Valneva Reports Nine-Month 2023 Financial Results and Provides
Corporate Updates
Product sales of €106.1 million, an
increase of 42.6% compared to the first nine months of
2022
- IXIARO® and DUKORAL® sales
benefited from a continued recovery of the travel industry
- Total revenues of
€111.8 million in the first nine months of 2023
Cash position of €171.3 million as of
September 30, 2023
- Includes $50 million of the $100
million available following upsize of credit facility with leading
U.S. Healthcare Funds Deerfield and OrbiMed in August 20231
- Includes a significant payment made
to Pfizer in the third quarter of 2023 related to the companies’
Phase 3 Lyme disease study “VALOR”
Chikungunya: progressing towards
potential licensure of the world’s first chikungunya
vaccine
- Biologic License Application (BLA)
currently under priority review by the U.S. Food and Drug
Administration (FDA) with a PDUFA date at the end of November
- New Drug Submission (NDS) under
review by Health Canada
- Marketing Authorization Application
(MAA) submitted to the European Medicines Agency (EMA) in October
20232; accelerated assessment granted by EMA’s Committee for
Medicinal Products for Human Use (CHMP).
Updated 2023 financial guidance reflects
lower R&D expenditure
- 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 (assuming a sale of the Priority Review Voucher
received upon a potential approval of VLA1553 before year-end)
- Expected R&D expenses now
between €60 million and €70 million (previously between
€70 million and €90 million); mainly driven by lower than
anticipated costs related to the closeout of the COVID-19
activities
Financial Information(Unaudited
results, consolidated per IFRS)
€ in
million |
Nine months ending September 30, |
|
2023 |
2022 |
Total revenues |
111.8 |
249.9 |
Product sales |
106.1 |
74.4 |
Net loss |
(69.3) |
(99.1) |
Adjusted EBITDA3 |
(46.0) |
(38.0) |
Cash |
171.3 |
261.0 |
Saint-Herblain (France), November 9,
2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a
specialty vaccine company, today reported consolidated financial
results for the first nine months of the year, ended September 30,
2023. The condensed consolidated interim financial results are
available on the Company’s website (Financial Reports –
Valneva).
Valneva will provide a live webcast of its
nine-month 2023 results conference call beginning at 3 p.m. CET/9
a.m. ET today. This webcast will also be available on the Company’s
website. Please refer to this link:
https://edge.media-server.com/mmc/p/do4mozxx.
Peter Bühler, Valneva’s Chief Financial
Officer, commented, “In the third quarter, we continued
growing our commercial sales and are confident that we will meet
our revenue target for the year. We remain focused on advancing our
key R&D programs with a strong emphasis on working with the FDA
to obtaining the first regulatory approval worldwide for a
chikungunya vaccine”.
Clinical Stage Vaccine
Candidates
CHIKUNGUNYA VACCINE CANDIDATE –
VLA1553BLA under priority review by the U.S. FDA;
accelerated assessment confirmed by EMA
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 countries4
with the potential to rapidly expand further. The Pan American
Health Organization issued an epidemiological alert in February
2023 as the number of cases and deaths due to chikungunya continues
to rise in the Americas5. 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 BLA is currently under priority review by
the U.S. FDA6 with a Prescription Drug User Fee Act (PDUFA) action
date planned for the end of November 20237.
Additionally, an MAA was submitted to EMA in
October 20238, and EMA’s CHMP confirmed accelerated assessment for
the application based on the vaccine candidate’s “major interest
for public health and therapeutic innovation”. A marketing
application is also under review by Health Canada9.
If approved, VLA1553 could become the first
licensed chikungunya vaccine available to address this unmet
medical need.
The regulatory submissions follow final pivotal
Phase 3 data in March 202210, final lot-to-lot consistency results
in May 202211, twelve-month persistence data in December 202212 and
positive initial Phase 3 safety data in adolescents13.
The pivotal Phase 3 data were published in The
Lancet, the world’s leading peer-reviewed medical journal, in June
202314. The article 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.
Earlier clinical data, published in the Lancet
Infectious Diseases, showed a rapid onset of immune response with a
single dose of VLA1553 between 7- and 14-days post-vaccination15.
This was later confirmed in a further analysis of the Phase 1 data,
which showed that 100% of vaccinated individuals reached the immune
threshold16 established with the FDA at day 1417.
Additionally, VLA1553 was able to demonstrate a
robust immune response which was sustained for 12 months by 99% of
participants and was equally durable in younger and older adults18.
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 initial safety data
in August 202319. 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.
Initial safety data generated from the study,
Valneva’s first clinical study in an endemic area and with
individuals previously infected with CHIKV, showed 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
signed an agreement in January 2021 for the development,
manufacturing, and marketing of VLA155320. The collaboration falls
within the framework of the agreement signed between CEPI and
Valneva in July 201921, 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
accelerated assessment in October 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 203222.
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 observed23,24,25. 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 studies26.
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 Europe27.
The VALOR study is currently ongoing and is
designed to follow vaccinated participants over two consecutive
tick seasons. 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 infection28;
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
Europe29.
Valneva plans to re-initiate clinical
development in the first quarter of 2024.
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 mononucleosis30 and is strongly associated
with the development of several types of cancer31 and multiple
sclerosis32.
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 infection33.
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 nine months of 2023,
IXIARO®/JESPECT® sales increased by 119.4% to €50.3 million
compared to €22.9 million in the first nine months 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.
In September 2023, Valneva announced the signing
of a one-year contract with the U.S. Department of Defense (DoD)
for the supply of IXIARO®. Under this new contract, the DoD will
buy a minimum of $32 million worth of IXIARO® vaccines and has the
possibility to purchase additional doses during the twelve months
of the contract. First doses were delivered in September.
CHOLERA /
ETEC34-DIARRHEA VACCINE
(DUKORAL®)
DUKORAL® is an oral vaccine for the prevention
of diarrhea caused by Vibrio cholerae and/or heat-labile toxin
producing ETEC35, 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 nine months of 2023, DUKORAL® sales
increased by 128.5% to €21.1 million compared to €9.2 million
in the first nine months of 2022, also benefiting from the
significant recovery in the private travel markets and price
increases. DUKORAL® sales for the first nine months of 2023
exceeded pre-COVID-19 sales levels during the first nine months of
2019.
SARS-CoV-2 INACTIVATED WHOLE-VIRUS
VACCINE
Valneva’s COVID-19 vaccine, VLA2001, is the only
inactivated whole-virus COVID-19 vaccine approved in Europe36 and
was the first COVID-19 vaccine to receive a full marketing
authorization from the EMA.
In light of reduced order volume linked to the
decline of the COVID-19 pandemic, Valneva suspended manufacturing
of the vaccine in August 2022 and inventories were fully written
down as of December 31, 2022. In order to save additional costs
linked to the vaccine including license fees, Valneva recently
requested the withdrawal of VLA2001’s marketing authorization in
Europe. The withdrawal was accepted by EMA and will become
effective on December 1, 2023.
In the first nine months of 2023, VLA2001 sales
amounted to €5.7 million compared to €23.9 million in the first
nine months of 2022.
THIRD-PARTY DISTRIBUTION
Valneva distributes certain third-party vaccines
in countries where it operates its own marketing and sales
infrastructure. In the first nine months of 2023, third party
product sales increased by 58% to €29.1 million from
€18.4 million in the first nine months of 2022.
Nine Months 2023 Financial
Review37(Unaudited, consolidated under
IFRS)
RevenuesValneva’s total
revenues were €111.8 million in the first nine months of 2023,
compared to €249.9 million in the first nine months of 2022.
The 55.3% decrease was related to non-recurring revenues recorded
in the prior year linked to the Company’s COVID-19 program.
Valneva’s total product sales reached €106.1
million in the nine months ended September 30, 2023, compared to
€74.4 million in the same period of 2022. This 42.6% increase
was driven by the continued recovery of travel vaccine sales.
Currency fluctuations of €1.6 million adversely impacted product
sales. COVID-19 vaccine sales in the first nine months of 2023
amounted to €5.7 million compared to €23.9 million in the
first nine months of 2022. Excluding COVID-19, product sales
reached €100.4 million in the first nine months of 2023 compared to
€50.6 million during the comparator period of 2022, an increase of
98.7%.
IXIARO®/JESPECT® product sales were €50.3
million in the first nine months of 2023 compared to
€22.9 million in the first nine months of 2022. The 119.4%
increase in sales is primarily the result of the continued travel
market recovery, as well as price increases. The increase in
IXIARO®/JESPECT® product sales included an adverse €0.7 million
foreign currency impact. DUKORAL® sales were €21.1 million in
the first nine months of 2023 compared to €9.2 million in the
first nine months of 2022. This 128.5% increase is also a result of
the significant recovery in the private travel markets and price
increases. Foreign currency fluctuations reduced DUKORAL® sales by
€0.5 million. Third Party product sales were
€29.1 million in the nine months ended September 30, 2023
compared to €18.4 million in the comparison period of 2022, a
58.0% increase which was mainly driven by sales of
Rabipur®/RabAvert® and Encepur® under the distribution agreement
with Bavarian Nordic.
Other revenues, including revenues from
collaborations, licensing and services amounted to
€5.7 million in the first nine months of 2023 compared to
€175.5 million in the first nine months of 2022. The first
nine months of 2022 included COVID-related one-time effects of
€200.2 million consisting of released refund liability as a result
of the settlement with the UK government, as well as released
non-refundable advance payments from EU Member States, partially
offset by €34.7 million of negative revenue resulting from an
increase in the refund liability linked to the amended VLA15
collaboration and license agreement with Pfizer.
Operating Result and adjusted
EBITDA Costs of goods and services sold (COGS) were
€74.8 million in the nine months ended September 30, 2023. The
gross margin on commercial product sales, excluding COVID-19
vaccines sales, was 43.7% compared to 55.4% in the first nine
months of 2022. COGS of €26.6 million were related to IXIARO®
product sales, yielding a product gross margin of 47.2%. COGS of
€12.7 million were related to DUKORAL® product sales, yielding a
product gross margin of 39.8%. The IXIARO® gross margin 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
nine months of 2023, €17.3 million were related to the
Third-Party product distribution business, €1.7 million to COVID-19
product sales and €9.3 million to initial COGS linked to the launch
preparations for the Company’s chikungunya vaccine candidate, as
well as idle capacity costs. The remaining COGS related to
services. In the nine months ended September 30, 2022, overall COGS
were €202.7 million, of which €196.6 million related to cost of
goods and €6.2 million related to cost of services. COGS in the
first nine months 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
€42.2 million in the first nine months of 2023 compared to €75.4
million in the first nine months of 2022. This decrease was
exclusively driven by the lower spend on Valneva’s COVID-19
vaccine, VLA2001. At the same time, costs related to the Zika
vaccine candidate increased as the Company has been working towards
re-initiation of clinical development. Marketing and distribution
expenses in the first nine months of 2023 amounted to €33.9 million
compared to €13.1 million in the first nine months of 2022.
Marketing and distribution expenses in the first nine months of
2023 notably included €13.8 million of expenses related to launch
preparations for the chikungunya vaccine candidate, VLA1553,
compared to €4.3 million in the first nine months of 2022. In the
first nine months of 2023, general and administrative expenses
increased to €35.1 million from €23.3 million in the first nine
months of 2022. In the first nine months of 2022, COGS, research
and development, marketing and distribution as well as general and
administrative expenses benefited from an accrual adjustment income
of €30.6 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 €17.0 million in the first nine months of 2023 versus €7.5
million in the first nine months of 2022. This increase was mainly
driven by the recognition of grant income received from Scottish
Enterprise during the first nine months of 2023.
Valneva recorded an operating loss of €57.2
million in the first nine months of 2023 compared to an operating
loss of €57.1 million in the first nine months of 2022. Adjusted
EBITDA loss in the first nine months of 2023 was €46.0 million
compared to an adjusted EBITDA loss of €38.0 million in the first
nine months of 2022 (as explained further below).
Net Result In the nine months
ended September 30, 2023, Valneva generated a net loss of €69.3
million compared to a net loss of €99.1 million in the nine months
ended September 30, 2022.
Finance expense and foreign currency effects in
the first nine months of 2023 resulted in a net finance expense of
€13.2 million, compared to a net finance expense of €39.8 million
in the first nine months of 2022. The difference is primarily
driven by a decrease of €25.1 million in the revaluation results of
non-Euro denominated balance sheet positions, to a €1.4 million net
foreign exchange loss in the first nine months of 2023 from €26.5
million in the first nine months of 2022. Interest expenses net of
interest income were €11.8 million in the first nine months of 2023
compared to €13.3 million in the first nine months of 2022.
Cash Flow and Liquidity Net
cash used in operating activities amounted to €136.8 million in the
first nine months of 2023 compared to €189.5 million in the first
nine months of 2022. Cash outflows in the first nine months of 2023
mainly resulted from the operating loss as well as payments of
refund liabilities to Pfizer related to the Lyme VLA15 R&D
collaboration agreement. Cash outflows in the first nine months of
2022 mainly resulted from the operating loss as well as releases
from the refund liabilities following the signing of the COVID-19
settlement agreement with the UK government.
Cash outflows from investing activities amounted
to €4.3 million in the first nine months of 2023 compared to €22.5
million in the first nine months of 2022. Cash outflows in the
first nine months of 2023 mainly related to construction activities
at the Scottish production site and purchases of equipment partly
offset by proceeds from the divestment of the Clinical Trial
Manufacturing unit in Sweden and from selling shares in BliNK
Biomedical SAS. Cash outflows in the first nine months of 2022
mainly related to construction activities at the Scottish
production site and purchases of equipment.
Net cash generated from financing activities
amounted to €26.1 million in the first nine months of 2023, which
mainly resulted from proceeds from the additional tranche added to
the existing credit facility with U.S. healthcare investment firms
Deerfield Management Company & OrbiMed, partly offset by
interest payments as well as payments of lease liabilities. Cash
inflows in the first nine months of 2022 amounted to €121.6 million
and mainly related to proceeds from the equity subscription
agreement with Pfizer as well as disbursements from the credit
facility provided by Deerfield Management Company &
OrbiMed.Cash and cash equivalents amounted to €171.3 million as at
September 30, 2023, compared to €289.4 million as at December 31,
2022.
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 provides 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
income, which is the most directly comparable IFRS measure, is set
forth below:
€ in million |
Nine months ended September 30, |
|
2023 |
2022 |
Loss for the period |
(69,271) |
(99,075) |
Add: |
|
|
Income tax (benefit)/expense |
(1,103) |
2,163 |
Total finance income |
(724) |
(59) |
Total finance expense |
12,477 |
13,395 |
Foreign currency (gain)/loss – net |
1,441 |
26,493 |
Result from investments in associates |
- |
(9) |
Amortization |
4,680 |
5,259 |
Depreciation |
8,396 |
10,581 |
Impairment excluding impairment loss of disposal |
(1,881) |
3,286 |
Adjusted EBITDA |
(45,985) |
(37,967) |
Subsequent events:
Following the expiry of the lease agreement, on
October 31, 2023 the Company’s subsidiary “Valneva Austria GmbH”
acquired the legal entity that owns the Vienna building it was
previously leasing, leveraging the security deposit. The
acquisition price, excluding the security deposit and the entity’s
cash, is approximately €10.9 million. The Company is evaluating the
possibility of a sale and lease-back transaction.
As an update on Note 5.17 in the 2023 half-year
financial statements38, the litigation related to the Humalys
acquisition has now finished, as no appeal was lodged prior to the
statutory deadline.”
About Valneva SEWe 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 two proprietary travel vaccines as well as
certain third-party vaccines leveraging our established commercial
infrastructure.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, potentially
the world’s first vaccine against the chikungunya virus, as well as
vaccine candidates against the Zika virus and other global public
health threats.
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 Valneva Submits Chikungunya Vaccine Marketing Application
to EMA and Announces CHMP Accelerated Assessment3 For additional
information on Adjusted EBITDA, please refer to the “Non-IFRS
Financial Measures” section at the end of the PR4
https://www.who.int/news-room/fact-sheets/detail/chikungunya5https://www.paho.org/en/documents/epidemiological-alert-chikungunya-increase-region-americas6
FDA Accepts Valneva’s Chikungunya Vaccine License Application for
Priority Review - Valneva7 Valneva Announces PDUFA Date Extension
for Chikungunya Virus Vaccine Candidate - Valneva8 Valneva Submits
Chikungunya Vaccine Marketing Application to EMA and Announces CHMP
Accelerated Assessment9 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
Lot-to-Lot Consistency Trial for its Single-Shot Chikungunya
Vaccine Candidate12 Valneva Reports Positive 12-Month Antibody
Persistence Data for Single-Shot Chikungunya Vaccine Candidate -
Valneva13 Valneva Reports Positive Initial Phase 3 Safety Data in
Adolescents for its Single-Shot Chikungunya Vaccine Candidate -
Valneva14 Valneva Announces Publication of its Chikungunya Vaccine
Candidate Phase 3 Data in The Lancet - Valneva15 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):1193-1203.16
Seroresponse17 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, 2023.18 Valneva Reports Positive 12-Month Antibody
Persistence Data for Single-Shot Chikungunya Vaccine Candidate -
Valneva19 Valneva Reports Positive Initial Phase 3 Safety Data in
Adolescents for its Single-Shot Chikungunya Vaccine Candidate -
Valneva20 Valneva and Instituto Butantan Sign Final Agreement on
Single-Shot Chikungunya Vaccine for Low and Middle Income
Countries21 CEPI awards up to $23.4 million to Valneva for
late-stage development of a single-dose Chikungunya vaccine22
VacZine Analytics Chikungunya virus vaccines Global demand
analysis. February 202023 Valneva and Pfizer Report Six-Month
Antibody Persistence Data in Children and Adults for Lyme Disease
Vaccine Candidate - Valneva24Pfizer and Valneva Initiate Phase 3
Study of Lyme Disease Vaccine Candidate VLA15 - Valneva25 Valneva
and Pfizer Report Further Positive Phase 2 Results, Including
Booster Response, for Lyme Disease Vaccine Candidate - Valneva26
Valneva and Pfizer Report Positive Pediatric and Adolescent Phase 2
Booster Results for Lyme Disease Vaccine Candidate - Valneva27
Pfizer and Valneva Initiate Phase 3 Study of Lyme Disease Vaccine
Candidate VLA15 - Valneva28 Zika virus disease (who.int)29 Valneva
Receives Marketing Authorization in Europe for Inactivated
Whole-Virus COVID-19 Vaccine VLA2001 -
Valneva30https://www.cdc.gov/epsteinbarr/index.html#:~:text=EBV%20can%20cause%20infectious%20mononucleosis,common%20among%20teens%20and%20adults.31https://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.32https://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%20sclerosis33
https://www.cdc.gov/ncird/human-metapneumovirus.html34 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.35
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.36 Valneva Receives Marketing
Authorization in Europe for Inactivated Whole-Virus COVID-19
Vaccine VLA200137 While the financial figures included in this
preliminary interim earnings announcement have been computed in
accordance with International Financial Reporting Standards (IFRS
Accounting Standards) applicable to interim periods, this
announcement does not contain sufficient information to constitute
an interim financial report as that term is defined in IFRS
Accounting Standards.
38 H1 2023 Financial Report EN (valneva.com)
- 2023_11_09_VLA_Nine-month_PR_EN_Final
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