Valneva Reports Preliminary Unaudited 2024 Revenue and Cash and Provides 2025 Outlook

   -- Met 2024 growth targets for sales revenue (+13% vs 2023) and total 
      revenues (+10% vs 2023) 
 
   -- Strong year-end cash position of EUR168.3 million 
 
   -- Substantial clinical and regulatory progress in 2024, leading to multiple 
      anticipated data readouts, product approvals and label extensions in 2025 
 
   -- 2025 outlook reflects solid revenue growth and positive commercial cash 
      flows to support strategic R&D investments with lower operating cash burn 

Saint-Herblain (France), February 18, 2025 -- Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) a specialty vaccine company, today reported its preliminary unaudited full-year 2024 revenue and cash results(1) and provided a 2025 outlook. The Company will publish its 2024 audited consolidated financial statements and host an analyst call on March 20, 2025.

2024 Performance

   -- Total revenues were EUR169.6 million for the year ended December 31, 2024 
      compared to EUR153.7 million in the year ended December 31, 2023, an 
      increase of 10% 
 
   -- Product sales revenue reached EUR163.3 million for the year ended 
      December 31, 2024 compared to EUR144.6 million in the same period of 
      2023, an increase of 13% 
 
   -- Cash and cash equivalents were EUR168.3 million as at December 31, 2024, 
      compared to EUR126.1 million at December 31, 2023. Year-end cash of 
      EUR168.3 million, significantly augmented by the sale of the Priority 
      Review Voucher2 and successful Private Placement3 

2025 Financial Outlook

   -- Sales revenues expected to grow to EUR170-180 million, driving positive 
      cash-flows for the overall commercial business 
 
   -- Total revenues expected to reach EUR180-190 million 
 
   -- Total R&D investments expected between EUR90 - EUR100 million, which will 
      be partially offset by grant funding and anticipated R&D tax credits 
 
   -- Continued stringent focus on cash management supporting sufficient cash 
      runway to reach key inflection points; substantially lower operating cash 
      burn expected in 2025, less than 30 million compared to over EUR60.0 
      million in 2024 

Peter Bühler, Valneva's Chief Financial Officer, commented, "Once again, we successfully delivered double digit sales growth, despite lower than anticipated launch-year IXCHIQ$(R)$ sales in the U.S. We made significant clinical and regulatory progress last year, setting the stage for several important catalysts to drive value in 2025, most notably with the first Phase 3 study results for our lead Lyme disease vaccine candidate, VLA15. In 2025, we will continue to focus on commercial execution while investing strategically in advancing our science-driven pipeline to generate substantial future value. With over EUR168 million of cash at the end of 2024, we are entering 2025 in a good financial position to support these objectives."

Regulatory, R&D and Strategic Highlights

   -- Continued to progress Lyme disease program according to plan, including 
      completion of primary vaccination in ongoing Phase 3 study, reporting of 
      further positive Phase 2 booster results, and publication of Phase 2 data 
      in the Lancet 
 
   -- Secured three additional regulatory approvals for world's first 
      chikungunya vaccine, IXCHIQ(R) (Canada, Europe, UK); filed adolescent 
      label extension submissions; awarded new $41.3 million grant from the 
      Coalition for Epidemic Preparedness $(CEPI)$4 
 
   -- Augmented clinical pipeline with a leading tetravalent Shigella vaccine 
      candidate5 and initiated Phase 2b trial; Granted Fast Track Designation 
      by the United States Food and Drug Administration (FDA) 
 
   -- Advanced novel Zika vaccine candidate into Phase 1 clinical development 
 
   -- Finalized new $32.8 million IXIARO(R) supply contract with the U.S. 
      Department of Defense in January 20256 

Key Upcoming Catalysts:

   -- Lyme disease Phase 3 first data readout by the end of 2025 
 
   -- Further chikungunya vaccine approvals, including the first endemic 
      country (Brazil) and adolescent label extensions for IXCHIQ(R) in major 
      travel markets 
 
   -- Initiation of Phase 3 pediatric trial of IXCHIQ(R) to support further 
      potential label expansion 
 
   -- Phase 2b efficacy data from Human Challenge Study $(CHIM)$ of tetravalent 
      Shigella vaccine candidate in mid-2025 and launch of pediatric study 
 
   -- Phase 1 results for Zika vaccine candidate in the first half of 2025 

About Valneva SE

We 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 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, the world's most clinically advanced Shigella vaccine candidate, as well as vaccine candidates against the Zika virus and other global public health threats. More information is available at www.valneva.com.

 
Valneva Investor and Media Contacts 
Laetitia Bachelot-Fontaine VP, Global        Joshua Drumm, Ph.D. 
Communications and European Investor         VP, Global Investor Relations 
Relations M +33 (0)6 4516 7099               M +001 917 815 4520 
investors@valneva.com                        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 business partnerships and the progress, timing, results and completion of technology transfer and regulatory approvals in additional markets. 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 sustained 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 and delays 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. Success in preclinical studies or earlier clinical trials may not be indicative of results in future clinical trials. 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 this information as of the date 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 The financial figures presented in this release are preliminary and unaudited. The final audited financial results, which remain subject to approval by the Board of Directors, are expected to be published on March 20.

2 Valneva Announces Sale of Priority Review Voucher for $103 Million - Valneva

3 Valneva Announces the Success of its Private Placement Raising approximately EUR60 Million - Valneva

4 CEPI Expands Partnership with Valneva with a $41.3 Million Grant to Support Broader Access to the World's First Chikungunya Vaccine - Valneva

5 Valneva and LimmaTech Enter into a Strategic Partnership to Accelerate the Development of the World's Most Clinically Advanced Tetravalent Shigella Vaccine Candidate - Valneva

6 Valneva Announces New IXIARO(R) Supply Contract with the U.S. Government Worth a Minimum of $32.8 Million - Valneva

Attachment

   -- 2025_02_18_FY2024_RevCash_PR_EN_Final 

(END) Dow Jones Newswires

February 18, 2025 01:00 ET (06:00 GMT)