France - Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) a specialty vaccine company, today reported its consolidated financial results for the year ending December 31, 2023 and provided several key corporate updates.
Peter Buhler, Valneva's Chief Financial Officer, commented, 'In 2023, Valneva successfully executed on key strategic objectives despite a difficult economic environment. Our chikungunya vaccine IXCHIQ became the world's first licensed chikungunya vaccine available to address this significant unmet medical need and we also managed to surpass our pre-pandemic product sales. Our objective for 2024 is to continue capitalizing on the travel industry recovery to generate further commercial growth and successfully launch our chikungunya vaccine IXCHIQ. With the recent successful sale of our PRV, and extension of our loan repayment, we have entered 2024 in a solid financial position to support our near- and mid-term commercial and R&D objectives.'
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
IXIARO, or JESPECT in Australia and New Zealand, is an inactivated Vero cell culture-derived Japanese encephalitis and is the only Japanese encephalitis vaccine currently approved for use in the United States, Canada and Europe. IXIARO is indicated for active immunization against Japanese encephalitis, the most prevalent cause of viral encephalitis in Asia, for adults, adolescents, children and infants aged two months and older, and is a required vaccine for U.S. military personnel who are deployed to areas of risk for Japanese encephalitis. The virus is spread by mosquitos and is the most important cause of viral encephalitis in Asia and the Western Pacific.
In 2023, IXIARO/JESPECT sales increased 78% to EUR73.5 million compared to EUR41.3 million in 2022, primarily benefiting from the continued travel market recovery after the COVID-19 pandemic, and price increases. At the end of September 2023, Valneva also signed a new one-year contract with the U.S. Department of Defense (DoD) worth a minimum of $32 million for the supply of IXIARO.
CHOLERA / ETEC[7]-DIARRHEA VACCINE DUKORAL
DUKORAL is an oral vaccine for the prevention of diarrhea caused by Vibrio cholerae and/or heat-labile toxin producing ETEC[8], 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 ETEC.
In 2023, DUKORAL sales increased 72% to EUR29.8 million compared to EUR17.3 million in 2022, of which Canada represented EUR17.5 million of global sales due to the strong overlap between Canadian travelers to regions of high ETEC prevalence and the vaccine's approved indication. Similar to IXIARO, DUKORAL benefitted from the significant recovery in the private travel markets.
CHIKUNGUNYA VACCINE IXCHIQ
IXCHIQ is a single-dose, live-attenuated vaccine against the chikungunya virus (CHIKV), which in November 2023 was approved in the U.S. by the Food and Drug Administration (FDA) for the prevention of disease caused by CHIKV in individuals 18 years of age and older who are at increased risk of exposure to the mosquito-borne CHIKV. With this approval, IXCHIQ became the world's first and only licensed chikungunya vaccine available to address this significant unmet medical need.
At the end of February 2024, the U.S. Advisory Committee on Immunization Practices (ACIP), which develops recommendations on how to use vaccines in the U.S., recommended IXCHIQ for persons aged 18 years and above traveling to a country or territory where a chikungunya outbreak is occurring. Additionally, IXCHIQ may be considered for persons traveling to a country or territory without an outbreak but with evidence of CHIKV transmission within the last five years, who are aged 65 years and above, and likely to have at least moderate exposure to mosquitos (at least two weeks, cumulatively) or who are traveling for a longer duration (six months or more, cumulatively). ACIP also recommended chikungunya vaccination for laboratory workers with potential for exposure to CHIKV. The ACIP recommendations were recently adopted by the Centers for Disease Control and Prevention[9].
Valneva's commercial team is currently launching the vaccine in the U.S. The single-shot vaccine 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 for these submissions are expected in 2024.
IXCHIQ's final pivotal Phase 3 data were published in The Lancet, the world's leading peer-reviewed medical journal, in June 2023[10]. The article provides a detailed analysis of the Phase 3 results showing that VLA1553 demonstrated a very high seroresponse rate of 98.9% in participants 28 days after receiving the single administration compared to the 70% threshold (for non-acceptance) agreed with the FDA. Valneva is working on the preparation of two Phase 4 post-marketing effectiveness studies, required as part of the FDA's approval under the accelerated pathway. The Company expects to launch these studies in 2025.
Earlier clinical data, published in the Lancet Infectious Diseases, showed a rapid onset of immune response with a single dose of VLA1553 between 7- and 14-days post-vaccination[11]. This was later confirmed in a further analysis of the Phase 1 data[12], which showed that 100% of vaccinated individuals reached the immune threshold[13] established with the FDA at day 14.
Additionally, VLA1553 was able to demonstrate a robust immune response which was sustained for 12 and 24 months by 99% and 97% of participants, respectively, and was equally durable in younger and older adults[14][15]. This dedicated antibody persistence trial (VLA1553-303) will continue to evaluate persistence for a period of at least five years.
A clinical study in adolescents, VLA1553-321, is ongoing in Brazil, for which Valneva reported initial safety data in August 2023[16]. Funded by the Coalition for Epidemic Preparedness Innovations (CEPI) and conducted 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 in children aged 1 to 11 years, VLA1553-221, in January 2024[17] 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.
Total revenues of EUR153.7 million, including product sales of EUR144.6 million
Product sales surpassed pre-pandemic (2019) sales by 12% and 2022 sales by 26%
Excluding COVID-19 vaccine sales, product sales grew by 63% compared to 2022
Cash position of EUR126.1 million at year-end 2023 enhanced by EUR95 million from sale of Priority Review Voucher (PRV)[1]
Extended the interest-only period of existing debt financing agreement to January 2026 significantly extending cash runway[2]
Operational business considered sufficiently funded (excluding debt repayment) until commercial revenues from Lyme program enable sustained profitability
Excellent progress across R&D pipeline
Approval of single-shot chikungunya vaccine IXCHIQ in the United States (U.S.)
The world's first and only vaccine to address this significant unmet medical need
U.S. CDC recently adopted ACIP recommendations[3]
Regulatory reviews ongoing in Europe, Canada and Brazil
Completion of recruitment for Lyme disease Phase 3 study conducted in collaboration with Pfizer
All execution milestones on track
Advancing second-generation ZIKA vaccine candidate into Phase 1 clinical trial
Addressing a re-emerging medical need
Updated FY 2024 guidance
Valneva raises its 2024 product sales[4] guidance to between EUR160 million and EUR180 million due to an improved outlook regarding the IXIARO supply constraints that were anticipated in February 2024.
As such, 2024 total revenues are now expected to reach between EUR170 million and EUR190 million compared to EUR153.7 million in 2023, driven by continued sales growth of the Company's proprietary travel vaccines and the launch-year sales of IXCHIQ.
Sales are expected to grow this year despite an estimated 20-30% reduction in third-party sales as a result of anticipated supply constraints.
In 2024, the Company anticipates lower R&D expenses than previously communicated, narrowing guidance to EUR60 million to EUR75 million, based on additional visibility for its chikungunya- and Zika- related expenses. Additionally, Valneva expects non-dilutive contributions from institutions for R&D costs in connection with its ongoing chikungunya activities and the product tech transfers to Valneva's brand-new state-of the art facility ('Almeida') in Scotland.
Other income is now expected between EUR100 million and EUR110 million in 2024, reflecting EUR95 million in proceeds from the PRV sale in early 2024.
Valneva anticipates a significantly lower cash burn this year than in 2023 and expects its commercial business to be cash-flow positive and contribute significantly to funding the Company's R&D from 2025.
Valneva's cost contributions for the Lyme disease Phase 3 study are expected to be completed in the first half of 2024. All remaining payments to Pfizer are reflected in current refund liability at December 31, 2023, and will not impact the Profit & Loss statement in 2024.
The Company has re-negotiated the terms of its loan agreement with Deerfield and OrbiMed[5] and will now start reimbursing the first $100 million tranche in January 2026 instead of July 2024. The loan interest rate remains unchanged and this portion of the loan will still mature in the first quarter of 2027.
Contact:
Laetitia Bachelot-Fontaine
Tel: +33 (0)6 4516 7099
Email: investors@valneva.com
Joshua Drumm
Tel: +001 917 815 4520
Email: 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 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 (Autorite des marches 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.
VALNEVA 
