Valneva Reports Strong Q4 and FY 2016 Business
Performance;
Expects Further Growth in Sales and
EBITDA, R&D Progress in 2017
The Company today announced its unaudited FY 2016 revenues
and cash-balance, estimated EBITDA and 2017
outlook
- Revenues and grants increased by 17.5% year-on-year and
amounted to €97.9 million in 2016 (vs €83.3 million in
2015); Q4 2016 revenues and grants were €27.2 million (vs
€22.7 million in Q4 2015) representing a 19.9% growth;
- FY revenue growth driven mainly by a 73.1% increase in
IXIARO®/JESPECT® revenues following the successful establishment
and development of the Company's marketing & distribution
network;
- Valneva reported a positive estimated EBITDA of €2.8 million in
2016 (vs. an EBITDA loss of €8.5 million in 2015);
- Cash position of €42.2 million at the end of 2016 further
strengthened by equity financing proceeds of €7.5 million in
Q4;
- Final 2016 results and audited full financial statements to be
released on March 23rd, 2017.
2017 Outlook
- Valneva expects 2017 overall IFRS revenues to reach €105 to
€115 million, reflecting up to 17% total revenue growth compared to
2016;
- The Company anticipates product sales this year to grow by
10-15% over the €80.4 million reported in 2016, driven mainly by
IXIARO®/JESPECT® and DUKORAL®;
- After reaching operational profitability in 2016 with a
positive EBITDA of €2.8 million for the full year, the Group
expects to further grow its operational performance to an EBITDA of
€5 to €10 million in 2017 while still investing approximately 20%
of annual revenues in R&D.
2017 R&D catalysts
- Valneva seeks to partner its Phase III-ready Clostridium
difficile vaccine candidate in 2017 following the publication of
positive final Phase II results in 2016;
- In 2017 the Company expects to execute the Phase I trial of its
Lyme vaccine candidate and to accelerate the program's progression
towards Phase II;
- Valneva also plans to advance at least one additional vaccine
candidate into Phase I in the second half of 2017. The preclinical
portfolio includes vaccine candidates against Chikungunya and
Zika.
Valneva's CFO resigns to pursue other interests
- After 15 years with Valneva (Intercell), Chief Financial
Officer, Reinhard Kandera, has decided to resign his position as
Management Board member and CFO to pursue other interests. Mr.
Kandera will leave at the end of March after the publication of the
fully audited 2016 Financial Statements.
- Valneva has initiated a process with Korn-Ferry to recruit a
new CFO. In the interim, Manfred Tiefenbacher, VP Finance will
manage operational Finance matters.
Key financial information
in million € |
3 months ended Dec 31, |
12 months ended Dec 31, |
|
2016 unaudited |
2015 |
2016 Unaudited |
2015 |
Product sales |
23.8 |
17.4 |
80.4 |
61.5 |
Revenues from collaborations and licensing |
2.2 |
3.6 |
13.6 |
16.8 |
Grant income |
1.1 |
1.7 |
3.8 |
5.0 |
Total revenues & grants |
27.2 |
22.7 |
97.9 |
83.3 |
EBITDA (2016 estimated) |
(0.7) |
(4.2) |
2.8 |
(8.5) |
Cash, short-term deposits and marketable securities, end of
period |
42.2 |
42.6 |
42.2 |
42.6 |
Lyon (France), February 23, 2017 -
Valneva SE ("Valneva" or "the Company"), a fully integrated,
commercial stage biotech company focused on developing innovative
lifesaving vaccines, published today its unaudited revenues and
cash balance, and estimated EBITDA for the fourth quarter and the
full year ended December 31, 2016. Audited full year financial
results are scheduled to be released on March 23, 2017.
Business highlights
JAPANESE ENCEPHALITIS VACCINE
(IXIARO®/JESPECT®)
Significant sales growth following
establishment of new commercial network
In 2016, IXIARO®/JESPECT® revenues increased to
€53.2 million compared to €30.7 million in 2015, representing
a 73.1% year-on-year growth which was supported by robust fourth
quarter revenues of €13.1 million. The increase in revenue was
largely the result of Valneva taking over marketing and
distribution responsibilities for the product in several geographic
territories. Valneva expects IXIARO®/JESPECT® revenues to continue
to grow double-digit in 2017 through continued marketing and sales
efforts and increase in product adoption by travelers.
CHOLERA / ETEC- DIARRHEA VACCINE
(DUKORAL®)
Strong sales performance
DUKORAL® revenues grew to €24.6 million in 2016
compared to €21.2 million reported in 2015. In the fourth quarter
of 2016, DUKORAL® revenues were €9.6 million compared to €8.5
million in the fourth quarter of 2015 primarily due to increased
sales in Canada, a country which accounts for more than 50% of
global revenue. Valneva will continue to invest in growing the
DUKORAL® vaccine by way of promotional efforts and geographic
expansion and expects DUKORAL® sales to grow by approximately 10%
in 2017.
Technologies and services
EB66® CELL LINE
In 2016, Valneva signed 10 new agreements (9
research agreements and 1 commercial agreement) for the development
of human and veterinary vaccines on its EB66® platform. GE
Healthcare and Valneva also announced the launch of a new cell
culture medium, CDM4Avian, to optimize virus productivity in the
EB66® cell-line. Valneva also expects that the European Medical
Agency's decision in 2016 to issue new guidelines allowing the
production of live attenuated vaccines in immortal cell-lines such
as EB66® will open new markets for the technology. Valneva will
continue to licence its vaccine platform in 2017 and has already
signed two new research agreements since the beginning of the
year.
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[1] 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[2]from the most
advanced vaccine program targeting primary prevention of
Clostridium Difficile Infections (CDI) indicates that Valneva's
VLA84 provides a comparable immunological profile to that other
product.
LYME BORRELIOSIS VACCINE CANDIDATE - VLA
15
Phase I clinical trial initiated - First
patient vaccinated at the end of January
Currently, there is no licensed vaccine
available to protect humans against Lyme disease, a multi systemic
tick-transmitted infection affecting 300,000 Americans each year.
Following clearance from the Food & Drug Administration (FDA)
and the Belgian authorities at the end of December 2016, Valneva
has initiated a Phase I clinical trial in the US and Europe, and
vaccinated the first patient at the end of January.In 2017, the
company expects to execute the Phase I trial of its Lyme vaccine
candidate and to accelerate the program's progression towards Phase
II.
Valneva also plans to progress at least one
additional vaccine candidate from its promising preclinical
portfolio into Phase I in the second half of 2017. The pipeline
includes candidates against Chikungunya and Zika.
Financial Review
Fourth quarter revenues and grants (unaudited)
Valneva's aggregate fourth quarter 2016 revenues
and grants increased by 19.9% to €27.2 million compared to
€22.7 million in the fourth quarter of 2015.
Product sales in the fourth quarter of 2016
increased to €23.8 million from €17.4 million in the same
period of the previous year. The increase in product sales was
driven by Valneva's two proprietary vaccines. IXIARO®/JESPECT®
sales contributed €13.1 million to revenues in the fourth
quarter of 2016 significantly increasing from €5.9 million in
the fourth quarter of 2015. DUKORAL® contributed €9.7 million
to the fourth quarter 2016 product sales, growing by 11.6% from
€8.7 million in the fourth quarter of 2015. Sales of third
party products marketed by Valneva decreased to €1.0 million
in the past quarter compared to €2.8 million in the fourth
quarter of 2015.
Revenues from collaborations and licensing in
the fourth quarter of 2016 decreased to €2.2 million compared
to €3.6 million in the fourth quarter of 2015. Grant income in
the fourth quarter of 2016 decreased to €1.1 million from
€1.7 million in the fourth quarter of 2015.
Full year 2016 revenues and grants (unaudited)
Valneva's aggregate revenues and grants in the
full year 2016 increased to €97.9 million from
€83.3 million in 2015. This increase was mainly a result of
strong growth of IXIARO®/JESPECT® product sales.
Total product sales increased to
€80.4 million in the full year 2016 from €61.5 million in
the year 2015. IXIARO®/JESPECT® product sales contributed
€53.0 million to revenues in 2016 compared to
€30.6 million in 2015 representing 73.1% growth. The strong
increase was driven by the capturing of additional revenue margins
under the new sales and distribution network and also benefited
from strong demand from the US military and from private markets in
Germany and the UK. DUKORAL® sales contributed €24.6 million
to 2016 product sales representing growth of €3.5 million, or
16.8% compared the year 2015. Third Party product sales for the
year 2016 decreased to €2.9 million from €9.9 million in
the year 2015, due to the fact that several GSK vaccines were no
longer marketed by Valneva.
Revenues from collaborations and licensing
decreased from €16.8 million in 2015 to €13.6 million in
the year 2016. Grant income decreased from €5.0 million in
2015 to €3.8 million in 2016.
Cash position at year-end (unaudited)
Liquid funds on December 31, 2016 stood at
€42.2 million, compared to €42.6 million on December 31,
2015 and consisted of €35.3 million in cash and cash
equivalents and €6.9 million in restricted cash.
Full year EBITDA (estimated)
Valneva's full year 2016 estimated EBITDA showed
a strong improvement and amounted to an EBITDA profit of
€2.8 million, compared to an EBITDA loss of €8.5 million
in the year 2015. EBITDA is calculated by excluding depreciation,
amortization and impairment charges from the operating loss as
recorded under IFRS. EBITDA also excludes gains from bargain
purchase in the calculation for the comparator period of the
previous year.
Final 2016 results
Final full year 2016 results and audited
financial statements will be released on March 23rd, 2017. As
previously reported, Valneva's operating loss for the year 2016
will be impacted by
€34.1 million of non-cash impairment charges
which were recognized in the second quarter following negative
Phase II/III study results for the Pseudomonas vaccine candidate
and discontinuation of the program.
2017 Financial Outlook
in million € |
2016 Actual unaudited |
2017 Forecast |
Growth |
Total revenues & grants |
97.9 |
105 - 115 |
up to 17% |
Product sales |
80.4 |
88 - 92 |
10 - 15% |
IXIARO®/JESPECT® sales |
53.2 |
58 - 62 |
10 - 15% |
DUKORAL® sales |
24.6 |
27 |
10% |
EBITDA (estimated) |
2.8 |
5 - 10 |
80 - 250% |
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 is listed on Euronext-Paris and the
Vienna stock exchange and 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:
Laetitia
Bachelot-Fontaine Nina
Waibel
Head of Investor
Relations
Communications Specialist
& Corporate
Communications
T +43-1-206 20-1116
T
+02-28-07-14-19 M
+43-676-84 55 67 357
M +33 (0)6 4516 7099
investors@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] Lessa et al, Burden of Clostridium difficile Infection in
the United States. N Engl J Med 2015;372:825-34
[2] G. de Bruyn et al. Vaccine 34 (2016) 2170-2178
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