Valneva SE
For the period ended Dec 31, 2024. Filed Mar 24, 2025.
View on SEC.govAbout this filing
The yearly report of a company based outside the US. It covers much of what a 10-K does, and may follow accounting rules other than US ones.
FY2024 · Filed Mar 24, 2025
Contents
Special Note Regarding Forward-Looking Statements
This Annual Report contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that are based on our management’s beliefs and assumptions and on information currently available to our management. All statements other than present and historical facts and conditions contained in this Annual Report, including statements regarding our future results of operations and financial position, business strategy, plans and our objectives for future operations, are forward-looking statements. When used in this Annual Report, the words “anticipate,” “believe,” “can,” “could,” “estimate,” “expect,” “intend,” “is designed to,” “may,” “might,” “plan,” “potential,” “predict,” “objective,” “should,” or the negative of these and similar expressions identify forward-looking statements. Forward-looking statements include, but are not limited to, statements about:
timing and expected outcomes of clinical trials and pre-clinical studies, particularly with respect to the Phase 3 clinical trial of our Lyme disease vaccine candidate VLA15 as well as the ongoing Phase 2 and 3 clinical trials and the planned Phase 4 clinical trials of our approved chikungunya vaccine IXCHIQ and the ongoing Phase 2 trials of the shigellosis vaccine candidate S4V2;
the likelihood, timing, and expected outcomes of regulatory filings and approvals, including, in the short-term, potential approval of the chikungunya vaccine candidate VLA1553 in Brazil and other markets and the potential filings and approvals of VLA15 and in the mid-term, potential filings and approvals of S4V2;
our ability to successfully market IXCHIQ in the United States, Europe, Canada, the UK, and other markets where it may be approved;
our expectations with respect to Pfizer’s regulatory and commercialization plans for our Lyme disease candidate;
our expectations and forecasts for sales of our approved products, particularly IXCHIQ, and estimates of market opportunity for our approved products and vaccine candidates;
our ability to expand, develop, and advance our pipeline of product candidates;
our ability to supply a sufficient quantity of our products and product candidates and to safely and effectively scale up our manufacturing capabilities, including at our Almeida manufacturing facility in Scotland;
the effectiveness and profitability of our collaborations and partnerships, our ability to maintain our current collaborations and partnerships and our ability to enter into new collaborations and partnerships;
the potential safety and effectiveness of our vaccine candidates in development;
the effects of any pandemics on our sales and operations, including our expectations and assumptions regarding the resumption of travel and the future demand for travel vaccines;
our expectations related to future milestone and royalty payments and other revenue under our collaborations and partnerships;
our ability to meet our obligations under our various collaboration, partnership, and distribution arrangements;
the effects of increased competition as well as innovations by new and existing competitors in our industry;
our ability to obtain, maintain, protect and enforce our intellectual property rights and proprietary technologies and to operate our business without infringing the intellectual property rights and proprietary technology of third parties;
regulatory and political developments in the United States, Europe, and other countries, including in particular regulatory developments relating to environmental, social, and governance issues and in response to anti-vaccine sentiments in the United States and elsewhere;
statements regarding future revenue, cash situation, hiring plans, expenses, capital expenditures, capital requirements, stock performance, and financing opportunities; and
other risks and uncertainties, including those listed in the section of this Annual Report titled “Item 3.D—Risk Factors.”
You should refer to the section of this Annual Report titled “Item 3.D—Risk Factors” for a discussion of important factors that may cause our actual results to differ materially from those expressed or implied by our forward-looking statements. As a result of these factors, we cannot assure you that the forward-looking statements in this Annual Report will prove to be accurate. Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame or at all. We undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. The Private Securities Litigation Reform Act of 1995 and Section 27A of the Securities Act do not protect any forward-looking statements that we make in connection with this Annual Report.
You should read this Annual Report and the documents that we reference in this Annual Report and have filed as exhibits to this Annual Report completely and with the understanding that our actual future results, levels of activity, performance and events and circumstances may be materially different from what we expect. We qualify all of our forward-looking statements by these cautionary statements.
Unless otherwise indicated, information contained in this Annual Report concerning our industry and the markets in which we operate, including our general expectations and market position, market opportunity and market size estimates, is based on information from independent industry analysts, third-party sources and management estimates. Management estimates are derived from publicly available information released by independent industry analysts and third-party sources, as well as data from our internal research, and are based on assumptions made by us based on such data and our knowledge of such industry and market, which we believe to be reasonable. In addition, while we believe the market opportunity information included in this Annual Report is generally reliable and is based on reasonable assumptions, such data involve risks and uncertainties and are subject to change based on various factors, including those discussed under the section of this Annual Report titled “Item 3.D—Risk Factors.”
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.