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
salesIn 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&DValneva 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 managementIn 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 –
VLA1601Entering 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 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 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 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 |
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Forward-Looking StatementsThis
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 - Valneva2 Valneva Announces Extension of the Interest-Only
Period of Its Debt Facility with Deerfield and OrbiMed - Valneva3
ACIP Vaccine Recommendations and Schedules | CDC4 Valneva Reports
Full Year 2023 Revenue and Cash, Provides First 2024 Guidance -
Valneva5 Valneva Announces Extension of the Interest-Only Period of
Its Debt Facility with Deerfield and OrbiMed - Valneva6 Valneva
Announces Extension of the Interest-Only Period of Its Debt
Facility with Deerfield and OrbiMed - Valneva7 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 | CDC10
Valneva Announces Publication of its Chikungunya Vaccine Candidate
Phase 3 Data in The Lancet - Valneva11 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 Seroresponse14 Valneva Reports Positive 12-Month
Antibody Persistence Data for Single-Shot Chikungunya Vaccine
Candidate - Valneva15 Valneva Reports Positive 24-Month Antibody
Persistence Data for its Single-Shot Chikungunya Vaccine IXCHIQ® -
Valneva16 Valneva Reports Positive Initial Phase 3 Safety Data in
Adolescents for its Single-Shot Chikungunya Vaccine Candidate -
Valneva17 Valneva Vaccinates First Participant in Pediatric Trial
of Single-Shot Chikungunya Vaccine - Valneva18 Valneva and Bavarian
Nordic Announce Marketing and Distribution Partnership - Valneva19
Valneva and VBI Vaccines Announce European Partnership for
Marketing and Distribution of PreHevbri® - Valneva20 Valneva and
Pfizer Report Six-Month Antibody Persistence Data in Children and
Adults for Lyme Disease Vaccine Candidate - Valneva21Pfizer and
Valneva Initiate Phase 3 Study of Lyme Disease Vaccine Candidate
VLA15 - Valneva22 Valneva and Pfizer Report Further Positive Phase
2 Results, Including Booster Response, for Lyme Disease Vaccine
Candidate - Valneva23 Valneva and Pfizer Report Positive Pediatric
and Adolescent Phase 2 Booster Results for Lyme Disease Vaccine
Candidate - Valneva24 Pfizer and Valneva Initiate Phase 3 Study of
Lyme Disease Vaccine Candidate VLA15 - Valneva25 Pfizer and Valneva
Complete Recruitment for Phase 3 VALOR Trial for Lyme Disease
Vaccine Candidate, VLA15 - Valneva26 Zika virus disease (who.int)27
Tropical Disease Priority Review Voucher Program | FDA28 Valneva
Receives Marketing Authorization in Europe for Inactivated
Whole-Virus COVID-19 Vaccine VLA2001 - Valneva29 Emergent
Biosolutions and Valneva Report Positive Phase 1 Results for Their
Vaccine Candidate Against the Zika Virus - Valneva30
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%20sclerosis33
https://www.cdc.gov/ncird/human-metapneumovirus.html34 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 (TG:AYJ)
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Valneva (TG:AYJ)
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