Valneva: U.S. DoD Exercises First Year Option on IXIARO® Supply Contract
03 September 2021 - 7:00AM
Saint Herblain
(France),
September 3, 2021 –
Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) a specialty vaccine
company, today announced that the U.S. Department of Defense (DoD)
has exercised the first option of the contract signed in September
20201 to purchase further supply of its Japanese encephalitis (JE)
vaccine IXIARO®.
Due to the ongoing impact of the COVID-19
pandemic on DoD operations, the option terms have been amended such
that the minimum number of doses for the first option year is now
200,000 with an approximate value of $28.8 million. This brings the
total minimum value of the contract to approximately $118 million,
assuming the exercise of the second year option which remains
unchanged, compared to a minimum value of $135 million in the
initial contract.
In order to support its customer through this
pandemic period, Valneva will also provide additional inventory to
DoD after September 2023 to mitigate the potential impact of unused
stock that may expire. This replacement inventory will be provided
free of charge and will be recognized as deferred revenue of up to
$9 million beginning in fiscal year 2021.
Franck Grimaud,
President and Chief Business Officer of
Valneva, commented “We thank the DoD for
their renewed confidence. It is important that we continue to
support our customers, both large and small, to help them navigate
through the uncertainty caused by the impact of the COVID-19
pandemic on their operations”.
Shipments associated with the option will
commence immediately.
About IXIARO®/JESPECT®
Valneva’s Japanese encephalitis vaccine is
indicated for active immunization for the prevention of the disease
for people who travel to, or live in, endemic areas. It has
received marketing approval in the U.S., Europe, Canada, Hong Kong,
Singapore, and Israel under the trade name IXIARO® and in Australia
and New Zealand where it is marketed as JESPECT®. It is the only
vaccine available to the U.S. military for Japanese Encephalitis.
IXIARO® is approved for use in individuals two months of age and
older in the U.S. and EU member states, Canada, Norway,
Liechtenstein, Iceland, Singapore, Hong Kong, Japan, the Republic
of Korea and Israel. In all other licensed territories,
IXIARO®/JESPECT® is indicated for use in persons aged 18 years or
more.
About Japanese Encephalitis
Japanese encephalitis is a deadly infectious
disease found mainly in Asia. About 70,000 cases of JE are
estimated to occur in Asia each year, although the actual number of
cases is likely much higher due to underreporting in rural areas.
JE is fatal in approximately 30 percent of those who show symptoms,
and leaves half of survivors with permanent brain damage. The
disease is endemic in Southeast Asia, India and China, a region
with a population of more than three billion. In 2005, JE killed
more than 1,200 children in only one month during an epidemic
outbreak in Uttar Pradesh, India, and Nepal.
About Valneva SEValneva is a
specialty vaccine company focused on the development 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, beginning
with the identification of deadly and debilitating infectious
diseases that lack a prophylactic vaccine solution and for which
there are limited therapeutic treatment options. It then applies
its deep understanding of vaccine science, including its expertise
across multiple vaccine modalities, as well as its established
vaccine development capabilities, to develop prophylactic vaccines
to address these diseases. The Company has leveraged its expertise
and capabilities both to successfully commercialize two vaccines
and to rapidly advance a broad range of vaccine candidates into and
through the clinic, including candidates against Lyme disease, the
chikungunya virus and COVID-19.
Media
& Investor ContactsLaëtitia Bachelot-FontaineVP Global
Communications & European Investor RelationsM +33 (0)6 4516
7099
laetitia.bachelot-fontaine@valneva.com |
Joshua
Drumm, Ph.D.VP Global Investor RelationsM +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 the exercise
of an option year and the ongoing impact of the COVID-19 pandemic
on Valneva’s customers. 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 and the impact of the COVID-19 pandemic. 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 New IXIARO® Supply Contract with the US
Government worth up to $166 million
- 2021_09_03_VLA_DoD_Option_PR_EN_Final