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4-Traders Homepage  >  Equities  >  Euronext Paris  >  Valneva    VLA   FR0004056851

VALNEVA (VLA)
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VALNEVA : Reports Strong Q1 Results and Continues to Advance Key R&D Programs

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05/17/2018 | 07:01am CEST

  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.

      * Total revenues were €32.1 million in Q1 2018 (vs. €28.4 million in Q1
        2017)[1].

  * 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'sFDA
    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 annually(8).

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 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 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            Teresa Pinzolits
  Global Head of Investor Relations &   Corporate Communications Specialist
  Corporate Communications              T +43 (0)1 20620 1116
  T +33 (0)2 2807 1419                  [email protected]
  M +33 (0)6 4516 7099
  [email protected]


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_Ph
ase_I_initiation_EN.pdf
[10] WHO, PAHO
[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_Initia
tion_VLA1601_EN.pdf
[16]http://www.valneva.com/download.php?dir=News_2017&file=2017_07_26_VLA_Emerge
nt_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&It
emid=42090&lang=en



2018_05_17_Valneva Q1 PR EN: 
http://hugin.info/143334/R/2193432/849565.pdf



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

 
  

© InPublic, source European Press Releases

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