Valneva Delivers
Strong IXIARO® Sales Growth
and reports Further Progress on Key R&D
Programs in H1
Double-digit
sales growth driven by IXIARO®
-
Product sales of €53.5 million in H1 2018,
representing 11.4% year on year growth (19% at CER[1]), in line
with Company guidance of double-digit product sales growth in FY
2018.
-
EBITDA of €5.8 million in H1 2018, in line with
Company 2018 guidance of €5.0 million to €10.0 million.
-
Increased R&D investment of €12.9 million
from €9.7 million in H1 2017, as planned.
-
Positive operating cash flow of €13.7 million in
H1 2018 resulting in cash position of €37.7 million at the end of
June 2018.
H1 Pipeline
Highlights
-
Phase 2 preparation activities ongoing for the
Company's Lyme vaccine candidate expected to enter Phase 2 at the
end of 2018[3].
-
Recruitment completed for the Phase 1 study of
the Company's Chikungunya vaccine candidate. Results expected early
2019.
-
Recruitment completed for the Phase 1 study of
the Company's Zika vaccine candidate. Results expected at the end
of 2018 or early 2019.
David Lawrence,
Valneva's Chief Financial Officer, commented, "We're extremely
pleased with our half-year performance as we continued to deliver
double-digit sales growth and are on track to meet our full-year
guidance. The strong growth in IXIARO® sales
validates our strategy to take direct control of the US private
market. We also continue to advance our clinical candidates and are
very much looking forward to the Phase 2 initiation of our Lyme
vaccine candidate."
Key Financial
Information
(Unaudited)
€ in million |
6 months ending June 30 |
|
2018 |
2017 |
Product Sales |
53.5 |
48.1 |
Total Revenues |
59.0 |
53.9[4] |
Net profit/(loss) |
(0.2) |
(4.4) |
EBITDA[5] |
5.8 |
7.6 |
Cash, short-term deposits and marketable securities, end
of period |
37.7 |
47.3 |
Saint Herblain
(France), August 2, 2018 - 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 half ended
June 30, 2018. The half year financial report, including the
condensed consolidated interim financial report and the half year
management report, is available on the Company's website
www.valneva.com.
A webcast for the financial
community and media will be held today at 2:00 pm (CET). A replay
will be available on the Company's website. Please refer to this
link: https://edge.media-server.com/m6/p/4p7bcso7
Commercial
Vaccines
JAPANESE
ENCEPHALITIS VACCINE (IXIARO®/JESPECT®)
Strong sales growth driven by the US private
market
In the first half of 2018,
revenues from IXIARO®/JESPECT® product
sales reached €37.6 million, compared to €31.5 million in the
first half of 2017. The increase was largely driven by growth in
the US, including in the private market where Valneva took direct
control of sales and marketing at the end of November 2017. There
were also increases in the Nordic and Canadian private markets. In
March 2018, Health Canada approved an accelerated IXIARO®
vaccination schedule for adult travelers (18-65 years old).
Based on first half sales, Valneva
reaffirms double-digit growth expectations for IXIARO®/JESPECT® sales
in 2018.
CHOLERA / ETEC-DIARRHEA VACCINE
(DUKORAL®)
In the first half of 2018,
revenues from DUKORAL® sales reached
€14.2 million, compared to €15.4 million in the first half of 2017.
Strong sales performance in Canada in the first half of 2018 was
eroded by a combination of adverse exchange rate movements (mainly
between the Canadian dollar and the Euro) and supply constraints.
Valneva is executing a plan to address further supply constraints
and aims for increased DUKORAL® sales in the
second half of 2018.
Clinical Vaccine
Candidates
LYME DISEASE
VACCINE CANDIDATE - VLA15
Progression into Phase 2 at end 2018
Valneva reported positive Phase 1
interim data in March[6] 2018.
Following these interim data, the Company amended the Phase 1
protocol to include a booster evaluation at one year post initial
vaccination, in approximately 60 trial subjects. This booster
evaluation is expected to accelerate the availability of safety and
immunogenicity data on general booster responses for VLA15. Results
are expected in the first half of 2019.
In July 2018, Valneva successfully
concluded the end of Phase 1 process with the US Food and Drug
Administration (FDA)[7], reaching
alignment with the FDA on the strategy for Phase 2 development.
Valneva is now finalizing details for Phase 2 and, subject to
regulatory clearances, will enter Phase 2 clinical development at
the end of 2018.
The primary endpoint of the Phase
2 will be the evaluation of immunogenicity, with the objective of
determining the final dose and schedule. The Phase 2 will evaluate
further dosages and schedules in addition to those evaluated in
Phase 1.
It is expected that the Phase 2
will be conducted in approximately 800 subjects, aged 18-70 years,
at more than 10 study sites in the U.S. and Europe, including
endemic areas within the US and in the EU, as well as some Lyme
seropositive subjects. Phase 2 duration is expected to be
approximately two years.
Pending a positive outcome in
Phase 2, the Company's preliminary plans for Phase 3 development
are that product licensure would be supported by a pivotal,
double-blind, placebo controlled field efficacy study in Lyme
Disease endemic areas in the U.S. and Europe, enrolling
approximately 16,000 subjects.
Assuming that the data generated
during a single tick season are sufficient to support licensing, a
first filing for licensure with regulators could be achieved in the
second half of 2023.
Lyme disease is the most common
vector-borne illness in the northern hemisphere for which there is
no other clinical vaccine candidate in development worldwide.
According to the US Centers for Disease Control and Prevention
(CDC), approximately 300,000[8] Americans
are infected with Lyme disease annually with at least a further
200,000 cases in Europe[9].
Valneva's vaccine candidate VLA15,
under Fast Track Designation by the FDA, is a multivalent, protein
subunit vaccine that targets the outer surface protein A (OspA) of
Borrelia and is intended to protect against
the majority of human pathogenic Borrelia
species. VLA15 is designed to confer protection by raising
antibodies that prevent Borrelia from
migrating from ticks to humans after a bite.
The global market for a vaccine
for Lyme disease is currently estimated at approximately €700 -
€800 million annually[10].
CHIKUNGUNYA
VACCINE CANDIDATE - VLA1553
Phase 1 study fully enrolled
Enrollment is now complete in a
Phase 1 trial of VLA1553 initiated in March 2018[11] in
the U.S., and Valneva is expecting to announce initial data in
early 2019.
The Phase 1 clinical trial is a
randomized, observer-blinded, dose-escalation, multi-center study.
It is investigating three different dose levels of VLA1553 in
approximately 120 healthy adults vaccinated with a single-shot
immunization. The trial design also includes measurements of
antibody persistence and will evaluate an additional vaccination
using the highest dose of VLA1553 at 6 and 12 months. This
re-vaccination will serve as an intrinsic human viral challenge,
with the goal of demonstrating that subjects are protected from
vaccine-induced viremia, thereby indicating potential efficacy of
VLA1553 early in clinical development.
Chikungunya is a mosquito-borne
viral disease caused by the chikungunya virus (CHIKV), a
Togaviridae virus, transmitted by Aedes
mosquitoes. As of December 2017, there have been more than 1
million reported cases in the Americas[12] and the
economic impact is considered significant (e.g. Columbia outbreak
2014: $73.6 million)[13]. The
medical burden is expected to grow as the distribution of the CHIKV
primary mosquito vectors continues to spread further
geographically. There are no preventive vaccines or effective
treatments available and as such, Chikungunya can be considered a
major public health threat.
VLA1553 is a monovalent, single
dose, live-attenuated vaccine candidate for protection against
various Chikungunya virus outbreak phylogroups and strains designed
for long-lasting protection conferred by neutralizing antibodies in
adults and children[14]. In
pre-clinical development, a single-vaccine shot was highly
immunogenic, eliciting a strong, long lasting neutralizing antibody
response. Vaccinated non-human primates (NHP) (cynomolgus macaques)
showed no signs of viremia after challenge[15].
The target populations for
vaccines against Chikungunya are travelers, military personnel or
individuals at risk who live in endemic regions. The global market
is estimated to be worth up to €500 million annually10.
ZIKA VACCINE
CANDIDATE - VLA1601
Phase 1 study fully enrolled, Partnered with
Emergent BioSolutions
After initiating a Phase 1 study
in the US in February 2018[16], Valneva
has completed enrollment of study participants, under the
partnership agreement with Emergent BioSolutions.
The Phase 1 study of VLA1601-101
is a randomized, observer-blinded, placebo-controlled, single
center study investigating two dose levels with two different
vaccination schedules in 67 healthy adults.
Initial data from the Phase 1
trial are expected to be available in late 2018 or early 2019.
Zika Virus infection is a
mosquito-borne viral disease caused by the Zika Virus (ZIKV), a
flavivirus transmitted by Aedes
mosquitoes[17]. Disease
outbreaks have been reported in tropical Africa, Southeast Asia,
the Pacific Islands, and, since 2015, in the Americas. According to
the World Health Organization (WHO), there is scientific consensus
that the ZIKV is a cause of microcephaly and Guillain-Barré
syndrome[18]. Between
2015 and beginning of January 2018, over 500,000 cases of suspected
Zika infection and many cases of the congenital syndrome associated
with the ZIKV were reported by countries and territories in the
Americas, according to the WHO[19]. There is
currently no specific treatment available.
VLA1601 is a highly purified
inactivated whole virus vaccine candidate developed using Valneva's
proven and licensed inactivated JE vaccine platform. In
pre-clinical development, VLA1601 demonstrated excellent purity,
in-vivo neutralization and overall a biological, chemical and
physical profile comparable to IXIARO®.
Half Year 2018
Financial Review
(Unaudited)
Revenues
Valneva's aggregate revenues in the first half of 2018 were €59.0
million compared to
€53.9 million in the first half of 2017.
Product sales in the first half of 2018 increased by 11.4% to €53.5
million from €48.1 million in the same period of the previous
year.
Revenues from collaborations and licensing amounted to €5.4 million
in the first half of 2018 compared to €5.8 million in the first
half of 2017. Reporting of grants has been re-classified and
included in the Company's Other Income / Expense line as of January
2018. The comparator period of 2017 was adjusted accordingly.
Operating result
and EBITDA
Cost of goods and services sold (COGS) were €24.0 million in the
first half of 2018, representing an overall gross margin of 59.3%
compared to 54.6% for the same period in 2017. €13.8 million of
COGS were related to IXIARO®/JESPECT® sales,
yielding a product gross margin of 63.4%. €6.5 million of COGS were
related to DUKORAL® sales,
yielding a product gross margin of 54.4%. Of the remaining COGS for
the first half of 2018, €1.1 million were related to the Third
Party product distribution business and €2.6 million were related
to cost of services. In the comparative period of 2017, COGS were
€24.4 million, of which €21.2 million were related to cost of
goods and €3.2 million to cost of services.
Research and development expenses in the first half of 2018
increased to €12.9 million from €9.7 million in the first half of
the previous year. This was driven by planned increased investments
into Valneva's clinical stage vaccine candidates. Marketing and
distribution expenses in the first half of 2018 amounted to €10.9
million, compared to €8.2 million in the first half of 2017. This
increase was mainly a result of investment in the US Travel market
combined with seasonally higher spending in other markets. In the
first half of 2018, general and administrative expenses amounted to
€8.8 million compared to €7.4 million in the comparator period of
2017. Amortization and impairment charges in the first half of 2018
amounted to €1.6 million compared to €3.6 million in the first half
of 2017. The reduction resulted from re-assessment of the lifetime
of IXIARO®/JESPECT® related
intangible assets, driven by patent extensions in both Europe and
the US (lifetime extended from 15 to 23.75 years).
In the first half of 2018, Valneva realized an operating profit of
€2.3 million compared to an operating profit of €1.8 million in the
first half of 2017. EBITDA in the first half 2018 was
€5.8 million, compared to a positive EBITDA of €7.6 million in the
first half of 2017. First half 2018 EBITDA was calculated by
excluding €3.5 million of depreciation and amortization from the
€2.3 million operating profit as recorded in the condensed
consolidated income statement under IFRS.
Net
result
In the first half of 2018, Valneva's net loss was €0.2 million
compared to a net loss of €4.4 million in the first half of
the prior year.
Finance costs and currency effects for the first half of 2018
resulted in a net finance expense of €2.0 million, compared to a
net finance expense of €5.1 million in the first half of 2017. The
reduced net finance expense year over year was partly the result of
lower interest expenses from continued loan re-payments and foreign
currency related losses incurred during the first half of 2017.
Cash flow and
liquidity
Net cash generated by operating activities in the first half of
2018 amounted to €13.7 million compared to €16.6 million in the
first half of 2017.
Cash outflows from investing activities in the first half of 2018
amounted to €1.1 million and resulted primarily from the purchase
of equipment. Cash outflows from investing activities amounted to
€2.6 million in the first half of 2017.
Cash outflows from financing activities amounted to €10.6 million
in the first half of 2018 and were mainly related to re-payment of
borrowings and interest payments. Cash outflows from financing
activities amounted to €5.5 million in the first half of
2017.
Liquid funds on June 30, 2018 stood at €37.7 million compared to
€38.1 million on December 31, 2017 and consisted of €34.6 million
in cash and cash equivalents and €3.1 million in restricted
cash.
About Valneva
SE
Valneva is a fully integrated, commercial stage biotech company
focused on developing innovative life-saving vaccines.
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 a unique vaccine against Lyme disease.
Valneva has operations in Austria, Sweden, the United Kingdom,
France, Canada and the US with over 450 employees. More information
is available at www.valneva.com.
Valneva Investor
and Media Contacts
Laetitia Bachelot-Fontaine
Global Head of Investor Relations &
Corporate Communications
T +33 (0)2 2807 1419
M +33 (0)6 4516 7099
investors@valneva.com |
Teresa Pinzolits
Corporate Communications Specialist
T +43 (0)1 20620 1116
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 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.
[1] CER and AER growth: In order to illustrate underlying
performance, Valneva has decided to include information on its
results in terms of constant exchange rate (CER) growth. This
represents growth calculated as if the exchange rates used to
determine the results of overseas companies in Euros had remained
unchanged from those used in the comparative period. CER%
represents growth at constant exchange rates. AER% represents
growth at actual exchange rates.
[2] For greater clarity, reporting of grants has been
re-classified and included in the company's Other Income / Expense
line as of 2018. The comparator period of 2017 was adjusted
accordingly.
[3]Subject to regulatory clearances
[4] For greater clarity, reporting of grants has been
re-classified and will, as of 2018, be included in the Company's
Other Income / Expense line. The comparator period of 2017 was
adjusted accordingly.
[5]EBITDA (Earnings before interest, taxes, depreciation and
amortization) was calculated by excluding depreciation,
amortization and impairment of tangible and intangible assets (H1
2018: €3.5m, H1 2017: €5.7m) from operating profit (H1 2018: €2.3m,
H1 2017: €1.8m).
[6]http://www.valneva.com/download.php?dir=News_2018&file=2018_03_19_VLA15_Phase_I_Results_PR_ENG.pdf
[7] Press Release, July 2, 2018: "Valneva Announces Significant
Progress of its Lyme Disease Vaccine Candidate"
http://www.valneva.com/en/investors-media/news/2018#290
[8] As estimated by the CDC
https://wwwnc.cdc.gov/eid/article/21/9/15-0417_article
[9] As estimated from available national data. Case reporting
is highly inconsistent in Europe and many LB infections still go
undiagnosed.
[10] Company estimate supported by independent market
studies
[11] Press Release, March 13, 2018: "Valneva Initiates Phase 1
Clinical Study to Evaluate its Single-Shot Vaccine Candidate
against Chikungunya"
http://www.valneva.com/en/investors-media/news/2018#281
[12] PAHA/WHO data: Number of reported cases of Chikungunya
Fever in the Americas - EW 51 (December 22, 2017)
[13] Cardona-Ospina et al., Trans R Soc Trip Med Hyg
2015
[14] Hallengärd et al. 2013 J. Virology 88: 2858-2866
[15] Roques et al. 2017JCI Insight 2 (6): e83527
[16]
http://www.valneva.com/download.php?dir=News_2018&file=2018_02_26_Phase_1_Initiation_VLA1601_EN.pdf
[17]
https://www.cdc.gov/zika/transmission/index.html
[18]
http://www.who.int/mediacentre/factsheets/zika/en/
[19]http://www.paho.org/hq/index.php?option=com_content&view=article&id=12390&Itemid=42090&lang=en
2018_08_02_VLA_HY
Results_PR_EN
This
announcement is distributed by Nasdaq Corporate Solutions on behalf
of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the
information contained therein.
Source: VALNEVA via Globenewswire
Valneva (EU:VLA)
Historical Stock Chart
From Mar 2024 to Apr 2024
Valneva (EU:VLA)
Historical Stock Chart
From Apr 2023 to Apr 2024