Product sales increased 98.6%
to
€32.1
million in the first
quarter of 2023
compared to
€16.2 million
in the first quarter of 2022
- Driven by IXIARO®
and DUKORAL® sales both of which more than
quadrupled year-over-year
- Total revenues of €33.5 million in
the first quarter of 2023 compared to €21.8 million in the first
quarter of 2022
Strong cash
position of
€254.5
million at March
31, 2023
Chikungunya:
progressing
towards
delivery of the world’s
first chikungunya vaccine
- Prescription Drug User Fee Act
(PDUFA) review goal date confirmed for end of August 2023 by the
U.S. Food and Drug Administration (FDA)
- Additional regulatory submission process to be initiated in the
second quarter of 2023
2023 financial guidance
confirmed
- Expected total revenues and other
income between €220 million and €260 million, including:
- €130 million to €150 million of
product sales
- €90 million to €110 million of
other income
- Expected R&D expenses between
€70 million and €90 million
Financial Information(Unaudited
results, consolidated per IFRS)
€ in million |
3 months ending March
31, |
|
2023 |
2022 |
Total revenues |
33.5 |
21.8 |
Product sales |
32.1 |
16.2 |
Net loss |
(18.1) |
(26.0) |
Adjusted EBITDA1 |
(12.3) |
(13.3) |
Cash |
254.5 |
311.3 |
Saint-Herblain
(France),
May 4,
2023 – Valneva SE (Nasdaq: VALN; Euronext
Paris: VLA), a specialty vaccine company, today reported its first
quarter financial results ending March 31, 2023, and provided
corporate updates.
Valneva will provide a live webcast of its first
quarter 2023 results conference call beginning at 3 p.m. CEST/9
a.m. EDT today. This webcast will also be available on the
Company’s website. Please refer to this link:
https://edge.media-server.com/mmc/p/82fytb7o
Peter
Bühler, Valneva’s Chief Financial
Officer, commented, “We entered 2023 with good momentum as
we managed to double our first quarter vaccine sales
year-over-year, keeping us on track to deliver on our full year
sales guidance of €130 million to 150 million. Our objective is to
continue driving these sales in 2023 and, at the same time,
continue to build a stronger vaccine portfolio and pipeline. As we
approach our ten-year anniversary, we look forward to celebrating
another major milestone with the potential approval of our
chikungunya vaccine candidate in the U.S. later this year.”
Clinical Stage Vaccine
Candidates
CHIKUNGUNYA VACCINE CANDIDATE –
VLA1553FDA
Mid-cycle review meeting for
Biologics License Application (BLA)
completed
VLA1553 is a live-attenuated, single-dose
vaccine candidate against the chikungunya virus (CHIKV), a
mosquito-borne virus that has spread to more than 110 countries2
with the potential to rapidly expand further. The Pan American
Health Organization (PAHO) issued an epidemiological alert in
February 2023 as the number of cases and deaths due to chikungunya
continues to rise in the Americas3. With no preventive vaccine or
specific treatment yet available, chikungunya is considered a major
public health threat.
In February 2023, the FDA accepted the filing of
a BLA for approval of VLA1553 in persons aged 18 years and above4,
and at a recent mid-cycle review meeting, indicated that no
significant review or safety concerns were noted. The FDA confirmed
the Prescription Drug User Fee Act (PDUFA) review goal date at the
end of August 2023, on which an approval decision on the VLA1553
BLA is expected.
VLA1553 is currently the only chikungunya
vaccine candidate worldwide for which a regulatory review process
is underway5 and, if approved, it could become the first licensed
chikungunya vaccine available to address this unmet medical need.
It would also represent the third vaccine Valneva6 has brought from
early R&D to approval. The sponsor of the first chikungunya
vaccine approved in the U.S. is eligible to receive a Priority
Review Voucher (PRV)7.
Valneva’s BLA application follows final pivotal
Phase 3 data in March 20228, final lot-to-lot consistency results
in May 20229 and positive twelve-month persistence data in December
202210. A clinical study of VLA1553 in adolescents is ongoing in
Brazil11, for which Valneva reported enrollment and vaccination
completion in February 202312. 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,
Breakthrough Therapy and Priority Review designations in 2018, 2021
and 2023, 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 Canada, Europe and the United Kingdom in 2023.
LYME DISEASE VACCINE
CANDIDATE – VLA15 Phase 3 study
ongoing
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 observed13,14,15. 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
Europe16.
The VALOR study is currently ongoing and, as
communicated in February 2023, Pfizer had to discontinue
approximately half of the total recruited participants in the trial
following violations of Good Clinical Practice (GCP) at certain
trial sites in the U.S. run by a third-party trial site operator.
The clinical trial remains ongoing with other sites not operated by
the third party, and Pfizer continues to enroll new participants at
those sites in addition to newly added sites in the U.S. and
Canada. The original study design and endpoints previously agreed
with regulators have not changed.
Currently enrolled participants will receive
their booster vaccination as planned in the second quarter of 2024
in advance of the 2024 tick season. Additional enrollment for
primary immunization will begin in the second quarter of 2023 with
overall trial continuation to include the 2025 tick season.
As a result, Pfizer is aiming to submit a
Biologics License Application (BLA) to the U.S. Food and Drug
Administration (FDA) and Marketing Authorization Application (MAA)
to the European Medicines Agency (EMA) in 2026, subject to positive
data. Current projected incremental study execution costs incurred
due to the agreed amount of additional enrollment will be borne by
Pfizer”.
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
mononucleosis17 and is strongly associated with the development of
several types of cancer18 and multiple sclerosis19. Valneva is also
developing a vaccine candidate targeting the human metapneumovirus
(hMPV), which is a major worldwide respiratory pathogen that causes
acute upper and lower respiratory tract infection20, and is
currently exploring potential partnering opportunities.
Additionally, Valneva initiated pre-clinical work on vaccine
candidates targeting parvovirus B19, a virus, which can cause
hydrops fetalis in pregnant women and aplastic crisis in persons
with anemia21, as well as Campylobacter, a bacterium often
associated with food poisoning22.
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 €17.4 million in the
first quarter of 2023 compared to €4.2 million in the first
quarter of 2022. This 315.2% sales increase was driven by the
significant recovery of the private travel markets following the
decline of the COVID-19 pandemic as well as price increases.
Valneva has started discussions with the U.S. Department of Defense
(DoD) and expects to sign a new contract with the DoD in the coming
months.
Valneva is also exploring options for its
Almeida manufacturing facility in Livingston (Scotland), initially
built to produce its COVID-19 vaccine, including a possible sale or
a repurposing to produce IXIARO® and its chikungunya vaccine, if
approved.
CHOLERA /
ETEC23-DIARRHEA VACCINE
(DUKORAL®)
DUKORAL® is an oral vaccine for
the prevention of diarrhea caused by Vibrio cholerae and/or
heat-labile toxin producing ETEC24, 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 by 302.6% to €10.2
million in the first quarter of 2023 compared to €2.5 million
in the first quarter of 2022, also benefitting from the significant
recovery in the private travel markets as well as price
increases.
THIRD-PARTY DISTRIBUTION
Valneva distributes certain third-party vaccines in countries where
it operates its own marketing and sales infrastructure. In the
first quarter of 2023, Valneva’s third party product sales were
€4.5 million compared to €5.6 million in the first quarter of
2022.
First Quarter 2023
Financial Review (Unaudited, consolidated under
IFRS)
RevenuesValneva’s total
revenues were €33.5 million in the first quarter of 2023
compared to €21.8 million in the first quarter of 2022, an
increase of 53.4%.Valneva’s total product sales reached €32.1
million in the first quarter of 2023 compared to €16.2 million
in the first quarter of 2022, an increase of 98.6%. This was driven
by a continued recovery of travel vaccine sales. On a constant
exchange rate (CER) basis, product sales increased by 101.0% in the
first quarter of 2023 compared to the first quarter of 2022. No
COVID-19 vaccine sales were recorded in the first quarter of 2023
while the previous year’s quarter included €3.8 million.
IXIARO®/JESPECT® product sales were €17.4 million in the first
quarter of 2023 compared to €4.2 million in the first quarter
of 2022, an increase of 315.2% (314.5% at CER) with sales
benefitting from the continuing recovery of travel markets and
price increases. DUKORAL® sales were €10.2 million in the
first quarter of 2023 compared to €2.5 million in the first
quarter of 2022, an increase of 302.6% (317.3% at CER), also
benefitting from the significant recovery in the private travel
markets and price increases. Third Party product sales declined to
€4.5 million in the first quarter of 2023 compared to
€5.6 million in the first quarter of 2022, a decrease of
19.7%, which was mainly driven by supply constraints of products
sold under the distribution agreement with Bavarian Nordic for the
sales of Rabipur®/RabAvert® and Encepur®.Other revenues, including
revenues from collaborations, licensing and services amounted to
€1.4 million in the first quarter of 2023 compared to
€5.7 million in the first quarter of 2022. The decline mainly
resulted from declining customer services in the Clinical Trial
Material (CTM) unit in Sweden and no further revenues recognized
from the Pfizer Lyme VLA15 collaboration agreement.
Operating Result and
adjusted EBITDA Costs of goods
and services sold (COGS) were €20.5 million in the first
quarter of 2023. The gross margin on commercial product sales
excluding COVID-19 sales was 48.4% compared to 68.5% in the first
quarter of 2022. COGS of €7.2 million related to IXIARO® product
sales yielded a product gross margin of 58.7%. COGS of €6.3 million
related to DUKORAL® product sales yielded a product gross margin of
38.3%. Of the remaining COGS for the first quarter of 2023,
€3.1 million were related to the Third-Party product
distribution business. In the first quarter of 2022, overall COGS
were €14.7 million, of which €9.6 million related to cost
of goods and €5.1 million related to cost of services.Research
and development expenses amounted to €14.1 million in the
first quarter of 2023 compared to €20.7 million in the first
quarter of 2022. This decrease was mainly driven by lower spend on
Valneva’s COVID-19 vaccine VLA2001. Marketing and distribution
expenses in the first quarter of 2023 amounted to €9.0 million
compared to €2.0 million in the first quarter of 2022.
Marketing and distribution expenses in the first quarter of 2023
notably included €3.4 million of expenses related to the
launch preparation costs of the chikungunya vaccine candidate,
VLA1553, compared to €1.2 million in the first quarter of
2022. In the first quarter of 2023, general and administrative
expenses increased to €10.0 million from €5.8 million in
the first quarter of 2022. COGS, research and development,
marketing and distribution as well as general and administrative
expenses benefited in the first quarter of 2022 from an accrual
adjustment income of €11.7 million related to the favorable effect
of the Company’s share price development on the employee
share-based compensation programs. Other income, net of other
expenses, increased to €3.5 million in the first quarter of
2023 from €2.1 million in the first quarter of 2022. This
increase was mainly driven by recognizing grant income received
from Scottish Enterprise into the income statement in the first
quarter of 2023.Valneva recorded an operating loss of €16.6 million
in the first quarter of 2023 compared to an operating loss of
€18.4 million in the first quarter of 2022. Adjusted EBITDA
loss in the first quarter of 2023 was €12.3 million compared to an
Adjusted EBITDA loss of €13.3 million in the first quarter of
2022 (as explained further below).
Net Result In the first quarter
of 2023, Valneva generated a net loss of €18.1 million
compared to a net loss of €26.0 million in the first quarter
of 2022. Finance expense and foreign currency effects in the first
quarter of 2023 resulted in a net finance expense of
€1.7 million, compared to a net finance expense of
€7.1 million in the first quarter of 2022. This was mainly a
result of a foreign exchange gain amounting to €3.2 million in
the first quarter of 2023, primarily driven by revaluation results
of non-Euro denominated balance sheet positions, compared to a net
foreign exchange loss of €2.4 million in the first quarter of 2022.
Interest expenses net of interest income were €4.8 million in
the first quarter of 2023 compared to €4.7 million in the
first quarter of 2022.
Cash Flow and Liquidity Net
cash used in operating activities amounted to €24.3 million in
the first quarter of 2023 compared to €26.9 million of cash
used in operating activities in the first quarter of 2022. Cash
outflows in the first quarter of 2023 and 2022 mainly resulted from
the operating loss generated in both periods.Cash outflows from
investing activities amounted to €3.6 million in the first
quarter of 2023 compared to €9.4 million in the first quarter
of 2022, both mainly related to construction activities at the
Scottish production site and purchases of equipment.Net cash used
in financing activities amounted to €3.8 million in the first
quarter of 2023, which was mainly due to interest payments as well
as payments of lease liabilities. Cash inflows in the first quarter
of 2022 amounted to €1.0 million and was a result of proceeds
from the issuance of new shares in relation to employee stock
option and free share programs. Cash, cash equivalents and
restricted cash amounted to €254.5 million as at March 31, 2023,
compared to €289.4 million as at December 31, 2022.
Non-IFRS Financial
MeasuresManagement uses and presents IFRS results, as well
as the non-IFRS measure of Adjusted EBITDA to evaluate and
communicate its performance. While non-IFRS measures should not be
construed as alternatives to IFRS measures, management believes
non-IFRS measures are useful to further understand Valneva’s
current performance, performance trends, and financial
condition.
Adjusted EBITDA is a 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) from continuing operations
before interest expense, income taxes, depreciation and
amortization.
A reconciliation of Adjusted EBITDA to operating
loss, which is the most directly comparable IFRS measure, is set
forth below:
€ in million |
3 months ending March 31 |
(unaudited results, consolidated per IFRS) |
2023 |
2022 |
Net Income |
(18.1) |
(26.0) |
Add: |
|
|
Income tax expense |
(0.1) |
0.5 |
Total Finance income |
(0.3) |
(0.0) |
Total Finance expense |
5.1 |
4.7 |
Foreign exchange gain/(loss) – net |
(3.2) |
2.4 |
Result from investments in associates |
- |
- |
Amortization |
1.6 |
1.6 |
Depreciation |
2.6 |
3.6 |
Impairment of Tangible Assets |
- |
- |
Adjusted EBITDA |
(12.3) |
(13.3) |
About Valneva
SEWe are a specialty vaccine company focused on the
development, manufacturing and commercialization of prophylactic
vaccines for infectious diseases. We take a highly specialized and
targeted approach to vaccine development by focusing on vaccine
solutions addressing unmet medical needs to ensure we can make a
difference to peoples’ lives. We apply our deep understanding of
vaccine science, including our expertise across multiple vaccine
modalities, and our established vaccine development capabilities,
to develop vaccines against diseases which are not yet
vaccine-preventable, or for which there are limited effective
treatment options. Today, we are leveraging our expertise and
capabilities to rapidly advance a broad range of vaccines into and
through the clinic, including candidates against the chikungunya
virus and Lyme disease.
Valneva Investor and Media ContactsLaetitia
Bachelot-FontaineVP, Global Communications and European Investor
RelationsM +33 (0)6 4516
7099investors@valneva.com |
Joshua Drumm, Ph.D.VP, Global Investor Relations M +001 917 815
4520joshua.drumm@valneva.com |
|
|
Forward-Looking StatementsThis
press release contains certain forward-looking statements relating
to the business of Valneva, including with respect to expected
total revenues and product sales for full fiscal year 2023 and the
expected timing for submissions to and responses by regulatory
authorities. In addition, even if the actual results or development
of Valneva are consistent with the forward-looking statements
contained in this press release, those results or developments of
Valneva may not be indicative of future results. In some cases, you
can identify forward-looking statements by words such as "could,"
"should," "may," "expects," "anticipates," "believes," "intends,"
"estimates," "aims," "targets," or similar words. These
forward-looking statements are based on the current expectations of
Valneva as of the date of this press release and are subject to a
number of known and unknown risks and uncertainties and other
factors that may cause actual results, performance or achievements
to be materially different from any future results, performance or
achievement expressed or implied by these forward-looking
statements. In particular, the expectations of Valneva could be
affected by, among other things, uncertainties involved in the
development and manufacture of vaccines, unexpected clinical trial
results or delays, unexpected regulatory actions or delays,
competition in general, currency fluctuations, the impact of the
global and European credit crisis, the ability to obtain or
maintain patent or other proprietary intellectual property
protection, the cancellation of existing contracts, and the impact
of the COVID-19 pandemic, the occurrence of any of which could
substantially harm Valneva’s business, financial condition,
prospects and results of operations. In light of these risks and
uncertainties, there can be no assurance that the forward-looking
statements made during this presentation will in fact be realized.
Valneva is providing the information in this press release as of
the date hereof and disclaims any intention or obligation to
publicly update or revise any forward-looking statements, whether
as a result of new information, future events, or
otherwise.
Annex 1. UNAUDITED INTERIM CONSOLIDATED
STATEMENTS OF INCOME (LOSS) AND COMPREHENSIVE INCOME
(LOSS)
€ in thousand |
Three months ended March 31, |
(except per share amounts) |
2023 |
2022 |
Product sales |
32,100 |
16,162 |
Other
revenues |
1,408 |
5,686 |
Revenues |
33,508 |
21,847 |
|
|
|
Cost of goods and
services |
(20,480) |
(13,860) |
Research and
development expenses |
(14,065) |
(20,689) |
Marketing and
distribution expenses |
(8,986) |
(2,034) |
General and
administrative expenses |
(10,038) |
(5,770) |
Other income and
expenses, net |
3,488 |
2,084 |
OPERATING LOSS |
(16,574) |
(18,422) |
|
|
|
Finance
income |
253 |
13 |
Finance
expenses |
(5,096) |
(4,718) |
Foreign exchange
gain/(loss), net |
3,170 |
(2,412) |
LOSS BEFORE INCOME TAX |
(18,247) |
(25,539) |
|
|
|
Income tax
income/(expense) |
120 |
(502) |
LOSS FOR THE PERIOD |
(18,127) |
(26,041) |
|
|
|
Losses per share
for profit/loss for the period attributable to the equity holders
of the Company, expressed in € per share |
|
|
- basic |
(0.13) |
(0.24) |
- diluted |
(0.13) |
(0.24) |
1.2 Unaudited Interim Condensed
Consolidated Statement of Comprehensive Income (Loss)
€ in thousand |
Three months ended March 31, |
|
2023 |
2022 |
Loss for the period |
(18,127) |
(26,041) |
Other
comprehensive income/(loss) |
|
|
Items that
may be reclassified to profit or loss |
|
|
Currency translation
differences |
1,628 |
(244) |
Other comprehensive income/(loss) for the
period, net of tax |
1,628 |
(244) |
TOTAL COMPREHENSIVE LOSS FOR THE PERIOD ATTRIBUTABLE TO THE
OWNERS OF THE COMPANY |
(16,500) |
(26,285) |
2. UNAUDITED INTERIM CONDENSED
CONSOLIDATED BALANCE SHEETS
€ in thousand |
March 31, |
December 31, |
|
2023 |
2022 |
ASSETS |
|
|
Non-current
assets |
200,671 |
196,685 |
Intangible
assets |
27,896 |
28,711 |
Right of use
assets |
43,640 |
41,603 |
Property, plant and
equipment |
114,399 |
112,435 |
Deferred tax
assets |
6,146 |
5,637 |
Other non-current assets |
8,590 |
8,299 |
Current assets |
389,329 |
424,660 |
Inventories |
38,999 |
35,104 |
Trade
receivables |
27,018 |
23,912 |
Other current
assets |
66,693 |
74,079 |
Cash and cash
equivalents |
254,485 |
289,430 |
Assets classified as held for sale |
2,134 |
2,134 |
TOTAL ASSETS |
590,000 |
621,344 |
EQUITY |
|
|
Capital and
reserves attributable to the Company’s equity holders |
204,783 |
219,797 |
Share capital |
20,752 |
20,755 |
Share premium |
594,043 |
594,043 |
Other reserves |
58,369 |
55,252 |
Retained
earnings/(Accumulated deficit) |
(450,253) |
(306,974) |
Loss for the period |
(18,127) |
(143,279) |
LIABILITIES |
|
|
Non-current
liabilities |
121,958 |
124,156 |
Borrowings |
83,228 |
87,227 |
Lease
liabilities |
29,556 |
28,163 |
Refund
liabilities |
6,684 |
6,635 |
Provisions |
1,326 |
1,320 |
Deferred tax
liabilities |
1,057 |
694 |
Other liabilities |
107 |
116 |
Current liabilities |
263,260 |
277,392 |
Borrowings |
14,157 |
11,580 |
Trade payables and
accruals |
33,520 |
41,491 |
Income tax
liability |
420 |
532 |
Tax and
Employee-related liabilities |
15,875 |
15,738 |
Lease
liabilities |
25,787 |
25,411 |
Contract
liabilities |
9,159 |
9,411 |
Refund
liabilities |
135,294 |
136,450 |
Provisions |
24,037 |
31,257 |
Other
liabilities |
5,010 |
5,523 |
TOTAL LIABILITIES |
385,217 |
401,547 |
TOTAL EQUITY AND LIABILITIES |
590,000 |
621,344 |
3. UNAUDITED INTERIM CONDENSED CONSOLIDATED STATEMENTS
OF CASH FLOWS
€ in thousand |
|
Three months ended March 31, |
|
|
2023 |
2022 |
Cash flows from operating activities |
|
|
|
Loss for the
period |
|
(18,127) |
(26,041) |
Adjustments for
non-cash transactions |
|
8,438 |
(6,922) |
Changes in
non-current operating assets and liabilities |
|
(269) |
(4,763) |
Changes in working capital |
|
(13,935) |
11,193 |
Cash generated from/(used in) operations |
|
(23,893) |
(26,533) |
Income tax paid |
|
(433) |
(318) |
Net cash generated from/(used in) operating
activities |
|
(24,326) |
(26,851) |
|
|
|
|
Cash flows
from investing activities |
|
|
|
Purchases of
property, plant and equipment, net of proceeds from sale |
|
(3,814) |
(9,385) |
Purchases of
intangible assets, net of proceeds from sale |
|
— |
(76) |
Interest received |
|
253 |
13 |
Net cash used in investing activities |
|
(3,561) |
(9,447) |
|
|
|
|
Cash flows
from financing activities |
|
|
|
Proceeds from
issuance of common stock, net of costs of equity transactions |
|
(194) |
3,726 |
Payment of lease
liabilities |
|
(933) |
(835) |
Interest paid |
|
(2,689) |
(1,909) |
Net cash generated from/(used in) financing
activities |
|
(3,816) |
982 |
|
|
|
|
Net change
in cash and cash equivalents |
|
(31,703) |
(35,316) |
Cash and cash
equivalents at beginning of the period |
|
286,532 |
346,642 |
Exchange
gains/(losses) on cash |
|
(344) |
(107) |
Restricted cash |
|
— |
45 |
Cash and cash equivalents at end of the
period |
|
254,485 |
311,264 |
1 For additional information on Adjusted EBITDA, please refer to
the “Non-IFRS Financial Measures” section at the end of the PR2
https://www.who.int/news-room/fact-sheets/detail/chikungunya3https://www.paho.org/en/documents/epidemiological-alert-chikungunya-increase-region-americas4
FDA Accepts Valneva’s Chikungunya Vaccine License Application for
Priority Review - Valneva5 Valneva Initiates Rolling Submission of
FDA Biologics License Application for its Single-Shot Chikungunya
Vaccine Candidate - Valneva6 This statement refers to Valneva and
its predecessor Intercell7 Tropical Disease Priority Review Voucher
Program | FDA8 Valneva Successfully Completes Pivotal Phase 3 Trial
of Single-Shot Chikungunya Vaccine Candidate9 Valneva Successfully
Completes Lot-to-Lot Consistency Trial for its Single-Shot
Chikungunya Vaccine Candidate10 Valneva Reports Positive 12-Month
Antibody Persistence Data for Single-Shot Chikungunya Vaccine
Candidate - Valneva11 Valneva Announces Initiation of Adolescent
Phase 3 Trial for its Single-Shot Chikungunya Vaccine Candidate –
Valneva12 Valneva Completes Enrollment for Adolescent Phase 3 Trial
of Single-Shot Chikungunya Vaccine Candidate - Valneva13 Valneva
and Pfizer Report Six-Month Antibody Persistence Data in Children
and Adults for Lyme Disease Vaccine Candidate - Valneva14Pfizer and
Valneva Initiate Phase 3 Study of Lyme Disease Vaccine Candidate
VLA15 - Valneva15 Valneva and Pfizer Report Further Positive Phase
2 Results, Including Booster Response, for Lyme Disease Vaccine
Candidate - Valneva16 Pfizer and Valneva Initiate Phase 3 Study of
Lyme Disease Vaccine Candidate VLA15 - Valneva17
https://www.cdc.gov/epstein-barr/index.html#:~:text=EBV%20can%20cause%20infectious%20mononucleosis,common%20among%20teens%20and%20adults.18
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.19
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%20sclerosis20
https://www.cdc.gov/ncird/human-metapneumovirus.html21 Macri A,
Crane JS. Parvoviruses. 2022 May 23. In: StatPearls [Internet].
Treasure Island (FL): StatPearls Publishing; 2023 Jan–. PMID:
29489222.22https://www.cdc.gov/campylobacter/faq.html#:~:text=Campylobacter%20infection%2C%20or%20campylobacteriosis%2C%20is,year%20for%20every%20100%2C000%20people.23
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.24
Enterotoxigenic Escherichia coli (ETEC) is a type of
Escherichia coli and one of the leading bacterial causes of
diarrhea in the developing world, as well as the most
common cause of travelers’ diarrhea.
- 2023_05_04_Q1_Results_PR_EN_Final
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