Cover
Cover | 6 Months Ended |
Jun. 30, 2024 | |
Cover [Abstract] | |
Document Type | 6-K |
Entity Registrant Name | Valneva SE |
Entity Central Index Key | 0001836564 |
Amendment Flag | false |
Document Fiscal Year Focus | 2024 |
Document Fiscal Period Focus | Q2 |
Current Fiscal Year End Date | --12-31 |
Document Period End Date | Jun. 30, 2024 |
Unaudited Interim Condensed Con
Unaudited Interim Condensed Consolidated Statement of Profit or Loss - EUR (€) € in Thousands | 6 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | |
Profit or loss [abstract] | ||
Product sales | € 68,279 | € 69,665 |
Other revenues | 2,534 | 4,078 |
REVENUES | 70,813 | 73,743 |
Cost of goods and services | (45,628) | (53,838) |
Research and development expenses | (29,683) | (25,978) |
Marketing and distribution expenses | (23,181) | (20,009) |
General and administrative expenses | (22,847) | (22,899) |
Gain from sale of Priority Review Voucher, net | 90,833 | 0 |
Other income and expenses, net | 6,357 | 14,015 |
OPERATING PROFIT/(LOSS) | 46,663 | (34,966) |
Finance income | 787 | 504 |
Finance expenses | (11,981) | (8,879) |
Foreign exchange gain/(loss), net | (1,652) | 4,517 |
PROFIT/(LOSS) BEFORE INCOME TAX | 33,818 | (38,824) |
Income tax benefit/(expense) | 158 | 3,778 |
PROFIT/(LOSS) FOR THE PERIOD | € 33,976 | € (35,046) |
Earnings/(losses) per share for profit/(loss) for the period attributable to the equity holders of the Company (expressed in € per share) | ||
Basic earnings (losses) per share for profit/(loss) for the period attributable to the equity holders of the Company (in euro per share) | € 0.25 | € (0.25) |
Diluted earnings (losses) per share for profit/(loss) for the period attributable to the equity holders of the Company (in euro per share) | € 0.24 | € (0.25) |
Unaudited Interim Condensed C_2
Unaudited Interim Condensed Consolidated Statement of Comprehensive Income - EUR (€) € in Thousands | 6 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | |
Statement of comprehensive income [abstract] | ||
PROFIT/(LOSS) FOR THE PERIOD | € 33,976 | € (35,046) |
Items that may be reclassified to profit or loss | ||
Currency translation differences | (369) | 2,735 |
Items that will not be reclassified to profit or loss | ||
Defined benefit plan actuarial gains/(losses) | (10) | (8) |
Other comprehensive income/(loss) for the period, net of tax | (379) | 2,727 |
TOTAL COMPREHENSIVE INCOME/(LOSS) FOR THE PERIOD | € 33,596 | € (32,318) |
Unaudited Interim Condensed C_3
Unaudited Interim Condensed Consolidated Statement of Financial Position - EUR (€) € in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
ASSETS | ||
Non-current assets | € 197,417 | € 197,238 |
Intangible assets | 24,190 | 25,567 |
Right of use assets | 19,068 | 20,392 |
Property, plant and equipment | 137,447 | 136,198 |
Deferred tax assets | 7,663 | 6,592 |
Other non-current assets | 9,049 | 8,490 |
Current assets | 269,152 | 262,824 |
Inventories | 48,867 | 44,466 |
Trade receivables | 30,519 | 41,645 |
Other current assets | 58,354 | 50,633 |
Cash and cash equivalents | 131,413 | 126,080 |
TOTAL ASSETS | 466,569 | 460,062 |
EQUITY | ||
Share capital | 20,892 | 20,837 |
Share premium | 593,948 | 594,003 |
Other reserves | 69,144 | 65,088 |
Retained earnings/(Accumulated deficit) | (551,682) | (450,253) |
Profit/(Loss) for the period | 33,976 | (101,429) |
TOTAL EQUITY | 166,278 | 128,247 |
LIABILITIES | ||
Non-current liabilities | 197,803 | 172,952 |
Borrowings | 160,549 | 132,768 |
Lease liabilities | 26,528 | 29,090 |
Refund liabilities | 6,396 | 6,303 |
Provisions | 562 | 1,074 |
Deferred tax liabilities | 3,744 | 3,638 |
Other liabilities | 23 | 79 |
Current liabilities | 102,488 | 158,863 |
Borrowings | 19,867 | 44,079 |
Trade payables and accruals | 32,650 | 44,303 |
Income tax liability | 151 | 632 |
Tax and Employee-related liabilities | 17,334 | 16,209 |
Lease liabilities | 2,691 | 2,879 |
Contract liabilities | 5,299 | 5,697 |
Refund liabilities | 17,165 | 33,637 |
Provisions | 6,962 | 10,835 |
Other liabilities | 370 | 592 |
TOTAL LIABILITIES | 300,291 | 331,815 |
TOTAL EQUITY AND LIABILITIES | € 466,569 | € 460,062 |
Unaudited Interim Condensed C_4
Unaudited Interim Condensed Consolidated Statement of Cash Flows € in Thousands, $ in Millions | 6 Months Ended | |
Jun. 30, 2024 EUR (€) | Jun. 30, 2023 EUR (€) | |
CASH FLOWS FROM OPERATING ACTIVITIES | ||
Profit/(Loss) for the period | € 33,976 | € (35,046) |
Gain from sale of Priority Review Voucher, net | (90,833) | 0 |
Adjustments for non-cash transactions | 23,973 | 12,764 |
Changes in non-current operating assets and liabilities | (1,117) | 279 |
Changes in working capital | (31,153) | (42,787) |
Cash generated/(used) in operations | (65,154) | (64,789) |
Income tax paid | (1,106) | (643) |
NET CASH GENERATED FROM/(USED IN) OPERATING ACTIVITIES | (66,261) | (65,432) |
CASH FLOWS FROM INVESTING ACTIVITIES | ||
Purchases of property, plant and equipment | (4,104) | (7,164) |
Proceeds from sale of property, plant and equipment | 172 | 42 |
Purchases of intangible assets | (79) | (12) |
Proceeds from sale of Priority Review Voucher | 90,833 | 0 |
Interest received | 787 | 504 |
NET CASH GENERATED FROM/(USED IN) INVESTING ACTIVITIES | 87,608 | (6,631) |
CASH FLOWS FROM FINANCING ACTIVITIES | ||
Proceeds/(payments) from issuance of common stock, net of costs of equity transactions | 0 | (285) |
Proceeds from borrowings, net of transaction costs | (944) | 0 |
Repayment of borrowings | (2,782) | (2,097) |
Payment of lease liabilities | (2,136) | (1,740) |
Interest paid | (10,727) | (5,353) |
NET CASH GENERATED FROM/(USED IN) FINANCING ACTIVITIES | (16,589) | (9,476) |
NET CHANGE IN CASH AND CASH EQUIVALENTS | 4,759 | (81,539) |
Cash and cash equivalents at beginning of the year | 126,080 | 286,532 |
Exchange gains/(losses) on cash | 575 | (582) |
CASH AND CASH EQUIVALENTS AT END OF THE PERIOD | € 131,413 | € 204,411 |
Unaudited Interim Condensed C_5
Unaudited Interim Condensed Consolidated Statement of Changes in Equity - EUR (€) € in Thousands | Total | Share capital | Share premium | Other reserves | Retained earnings/ (Accumulated deficit) | Profit/(loss) for the period |
Equity, beginning balance at Dec. 31, 2022 | € 219,797 | € 20,755 | € 594,043 | € 55,252 | € (306,974) | € (143,279) |
Total comprehensive income/(loss) | (32,318) | 2,727 | (35,046) | |||
Income appropriation | 0 | (143,279) | 143,279 | |||
Share-based compensation expense: | ||||||
Value of services | 3,232 | 3,232 | ||||
Exercises | (3) | 79 | (82) | |||
Equity, ending balance at Jun. 30, 2023 | 190,707 | 20,834 | 593,960 | 61,211 | (450,253) | (35,046) |
Equity, beginning balance at Dec. 31, 2023 | 128,247 | 20,837 | 594,003 | 65,088 | (450,253) | (101,429) |
Total comprehensive income/(loss) | 33,596 | (379) | 33,976 | |||
Income appropriation | 0 | (101,429) | 101,429 | |||
Share-based compensation expense: | ||||||
Value of services | 4,435 | 4,435 | ||||
Exercises | 0 | 55 | (55) | |||
Equity, ending balance at Jun. 30, 2024 | € 166,278 | € 20,892 | € 593,948 | € 69,144 | € (551,682) | € 33,976 |
General information
General information | 6 Months Ended |
Jun. 30, 2024 | |
General Information And Significant Events Of Period | |
General information | Note 1 General information 1.1 Corporate Information Valneva SE (the Company) together with its subsidiaries (the Group or Valneva) is a company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical needs. The Company takes a highly specialized and targeted approach, applying deep expertise across multiple vaccine modalities, focused on providing either first-, best- or only-in-class vaccine solutions. The Group has a strong track record of advancing multiple vaccines from early R&D to approval. Valneva currently markets three proprietary travel vaccines as well as certain third-party vaccines leveraging the Group’s established commercial infrastructure. Revenues from the growing commercial business help fuel the continued advancement of the 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. As at June 30, 2024, the Group’s portfolio includes three commercial vaccines: ▪ IXIARO (also marketed as JESPECT), indicated for the prevention of Japanese encephalitis; ▪ DUKORAL, indicated for the prevention of cholera, and, in some countries, prevention of diarrhea caused by enterotoxigenic Escherichia coli; and ▪ IXCHIQ, Valneva’s single-shot chikungunya vaccine, approved by the U.S. Food & Drug Administration (FDA), the European Medicines Agency (EMA) and by Health Canada. The Company is registered at 6 rue Alain Bombard, 44800 Saint-Herblain, France. Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the United States and around 700 employees worldwide. Valneva SE is a public company listed on the Euronext Paris (symbol: VLA) and on the The Nasdaq Global Select Market (symbol: VALN). Significant events of the period and significant agreements Sale of Priority Review Voucher for $103 million The Company sold the Priority Review Voucher (PRV) it received from the FDA for $103 million (€95 million) on February 2, 2024. The Company was awarded a tropical disease PRV in November 2023 following the U.S. FDA’s approval of IXCHIQ, Valneva’s single-dose, live-attenuated vaccine against the chikungunya virus (CHIKV). With this approval, IXCHIQ became the world’s first licensed chikungunya vaccine available to address this unmet medical need. Valneva will invest proceeds from the sale of the PRV into its R&D projects, including the co-development of its Phase 3 vaccine candidate against Lyme disease, additional clinical trials for its chikungunya vaccine IXCHIQ and the expansion of the Company’s clinical pipeline. Amendment of the D&O Loan Agreement On March 18, 2024, Valneva signed an amendment to its loan agreement (the D&O Loan Agreement) with U.S. Healthcare funds Deerfield Management Company and OrbiMed. Reimbursements of the first $100 million tranche will now start in January 2026 instead of July 2024. Maturity of this first tranche will remain in the first quarter of 2027. The interest-only period has been extended by 18 months. The terms of the second $100 million tranche remain unchanged. 1.2 Group information The following list shows all subsidiaries held by the Company directly or indirectly: Name Country of incorporation Consolidation Method Interest held as at June 30, 2024 December 31, 2023 Vaccines Holdings Sweden AB SE Full Consolidation 100 % 100 % Valneva Austria GmbH AT Full Consolidation 100 % 100 % Valneva Canada Inc. CA Full Consolidation 100 % 100 % Valneva France SAS FR Full Consolidation 100 % 100 % Valneva Scotland Ltd. UK Full Consolidation 100 % 100 % Valneva Sweden AB SE Full Consolidation 100 % 100 % Valneva UK Ltd. UK Full Consolidation 100 % 100 % Valneva USA, Inc. US Full Consolidation 100 % 100 % VBC 3 Errichtungs GmbH AT Full Consolidation 100 % 100 % The closing date for the consolidated financial statements is December 31 of each year. The Company’s site in Saint-Herblain (Nantes, France) includes general and administrative functions as well as research and development facilities. Valneva SE also has a site in Lyon which operates commercial activities. Vaccines Holdings Sweden AB (Solna, Sweden) is the holding company of Valneva Sweden AB, also located in Solna, which manufactures DUKORAL and commercializes DUKORAL, IXIARO and third-party products such as Moskito Guard and other vaccines in the Nordic countries. Valneva Austria GmbH (Vienna, Austria) focuses on pre-clinical and clinical development activities of vaccines. The facilities accommodate departments for pre-clinical R&D, technical/clinical product development, quality and regulatory affairs, general and administrative as well as commercial functions. Valneva Austria GmbH commercializes IXIARO, DUKORAL and third-party products such as FLUCELVAX TETRA, FLUAD, Moskito Guard, Rabipur/RabAvert and Encepur. Valneva Canada Inc. , located in Kirkland, Canada, commercializes IXIARO, DUKORAL and third-party products such as KAMRAB and Rabipur. Valneva France SAS (Lyon, France) commercializes IXIARO, DUKORAL and third-party products such as PreHevbri, Rabipur and Encepur. Valneva Scotland Ltd. (Livingston, Scotland, United Kingdom) is primarily involved in the production of IXIARO and IXCHIQ. Valneva UK Ltd. (Fleet, England, United Kingdom) commercializes DUKORAL, IXIARO and third-party products such as PreHevbri, Rabipur in the United Kingdom. Valneva USA, Inc. (Bethesda, Maryland, USA) focuses on the commercialization of IXIARO and IXCHIQ to the U.S. military and the U.S. private market. VBC 3 Errichtungs GmbH (Vienna, Austria), owns the administration and research building used by Valneva Austria GmbH. |
Summary of significant accounti
Summary of significant accounting policies | 6 Months Ended |
Jun. 30, 2024 | |
Summary Of Significant Accounting Policies | |
Summary of significant accounting policies | Note 2 Summary of significant accounting policies The principal accounting policies applied in preparing these interim consolidated financial statements are outlined below. These policies have been consistently applied to all years presented to date. 2.1 Basis of preparation The unaudited interim condensed consolidated financial statements as at June 30, 2024 and for the six months ended June 30, 2024 and June 30, 2023, have been prepared in accordance with IAS 34 Interim Financial Reporting as adopted by the European Union (EU) and as issued by the IASB authorizing the presentation of selected explanatory notes. In consequence, these interim consolidated financial statements must be read in conjunction with the consolidated annual financial statements for the year ended December 31, 2023. The preparation of financial statements in conformity with IFRS as issued by the IASB requires the use of certain critical accounting estimates. It also requires the Group’s management to exercise its judgement in applying its accounting policies. The areas involving a higher degree of judgement or complexity, or areas where assumptions and estimates are significant to the consolidated financial statements are disclosed in Note 3. For ease of presentation, numbers have been rounded and, where indicated, are presented in thousands of Euros. Calculations, however, are based on exact figures. Therefore, the sum of the numbers in a column of a table may not conform to the total figure displayed in the column. The unaudited interim condensed consolidated financial statements of the Company were adopted by the Board of Directors after review by the Audit, Compliance and Risk Committee. 2.2 Impact of new, revised or amended Standards and Interpretations Standards, amendments to existing standards and interpretations issued by IASB and adopted by the European Union whose application has been mandatory since January 1, 2024 New standards and interpretations adopted by the Group Effective date Effects IAS 1 Amendments to IAS 1: Classification of Liabilities as Current or Non-current and Non-current liabilities with covenants January 1, 2024 none IFRS 16 Amendments to IFRS 16 Leases: Lease Liability in a Sale and Leaseback January 1, 2024 none IAS 7 & IFRS 7 Amendments to IAS 7 Statement of Cash Flows and IFRS 7 Financial Instruments: Disclosures: Supplier Finance Arrangements January 1, 2024 none The interpretations listed above did not have any material impact on the amounts recognized in prior periods and are not expected to significantly affect the current or future periods. Standards, amendments to existing standards and interpretations whose application is not yet mandatory. The Group did not elect for early application of the following new standards, amendments and interpretations which were issued but not mandatory as at January 1, 2024. New standards, Interpretations and Amendments Effective date Effects IAS 21 Amendments to IAS 21 The Effects of Changes in Foreign Exchange Rates: Lack of Exchangeability January 1, 2025 none IFRS 18 New standard, IFRS 18 Presentation and Disclosures in Financial Statements January 1, 2027 under assessment IFRS 19 New standard, IFRS 19 Subsidiaries without Public Accountability: Disclosures January 1, 2027 none IFRS 7 & IFRS 9 Amendments IFRS 9 and IFRS 7 regarding the classification and measurement of financial instruments January 1, 2026 none The Group has not adopted any of the above standards, interpretations or amendments that have been issued, but are not yet effective. Such standards are not currently expected to have a material impact on the Group in the current or future reporting periods and on foreseeable future transactions, except for IFRS 18 for which the Group is currently assessing the impact in future reporting periods. |
Critical accounting judgements
Critical accounting judgements and key sources of estimation uncertainty | 6 Months Ended |
Jun. 30, 2024 | |
Critical Accounting Judgements And Key Sources Of Estimation Uncertainty | |
Critical accounting judgements and key sources of estimation uncertainty | Note 3 Critical accounting judgements and key sources of estimation uncertainty In applying the Group’s accounting policies, which are described in Note 2: Summary of significant accounting policies, management is required to make judgements (other than those involving estimations) that have a significant impact on the amounts recognized and to make estimates and assumptions about the carrying amounts of assets and liabilities that are not readily apparent from other sources. The estimates and associated assumptions are based on historical experience and other factors that are considered to be relevant. Actual results may differ from these estimates. The estimates and underlying assumptions are reviewed on an ongoing basis. Revisions to accounting estimates are recognized in the period in which the estimate is revised if the revision affects only that period, or in the period of the revision and future periods if the revision affects both current and future periods. Although it is difficult to predict future liquidity requirements, the Group believes that its existing cash and cash equivalents will be sufficient to fund its operations through at least 12 months after publication of this report. No additional key sources of estimation uncertainty that may have a significant risk of causing a material adjustment to the carrying amounts of assets and liabilities within the next financial year have been added to those reported as of December 31, 2023. |
Segment information
Segment information | 6 Months Ended |
Jun. 30, 2024 | |
Disclosure of operating segments [abstract] | |
Segment information | Note 4 Segment information The Executive Committee, as the Company’s chief operating decision maker (CDM), considers Valneva’s operating business in its entirety to allocate resources and assess performance. The Executive Committee evaluates all vaccine candidates and vaccine products together as a single operating segment, “development and commercialization of prophylactic vaccines”. Therefore, the split used to allocate resources and assess performance is based on a functional view, thus correlating to the income statement format. |
Revenues
Revenues | 6 Months Ended |
Jun. 30, 2024 | |
Disclosure of disaggregation of revenue from contracts with customers [abstract] | |
Revenues | Note 5 Revenues Revenues include both revenues from contracts with customers and other revenues (mainly subleases) which are out of scope from IFRS 15: Six months ended June 30, in € thousand 2024 2023 Product sales 68,279 69,665 Other revenues from contracts with customers 1,847 3,710 Other non-IFRS 15 revenue 687 368 REVENUES 70,813 73,743 Disaggregated revenue information The Group’s revenues are disaggregated as follows: Type of goods or service Six months ended June 30, in € thousand 2024 2023 IXIARO 41,891 30,288 DUKORAL 14,945 17,140 Third party products 10,490 16,545 IXCHIQ 952 — COVID VLA2001 — 5,691 PRODUCT SALES 68,279 69,665 IXCHIQ (1) (420) 1,628 Services related to clinical trial material — 1,396 Others 2,267 686 OTHER REVENUES FROM CONTRACTS WITH CUSTOMERS 1,847 3,710 Other non-IFRS 15 revenue 687 368 REVENUES 70,813 73,743 (1) Revenues from these products were derived from contractual arrangements in connection with clinical trials and do not represent product sales. In the six months ended June 30, 2024 product sales revenues were down by €1.4 million compared to the same period in 2023. Excluding last COVID VLA2001 sales in 2023, product sales increased by €4.3 million or 7% due to favorable sales in IXIARO. IXIARO/JESPECT sales showed a 38% increase in sales, which was primarily the result of the U.S. Military returning to a more regular supply pattern in 2024 while no sales to the Department of Defense (DoD) were recorded in the first half of 2023. Foreign currency movements had no impact on product sales compared to the first half of 2023. DUKORAL sales in the six months ended June 30, 2024 were 13% lower compared to the same period of 2023. This decrease is coming from lower volumes sold in most markets, as the sales in the first half of 2023 were positively impacted by customers rebuilding inventory, This was partly offset by effects from price increases. Foreign currency fluctuations had an immaterial impact on DUKORAL sales. The first IXCHIQ product sales were recorded in the six months ended June 30, 2024, following the adoption of the U.S. Advisory Committee on Immunization Practices (ACIP)’s recommendations by the U.S. Centers for Disease Control and Prevention (CDC) in March 2024. Due to the limited shelf life of initial launch volumes and return rights granted to the U.S. distribution partners, revenue recognition was restricted only to doses sold by distributors. Third Party product sales recorded a 37% decrease, which was mainly driven by lower sales of Rabipur/RabAvert and Encepur under the distribution agreement with Bavarian Nordic, following supply shortages primarily in the first quarter of 2024. Other revenues, including revenues from collaborations, licensing and services amounted to €1.8 million in the six months ended June 30, 2024 compared to €3.7 million in the six months ended June 30, 2023 with the reduction mainly resulting from lower revenue recognition related to the R&D collaboration activities for chikungunya with Instituto Butantan. Sales channels for product sales Products are sold via the following sales channels: Six months ended June 30, in € thousand 2024 2023 Direct product sales 57,423 50,879 Indirect product sales (Sales through distributors) 10,856 18,786 TOTAL PRODUCT SALES 68,279 69,665 Geographical markets In presenting information on the basis of geographical markets, revenue is based on the final location where Valneva’s distribution partner sells the product or where the customer/partner is located. Six months ended June 30, in € thousand 2024 2023 United States 20,137 8,299 Canada 16,034 15,374 Germany 7,611 9,977 Nordics 6,502 6,176 Austria 5,873 5,645 United Kingdom 5,554 9,536 France 2,955 2,753 Other Europe 4,048 6,111 Rest of World 2,099 9,872 REVENUE TOTAL 70,813 73,743 Nordics includes Finland, Denmark, Norway and Sweden In the six months ended June 30, 2024, total revenues were down €2.9 million in comparison to the same period in 2023. Revenues from the United States and Canada positively contributed to this result. Sales to the U.S. military organizations increased considerably, being |
Expenses by nature
Expenses by nature | 6 Months Ended |
Jun. 30, 2024 | |
Expenses by nature [abstract] | |
Expenses by nature | Note 6 Expenses by nature The consolidated income statement line items cost of goods and services, research and development expenses, marketing and distribution expenses and general and administrative expenses include the following items by nature of cost: Six months ended June 30, in € thousand 2024 2023 Consulting and other purchased services 31,309 35,442 Cost of services and change in inventory 4,147 7,843 Employee benefit expense other than share-based compensation 40,956 39,028 Share-based compensation expense 3,770 3,028 Raw materials and consumables used 7,802 8,611 Depreciation and amortization and impairment 9,496 6,669 Building and energy costs 6,048 6,210 Supply, office and IT costs 3,694 4,892 License fees and royalties 1,816 1,971 Advertising costs 6,979 4,159 Warehousing and distribution costs 1,743 1,826 Travel and transportation costs 1,847 1,128 Other expenses 1,733 1,915 OPERATING EXPENSES 121,339 122,723 The operating expenses in the six months ended June 30, 2024 amounted to €121.3 million, showing a slight decrease compared to the €122.7 million in the six months ended June 30, 2023. Expenses for “cost of services and change in inventory” decreased in 2024 by €3.7 million mostly due to lower level of sales. Expenses for “consulting and other purchased services” reduced by €4.1 million in the six months ended June 30, 2024, as the comparison period of 2023 included higher service fees for clinical studies related to research and development of the Zika vaccine candidate. Additionally the decrease was driven by lower spend on Valneva’s COVID-19 vaccine. “Employee benefit expenses other than share-based compensation” increased by €1.9 million in the six months ended June 30, 2024 compared to the six months ended June 30, 2023 because of inflation-related higher salaries and social security contributions. The “share-based compensation expense” showed an increase of €0.7 million from an additional stock option program granted in December 2023. During the six months ended June 30, 2024, the Group had an average of 695 employees (Half Year 2023: 702 employees). The increase of “advertising costs” by €2.8 million in the six months ended June 30, 2024 compared to the six months ended June 30, 2023 is driven by the launch of IXCHIQ. |
Other income_(expenses), net
Other income/(expenses), net | 6 Months Ended |
Jun. 30, 2024 | |
Analysis of income and expense [abstract] | |
Other income/(expenses), net | Note 7 Other income/(expenses), net Gain from sale of Priority Review Voucher, net The Company sold the PRV received from the FDA for $103 million (€95 million) on February 2, 2024. The Company was awarded a tropical disease PRV in November 2023 following the FDA’s approval of IXCHIQ, Valneva’s single-dose, live-attenuated vaccine indicated for the prevention of disease caused by chikungunya virus. The net gain from the sale of the PRV amounted to €90.8 million , This includes expenses in the amount of €4.2 million which refer to transaction fees as well as to expenses in connection with contractual payment obligations related to the PRV sale. Remaining other income/(expenses), net The remaining other income and expenses, net include the following: Six months ended June 30, in € thousand 2024 2023 Research and development tax credit 3,610 4,955 Grant income 1,822 9,946 Gain/(loss) on disposal of fixed assets and intangible assets, net 48 (73) Gain/(loss) from revaluation of lease agreements 723 64 Taxes, duties, fees, charges, other than income tax (171) (353) Miscellaneous income/(expenses), net 324 (525) OTHER INCOME AND EXPENSES, NET 6,357 14,015 The other operating income and expenses, net decreased by €7.7 million, or 55%, to €6.4 million for the six months ended June 30, 2024 primarily due to lower grant income. The research and development tax credit in Austria reduced by €1.3 million due to a lower eligible expense base compared to the same period of 2023. In the six months ended June 30, 2023, the Group recognized a grant income from Scottish Enterprise, Scotland’s national economic development agency, of €8.7 million , while in the six months ended June 30, 2024, the amount recognized was €1.8 million. The gain from revaluation of lease agreements came from the termination of a lease for a plant building in Livingston, Scotland, which was no longer in use. |
Finance income_(expenses), net
Finance income/(expenses), net | 6 Months Ended |
Jun. 30, 2024 | |
Finance Income (Expense) [Abstract] | |
Finance income/(expenses), net | Note 8 Finance income/(expenses), net Interest income is recognized on a time-proportion basis using the effective interest method. Six months ended June 30, in € thousand 2024 2023 FINANCE INCOME Interest income from other parties 787 504 TOTAL FINANCE INCOME 787 504 FINANCE EXPENSES Interest expense on loans (11,296) (5,623) Interest expense on refund liabilities (266) (2,615) Interest expenses on lease liabilities (418) (619) Other interest expense (2) (22) TOTAL FINANCE EXPENSES (11,981) (8,879) FOREIGN EXCHANGE GAIN/(LOSSES), NET (1,652) 4,517 FINANCE INCOME/(EXPENSES), NET (12,845) (3,858) The increase in interest expense on loans is mainly due to the 85% increase in Valneva's average loan volume in the first half of 2024 compared to the same period in 2023. During the second half of 2023, additional tranches of the D&O Loan Agreement were added and drawn. For further details, see Note 13. The interest expense on refund liabilities for the six months ended June 30, 2023 of €2.6 million was mainly caused by accumulated payment deferrals related to the Pfizer agreement. The interest expense on refund liabilities for the six months ended June 30, 2024 decreased to €0.3 million due to the significant payments made to Pfizer during the second half of 2023 and the first half of 2024. Please refer to Note 16 for more information on the refund liability balances. The foreign exchange losses in the six months ended June 30, 2024 are primarily driven by non-cash revaluation results of USD denominated liabilities as the USD appreciated against the EUR by more than 3% in 2024. A contrary movement of the USD/EUR rate could be observed in 2023. |
Impairment testing
Impairment testing | 6 Months Ended |
Jun. 30, 2024 | |
Disclosure of impairment loss and reversal of impairment loss [abstract] | |
Impairment testing | Note 9 Impairment testing At the end of each reporting period Valneva assesses whether there is any indication that an asset may be impaired. Indicators for the necessity of an impairment test are, among others, actual or expected declines in sales or margins and significant changes in the economic environment with an adverse effect on Valneva’s business. An impairment loss is recognized for the amount by which the asset’s carrying amount exceeds its recoverable amount. The recoverable amount is the higher of an asset’s fair value less selling costs and value in use. For the purposes of assessing impairment, assets are grouped at the lowest levels for which there are separately identifiable cash flows (cash-generating units or CGUs). The cash-generating units correspond with the specific vaccine products and vaccine candidates. Non-financial assets, other than goodwill, that suffered impairment are reviewed for possible reversal of the impairment at each reporting date. As at June 30, 2024, no triggering event was identified and no impairment testing procedures were performed. The cumulative impairments amounted to €17.1 million as of the period-end ( December 31, 2023: €18.4 million ). Besides currency revaluation effects, an impairment on a right-of-use for a building in the amount of €1.0 million was released due to contract termination for a plant building in Livingston, Scotland. The total impairments divide into €4.4 million ( December 31, 2023: €4.4 million ) for leasehold improvements, €9.6 million ( December 31, 2023: €9.8 million ) for manufacturing equipment and €3.1 million ( December 31, 2023: €4.2 million ) for right of use assets. |
Inventories
Inventories | 6 Months Ended |
Jun. 30, 2024 | |
Classes of current inventories [abstract] | |
Inventories | Note 10 Inventories Inventories are stated at the lower of cost and net realizable value. The cost of finished goods and work in progress comprises raw materials, direct labor, other direct costs and related production overheads (based on normal operating capacity) at standard costs. The variances between the actual costs and the standard costs are calculated monthly and allocated to the inventory, so there is no difference between actual and standard costs. Inventories exclude borrowing costs. Provisions for batches which fail to meet quality requirements and may not be sold (failed batches) are deducted from the value of inventories. in € thousand June 30, 2024 December 31, 2023 Raw materials 28,615 35,379 Work in progress 32,117 38,094 Finished goods 20,613 12,968 Purchased goods (third party products) 2,298 3,626 GROSS AMOUNT OF INVENTORIES BEFORE WRITE-DOWN 83,642 90,067 Less: write-down provision (34,776) (45,601) INVENTORIES 48,867 44,466 As of June 30, 2024 the decrease in gross amounts of inventories before write-down is primarily related to the decrease in the inventory of raw materials and work in progress, partially offset by the increase in the finished goods IXCHIQ and DUKORAL. The total write-down provision on inventory amounts to €34.8 million as of June 30, 2024 (December 31, 2023: €45.6 million). The decrease in the write-down provision compared to prior year is mainly attributable to the scrapping of COVID VLA2001 following the suspension of manufacturing of the product in 2022. All raw material and work in progress related to COVID VLA2001 which could not be repurposed and used for other products was already written down during prior years. Write-down provisions related to the inventory categories as follows: in € thousand June 30, 2024 December 31, 2023 Raw materials 22,217 28,158 Work in progress 10,151 15,177 Finished goods 1,696 1,524 Purchased goods (third party products) 712 743 TOTAL WRITE-DOWN PROVISION 34,776 45,601 As at June 30, 2024, €18.8 million of the w rite-down provisions were attributable to COVID VLA2001 (December 31, 2023: €31.2 million ), of which €18.8 million related to the raw materials (December 31, 2023: €26.6 million). As at June 30, 2024, the remaining write-down provision of €13.6 million in raw materials and work in progress relate to Valneva's commercialized vaccines IXIARO , DUKORAL and IXCHIQ (December 31, 2023: €12.2 million ). As at June 30, 2024, the write down provision for finished goods for Valneva's commercialized vaccines IXIARO and IXCHIQ based on sales expectations and limited shelf life of the products amounts to €1.7 million (December 31, 2023: €1.5 million). A slight decrease in the provision for third party products was visible as at June 30, 2024 (December 31, 2023: €0.7 million). |
Trade receivables
Trade receivables | 6 Months Ended |
Jun. 30, 2024 | |
Trade and other receivables [abstract] | |
Trade receivables | Note 11 Trade receivables Trade receivables are initially recognized at fair value. The carrying amount of trade receivables is reduced through an allowance for doubtful account. When a trade receivable is considered uncollectible, it is written off against this allowance account. Subsequent recoveries of amounts previously written off are credited against the allowance account. Changes in the carrying amount of the allowance account are recognized in the profit or loss. Trade receivables include the following: in € thousand June 30, 2024 December 31, 2023 Trade receivables 30,587 41,714 Less: loss allowance of receivables (68) (69) TRADE RECEIVABLES, NET 30,519 41,645 In 2024 and 2023, no material impairment losses were recognized. As at June 30, 2024, the amount of trade receivables past due (which is defined as being more than 30 days late) reached €0.8 million (December 31, 2023: €4.5 million). Due to the short-term nature of the current receivables, their carrying amount is considered to be the same as their fair value. As at June 30, 2024, trade receivables included €30.5 million (December 31, 2023: €41.6 million) of receivables from contracts with customers. |
Cash and cash equivalents
Cash and cash equivalents | 6 Months Ended |
Jun. 30, 2024 | |
Cash and cash equivalents [abstract] | |
Cash and cash equivalents | Note 12 Cash and cash equivalents Cash includes cash at bank, cash in hand, and deposits held at call with banks. Cash equivalents include short-term bank deposits and medium-term notes with a maximum maturity of three months that can be assigned or sold on very short notice and are subject to insignificant risk of changes in value in response to fluctuations in interest rates. in € thousand June 30, 2024 December 31, 2023 Cash in hand 7 9 Cash at bank 131,406 126,070 CASH AND CASH EQUIVALENTS 131,413 126,080 |
Borrowings
Borrowings | 6 Months Ended |
Jun. 30, 2024 | |
Borrowings [abstract] | |
Borrowings | Note 13 Borrowings Borrowings are initially recognized at fair value if determinable, net of transaction costs incurred. Borrowings are subsequently stated at amortized cost. Any difference between the proceeds (net of transaction costs) and the redemption value is recognized in the income statement over the period of the borrowings using the effective interest method. Borrowings are classified as current liabilities unless the Group has an unconditional right to defer settlement of the liability for at least 12 months after the balance sheet date. Borrowings of the Group at period-end include the following: in € thousand June 30, 2024 December 31, 2023 NON-CURRENT Debentures and other loans 160,549 132,768 CURRENT Debentures and other loans 19,867 44,079 TOTAL BORROWINGS 180,415 176,847 As of June 30, 2024, the carrying amount of bank borrowings and other loans was €180.4 million. Of this, €173.5 million related to the D&O Loan Agreement. Other borrowings related to financing of research and development expenses included the CIR (research and development tax credit in France) of €3.6 million (December 31, 2023: €3.6 million) and the CEPI loan in the amount of €3.3 million (December 31, 2023: €5.7 million), which relates to advanced payments received which are expected to be paid back in the future. The maturity of the borrowings is as follows: in € thousand June 30, 2024 December 31, 2023 Between 1 and 3 years 122,697 62,378 Between 3 and 5 years 37,852 70,390 NON-CURRENT BORROWINGS 160,549 132,768 Current borrowings 19,867 44,079 TOTAL BORROWINGS 180,415 176,847 The carrying amounts of the Group’s borrowings are denominated in the following currencies: in € thousand June 30, 2024 December 31, 2023 Borrowings denominated in EUR 3,592 3,581 Borrowings denominated in USD 176,824 173,266 TOTAL BORROWINGS 180,415 176,847 13.1 Other loans As at June 30, 2024, a total of $200.0 million have been drawn under the D&O Loan Agreement. The book value of the loan amounts to $185.7 million (€173.5 million). Following amendments to the D&O Loan Agreement, most recently in March 2024, the interest-only period on the initial $100.0 million (€93.4 million) tranche extends until the first quarter of 2026, and this portion of the loan will mature in the first quarter of 2027. The interest-only period for the tranches drawn in 2023 amounting to $100.0 million extends until the first quarter of 2027, and this portion of the loan will mature in the fourth quarter of 2028. The interest rate on the new debt remains unchanged at 9.95%, translating into an effective interest rate for the first draw of 14.17% and for the second draw of 13.47% as of June 30, 2024. Transaction costs amounting to €0.9 million have been deducted from the loan proceeds received. The net present value of the modified loan was less than 10% different from the previous net present value of the loan, therefore the modification is not treated as an extinguishment under IFRS 9. The loan is secured by substantially all of Valneva’s assets, including its intellectual property, and is guaranteed by Valneva SE and certain of its subsidiaries. The minimum liquidity requirement is €35.0 million for 2024. The twelve-month rolling minimum revenue requirement of €115.0 million is effective for 2024. The Group does not expect these limitations to affect its ability to meet its cash obligations. The D&O Loan Agreement is included in the balance sheet item “Borrowings” and developed as follows: in € thousand June 30, 2024 December 31, 2023 BALANCE AS AT JANUARY 1 167,520 89,182 Proceeds of issue — 91,111 Transaction costs (944) (11,198) Accrued interest 10,152 12,942 Payment of interest (9,351) (11,022) Exchange rate difference 6,137 (3,494) BALANCE AS AT CLOSING DATE 173,515 167,520 Less: non-current portion (154,616) (127,119) CURRENT PORTION 18,899 40,401 13.2 Fair value of borrowings and other loans The fair value of the borrowings and other loans are calculated by discounting the contractual cash flows with interest rates derived from relevant bond yields and swap rates and adjusted for any further potential risk and liquidity risks related to the nature of each loan. The |
Trade payables and accruals
Trade payables and accruals | 6 Months Ended |
Jun. 30, 2024 | |
Trade and other payables [abstract] | |
Trade payables and accruals | Note 14 Trade payables and accruals Trade payables and accruals include the following: in € thousand June 30, 2024 December 31, 2023 Trade payables 8,526 17,564 Accrued expenses 24,124 26,739 TOTAL 32,650 44,303 Less non-current portion — — CURRENT PORTION 32,650 44,303 |
Contract liabilities
Contract liabilities | 6 Months Ended |
Jun. 30, 2024 | |
Contract liabilities [abstract] | |
Contract liabilities | Note 15 Contract liabilities A contract liability has to be recognized when the customer already provided the consideration or part of the consideration before an entity has fulfilled its performance obligation (agreed goods or services which should be delivered or provided) resulting from the “contract”. Development of contract liabilities is presented in the table below: in € thousand 2024 2023 BALANCE AS AT JANUARY 1 5,697 9,411 Revenue recognition (104) (4,394) Redemption (411) — Addition — 1,870 Other releases — (1,032) Exchange rate differences 117 (159) BALANCE AS AT CLOSING DATE 5,299 5,697 Less non-current portion — — CURRENT PORTION 5,299 5,697 As at June 30, 2024, from the total of €5.3 million, an amount of €4.4 million is connected to the US distributor agreements (December 31, 2023: €4.7 million). In the six months ended June 30, 2024. The redemption of €0.4 million relates to these contracts, which cover an obligation to replace vaccine doses. |
Refund liabilities
Refund liabilities | 6 Months Ended |
Jun. 30, 2024 | |
Refund Liabilities [Abstract] | |
Refund liabilities | Note 16 Refund liabilities A refund liability has to be recognized when the customer already provided a consideration which is expected to be refunded partially or totally. It is measured at the amount the Company has an obligation to repay or amounts which did not meet the criteria for revenue recognition in the past, but there are no remaining goods and services to be provided in the future. in € thousand June 30, 2024 December 31, 2023 BALANCE AS AT JANUARY 1 39,941 143,085 Additions 1,271 465 Payments (50) (352) Other releases (18,922) (108,542) Revenue recognition — (40) Interest expense capitalized 266 8,419 Exchange rate difference 1,056 (3,095) BALANCE AS AT CLOSING DATE 23,561 39,941 Less non-current portion (6,396) (6,303) CURRENT PORTION 17,165 33,637 As at June 30, 2024, from the total of €23.6 million, an amount of €15.8 million is connected to the Collaboration and License Agreement with Pfizer. In the first half of 2024 payments were made in connection with the terms and schedule of the Pfizer Collaboration and License Agreement, disclosed under other releases. Refund liabilities of €6.6 million (of which €6.4 million is non-current) relate to the expected payment to GlaxoSmithKline (GSK) due to the termination of the strategic alliance agreements (SAA) in 2019. |
Cash flow information
Cash flow information | 6 Months Ended |
Jun. 30, 2024 | |
Cash Flow Information [Abstract] | |
Cash flow information | Note 17 Cash flow information The following table shows the adjustments to reconcile profit/(loss) to cash generated/(used) from operations: Six months ended June 30, in € thousand 2024 2023 PROFIT/(LOSS) FOR THE PERIOD 33,976 (35,046) Gain from sale of Priority Review Voucher, net (90,833) — Adjustments for non-cash transactions: Depreciation and amortization 9,496 8,557 Write-off / impairment fixed assets/intangibles — (1,888) Share-based compensation expense 3,770 2,192 Income tax expense/(income) (158) (3,778) (Profit)/loss from disposal of property, plant, equipment and intangible assets (48) 41 Provision for employer contribution costs on share-based compensation plans (1,442) (440) Other non-cash (income)/expense 1,161 (294) Interest income (787) (504) Interest expense 11,981 8,879 Total adjustments for non-cash transactions 23,973 12,764 Changes in non-current operating assets and liabilities (excluding the effects of acquisition and consolidation): Other non-current assets (558) 365 Long term refund liabilities 93 (16) Other non-current liabilities and provisions (652) (70) Total changes in non-current operating assets and liabilities (1,117) 279 Changes in working capital (excluding the effects of acquisition and exchange rate differences on consolidation): Inventory (3,331) 1,724 Trade and other receivables 3,745 2,872 Contract liabilities (560) 2,346 Refund liabilities (16,749) (57,448) Trade and other payables and provisions (14,258) 7,720 Total changes in working capital (31,153) (42,787) CASH GENERATED/(USED) IN OPERATIONS (65,154) (64,789) |
Contingencies and litigations
Contingencies and litigations | 6 Months Ended |
Jun. 30, 2024 | |
Commitments And Contingencies [Abstract] | |
Contingencies and litigations | Note 18 Contingencies and litigations Following the merger between the companies Vivalis SA and Intercell AG in 2013, certain former Intercell shareholders initiated legal proceedings before the Commercial Court of Vienna to request a revision of either the cash compensation paid to departing shareholders or the exchange ratio between Intercell and Valneva shares used in the merger. In October 2021, Valneva received an opinion from a court-appointed expert with respect to the exchange ratio. The expert confirmed the prior calculation used but also recommended the calculation of safety margins. Additionally, the expert addressed the cash compensation paid to departing shareholders and recommended an increase in such compensation. The expert provided a supplemental opinion in April 2022, and the judicial committee in charge of the proceedings gave its opinion to the Commercial Court of Vienna in April 2023. Nonetheless, the final outcome will depend on the court’s position on specific legal points and the Court has not made a decision yet. The Company therefore assessed the probability of several scenarios and decided to hold a provision of €5.2 million to cover the reassessed risk and potential legal costs (December 31, 2023: €5.2 million). |
Related-party transactions
Related-party transactions | 6 Months Ended |
Jun. 30, 2024 | |
Related party transactions [abstract] | |
Related-party transactions | Note 19 Related-party transactions In the six months ended June 30, 2024, there have been no changes to related parties. Due to their significant influence through material transactions and provision of essential technical information Groupe Grimaud La Corbière SAS (Sevremoine - France) and its affiliate Vital Meat SAS are considered as related parties. Bpifrance (Maisons-Alfort - France) is considered as a related party with a significant influence through a membership in the Company’s Board of Directors. Since the transition to a one-tier governance model, the key management consists of the Board of Directors as well as the Executive Committee while in 2023, it included the Management Board and the Supervisory Board. Rendering of services Transactions with related parties are carried out similar to those of the market and were not material during the six months ended June 30, 2024. Valneva has borrowed amounts amounting to 80% of French Tax Authorities receivables relating to Research Tax Credits for 2020, 2021 and 2022 from Bpifrance. The total amount borrowed from Bpifrance is €3.5 million on which Valneva pays interest. No material transactions were carried out during the period with the key management. Key management compensation |
Events after the reporting peri
Events after the reporting period | 6 Months Ended |
Jun. 30, 2024 | |
Disclosure of non-adjusting events after reporting period [abstract] | |
Events after the reporting period | Note 20 Events after the reporting period Valneva expands partnership with CEPI On July 22, 2024 Valneva announced that it has expanded the partnership with the Coalition for Epidemic Preparedness Innovations (CEPI) to support broader access to the world’s first chikungunya vaccine, IXCHIQ, in Low- and Middle-Income countries (LMICs), as well as post-marketing trials and potential label extensions in children, adolescents and pregnant women. CEPI will provide Valneva up to $41.3 million of additional funding over the next five years, with support from the European Union’s (EU) Horizon Europe program. The project will help generate additional data to potentially support extended IXCHIQ labels in chikungunya-endemic countries and vulnerable populations at risk of being infected with this debilitating mosquito-borne disease. The expanded partnership strengthens an earlier agreement, which awarded Valneva $24.6 million in CEPI-EU funding to develop, manufacture, and market its single-shot vaccine in certain LMICs affected by chikungunya. Under this initial agreement, Valneva partnered with Brazil’s Instituto Butantan in 2021 and conducted an adolescent clinical trial in Brazil to support licensure of the vaccine in this country. Strategic Partnership with LimmaTech for development of Shigella vaccine On August 1, 2024 Valneva announced that it has entered into a strategic partnership with LimmaTech Biologics AG (Schlieren, Switzerland), a clinical-stage biotech company developing vaccines for the prevention of life-threatening diseases. This includes an exclusive licensing agreement for the development, manufacturing and commercialization of Shigella4V (S4V), a tetravalent bioconjugate vaccine candidate against shigellosis. Under the terms of the agreement with Valneva, LimmaTech will receive an upfront payment of €10 million and be eligible to receive additional regulatory, development and sales-based milestone payments as well as low double-digit royalties on sales. LimmaTech will be responsible for conducting a Phase 2 Controlled Human Infection Model (CHIM) and a Phase 2 pediatric study in LMICs. Both clinical trials are expected to begin in the second half of 2024. Valneva will assume all further development, including CMC (chemistry, manufacturing and controls) and regulatory activities, and be responsible for its commercialization worldwide if approved. |
Summary of significant accoun_2
Summary of significant accounting policies (Policies) | 6 Months Ended |
Jun. 30, 2024 | |
Summary Of Significant Accounting Policies | |
Basis of preparation | 2.1 Basis of preparation The unaudited interim condensed consolidated financial statements as at June 30, 2024 and for the six months ended June 30, 2024 and June 30, 2023, have been prepared in accordance with IAS 34 Interim Financial Reporting as adopted by the European Union (EU) and as issued by the IASB authorizing the presentation of selected explanatory notes. In consequence, these interim consolidated financial statements must be read in conjunction with the consolidated annual financial statements for the year ended December 31, 2023. The preparation of financial statements in conformity with IFRS as issued by the IASB requires the use of certain critical accounting estimates. It also requires the Group’s management to exercise its judgement in applying its accounting policies. The areas involving a higher degree of judgement or complexity, or areas where assumptions and estimates are significant to the consolidated financial statements are disclosed in Note 3. For ease of presentation, numbers have been rounded and, where indicated, are presented in thousands of Euros. Calculations, however, are based on exact figures. Therefore, the sum of the numbers in a column of a table may not conform to the total figure displayed in the column. The unaudited interim condensed consolidated financial statements of the Company were adopted by the Board of Directors after review by the Audit, Compliance and Risk Committee. |
Impact of new, revised or amended Standards and Interpretations | 2.2 Impact of new, revised or amended Standards and Interpretations Standards, amendments to existing standards and interpretations issued by IASB and adopted by the European Union whose application has been mandatory since January 1, 2024 New standards and interpretations adopted by the Group Effective date Effects IAS 1 Amendments to IAS 1: Classification of Liabilities as Current or Non-current and Non-current liabilities with covenants January 1, 2024 none IFRS 16 Amendments to IFRS 16 Leases: Lease Liability in a Sale and Leaseback January 1, 2024 none IAS 7 & IFRS 7 Amendments to IAS 7 Statement of Cash Flows and IFRS 7 Financial Instruments: Disclosures: Supplier Finance Arrangements January 1, 2024 none The interpretations listed above did not have any material impact on the amounts recognized in prior periods and are not expected to significantly affect the current or future periods. Standards, amendments to existing standards and interpretations whose application is not yet mandatory. The Group did not elect for early application of the following new standards, amendments and interpretations which were issued but not mandatory as at January 1, 2024. New standards, Interpretations and Amendments Effective date Effects IAS 21 Amendments to IAS 21 The Effects of Changes in Foreign Exchange Rates: Lack of Exchangeability January 1, 2025 none IFRS 18 New standard, IFRS 18 Presentation and Disclosures in Financial Statements January 1, 2027 under assessment IFRS 19 New standard, IFRS 19 Subsidiaries without Public Accountability: Disclosures January 1, 2027 none IFRS 7 & IFRS 9 Amendments IFRS 9 and IFRS 7 regarding the classification and measurement of financial instruments January 1, 2026 none The Group has not adopted any of the above standards, interpretations or amendments that have been issued, but are not yet effective. Such standards are not currently expected to have a material impact on the Group in the current or future reporting periods and on foreseeable future transactions, except for IFRS 18 for which the Group is currently assessing the impact in future reporting periods. |
Segment information | The Executive Committee, as the Company’s chief operating decision maker (CDM), considers Valneva’s operating business in its entirety to allocate resources and assess performance. The Executive Committee evaluates all vaccine candidates and vaccine products together as a single operating segment, “development and commercialization of prophylactic vaccines”. Therefore, the split used to allocate resources and assess performance is based on a functional view, thus correlating to the income statement format. |
Impairment testing | At the end of each reporting period Valneva assesses whether there is any indication that an asset may be impaired. Indicators for the necessity of an impairment test are, among others, actual or expected declines in sales or margins and significant changes in the economic environment with an adverse effect on Valneva’s business. An impairment loss is recognized for the amount by which the asset’s carrying amount exceeds its recoverable amount. The recoverable amount is the higher of an asset’s fair value less selling costs and value in use. For the purposes of assessing impairment, assets are grouped at the lowest levels for which there are separately identifiable cash flows (cash-generating units or CGUs). The cash-generating units correspond with the specific vaccine products and vaccine candidates. Non-financial assets, other than goodwill, that suffered impairment are reviewed for possible reversal of the impairment at each reporting date. |
Inventories | Inventories are stated at the lower of cost and net realizable value. The cost of finished goods and work in progress comprises raw materials, direct labor, other direct costs and related production overheads (based on normal operating capacity) at standard costs. The variances between the actual costs and the standard costs are calculated monthly and allocated to the inventory, so there is no difference between actual and standard costs. Inventories exclude borrowing costs. Provisions for batches which fail to meet quality requirements and may not be sold (failed batches) are deducted from the value of inventories. |
Trade receivables | Trade receivables are initially recognized at fair value. The carrying amount of trade receivables is reduced through an allowance for doubtful account. When a trade receivable is considered uncollectible, it is written off against this allowance account. Subsequent recoveries of |
Cash and cash equivalents | Cash includes cash at bank, cash in hand, and deposits held at call with banks. Cash equivalents include short-term bank deposits and medium-term notes with a maximum maturity of three months that can be assigned or sold on very short notice and are subject to insignificant risk of changes in value in response to fluctuations in interest rates. |
Borrowings | Borrowings are initially recognized at fair value if determinable, net of transaction costs incurred. Borrowings are subsequently stated at amortized cost. Any difference between the proceeds (net of transaction costs) and the redemption value is recognized in the income statement over the period of the borrowings using the effective interest method. Borrowings are classified as current liabilities unless the Group has an unconditional right to defer settlement of the liability for at least 12 months after the balance sheet date. |
Contract liabilities | A contract liability has to be recognized when the customer already provided the consideration or part of the consideration before an entity has fulfilled its performance obligation (agreed goods or services which |
Refund liabilities | A refund liability has to be recognized when the customer already provided a consideration which is expected to be refunded partially or totally. It is measured at the amount the Company has an obligation to repay or amounts |
General information (Tables)
General information (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
General Information And Significant Events Of Period | |
Summary of all subsidiaries held by the company directly or indirectly | The following list shows all subsidiaries held by the Company directly or indirectly: Name Country of incorporation Consolidation Method Interest held as at June 30, 2024 December 31, 2023 Vaccines Holdings Sweden AB SE Full Consolidation 100 % 100 % Valneva Austria GmbH AT Full Consolidation 100 % 100 % Valneva Canada Inc. CA Full Consolidation 100 % 100 % Valneva France SAS FR Full Consolidation 100 % 100 % Valneva Scotland Ltd. UK Full Consolidation 100 % 100 % Valneva Sweden AB SE Full Consolidation 100 % 100 % Valneva UK Ltd. UK Full Consolidation 100 % 100 % Valneva USA, Inc. US Full Consolidation 100 % 100 % VBC 3 Errichtungs GmbH AT Full Consolidation 100 % 100 % |
Summary of significant accoun_3
Summary of significant accounting policies (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Summary Of Significant Accounting Policies | |
Schedule of new and amended standards adopted by the Group | New standards and interpretations adopted by the Group Effective date Effects IAS 1 Amendments to IAS 1: Classification of Liabilities as Current or Non-current and Non-current liabilities with covenants January 1, 2024 none IFRS 16 Amendments to IFRS 16 Leases: Lease Liability in a Sale and Leaseback January 1, 2024 none IAS 7 & IFRS 7 Amendments to IAS 7 Statement of Cash Flows and IFRS 7 Financial Instruments: Disclosures: Supplier Finance Arrangements January 1, 2024 none New standards, Interpretations and Amendments Effective date Effects IAS 21 Amendments to IAS 21 The Effects of Changes in Foreign Exchange Rates: Lack of Exchangeability January 1, 2025 none IFRS 18 New standard, IFRS 18 Presentation and Disclosures in Financial Statements January 1, 2027 under assessment IFRS 19 New standard, IFRS 19 Subsidiaries without Public Accountability: Disclosures January 1, 2027 none IFRS 7 & IFRS 9 Amendments IFRS 9 and IFRS 7 regarding the classification and measurement of financial instruments January 1, 2026 none |
Schedule of maturity analysis for Group’s financial liabilities | The maturity of the borrowings is as follows: in € thousand June 30, 2024 December 31, 2023 Between 1 and 3 years 122,697 62,378 Between 3 and 5 years 37,852 70,390 NON-CURRENT BORROWINGS 160,549 132,768 Current borrowings 19,867 44,079 TOTAL BORROWINGS 180,415 176,847 |
Revenues (Tables)
Revenues (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Disclosure of disaggregation of revenue from contracts with customers [abstract] | |
Schedule of disaggregated revenue | Revenues include both revenues from contracts with customers and other revenues (mainly subleases) which are out of scope from IFRS 15: Six months ended June 30, in € thousand 2024 2023 Product sales 68,279 69,665 Other revenues from contracts with customers 1,847 3,710 Other non-IFRS 15 revenue 687 368 REVENUES 70,813 73,743 |
Disclosure of disaggregated revenue by type of goods or services | The Group’s revenues are disaggregated as follows: Type of goods or service Six months ended June 30, in € thousand 2024 2023 IXIARO 41,891 30,288 DUKORAL 14,945 17,140 Third party products 10,490 16,545 IXCHIQ 952 — COVID VLA2001 — 5,691 PRODUCT SALES 68,279 69,665 IXCHIQ (1) (420) 1,628 Services related to clinical trial material — 1,396 Others 2,267 686 OTHER REVENUES FROM CONTRACTS WITH CUSTOMERS 1,847 3,710 Other non-IFRS 15 revenue 687 368 REVENUES 70,813 73,743 (1) Revenues from these products were derived from contractual arrangements in connection with clinical trials and do not represent product sales. |
Disclosure of products sales by channel | Products are sold via the following sales channels: Six months ended June 30, in € thousand 2024 2023 Direct product sales 57,423 50,879 Indirect product sales (Sales through distributors) 10,856 18,786 TOTAL PRODUCT SALES 68,279 69,665 |
Disclosure of revenue by geographical markets | Six months ended June 30, in € thousand 2024 2023 United States 20,137 8,299 Canada 16,034 15,374 Germany 7,611 9,977 Nordics 6,502 6,176 Austria 5,873 5,645 United Kingdom 5,554 9,536 France 2,955 2,753 Other Europe 4,048 6,111 Rest of World 2,099 9,872 REVENUE TOTAL 70,813 73,743 Nordics includes Finland, Denmark, Norway and Sweden |
Expenses by nature (Tables)
Expenses by nature (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Expenses by nature [abstract] | |
Schedule of income statement items by nature of cost | The consolidated income statement line items cost of goods and services, research and development expenses, marketing and distribution expenses and general and administrative expenses include the following items by nature of cost: Six months ended June 30, in € thousand 2024 2023 Consulting and other purchased services 31,309 35,442 Cost of services and change in inventory 4,147 7,843 Employee benefit expense other than share-based compensation 40,956 39,028 Share-based compensation expense 3,770 3,028 Raw materials and consumables used 7,802 8,611 Depreciation and amortization and impairment 9,496 6,669 Building and energy costs 6,048 6,210 Supply, office and IT costs 3,694 4,892 License fees and royalties 1,816 1,971 Advertising costs 6,979 4,159 Warehousing and distribution costs 1,743 1,826 Travel and transportation costs 1,847 1,128 Other expenses 1,733 1,915 OPERATING EXPENSES 121,339 122,723 |
Other income_(expenses), net (T
Other income/(expenses), net (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Analysis of income and expense [abstract] | |
Disclosure of other income (expenses) | The remaining other income and expenses, net include the following: Six months ended June 30, in € thousand 2024 2023 Research and development tax credit 3,610 4,955 Grant income 1,822 9,946 Gain/(loss) on disposal of fixed assets and intangible assets, net 48 (73) Gain/(loss) from revaluation of lease agreements 723 64 Taxes, duties, fees, charges, other than income tax (171) (353) Miscellaneous income/(expenses), net 324 (525) OTHER INCOME AND EXPENSES, NET 6,357 14,015 |
Finance income_(expenses), net
Finance income/(expenses), net (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Finance Income (Expense) [Abstract] | |
Disclosure of detailed information about finance income (cost) | Six months ended June 30, in € thousand 2024 2023 FINANCE INCOME Interest income from other parties 787 504 TOTAL FINANCE INCOME 787 504 FINANCE EXPENSES Interest expense on loans (11,296) (5,623) Interest expense on refund liabilities (266) (2,615) Interest expenses on lease liabilities (418) (619) Other interest expense (2) (22) TOTAL FINANCE EXPENSES (11,981) (8,879) FOREIGN EXCHANGE GAIN/(LOSSES), NET (1,652) 4,517 FINANCE INCOME/(EXPENSES), NET (12,845) (3,858) |
Inventories (Tables)
Inventories (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Classes of current inventories [abstract] | |
Schedule of inventories | in € thousand June 30, 2024 December 31, 2023 Raw materials 28,615 35,379 Work in progress 32,117 38,094 Finished goods 20,613 12,968 Purchased goods (third party products) 2,298 3,626 GROSS AMOUNT OF INVENTORIES BEFORE WRITE-DOWN 83,642 90,067 Less: write-down provision (34,776) (45,601) INVENTORIES 48,867 44,466 |
Schedule of write-down provisions related to the inventory categories | Write-down provisions related to the inventory categories as follows: in € thousand June 30, 2024 December 31, 2023 Raw materials 22,217 28,158 Work in progress 10,151 15,177 Finished goods 1,696 1,524 Purchased goods (third party products) 712 743 TOTAL WRITE-DOWN PROVISION 34,776 45,601 |
Trade receivables (Tables)
Trade receivables (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Trade and other receivables [abstract] | |
Disclosure of detailed information about trade receivables | Trade receivables include the following: in € thousand June 30, 2024 December 31, 2023 Trade receivables 30,587 41,714 Less: loss allowance of receivables (68) (69) TRADE RECEIVABLES, NET 30,519 41,645 |
Cash and cash equivalents (Tabl
Cash and cash equivalents (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Cash and cash equivalents [abstract] | |
Disclosure of composition of cash and cash equivalents | in € thousand June 30, 2024 December 31, 2023 Cash in hand 7 9 Cash at bank 131,406 126,070 CASH AND CASH EQUIVALENTS 131,413 126,080 |
Borrowings (Tables)
Borrowings (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Borrowings [abstract] | |
Schedule of composition of borrowings | Borrowings of the Group at period-end include the following: in € thousand June 30, 2024 December 31, 2023 NON-CURRENT Debentures and other loans 160,549 132,768 CURRENT Debentures and other loans 19,867 44,079 TOTAL BORROWINGS 180,415 176,847 |
Schedule of maturity analysis of non-current borrowings | The maturity of the borrowings is as follows: in € thousand June 30, 2024 December 31, 2023 Between 1 and 3 years 122,697 62,378 Between 3 and 5 years 37,852 70,390 NON-CURRENT BORROWINGS 160,549 132,768 Current borrowings 19,867 44,079 TOTAL BORROWINGS 180,415 176,847 |
Schedule of borrowings by denominated currency | The carrying amounts of the Group’s borrowings are denominated in the following currencies: in € thousand June 30, 2024 December 31, 2023 Borrowings denominated in EUR 3,592 3,581 Borrowings denominated in USD 176,824 173,266 TOTAL BORROWINGS 180,415 176,847 |
Schedule of reconciliation of loan | The D&O Loan Agreement is included in the balance sheet item “Borrowings” and developed as follows: in € thousand June 30, 2024 December 31, 2023 BALANCE AS AT JANUARY 1 167,520 89,182 Proceeds of issue — 91,111 Transaction costs (944) (11,198) Accrued interest 10,152 12,942 Payment of interest (9,351) (11,022) Exchange rate difference 6,137 (3,494) BALANCE AS AT CLOSING DATE 173,515 167,520 Less: non-current portion (154,616) (127,119) CURRENT PORTION 18,899 40,401 |
Trade payables and accruals (Ta
Trade payables and accruals (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Trade and other payables [abstract] | |
Schedule of trade and other payables | Trade payables and accruals include the following: in € thousand June 30, 2024 December 31, 2023 Trade payables 8,526 17,564 Accrued expenses 24,124 26,739 TOTAL 32,650 44,303 Less non-current portion — — CURRENT PORTION 32,650 44,303 |
Contract liabilities (Tables)
Contract liabilities (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Contract liabilities [abstract] | |
Disclosure of development of contract liabilities | Development of contract liabilities is presented in the table below: in € thousand 2024 2023 BALANCE AS AT JANUARY 1 5,697 9,411 Revenue recognition (104) (4,394) Redemption (411) — Addition — 1,870 Other releases — (1,032) Exchange rate differences 117 (159) BALANCE AS AT CLOSING DATE 5,299 5,697 Less non-current portion — — CURRENT PORTION 5,299 5,697 |
Refund liabilities (Tables)
Refund liabilities (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Refund Liabilities [Abstract] | |
Disclosure of development of refund liabilities | in € thousand June 30, 2024 December 31, 2023 BALANCE AS AT JANUARY 1 39,941 143,085 Additions 1,271 465 Payments (50) (352) Other releases (18,922) (108,542) Revenue recognition — (40) Interest expense capitalized 266 8,419 Exchange rate difference 1,056 (3,095) BALANCE AS AT CLOSING DATE 23,561 39,941 Less non-current portion (6,396) (6,303) CURRENT PORTION 17,165 33,637 |
Cash flow information (Tables)
Cash flow information (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Cash Flow Information [Abstract] | |
Schedule of adjustments to reconcile net loss to net cash generated from operations | The following table shows the adjustments to reconcile profit/(loss) to cash generated/(used) from operations: Six months ended June 30, in € thousand 2024 2023 PROFIT/(LOSS) FOR THE PERIOD 33,976 (35,046) Gain from sale of Priority Review Voucher, net (90,833) — Adjustments for non-cash transactions: Depreciation and amortization 9,496 8,557 Write-off / impairment fixed assets/intangibles — (1,888) Share-based compensation expense 3,770 2,192 Income tax expense/(income) (158) (3,778) (Profit)/loss from disposal of property, plant, equipment and intangible assets (48) 41 Provision for employer contribution costs on share-based compensation plans (1,442) (440) Other non-cash (income)/expense 1,161 (294) Interest income (787) (504) Interest expense 11,981 8,879 Total adjustments for non-cash transactions 23,973 12,764 Changes in non-current operating assets and liabilities (excluding the effects of acquisition and consolidation): Other non-current assets (558) 365 Long term refund liabilities 93 (16) Other non-current liabilities and provisions (652) (70) Total changes in non-current operating assets and liabilities (1,117) 279 Changes in working capital (excluding the effects of acquisition and exchange rate differences on consolidation): Inventory (3,331) 1,724 Trade and other receivables 3,745 2,872 Contract liabilities (560) 2,346 Refund liabilities (16,749) (57,448) Trade and other payables and provisions (14,258) 7,720 Total changes in working capital (31,153) (42,787) CASH GENERATED/(USED) IN OPERATIONS (65,154) (64,789) |
General information - Narrative
General information - Narrative (Details) € in Thousands, $ in Millions | 6 Months Ended | |||||
Mar. 18, 2024 | Feb. 02, 2024 EUR (€) | Feb. 02, 2024 USD ($) | Jun. 30, 2024 EUR (€) employee vaccine | Jun. 30, 2023 EUR (€) | Sep. 30, 2022 USD ($) | |
Disclosure Of General Information And Significant Events Of The Period [Line Items] | ||||||
Number of commercial vaccines | vaccine | 3 | |||||
Proceeds from sale of Priority Review Voucher | € 95,000 | $ 103 | € 90,833 | € 0 | ||
Debt financing agreement due 2027 | ||||||
Disclosure Of General Information And Significant Events Of The Period [Line Items] | ||||||
Borrowing facilities, extended interest-only period | 18 months | |||||
Tranche one | Debt financing agreement due 2027 | ||||||
Disclosure Of General Information And Significant Events Of The Period [Line Items] | ||||||
Borrowing facilities, maximum borrowing capacity | $ 100 | |||||
Tranche two | Amended debt financing agreement due 2028 | ||||||
Disclosure Of General Information And Significant Events Of The Period [Line Items] | ||||||
Borrowing facilities, maximum borrowing capacity | $ 100 | |||||
Minimum | ||||||
Disclosure Of General Information And Significant Events Of The Period [Line Items] | ||||||
Number of employees | employee | 700 |
General information - Summary o
General information - Summary of all subsidiaries held by the company directly or indirectly (Details) | Jun. 30, 2024 | Dec. 31, 2023 |
Vaccines Holdings Sweden AB | ||
Disclosure of subsidiaries [line items] | ||
Proportion of ownership interest in subsidiary | 100% | 100% |
Valneva Austria GmbH | ||
Disclosure of subsidiaries [line items] | ||
Proportion of ownership interest in subsidiary | 100% | 100% |
Valneva Canada Inc. | ||
Disclosure of subsidiaries [line items] | ||
Proportion of ownership interest in subsidiary | 100% | 100% |
Valneva France SAS | ||
Disclosure of subsidiaries [line items] | ||
Proportion of ownership interest in subsidiary | 100% | 100% |
Valneva Scotland Ltd. | ||
Disclosure of subsidiaries [line items] | ||
Proportion of ownership interest in subsidiary | 100% | 100% |
Valneva Sweden AB | ||
Disclosure of subsidiaries [line items] | ||
Proportion of ownership interest in subsidiary | 100% | 100% |
Valneva UK Ltd. | ||
Disclosure of subsidiaries [line items] | ||
Proportion of ownership interest in subsidiary | 100% | 100% |
Valneva USA, Inc. | ||
Disclosure of subsidiaries [line items] | ||
Proportion of ownership interest in subsidiary | 100% | 100% |
VBC 3 Errichtungs GmbH | ||
Disclosure of subsidiaries [line items] | ||
Proportion of ownership interest in subsidiary | 100% | 100% |
Revenues - Schedule of disaggre
Revenues - Schedule of disaggregated revenue (Details) - EUR (€) € in Thousands | 6 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | |
Disclosure of disaggregation of revenue from contracts with customers [abstract] | ||
Product sales | € 68,279 | € 69,665 |
Other revenues from contracts with customers | 1,847 | 3,710 |
Other non-IFRS 15 revenue | 687 | 368 |
REVENUES | € 70,813 | € 73,743 |
Revenues - Disclosure of disagg
Revenues - Disclosure of disaggregated revenue by type of goods or services (Details) - EUR (€) € in Thousands | 6 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | |
Disclosure of disaggregation of revenue from contracts with customers [line items] | ||
PRODUCT SALES | € 68,279 | € 69,665 |
OTHER REVENUES FROM CONTRACTS WITH CUSTOMERS | 1,847 | 3,710 |
Other non-IFRS 15 revenue | 687 | 368 |
REVENUES | 70,813 | 73,743 |
IXIARO | ||
Disclosure of disaggregation of revenue from contracts with customers [line items] | ||
PRODUCT SALES | 41,891 | 30,288 |
DUKORAL | ||
Disclosure of disaggregation of revenue from contracts with customers [line items] | ||
PRODUCT SALES | 14,945 | 17,140 |
Third party products | ||
Disclosure of disaggregation of revenue from contracts with customers [line items] | ||
PRODUCT SALES | 10,490 | 16,545 |
IXCHIQ | ||
Disclosure of disaggregation of revenue from contracts with customers [line items] | ||
PRODUCT SALES | 952 | 0 |
OTHER REVENUES FROM CONTRACTS WITH CUSTOMERS | (420) | 1,628 |
COVID VLA2001 | ||
Disclosure of disaggregation of revenue from contracts with customers [line items] | ||
PRODUCT SALES | 0 | 5,691 |
Services related to clinical trial material | ||
Disclosure of disaggregation of revenue from contracts with customers [line items] | ||
OTHER REVENUES FROM CONTRACTS WITH CUSTOMERS | 0 | 1,396 |
Others | ||
Disclosure of disaggregation of revenue from contracts with customers [line items] | ||
OTHER REVENUES FROM CONTRACTS WITH CUSTOMERS | € 2,267 | € 686 |
Revenues - Narrative (Details)
Revenues - Narrative (Details) - EUR (€) € in Thousands | 6 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | |
Disclosure of disaggregation of revenue from contracts with customers [line items] | ||
(Decrease) increase in revenue from sales of goods | € (1,400) | |
Other revenues from contracts with customers | 1,847 | € 3,710 |
Decrease in revenue | 2,900 | |
All Products Excluding COVID VLA2001 | ||
Disclosure of disaggregation of revenue from contracts with customers [line items] | ||
(Decrease) increase in revenue from sales of goods | € 4,300 | |
Increase (decrease) in revenue from sales of goods, percentage | 7% | |
IXIARO | ||
Disclosure of disaggregation of revenue from contracts with customers [line items] | ||
Increase (decrease) in revenue from sales of goods, percentage | 38% | |
DUKORAL | ||
Disclosure of disaggregation of revenue from contracts with customers [line items] | ||
Increase (decrease) in revenue from sales of goods, percentage | (13.00%) | |
Third party products | ||
Disclosure of disaggregation of revenue from contracts with customers [line items] | ||
Increase (decrease) in revenue from sales of goods, percentage | (37.00%) |
Revenues - Disclosure of produc
Revenues - Disclosure of products sales by channel (Details) - EUR (€) € in Thousands | 6 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | |
Disclosure of disaggregation of revenue from contracts with customers [line items] | ||
TOTAL PRODUCT SALES | € 68,279 | € 69,665 |
Direct product sales | ||
Disclosure of disaggregation of revenue from contracts with customers [line items] | ||
TOTAL PRODUCT SALES | 57,423 | 50,879 |
Indirect product sales (Sales through distributors) | ||
Disclosure of disaggregation of revenue from contracts with customers [line items] | ||
TOTAL PRODUCT SALES | € 10,856 | € 18,786 |
Revenues - Disclosure of revenu
Revenues - Disclosure of revenue by geographical markets (Details) - EUR (€) € in Thousands | 6 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | |
Disclosure of disaggregation of revenue from contracts with customers [line items] | ||
REVENUE TOTAL | € 70,813 | € 73,743 |
United States | ||
Disclosure of disaggregation of revenue from contracts with customers [line items] | ||
REVENUE TOTAL | 20,137 | 8,299 |
Canada | ||
Disclosure of disaggregation of revenue from contracts with customers [line items] | ||
REVENUE TOTAL | 16,034 | 15,374 |
Germany | ||
Disclosure of disaggregation of revenue from contracts with customers [line items] | ||
REVENUE TOTAL | 7,611 | 9,977 |
Nordics | ||
Disclosure of disaggregation of revenue from contracts with customers [line items] | ||
REVENUE TOTAL | 6,502 | 6,176 |
Austria | ||
Disclosure of disaggregation of revenue from contracts with customers [line items] | ||
REVENUE TOTAL | 5,873 | 5,645 |
United Kingdom | ||
Disclosure of disaggregation of revenue from contracts with customers [line items] | ||
REVENUE TOTAL | 5,554 | 9,536 |
France | ||
Disclosure of disaggregation of revenue from contracts with customers [line items] | ||
REVENUE TOTAL | 2,955 | 2,753 |
Other Europe | ||
Disclosure of disaggregation of revenue from contracts with customers [line items] | ||
REVENUE TOTAL | 4,048 | 6,111 |
Rest of World | ||
Disclosure of disaggregation of revenue from contracts with customers [line items] | ||
REVENUE TOTAL | € 2,099 | € 9,872 |
Expenses by nature - Schedule o
Expenses by nature - Schedule of income statement items by nature of cost (Details) - EUR (€) € in Thousands | 6 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | |
Expenses by nature [abstract] | ||
Consulting and other purchased services | € 31,309 | € 35,442 |
Cost of services and change in inventory | 4,147 | 7,843 |
Employee benefit expense other than share-based compensation | 40,956 | 39,028 |
Share-based compensation expense | 3,770 | 3,028 |
Raw materials and consumables used | 7,802 | 8,611 |
Depreciation and amortization and impairment | 9,496 | 6,669 |
Building and energy costs | 6,048 | 6,210 |
Supply, office and IT costs | 3,694 | 4,892 |
License fees and royalties | 1,816 | 1,971 |
Advertising costs | 6,979 | 4,159 |
Warehousing and distribution costs | 1,743 | 1,826 |
Travel and transportation costs | 1,847 | 1,128 |
Other expenses | 1,733 | 1,915 |
OPERATING EXPENSES | € 121,339 | € 122,723 |
Expenses by nature - Narrative
Expenses by nature - Narrative (Details) € in Thousands | 6 Months Ended | |
Jun. 30, 2024 EUR (€) employee | Jun. 30, 2023 EUR (€) employee | |
Expenses by nature [abstract] | ||
Operating expense | € 121,339 | € 122,723 |
Decrease in cost of services and change in inventory | 3,700 | |
Decrease in consulting and other purchased services | 4,100 | |
Increase in employee benefit expense other than share-based compensation | 1,900 | |
Increase in share-based compensation expense | € 700 | |
Average number of employees | employee | 695 | 702 |
Increase in advertising costs | € 2,800 |
Other income_(expenses), net -
Other income/(expenses), net - Narrative (Details) € in Thousands, $ in Millions | 6 Months Ended | |||
Feb. 02, 2024 EUR (€) | Feb. 02, 2024 USD ($) | Jun. 30, 2024 EUR (€) | Jun. 30, 2023 EUR (€) | |
Disclosure of attribution of expenses by nature to their function [line items] | ||||
Proceeds from sale of Priority Review Voucher | € 95,000 | $ 103 | € 90,833 | € 0 |
Gain from sale of Priority Review Voucher, net | 90,800 | 90,833 | 0 | |
Transaction costs on sale of priority review voucher | € 4,200 | |||
Decrease in other operating income (expense) | € 7,700 | |||
Decrease in other operating income (expense), percentage | 55% | |||
Other income and expenses, net | € 6,357 | 14,015 | ||
Grant income | 1,822 | 9,946 | ||
Austria | ||||
Disclosure of attribution of expenses by nature to their function [line items] | ||||
Decrease in research and development tax credit | 1,300 | |||
Scottish Enterprise | ||||
Disclosure of attribution of expenses by nature to their function [line items] | ||||
Grant income | € 1,800 | 8,700 | ||
CTM Unit, Sweden | Disposal groups classified as held for sale | ||||
Disclosure of attribution of expenses by nature to their function [line items] | ||||
Disposal loss | € 1,400 |
Other income_(expenses), net _2
Other income/(expenses), net - Disclosure of other income (expenses) (Details) - EUR (€) € in Thousands | 6 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | |
Analysis of income and expense [abstract] | ||
Research and development tax credit | € 3,610 | € 4,955 |
Grant income | 1,822 | 9,946 |
Gain/(loss) on disposal of fixed assets and intangible assets, net | 48 | (73) |
Gain/(loss) from revaluation of lease agreements | 723 | 64 |
Taxes, duties, fees, charges, other than income tax | (171) | (353) |
Miscellaneous income/(expenses), net | 324 | (525) |
OTHER INCOME AND EXPENSES, NET | € 6,357 | € 14,015 |
Finance income_(expenses), ne_2
Finance income/(expenses), net - Disclosure of detailed information about finance income (cost) (Details) - EUR (€) € in Thousands | 6 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | |
FINANCE INCOME | ||
Interest income from other parties | € 787 | € 504 |
TOTAL FINANCE INCOME | 787 | 504 |
FINANCE EXPENSES | ||
Interest expense on loans | (11,296) | (5,623) |
Interest expense on refund liabilities | (266) | (2,615) |
Interest expenses on lease liabilities | (418) | (619) |
Other interest expense | (2) | (22) |
TOTAL FINANCE EXPENSES | (11,981) | (8,879) |
FOREIGN EXCHANGE GAIN/(LOSSES), NET | (1,652) | 4,517 |
FINANCE INCOME/(EXPENSES), NET | € (12,845) | € (3,858) |
Finance income_(expenses), ne_3
Finance income/(expenses), net - Narrative (Details) - EUR (€) € in Thousands | 6 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | |
Disclosure of attribution of expenses by nature to their function [line items] | ||
Increase in loan volume | 85% | |
Interest expense on refund liabilities | € 266 | € 2,615 |
Minimum | ||
Disclosure of attribution of expenses by nature to their function [line items] | ||
Exchange rate, appreciation of US dollar against Euro | 3% |
Impairment testing (Details)
Impairment testing (Details) - EUR (€) € in Thousands | 6 Months Ended | |
Jun. 30, 2024 | Dec. 31, 2023 | |
Disclosure of impairment loss and reversal of impairment loss [line items] | ||
Assets | € (466,569) | € (460,062) |
Right-of-use assets | Buildings | ||
Disclosure of impairment loss and reversal of impairment loss [line items] | ||
Impairment charge released | 1,000 | |
Accumulated impairment | ||
Disclosure of impairment loss and reversal of impairment loss [line items] | ||
Assets | 17,100 | 18,400 |
Accumulated impairment | Right-of-use assets | ||
Disclosure of impairment loss and reversal of impairment loss [line items] | ||
Assets | 3,100 | 4,200 |
Accumulated impairment | Leasehold improvements | ||
Disclosure of impairment loss and reversal of impairment loss [line items] | ||
Assets | 4,400 | 4,400 |
Accumulated impairment | Manufacturing equipment | ||
Disclosure of impairment loss and reversal of impairment loss [line items] | ||
Assets | € 9,600 | € 9,800 |
Inventories - Schedule of inven
Inventories - Schedule of inventories (Details) - EUR (€) € in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Classes of current inventories [abstract] | ||
Raw materials | € 28,615 | € 35,379 |
Work in progress | 32,117 | 38,094 |
Finished goods | 20,613 | 12,968 |
Purchased goods (third party products) | 2,298 | 3,626 |
GROSS AMOUNT OF INVENTORIES BEFORE WRITE-DOWN | 83,642 | 90,067 |
Less: write-down provision | (34,776) | (45,601) |
INVENTORIES | € 48,867 | € 44,466 |
Inventories - Narrative (Detail
Inventories - Narrative (Details) - EUR (€) € in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Disclosure Of Inventories [Line Items] | ||
Inventories, write-down provision | € 34,776 | € 45,601 |
Raw materials, write-down provision | 22,217 | 28,158 |
Finished goods, write-down provision | 1,696 | 1,524 |
Purchased goods, write-down provision | 712 | 743 |
COVID VLA2001 | ||
Disclosure Of Inventories [Line Items] | ||
Inventories, write-down provision | 18,800 | 31,200 |
Raw materials, write-down provision | 18,800 | 26,600 |
IXIARO, DUKORAL and IXCHIQ | ||
Disclosure Of Inventories [Line Items] | ||
Inventories, write-down provision | 13,600 | 12,200 |
IXIARO and IXCHIQ | ||
Disclosure Of Inventories [Line Items] | ||
Finished goods, write-down provision | € 1,700 | 1,500 |
Purchased goods, write-down provision | € 700 |
Inventories - Schedule of write
Inventories - Schedule of write-down provisions related to the inventory categories (Details) - EUR (€) € in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Classes of current inventories [abstract] | ||
Raw materials | € 22,217 | € 28,158 |
Work in progress | 10,151 | 15,177 |
Finished goods | 1,696 | 1,524 |
Purchased goods (third party products) | 712 | 743 |
TOTAL WRITE-DOWN PROVISION | € 34,776 | € 45,601 |
Trade receivables - Disclosure
Trade receivables - Disclosure of detailed information about trade receivables (Details) - EUR (€) € in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Trade and other receivables [abstract] | ||
Trade receivables | € 30,587 | € 41,714 |
Less: loss allowance of receivables | (68) | (69) |
TRADE RECEIVABLES, NET | € 30,519 | € 41,645 |
Trade receivables - Narrative (
Trade receivables - Narrative (Details) - EUR (€) € in Millions | Jun. 30, 2024 | Dec. 31, 2023 |
Trade and other receivables [abstract] | ||
Trade receivables past due | € 0.8 | € 4.5 |
Receivables from contracts with customers | € 30.5 | € 41.6 |
Cash and cash equivalents - Dis
Cash and cash equivalents - Disclosure of composition of cash and cash equivalents (Details) - EUR (€) € in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Cash and cash equivalents [abstract] | ||
Cash in hand | € 7 | € 9 |
Cash at bank | 131,406 | 126,070 |
CASH AND CASH EQUIVALENTS | € 131,413 | € 126,080 |
Cash and cash equivalents - Nar
Cash and cash equivalents - Narrative (Details) € in Millions | 6 Months Ended |
Jun. 30, 2024 EUR (€) | |
Amended debt financing agreement due 2028 | |
Disclosure Of Cash And Cash Equivalents [Line Items] | |
Financial covenant, minimum cash requirement | € 35 |
Borrowings - Schedule of compos
Borrowings - Schedule of composition of borrowings (Details) - EUR (€) € in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
NON-CURRENT | ||
Debentures and other loans | € 160,549 | € 132,768 |
CURRENT | ||
Debentures and other loans | 19,867 | 44,079 |
TOTAL BORROWINGS | € 180,415 | € 176,847 |
Borrowings - Narrative (Details
Borrowings - Narrative (Details) € in Thousands, $ in Millions | 6 Months Ended | 53 Months Ended | ||||
Jun. 30, 2024 EUR (€) | Jun. 30, 2024 USD ($) | Jun. 30, 2024 USD ($) | Dec. 31, 2023 EUR (€) | Aug. 16, 2023 | Dec. 31, 2022 EUR (€) | |
Disclosure of detailed information about borrowings [line items] | ||||||
Borrowings | € 180,415 | € 176,847 | ||||
Amended debt financing agreement due 2028 | ||||||
Disclosure of detailed information about borrowings [line items] | ||||||
Borrowings | 173,515 | $ 185.7 | 167,520 | € 89,182 | ||
Proceeds from borrowings, net of transaction costs | $ | $ 200 | |||||
Borrowings, interest rate | 9.95% | |||||
Borrowings, transaction costs | 900 | |||||
Financial covenant, minimum cash requirement | 35,000 | |||||
Financial covenant, twelve-month rolling minimum revenue requirement | € 115,000 | |||||
Amended debt financing agreement due 2028 | Tranche one | ||||||
Disclosure of detailed information about borrowings [line items] | ||||||
Borrowings, effective interest rate | 14.17% | 14.17% | ||||
Amended debt financing agreement due 2028 | Tranche two | ||||||
Disclosure of detailed information about borrowings [line items] | ||||||
Borrowings, effective interest rate | 13.47% | 13.47% | ||||
CIR | ||||||
Disclosure of detailed information about borrowings [line items] | ||||||
Borrowings | € 3,600 | 3,600 | ||||
CEPI | ||||||
Disclosure of detailed information about borrowings [line items] | ||||||
Borrowings | 3,300 | € 5,700 | ||||
Amended Debt Financing Agreement Due First Quarter 2027 | Cost | ||||||
Disclosure of detailed information about borrowings [line items] | ||||||
Borrowings | € 93,400 | $ 100 | ||||
Amended Debt Financing Agreement Due Fourth Quarter 2028 | Cost | ||||||
Disclosure of detailed information about borrowings [line items] | ||||||
Borrowings | $ | $ 100 |
Borrowings - Schedule of maturi
Borrowings - Schedule of maturity analysis of non-current borrowings (Details) - EUR (€) € in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Disclosure of detailed information about borrowings [line items] | ||
NON-CURRENT BORROWINGS | € 160,549 | € 132,768 |
Current borrowings | 19,867 | 44,079 |
TOTAL BORROWINGS | 180,415 | 176,847 |
Between 1 and 3 years | ||
Disclosure of detailed information about borrowings [line items] | ||
NON-CURRENT BORROWINGS | 122,697 | 62,378 |
Between 3 and 5 years | ||
Disclosure of detailed information about borrowings [line items] | ||
NON-CURRENT BORROWINGS | € 37,852 | € 70,390 |
Borrowings - Schedule of borrow
Borrowings - Schedule of borrowings by denominated currency (Details) - EUR (€) € in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Disclosure of detailed information about borrowings [line items] | ||
TOTAL BORROWINGS | € 180,415 | € 176,847 |
Borrowings denominated in EUR | ||
Disclosure of detailed information about borrowings [line items] | ||
TOTAL BORROWINGS | 3,592 | 3,581 |
Borrowings denominated in USD | ||
Disclosure of detailed information about borrowings [line items] | ||
TOTAL BORROWINGS | € 176,824 | € 173,266 |
Borrowings - Schedule of reconc
Borrowings - Schedule of reconciliation of loan (Details) € in Thousands, $ in Millions | 6 Months Ended | 12 Months Ended | |
Jun. 30, 2024 EUR (€) | Jun. 30, 2024 USD ($) | Dec. 31, 2023 EUR (€) | |
Disclosure of detailed information about borrowings [line items] | |||
Borrowings, beginning period | € 176,847 | ||
Borrowings, ending period | 180,415 | € 176,847 | |
Less: non-current portion | (160,549) | (132,768) | |
CURRENT PORTION | 19,867 | 44,079 | |
Amended debt financing agreement due 2028 | |||
Disclosure of detailed information about borrowings [line items] | |||
Borrowings, beginning period | 167,520 | 89,182 | |
Proceeds of issue | 0 | 91,111 | |
Transaction costs | (944) | (11,198) | |
Accrued interest | 10,152 | 12,942 | |
Payment of interest | (9,351) | (11,022) | |
Exchange rate difference | 6,137 | (3,494) | |
Borrowings, ending period | 173,515 | $ 185.7 | 167,520 |
Less: non-current portion | (154,616) | (127,119) | |
CURRENT PORTION | € 18,899 | € 40,401 |
Trade payables and accruals (De
Trade payables and accruals (Details) - EUR (€) € in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Trade and other payables [abstract] | ||
Trade payables | € 8,526 | € 17,564 |
Accrued expenses | 24,124 | 26,739 |
TOTAL | 32,650 | 44,303 |
Less non-current portion | 0 | 0 |
CURRENT PORTION | € 32,650 | € 44,303 |
Contract liabilities - Disclosu
Contract liabilities - Disclosure of development of contract liabilities (Details) - EUR (€) € in Thousands | 6 Months Ended | 12 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | Dec. 31, 2023 | |
Contract liabilities [abstract] | |||
BALANCE AS AT JANUARY 1 | € 5,697 | € 9,411 | € 9,411 |
Revenue recognition | (104) | (4,394) | |
Redemption | (411) | 0 | |
Addition | 0 | 1,870 | |
Other releases | 0 | € (1,000) | (1,032) |
Exchange rate differences | 117 | (159) | |
BALANCE AS AT CLOSING DATE | 5,299 | 5,697 | |
Less non-current portion | 0 | 0 | |
CURRENT PORTION | € 5,299 | € 5,697 |
Contract liabilities - Narrativ
Contract liabilities - Narrative (Details) - EUR (€) € in Thousands | 6 Months Ended | 12 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | Dec. 31, 2023 | |
Disclosure of disaggregation of revenue from contracts with customers [line items] | |||
Contract liabilities | € 5,299 | € 5,697 | |
Redemption | 411 | 0 | |
Revenue recognition | 104 | 4,394 | |
Other releases | 0 | € 1,000 | 1,032 |
US distributor agreements | United States | |||
Disclosure of disaggregation of revenue from contracts with customers [line items] | |||
Contract liabilities | 4,400 | € 4,700 | |
Redemption | € 400 | ||
Kingdom of Bahrain | COVID VLA2001 | Advance Purchase Agreement (APA) | |||
Disclosure of disaggregation of revenue from contracts with customers [line items] | |||
Revenue recognition | € 3,800 |
Refund liabilities - Disclosure
Refund liabilities - Disclosure of development of refund liabilities (Details) - EUR (€) € in Thousands | 6 Months Ended | 12 Months Ended |
Jun. 30, 2024 | Dec. 31, 2023 | |
Refund Liabilities [Abstract] | ||
BALANCE AS AT JANUARY 1 | € 39,941 | € 143,085 |
Additions | 1,271 | 465 |
Payments | (50) | (352) |
Other releases | (18,922) | (108,542) |
Revenue recognition | 0 | (40) |
Interest expense capitalized | 266 | 8,419 |
Exchange rate difference | 1,056 | (3,095) |
BALANCE AS AT CLOSING DATE | 23,561 | 39,941 |
Less non-current portion | (6,396) | (6,303) |
CURRENT PORTION | € 17,165 | € 33,637 |
Refund liabilities - Narrative
Refund liabilities - Narrative (Details) - EUR (€) € in Thousands | Jun. 30, 2024 | Dec. 31, 2023 | Dec. 31, 2022 |
Disclosure of disaggregation of revenue from contracts with customers [line items] | |||
Refund liabilities | € 23,561 | € 39,941 | € 143,085 |
Non-current refund liabilities | 6,396 | 6,303 | |
Pfizer Inc. | Lyme VLA15 | Amended Collaboration and License agreement | |||
Disclosure of disaggregation of revenue from contracts with customers [line items] | |||
Refund liabilities | 15,800 | 33,100 | |
GSK | Supply agreement | |||
Disclosure of disaggregation of revenue from contracts with customers [line items] | |||
Refund liabilities | 6,600 | 6,500 | |
Non-current refund liabilities | € 6,400 | € 6,300 |
Cash flow information (Details)
Cash flow information (Details) - EUR (€) € in Thousands | 6 Months Ended | ||
Feb. 02, 2024 | Jun. 30, 2024 | Jun. 30, 2023 | |
Cash Flow Information [Abstract] | |||
PROFIT/(LOSS) FOR THE PERIOD | € 33,976 | € (35,046) | |
Gain from sale of Priority Review Voucher, net | € (90,800) | (90,833) | 0 |
Adjustments for non-cash transactions: | |||
Depreciation and amortization | 9,496 | 8,557 | |
Write-off / impairment fixed assets/intangibles | 0 | (1,888) | |
Share-based compensation expense | 3,770 | 2,192 | |
Income tax expense/(income) | (158) | (3,778) | |
(Profit)/loss from disposal of property, plant, equipment and intangible assets | (48) | 41 | |
Provision for employer contribution costs on share-based compensation plans | (1,442) | (440) | |
Other non-cash (income)/expense | 1,161 | (294) | |
Interest income | (787) | (504) | |
Interest expense | 11,981 | 8,879 | |
Adjustments for non-cash transactions | 23,973 | 12,764 | |
Changes in non-current operating assets and liabilities (excluding the effects of acquisition and consolidation): | |||
Other non-current assets | (558) | 365 | |
Long term refund liabilities | 93 | (16) | |
Other non-current liabilities and provisions | (652) | (70) | |
Changes in non-current operating assets and liabilities | (1,117) | 279 | |
Changes in working capital (excluding the effects of acquisition and exchange rate differences on consolidation): | |||
Inventory | (3,331) | 1,724 | |
Trade and other receivables | 3,745 | 2,872 | |
Contract liabilities | (560) | 2,346 | |
Refund liabilities | (16,749) | (57,448) | |
Trade and other payables and provisions | (14,258) | 7,720 | |
Changes in working capital | (31,153) | (42,787) | |
Cash generated/(used) in operations | € (65,154) | € (64,789) |
Contingencies and litigations (
Contingencies and litigations (Details) - EUR (€) € in Millions | Jun. 30, 2024 | Dec. 31, 2023 |
Legal proceedings provision | ||
Disclosure of other provisions [line items] | ||
Other provisions | € 5.2 | € 5.2 |
Related-party transactions (Det
Related-party transactions (Details) - EUR (€) € in Thousands | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Dec. 31, 2023 | |
Disclosure of transactions between related parties [line items] | |||
Borrowings | € 180,415 | € 176,847 | |
Key management personnel compensation | 3,500 | € 1,500 | |
CIR | |||
Disclosure of transactions between related parties [line items] | |||
Borrowings | € 3,600 | € 3,600 | |
CIR | BPI France | |||
Disclosure of transactions between related parties [line items] | |||
Borrowings, percentage of receivables | 80% | ||
Borrowings | € 3,500 |
Events after the reporting pe_2
Events after the reporting period (Details) - Strategic partnership agreement € in Millions, $ in Millions | Aug. 01, 2024 EUR (€) | Jul. 22, 2024 USD ($) | Jul. 25, 2019 USD ($) |
Coalition for Epidemic Preparedness Innovations (CEPI) | IXCHIQ | |||
Disclosure of non-adjusting events after reporting period [line items] | |||
Maximum amount to be released under contract | $ 24.6 | ||
Major partnership agreement | Coalition for Epidemic Preparedness Innovations (CEPI) | IXCHIQ | |||
Disclosure of non-adjusting events after reporting period [line items] | |||
Maximum amount to be released under contract | $ 41.3 | ||
Partnership, period | 5 years | ||
Major partnership agreement | LimmaTech Biologics AG | Shigella vaccine | |||
Disclosure of non-adjusting events after reporting period [line items] | |||
Partnership, upfront payment | € | € 10 |