Valneva Reports Strong Q1 Revenue Growth and
Positive EBITDA Reaffirms Financial Guidance and Pipeline Outlook
for 2017
Robust Q1 financial results - confirming financial
self-sustainability strategy
- Total revenues and grants of €29.1 million in Q1 2017 (vs €24.7
million in Q1 2016) driven by a strong increase in vaccine
sales;
- Q1 product sales performance up 26.7% compared to Q1 2016,
mainly driven by IXIARO® sales to the US military and strong sales
in the travel market;
- EBITDA of €3.4 million and operating profit of €0.5 million in
Q1 2017 compared to an operating loss of €2.7 million in Q1
2016;
- Net loss reduced to €1.7 million in Q1 2017 compared to a
net loss of €5.0 million in Q1 2016;
- Cash position at €45.2 million at end of March 2017.
2017 outlook confirmed
- Valneva confirms it expects 2017 overall IFRS revenues to reach
€105 to €115 million, reflecting up to 17% total revenue growth
compared to 2016, driven mainly by IXIARO®/JESPECT® and DUKORAL®
sales;
- The Company confirms it intends to invest between €21 million
and €23 million in R&D in 2017, corresponding to approximately
20% of annual revenues;
- Valneva confirms it expects an EBITDA of €5 to €10 million in
2017.
R&D Highlights
- Patient recruitment for the Phase I trials of Valneva's Lyme
vaccine candidate in the US and EU is advancing in accordance with
the study protocol and the Company intends to accelerate the
program's progression towards Phase II;
- Valneva plans to advance its Chikungunya vaccine candidate into
Phase I in the second half of 2017;
- Valneva also seeks to partner its Phase III-ready Clostridium
difficile vaccine candidate in 2017.
Thomas Lingelbach, President and CEO and
Franck Grimaud, Deputy CEO of Valneva, commented, "We are very
pleased with our first-quarter operational performance which
validates our financial guidance for the full year. We will
continue to focus on commercial execution while at the same time
allocating our capital to promising R&D projects that we
believe will create substantial value and patient benefit, such as
our Lyme disease vaccine candidate".
Key Financial Information
€ in thousand |
3 months ending March 31(unaudited) |
|
2017 |
2016 |
Revenues & grants |
29,122 |
24,687 |
Net profit/(loss) |
(1,657) |
(5,037) |
EBITDA[1] |
3,359 |
14 |
Net operating cash flow |
12,131 |
(6,602) |
Cash, short-term deposits and marketable securities, end of
period |
45,208 |
33,408 |
Lyon (France), May 11, 2017 - Valneva SE
("Valneva" or "the Company"), a fully integrated, commercial stage
biotech company focused on developing innovative lifesaving
vaccines, reported today its consolidated financial results for the
first quarter ended March 31, 2017. The condensed consolidated
interim financial report is available on the Company's website at
www.valneva.com.
A webcast for financial analysts, fund managers,
investors and journalists will be held today at 2:00 pm (CET). A
replay will be available on the Company's website. Please refer to
this link: http://edge.media-server.com/m/p/axsxyw36.
Commercialized vaccines
JAPANESE ENCEPHALITIS VACCINE
(IXIARO®/JESPECT®)
Strong sales growth driven by US military
supply
In the first quarter of 2017, IXIARO®/JESPECT®
revenues increased to €15.6 million compared to €14.6 million
in the first quarter of 2016, mainly driven by strong sales to the
US military. This sales increase follows an update in the US Navy
medical guidance at the end of 2016, stating that Japanese
Encephalitis vaccination is now required for all Navy personnel and
DoD employees assigned to Japan or the Korean peninsula for over 30
days. At the time of this update, vaccination against Japanese
encephalitis was already required for U.S Air Force personnel and
the Marine Corps so assigned. Based on first quarter revenues,
Valneva confirms it expects IXIARO®/JESPECT® revenues to reach
between €58 and €62 million in 2017, through continued marketing
and sales activities and an increase in product adoption by
travelers.
CHOLERA / ETEC- DIARRHEA VACCINE
(DUKORAL®[2])
Strong sales performance in Canada, the UK
and the Nordics
DUKORAL® revenues grew to €9.8 million in the
first quarter of 2017 compared to €5.4 million in the first quarter
of 2016, primarily due to increased sales in Canada (which accounts
for more than 50% of global revenue for this product), the United
Kingdom and the Nordics. Valneva will continue to invest in growing
the DUKORAL® vaccine through promotional activities and geographic
expansion and expects DUKORAL® sales to grow by approximately 10%
in 2017 to €27 million.
Technologies and services
EB66® CELL LINE
In the first quarter of 2017, Valneva signed 5
new EB66® agreements including a research license with MSD Animal
Health for the development of new EB66®-based veterinary vaccines
and a commercial license with Bavarian Nordic.
Under the terms of the commercial agreement
signed with Bavarian Nordic, the Danish biotech company has the
rights to develop and commercialize multiple poxvirus-based
vaccines on the EB66® cell-line. The deal also includes the
possibility for Bavarian Nordic to transfer, upon regulatory
approvals, some of its existing product candidates produced on
chicken embryonic fibroblast (CEF) onto Valneva's EB66®
technology.
Valneva expects to sign additional agreements
for the licensing of its EB66® vaccine platform in the coming
quarters.
Vaccine Candidates
CLOSTRIDIUM DIFFICILE VACCINE CANDIDATE- VLA
84
Partnering agreement sought in 2017
Clostridium difficile (C. difficile) is the most
common infectious cause for nosocomial diarrhea in Europe and the
US. There are an estimated 450,000 cases of C. difficile in the US
annually[3] and no vaccine against the disease is commercially
available.
Valneva seeks to partner its Clostridium
difficile vaccine candidate and has ongoing discussions with
interested parties. Published Phase II data[4]from the most
advanced vaccine program targeting primary prevention of
Clostridium Difficile Infections (CDI) indicates that Valneva's
VLA84 provides an immunological profile comparable to that other
product.
LYME BORRELIOSIS VACCINE CANDIDATE - VLA
15
Patient recruitment progressing in the US
& EU
Following clearance from the Food & Drug
Administration (FDA) and the Belgian authorities at the end of
2016, Valneva has initiated Phase I clinical trials in the US and
Europe, and vaccinated the first subject at the end of January
2017.
Patient recruitment for the Phase I trials is
advancing in accordance with the study protocol and the Company
intends to accelerate the program's progression with a view to
starting Phase II in early 2018.
Currently, there is no licensed vaccine
available to protect humans against Lyme disease, a multi systemic
tick-transmitted infection affecting more than 300,000 Americans
each year. The global market for a vaccine against Lyme disease is
estimated at approximately €700 - €800 million annually[5].
CHIKUNGUNYA VACCINE CANDIDATE - VLA
1553
Expected to enter Phase I in the second half
of 2017
Valneva is also working actively on the
development of a Chikungunya vaccine and expects to enter Phase I
clinical development in the second part of 2017. Pre-clinical data
has shown that Valneva's live attenuated vaccine candidate has a
good safety profile and the potential to provide long term
protection against Chikungunya after a single immunization. The
Chikungunya virus (CHIKV) re-emerged from East Africa in 2014,
causing devastating epidemics of debilitating and often chronic
arthralgia, and is now considered as a major health threat with
180,000 reported cases in the Americas in 2016[6]. There is
currently no antiviral treatment for CHIKV infection and no
licensed vaccine to prevent the disease. The global market for a
Chikungunya vaccine is estimated at approximately €500 million
annually[7].
Other Business Update
VALNEVA SHARES NOW TRADABLE ON DEUTSCHE BÖRSE XETRA®
PLATFORM
Valneva's common shares have recently been
accepted for continuous trading on the electronic trading platform
Xetra® under the symbol VLA FP.
Xetra®, one of the biggest electronic and global
trading systems, is a leading European trading venue operated by
Deutsche Börse which handles over 90% of all of the stock trades
for the Frankfurt Stock Exchange.
Valneva SE common shares will continue to trade
in Segment B of Euronext Paris (ticker: VLA.PA) and on the Prime
Market of the Vienna stock exchange (ticker: VALNEVA SE ST).
Financial Review
FIRST quarter 2017 financial review
(unaudited)
Revenues and grants
Valneva's aggregate first quarter 2017 revenues
and grants were €29.1 million compared to €24.7 million
in the first quarter of 2016.
Product sales in the first quarter of 2017
increased by 26.7% to €25.9 million from €20.4 million in
the same period of the previous year.
Revenues from collaborations and licensing in
the first quarter of 2017 decreased to €2.5 million compared
to €3.3 million in the first quarter of 2016. Grant income in
the first quarter of 2017 decreased to €0.7 million from
€0.9 million in the first quarter of 2016.
Operating result and EBITDA
Cost of goods and services sold (COGS) were
€13.3 million in the first quarter of 2017 of which
€5.7 million were related to IXIARO®/JESPECT® sales, yielding
a product gross margin of 63.2%. €5.4 million of COGS were
related to DUKORAL® sales, yielding a product gross margin of
44.7%. Of the remaining COGS for the first quarter of 2017,
€0.4 million were related to the Third Party product
distribution business and €1.8 million related to cost of
services. In the comparative period of 2016, COGS were
€12.9 million, of which €11.3 million were related to
cost of goodsand €1.6 million to cost of services.
Research and development expenses in the first
quarter of 2017 decreased to €5.2 million from
€5.8 million in the first quarter of the previous year.
Distribution and marketing expenses in the first quarter of 2017
amounted to €4.3 million, compared to €3.3 million in the
first quarter of 2016. General and administrative expenses amounted
to €4.0 million compared to €3.8 million in the first
quarter of 2016. Amortization and impairment charges in the first
quarter of 2017 were €1.8 million compared to €1.7 million
during the first quarter of 2016.
As a result of the increased revenues, Valneva
realized in the first quarter of 2017 an operating profit of €0.5
million compared to an operating loss of €2.7 million in the
first quarter of 2016. Valneva's first quarter 2017 showed a
positive EBITDA of €3.4 million which compared to a balanced
EBITDA result in the first quarter of 2016 due to the timing of
sales to the US Military, the majority of which are made in the
first half of the year. First quarter 2017 EBITDA was calculated by
excluding depreciation, amortization and impairment charges
amounting to €2.9 million from the operating profit of
€0.5 million as recorded in the condensed consolidated income
statement under IFRS.
Net result
Valneva's net loss in the first quarter of 2017
was €1.7 million compared to a net loss of €5.0 million
in the first quarter of the prior year.
The finance loss for the first quarter of 2017
amounted to €2.0 million compared to €2.3 million in the
first quarter of 2016.
Cash flow and liquidity
Net cash generated by operating activities in
the first quarter 2017 was €12.1 million compared to a net
cash-flow used in operating activities of €6.6 million in the
first quarter of 2016. This strong improvement resulted from the
positive EBITDA development and was also helped by working capital
effects.
Cash outflows from investing activities in the
first quarter of 2017 amounted to €1.1 million and resulted
primarily from purchase of equipment. Cash inflows from investing
activities in the first quarter of 2016 amounted to €17.8 million
and primarily were related to a re-payment received from Johnson
& Johnson in connection with the adjustment of the purchase
consideration for the acquisition of Crucell Sweden AB and the
DUKORAL® business.
Cash out-flows from financing activities in the
first quarter of 2017 amounted to €4.9 million and primarily
were related to re-payment of borrowings. Cash outflows from
financing activities in the first quarter of 2016 amounted to €19.8
million and included the re-payment of borrowings to Athyrium LLC
as well as re-payments of loans in connection with grants.
Liquid funds on March 31, 2017 stood at
€45.2 million compared to €42.2 million on December 31,
2016 and consisted of €41.5 million in cash and cash
equivalents and €3.7 million in restricted cash.
2017 Financial Outlook
in million € |
2016 Actual |
2017 Estimates |
Growth |
Total revenues & grants |
97.9 |
105 - 115 |
up to 17% |
Product sales |
80.4 |
88 - 92 |
10 - 15% |
IXIARO®/JESPECT® sales |
53.0 |
58 - 62 |
10 - 15% |
DUKORAL® sales |
24.6 |
27 |
10% |
EBITDA |
2.8 |
5 - 10 |
80 - 250% |
R&D expenses (20% of revenues) |
(24.6) |
(21) - (23) |
- |
About Valneva SE
Valneva is a fully integrated, commercial stage
biotech company focused on developing innovative lifesaving
vaccines.
The Company seeks financial returns through
focused R&D investments in promising product candidates and
growing financial contributions from commercial products, striving
towards financial self-sustainability.
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 proprietary vaccines in
development including candidates against Clostridium difficile and
Lyme Borreliosis. A variety of partnerships with leading
pharmaceutical companies complement the Company's value proposition
and include vaccines being developed using Valneva's innovative and
validated technology platforms (EB66® vaccine production cell line,
IC31® adjuvant).
Valneva shares are tradable on Euronext-Paris,
the Vienna stock exchange and Deutsche Börse's electronic platform
Xetra®. The Company has operations in France, Austria, Great
Britain, Sweden, Canada and the US with over 400 employees. More
information is available at www.valneva.com.
Contacts Valneva
SE Laetitia Bachelot Fontaine Head of Investor Relations &
Corporate Communications T +33 (0)2 2807 1419 M +33 (0)6 4516 7099
investors@valneva.com |
Nina Waibel
Corporate Communications Specialist T +43 1206 201 149 M +43
6768 455 6719 Communications@valneva.com |
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 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 in this press
release will in fact be realized. Valneva is providing the
information in these materials as of the date of this press
release, 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] EBITDA (Earnings before interest, taxes,
depreciation and amortization) was calculated by excluding
depreciation, amortization and impairment of tangible and
intangible assets from the operating loss.
[2] Indications differ by country - Please refer to Product /
Prescribing Information (PI) / Medication Guide approved in your
respective countries for complete information, including dosing,
safety and age groups in which this vaccine is licensed. ETEC:
Enterotoxigenic Escherichia coli (E. Coli) bacterium
[3]Lessa et al, Burden of Clostridium difficile Infection in the
United States. N Engl J Med 2015;372:825-34
[4]G. de Bruyn et al. Vaccine 34 (2016) 2170-2178
[5] Company estimate supported by independent market studies
[6]PAHA/WHO data: Number of reported cases of Chikungunya Fever
in the Americas - EW 33 (August 19, 2016)
[7] Company estimate supported by independent market studies
Attachments:
http://www.globenewswire.com/NewsRoom/AttachmentNg/95f532a4-e258-4803-bb9f-fbaedc469b8b