Valneva Reports First Quarter 2024 Financial Results and Provides
Corporate Updates
Valneva Reports First Quarter 2024
Financial Results and Provides Corporate
Updates
Q1 financial highlights
- Total revenues of
€32.8 million, including sales of €32.1 million, on track to
meet anticipated full year guidance
- Cash position of €176.6 million,
including €95 million from sale of Priority Review Voucher (PRV)1.
- Significantly extended cash runway
with recent update of debt financing agreement2
- Substantially lower cash burn
expected in 2024 as Valneva expects to complete its cost
contributions for the Lyme disease Phase 3 study in the second
quarter
- Net Profit of €58.9 million,
reflecting PRV sale
2024 financial guidance
confirmed
- Expected total revenues between
€170 million and €190 million, including:
- €160 million to €180 million of
sales driven by growth of Valneva’s proprietary products
- Expected R&D investments
between €60 million and €75 million, mostly dedicated to ongoing
chikungunya development activities, the Zika trial and advancement
of pre-clinical programs
- Expected Other income between €100
million and €110 million, reflecting €95 million in proceeds from
the PRV sale
Strong R&D execution
- Single-shot chikungunya vaccine
IXCHIQ® recommended by ACIP and adopted by U.S. CDC3; Regulatory
processes with the European, Canadian and Brazilian authorities on
track;
- Six-month data for Phase 3
adolescent study of IXCHIQ® to be reported shortly and label
extensions to be submitted based on results; Enrolment of children
for pediatric Phase 2 study on track;
- Primary vaccinations for all
participants in the VALOR Lyme disease Phase 3 trial expected to be
completed in Q2;
- Phase 1 clinical trial for
second-generation Zika vaccine candidate initiated4.
Financial Information(Unaudited
results, consolidated per IFRS)
€ in million |
3 months ending March 31 |
|
2024 |
2023 |
Product sales |
32.1 |
32.1 |
Total revenues |
32.8 |
33.5 |
Net profit/(loss) |
58.9 |
(18.1) |
Adjusted EBITDA (profit/loss) |
73.0 |
(12.3) |
Cash |
176.6 |
254.5 |
Saint-Herblain (France), May 7,
2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a
specialty vaccine company, today reported its financial results for
the first quarter ending March 31, 2024, and provided corporate
updates. The condensed consolidated interim financial results are
available on the Company’s website (Financial Reports –
Valneva).
Valneva will host a live webcast of its first
quarter 2024 results conference call at 3 p.m. CEST/9 a.m. EDT
today. This webcast will also be available on the Company’s
website. Please refer to this link:
https://edge.media-server.com/mmc/p/wrc2a7s3.
Peter Bühler, Valneva’s Chief Financial
Officer, commented, “The first quarter performance has
been in line with our expectations. We are aiming to further
capitalize on the travel industry recovery during the rest of the
year including ramping-up sales for IXCHIQ® to support our
commercial sales growth while executing on our key R&D
milestones. The successful sale of our PRV and deferral of our loan
reimbursement in Q1 allowed us to maintain a solid cash position
and, with the expected completion of our payments for the Lyme
Phase 3 trial in the second quarter, we anticipate a significantly
lower cash burn in 2024.”
Commercial Portfolio
Valneva’s commercial portfolio is composed of
three travel vaccines, IXIARO®/JESPECT®, DUKORAL® and IXCHIQ®. The
Company also distributes certain third-party products in countries
where it operates its own marketing and sales infrastructure.
JAPANESE ENCEPHALITIS VACCINE
IXIARO®/JESPECT®In
the first quarter of 2024, IXIARO®/JESPECT® sales were €16.6
million compared to €17.4 million in the first quarter of 2023.
Sales to the U.S. military counterbalanced most of the supply
constraints experienced during the period. These constraints have
now been resolved, and as communicated last month in its full-year
publication5, Valneva expects double-digit annual growth for
IXIARO® sales for at least the next three years.
CHOLERA /
ETEC6-DIARRHEA VACCINE
DUKORAL®
In the first quarter of 2024, DUKORAL® sales
increased by 10.3% to €11.3 million compared to €10.2 million
in the first quarter of 2023, as the vaccine continued to benefit
from the significant recovery in the private travel markets.
CHIKUNGUNYA VACCINE
IXCHIQ®
IXCHIQ® is the world’s first and only licensed
chikungunya vaccine available to address this significant unmet
medical need. Following adoption of the U.S. Advisory Committee on
Immunization Practices (ACIP)’s recommendations7 by the U.S.
Centers for Disease Control and Prevention (CDC)8 at the beginning
of March 2024, Valneva has focused on launching its single-dose
chikungunya vaccine in the U.S. and recorded initial sales of €0.2
million in the first quarter.
IXCHIQ® is also under regulatory review in
Canada, Brazil and Europe, where it was granted accelerated
assessment by the European Medicine Agency’s Committee for
Medicinal Products for Human Use (CHMP). Decisions on these
submissions are expected in 2024.
A clinical study in adolescents, VLA1553-321, is
ongoing. Valneva reported initial safety data in August 20239 and
expects to report six-month data in the coming weeks. Funded by the
Coalition for Epidemic Preparedness Innovations (CEPI) and
conducted in Brazil in collaboration with Instituto Butantan, the
VLA1553-321 adolescent trial is intended to support the label
extension to this age group following initial approvals in adults.
The trial is also expected to support licensure of the vaccine in
Brazil, which would be the first potential approval for use in
endemic populations. Additionally, the Company initiated a Phase 2
pediatric trial, VLA1553-221, in children aged 1 to 11 years, in
January 202410. This is designed to support a Phase 3 pivotal
pediatric study and potentially extend the label to this age group
following initial regulatory approvals in adults and possibly in
adolescents.
THIRD-PARTY
DISTRIBUTION
Valneva distributes certain third-party vaccines
in countries where it operates its own marketing and sales
infrastructure. During the first quarter of 2024, third-party sales
decreased by 8.9% to €4.1 million compared to €4.5 million in
the first quarter of 2023 as a result of anticipated supply
constraints. Valneva expects that third-party sales will gradually
wind down to less than 5% of overall product sales by 2026/2027,
allowing the Company to improve gross margins.
Clinical Stage Vaccine
Candidates
LYME DISEASE VACCINE CANDIDATE –
VLA15 Phase 3 study ongoing
Valneva and Pfizer are developing VLA15, a Phase
3 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 the only
Lyme disease program in late-stage clinical development today and
has received Fast Track designation from the FDA.
Vaccinations across the two cohorts of the Phase
3 trial “Vaccine Against Lyme for Outdoor Recreationists” (VALOR)
are on track and Valneva and Pfizer expect all participants (9,437)
to complete primary vaccinations (three doses) in the coming
weeks.
Topline data from the VALOR trial are expected
by the end of 2025, with the aim for Pfizer to submit a Biologic
License Application (BLA) to the FDA and a Marketing Authorization
Application (MAA) to the EMA in 2026, subject to positive data.
Valneva’s cost contributions for the Lyme
disease Phase 3 study are expected to be completed in the second
quarter of 2024. All remaining payments to Pfizer are included in
current refund liability at December 31, 2023, and will not impact
the Profit & Loss statement in 2024.
ZIKA VACCINE CANDIDATE –
VLA1601Phase 1 ongoing with second-generation
vaccine candidate
VLA1601 is a second-generation adjuvanted
inactivated vaccine candidate against the mosquito-borne viral
disease caused by the Zika virus (ZIKV). In March 2024, Valneva
initiated a Phase 1 clinical trial to investigate the safety and
immunogenicity of VLA160111. The randomized, placebo-controlled,
Phase 1 trial, VLA1601-102, is planned to enroll approximately 150
participants aged 18 to 49 years in the United States. Participants
will receive a low, medium or high dose of VLA1601. In addition,
the low dose of VLA1601 will be evaluated with an additional
adjuvant. Topline data from the trial are expected in the first
half of 2025.
Zika disease outbreaks have been reported in
tropical Africa, Southeast Asia, the Pacific Islands, and, since
2015, in the Americas. Zika virus transmission persists in several
countries in the Americas and in other endemic regions. To date, a
total of 89 countries and territories have reported evidence of
mosquito transmitted Zika virus infection12; however, surveillance
remains limited globally. There are no preventive vaccines or
effective treatments available and, as such, Zika remains a public
health threat and is included in theFDA’s Tropical Disease Priority
Review Voucher Program13.
A vaccine against ZIKV would be a valuable
addition to Valneva’s portfolio of travel vaccines against
mosquito-borne diseases, which already includes IXCHIQ® and
IXIARO®.
First Quarter 2024 Financial
Review (Unaudited, consolidated under
IFRS)
Revenues
Valneva’s total revenues were €32.8 million in
the first quarter of 2024 compared to €33.5 million in the first
quarter of 2023.
Valneva’s sales reached €32.1 million in the
first quarter of 2024 and remained comparable to the first quarter
of 2023. Currency fluctuations had an immaterial impact on sales
compared to the comparator period.
IXIARO®/JESPECT® sales were €16.6 million in the
first quarter of 2024 compared to €17.4 million in the first
quarter of 2023. The 4% decrease in sales is primarily the result
of constrained supplies, which temporarily impacted sales during
the first quarter and are now resolved.
DUKORAL® sales were €11.3 million in the first
quarter of 2024 compared to €10.2 million in the first quarter
of 2023. This 10% increase results from the continued recovery in
the private travel markets primarily driven by Canada, and price
increases.
IXCHIQ® sales were €0.2 million in the first
quarter of 2024. The U.S. CDC adopted recommendations by the ACIP14
at the beginning of March 2024.
Third Party product sales were €4.1 million in
the first quarter of 2024 compared to €4.5 million in the first
quarter of 2023, a 9% decrease which was mainly driven by supply
constraints of Rabipur®/RabAvert® and Encepur® sold under the
distribution agreement with Bavarian Nordic.
Other revenues, including revenues from
collaborations, licensing and services amounted to
€0.6 million in the first quarter of 2024 compared to €1.4
million in the first quarter of 2023 with the reduction mainly
resulting from lower revenue recognition related to the R&D
collaboration activities for chikungunya with Instituto
Butantan.
Operating Result and adjusted
EBITDA
Costs of goods and services sold (COGS) were
€22.2 million in the first quarter of 2024. The gross margin on
commercial product sales amounted to 43.9% (excluding IXCHIQ®)
compared to 48.4% in the first quarter of 2023. COGS of
€8.0 million related to IXIARO® sales, yielding a product
gross margin of 52.0%, which was impacted by €1.7 million recorded
as write-offs for failed batches. COGS of €7.0 million related to
DUKORAL® sales, yielding a product gross margin of 37.9%. Of the
remaining COGS in the first quarter of 2024, €3.0 million related
to the third-party products distribution business,
€0.8 million to IXCHIQ®, €1.0 million to idle capacity costs
and €2.4 million to cost of services. In the first quarter of
2023, overall COGS were €20.5 million, of which €17.9 million
related to cost of goods and €2.6 million related to cost of
services.
Research and development expenses amounted to
€13.1 million in the first quarter of 2024, compared to €14.1
million in the first quarter of 2023. This decrease was mainly
driven by lower spend on Valneva’s COVID-19 vaccine, VLA2001 as
well as lower spend on IXCHIQ® following licensure in the fourth
quarter of 2023. At the same time, costs related to the ongoing
transfer of operations into the new Almeida manufacturing facility
resulted in higher R&D spend on commercial products. Marketing
and distribution expenses in the first quarter of 2024 amounted to
€11.3 million compared to €9.0 million in the first quarter of
2023. The increase is mainly related to €4.9 million of expenses
associated with launch activities for IXCHIQ® (first quarter of
2023: €3.4 million). In the first quarter of 2024, general and
administrative expenses increased to €11.7 million from
€10.0 million in the first quarter of 2023, mainly resulting
from higher costs related to the Company’s stock-based employee
compensation program, higher recruiting charges and higher costs
for digitalization & automation initiatives.
During the first quarter of 2024, a net gain of
€90.8 million from the sale of the PRV was recorded in the income
statement. The net proceeds of $103 million were reduced by
transaction costs as well as contractual payment obligations
related to the sale of the PRV.
Other income, net of other expenses, decreased
to €2.9 million in the first quarter of 2024 from €3.5 million
in the first quarter of 2023. The decrease was mainly driven by
lower R&D tax credits recorded in the first quarter of 2024
following the reduction in eligible R&D spend.
Valneva recorded an operating profit of €68.2
million in the first quarter of 2024 compared to an operating loss
of €16.6 million in the first quarter of 2023. The significant
improvement is largely related to the proceeds from the sales of
the PRV recorded in the income statement in the first quarter of
2024. Adjusted EBITDA (as defined below) profit in the first
quarter of 2024 was €73.0 million, compared to an EBITDA loss
of €12.3 million in the first quarter of 2023.
Net Result
In the first quarter of 2024, Valneva generated
a net profit of €58.9 million compared to a net loss of €18.1
million in the first quarter of 2023.
Finance expenses and currency effects in the
first quarter of 2024 resulted in a net finance expense of
€9.3 million, compared to a net finance expense of €1.7
million in the first quarter of 2023. The increase in finance
expenses, net was mainly due to foreign exchange losses of €2.5
million in the first quarter of 2024 compared to a profit of €3.2
million in the first quarter of 2023, primarily related to the
development of the USD / EUR exchange rate. In addition, interest
charges increased to €7.0 million in the first quarter of 2024
compared to €5.1 million in the first quarter of 2023 following the
increase of the Deerfield Management Company and OrbiMed (D&O)
loan facility during the second half of
2023. Cash
Flow and Liquidity
Net cash used in operating activities amounted
to €28.4 million in the first quarter of 2024 compared to
€24.3 million in the first quarter of 2023. Cash outflows in
the first quarter of 2024 were mainly a result of the net loss for
the period excluding proceeds from the sale of the PRV and by
increases in working capital.
Cash inflows from investing activities amounted
to €86.7 million in the first quarter of 2024 compared to cash
outflows of €3.6 million in the first quarter of 2023. Cash inflows
in the first quarter of 2024 were driven by €90.8 million net
proceeds from the sale of the PRV, partly offset by construction
activities in the Almeida manufacturing site in Scotland as well as
equipment purchases.
Net cash used in financing activities increased
to €7.5 million in the first quarter of 2024 from €3.8 million
in the first quarter of 2023. The increase in cash outflows in the
first quarter of 2024 were primarily due to increased interest
payments and transaction costs resulting from the upsized loan
facility provided by D&O.
Cash and cash equivalents were €176.6 million as
at March 31, 2024, compared to €126.1 million as at December 31,
2023.
Non-IFRS Financial Measures
Management uses and presents IFRS results as
well as the non-IFRS measure of Adjusted 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 to further understand Valneva’s
current performance, performance trends, and financial
condition.
Adjusted EBITDA is a common supplemental measure
of performance used by investors and financial analysts. Management
believes this measure provide additional analytical tools. Adjusted
EBITDA is defined as earnings (loss) for the period before income
tax, finance income/expense, foreign exchange gain/(loss),
amortization, depreciation, and impairment (excluding impairment
loss of disposal).
A reconciliation of Adjusted EBITDA to net loss
for the period, which is the most directly comparable IFRS measure,
is set forth below:
€ in million |
Three months ending March 31 |
(consolidated per IFRS) |
2024 |
2023 |
Profit/(Loss) for the period |
58.9 |
(18.1) |
Add: |
|
|
Income tax expense |
- |
(0.1) |
Total Finance income |
(0.3) |
(0.3) |
Total Finance expense |
7.0 |
5.1 |
Foreign exchange gain/(loss) – net |
2.5 |
(3.2) |
Amortization |
1.3 |
1.6 |
Depreciation |
3.5 |
2.6 |
Impairment |
- |
- |
Adjusted EBITDA |
73.0 |
(12.3) |
About Valneva SEWe are a
specialty vaccine company that develops, manufactures, and
commercializes prophylactic vaccines for infectious diseases
addressing unmet medical needs. We take a highly specialized and
targeted approach, applying our deep expertise across multiple
vaccine modalities, focused on providing either first-, best- or
only-in-class vaccine solutions.
We have a strong track record, having advanced
multiple vaccines from early R&D to approvals, and currently
market three proprietary travel vaccines, including the world’s
first and only chikungunya vaccine, as well as certain third-party
vaccines.
Revenues from our growing commercial business
help fuel the continued advancement of our vaccine pipeline. This
includes the only Lyme disease vaccine candidate in advanced
clinical development, which is partnered with Pfizer, as well as
vaccine candidates against the Zika virus and other global public
health threats.
About
IXCHIQ®In the U.S., IXCHIQ® is a
live-attenuated vaccine indicated for the prevention of disease
caused by chikungunya virus (CHIKV) in individuals 18 years of age
and older who are at increased risk of exposure to CHIKV. As for
all products approved under FDA’s accelerated approval pathway,
continued approval for this indication is contingent upon
verification and description of clinical benefit in confirmatory
studies.
Please click here for
full Prescribing Information for
IXCHIQ®.
Valneva Investor and Media ContactsLaetitia
Bachelot-FontaineVP, Global Communications and European Investor
RelationsM +33 (0)6 4516
7099investors@valneva.com |
Joshua Drumm, Ph.D.VP, Global Investor Relations M +001 917 815
4520joshua.drumm@valneva.com |
|
|
Forward-Looking StatementsThis
press release contains certain forward-looking statements relating
to the business of Valneva, including with respect to guidance for
certain financial results in fiscal year 2024 and mid-term outlook
on financial results, cash position, and other business
developments, including results of ongoing clinical trials, the
timing and possible occurrence of further or initial regulatory
approvals of its product candidates, the anticipated size of
markets for its approved products and sales of those products,
receipt of funding from external sources, supply of products sold
by Valneva, and relationships with current business partners. 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 results. 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 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. These risks and uncertainties include those developed
or identified in any public documents filed with the French
financial markets authority (Autorité des marchés financiers) and
the U.S. Securities and Exchange Commission made or to be made by
Valneva. In particular, the expectations of Valneva could be
affected by, among other things, uncertainties involved in the
development and manufacture of vaccines (including in relation to
organic or strategic expansion of Valneva’s clinical pipeline),
unexpected clinical trial results, unexpected regulatory actions or
delays, competition in general, currency fluctuations, the impact
of the global and European credit crisis and other global economic
or political events, the ability to obtain or maintain patent or
other proprietary intellectual property protection, the
cancellation of existing contracts, the impact of a pandemic, and
changes in the regulatory environment in which Valneva operates.
The occurrence of any of these risks and uncertainties could
substantially harm Valneva’s business, financial condition,
prospects and results of operations. 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 this press release as of
the date hereof 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 Announces Sale of Priority Review Voucher for $103
Million - Valneva2 Valneva Announces Extension of the Interest-Only
Period of Its Debt Facility with Deerfield and OrbiMed - Valneva3
ACIP Vaccine Recommendations and Schedules | CDC4 Valneva Initiates
Phase 1 Trial of Second-Generation Zika Vaccine Candidate -
Valneva5 Valneva Reports Full Year 2023 Results and Provides
Business Updates and Outlook - Valneva6 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.7 ACIP Vaccine Recommendations and Schedules | CDC8
ACIP Vaccine Recommendations and Schedules | CDC9 Valneva Reports
Positive Initial Phase 3 Safety Data in Adolescents for its
Single-Shot Chikungunya Vaccine Candidate - Valneva10 Valneva
Vaccinates First Participant in Pediatric Trial of Single-Shot
Chikungunya Vaccine - Valneva11 Valneva Initiates Phase 1 Trial of
Second-Generation Zika Vaccine Candidate - Valneva12 Zika virus
disease (who.int)13 Tropical Disease Priority Review Voucher
Program | FDA14 ACIP Vaccine Recommendations and Schedules |
CDC
- 2024_05_07_VLA_Q1_Results_PR_EN_Final
Valneva (EU:VLA)
Historical Stock Chart
From Aug 2024 to Sep 2024
Valneva (EU:VLA)
Historical Stock Chart
From Sep 2023 to Sep 2024