Total revenues
of
€361.3
million in 2022
compared to
€348.1
million in
2021
- Driven by product sales of €114.8
million (82.3% increase compared to 2021), including €85.2 million
of travel vaccine sales and €29.6 million of COVID-19 vaccine
sales
- €246.5 million of Other Revenues,
primarily driven by revenue recognition related to previous
COVID-19 vaccine supply agreements
Strong
cash
position of
€289.4
million at
December 31,
2022
- Raised over €190 million in equity:
- €102.9 million of gross proceeds
from an upsized global offering1 in a challenging economic
environment
- €90.5 ($95) million equity
investment by Pfizer
- Included drawing a total of $40 million from the Deerfield
& OrbiMed loan agreement2
2023
financial guidance
- Expected total revenues and other
income between €220 million and €260 million:
- €130 million to €150 million of
product sales, including marginal COVID-19 vaccine sales under an
existing supply agreement with the Kingdom of Bahrain
- Between €90 million and €110
million of other income
- R&D expenses expected between
€70 million and €90 million
Financial Information(Audited3
2022 results, consolidated per IFRS)
€ in million |
12 months ending December 31 |
|
2022 |
2021 |
Total revenues |
361.3 |
348.1 |
Product sales |
114.8 |
63.0 |
Net profit/(loss) |
(143.3) |
(73.4) |
Adjusted EBITDA (loss) |
(69.2) |
(47.1) |
Cash |
289.4 |
346.7 |
Saint-Herblain
(France), March
23, 2023 –
Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) a specialty vaccine
company, today reported its consolidated financial results for the
year ending December 31, 20224 and provided corporate updates.
Valneva will provide a live webcast of its
full-year 2022 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/n2f4om2y
Peter
Bühler, Valneva’s Chief Financial
Officer, commented, “In 2022, Valneva successfully
executed on key strategic objectives despite a difficult economic
environment. After achieving clinical and regulatory success, we
decided to wind-down our COVID-19 activities and focus on our lead
programs. We were agile in reactivating production of our
commercial vaccines to capitalize on the travel industry recovery.
We also managed to strengthen our cash level and shareholder base,
attracting leading investors and maintaining the support of
existing shareholders. With close to €290 million in cash, we
entered 2023 in a strong position to support expected commercial
growth and R&D programs.”
Clinical Stage Vaccine
Candidates
CHIKUNGUNYA VACCINE CANDIDATE –
VLA1553FDA Priority Review of vaccine
license application
granted
VLA1553 is a live-attenuated, single-dose
vaccine candidate against the chikungunya virus (CHIKV), a
mosquito-borne virus that has spread to more than 100 countries
with the potential to rapidly expand further. The Pan American
Health Organization (PAHO) issued an epidemiological alert last
month 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.
Valneva announced last month that the U.S. Food
and Drug Administration (FDA) accepted the filing of a Biologics
License Application (BLA)6 for approval of VLA1553 in persons aged
18 years and above and granted priority review for the
application7. Under this priority review, VLA1553 has currently
been assigned a Prescription Drug User Fee Act (PDUFA) review goal
date at the end of August 2023, which is the date by which the FDA
intends to take action on the application subject to progress of
the BLA review. VLA1553 is currently the only chikungunya vaccine
candidate worldwide for which a regulatory review process is
underway8 and, if approved, it could become the first chikungunya
vaccine available to address this unmet medical need.
Valneva’s BLA application follows final pivotal
Phase 3 data in March 20229, final lot-to-lot consistency results
in May 202210 and positive twelve-month persistence data in
December 202211. A clinical study of VLA1553 in adolescents is
ongoing in Brazil12, for which Valneva reported enrollment and
vaccination completion in February 202313. This trial, conducted by
Valneva’s partner Instituto Butantan and funded by the Coalition
for Epidemic Preparedness Innovations (CEPI), may support future
regulatory submissions in this age group, if VLA1553 is initially
approved in adults, as well as licensure of the vaccine in Europe
and Brazil, which would be the first potential approval for use in
an endemic population. Topline results are expected mid-2023.
The program received FDA Fast Track and
Breakthrough Therapy designations in 2018 and 2021, respectively.
VLA1553 was also granted PRIority MEdicine (PRIME) designation by
the European Medicines Agency (EMA) in 2020. Valneva currently
plans to make additional regulatory submissions for VLA1553 in the
second half of 2023. The sponsor of the first chikungunya vaccine
approved in the U.S. is eligible to receive a Priority Review
Voucher (PRV)14.
LYME DISEASE VACCINE
CANDIDATE – VLA15 Phase 3 study
initiated
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 observed15,16,17. 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
Europe18.
In February 2023, Pfizer, as the study sponsor,
decided to discontinue half of the total enrolled participants in
the trial following violations of Good Clinical Practice (GCP) at
certain clinical trial sites run by a third-party clinical trial
site operator19. The clinical trial remains ongoing at sites not
operated by the third party. The companies intend to work with
regulatory authorities and, as previously announced, aim for Pfizer
to potentially maintain the original submission timelines, pending
successful completion of the Phase 3 studies and subject to the
agreement of these regulatory agencies to proposed modifications of
the clinical trial plan.
According to the terms of Valneva’s
collaboration with Pfizer, Pfizer leads late phase development of
VLA15 and, if approved, Pfizer will have sole control over its
commercialization with Valneva eligible to receive up to $408
million in milestones, plus royalty payments. In June 2022, the
terms of this collaboration were updated, and Pfizer invested €90.5
($95) million in Valneva as part of an equity subscription
agreement20. As per the terms of the collaboration agreement,
Valneva received a $25 million milestone payment from Pfizer in
2022 following initiation of the Phase 3 study.
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
mononucleosis21 and is strongly associated with the development of
several types of cancer22 and multiple sclerosis23. 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
infection24 and is currently exploring potential partnering
opportunities. Additionally, Valneva initiated pre-clinical work on
vaccine candidates targeting parvovirus B19, a virus most commonly
causing fifth disease25, and Campylobacter, a bacterium often
associated with food poisoning26.
Commercial Vaccines
JAPANESE ENCEPHALITIS VACCINE
(IXIARO®/JESPECT®)
IXIARO® is an inactivated Vero cell culture-derived Japanese
encephalitis that is the only Japanese encephalitis 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.
IXIARO®/JESPECT® sales were €41.3 million in
2022 compared to €45.1 million in 2021. This decrease was the
result of lower sales to the U.S. Department of Defense. The
significant recovery of the private travel markets partly offset
this impact, with IXIARO®/JESPECT® private sales reaching €28.8
million in 2022 compared to €7.1 million in 2021.
CHOLERA /
ETEC27-DIARRHEA VACCINE
(DUKORAL®)
DUKORAL® is an oral vaccine for
the prevention of diarrhea caused by Vibrio cholerae and/or
heat-labile toxin producing ETEC28, 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.
DUKORAL® sales increased to €17.3 million in
2022 compared to €2.4 million in 2021, also benefitting from
the significant recovery in the private travel markets.
SARS-CoV-2 INACTIVATED
WHOLE-VIRUS VACCINE
Valneva’s COVID-19 vaccine, VLA2001, is the only
inactivated whole-virus COVID-19 vaccine approved in Europe29 and
was the first COVID-19 vaccine to receive a full marketing
authorization from the EMA. In addition to its marketing approval
in Europe, Valneva’s COVID-19 vaccine received conditional
marketing authorization in the United Kingdom30 and emergency use
authorization in the United Arab Emirates31 and the Kingdom of
Bahrain32. In 2022, sales of VLA2001 to the Kingdom of Bahrain and
certain EU Member States amounted to €29.6 million. Valneva will
provide additional doses to the Kingdom of Bahrain in 2023 pursuant
to the advance purchase agreement signed in December 2021.
In July 2022, Valneva entered into an amendment
to the purchase agreement originally entered into in November 2021
with the European Commission.33 In light of the reduced order
volume of 1.25 million doses, which were delivered to Germany,
Austria, Denmark, Finland, and Bulgaria in 2022, Valneva suspended
manufacturing of the vaccine in August 2022 and has been reshaping
the Company to increase efficiency and focus on its operational and
strategic business objectives. The Company is continuing to explore
potential additional supply agreements to deploy the remaining
eight to ten million doses of inventory. However, these inventories
were fully written down as of December 31, 2022. Earlier this
month, Valneva provided clinical and regulatory updates for
VLA200134. VLA2001’s shelf life was notably extended to 21 months
compared to 18 months previously. The Company will continue to
submit data to further extend it.
THIRD-PARTY DISTRIBUTION
Valneva distributes certain third-party vaccines in countries where
it operates its own marketing and sales infrastructure. In
September 2022, Valneva announced a partnership with VBI Vaccines
for the marketing and distribution of the only 3-antigen Hepatitis
B vaccine, PreHevbri®, in select European markets35.
In 2022, Valneva’s third party product sales
increased by 72.1% to €26.5 million from €15.4 million in
2021.
Full Year 2022
Financial Review (Audited36, consolidated under
IFRS)
Revenues
Valneva’s total revenues were €361.3 million in
2022 compared to €348.1 million in 2021, an increase of 3.8%.
Valneva’s total product sales reached €114.8
million in 2022 compared to €63.0 million in 2021, an increase of
82.3%. This was driven by a continued recovery of travel vaccine
sales that surpassed expectations (€85.2 million versus guidance of
€70 to €80 million) complemented by COVID-19 vaccine sales in
Europe and Bahrain (€29.6 million). On a constant exchange rate
(CER) basis, product sales increased by 66.7% in 2022 as compared
to 2021.
IXIARO®/JESPECT® sales were €41.3 million in
2022 compared to €45.1 million in 2021, a decrease of 8.4% (18.6%
at CER), driven by lower sales to the U.S. Department of Defense.
This decrease was partly offset by the significant recovery of the
private travel markets, with IXIARO®/JESPECT® private sales
reaching €28.8 million in 2022 compared to €7.1 million in
2021.
DUKORAL® sales were €17.3 million in 2022
compared to €2.4 million in 2021, an increase of 610.3% (629.2% at
CER), also benefitting from the significant recovery in the private
travel markets.
Third-party product sales grew to €26.5 million
in 2022 compared to €15.4 million in 2021, an increase of 72.1%.
This increase was primarily due to the marketing and distribution
partnership with Bavarian Nordic.
Other Revenues, including revenues from
collaborations, licensing and services, amounted to €246.5 million
in 2022 compared to €285.1 million in 2021. These were mainly
driven by revenue recognition related to previous COVID-19 vaccine
supply agreements.
Operating Result and adjusted
EBITDA
Costs of goods and services sold (COGS) were
€324.4 million in 2022. The gross margin on commercial product
sales amounted to 45.5% compared to 36.5% in 2021. COGS of €15.6
million related to IXIARO® product sales, yielding a product gross
margin of 62.2%. COGS of €14.2 million related to DUKORAL® product
sales, yielding a product gross margin of 18.2%. The DUKORAL® gross
margin was impacted by €8.3 million of impairment charges for
Valneva Sweden’s manufacturing facilities following suspension of
the COVID-19 vaccine fill and finish activities at that site. Of
the remaining COGS in 2022, €16.7 million related to the
third-party products distribution business, €267.1 million to the
COVID-19 vaccine business and €9.7 million to cost of services.
COGS of the COVID-19 vaccine program included effects from the
significant reduction of sales volumes to the European Union Member
States which resulted in impairment of fixed assets and
inventories. In 2021, overall COGS were €187.9 million, of
which €162.9 million related to cost of goods and
€25.1 million related to cost of services. Research and
development expenses amounted to €104.9 million in 2022,
compared to €173.3 million in 2021. This decrease was mainly
driven by lower clinical trial costs for Valneva’s chikungunya
vaccine program advancing towards licensure as well as reduced
spend on the COVID-19 program. Marketing and distribution expenses
in 2022 amounted to €23.5 million compared to
€23.6 million in 2021. Marketing and distribution expenses in
2022 notably included €7.3 million of expenses related to
launch preparation costs for Valneva’s chikungunya vaccine
candidate, VLA1553, compared to €3.8 million in 2021. In 2022,
general and administrative expenses declined to €34.1 million
from €47.6 million in 2021. COGS, research and development,
marketing and distribution as well as general and administrative
expenses 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 2021.
Other income, net of other expenses, reduced to
€12.2 million in 2022 from €23.0 million in 2021. This
decrease was mainly driven by reduced R&D tax credits directly
resulting from lower R&D spending and an increase of other
expenses related to the provision for the ongoing Vivalis/Intercell
merger litigation proceedings.
Valneva recorded an operating loss of €113.4
million in 2022 compared to an operating loss of €61.4 million in
2021, of which the COVID-19 program contributed a loss of €42.8
million in 2022 and a profit of €3.9 million in 2021. The other
segments represented an operating loss of €70.6 million in 2022
compared to an operating loss of €65.3 million in 2021.
Adjusted EBITDA (as defined below) loss in 2022 was
€69.2 million compared to an adjusted EBITDA loss of
€47.1 million in 2021.
Net Result
In 2022, Valneva generated a net loss of
€143.3 million compared to a net loss of €73.4 million in
2021.
Finance expense and foreign currency effects in
2022 resulted in a net finance expense of €31.4 million,
compared to a net finance expense of €8.6 million in 2021.
This was mainly a result of a foreign exchange loss amounting to
€12.6 million in 2022, primarily driven by non-cash
revaluation results of non-Euro denominated balance sheet
positions, compared to a net foreign exchange gain of €8.1 million
in 2021. Interest expenses net of interest income were
€18.8 million in 2022 compared to €16.7 million in
2021. Cash
Flow and Liquidity
Net cash used in operating activities amounted
to €245.3 million in 2022 compared to €76.9 million of
cash generated by operating activities in 2021. Cash outflows in
2022 were mainly related to the operating loss generated in the
period and non-cash revenues (cash received in previous periods),
while during 2021 cash inflows mainly resulted from pre-payments
received under the vaccine supply agreement signed with the UK
government.
Cash outflows from investing activities amounted
to €29.1 million in 2022 compared to €93.1 million in
2021, both mainly a result of COVID-19-related construction
activities across production sites in Scotland and Sweden, as well
as equipment purchases.
Net cash generated from financing activities
amounted to €215.1 million in 2022, which was 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
credit facility provided by Deerfield Management Company &
OrbiMed37. Cash inflows in 2021 amounted to €154.5 million
which was mainly a result of proceeds from issuance of new shares
in the U.S. initial public offering and European private placement
in May as well as an additional global offering in November
2021.
Cash and cash equivalents amounted to €289.4
million as at December 31, 2022, compared to €346.7 million as
at December 31, 2021. This included €102.9 million of gross
proceeds from an upsized global offering completed in October 2022,
€90.5 ($95) million from an equity investment by Pfizer completed
in June 2022 as well as drawing of a total $40 million from the
Deerfield Management Company & OrbiMed loan
agreement.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.
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) |
2022 |
2021 |
Loss for the period |
(143.3) |
(73.4) |
Add: |
|
|
Income tax expense |
(1.5) |
3.4 |
Total Finance income |
(0.3) |
(0.2) |
Total Finance expense |
19.1 |
17.0 |
Foreign exchange gain/(loss) – net |
12.6 |
(8.1) |
Result from investments in associates |
- |
- |
Amortization |
7.0 |
6.6 |
Depreciation |
14.0 |
7.7 |
Impairment |
23.2 |
- |
Adjusted EBITDA |
(69.2) |
(47.1) |
About Valneva SEValneva is a
specialty vaccine company focused on the development, manufacturing
and commercialization of prophylactic vaccines for infectious
diseases with significant unmet medical need. The Company takes a
highly specialized and targeted approach to vaccine development and
then applies its deep understanding of vaccine science to develop
prophylactic vaccines addressing these diseases. Valneva has
leveraged its expertise and capabilities both to commercialize
three vaccines and to rapidly advance a broad range of vaccine
candidates into and through the clinic, including candidates
against Lyme disease and the chikungunya virus.
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. 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, 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, including but not limited to
the HMG Supply Agreement, 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.
Annex
1. CONSOLIDATED STATEMENTS OF INCOME
(LOSS) AND COMPREHENSIVE INCOME (LOSS)
1.1 Consolidated Statements of Income
(Loss)
(€ in
thousand)(except
per share amounts) |
Year ended December 31, |
|
2022 |
2021 |
2020 |
Product sales |
114,797 |
62,984 |
65,938 |
Other
revenues |
246,506 |
285,101 |
44,383 |
REVENUES |
361,303 |
348,086 |
110,321 |
|
|
|
|
Cost of goods and
services |
(324,441) |
(187,920) |
(54,302) |
Research and
development expenses |
(104,922) |
(173,283) |
(84,454) |
Marketing and
distribution expenses |
(23,509) |
(23,643) |
(18,264) |
General and
administrative expenses |
(34,073) |
(47,606) |
(27,539) |
Other income and
expenses, net |
12,199 |
22,976 |
19,117 |
OPERATING LOSS |
(113,443) |
(61,390) |
(55,120) |
|
|
|
|
Finance
income |
260 |
249 |
516 |
Finance
expenses |
(19,054) |
(16,964) |
(10,738) |
Foreign exchange
gain/(loss), net |
(12,587) |
8,130 |
173 |
Result from
investments in associates |
9 |
(5) |
(133) |
LOSS BEFORE INCOME TAX |
(144,815) |
(69,979) |
(65,302) |
|
|
|
|
Income tax
benefit/(expense) |
1,536 |
(3,446) |
909 |
LOSS FOR THE PERIOD |
(143,279) |
(73,425) |
(64,393) |
Losses per share for loss for the period attributable to
the equity holders of the Company (expressed in € per
share) |
|
|
|
Basic |
(1.24) |
(0.75) |
(0.71) |
Diluted |
(1.24) |
(0.75) |
(0.71) |
"Foreign exchange gain/(loss), net" was
reclassified from the categories "Finance income" and "Finance
expenses" for period starting January 1, 2022. The comparable
periods were adjusted accordingly to maintain the
comparability.
1.2 Comprehensive Income (Loss)
€ in thousand |
|
Year ended December 31, |
|
|
2022 |
2021 |
2020 |
Loss for the period |
|
(143,279) |
(73,425) |
(64,393) |
Other
comprehensive income/(loss) |
|
|
|
|
Items that
may be reclassified to profit or loss |
|
|
|
|
Currency translation
differences |
|
(73) |
(2,877) |
2,438 |
Items that
will not be reclassified to profit or loss |
|
|
|
|
Defined benefit plan actuarial gains/(losses) |
|
178 |
205 |
(78) |
Other comprehensive income/(loss) for the year, net of
tax |
|
105 |
(2,672) |
2,360 |
TOTAL COMPREHENSIVE LOSS FOR THE YEAR ATTRIBUTABLE TO THE
OWNERS OF THE COMPANY |
|
(143,174) |
(76,097) |
(62,033) |
|
|
|
|
|
- CONSOLIDATED BALANCE
SHEETS
(In € thousand) |
As at December
31, |
|
2022 |
2021 |
ASSETS |
|
|
Non-current
assets |
196,685 |
231,520 |
Intangible
assets |
28,711 |
32,700 |
Right of use
assets |
41,603 |
48,285 |
Property, plant and
equipment |
112,435 |
125,545 |
Investments in
associates |
— |
2,124 |
Deferred tax
assets |
5,637 |
3,582 |
Other non-current assets |
8,299 |
19,282 |
Current assets |
424,660 |
585,832 |
Inventories |
35,104 |
124,098 |
Trade
receivables |
23,912 |
44,013 |
Other current
assets |
74,079 |
71,036 |
Cash and cash
equivalents |
289,430 |
346,686 |
Assets classified as held for sale |
2,134 |
— |
TOTAL ASSETS |
621,344 |
817,352 |
EQUITY |
|
|
Capital and reserves
attributable to the Company’s equity holders |
219,797 |
170,581 |
Share capital |
20,755 |
15,786 |
Share premium |
594,043 |
409,258 |
Other reserves |
55,252 |
52,512 |
Retained
earnings/(Accumulated deficit) |
(306,974) |
(233,549) |
Loss for the period |
(143,279) |
(73,425) |
LIABILITIES |
|
|
Non-current
liabilities |
124,156 |
277,791 |
Borrowings |
87,227 |
50,726 |
Lease
liabilities |
28,163 |
53,687 |
Contract
liabilities |
— |
4,741 |
Refund
liabilities |
6,635 |
158,970 |
Provisions |
1,320 |
8,308 |
Deferred tax
liabilities |
694 |
1,290 |
Other liabilities |
116 |
69 |
Current liabilities |
277,392 |
368,979 |
Borrowings |
11,580 |
7,107 |
Trade payables and
accruals |
41,491 |
68,119 |
Income tax
liability |
532 |
83 |
Tax and
Employee-related liabilities |
15,738 |
17,249 |
Lease
liabilities |
25,411 |
3,135 |
Contract
liabilities |
9,411 |
124,017 |
Refund
liabilities |
136,450 |
95,611 |
Provisions |
31,257 |
48,708 |
Other
liabilities |
5,523 |
4,950 |
TOTAL LIABILITIES |
401,547 |
646,771 |
TOTAL EQUITY AND LIABILITIES |
621,344 |
817,352 |
|
|
|
-
CONSOLIDATED STATEMENTS OF CASH FLOWS
€ in thousand |
|
Year ended December 31, |
|
|
2022 |
2021 |
2020 |
CASH FLOWS FROM OPERATING ACTIVITIES |
|
|
|
|
Loss for the
year |
|
(143,279) |
(73,425) |
(64,393) |
Adjustments for
non-cash transactions |
|
44,070 |
56,476 |
37,941 |
Changes in
non-current operating assets and liabilities |
|
(147,713) |
59,353 |
88,472 |
Changes in working capital |
|
1,732 |
36,127 |
77,740 |
Cash generated from operations |
|
(245,189) |
78,532 |
139,759 |
Income tax paid |
|
(154) |
(1,631) |
(2,021) |
NET CASH GENERATED FROM
OPERATINGACTIVITIES |
|
(245,343) |
76,901 |
137,738 |
|
|
|
|
|
CASH FLOWS
FROM INVESTING ACTIVITIES |
|
|
|
|
Purchases of
property, plant and equipment |
|
(29,246) |
(92,229) |
(18,936) |
Proceeds from sale
of property, plant and equipment |
|
8 |
— |
— |
Purchases of
intangible assets |
|
(76) |
(942) |
(535) |
Proceeds from sale
of intangible assets |
|
— |
— |
24 |
Interest received |
|
260 |
54 |
107 |
NET CASH USED IN INVESTING ACTIVITIES |
|
(29,054) |
(93,116) |
(19,340) |
|
|
|
|
|
CASH FLOWS
FROM FINANCING ACTIVITIES |
|
|
|
|
Proceeds from
issuance of common stock, net of costs of equity transactions |
|
189,837 |
166,614 |
75 |
Disposal of treasury
shares |
|
— |
209 |
215 |
Proceeds from
borrowings, net of transaction costs |
|
39,331 |
859 |
50,266 |
Repayment of
borrowings |
|
(1,793) |
(1,956) |
(21,995) |
Payment of lease
liabilities |
|
(3,048) |
(2,805) |
(2,111) |
Interest paid |
|
(9,211) |
(8,417) |
(4,711) |
NET CASH GENERATED
FROM/(USED IN) FINANCING
ACTIVITIES |
|
215,116 |
154,504 |
21,740 |
|
|
|
|
|
NET CHANGE
IN CASH AND CASH EQUIVALENTS |
|
(59,282) |
138,288 |
140,138 |
Cash and cash
equivalents at beginning of the year |
|
346,642 |
204,394 |
64,439 |
Exchange
gains/(losses) on cash |
|
(828) |
3,960 |
(183) |
Restricted cash |
|
2,898 |
44 |
41 |
CASH AND CASH EQUIVALENTS AT END OF THE YEAR |
|
289,430 |
346,686 |
204,435 |
1 Valneva Announces Closing of Upsized €102.9 Million Global
Offering - Valneva2 Valneva Announces Upsized Financing Arrangement
with Leading US Healthcare Funds Deerfield and OrbiMed -
Valneva3The audit procedures on the consolidated financial
statements have been performed. The audit report will be issued
upon finalization of procedures regarding the filing.4 The audit
procedures on the consolidated financial statements have been
performed. The certification report is in the process of being
issued.5https://www.paho.org/en/documents/epidemiological-alert-chikungunya-increase-region-americas6
FDA Accepts Valneva’s Chikungunya Vaccine License Application for
Priority Review - Valneva7 FDA Accepts Valneva’s Chikungunya
Vaccine License Application for Priority Review - Valneva8 Valneva
Initiates Rolling Submission of FDA Biologics License Application
for its Single-Shot Chikungunya Vaccine Candidate - Valneva9
Valneva Successfully Completes Pivotal Phase 3 Trial of Single-Shot
Chikungunya Vaccine Candidate10 Valneva Successfully Completes
Lot-to-Lot Consistency Trial for its Single-Shot Chikungunya
Vaccine Candidate11 Valneva Reports Positive 12-Month Antibody
Persistence Data for Single-Shot Chikungunya Vaccine Candidate -
Valneva12 Valneva Announces Initiation of Adolescent Phase 3 Trial
for its Single-Shot Chikungunya Vaccine Candidate – Valneva13
Valneva Completes Enrollment for Adolescent Phase 3 Trial of
Single-Shot Chikungunya Vaccine Candidate - Valneva14 Tropical
Disease Priority Review Voucher Program | FDA15 Valneva and Pfizer
Report Six-Month Antibody Persistence Data in Children and Adults
for Lyme Disease Vaccine Candidate - Valneva16Pfizer and Valneva
Initiate Phase 3 Study of Lyme Disease Vaccine Candidate VLA15 -
Valneva17 Valneva and Pfizer Report Further Positive Phase 2
Results, Including Booster Response, for Lyme Disease Vaccine
Candidate - Valneva18 Pfizer and Valneva Initiate Phase 3 Study of
Lyme Disease Vaccine Candidate VLA15 - Valneva19 Pfizer and Valneva
Issue Update on Phase 3 Clinical Trial Evaluating Lyme Disease
Vaccine Candidate VLA15 - Valneva20 Valneva and Pfizer Enter into
an Equity Subscription Agreement and Update Terms of Collaboration
Agreement for Lyme Disease Vaccine Candidate VLA1521
https://www.cdc.gov/epstein-barr/index.html#:~:text=EBV%20can%20cause%20infectious%20mononucleosis,common%20among%20teens%20and%20adults.22
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.23
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%20sclerosis24
https://www.cdc.gov/ncird/human-metapneumovirus.html25 Parvovirus
B19 and Fifth Disease |
CDC26https://www.cdc.gov/campylobacter/faq.html#:~:text=Campylobacter%20infection%2C%20or%20campylobacteriosis%2C%20is,year%20for%20every%20100%2C000%20people.27
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.28
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.29 Valneva Receives Marketing
Authorization in Europe for Inactivated Whole-Virus COVID-19
Vaccine VLA200130 Valneva Receives Conditional Marketing
Authorization from UK MHRA for its Inactivated COVID-19 Vaccine –
Valneva31 Valneva Receives Emergency Use Authorization from the
United Arab Emirates for its Inactivated COVID-19 Vaccine32 Valneva
Receives Emergency Use Authorization from Bahrain for its
Inactivated COVID-19 Vaccine VLA2001 – Valneva33 Valneva Confirms
Amendment of Advance Purchase Agreement with European Commission
for Valneva’s Inactivated COVID-19 Vaccine - Valneva34Valneva
Provides Clinical and Regulatory Updates for its COVID-19 Vaccine
VLA2001 - Valneva35 Valneva and VBI Vaccines Announce European
Partnership for Marketing and Distribution of PreHevbri® -
Valneva36 The audit procedures on the consolidated financial
statements have been performed. The audit report will be issued
upon finalization of procedures regarding the filing.37 Valneva
Announces Upsized Financing Arrangement with Leading US Healthcare
Funds Deerfield and OrbiMed - Valneva
- 2023_03_23_VLA_FY2022_Results_PR_EN_Final
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