Valneva Reports Full Year 2023 Results and Provides Business
Updates and Outlook
Total revenues of €153.7 million, including
product sales of €144.6 million
- Product sales surpassed
pre-pandemic (2019) sales by 12% and 2022 sales by 26%
- Excluding COVID-19 vaccine sales,
product sales grew by 63% compared to 2022
Cash position of €126.1 million at
year-end 2023 enhanced by €95 million from sale of
Priority Review Voucher
(PRV)1
- Extended the interest-only period
of existing debt financing agreement to January 2026 significantly
extending cash runway2
- Operational business considered
sufficiently funded (excluding debt repayment) until commercial
revenues from Lyme program enable sustained profitability
Excellent progress across R&D
pipeline
- Approval of single-shot chikungunya
vaccine IXCHIQ® in the United States (U.S.)
- The world’s first and only vaccine
to address this significant unmet medical need
- U.S. CDC recently adopted ACIP
recommendations3
- Regulatory reviews ongoing in
Europe, Canada and Brazil
- Completion of recruitment for Lyme
disease Phase 3 study conducted in collaboration with Pfizer
- All execution milestones on
track
- Advancing second-generation ZIKA
vaccine candidate into Phase 1 clinical trial
- Addressing a re-emerging medical
need
Updated FY 2024 guidance
Valneva raises its 2024 product
sales4 guidance to between €160 million and €180 million
due to an improved outlook regarding the IXIARO® supply
constraints that were anticipated in February 2024.
As such, 2024 total revenues are now expected to reach between €170
million and €190 million compared to €153.7 million in 2023,
driven by continued sales growth of the Company’s proprietary
travel vaccines and the launch-year sales of
IXCHIQ®.
Sales are expected to grow this year despite an estimated 20-30%
reduction in third-party sales as a result of anticipated supply
constraints.
In 2024, the Company anticipates lower R&D expenses than
previously communicated, narrowing guidance to €60 million to €75
million, based on additional visibility for its chikungunya- and
Zika- related expenses. Additionally, Valneva expects non-dilutive
contributions from institutions for R&D costs in connection
with its ongoing chikungunya activities and the product tech
transfers to Valneva’s brand-new state-of the art facility
(“Almeida”) in Scotland.
Other income is now expected between €100 million and €110 million
in 2024, reflecting €95 million in proceeds from the PRV sale in
early 2024.
Valneva anticipates a significantly lower cash burn this year than
in 2023 and expects its commercial business to be cash-flow
positive and contribute significantly to funding the Company’s
R&D from 2025.
Valneva’s cost contributions for the Lyme disease Phase 3 study are
expected to be completed in the first half of 2024. All remaining
payments to Pfizer are reflected in current refund liability at
December 31, 2023, and will not impact the Profit & Loss
statement in 2024.
The Company has re-negotiated the terms of its loan agreement with
Deerfield and OrbiMed5 and will now start reimbursing
the first $100 million tranche in January 2026 instead of July
2024. The loan interest rate remains unchanged and this portion of
the loan will still mature in the first quarter of 2027.
Mid-term outlook
Product sales
In the mid-term, Valneva expects continued sales growth for its
travel vaccines IXIARO® and DUKORAL®, and
with the current launch of IXCHIQ®, the Company
anticipates annual product sales to approximately double by the end
of 2026. This will be driven by IXIARO®, for which
continued double-digit annual growth is expected for at least the
next three years, and by ramping IXCHIQ® sales, which
are expected to exceed €100 million in year three after initial
launch, subject to anticipated regulatory approvals and even
assuming potential competitive product entry. There may also be
upside from potential IXCHIQ® stockpiling opportunities.
Regulatory reviews are ongoing in Europe, Canada and Brazil, and
decisions for these submissions are expected in 2024. The Company
currently estimates that the travel market opportunity for
chikungunya vaccines could be valued between €300 million to €400
million based on the number of travelers to endemic regions and
their anticipated adoption of the vaccine. Additionally,
considering the high unmet medical need that chikungunya represents
in Low- and Middle-Income Countries (LMICs), Valneva expects strong
adoption of its chikungunya vaccine in these countries.
The third-party product business supported Valneva’s revenues as a
complement to its existing travel vaccine portfolio, especially
during the COVID-19 pandemic. However, 2023 third-party sales of
more than €35 million yielded only 36% gross margin, diluting
Valneva’s overall margins, and the Company has therefore decided to
focus resources on direct sales of its proprietary products.
Valneva expects that third-party sales will gradually wind down to
less than 5% of product sales by 2026/2027, considering the
anticipated end to its collaboration with Bavarian Nordic by the
end of 2025. This is expected to bring the gross margin back to
pre-COVID levels or better, with additional margin improvements
expected from the cost-efficient manufacturing process of
IXCHIQ® and scaling effects from leveraging the
Company’s new manufacturing facilities in Livingston (Scotland) and
Solna (Sweden).
R&D
Valneva will continue leveraging its proven capabilities to develop
differentiated first-, best- or only-in-class vaccine solutions in
areas of high unmet medical need. As in previous years, the Company
will focus on advancing a limited number of promising product
candidates with the aim to have an additional clinical program
entering Phase 3 upon completion of the Phase 3 program for Lyme.
Valneva may reach its pipeline development objective organically
and/or via strategic transactions.
Over the next three years, the Company expects approximately 40% of
its R&D expenses to be linked to chikungunya development
activities, including ongoing and anticipated clinical studies.
These chikungunya expenses are expected to be supported at a
sizable level by non-dilutive contributions from several
institutions.
Cash management
In the mid-term, Valneva will continue focusing on stringent cost
management with a particular focus on marketing and distribution as
well as general and administrative costs. In parallel,
IXCHIQ® sales ramp-up and anticipated gross margin
improvements will further reduce the Company’s cash burn. The
Company reduced its loss by more than €40 million in 2023 and
expects to further reduce it in the coming years, anticipating that
Valneva may achieve sustained profitability with potential
commercial revenues from a successful development, approval and
launch of its Lyme disease vaccine candidate partnered with
Pfizer.
With the eighteen-month extension of the interest-only period of
its Deerfield and OrbiMed loan6, and based on 2023
year-end cash as augmented by the proceeds from the PRV sale,
Valneva believes that it is sufficiently financed for its
operational business, excluding debt repayment, until potential
commercial revenues from its Lyme program enable the Company to
operate in a sustained profitable way.
Financial Information
(Audited 2023 results, consolidated per IFRS)
€ in million |
12 months ending December 31 |
|
2023 |
2022 |
Total revenues |
153.7 |
361.3 |
Product sales |
144.6 |
114.8 |
Net profit/(loss) |
(101.4) |
(143.3) |
Adjusted EBITDA (loss) |
(65.2) |
(69.2) |
Cash |
126.1 |
289.4 |
Saint-Herblain (France), March 20,
2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) a
specialty vaccine company, today reported its consolidated
financial results for the year ending December 31, 2023 and
provided several key corporate updates.
Valneva will provide a live webcast of its
full-year 2023 results conference call beginning
at 3 p.m. CET/10 a.m. EDT today. This webcast will also be
available on the Company’s website. Please refer to this link:
https://edge.media-server.com/mmc/p/hom3riyt
Peter Bühler, Valneva’s Chief Financial
Officer, commented, “In 2023, Valneva successfully
executed on key strategic objectives despite a difficult economic
environment. Our chikungunya vaccine IXCHIQ® became the
world’s first licensed chikungunya vaccine available to address
this significant unmet medical need and we also managed to surpass
our pre-pandemic product sales. Our objective for 2024 is to
continue capitalizing on the travel industry recovery to generate
further commercial growth and successfully launch our chikungunya
vaccine IXCHIQ®. With the recent successful sale of our
PRV, and extension of our loan repayment, we have entered 2024 in a
solid financial position to support our near- and mid-term
commercial and R&D objectives.”
Commercial Portfolio
Valneva’s commercial portfolio is composed of
three travel vaccines, IXIARO®/JESPECT®,
DUKORAL® and IXCHIQ®. The Company also
distributes certain third-party products in countries where it
operates its own marketing and sales infrastructure.
JAPANESE ENCEPHALITIS VACCINE
IXIARO®/JESPECT®
IXIARO®, or JESPECT® in Australia and New
Zealand, is an inactivated Vero cell culture-derived Japanese
encephalitis and is the only Japanese encephalitis vaccine
currently approved for use 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, and is a required vaccine for U.S.
military personnel who are deployed to areas of risk for Japanese
encephalitis. The virus is spread by mosquitos and is the most
important cause of viral encephalitis in Asia and the Western
Pacific.
In 2023, IXIARO®/JESPECT®
sales increased 78% to €73.5 million compared to €41.3 million in
2022, primarily benefiting from the continued travel market
recovery after the COVID-19 pandemic, and price increases. At the
end of September 2023, Valneva also signed a new one-year contract
with the U.S. Department of Defense (DoD) worth a minimum of $32
million for the supply of IXIARO®.
CHOLERA /
ETEC7-DIARRHEA VACCINE
DUKORAL®
DUKORAL® is an oral
vaccine for the prevention of diarrhea caused by Vibrio
cholerae and/or heat-labile toxin producing ETEC8,
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 2023, DUKORAL® sales increased 72%
to €29.8 million compared to €17.3 million in 2022, of which
Canada represented €17.5 million of global sales due to the strong
overlap between Canadian travelers to regions of high ETEC
prevalence and the vaccine’s approved indication. Similar to
IXIARO®, DUKORAL® benefitted from the
significant recovery in the private travel markets.
CHIKUNGUNYA VACCINE
IXCHIQ®
IXCHIQ® is a single-dose,
live-attenuated vaccine against the chikungunya virus (CHIKV),
which in November 2023 was approved in the U.S. by the Food and
Drug Administration (FDA) for the prevention of disease caused by
CHIKV in individuals 18 years of age and older who are at increased
risk of exposure to the mosquito-borne CHIKV. With this approval,
IXCHIQ® became the world’s first and only licensed
chikungunya vaccine available to address this significant unmet
medical need.
At the end of February 2024, the U.S. Advisory
Committee on Immunization Practices (ACIP), which develops
recommendations on how to use vaccines in the U.S., recommended
IXCHIQ® for persons aged 18 years and above traveling to
a country or territory where a chikungunya outbreak is occurring.
Additionally, IXCHIQ® may be considered for persons
traveling to a country or territory without an outbreak but with
evidence of CHIKV transmission within the last five years, who are
aged 65 years and above, and likely to have at least moderate
exposure to mosquitos (at least two weeks, cumulatively) or who are
traveling for a longer duration (six months or more, cumulatively).
ACIP also recommended chikungunya vaccination for laboratory
workers with potential for exposure to CHIKV. The ACIP
recommendations were recently adopted by the Centers for Disease
Control and Prevention9.
Valneva’s commercial team is currently launching
the vaccine in the U.S. The single-shot vaccine is also under
regulatory review in Canada, Brazil and Europe, where it was
granted accelerated assessment by the European Medicine Agency’s
Committee for Medicinal Products for Human Use (CHMP). Decisions
for these submissions are expected in 2024.
IXCHIQ®’s final pivotal Phase 3 data
were published in The Lancet, the world’s leading peer-reviewed
medical journal, in June 202310. 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 compared to the
70% threshold (for non-acceptance) agreed with the FDA. Valneva is
working on the preparation of two Phase 4 post-marketing
effectiveness studies, required as part of the FDA’s approval under
the accelerated pathway. The Company expects to launch these
studies in 2025.
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-vaccination11. This was later confirmed in a
further analysis of the Phase 1 data12, which showed
that 100% of vaccinated individuals reached the immune
threshold13 established with the FDA at day 14.
Additionally, VLA1553 was able to demonstrate a
robust immune response which was sustained for 12 and 24 months by
99% and 97% of participants, respectively, and was equally durable
in younger and older adults1415. This
dedicated antibody persistence trial (VLA1553-303) will continue to
evaluate persistence for a period of at least five years.
A clinical study in adolescents, VLA1553-321, is
ongoing in Brazil, for which Valneva reported initial safety data
in August 202316. 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 to this age group following initial
approvals 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 Company initiated a Phase 2 pediatric trial in children aged 1
to 11 years, VLA1553-221, in January 202417 to support a
Phase 3 pivotal pediatric study and potentially extend the label to
this age group following initial regulatory approvals in adults and
possibly in adolescents.
THIRD-PARTY
DISTRIBUTION
Valneva distributes certain third-party vaccines
in countries where it operates its own marketing and sales
infrastructure. The Company notably has distribution agreements
with Bavarian Nordic18 and VBI
Vaccines19.
In the year ended December 31, 2023, third-party
product sales grew 34% to €35.7 million compared to €26.5 million
in the year ended December 31, 2022.
Clinical Stage Vaccine
Candidates
LYME DISEASE VACCINE CANDIDATE –
VLA15
Phase 3 study ongoing
Valneva and Pfizer are developing VLA15, a Phase
3 vaccine candidate targeting Borrelia, 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 the United States and Europe. VLA15 is the only
Lyme disease program in late-stage 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
observed20,21,22.
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 studies23.
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 Europe24.
Recruitment completion for the study was
announced in December 2023. 9,437 participants five years of age
and older were enrolled in the trial and will receive, as part of
the primary series, three doses of VLA15 or a saline placebo (1:1
ratio) within the first year, and one booster dose approximately
one year after vaccination with the first three doses25.
The VALOR study is currently ongoing and is designed to follow
vaccinated participants over two consecutive tick seasons. In the
second quarter of 2024, participants enrolled in the first cohort
will receive their booster vaccination and participants of the
second cohort will receive the last of their initial three doses
ahead of the 2024 tick season.
Topline data from the VALOR trial are expected
by the end of 2025, with the aim for Pfizer to submit a Biologic
License Application to the FDA and Marketing Authorization
Application to the EMA in 2026, subject to positive data.
ZIKA VACCINE CANDIDATE –
VLA1601
Entering Phase 1, 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
infection26; however, surveillance remains limited
globally. There are no preventive vaccines or effective treatments
available and, as such, Zika remains a public health threat and is
included in the Food and Drug Administration’s Tropical Disease
Priority Review Voucher Program27.
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
Europe28. Valneva reported Phase 1 results from its
first-generation Zika vaccine candidate in 2019 showing excellent
immunogenicity and safety results in all tested doses and
schedules29. The Company now expects to start the
clinical evaluation of its second-generation vaccine in the coming
weeks.
A vaccine against the Zika virus (ZIKV) would
nicely complement Valneva’s portfolio of travel vaccines against
mosquito-borne diseases, which already includes IXCHIQ®
and IXIARO®.
Pre-Clinical Vaccine
Candidates
Valneva continues to progress select
pre-clinical assets and focus on strengthening its future clinical
pipeline.
The Company is currently focused on VLA2112, a
vaccine candidate targeting the Epstein-Barr virus (EBV), which is
one of the most common human viruses. EBV can cause infectious
mononucleosis30 and is strongly associated with the
development of several types of cancer31 and multiple
sclerosis32.
Valneva has also been working on a vaccine
candidate targeting the human metapneumovirus (hMPV), which is a
major worldwide respiratory pathogen that causes acute upper and
lower respiratory tract infection33 and is exploring
potential partnering opportunities.
Additionally, Valneva initiated pre-clinical
work on vaccine candidates against different enteric diseases.
Full Year 2023 Financial
Review
(Audited34, consolidated under IFRS)
Revenues
Valneva’s total revenues were €153.7 million in
2023 compared to €361.3 million in 2022. Total revenues in 2022
included €280.0 million of revenue recognition mainly related to
the COVID-19 supply agreements in the prior year.
Valneva’s total product sales reached €144.6
million in 2023 compared to €114.8 million in 2022. Currency
fluctuations of €2.8 million adversely impacted product sales.
COVID-19 vaccine sales in 2023 amounted to €5.7 million compared to
€29.6 million in 2022. Excluding COVID-19, product sales reached
€138.9 million in 2023 compared to €85.2 million in 2022, an
increase of 63%.
IXIARO®/JESPECT® sales
were €73.5 million in 2023 compared to €41.3 million in 2022. The
78% 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 €1.5 million foreign currency impact.
DUKORAL® sales were €29.8 million in
2023 compared to €17.3 million in 2022. This 72% increase is
also a result of the significant recovery in the private travel
markets and price increases. Foreign currency fluctuations reduced
DUKORAL® sales by €0.9 million.
Third Party product sales were €35.7 million in
2023 compared to €26.5 million in 2022, a 34% 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 €9.1 million in
2023 compared to €246.5 million in 2022. Other revenues in 2022
included COVID related one-time effects of €280.0 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 European Member States,
partially offset by €45.9 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
€100.9 million in 2023. The gross margin on commercial product
sales amounted to 46.0% compared to 45.5% in 2022. COGS of
€35.1 million related to IXIARO® product sales,
yielding a product gross margin of 52.3%. COGS of €17.1 million
related to DUKORAL® product sales, yielding a product
gross margin of 42.4%. Of the remaining COGS in 2023, €22.8 million
related to the third-party products distribution business,
€5.3 million to VLA2001 and €10.2 million to cost of services.
In 2022, overall COGS were €324.4 million, of which €314.7 million
related to cost of goods and €9.7 million related to cost of
services. In 2022, COGS of the COVID-19 vaccine program amounted to
€267.1 million and included effects from the significant reduction
of sales volumes to the European Union Member States which resulted
in impairment of fixed assets and inventories.
Research and development expenses amounted to
€59.9 million in 2023, compared to €104.9 million in 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 2023 amounted to €48.8 million compared to
€23.5 million in 2022. The increase is mainly related to €20.7
million of expenses associated with launch preparations for
IXCHIQ® (2022: €7.3 million). In 2023, general and
administrative expenses increased to €47.8 million from
€34.1 million in 2022. In the previous year 2022, COGS,
research and development, marketing and distribution as well as
general and administrative expenses all benefited from a non-cash
accrual adjustment related to the positive effect of the Company’s
share price development on employee share-based compensation
programs. This income compares to an expense in 2023.
Other income, net of other expenses, increased
to €21.5 million in 2023 from €12.2 million in 2022. The increase
was mainly driven by grant income received from Scottish Enterprise
in the amount of €11.1 million and by a gain from a settlement
with a supplier in connection with COVID-19 activities of
€4.7 million.
Valneva recorded an operating loss of €82.1
million in 2023 compared to an operating loss of
€113.4 million in 2022. The higher loss in 2022 was primarily
driven by non-recurring expenses of goods and services related to
valuation of inventory, and onerous agreement provisions for
material in connection with our COVID-19 vaccine and its program
suspension. Adjusted EBITDA (as defined below) loss in 2023 was
€65.2 million, nearly unchanged to the Adjusted EBITDA loss of
€69.2 million in 2022.
Net Result
In 2023, Valneva generated a net loss of €101.4
million compared to a net loss of €143.3 million in 2022.
Finance expense and currency effects in 2023
resulted in a net finance expense of €16.5 million, compared
to a net finance expense of €31.4 million in 2022. This increase in
finance income/expenses, net was mainly due to foreign exchange
gains of €5.6 million in 2023 compared to a loss of €12.6 million
in 2022, primarily related to the development of the USD and GBP
exchange rates.
Cash Flow and Liquidity
Net cash used in operating activities amounted
to €202.7 million in 2023 compared to €245.3 million of cash
used in operating activities in 2022. Cash outflows in 2023 were
derived from the loss for the period amounting to €101.4 million
and from working capital in the amount of €145.6 million,
which largely were related to payments to Pfizer in conjunction
with Valneva’s contribution to the Phase 3 costs of the Lyme VLA15
R&D program, reducing the refund liability.
Cash outflows from investing activities amounted
to €20.6 million in 2023 compared to €29.1 million in 2022, both
mainly a result of construction activities across production sites
in Scotland and Sweden, as well as equipment purchases.
Net cash generated from financing activities
decreased to €63.1 million in 2023 from €215.1 million in 2022.
Cash inflows in 2023 were primarily due to €81.1 million of net
proceeds from the additional tranches from the loan agreement with
Deerfield and OrbiMed drawn in the second half of the year. Cash
inflows in 2022 were mainly a result of proceeds from the equity
subscription agreement with Pfizer, proceeds from a global offering
as well as a draw-down of the loan provided by Deerfield and
OrbiMed.
Cash and cash equivalents were €126.1 million as
at December 31, 2023, compared to €289.4 million as at December 31,
2022. Cash and Cash equivalents in 2023 included the drawing of a
total of $100 million from the Deerfield and OrbiMed loan agreement
as well as significant payments made to Pfizer related to the
companies’ Phase 3 Lyme disease study “VALOR”. Cash at the end of
2023 does not include $103 million of proceeds from the PRV, which
Valneva sold in February 2024.
Non-IFRS Financial Measures
Management uses and presents IFRS results as
well as the non-IFRS measure of Adjusted EBITDA to evaluate and
communicate its performance. While non-IFRS measures should not be
construed as alternatives to IFRS measures, management believes
non-IFRS measures are useful to further understand Valneva’s
current performance, performance trends, and financial
condition.
Adjusted EBITDA is a common supplemental measure
of performance used by investors and financial analysts. Management
believes this measure provide additional analytical tools. Adjusted
EBITDA is defined as earnings (loss) for the period before income
tax, finance income/expense, foreign exchange gain/(loss), results
from investments in associates, amortization, depreciation, and
impairment (excluding impairment loss of disposal).
A reconciliation of Adjusted EBITDA to net loss
for the period, which is the most directly comparable IFRS measure,
is set forth below:
€ in million |
Twelve months ending December 31 |
(consolidated per IFRS) |
2023 |
2022 |
Loss for the period |
(101.4) |
(143.3) |
Add: |
|
|
Income tax expense |
2.8 |
(1.5) |
Total Finance income |
(1.2) |
(0.3) |
Total Finance expense |
23.3 |
19.1 |
Foreign exchange gain/(loss) – net |
(5.6) |
12.6 |
Result from investments in associates |
- |
- |
Amortization |
5.8 |
7.0 |
Depreciation |
11.8 |
14.0 |
Impairment |
(0.7) |
23.2 |
Adjusted EBITDA |
(65.2) |
(69.2) |
About Valneva SE
We are a specialty vaccine company that develops, manufactures, and
commercializes prophylactic vaccines for infectious diseases
addressing unmet medical needs. We take a highly specialized and
targeted approach, applying our deep expertise across multiple
vaccine modalities, focused on providing either first-, best- or
only-in-class vaccine solutions.
We have a strong track record, having advanced
multiple vaccines from early R&D to approvals, and currently
market three proprietary travel vaccines, including the world’s
first and only chikungunya vaccine, as well as certain third-party
vaccines.
Revenues from our growing commercial business
help fuel the continued advancement of our vaccine pipeline. This
includes the only Lyme disease vaccine candidate in advanced
clinical development, which is partnered with Pfizer, as well as
vaccine candidates against the Zika virus and other global public
health threats.
About
IXCHIQ®
In the U.S., IXCHIQ® is a live-attenuated vaccine
indicated for the prevention of disease caused by chikungunya virus
(CHIKV) in individuals 18 years of age and older who are at
increased risk of exposure to CHIKV. As for all products approved
under FDA’s accelerated approval pathway, continued approval for
this indication is contingent upon verification and description of
clinical benefit in confirmatory studies.
Please click here for
full Prescribing Information for
IXCHIQ®.
Valneva Investor and Media Contacts
Laetitia Bachelot-Fontaine
VP, Global Communications and European Investor Relations
M +33 (0)6 4516 7099
investors@valneva.com
|
Joshua Drumm, Ph.D.
VP, Global Investor Relations
M +001 917 815 4520
joshua.drumm@valneva.com
|
|
|
Forward-Looking Statements
This press release contains certain forward-looking statements
relating to the business of Valneva, including with respect to
guidance for certain financial results in fiscal year 2024 and
mid-term outlook on financial results, cash position, and other
business developments, including results of ongoing clinical
trials, the timing and possible occurrence of further or initial
regulatory approvals of its product candidates, the anticipated
size of markets for its approved products and sales of those
products, receipt of funding from external sources, supply of
products sold by Valneva, and relationships with current business
partners. In addition, even if the actual results or development of
Valneva are consistent with the forward-looking statements
contained in this press release, those results or developments of
Valneva may not be indicative of future results. In some cases, you
can identify forward-looking statements by words such as "could,"
"should," "may," "expects," "anticipates," "believes," "intends,"
"estimates," "aims," "targets," or similar words. These
forward-looking statements are based on the current expectations of
Valneva as of the date of this press release and are subject to a
number of known and unknown risks and uncertainties and other
factors that may cause actual results, performance or achievements
to be materially different from any future results, performance or
achievement expressed or implied by these forward-looking
statements. These risks and uncertainties include those developed
or identified in any public documents filed with the French
financial markets authority (Autorité des marchés
financiers) and the U.S. Securities and Exchange Commission
made or to be made by Valneva. In particular, the expectations of
Valneva could be affected by, among other things, uncertainties
involved in the development and manufacture of vaccines (including
in relation to organic or strategic expansion of Valneva’s clinical
pipeline), unexpected clinical trial results, unexpected regulatory
actions or delays, competition in general, currency fluctuations,
the impact of the global and European credit crisis and other
global economic or political events, the ability to obtain or
maintain patent or other proprietary intellectual property
protection, the cancellation of existing contracts, the impact of a
pandemic, and changes in the regulatory environment in which
Valneva operates. The occurrence of any of these risks and
uncertainties could substantially harm Valneva’s business,
financial condition, prospects and results of operations. In light
of these risks and uncertainties, there can be no assurance that
the forward-looking statements made during this presentation will
in fact be realized. Valneva is providing the information in this
press release as of the date hereof and disclaims any intention or
obligation to publicly update or revise any forward-looking
statements, whether as a result of new information, future events,
or otherwise.
1 Valneva Announces Sale of Priority Review Voucher for $103
Million - Valneva
2 Valneva Announces Extension of the Interest-Only
Period of Its Debt Facility with Deerfield and OrbiMed -
Valneva
3 ACIP Vaccine Recommendations and Schedules |
CDC
4 Valneva Reports Full Year 2023 Revenue and Cash,
Provides First 2024 Guidance - Valneva
5 Valneva Announces Extension of the Interest-Only Period of
Its Debt Facility with Deerfield and OrbiMed - Valneva
6 Valneva Announces Extension of the Interest-Only Period of
Its Debt Facility with Deerfield and OrbiMed - Valneva
7 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.
8 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.
9 ACIP Vaccine Recommendations and Schedules |
CDC
10 Valneva Announces Publication of its Chikungunya
Vaccine Candidate Phase 3 Data in The Lancet - Valneva
11 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.
12 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.
13 Seroresponse
14 Valneva Reports Positive 12-Month Antibody
Persistence Data for Single-Shot Chikungunya Vaccine Candidate -
Valneva
15 Valneva Reports Positive 24-Month Antibody
Persistence Data for its Single-Shot Chikungunya Vaccine IXCHIQ® -
Valneva
16 Valneva Reports Positive Initial Phase 3 Safety
Data in Adolescents for its Single-Shot Chikungunya Vaccine
Candidate - Valneva
17 Valneva Vaccinates First Participant in Pediatric
Trial of Single-Shot Chikungunya Vaccine - Valneva
18 Valneva and Bavarian Nordic Announce Marketing and
Distribution Partnership - Valneva
19 Valneva and VBI Vaccines Announce European
Partnership for Marketing and Distribution of
PreHevbri® - Valneva
20 Valneva and Pfizer Report Six-Month Antibody
Persistence Data in Children and Adults for Lyme Disease Vaccine
Candidate - Valneva
21Pfizer and Valneva Initiate Phase 3 Study of Lyme
Disease Vaccine Candidate VLA15 - Valneva
22 Valneva and Pfizer Report Further Positive Phase 2
Results, Including Booster Response, for Lyme Disease Vaccine
Candidate - Valneva
23 Valneva and Pfizer Report Positive Pediatric and
Adolescent Phase 2 Booster Results for Lyme Disease Vaccine
Candidate - Valneva
24 Pfizer and Valneva Initiate Phase 3 Study of Lyme
Disease Vaccine Candidate VLA15 - Valneva
25 Pfizer and Valneva Complete Recruitment for Phase 3
VALOR Trial for Lyme Disease Vaccine Candidate, VLA15 -
Valneva
26 Zika virus disease (who.int)
27 Tropical Disease Priority Review Voucher Program |
FDA
28 Valneva Receives Marketing Authorization in Europe
for Inactivated Whole-Virus COVID-19 Vaccine VLA2001 -
Valneva
29 Emergent Biosolutions and Valneva Report Positive
Phase 1 Results for Their Vaccine Candidate Against the Zika Virus
- Valneva
30
https://www.cdc.gov/epstein-barr/index.html#:~:text=EBV%20can%20cause%20infectious%20mononucleosis,common%20among%20teens%20and%20adults.
31
https://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.
32
https://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%20sclerosis
33
https://www.cdc.gov/ncird/human-metapneumovirus.html
34 The audit procedures on the consolidated financial
statements have been performed. The audit report will be issued
upon finalization of procedures regarding the filing.
- 2024_03_20_VLA_FY2023_Results_PR_Annex_EN_Final
Valneva (LSE:0OB3)
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Valneva (LSE:0OB3)
過去 株価チャート
から 7 2023 まで 7 2024