Valneva Provides Business Update on COVID-19 Situation
24 Marzo 2020 - 07:00AM
Saint Herblain (France), March 24, 2020 –
Valneva SE (“Valneva” or “the Company”), a specialty vaccine
company, today provided an update on its operations as the COVID-19
situation evolves.
Valneva is actively managing its operations to
maintain business continuity while taking measures to protect the
health and wellbeing of its employees, their families and the local
communities in which they live and work. The Company has instituted
a work from home policy and for critical areas of its business that
necessitate employees to be onsite, such as certain R&D and
manufacturing functions, the Company is implementing strategies to
promote additional social distancing. The continuous supply of
Valneva’s products to its patients and customers is of utmost
priority to the Company. Valneva’s scientific and commercial teams
are in close dialogue with their partners and are providing
project-specific information on a real-time basis.
Valneva is cognizant of the impact of the
COVID-19 outbreak on the travel market. As the provider of two
travel vaccines, one against Japanese encephalitis and one against
cholera/ETEC, the Company expects that its 2020 revenues may be
adversely affected. The Company estimates that 2020 product sales
revenues could be impacted by between €20 million and €40 million
(compared to guidance of €125 million to €135 million announced
previously). First-quarter sales 2020 will not be materially
adversely affected as the impact of the COVID-19 crisis did not
affect its major markets until March.
This reduction in product sales revenue, offset
by the likely delay in chikungunya Phase 3 initiation and therefore
delay of initial Phase 3 costs, may lead to negative EBITDA of up
to €50 million in 2020 compared to earlier guidance of negative
EBITDA of up to €35 million.
While uncertainty remains around the duration,
severity and geographic scope of the COVID-19 outbreak, the Company
is well positioned to deal with the crisis. At the end of December
2019, Valneva reported cash of €64.4 million and, in February 2020,
the Company announced an $85 million debt financing arrangement;
the Company has drawn $45 million from this facility to date.
Valneva is also well placed to take cost management measures if
required and has commenced a review of non-mission critical
projects and expenses. Excluding further cost containment measures,
national government support mechanisms and Lyme partnering but
including full draw down of the $85 million debt facility, the cash
position at the end of 2020 could be in the range of €35 million to
€40 million.
Lyme disease vaccine candidate (VLA15): The two
Phase 2 studies VLA15-201 and VLA15-202 are fully recruited and all
subjects have been fully vaccinated. Valneva continues to closely
follow the study monitoring/visits/blood draws within the COVID-19
framework and sees the Phase 2 progress as relatively unaffected.
All testing activities relating to the data analysis are proceeding
as planned to provide first Phase 2 data mid-2020. The Company also
re-affirms its commitment to complete the partnering process for
the late stage development and commercialization in the next few
months.
Chikungunya vaccine candidate (VLA1553): The
Company recently held its End of Phase 2 meeting with the U.S. Food
and Drug Administration (FDA) and has received clearance for an
Accelerated Approval Pathway. Finalization of remaining activities
for Phase 3 entry including the alignment on execution plans and
protocols with the Company’s Contract Research Organization partner
and the FDA are progressing. Valneva is advancing all
activities to allow Phase 3 initiation as soon as the COVID-19
situation permits. Currently, the Company’s assumption is that it
may start Phase 3 in the fourth quarter of this year, representing
approximately a delay of 3 to 6 months compared to its original
plans.
Thomas Lingelbach, Chief Executive
Officer at Valneva, commented “Our fully integrated
business model combined with a strong balance sheet provides a
strong basis for sustainability even in this global crisis. While
it is difficult to predict the precise impact, and we feel that
there may even be a positive mid to long term effect on the vaccine
market leading to an increase in vaccination awareness, we estimate
that 2020 product sales in the travelers segment will be
significantly impacted, notably in the second and third quarters,
with a market recovery in the fourth quarter. We are pleased that
the current stage of our two leading, unique development programs
against Lyme and Chikungunya largely permits progression according
to plan with very moderate impact.”
Valneva will continue to monitor the COVID-19
situation carefully and work closely with its partners, customers
and the regulatory agencies. The Company plans to provide a
complete business update during the publication of its first
quarter results on May 7, 2020.
About Valneva SE
Valneva is a specialty vaccine company focused
on prevention against diseases with major unmet needs. Valneva’s
portfolio includes two commercial vaccines for travelers:
IXIARO®/JESPECT® indicated for the prevention of Japanese
encephalitis and DUKORAL® indicated for the prevention of cholera
and, in some countries, prevention of diarrhea caused by ETEC. The
Company has various vaccines in development including unique
vaccines against Lyme disease and chikungunya. Valneva has
operations in Austria, Sweden, the United Kingdom, France, Canada
and the US with over 500 employees. More information is available
at www.valneva.com
Valneva
Investor and Media ContactsLaetitia
Bachelot-FontaineDirector of Investor Relations & Corporate
CommunicationsM +33 (0)6 4516 7099investors@valneva.com |
Teresa
PinzolitsCorporate Communications SpecialistT +43 (0)1 20620
1116communications@valneva.com |
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Forward-Looking Statements
This press release contains certain
forward-looking statements relating to the business of Valneva,
including with respect to the progress, timing and completion of
research, development and clinical trials for product candidates,
the ability to manufacture, market, commercialize and achieve
market acceptance for product candidates, the ability to protect
intellectual property and operate the business without infringing
on the intellectual property rights of others, estimates for future
performance and estimates regarding anticipated operating losses,
future revenues, capital requirements and needs for additional
financing. 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 their in the future. 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 largely 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, and the ability to obtain or
maintain patent or other proprietary intellectual property
protection. 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 these materials as of this press release, and
disclaim any intention or obligation to publicly update or revise
any forward-looking statements, whether as a result of new
information, future events, or otherwise.
- 2020_03_24_VLA_Covid-19_PR_EN_Final