Key R&D Milestones
Achieved
- Positive topline Phase 3 results
for single-shot chikungunya vaccine candidate VLA1553
- Protective neutralizing antibodies
induced in 98.5% of trial participants
- Recruitment completed for Phase 2
trial VLA15-221 of Lyme disease vaccine candidate including
pediatric age group
- Recruitment
completed for pivotal Phase 3 trial of inactivated, adjuvanted
COVID-19 vaccine candidate VLA2001
- Phase 3 topline
data now expected early in fourth quarter 2021
Strong financial position
- $107.6 million of gross proceeds raised in a US initial public
offering and a concurrent private placement in Europe
- Cash and cash equivalents of €329.8 million at June 30,
2021
2021 financial guidance
(excluding
COVID)
reconfirmed
- Total revenues, excluding VLA2001,
of €80 million to €105 million
- R&D expenses, excluding
VLA2001, of €65 million to €75 million
Thomas
Lingelbach,
Valneva’s Chief
Executive Officer, commented,
“Valneva is continuing to hit its major R&D objectives. We have
just reported great results in the world’s first ever Phase 3 trial
for a chikungunya vaccine alongside excellent progress for our
unique COVID and Lyme disease programs. Our successful Nasdaq
listing marked a significant strategic step for Valneva as we look
to continue to build our Company. Our team has delivered
phenomenally well this year already and I would like to thank them
for their continued commitment and dedication.”
Financial Information
(unaudited results, consolidated under IFRS)
€ in million |
6 months ending June 30 |
|
2021 |
2020 |
Total revenues |
47.5 |
47.9 |
Product sales |
31.8 |
40.9 |
Net profit/(loss) |
(86.4) |
(25.6) |
EBITDA |
(80.1) |
(17.2) |
Cash (at end of period) |
329.8 |
200.0 |
Saint Herblain
(France), August 10,
2021 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) a
specialty vaccine company focused on the development and
commercialization of prophylactic vaccines for infectious diseases
with significant unmet medical needs, today reported its
consolidated financial results for the first half of the year,
ended June 30, 2021. 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.
Valneva will provide a live webcast of its first
half financial results conference call beginning at 3 p.m. CEST
today. This webcast will also be available on the Company’s
website. Please refer to this link:
https://edge.media-server.com/mmc/p/qror7sgm
Clinical Stage
Vaccine Candidates
LYME DISEASE VACCINE
CANDIDATE – VLA15 Acceleration of Pediatric
Development
Valneva is developing VLA15, a vaccine candidate
targeting Borrelia, the bacterium that causes Lyme disease. VLA15
is a multivalent recombinant protein vaccine that targets six
serotypes of Borrelia representing the most common strains found in
the United States and Europe. VLA15 is currently the only vaccine
undergoing clinical trials against Lyme disease.
Valneva has previously announced a collaboration
with Pfizer for late phase development and, if approved,
commercialization of VLA151. Valneva has reported positive initial
results for two Phase 2 clinical trials of VLA15 in over 800
healthy adults.
To accelerate VLA15’s pediatric development,
Valneva and Pfizer initiated an additional Phase 2 trial in March
2021, VLA15-221. In July 2021, Pfizer and Valneva announced
recruitment completion for VLA15-221 with a total of 625
participants, 5 to 65 years of age, randomized in the trial. The
objective of the trial is to show safety and immunogenicity down to
5 years of age and to evaluate the optimal vaccination schedule for
use in Phase 3. Topline results for VLA15-221 are expected in the
first half of 2022.
CHIKUNGUNYA VACCINE CANDIDATE –
VLA1553Positive Phase 3
Results reported
VLA1553 is a live-attenuated, single-dose
vaccine candidate against the chikungunya virus, a mosquito-borne
virus that has spread to more than 100 countries with the potential
to rapidly expand further. There are currently no preventive
vaccines or effective treatments for the chikungunya virus
available and, to Valneva’s knowledge, VLA1553 is the only
chikungunya vaccine candidate in Phase 3 clinical trials
worldwide.
At the beginning of August 2021, Valneva
announced positive topline results for the Phase 3 pivotal trial of
VLA1553. The trial, involving 4,115 adults, aged 18 years and
above, across 44 sites in the U.S., met its primary endpoint
inducing protective CHIKV neutralizing antibody titers in 98.5% of
participants 28 days after receiving a single shot (264 of 268
subjects from the per-protocol subgroup tested for immunogenicity,
95%CI: 96.2-99.6). The seroprotection rate result of 98.5% exceeded
the 70% threshold (for non-acceptance) agreed with the FDA. The
seroprotective titer was agreed with the FDA to serve as a
surrogate of protection that can be utilized in a potential FDA
submission of VLA1553 under the accelerated approval pathway. The
vaccine candidate was highly immunogenic with a Geometric Mean
Titer of approximately 3,270, confirming the immunogenicity profile
seen in the Phase 1 trial.
Additionally, VLA1553 was also highly
immunogenic in elderly study participants, who achieved equally
high seroprotection rates and neutralizing antibody titers as
younger adults, as well as an equally good safety profile.
VLA1553 was generally well tolerated among the
3,082 subjects evaluated for safety. An independent Data Safety
Monitoring Board continuously monitored the study and identified no
safety concerns. The safety profile is consistent with results from
the Phase 1 clinical trial. The majority of solicited adverse
events were mild or moderate and resolved within 3 days. 1.6% of
study participants reported severe solicited adverse events, most
commonly fever. Approximately 50% of study participants experienced
solicited systemic adverse events, most commonly headache, fatigue
and myalgia (seen in more than 20% of subjects). The local
tolerability profile showed that approximately 15% of participants
experienced solicited local adverse events. The trial will continue
towards final analysis including the six-month safety data. Final
trial results are expected within the next six months.
Valneva’s chikungunya program was awarded
Breakthrough Therapy Designation by the FDA in July 2021. This new
milestone came in addition to the FDA Fast Track designation and
the European Medicines Agency (EMA)’s PRIME designation which the
Company received in December 2018 and in October 2020,
respectively. The sponsor of the first chikungunya vaccine approved
in the U.S. will be eligible to receive a Priority Review Voucher
(PRV).
To make VLA1553 more accessible to Low- and
Middle-Income Countries (LMIC), Valneva and Instituto Butantan in
Brazil signed an agreement in January 2021 for the development,
manufacturing and marketing of VLA15532. The collaboration falls
within the framework of the funding agreement between Valneva and
the Coalition for Epidemic Preparedness Innovations (CEPI) signed
in July 20193, which provides funding of up to $23.4 million with
support from the European Union’s Horizon 2020 program.
SARS-CoV-2 VACCINE CANDIDATE –
VLA2001
Recruitment Completed for
Pivotal Phase 3
Trial
VLA2001 is currently the only whole virus,
inactivated, adjuvanted vaccine candidate in clinical trials
against COVID-19 in Europe. It is produced using Valneva’s
established Vero-cell platform, leveraging the manufacturing
technology for Valneva’s licensed Japanese encephalitis vaccine,
IXIARO®.
At the beginning of June 2021, Valneva announced
that recruitment had been completed for VLA2001’s pivotal Phase 3
trial “Cov-Compare” (VLA2001-301) with over 4,000 randomized
participants. In the Phase 1/2 clinical trial, VLA2001 showed high
immunogenicity and was generally well tolerated, with no safety
concerns identified4. Cov-Compare phase 3 topline data are expected
early in the fourth quarter of 2021. Valneva expects to commence
rolling submission with the UK Medicines and Healthcare products
Regulatory Agency in the coming weeks and, subject to the Phase 3
data, believes that initial approval may be granted by the end of
2021.
In parallel to the Cov-Compare trial, Valneva is
studying COVID-19 variants to be in a position to manufacture
variant-based vaccines. Valneva is also participating in a UK
Government-funded clinical trial looking at different COVID-19
“booster” vaccines. The COV-Boost trial, led by University Hospital
Southampton NHS Foundation Trust, looks at seven different COVID-19
vaccines, including VLA2001, as potential boosters, and is also
evaluating dosage levels. It will be the first trial in the world
to provide vital data on how effective a booster of each vaccine is
in protecting individuals from the virus. The COV-Boost trial is
fully recruited. Valneva has also commenced production of VLA2001
at its facilities in Scotland and Sweden in order to optimize the
timeline for potential deliveries of the vaccine.
Although vaccines against SARS-CoV-2 have
already been approved, given the potential advantages often
associated with inactivated whole virus vaccines, Valneva believes
its vaccine candidate could play a role in the overall portfolio of
SARS-CoV-2 vaccines that will address the global need during the
pandemic and in the future.
In September 2020, Valneva announced a
collaboration with the UK Government, which has the option to
purchase up to 190 million doses through 20255. So far, the UK
Government has ordered 100 million doses for supply in 2021 and
2022.
Commercial Vaccines
JAPANESE ENCEPHALITIS VACCINE
(IXIARO®/JESPECT®)
IXIARO® is the only Japanese encephalitis vaccine licensed and
available in the United States, Canada and Europe.
Sales of IXIARO® were €25.4 million in the
first half of 2021 compared to €28.4 million in the first half of
2020. While the COVID-19 pandemic is continuing to adversely impact
the travel industry and vaccine sales to the private market, the
impact on IXIARO® sales during the first half of 2021 was mitigated
by the Company’s contract with the U.S. Government’s Department of
Defense (DoD).
CHOLERA /
ETEC6-DIARRHEA VACCINE
(DUKORAL®)
DUKORAL® is an oral vaccine for
the prevention of diarrhea caused by Vibrio cholerae and/or
heat-labile toxin producing ETEC, the leading cause of travelers’
diarrhea. DUKORAL® is authorized for use in the
European Union and Australia to protect against cholera and in
Canada, Switzerland, New Zealand and Thailand to protect against
cholera and ETEC5.
DUKORAL® recorded sales of €0.4
million in the first half of 2021 compared to €12.1 million in the
first half of 2020. First half 2021 sales continued to be
significantly affected by the COVID-19 pandemic’s impact on the
travel industry.
First Half
2021 Financial Review (Unaudited,
consolidated under IFRS)
RevenuesValneva’s total
revenues were €47.5 million in the first half of 2021 compared to
€47.9 million in the first half of 2020. Product sales declined by
22.4% to €31.8 million in the first half of 2021 compared to €40.9
million in the first half of 2020. On a constant exchange rate
(CER) basis, product sales declined by 18.6% in the first half of
2021 compared to the first half of 2020 due to the impact of the
COVID-19 pandemic on the travel industry. IXIARO®/JESPECT® sales
declined by 10.6% (3.5% at CER) to €25.4 million and DUKORAL® sales
by 96.5% (96.6% at CER) to €0.4 million in the first half of 2021
compared to €28.4 million and €12.1 million respectively in the
first half of 2020. Third Party product sales grew to €5.9 million
in the first half of 2021 from €0.4 million in the first half of
2020. The increase in Third Party product sales was driven by
incremental sales related to Valneva’s distribution agreement with
Bavarian Nordic for the sales of Rabipur®/RabAvert® and Encepur® in
certain territories that commenced in 2021. Other Revenues,
including revenues from collaborations, licensing and services,
amounted to €15.7 million in the first half of 2021 compared to
€7.0 million in the first half of 2020. This increase was
attributable to higher revenues related to the Lyme R&D
collaboration agreement with Pfizer, incremental revenues related
to the collaboration with Instituto Butantan for providing VLA1553
in LMICs as well as higher revenues generated in the CTM
Manufacturing unit in Sweden.
Operating Result and EBITDA
Costs of goods and services sold (COGS) were €34.8 million in the
first half of 2021. Gross margin on product sales was 39.2%
compared to 55.7% in the first half of 2020. The decline was mainly
related to idle capacity costs combined with compressed product
sales, both impacting gross margin as a percentage of sales. COGS
of €11.7 million were related to IXIARO®/JESPECT® sales, yielding a
product gross margin of 54.1%. COGS of €3.6 million were related to
DUKORAL® sales, causing a negative product gross margin. Of the
remaining COGS in the first half of 2021, €4.1 million were related
to the Third-Party product distribution business, €4.2 million to
start-up costs of the COVID-19 business and €11.3 million to cost
of services. In the first half of 2020, overall COGS were €22.5
million, of which €18.1 million related to cost of goods and €4.4
million related to cost of services.Research and development
investments continued to increase in the first half of 2021,
growing to €78.7 million compared to €33.1 million in the first
half of 2020. This was mainly driven by investments in Valneva’s
COVID-19 vaccine candidate VLA2001 as well as Phase 3 clinical
study costs for Valneva’s chikungunya vaccine program VLA1553.
Excluding COVID-19, research and development investments amounted
to €32.6 million in the first half of 2021 compared to €31.5
million in the first half of 2020. Marketing and distribution
expenses in the first half of 2021 amounted to €9.6 million
compared to €10.0 million in the first half of 2020. The decrease
was the result of lower marketing and distribution spend across all
Valneva’s direct markets due to reduced sales activity as a result
of the COVID-19 pandemic. Marketing and distribution expenses in
the first half of 2021 notably included €2.0 million of expenses
related to the launch preparation costs of the chikungunya vaccine
candidate (compared to none in the first half of 2020). In the
first half of 2021, general and administrative expenses increased
to €20.9 million from €10.6 million in the first half of 2020,
mainly driven by increased costs to support corporate transactions
and projects including increased resources in support of
incremental COVID activities.Other income, net of other expenses,
increased to €10.4 million in the first half of 2021 from €6.5
million in the first half of 2020. This increase was mainly driven
by increased R&D tax credits directly resulting from increased
R&D spending.Valneva recorded an operating loss of €86.2
million in the first half of 2021 compared to an operating loss of
€21.9 million in the first half of 2020. EBITDA loss in the first
half of 2021 was €80.1 million compared to an EBITDA loss of €17.2
million in the first half of 2020.
Net Result In the first half of
2021, Valneva generated a net loss amounting to €86.4 million
compared to a net loss of €25.6 million in the first half of 2020.
Finance costs and currency effects in the first half of 2021
resulted in a net finance income of €0.5 million, compared to a net
finance expense of €5.6 million in the first half of 2020. This was
mainly a result of foreign exchange gains amounting to €8.7 million
in the first half of 2021 primarily driven by revaluation gains of
non-Euro denominated balance sheet positions compared to a net
foreign exchange loss (net of gains on derivative financial
instruments) of €1.7 million in the first half of 2020. Interest
charges increased to €8.4 million in the first half of 2021
compared to €3.9 million in the same period of 2020. This growth
was driven by increased interest charges related to refund
liabilities as well as increased interest charges related to the
financing agreement with U.S. healthcare funds Deerfield &
OrbiMed entered into in 2020.
Cash Flow and Liquidity Net
cash generated by operating activities amounted to €84.2 million in
the first half of 2021 compared to €113.2 million in the first half
of 2020 mainly derived by milestone payments related to the COVID
supply agreement concluded with the UK Government in September
2020. The net cash generated by operating activities in the first
half of 2020 mainly derived from the $130 million upfront payment
received from Pfizer related to the Lyme R&D collaboration
agreement.Cash outflows from investing activities amounted to €39.9
million in the first half of 2021 compared to €1.8 million in the
first half of 2020 mainly as a result of purchases of equipment
related to the site expansion activities for COVID vaccine
manufacturing in both Scotland and Sweden.Net cash generated from
financing activities amounted to €78.7 million in the first half of
2021 which was mainly a result of proceeds from issuance of new
shares in the U.S. initial public offering and European private
placement (Global Offering). Cash inflows in the first half of 2020
amounted to €24.5 million and mainly consisted of net proceeds from
the financing arrangement with U.S. healthcare funds Deerfield and
OrbiMed, offset by €20.0 million of repayments of borrowings to the
European Investment Bank. Liquid funds increased to €329.8 million
as of June 30, 2021 compared to €204.4 million as of December 31,
2020. The main changes related to payments made by the UK
Government within the framework of the UK COVID-19 partnership as
well as the proceeds from the Global Offering in May 2021.
Non-IFRS Financial Measures
Management uses and presents IFRS results as
well as the non-IFRS measure of EBITDA to evaluate and communicate
its performance. While non-IFRS measures should not be construed as
alternatives to IFRS measures, management believes non-IFRS
measures are useful as an aid to further understand Valneva’s
current performance, performance trends, and financial
condition.
EBITDA is a common supplemental measure of
performance used by investors and financial analysts. Management
believes this measure provide additional analytical tools. EBITDA
is defined as earnings (loss) from continuing operations before
interest expense, income taxes, depreciation and amortization.
A reconciliation of EBITDA to operating loss,
the most directly comparable IFRS measure, is set forth below:
€ in million |
6 months ending June
30 |
|
2021 |
2020 |
Operating Loss |
(86.2) |
(21.9) |
Add: |
|
|
Amortization |
3.1 |
3.0 |
Depreciation |
3.0 |
1.7 |
EBITDA |
(80.1) |
(17.2) |
About Valneva
SEValneva is a specialty vaccine company focused on the
development and commercialization of prophylactic vaccines for
infectious diseases with significant unmet medical need. The
Company takes a highly specialized and targeted approach to vaccine
development, beginning with the identification of deadly and
debilitating infectious diseases that lack a prophylactic vaccine
solution and for which there are limited therapeutic treatment
options. It then applies its deep understanding of vaccine science,
including its expertise across multiple vaccine modalities, as well
as its established vaccine development capabilities, to develop
prophylactic vaccines to address these diseases. Valneva has
leveraged its expertise and capabilities to successfully
commercialize two wholly owned vaccines and rapidly advance
multiple vaccine candidates into late-stage clinical development,
including candidates against Lyme disease (partnered with Pfizer),
the chikungunya virus and COVID-19.
Media
& Investors ContactsLaëtitia Bachelot-FontaineVP
Global Communications & European Investor RelationsM +33 (0)6
4516 7099
laetitia.bachelot-fontaine@valneva.com |
Joshua
DrummVP Global Investor RelationsM +1 917 815
4520 joshua.drumm@valneva.com |
Forward-Looking Statements
This press release contains certain
forward-looking statements relating to the business of Valneva,
including with respect to expected total revenues and R&D
expenses for full fiscal year 2021, 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 and estimates for
future performance. 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 future
performance. 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, as well as those
risks and uncertainties discussed or identified in Valneva’s public
filings with the Autorité des Marchés Financiers (AMF) in France,
including those listed in the Company’s 2020 Universal Registration
Document filed with the AMF on April 9, 2021, which is available on
the Company’s website and on the website of the AMF
(www.amf-france.org), and public filings and reports filed with the
U.S. Securities and Exchange Commission. 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 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 Valneva and Pfizer Announce Collaboration to Co-Develop and
Commercialize Lyme Disease Vaccine, VLA152 Valneva and Instituto
Butantan Sign Final Agreement on Single-Shot Chikungunya Vaccine
for Low and Middle Income Countries3 CEPI awards up to $23.4
million to Valneva for late-stage development of a single-dose
Chikungunya vaccine4 Valneva Reports Positive Phase 1/2 Data for
Its Inactivated, Adjuvanted COVID-19 Vaccine Candidate, VLA20015
Valneva Confirms Participation in UK Government COVID-19 Vaccine
Response Program6 Indications differ by country - Please refer to
Product / Prescribing Information (PI) / Medication Guide approved
in your respective countries for complete information, incl.
dosing, safety and age groups in which this vaccine is licensed,
ETEC = Enterotoxigenic Escherichia coli (E. Coli) bacterium.
- 2021_08_10_VLA_H1_2021_Results_PR_EN_Final