Livingston, Scotland and also in Solna, Sweden. Valneva is also in
discussions with further potential customers for the vaccine.
Valneva is leveraging its technical and platform
capabilities derived from IXIARO®, the Company’s commercial vaccine
product indicated for active immunization for the prevention of
Japanese encephalitis, to develop an inactivated, whole virus
vaccine candidate. The Company is collaborating with Dynavax to
evaluate the adjuvant CpG 1018, which is a component of the US
FDA-approved HEPLISAV-B® vaccine.
Valneva is in the process of industrializing the
potential commercial manufacturing process for VLA2001 and has
already produced first Clinical Trial Material. Assuming that
preclinical activities are successful, Valneva plans to commence
clinical studies by the end of 2020 with the objective to achieve a
first regulatory approval in the second half of 2021, subject to
the appropriate regulatory authority requirements.
SARS-CoV-2 is a new coronavirus identified in
late 2019 and belongs to a family of enveloped RNA viruses that
include MERS and SARS, both of which caused serious human
infections of respiratory system. The virus, which causes a disease
named COVID-19, has never before been found in humans. To date,
there has been over one million COVID-19 related deaths reported
worldwide22. It has been declared a pandemic by the World Health
Organization (WHO). Currently, there is no vaccine available for
COVID-19.
Nine-Month 2020 Financial
Review(Unaudited, consolidated under IFRS)
RevenuesValneva’s total
revenues in the first nine months of 2020 were €58.8 million
compared to €81.4 million in the first nine months of
2019.
Product sales revenues in the first nine months
of 2020 declined to €45.9 million compared to €86.4 million in
the same period of 2019. On a CER basis23, product sales declined
by 47.6% compared to the first nine months of 2019 with both
commercial vaccines impacted by COVID-19 related consequences on
the travel market. The sales decline was primarily driven by a
52.8% decrease at CER in IXIARO®/JESPECT® sales while DUKORAL®
sales declined by 34.0% at CER compared to the first nine months of
2019.
Other Revenues, including revenues from
collaborations, licensing and services, amounted to €13.0 million
in the first nine months of 2020 and included revenues related to
the Lyme R&D collaboration agreement with Pfizer amounting to
€4.0 million. In the comparator period of 2019, negative Other
Revenues amounting to €5.0 million were reported, including the
effect of the termination of the SAA with GSK. Excluding the
termination effect, other revenues would have amounted to €5.7
million in the first nine months of 2019.
Operating result and EBITDA
Costs of goods and services sold (COGS) were €35.1 million in the
first nine months of 2020. Gross margin on product sales was 37.4%
compared to 65.2% in the first nine months of 2019, with the
decline mainly related to provisions taken for excess stock driven
by reduced demand (due to the COVID-19 pandemic), idle capacity
costs in both of Valneva’s manufacturing sites as well as lower
sales to US military prior to the execution of the new IXIARO®
supply agreement. COGS of €16.2 million were related to
IXIARO®/JESPECT® sales, yielding a product gross margin of 47.5%.
€11.1 million of COGS were related to DUKORAL® sales, yielding a
product gross margin of 15.4%. Of the remaining COGS in the first
nine months of 2020, €1.4 million were related to the Third Party
Product distribution business and €6.4 million were related to cost
of services. In the first nine months of 2019, overall COGS were
€33.4 million, of which €30.1 million related to cost of goods and
€3.3 million related to cost of services.
Research and development investments in the
first nine months of 2020 continued to increase as planned, more
than doubling to €51.7 million compared to €23.2 million in the
first nine months of 2019. This was driven by investments into
Valneva’s clinical stage vaccine candidates, notably Lyme and
chikungunya, and was also impacted by spending related to Valneva’s
SARS-CoV-2 vaccine candidate. Marketing and distribution expenses
in the first nine months of 2020 amounted to €13.8 million compared
to €17.1 million in the first nine months of 2019. The decrease was
the result of lower marketing and distribution spend across all
Valneva’s direct markets due to reduced sales activity further to
the COVID-19 pandemic. In the first nine months of 2020, general
and administrative expenses increased to €19.3 million from €13.0
million in the first nine months of 2019, mainly driven by
increased costs to support corporate transactions and projects as
well as costs related to Valneva’s employee share option program.
Amortization and impairment charges of fixed assets/intangibles in
the first nine months of 2020 remained unchanged compared to the
same period of 2019 and amounted to €2.2 million.
Other income, net of other expenses in the first
nine months of 2020 increased to €10.7 million from €4.2 million in
the first nine months of 2019. This increase was mainly driven by
increased R&D tax credit directly resulting from increased
R&D spending along with income from the CEPI funding for
Valneva’s chikungunya R&D program.
Valneva recorded an operating loss of €52.5
million in the first nine months of 2020 compared to €3.2 million
in the first nine months of 2019. EBITDA loss in the first nine
months of 2020 was €45.2 million compared to an EBITDA profit
of €3.0 million in the first nine months of 2019.
Net result In the first nine
months of 2020, Valneva generated a net loss amounting to €62.3
million compared to a net loss of €2.4 million in the first nine
months of 2019.
Finance costs and currency effects in the first
nine months of 2020 resulted in a net finance expense of €10.8
million, compared to a net finance expense of €0.4 million in the
first nine months of 2019. The increase of expenses was the result
of increased interest charges related to the newly entered
financing arrangement with the US Healthcare Funds Deerfield and
OrbiMed as well as foreign currency losses.
Cash flow and liquidity Net
cash generated by operating activities in the first nine months of
2020 amounted to €77.6 million compared to €5.0 million in the
first nine months of 2019 mainly driven by the $130 million upfront
payment received from Pfizer related to the Lyme R&D
collaboration agreement.
Cash outflows from investing activities in the
first nine months of 2020 amounted to €8.1 million, compared to
€8.0 million in the first nine months of 2019 mainly as a result of
purchases of equipment.
Cash inflows from financing activities amounted
to €22.4 million in the first nine months of 2020 and consisted
mainly of €48.8 million net proceeds from the financing arrangement
with US Healthcare Funds Deerfield and OrbiMed, offset by €20
million repayments of borrowings to the European Investment Bank
(EIB). Cash outflows from financing activities amounted to €6.8
million in the first nine months of 2019, which included the
repayment of the Biopharma (Pharmakon) loan of €11.3 million in
early 2019.
Liquid funds on September 30, 2020 strongly
increased and stood at €156.2 million compared to €64.4 million on
December 31, 2019. The main change was driven by the $130.0 million
upfront payment related to the Lyme collaboration agreement with
Pfizer and proceeds from the new debt line net of loan repayment to
the EIB in March 2020. Liquid funds by September 30, 2020 did not
include any payments made by the UK government within the framework
of the UK COVID-19 partnership. These payments were received in
October.
About Valneva SEValneva is a
specialty vaccine company focused on prevention against diseases
with major unmet needs. Valneva’s portfolio includes two commercial
vaccines for travelers: IXIARO®/JESPECT® indicated for the
prevention of Japanese encephalitis and DUKORAL® indicated for the
prevention of cholera and, in some countries, prevention of
diarrhea caused by ETEC. The Company has various vaccines in
development including unique vaccines against Lyme disease,
COVID-19 and chikungunya. Valneva has operations in Austria,
Sweden, the United Kingdom, France, Canada and the US with over 500
employees. For more information, visit www.valneva.com and
follow the Company on LinkedIn.
Valneva Investor and Media
ContactsLaetitia Bachelot-FontaineDirector of Investor
Relations & Corporate CommunicationsM +33 (0)6 4516
7099investors@valneva.com |
Teresa PinzolitsCorporate Communications SpecialistT
+43 (0)1 20620 1116communications@valneva.com |
Forward-Looking Statements
This press release contains certain
forward-looking statements relating to the business of Valneva,
including with respect to the progress, timing and completion of
research, development and clinical trials for product candidates,
the ability to manufacture, market, commercialize and achieve
market acceptance for product candidates, the ability to protect
intellectual property and operate the business without infringing
on the intellectual property rights of others, estimates for future
performance and estimates regarding anticipated operating losses,
future revenues, capital requirements and needs for additional
financing. 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 performance. 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
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. 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 Nine-month 2020 EBITDA was calculated by excluding €7.3
million of depreciation and amortization (€6.2 million in the first
nine months of 2019) from the €52.5 million operating loss
(€3.2 million in the first nine months of 2019) as recorded in the
consolidated income statement under IFRS
2 Valneva Announces New IXIARO® Supply Contract with the US
Government worth up to $166 million
3 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.
4 Valneva and Bavarian Nordic Announce Marketing and
Distribution Partnership
5 Valneva Receives FDA Fast Track Designation for its Lyme
Disease Vaccine Candidate VLA15
6 Valneva and Pfizer Announce Collaboration to Co-Develop and
Commercialize Lyme Disease Vaccine, VLA15
7 Valneva Announces Positive Initial Results for Phase 2 Study
of Lyme Disease Vaccine Candidate
8 Valneva Announces Positive Initial Results for Second Phase 2
Study of Lyme Disease Vaccine Candidate VLA15
9 As estimated from available national data. Case reporting is
highly inconsistent in Europe and many LB infections still go
undiagnosed.
10 Lyme Disease research and analysis conducted by an
independent market research firm
11 Valneva Initiates Phase 3 Clinical Study for its Chikungunya
Vaccine Candidate VLA1553
12 https://priorityreviewvoucher.org/
13 Valneva Awarded FDA Fast Track Designation for Chikungunya
vaccine candidate
14 Valneva’s Chikungunya Vaccine Candidate Awarded EMA Prime
Designation
[15] Valneva to Partner with Instituto Butantan
on Single-Shot Chikungunya Vaccine for Low- and Middle- Income
Countries
16 CEPI awards up to $23.4 million to Valneva for late-stage
development of a single-dose Chikungunya vaccine
17 PAHO/WHO data: Number of reported cases of chikungunya fever
in the Americas.
https://www.paho.org/data/index.php/en/mnu-topics/chikv-en/550-chikv-weekly-en.html.
Last accessed 13 Oct 2020.
18 Cardona-Ospina et al. 2015, Trans R Soc Trip Med Hyg
109:793-802.
19 VacZine Analytics Chikungunya virus vaccines Global demand
analysis. February 2020
20 Valneva and Dynavax Announce Collaboration to Advance Vaccine
Development for COVID-19
21 Valneva Confirms Participation in UK Government COVID-19
Vaccine Response Program
22 https://www.worldometers.info/coronavirus/
23 CER: Constant Exchange Rate; Nine-months 2019 actuals
restated to Nine-months 2020 average exchange rates
- 2020_11_03_VLA_Nine_Month_Results_PR_EN_Final
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