Product sales more than
doubled in the first
half of
2023 to €69.7 million
compared to
€33.3 million in the first half of
2022
- Driven by IXIARO® and DUKORAL®
sales, both of which benefited from a continued recovery of the
travel industry as well as from price increases
- Bringing total revenues to
€73.7 million in the first half of 2023
Strong cash
position of €204.4
million as at June 30,
2023
- Excludes up to an additional $100
million made available as part of a recent upsized financing
arrangement with leading U.S. Healthcare Funds Deerfield and
OrbiMed1
Chikungunya:
progressing
towards
delivery of the world’s
first chikungunya vaccine
- Biologic License Application (BLA)
currently under priority review by the U.S. Food and Drug
Administration (FDA)
- Second regulatory application
accepted for review by Health Canada
- Initial safety data in adolescents,
required for submission to the European Medicines Agency (EMA),
reported in August 2023
2023 financial guidance
confirmed
- Expected total revenues and other
income between €220 million and €260 million, including:
- €130 million to €150 million of
product sales
- €90 million to €110 million of
other income
- Expected R&D expenses between
€70 million and €90 million
Financial Information(Unaudited
results, consolidated per IFRS)
€ in million |
6 months ending
June 30, |
|
2023 |
2022 |
Total revenues |
73.7 |
93.2 |
Product sales |
69.7 |
33.3 |
Net loss |
(35.0) |
(171.5) |
Adjusted EBITDA2 |
(28.3) |
(136.0) |
Cash |
204.4 |
336.2 |
Saint-Herblain
(France), September
21, 2023
– 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,
2023. 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 of its first
half 2023 results conference call 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/qbnasrnq
Peter
Bühler, Valneva’s Chief Financial
Officer, commented, “We delivered another strong quarter
of growth, leading our first half vaccine sales to more than double
year-over-year, while continuing to progress our clinical studies.
Our objective is to continue driving these sales in 2023 and, at
the same time, continue to build a stronger commercial vaccine
portfolio, notably with the potential addition of our chikungunya
vaccine candidate later this year.”
Clinical Stage Vaccine
Candidates
CHIKUNGUNYA VACCINE CANDIDATE –
VLA1553BLA under priority review by the U.S.
FDA
VLA1553 is a live-attenuated, single-dose
vaccine candidate against the chikungunya virus (CHIKV), a
mosquito-borne virus that has spread to more than 110 countries3
with the potential to rapidly expand further. The Pan American
Health Organization (PAHO) issued an epidemiological alert in
February 2023 as the number of cases and deaths due to chikungunya
continues to rise in the Americas4. With no preventive vaccine or
specific treatment yet available, chikungunya is considered a major
public health threat.
VLA1553 is currently the first and only
chikungunya vaccine candidate worldwide for which regulatory review
processes are underway. A Biologic License Application (BLA) is
currently under priority review by the U.S. Food and Drug
Administration (FDA)5 with a Prescription Drug User Fee Act (PDUFA)
action date planned for end of November 20236. The FDA extended the
PDUFA date by three months in August 2023 to allow sufficient time
to align and agree on the Phase 4 program (post marketing
requirements) necessary under the accelerated approval pathway7. No
additional clinical data have been requested for the approval
process.
Additionally, a regulatory application was filed
with Health Canada at the end of May 20238 and accepted for review
at the end of August 20239.
If approved, VLA1553 could become the first
licensed chikungunya vaccine available to address this unmet
medical need.
The regulatory submissions with Health Canada
and the FDA follow final pivotal Phase 3 data in March 202210,
final lot-to-lot consistency results in May 202211 and positive
twelve-month persistence data in December 202212. The pivotal Phase
3 data were published in The Lancet, the world’s leading
peer-reviewed medical journal, in June 202313. The article, titled,
“Safety and immunogenicity of a single-shot live-attenuated
chikungunya vaccine: a double-blind, multicenter, randomized,
placebo-controlled phase 3 trial,” provides a detailed analysis of
the Phase 3 results showing that VLA1553 demonstrated a very high
seroresponse rate of 98.9% in participants 28 days after receiving
the single administration. This immunogenicity profile was similar
in both younger and older adults, and 96% of participants
maintained seroresponse six months after vaccination. VLA1553 was
equally well tolerated in younger and older adults. Earlier
clinical data, published in the Lancet Infectious Diseases, showed
that the onset of the immune response after a single dose of
VLA1553 is between 7- and 14-days post-vaccination14. This
potential for a rapid onset of seroresponse was later confirmed in
a post-hoc analysis of the Phase 1 study which showed that 100% of
vaccinated individuals reached the seroresponse threshold at day
1415. Additionally, VLA1553 was able to demonstrate a robust immune
response which was sustained for 12 months with a 99% seroresponse
rate and was equally durable in younger and older adults16. This
dedicated antibody persistence trial (VLA1553-303) will continue to
evaluate persistence for a period of at least five years. VLA1553
uses the live-attenuated virus vaccine technology, known to induce
long-lasting immunity after a single dose. Examples of
live-attenuated vaccines include the combined measles, mumps and
rubella (MMR), yellow fever, and chickenpox (varicella)
vaccines.
A clinical study in adolescents, VLA1553-321, is
ongoing in Brazil, for which Valneva reported enrollment and
vaccination completion in February 202317 and initial safety data
in August 202318. Funded by the Coalition for Epidemic Preparedness
Innovations (CEPI) and conducted in collaboration with Instituto
Butantan, the VLA1553-321 adolescent trial is intended to support
the label extension in this age group following a potential initial
FDA approval in adults. 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,
the present safety analysis is expected to enable regulatory
submission to the European Medicines Agency (EMA) later this
year.
Initial safety data generated from the study,
Valneva’s first clinical study in an endemic area and with
individuals previously infected with CHIKV, show that VLA1553 was
generally well tolerated in 754 adolescents aged 12 to 17 years,
regardless of previous CHIKV infection. Immunogenicity data for the
trial are expected in November 2023.
To make VLA1553 more accessible to Low- and
Middle-Income Countries (LMIC), Valneva and Instituto Butantan in
Brazil signed an agreement in January 2021 for the development,
manufacturing, and marketing of VLA155319. The collaboration falls
within the framework of the agreement signed between CEPI and
Valneva in July 201920, which provides funding of up to
$24.6 million with support from the European Union’s Horizon
2020 program.
VLA1553 received FDA Fast Track, Breakthrough
Therapy and Priority Review designations in 2018, 2021 and 2023
respectively. The sponsor of the first chikungunya vaccine BLA to
be approved in the United States will be eligible to receive a
Priority Review Voucher, or PRV. The program was also granted
PRIority MEdicine (PRIME) designation by the EMA in 2020, and
Valneva plans to make regulatory submissions for VLA1553 in Europe
in the second half of 2023.
Valneva intends to commercialize VLA1553, if
approved, by leveraging its existing manufacturing and commercial
infrastructures. The global market for vaccines against chikungunya
is estimated to exceed $500 million annually by 203221.
LYME DISEASE VACCINE CANDIDATE –
VLA15 Phase 3 study
ongoing and first
positive
pediatric and
adolescent
booster
results
reported
Valneva and Pfizer are developing VLA15, a Lyme
disease vaccine candidate that targets the outer surface protein A
(OspA) of Borrelia burgdorferi, the bacterium that causes Lyme
disease. VLA15 is a multivalent recombinant protein vaccine that
targets six serotypes of Borrelia representing the most common
strains found in North America and Europe. VLA15 is the only Lyme
disease vaccine program in advanced clinical development today and
has received Fast Track designation from the FDA.
Valneva and Pfizer reported results for three
Phase 2 clinical trials of VLA15 in both adult and pediatric
populations, in which high levels of antibodies against all six
strains were observed22,23,24. These include the announcement in
September 2023 of positive Phase 2 pediatric and adolescent
immunogenicity and safety data following a booster vaccination with
VLA15. These results from the VLA15-221 Phase 2 study showed a
strong anamnestic antibody response for all serotypes in pediatric
(5 to 11 years of age) and adolescent participants (12 to 17 years
of age), as well as in adults (18 to 65 years of age), one month
after administration of a booster dose (month 19). The safety and
tolerability profile of VLA15 after a booster dose was consistent
with previous studies25.
In August 2022, the companies initiated a Phase
3 clinical study, "Vaccine Against Lyme for Outdoor Recreationists
(VALOR)", to investigate the efficacy, safety and immunogenicity of
VLA15 in participants five years of age and older in highly endemic
regions in the United States and Europe26.
The VALOR study is currently ongoing and is
designed to follow vaccinated participants over two consecutive
tick seasons. As communicated in February 2023, Pfizer had to
discontinue approximately half of the total recruited participants
in the trial following violations of Good Clinical Practice (GCP)
at certain trial sites in the U.S. run by a third-party trial site
operator. The clinical study remains ongoing with other sites not
operated by the third party, and Pfizer has begun enrolling new
participants into a second, identical cohort at those sites in
addition to newly added sites in the U.S. and Canada. The original
study design and endpoints previously agreed with regulators have
not changed. Current projected incremental study execution costs
incurred due to the agreed amount of additional enrollment will be
borne by Pfizer.
Participants enrolled in the first cohort will
receive their booster vaccination as planned in the second quarter
of 2024 in advance of the 2024 tick season. Enrollment for primary
immunization of the second cohort began in the second quarter of
2023 with overall trial continuation to include the 2025 tick
season.
Pfizer is aiming to submit a BLA to the FDA and
Marketing Authorization Application (MAA) to the EMA in 2026,
subject to positive data.
ZIKA VACCINE CANDIDATE
– VLA1601Re-initiation of
clinical development with further program evaluation
planned
VLA1601 is a highly purified inactivated,
adjuvanted vaccine candidate against the mosquito-borne viral
disease caused by the Zika virus (ZIKV). 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 infection;
however, surveillance remains limited globally. There are no
preventive vaccines or effective treatments available and, as such,
Zika remains a public health threat.
VLA1601 is being developed on the original
manufacturing platform of Valneva’s licensed Japanese Encephalitis
vaccine IXIARO®, which was further optimized to develop the
Company’s inactivated, adjuvanted COVID-19 vaccine VLA2001, the
first one to receive a standard marketing authorization in
Europe27.
Valneva has decided to re-initiate clinical
development with further program evaluation to be conducted subject
to data, medical need and market prospects. This decision is based
on the persistence of Zika transmission in several countries28, the
possibility to leverage the Company’s existing inactivated viral
platform and potentially its expertise in accelerated regulatory
pathways, as well as VLA1601’s compelling Target Product Profile
(TPP).
Pre-Clinical Vaccine
Candidates
Valneva continues to progress selected
pre-clinical assets to further strengthen its future clinical
pipeline.
In preclinical R&D, the Company is currently
prioritizing VLA2112, a vaccine candidate targeting the
Epstein-Barr virus (EBV). EBV is a ubiquitous human pathogen that
can cause infectious mononucleosis29 and is strongly associated
with the development of several types of cancer30 and multiple
sclerosis31.
Other early-stage activities include vaccine
candidates against different enteric diseases.
Valneva continues to explore potential
partnering opportunities for VLA1554, its vaccine candidate
targeting the human metapneumovirus (hMPV), a major worldwide
respiratory pathogen that causes acute upper and lower respiratory
tract infection32.
Commercial Vaccines
JAPANESE ENCEPHALITIS VACCINE
(IXIARO®/JESPECT®)
IXIARO® is a Vero cell culture-derived
inactivated Japanese encephalitis (JE) vaccine that is the only JE
vaccine licensed and available in the United States, Canada and
Europe. IXIARO® is indicated for active immunization against
Japanese encephalitis, the most prevalent cause of viral
encephalitis in Asia, for adults, adolescents, children and infants
aged two months and older.
In the first half of 2023, IXIARO®/JESPECT®
sales increased by to 147% to €30.3 million compared to €12.3
million in the first half of 2022, benefiting from a significant
recovery in the private travel markets following the decline of the
COVID-19 pandemic, as well as from price increases.
Valneva distributes IXIARO® directly to the U.S.
Department of Defense (DoD) and the Company expects to announce a
new contract with the U.S. Defense Logistics Agency (DLA)
imminently.
CHOLERA /
ETEC33-DIARRHEA VACCINE
(DUKORAL®)
DUKORAL® is an oral vaccine for the prevention
of diarrhea caused by Vibrio cholerae and/or heat-labile toxin
producing ETEC34, the leading cause of travelers’ diarrhea.
DUKORAL® is authorized for use in the European Union and Australia
to protect against cholera, and in Canada, Switzerland, New Zealand
and Thailand to protect against cholera and ETEC.
In the first half of 2023, DUKORAL® sales
increased by 197% to €17.1 million compared to €5.8 million in
the first half of 2022, also benefiting from the significant
recovery in the private travel markets and price increases.
THIRD-PARTY DISTRIBUTION
Valneva distributes certain third-party vaccines
in countries where it operates its own marketing and sales
infrastructure. In the first half of 2023, third party product
sales increased by 44% to €16.5 million from
€11.5 million in the first half of 2022.
MANUFACTURING UPDATE
Valneva’s Management Board
decides on
strategic
direction for
new Scottish
manufacturing
facility Almeida
In July 2023, Valneva’s Management Board took
the decision to begin a staggered transfer of production for
Valneva’s Japanese encephalitis vaccine and chikungunya vaccine
candidate to its state-of-the-art Almeida manufacturing facility,
which was initially built to produce the Company’s COVID-19
vaccine. As communicated in its first quarter results on May 4,
2023, the Company had been exploring options for the facility,
including a possible sale of the facility. The Company will
carefully balance resources across its two Scottish facilities to
ensure a smooth and efficient transfer of production to
Almeida.
Valneva divests Swedish clinical
trial manufacturing unit
to NorthX Biologics
As part of its strategy to focus on core
business activities, Valneva divested its clinical trial
manufacturing, or CTM, unit in Solna, Sweden, to NorthX Biologics,
an established Nordic contract development and manufacturing
organization (CDMO) in July 2023. The deal comprised Valneva’s CTM
production facility and approximately 30 staff members in Sweden.
Valneva Sweden retains 150 employees at its Swedish site, working
in the Company’s dedicated production unit for its cholera vaccine
DUKORAL® and its center of excellence for fill and finish
operations.
First Half 2023
Financial Review (Unaudited, consolidated under IFRS)
RevenuesValneva’s total
revenues were €73.7 million in the first half of 2023 compared
to €93.2 million in the first half of 2022, a decrease of
20.9%. The decrease was related to non-recurring revenues recorded
in the prior year related to the Company’s COVID-19
program.Valneva’s total product sales reached €69.7 million in the
first half of 2023 compared to €33.3 million in the first half
of 2022, an increase of 109.0%. This was driven by a continued
recovery of travel vaccine sales. Foreign currency fluctuations
contributed to a €0.7 million decline in product sales.
COVID-19 vaccine sales in the first half of 2023 amounted to €5.7
million compared to €3.8 million in the first half of 2022.
Excluding COVID-19, product sales reached €64.0 million in the
first half of 2023 compared to €29.5 million in the comparator
period of 2022, an increase of 116.6%. IXIARO®/JESPECT® product
sales were €30.3 million in the first half of 2023 compared to
€12.3 million in the first half of 2022, an increase of 146.8%
with sales benefitting from the continuing recovery of travel
markets as well as price increases. Foreign currency fluctuations
contributed to a €0.2 million decline in product sales. DUKORAL®
sales were €17.1 million in the first half of 2023 compared to
€5.8 million in the first half of 2022, an increase of 197.4%,
also benefitting from the significant recovery in the private
travel markets and price increases. Foreign currency fluctuations
contributed to a €0.3 million decline in product sales. Third Party
product sales were €16.5 million in the first half of 2023
compared to €11.5 million in the first half of 2022, an
increase of 43.8%, which was mainly driven by sales under the
distribution agreement with Bavarian Nordic for Rabipur®/RabAvert®
and Encepur®.Other revenues, including revenues from
collaborations, licensing and services amounted to
€4.1 million in the first half of 2023 compared to
€59.9 million in the first half of 2022. The prior year period
included €89.4 million released from the refund liability as a
result of the settlement with the UK government, partially offset
by €36.1 million of negative revenue resulting from an increase in
the refund liability linked to the amendment to the VLA15
collaboration and license agreement with Pfizer.
Operating Result and
Adjusted EBITDA
Costs of goods and services sold (COGS) were €53.8 million in
the first half of 2023. The gross margin on commercial product
sales excluding COVID-19 sales was 40.0% compared to 58.3% in the
first half of 2022. COGS of €18.1 million related to IXIARO®
product sales yielding a product gross margin of 40.2%. COGS of
€10.1 million related to DUKORAL® product sales yielding a product
gross margin of 40.9%. The gross margin of IXIARO® was impacted by
batch write-offs in the Scottish manufacturing site. Additionally,
the gross margins of both IXIARO® and DUKORAL® were adversely
impacted by high indirect sales in markets where Valneva sells
through distributors. Of the remaining COGS for the first half of
2023, €10.2 million were related to the Third-Party product
distribution business, €3.8 million to COVID-19 product sales and
€6.1 million to initial COGS related to the launch
preparations for the chikungunya vaccine candidate as well as to
idle capacity costs. In the first half of 2022, overall COGS were
€171.5 million, of which €167.2 million related to cost
of goods and €4.3 million related to cost of services. COGS in
the first half of 2022 included write-offs related to the
significant reduction of COVID-19 sales volumes to EC Member
States.Research and development expenses amounted to
€26.0 million in the first half of 2023 compared to
€51.9 million in the first half of 2022. This decrease was
exclusively driven by the lower spend on Valneva’s COVID-19 vaccine
VLA2001. At the same time, cost related to the Zika vaccine
candidate increased as the Company has been working towards a
re-initiation of clinical development. Marketing and distribution
expenses in the first half of 2023 amounted to €20.0 million
compared to €7.8 million in the first half of 2022. Marketing
and distribution expenses in the first half of 2023 notably
included €7.8 million of expenses related to the launch
preparation costs of the chikungunya vaccine candidate, VLA1553,
compared to €2.2 million in the first half of 2022. In the
first half of 2023, general and administrative expenses increased
to €22.9 million from €16.0 million in the first half of
2022. COGS, research and development, marketing and distribution as
well as general and administrative expenses benefited in the first
half of 2022 from an accrual adjustment income of €19.5 million
related to the favorable effect of the Company’s share price
development on the employee share-based compensation programs.
Other income, net of other expenses, increased to
€15.9 million in the first half of 2023 from €3.6 million
in the first half of 2022. This increase was mainly driven by
recognizing grant income received from Scottish Enterprise into the
income statement in the first half of 2023.Valneva recorded an
operating loss of €35.0 million in the first half of 2023 compared
to an operating loss of €150.4 million in the first half of
2022. Adjusted EBITDA loss in the first half of 2023 was €28.3
million compared to an Adjusted EBITDA loss of €136.0 million
in the first half of 2022 (as explained further below).
Net Result In the first half of
2023, Valneva generated a net loss of €35.0 million compared
to a net loss of €171.5 million in the first half of 2022.
Finance expense and foreign currency effects in the first half of
2023 resulted in a net finance expense of €3.9 million,
compared to a net finance expense of €18.8 million in the
first half of 2022. This was mainly a result of a foreign exchange
gain amounting to €4.5 million in the first half of 2023,
primarily driven by revaluation results of non-Euro denominated
balance sheet positions, compared to a net foreign exchange loss of
€10.7 million in the first half of 2022. Interest expenses net of
interest income were €8.4 million in the first half of 2023
compared to €8.2 million in the first half of 2022.
Cash Flow and Liquidity Net
cash used in operating activities amounted to €65.4 million in
the first half of 2023 compared to €100.2 million in the first
half of 2022. Cash outflows in the first half of 2023 mainly
resulted from the operating loss as well as increased working
capital. Cash outflows in the first half of 2022 mainly resulted
from the operating loss generated.Cash outflows from investing
activities amounted to €6.6 million in the first half of 2023
compared to €16.0 million in the first half of 2022, both
mainly related to construction activities at the Scottish
production site and purchases of equipment.Net cash used in
financing activities amounted to €9.5 million in the first
half of 2023, which was mainly due to interest payments as well as
payments of lease liabilities. Cash inflows in the first half of
2022 amounted to €105.0 million and mainly related to proceeds
from the equity subscription agreement with Pfizer as well as
disbursements from the credit facility provided by Deerfield &
OrbiMed. Cash and cash equivalents amounted to €204.4 million as at
June 30, 2023, compared to €289.4 million as at December 31,
2022.
Non-IFRS Financial
MeasuresManagement 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 supplemental measure of
performance used by investors and financial analysts. Management
believes this measure provides additional analytical tools.
Adjusted EBITDA is defined as earnings (loss) from continuing
operations before interest expense, income taxes, depreciation and
amortization.
A reconciliation of Adjusted EBITDA to operating
loss, which is the most directly comparable IFRS measure, is set
forth below:
€ in million |
6 months ending June 30 |
(unaudited results, consolidated per IFRS) |
2023 |
2022 |
Net Income |
(35.0) |
(171.5) |
Add: |
|
|
Income tax expense |
(3.8) |
2.3 |
Total Finance income |
(0.5) |
(0.0) |
Total Finance expense |
8.9 |
8.2 |
Foreign exchange gain/(loss) – net |
(4.5) |
10.7 |
Result from investments in associates |
- |
(0.0) |
Amortization |
3.2 |
3.5 |
Depreciation |
5.4 |
7.7 |
Impairment, excluding impairment loss of disposal |
(1.9) |
3.3 |
Adjusted EBITDA |
(28.3) |
(136.0) |
About Valneva
SEWe are a specialty vaccine company focused on the
development, manufacturing and commercialization of prophylactic
vaccines for infectious diseases. We take a highly specialized and
targeted approach to vaccine development by focusing on vaccine
solutions addressing unmet medical needs to ensure we can make a
difference to peoples’ lives. We apply our deep understanding of
vaccine science, including our expertise across multiple vaccine
modalities, and our established vaccine development capabilities,
to develop vaccines against diseases which are not yet
vaccine-preventable, or for which there are limited effective
treatment options. Today, we are leveraging our expertise and
capabilities to rapidly advance a broad range of vaccines into and
through the clinic, including candidates against the chikungunya
virus and Lyme disease.
Valneva Investor and Media ContactsLaetitia
Bachelot-FontaineVP, Global Communications and European Investor
RelationsM +33 (0)6 4516
7099investors@valneva.com |
Joshua Drumm, Ph.D.VP, Global Investor Relations M +001 917 815
4520joshua.drumm@valneva.com |
|
|
Forward-Looking StatementsThis
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 the
expected timing for submissions to and responses by regulatory
authorities. 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 or delays, unexpected regulatory actions or delays,
competition in general, currency fluctuations, the impact of the
global and European credit crisis, the ability to obtain or
maintain patent or other proprietary intellectual property
protection, the cancellation of existing contracts, and the impact
of the COVID-19 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 Extension of Existing Loan Agreement -
Valneva2 For additional information on Adjusted EBITDA, please
refer to the “Non-IFRS Financial Measures” section at the end of
the PR3
https://www.who.int/news-room/fact-sheets/detail/chikungunya4https://www.paho.org/en/documents/epidemiological-alert-chikungunya-increase-region-americas5
FDA Accepts Valneva’s Chikungunya Vaccine License Application for
Priority Review - Valneva6 Valneva Announces PDUFA Date Extension
for Chikungunya Virus Vaccine Candidate - Valneva7 Valneva
Announces PDUFA Date Extension for Chikungunya Virus Vaccine
Candidate - Valneva8 Valneva Files for Chikungunya Vaccine
Authorization with Health Canada - Valneva9 Health Canada Accepts
Valneva’s Chikungunya Vaccine License Application for Review -
Valneva10 Valneva Successfully Completes Pivotal Phase 3 Trial of
Single-Shot Chikungunya Vaccine Candidate11 Valneva Successfully
Completes Pivotal Phase 3 Trial of Single-Shot Chikungunya Vaccine
Candidate12 Valneva Reports Positive 12-Month Antibody Persistence
Data for Single-Shot Chikungunya Vaccine Candidate - Valneva13
Valneva Announces Publication of its Chikungunya Vaccine Candidate
Phase 3 Data in The Lancet - Valneva14 Wressnigg N, Hochreiter R,
Zoihsl O, Fritzer A, Bézay N, Klingler A, Lingnau K, Schneider M,
Lundberg U, Meinke A, Larcher-Senn J, Čorbic-Ramljak I,
Eder-Lingelbach S, Dubischar K, Bender W. "Single-shot
live-attenuated chikungunya vaccine in healthy adults: a phase 1,
randomised controlled trial." Lancet ID, 2020: 20(10):1193-1203.15
McMahon R, Töpfer S, Schneider M, Hadl S, Hochreiter R, Kosulin K,
Mader R, Zoihsl O, Wressnigg N, Dubischar K, Buerger V,
Eder-Lingelbach S, Jaramillo JC. "One year antibody persistence and
safety of a live-attenuated chikungunya virus (CHIKV) vaccine
candidate (VLA1553) in adults aged 18 years and above." CISTM.
Basel, 2023.16 Valneva Reports Positive 12-Month Antibody
Persistence Data for Single-Shot Chikungunya Vaccine Candidate -
Valneva17 Valneva Completes Enrollment for Adolescent Phase 3 Trial
of Single-Shot Chikungunya Vaccine Candidate - Valneva18 Valneva
Reports Positive Initial Phase 3 Safety Data in Adolescents for its
Single-Shot Chikungunya Vaccine Candidate - Valneva19 Valneva and
Instituto Butantan Sign Final Agreement on Single-Shot Chikungunya
Vaccine for Low and Middle Income Countries20 CEPI awards up to
$23.4 million to Valneva for late-stage development of a
single-dose Chikungunya vaccine21 VacZine Analytics Chikungunya
virus vaccines Global demand analysis. February 202022 Valneva and
Pfizer Report Six-Month Antibody Persistence Data in Children and
Adults for Lyme Disease Vaccine Candidate - Valneva23Pfizer and
Valneva Initiate Phase 3 Study of Lyme Disease Vaccine Candidate
VLA15 - Valneva24 Valneva and Pfizer Report Further Positive Phase
2 Results, Including Booster Response, for Lyme Disease Vaccine
Candidate - Valneva25 Valneva and Pfizer Report Positive Pediatric
and Adolescent Phase 2 Booster Results for Lyme Disease Vaccine
Candidate - Valneva26 Pfizer and Valneva Initiate Phase 3 Study of
Lyme Disease Vaccine Candidate VLA15 - Valneva27 Valneva Receives
Marketing Authorization in Europe for Inactivated Whole-Virus
COVID-19 Vaccine VLA2001 - Valneva28 Zika virus disease
(who.int)29https://www.cdc.gov/epsteinbarr/index.html#:~:text=EBV%20can%20cause%20infectious%20mononucleosis,common%20among%20teens%20and%20adults.30https://www.cancer.org/healthy/cancer-causes/infectious-agents/infections-that-can-lead-to
cancer/viruses.html#:~:text=EBV%20infection%20increases%20a%20person's,some%20cases%20of%20stomach%20cancer.31https://www.nih.gov/news-events/nih-research-matters/study-suggests-epstein-barr-virus-may-cause-multiple-sclerosis#:~:text=Infection%20with%20Epstein%2DBarr%20virus,could%20help%20prevent%20multiple%20sclerosis32
https://www.cdc.gov/ncird/human-metapneumovirus.html33 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.34
Enterotoxigenic Escherichia coli (ETEC) is a type of
Escherichia coli and one of the leading bacterial causes of
diarrhea in the developing world, as well as the most
common cause of travelers’ diarrhea.
- 2023_09_21_VLA_HY_Results_PR_EN_Final
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