SEC Form 6-K filed by Valneva SE
$VALN
Biotechnology: Biological Products (No Diagnostic Substances)
Health Care
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934
Date of Report: May 7, 2025
Commission File Number: 001-40377
(Translation of registrant's name into English)
6 rue Alain Bombard
44800 Saint-Herblain, France
(Address of principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F ☒ Form 40-F ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):
Note: Regulation S-T Rule 101(b)(1) only permits the submission in paper of a Form 6-K if submitted solely to provide an attached annual report to security holders.
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):
Note: Regulation S-T Rule 101(b)(7) only permits the submission in paper of a Form 6-K if submitted to furnish a report or other document that the registrant foreign private issuer must furnish and make public under the laws of the jurisdiction in which the registrant is incorporated, domiciled or legally organized (the registrant's "home country"), or under the rules of the home country exchange on which the registrant's securities are traded, as long as the report or other document is not a press release, is not required to be and has not been distributed to the registrant's security holders, and, if discussing a material event, has already been the subject of a Form 6-K submission or other Commission filing on EDGAR.
On May 7, 2025, the Registrant announced its results for the three months ended March 31, 2025 and issued a press release and unaudited interim condensed consolidated financial statements, copies of which are attached hereto as Exhibits 99.1, and 99.3, respectively, and incorporated herein by reference. The Registrant also issued an additional press release, a copy of which is attached hereto as Exhibit 99.2 and incorporated herein by reference. The information contained in this Form 6-K, including Exhibits 99.1 and 99.2, is hereby incorporated by reference into the registrant's Registration Statement on Form F-3 (File No. 333-268071).
| Exhibits | |||||
| Exhibit 99.1 | |||||
Exhibit 99.2 | |||||
Exhibit 99.3 | Unaudited Interim Condensed Consolidated Financial Statements as at March 31, 2025 and for the three months ended March 31, 2025 | ||||
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
Valneva SE (Registrant) | ||||||||||||||||||||
Date: May 7, 2025 | /s/ Thomas Lingelbach Thomas Lingelbach Chief Executive Officer and President | |||||||||||||||||||
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Unaudited interim condensed consolidated financial statements as at March 31, 2025 | ||||||||
| Valneva SE | ||||||||
| I. | Unaudited Interim Consolidated Statement of Profit or Loss and Comprehensive Income | ||||
Unaudited Interim Condensed Consolidated Statement of Profit or Loss
| Three months ended March 31, | ||||||||
| in € thousand | 2025 | 2024 | ||||||
| Product sales | ||||||||
| Other revenues | ||||||||
| REVENUES | ||||||||
| Cost of goods and services | ( | ( | ||||||
| Research and development expenses | ( | ( | ||||||
| Marketing and distribution expenses | ( | ( | ||||||
| General and administrative expenses | ( | ( | ||||||
| Gain from sale of Priority Review Voucher, net | ||||||||
| Other income and expenses, net | ||||||||
| OPERATING PROFIT/(LOSS) | ( | |||||||
| Finance income | ||||||||
| Finance expenses | ( | ( | ||||||
| Foreign exchange gain/(loss), net | ( | |||||||
| PROFIT/(LOSS) BEFORE INCOME TAX | ( | |||||||
| Income tax benefit/(expense) | ( | ( | ||||||
| PROFIT/(LOSS) FOR THE PERIOD | ( | |||||||
| EARNINGS/(LOSSES) PER SHARE | ||||||||
for profit/(loss) for the period attributable to the equity holders of the Company (expressed in € per share) | ||||||||
| Basic | ( | |||||||
| Diluted | ( | |||||||
Unaudited Interim Condensed Consolidated Statement of Comprehensive Income
| Three months ended March 31, | ||||||||
| in € thousand | 2025 | 2024 | ||||||
| PROFIT/(LOSS) FOR THE PERIOD | ( | |||||||
| OTHER COMPREHENSIVE INCOME/(LOSS) | ||||||||
| Items that may be reclassified to profit or loss | ||||||||
| Currency translation differences | ( | |||||||
| Other comprehensive income/(loss) for the period, net of tax | ( | |||||||
| TOTAL COMPREHENSIVE INCOME/(LOSS) FOR THE PERIOD | ( | |||||||
2 |  | |||||||||||||
Unaudited interim condensed consolidated financial statements as at March 31, 2025 | ||||||||
| Valneva SE | ||||||||
| II. | Unaudited Interim Condensed Consolidated Statement of Financial Position | ||||
| in € thousand | March 31, 2025 | December 31, 2024 | ||||||
| ASSETS | ||||||||
| Non-current assets | ||||||||
| Intangible assets | ||||||||
| Right of use assets | ||||||||
| Property, plant and equipment | ||||||||
| Deferred tax assets | ||||||||
| Other non-current assets | ||||||||
| Current assets | ||||||||
| Inventories | ||||||||
| Trade receivables | ||||||||
| Other current assets | ||||||||
| Cash and cash equivalents | ||||||||
| TOTAL ASSETS | ||||||||
| EQUITY | ||||||||
| Share capital | ||||||||
| Share premium | ||||||||
| Other reserves | ||||||||
| Retained earnings/(Accumulated deficit) | ( | ( | ||||||
| Profit/(Loss) for the period | ( | ( | ||||||
| TOTAL EQUITY | ||||||||
| LIABILITIES | ||||||||
| Non-current liabilities | ||||||||
| Borrowings | ||||||||
| Lease liabilities | ||||||||
| Refund liabilities | ||||||||
| Provisions | ||||||||
| Deferred tax liabilities | ||||||||
| Other non-current liabilities | ||||||||
| Current liabilities | ||||||||
| Borrowings | ||||||||
| Trade payables and accruals | ||||||||
| Income tax liability | ||||||||
| Tax and Employee-related liabilities | ||||||||
| Lease liabilities | ||||||||
| Contract liabilities | ||||||||
| Refund liabilities | ||||||||
| Provisions | ||||||||
| Other current liabilities | ||||||||
| TOTAL LIABILITIES | ||||||||
| TOTAL EQUITY AND LIABILITIES | ||||||||
| 3 | |||||||||||||
Unaudited interim condensed consolidated financial statements as at March 31, 2025 | ||||||||
| Valneva SE | ||||||||
| III. | Unaudited Interim Condensed Consolidated Statement of Cash Flows | ||||
| Three months ended March 31, | ||||||||
| in € thousand | 2025 | 2024 | ||||||
| CASH FLOWS FROM OPERATING ACTIVITIES | ||||||||
| Profit/(Loss) for the period | ( | |||||||
| Gain from sale of Priority Review Voucher, net | ( | |||||||
| Adjustments for non-cash transactions | ||||||||
| Changes in non-current operating assets and liabilities | ( | |||||||
| Changes in working capital | ( | ( | ||||||
| Cash used in operations | ( | ( | ||||||
| Income tax paid | ( | ( | ||||||
| NET CASH GENERATED FROM/(USED IN) OPERATING ACTIVITIES | ( | ( | ||||||
| CASH FLOWS FROM INVESTING ACTIVITIES | ||||||||
| Purchases of property, plant and equipment | ( | ( | ||||||
| Proceeds from sale of property, plant and equipment | ||||||||
| Purchases of intangible assets | ( | ( | ||||||
| Proceeds from sale of Priority Review Voucher | ||||||||
| Interest received | ||||||||
| NET CASH GENERATED FROM/(USED IN) INVESTING ACTIVITIES | ( | |||||||
| CASH FLOWS FROM FINANCING ACTIVITIES | ||||||||
| Proceeds from borrowings, net of transaction costs | ( | |||||||
| Payment of lease liabilities | ( | ( | ||||||
| Interest paid | ( | ( | ||||||
| NET CASH GENERATED FROM FROM/(USED IN) FINANCING ACTIVITIES | ( | ( | ||||||
| NET CHANGE IN CASH AND CASH EQUIVALENTS | ( | |||||||
| Cash and cash equivalents at beginning of the year | ||||||||
| Exchange gains/(losses) on cash | ( | ( | ||||||
| CASH AND CASH EQUIVALENTS AT END OF THE PERIOD | ||||||||
4 | | |||||||||||||
Unaudited interim condensed consolidated financial statements as at March 31, 2025 | ||||||||
| Valneva SE | ||||||||
| IV. | Unaudited Interim Condensed Consolidated Statement of Changes in Equity | ||||
| in € thousand | Share capital | Share premium | Other reserves | Retained earnings/ (Accumulated deficit) | Profit/(loss) for the period | Total equity | ||||||||||||||
| BALANCE AS AT JANUARY 1, 2025 | ( | ( | ||||||||||||||||||
| Total comprehensive income/(loss) | — | — | — | ( | ( | |||||||||||||||
| Income appropriation | — | — | — | ( | ||||||||||||||||
| Share-based compensation expense: | ||||||||||||||||||||
| Value of services | — | — | — | — | ||||||||||||||||
| BALANCE AS AT MARCH 31, 2025 | ( | ( | ||||||||||||||||||
| in € thousand | Share capital | Share premium | Other reserves | Retained earnings/ (Accumulated deficit) | Profit/(loss) for the period | Total equity | ||||||||||||||
| BALANCE AS AT JANUARY 1, 2024 | ( | ( | ||||||||||||||||||
| Total comprehensive income/(loss) | — | — | ( | — | ||||||||||||||||
| Income appropriation | — | — | — | ( | ||||||||||||||||
| Share-based compensation expense: | ||||||||||||||||||||
| Value of services | — | — | — | — | ||||||||||||||||
| Exercises | ( | — | — | — | ||||||||||||||||
| BALANCE AS AT MARCH 31, 2024 | ( | |||||||||||||||||||
| 5 | |||||||||||||