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.
- Strong IXIARO® sales revenue growth of over 19% driven by the
US private market
- Total revenues were €59.0 million in H1 2018 (vs. €53.9 million
in H1 2017)[2].
- 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.
- Position includes ongoing debt repayments and no further debt
drawdown in H1
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 -
VLA1553Phase 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 - VLA1601Phase
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)
RevenuesValneva'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 SEValneva 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 ContactsLaetitia Bachelot-FontaineGlobal Head of Investor
Relations & Corporate CommunicationsT +33 (0)2 2807 1419M +33
(0)6 4516 7099investors@valneva.com |
Teresa
PinzolitsCorporate Communications SpecialistT +43 (0)1 20620
1116communications@valneva.com |
Forward-Looking StatementsThis 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.pdf
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