Valneva Reports
Strong Q1 Results and Continues to Advance Key R&D
Programs
Strong sales and
EBITDA performance in Q1 2018
-
Product sales of €28.9 million in Q1 2018,
representing 11.5% year on year growth, in line with Company
guidance of double-digit product sales growth in FY 2018.
-
EBITDA of €4.9 million in Q1 2018 (vs. €3.4
million in Q1 2017); R&D investment to progress its Lyme and
Chikungunya vaccine candidates will increase during the year.
-
Gross margin of 59.4% in Q1 2018 (vs. 53.2% in
Q1 2017) driven by Q1 country and product sales mix.
-
Positive operating cash flow of €4.5 million in
Q1 2018 resulting in cash position of €36.2 million at the end of
March 2018.
Q1 Pipeline
Highlights
-
Phase 2 consultation and preparation activities
ongoing for Valneva's FDA fast-tracked Lyme vaccine candidate
VLA15. The study is expected to commence in the second half of
2018.
-
Recruitment for the Company's Chikungunya
vaccine candidate VLA1553 Phase 1 progressing according to
plan.
-
Recruitment for Zika vaccine candidate VLA1601
Phase 1 has been completed. Initial results expected at the end of
2018 or early 2019.
David Lawrence,
Valneva's Chief Financial Officer, commented, "The first
quarter of 2018 marked a robust start to the year. For
IXIARO®, in the US
Private market, we can begin to see early, positive results from
our newly established in-house sales and marketing team. We remain
focused on the execution of our commercial products and investing
in the progression of our valuable vaccine candidates to maintain
the sustainable longer-term growth of the Company."
Key Financial Information
(Unaudited)
€ in million |
3 months ending March 31 |
|
2018 |
2017 |
Product Sales |
28.9 |
25.9 |
Total Revenues |
32.1 |
28.4[2] |
Net profit/(loss) |
1.5 |
(1.7) |
EBITDA[3] |
4.9 |
3.4 |
Cash, short-term deposits and marketable securities, end
of period |
36.2 |
45.2 |
Lyon (France),
May 17, 2018 - Valneva SE ("Valneva" or "the Company"), a fully
integrated, commercial stage biotech company focused on developing
innovative lifesaving vaccines, reported today its first quarter
financial results ending March 31, 2018. The condensed consolidated
interim financial results are available on the Company's website
www.valneva.com.
Commercial
Vaccines
JAPANESE
ENCEPHALITIS VACCINE (IXIARO®/JESPECT®)
Strong sales
growth driven by the US private market
In the first quarter of 2018,
IXIARO®/JESPECT®
sales reached €18.2 million compared to €15.5 million in the first
quarter of 2017, representing 17.3% year-on-year growth. This
increase was largely driven by growth in the US private market
where Valneva took direct control of sales and marketing at the end
of November 2017. Additional growth in the UK, Nordics and Canadian
private markets also drove the sales.
In 2018, Valneva expects continued
double-digit growth in IXIARO®/JESPECT®
revenues through increased market penetration via the development
of its commercial network, notably in the US private market.
CHOLERA / ETEC-DIARRHEA VACCINE
(DUKORAL®)
In the first quarter of 2018,
DUKORAL® sales
reached €9.5 million compared to €9.8 million in the first quarter
of 2017. The slight decline in sales was attributable to negative
exchange rate movements and supply phasing in certain European
markets. The Company expects this effect to even out over the
course of the year and confirms it expects DUKORAL® revenues
to continue to grow healthily in 2018 through continued market
penetration.
Clinical Vaccine
Candidates
LYME DISEASE
VACCINE CANDIDATE - VLA15
Phase 2 study to
be initiated in the second half of 2018
After reporting positive Phase 1
interim data for VLA15 in March 2018[4], Valneva
expects to launch a Phase 2 study in the second half of 2018,
subject to regulatory clearances.
Phase 2 is intended to be
conducted in Lyme-endemic regions in the US and Europe and will
include subjects previously infected with Borrelia, the bacteria that causes Lyme disease.
Further dose and schedule optimizations are being considered.
As part of its development
acceleration strategy, the Company has elected to augment the Phase
1 study with a booster dose, to gather additional data
expeditiously.
A subset of subjects in the higher
dose groups who received a complete primary immunization schedule
(three vaccinations), will be included in a booster extension to
investigate the safety and immunogenicity of a booster dose of
VLA15 administered approximately thirteen months after the first
immunization. An analysis on safety and immunogenicity will be
performed after the last subject has completed the last study visit
six months after booster vaccination. In addition, an interim
analysis on immunogenicity data one month post booster will be
performed.
Lyme disease is the most common
and one of the fastest growing vector-borne illnesses in the
Northern Hemisphere for which there is no other clinical vaccine
candidate in development worldwide. The systemic infection is
caused by Borrelia bacteria transmitted to
humans by infected Ixodes ticks. According to
the US Centers for Disease Control and Prevention (CDC),
approximately 300,000[5] Americans
are infected with Lyme disease each year with at least a further
200,000 cases in Europe[6]. Early
symptoms of Lyme disease (such as a gradually expanding
erythematous rash called Erythema migrans or more unspecific
symptoms like fatigue, fever, headache, mild stiff neck, arthralgia
or myalgia) are often overlooked or misinterpreted. Left untreated,
the disease can disseminate and cause more serious complications
affecting the joints (arthritis), the heart (carditis) or the
nervous system.
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.
Vaccination with OspA was already
proven to work in the 1990s and VLA15 pre-clinical data showed that
the vaccine has the potential to provide protection against the
majority of the Borrelia species pathogenic
for humans[7].
The global market for a vaccine
against Lyme disease is currently estimated at approximately €700 -
€800 million annually[8].
CHIKUNGUNYA
VACCINE CANDIDATE - VLA1553
Phase 1 study
(VLA1553-101) progressing according to plan
Recruitment for Phase 1,
VLA1553-101, which was initiated in March 2018[9], to
evaluate Valneva's single-shot vaccine candidate against
Chikungunya is progressing according to plan.
VLA1553-101 is a randomized,
observer-blinded, dose-escalation, multi-center study investigating
three different dose levels of VLA1553 in approximately 120 healthy
adults vaccinated with a single-shot immunization.
The trial design includes the
investigation of antibody persistence and an additional vaccination
with the highest dose of the live-attenuated vaccine candidate at 6
or 12 months. This re-vaccination serves as an intrinsic human
viral challenge demonstrating that subjects are protected from
vaccine-induced viremia and thereby potentially indicating 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. Clinical symptoms include acute onset of fever,
debilitating joint and muscle pain, headache, nausea and rash
potentially developing into long-term, serious health
impairments[10].
Chikungunya outbreaks were reported in Asia, Africa, the Americas
and recently (2017) in Europe. As of December 2017, there have been
more than 1 million reported cases in the Americas[11] and the
economic impact can be considered significant (e.g. Columbia
outbreak 2014: $73.6 million)[12]. The
medical burden is expected to grow as the distribution of the CHIKV
primary mosquito vectors continues to further spread
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 aiming
for a long-lasting protection conferred by neutralizing antibodies
in adults and children[13]. The
target populations are travelers, military personnel or individuals
at risk who live in endemic regions.
In pre-clinical development, a
single-vaccine shot was highly immunogenic with a strong, long
lasting neutralizing antibody response and vaccinated Non-Human
Primates (NHP) (cynomolgus macaques) showed no signs of viremia
after challenge[14].
First data from the Phase 1 trial
are expected to be available by early 2019.
The global market for vaccines
against Chikungunya is estimated at up to €500 million
annually8.
ZIKA VACCINE
CANDIDATE - VLA1601
Phase 1 study
fully recruited, Partnered with Emergent BioSolutions
After initiating Phase 1 in the US
in February 2018[15], Valneva
has finalized the recruitment of study participants for this
clinical trial 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.
First data from the Phase 1 trial
are expected to be available in late 2018 or early 2019. Upon
availability of Phase 1 data, Emergent will have the option to
continue the development arrangement with Valneva for a milestone
payment of €5 million. The agreement also provides Valneva
potential additional milestone payments of up to €44 million
related to product development, approval, commercialization and
product sales, as well as future royalties on annual net
sales[16].
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, 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 had been reported by countries and territories in the
Americas, according to the World Health Organization[19]. Today
there is 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®.
First Quarter
2018 Financial Review
(Unaudited)
Revenues
Product sales in the first quarter
of 2018 increased by 11.5% to €28.9 million from €25.9 million
in the same period of the previous year.
Valneva's aggregate first quarter
2018 revenues were €32.1 million compared to €28.4 million in the
first quarter of 2017.
Revenues from collaborations and
licensing amounted to €3.2 million compared to €2.5 million in the
first quarter of 2017. For greater clarity, reporting of grant
income has been re-classified in 2018 and is included in the
Company's other income and expenses, net. The comparator period of
2017 has been adjusted accordingly.
Operating result
and EBITDA
Cost of goods and services sold
(COGS) were €13.0 million in the first quarter of 2018,
representing an overall gross margin of 59.4% compared to 53.2% for
the same period in 2017. €7.2 million of COGS were related to
IXIARO®/JESPECT® sales,
yielding a product gross margin of 60.6%. €3.8 million of COGS were
related to DUKORAL® sales,
yielding a product gross margin of 59.6%. Of the remaining COGS for
the first quarter of 2018, €0.8 million were related to the
Third Party product distribution business and €1.3 million were
related to cost of services. In the comparative period of 2017,
COGS were €13.3 million, of which €11.5 million were related to
cost of goods and €1.8 million to cost of services.
Research and development expenses
in the first quarter of 2018 increased to €5.8 million from €5.2
million in the first quarter of the previous year. This was driven
by increased investments into Valneva's clinical stage vaccine
candidates. Distribution and marketing expenses in the first
quarter of 2018 amounted to €6.0 million, compared to €4.3 million
in the first quarter of 2017, reflecting increased direct
commercial efforts. In the first quarter of 2018, general and
administrative expenses equalled the first quarter of 2017, at €4.0
million. Amortization and impairment charges in the first quarter
of 2018 amounted to €0.8 million compared to €1.8 million in
the first quarter of 2017. The reduction is resulting from the
re-assessment of the lifetime of IXIARO®/JESPECT® related
intangible assets driven by extension of patents in both Europe and
the USA.
In the first quarter of 2018,
Valneva realized an operating profit of €3.2 million compared to
€0.5 million in the first quarter of 2017. Valneva's Q1 2018 saw a
positive EBITDA of €4.9 million compared to €3.4 million in
the first quarter of 2017. First quarter 2018 EBITDA was calculated
by excluding depreciation and amortization amounting to €1.7
million from the operating profit of €3.2 million as recorded in
the condensed consolidated income statement under IFRS.
Net
result
Valneva achieved in the first
quarter of 2018 a net profit amounting to €1.5 million compared to
a net loss of €1.7 million in the first quarter of 2017.
Finance costs and currency effects
in the first quarter of 2018 amounted to a net finance expense of
€1.3 million compared to a net finance expense of €2.0 million
in the first quarter of 2017.
Cash flow and
liquidity
Net cash generated by operating
activities in the first quarter of 2018 was €4.5 million compared
to €12.1 million in the same period in 2017.
Cash outflows from investing
activities in the first quarter of 2018 amounted to €0.6 million,
compared to €1.1 million in the first quarter of 2017, and
resulted primarily from purchase of equipment.
Cash outflows from financing
activities in the first quarter of 2018 amounted to €3.8 million
compared to €4.9 million in the first quarter of 2017 and were
mainly related to re-payment of borrowings and interest
payments.
Liquid funds on March 31, 2018
stood at €36.2 million compared to €38.1 million on December 31,
2017 and consisted of €33.2 million in cash and cash equivalents
and €3.0 million in restricted cash.
From the first quarter of 2018
onwards, Valneva will only present quarterly primary statements
based on IFRS with the same accounting principles applied as for
the IFRS financial statements. Full results, in line with IAS34,
will be issued for Half Year 2018.
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 proprietary 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 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] 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.
[2] 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.
[3] EBITDA (Earnings before interest, taxes, depreciation and
amortization) was calculated by excluding depreciation,
amortization and impairment of tangible and intangible assets (Q1
2018: €1.7m, Q1 2017: €2.9m) from operating profit (Q1 2018: €3.2m,
Q1 2017: €0.5m).
[4]http://www.valneva.com/download.php?dir=News_2018&file=2018_03_19_VLA15_Phase_I_Results_PR_ENG.pdf
[5] As estimated by the CDC
https://wwwnc.cdc.gov/eid/article/21/9/15-0417_article
[6] As estimated from available national data. Case reporting
is highly inconsistent in Europe and many LB infections still go
undiagnosed.
[7] New Scientist, Lyme disease is set to explode and we still
don't have a vaccine; March 29, 2017
https://www.newscientist.com/article/mg23431195-800-lyme-disease-is-set-to-explode-and-you-cant-protect-yourself/
[8] Company estimate supported by independent market
studies
[9]
http://www.valneva.com/download.php?dir=News_2018&file=2018_03_13_Chikungunya_Phase_I_initiation_EN.pdf
[11] PAHA/WHO data: Number of reported cases of Chikungunya
Fever in the Americas - EW 51 (December 22, 2017)
[12] Cardona-Ospina et al., Trans R Soc Trip Med Hyg
2015
[13] Hallengärd et al. 2013 J. Virology 88: 2858-2866
[14] Roques et al. 2017JCI Insight 2 (6): e83527
[15]
http://www.valneva.com/download.php?dir=News_2018&file=2018_02_26_Phase_1_Initiation_VLA1601_EN.pdf
[16]http://www.valneva.com/download.php?dir=News_2017&file=2017_07_26_VLA_Emergent_ZIKA_PR_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_05_17_Valneva Q1 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