Valneva(VALN) - 2025 Q2 - Quarterly Report

Filing Information Form 6-K Details This document is a Form 6-K filed by Valneva SE on August 12, 2025, reporting its unaudited interim condensed consolidated financial statements for the six months ended June 30, 2025, and includes a press release as Exhibit 99.1. The information, excluding the 'Financial Outlook' section of the press release, is incorporated by reference into the company's Form F-3 Registration Statement - Valneva SE filed Form 6-K on August 12, 2025, to report results for the six months ended June 30, 2025, including unaudited interim condensed consolidated financial statements[6] - A press release (Exhibit 99.1) is attached, and the Form 6-K content (excluding 'Financial Outlook' in Exhibit 99.1) is incorporated by reference into the company's Form F-3 Registration Statement[6][7] Signatures The report was duly signed on behalf of Valneva SE by Thomas Lingelbach, Chief Executive Officer and President, on August 12, 2025, in accordance with the Securities Exchange Act of 1934 - The report was signed by Thomas Lingelbach, CEO and President of Valneva SE, on August 12, 2025[9][10] General Introductory Comments and Disclaimer Terminology and Trademarks This section defines key terms like 'Company,' 'Valneva,' and 'Group' as Valneva SE and its subsidiaries. It also clarifies the ownership and usage of trademarks and service marks mentioned in the report - The terms 'Company', 'Valneva', and 'Group' refer to Valneva SE and its subsidiaries[13] - Trademarks like 'Valneva,' 'IXIARO,' 'JESPECT,' 'DUKORAL,' and 'IXCHIQ' are proprietary to Valneva or its partners[14] Forward-Looking Statements and Risk Factors The report contains forward-looking statements, particularly in the 'Operational and Strategic Outlook 2025' chapter, which are subject to inherent uncertainties in R&D, economic, financial, competitive, and regulatory environments. Investors are cautioned to review the 'Risk Factors' chapter, as these risks could significantly impact the Company's activities, financial condition, and future results - The interim financial report contains forward-looking statements, especially in 'I.4 Operational and Strategic Outlook 2025', based on reasonable data, assumptions, and estimates[15] - Forward-looking statements are subject to change due to uncertainties in R&D, economic, financial, competitive, and regulatory environments[16] - Investors are urged to pay careful attention to the risk factors in 'I.5 Risk Factors' before making investment decisions, as these risks could adversely affect the Company's operations, condition, results, or targets[17] Management Report Overview Valneva is a specialty vaccine company focused on developing, manufacturing, and commercializing prophylactic vaccines for infectious diseases with unmet medical needs. The company employs a specialized approach to deliver first-, best-, or only-in-class vaccine solutions, leveraging its commercial business to fund a pipeline that includes a Lyme disease vaccine candidate (VLA15) partnered with Pfizer, a tetravalent Shigella vaccine candidate, and Zika virus vaccine candidates - Valneva is a specialty vaccine company developing, manufacturing, and commercializing prophylactic vaccines for infectious diseases[20] - The company focuses on providing first-, best-, or only-in-class vaccine solutions and has a pipeline including a Lyme disease vaccine candidate (VLA15) partnered with Pfizer, a tetravalent Shigella vaccine candidate, and Zika virus vaccine candidates[20][21] - Valneva has approximately 700 employees across operations in Austria, Sweden, the UK, France, Canada, and the U.S[22] Operational Review Valneva's operational review highlights significant progress in both its R&D pipeline and commercialized products during the first half of 2025. Key advancements include positive Phase 2 booster data for the Lyme disease vaccine candidate VLA15, initiation of Phase 2 studies for the Shigella vaccine candidate S4V2, and reinitiation of clinical development for the Zika vaccine candidate VLA1601. Commercial product sales, particularly IXIARO/JESPECT and DUKORAL, saw strong growth, and IXCHIQ received its first marketing authorization in an endemic country (Brazil) and expanded its label in Europe, despite temporary usage restrictions for elderly individuals being lifted Vaccine Research & Development (R&D) Valneva's R&D pipeline focuses on differentiated vaccine candidates that are first-, best-, or only-in-class, addressing unmet needs in infectious diseases - Valneva's R&D pipeline focuses on differentiated vaccine candidates that are first-, best-, or only-in-class, addressing unmet needs in infectious diseases[24][25] - Lyme Disease Vaccine Candidate (VLA15): Partnered with Pfizer, VLA15 is in Phase 3 (VALOR study) with recruitment completed (9,437 participants) and full vaccination achieved in August 2025. Positive Phase 2 pediatric and adolescent immunogenicity and safety data were reported in September 2024, showing high antibody levels and seroconversion rates above 90% across all six serotypes after a second booster dose[31][32][33] - Shigella Vaccine Candidate (S4V2): Valneva licensed S4V2 from LimmaTech Biologics in August 2024. LimmaTech received an upfront payment of €10 million and is eligible for up to €40 million in milestones plus low double-digit royalties. Phase 2 Controlled Human Infection Model (CHIM) and pediatric studies were initiated in November 2024 and April 2025, respectively[37] - Zika Vaccine Candidate (VLA1601): Clinical development reinitiated in March 2024 for VLA1601, a highly purified inactivated, adjuvanted vaccine candidate. A Phase 1 trial (VLA1601-102) with ~150 participants is ongoing, with results expected in H2 2025[41] - Pre-clinical Vaccine Candidates: Prioritizing VLA2112, a vaccine candidate targeting the Epstein-Barr virus (EBV), and other early-stage candidates for enteric diseases[42][43] Marketed Products Valneva commercializes three proprietary travel vaccines: IXIARO/JESPECT (Japanese encephalitis), DUKORAL (cholera/ETEC), and IXCHIQ (chikungunya) - Valneva commercializes three proprietary travel vaccines: IXIARO/JESPECT (Japanese encephalitis), DUKORAL (cholera/ETEC), and IXCHIQ (chikungunya)[43] - In June 2025, Valneva signed an exclusive marketing and distribution agreement with CSL Seqirus for its three proprietary vaccines in Germany, starting with IXCHIQ in July 2025 and IXIARO/DUKORAL from January 2026[44] Product Sales (H1 2025 vs H1 2024) | Product | H1 2025 Sales (€ million) | H1 2024 Sales (€ million) | YoY Change (%) | | :-------- | :------------------------ | :------------------------ | :------------- | | Total Sales | 91.0 | 68.3 | 33.2% | | IXIARO/JESPECT | 54.7 | 41.9 | 30.5% | | DUKORAL | 17.4 | 14.9 | 16.8% | | IXCHIQ | 7.5 | 1.0 | 650.0% | | Third-party sales | 11.4 | 10.5 | 8.6% | - IXIARO/JESPECT sales increased by 31% to €54.7 million in H1 2025, driven by growth in both traveler and U.S. Department of Defense (DoD) channels, including a new $32.8 million contract with the DoD in January 2025[49][50] - DUKORAL sales grew by 16% to €17.4 million in H1 2025, supported by supply to Mayotte (€1.1 million) and growth in travel markets[54] - IXCHIQ sales surged to €7.5 million in H1 2025 (from €1.0 million in H1 2024), benefiting from its launch in additional countries (Nordics, Austria, Germany), marketing authorization in Brazil (first in an endemic country), and supply to La Réunion during an outbreak[58][61] - Temporary restrictions on IXCHIQ use for elderly individuals (due to SAE reports) by FDA, EMA, and France's Haute Autorité de Santé were lifted in July/August 2025, with agencies emphasizing careful benefit-risk consideration[60] - Valneva expanded its partnership with CEPI for broader IXCHIQ access in LMICs (up to $41.3 million additional funding) and signed an exclusive license agreement with Serum Institute of India (SII) for supply in Asia, complementing an existing agreement with Instituto Butantan for Latin America[62][63] - Third-party sales increased by 9% to €11.4 million in H1 2025 but are expected to gradually wind down to less than 5% of total sales by 2026/2027 to improve gross margins[64][65] Other Revenues / Income Other revenues, including collaborations, licensing, and services, increased to €6.5 million in H1 2025, primarily due to the exclusive license agreement with Serum Institute of India for the chikungunya vaccine, while other income decreased due to the non-recurrence of the Priority Review Voucher sale - Other revenues, including collaborations, licensing, and services, increased to €6.5 million in H1 2025 from €2.5 million in H1 2024, primarily due to revenues from the exclusive license agreement with Serum Institute of India for the chikungunya vaccine[66][67][80] - Valneva is eligible to receive up to $143 million in early commercial milestones and tiered royalties (14% to 22%) from Pfizer for VLA15, plus an additional $100 million in cumulative sales-based milestones[66] - Other income decreased to €4.6 million in H1 2025 from €6.4 million in H1 2024, as the net gain of €90.8 million from the Priority Review Voucher (PRV) sale in H1 2024 did not recur[67][85] Other Business Updates Valneva renewed its At-the-Market (ATM) offering facility, raising $23.3 million in gross proceeds, and made changes to its Board of Directors and executive team - Valneva renewed its At-the-Market (ATM) offering facility in March 2025, allowing it to offer and sell up to $75.0 million in American Depositary Shares (ADS)[70][71] - Since the renewal, Valneva raised $14.3 million gross proceeds from an ATM transaction with Novo Holdings A/S in April 2025 and $9.0 million gross proceeds from Frazier Life Sciences in May 2025[73] - Dr. Gerd Zettlmeissl was appointed to Valneva's Board of Directors for a three-year term in June 2025[75] - James Sulat was reappointed to the Board for a one-year term in June 2025, and Franck Grimaud, Chief Business Officer and co-founder, departed the company on June 25, 2025[76][77] Financial Review Valneva's financial performance in the first half of 2025 showed a significant increase in total revenues and product sales, driven by strong commercial product performance. However, the company reported a net loss and Adjusted EBITDA loss, primarily due to the non-recurrence of a substantial gain from the sale of a Priority Review Voucher in H1 2024. Operating expenses saw some reductions, and cash used in operating activities decreased significantly, reflecting improved sales and cost management Key Financial Information (H1 2025 vs H1 2024) | in € thousand | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :-------------- | :----------------------------- | :----------------------------- | | Total Revenues | 97,562 | 70,813 | | Product Sales | 91,020 | 68,279 | | Profit/(loss) for the period | (20,818) | 33,976 | | Adjusted EBITDA | (6,020) | 56,159 | | Cash and cash equivalents | 161,307 | 131,413 | - Total revenues increased by 37.8% to €97.6 million in H1 2025 (H1 2024: €70.8 million), with product sales growing by 33.3% to €91.0 million (H1 2024: €68.3 million). Foreign currency fluctuations adversely impacted product sales by €0.5 million[79] - Operating loss was €16.8 million in H1 2025, compared to an operating profit of €46.7 million in H1 2024, mainly due to the non-recurrence of the €90.8 million net gain from the PRV sale in 2024[85][86] - Adjusted EBITDA was a loss of €6.0 million in H1 2025, a significant decrease from a profit of €56.2 million in H1 2024, which had benefited from the PRV sale[87] - Net loss for the period was a net loss of €20.8 million in H1 2025, contrasting with a net profit of €34.0 million in H1 2024, primarily due to the PRV sale in the prior year[88] - Net cash used in operating activities significantly reduced to €10.9 million in H1 2025 (H1 2024: €66.3 million), driven by increased sales and efficient cost management[90] - Cash and cash equivalents stood at €161.3 million as of June 30, 2025, down from €168.3 million at December 31, 2024[93] Adjusted EBITDA Reconciliation (H1 2025 vs H1 2024) | in € thousand | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :------------------------------------------------ | :----------------------------- | :----------------------------- | | PROFIT/(LOSS) FOR THE PERIOD | (20,818) | 33,976 | | Add: | | | | Income tax (benefits)/expense | 1,251 | (158) | | Financing income | (1,065) | (787) | | Financing expenses | 11,585 | 11,981 | | Foreign currency (gain)/loss – net | (7,783) | 1,652 | | Amortization | 2,439 | 2,471 | | Depreciation | 8,371 | 7,024 | | Impairment | — | — | | ADJUSTED EBITDA | (6,020) | 56,159 | Operational and Strategic Outlook 2025 Valneva's 2025 strategy focuses on advancing its vaccine pipeline, growing proprietary product sales, and expanding market access. Key goals for the second half of 2025 include progressing the Phase 3 study for the Lyme disease vaccine VLA15 with Pfizer, aiming for regulatory submissions in 2026, continuing to build a leading position in the travel vaccines market, securing additional label extensions for IXCHIQ, and advancing clinical trials for Shigella and Zika vaccine candidates, alongside ESG initiatives - Valneva's strategy is to develop, manufacture, and commercialize prophylactic vaccines, aiming for first-, best-, or only-in-class solutions for unmet medical needs[99] - Key goals for H2 2025 include[100][101] - Continue Phase 3 VALOR study for Lyme disease vaccine VLA15 with Pfizer, targeting BLA/MAA submissions in 2026[100] - Grow proprietary product sales (IXIARO, DUKORAL, IXCHIQ) to build a leading position in the travel vaccines market[101] - Secure additional label extensions for chikungunya vaccine IXCHIQ in the U.S., UK, and Canada, and prepare for Phase 4 post-marketing studies[101] - Ensure continued progress of Phase 2 clinical trials for Shigella vaccine candidate S4V2 and Phase 1 study for Zika vaccine candidate VLA1601, along with preclinical studies[101] - Continue executing Valneva's ESG strategy and initiatives[101] Risk Factors Valneva identifies several significant risks for the remainder of 2025, including dependence on the Pfizer partnership for the Lyme disease vaccine VLA15 (where Pfizer has considerable discretion and a development failure would be critical). Other risks include reliance on sales of key marketed products (IXIARO, DUKORAL, IXCHIQ), which are sensitive to travel industry strength, side effects (e.g., IXCHIQ temporary restrictions), and competition. Geopolitical risks, financing needs, operational risks related to manufacturing facilities and supply chains, and compliance with listed company requirements (including new EU CSRD obligations and U.S. shareholder litigation risk) also pose challenges - Risks relating to the Lyme disease vaccine candidate and the Pfizer Partnership: Pfizer has considerable discretion over VLA15's development and commercialization. A development failure or partnership termination would result in a total loss of expected commercial and financial upside[103][104] - Risk of Dependence on Sales of Key Products: Revenues are primarily from IXIARO, DUKORAL, and IXCHIQ, affected by the travel industry, customer payment ability, and product side effects (e.g., temporary restrictions on IXCHIQ for elderly due to SAEs)[105][107] - Product sales also depend on Valneva's manufacturing capacity and ability to respond to demand changes, with past supply shortages for IXIARO and DUKORAL[108] - Geopolitical risks: Volatility in the political environment, legislative changes, budget cuts, tariffs (e.g., 15% on EU pharma imports to U.S.), and currency fluctuations (especially USD) could impact business[109] - Risks relating to Financing: Valneva is capital-intensive and will need additional capital, which may not be available on acceptable terms. The company is subject to debt covenants (minimum revenue and liquidity) under the Deerfield and OrbiMed loan agreement[110] - Operational risks: Dependence on primary manufacturing facilities (Livingston, Scotland; Solna, Sweden) for key products, vulnerability to contamination, manufacturing failures, supply chain disruptions, and non-compliance with Good Manufacturing Practices (GMP)[111][113][114][115] - Cybersecurity risks: Internal IT systems are vulnerable to cyber-attacks and data breaches, potentially damaging business processes or exposing confidential information[116] - Listed company requirements: Compliance with complex regulations in France and the U.S. (e.g., EU CSRD, U.S. shareholder litigation risk) requires significant time and expense, potentially diverting management attention[117] Related Parties' Transactions Bpifrance is considered a related party due to its shareholding and Board representation until June 25, 2025. No material transactions or changes in transactions between related parties significantly affected Valneva's financial position or performance in the first half of 2025 - Bpifrance is a related party due to its shareholding and Board representation until June 25, 2025[119] - No material transactions or changes in transactions between related parties significantly affected Valneva's financial position or performance in H1 2025[119] Statutory Auditors' Review Report on the Half Year Financial Information The content for the Statutory Auditors' Review Report on the Half Year Financial Information (Period from January 1 to June 30, 2025) was not provided in the original document Unaudited Interim Condensed Consolidated Financial Statements as at June 30, 2025 Unaudited Interim Consolidated Statement of Profit or Loss and Comprehensive Income Valneva reported a net loss of €20.8 million for the six months ended June 30, 2025, a significant shift from a net profit of €34.0 million in the prior year, primarily due to the non-recurrence of the gain from the sale of a Priority Review Voucher. Total revenues increased to €97.6 million, driven by higher product sales and other revenues, but operating profit turned into a loss Unaudited Interim Condensed Consolidated Statement of Profit or Loss | in € thousand | Note | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :-------------- | :--- | :----------------------------- | :----------------------------- | | Product sales | 5.5 | 91,020 | 68,279 | | Other revenues | 5.5 | 6,542 | 2,534 | | REVENUES | | 97,562 | 70,813 | | Cost of goods and services | 5.6 | (47,162) | (45,628) | | Research and development expenses | 5.6 | (32,441) | (29,683) | | Marketing and distribution expenses | 5.6 | (20,310) | (23,181) | | General and administrative expenses | 5.6 | (19,034) | (22,847) | | Gain from sale of Priority Review Voucher, net | 5.7 | — | 90,833 | | Other income and expenses, net | 5.7 | 4,555 | 6,357 | | OPERATING PROFIT/(LOSS) | | (16,830) | 46,663 | | Finance income | 5.8 | 1,065 | 787 | | Finance expenses | 5.8 | (11,585) | (11,981) | | Foreign exchange gain/(loss), net | 5.8 | 7,783 | (1,652) | | PROFIT/(LOSS) BEFORE INCOME TAX | | (19,567) | 33,818 | | Income tax benefit/(expense) | | (1,251) | 158 | | PROFIT/(LOSS) FOR THE PERIOD | | (20,818) | 33,976 | | EARNINGS/(LOSSES) PER SHARE | | | | | Basic | | (0.13) | 0.25 | | Diluted | | (0.13) | 0.24 | Unaudited Interim Condensed Consolidated Statement of Comprehensive Income | in € thousand | Note | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :-------------- | :--- | :----------------------------- | :----------------------------- | | PROFIT/(LOSS) FOR THE PERIOD | | (20,818) | 33,976 | | OTHER COMPREHENSIVE INCOME/(LOSS) | | | | | Items that may be reclassified to profit or loss | | | | | Currency translation differences | | 1,402 | (369) | | Defined benefit plan actuarial gains/(losses) | | 24 | (10) | | Other comprehensive income/(loss) for the period, net of tax | | 1,426 | (379) | | TOTAL COMPREHENSIVE INCOME/(LOSS) FOR THE PERIOD | | (19,391) | 33,596 | Unaudited Interim Condensed Consolidated Statement of Financial Position As of June 30, 2025, Valneva's total assets decreased to €472.6 million from €500.0 million at December 31, 2024, primarily due to a reduction in non-current assets and trade receivables. Total equity increased to €186.4 million, while total liabilities decreased to €286.2 million, driven by a significant reduction in non-current borrowings Unaudited Interim Condensed Consolidated Statement of Financial Position | in € thousand | Note | June 30, 2025 | December 31, 2024 | | :-------------- | :--- | :------------ | :---------------- | | ASSETS | | | | | Non-current assets | | 187,908 | 201,020 | | Current assets | | 284,717 | 299,012 | | TOTAL ASSETS | | 472,625 | 500,032 | | EQUITY | | | | | TOTAL EQUITY | | 186,432 | 181,253 | | LIABILITIES | | | | | Non-current liabilities | | 160,534 | 204,199 | | Current liabilities | | 125,660 | 114,580 | | TOTAL LIABILITIES | | 286,193 | 318,779 | | TOTAL EQUITY AND LIABILITIES | | 472,625 | 500,032 | - Total assets decreased by €27.4 million from December 31, 2024, to June 30, 2025, mainly due to decreases in non-current assets and trade receivables[123] - Total equity increased by €5.2 million, while total liabilities decreased by €32.6 million, primarily driven by a reduction in non-current borrowings[123] Unaudited Interim Condensed Consolidated Statement of Cash Flows Valneva significantly reduced cash used in operating activities to €10.9 million in H1 2025 from €66.3 million in H1 2024, reflecting improved sales and cost management. Investing activities resulted in a net cash outflow of €1.6 million, a stark contrast to the €87.6 million inflow in H1 2024 which included the PRV sale. Financing activities generated €9.3 million, primarily from ATM transactions, compared to an outflow in the prior year Unaudited Interim Condensed Consolidated Statement of Cash Flows | in € thousand | Note | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :-------------- | :--- | :----------------------------- | :----------------------------- | | NET CASH GENERATED FROM/(USED IN) OPERATING ACTIVITIES | | (10,943) | (66,261) | | NET CASH GENERATED FROM/(USED IN) INVESTING ACTIVITIES | | (1,642) | 87,608 | | NET CASH GENERATED FROM FROM/(USED IN) FINANCING ACTIVITIES | | 9,299 | (16,589) | | NET CHANGE IN CASH AND CASH EQUIVALENTS | | (3,286) | 4,759 | | Cash and cash equivalents at beginning of the year | 5.13 | 168,271 | 126,080 | | Exchange gains/(losses) on cash | | (3,677) | 575 | | CASH AND CASH EQUIVALENTS AT END OF THE PERIOD | | 161,307 | 131,413 | - Net cash used in operating activities decreased significantly to €10.9 million in H1 2025 from €66.3 million in H1 2024, driven by increased sales and efficient cost management[90][125] - Net cash used in investing activities was €1.6 million in H1 2025, compared to a net cash generated of €87.6 million in H1 2024, which included €90.8 million net proceeds from the PRV sale[91][125] - Net cash generated from financing activities was €9.3 million in H1 2025, including €20.1 million net proceeds from ATM transactions, contrasting with a net cash outflow of €16.6 million in H1 2024[92][125] Unaudited Interim Condensed Consolidated Statement of Changes in Equity Valneva's total equity increased to €186.4 million as of June 30, 2025, from €181.3 million at January 1, 2025. This increase was primarily driven by a capital increase of €21.0 million from ATM program share issuances and share-based compensation expense, partially offset by a net loss for the period Unaudited Interim Condensed Consolidated Statement of Changes in Equity (H1 2025) | in € thousand | Share capital | Share premium | Other reserves | Retained earnings/ (Accumulated deficit) | Profit/(loss) for the period | Total equity | | :-------------- | :------------ | :------------ | :------------- | :--------------------------------------- | :--------------------------- | :----------- | | BALANCE AS AT JANUARY 1, 2025 | 24,378 | 647,600 | 73,203 | (551,682) | (12,247) | 181,253 | | Total comprehensive income/(loss) | — | — | 1,426 | — | (20,818) | (19,391) | | Income appropriation | — | — | — | (12,247) | 12,247 | — | | Share-based compensation expense: Value of services | — | — | 4,498 | — | — | 4,498 | | Capital Increase | 1,150 | 19,850 | — | — | — | 21,000 | | Cost of equity transaction, net of tax | — | (928) | — | — | — | (928) | | BALANCE AS AT JUNE 30, 2025 | 25,528 | 666,523 | 79,126 | (563,928) | (20,818) | 186,432 | - Total equity increased from €181.3 million at January 1, 2025, to €186.4 million at June 30, 2025[126] - Capital increase of €21.0 million resulted from the issuance of 4.75 million shares in April 2025 and 2.92 million shares in May 2025 under the ATM program[134] - Share-based compensation expense contributed €4.5 million to equity[126] Selected Notes to the Unaudited Interim Condensed Consolidated Financial Statements These notes provide detailed explanations and breakdowns for the interim condensed consolidated financial statements. They cover corporate information, significant accounting policies, critical judgments, segment information, and detailed analyses of revenues, expenses, financial income/expenses, impairment testing, and various balance sheet items like inventories, receivables, cash, borrowings, and liabilities. Key events include new contracts, marketing authorizations, and financing activities, alongside disclosures on related-party transactions and contingencies General Information This section provides an overview of Valneva SE, its stock exchange listings, global operations, and key significant events during the first half of 2025 - Valneva SE is a specialty vaccine company listed on Euronext Paris (VLA) and Nasdaq Global Select Market (VALN), with operations in Austria, Sweden, UK, France, Canada, and the U.S., employing around 700 people[128][130][135] - Significant events in H1 2025 include a new $32.8 million supply contract for IXIARO with the U.S. DoD, UK marketing authorization for IXCHIQ, renewal of the $75 million ATM program (raising €21.0 million), first vaccination in Phase 2 infant study for Shigella vaccine candidate S4V2, and first marketing authorization for IXCHIQ in an endemic country (Brazil)[131][132][133][134][135][136][137] - Valneva Austria GmbH is involved in external manufacturing steps of IXCHIQ[141] - Valneva Scotland Ltd. is primarily involved in the production of IXIARO and IXCHIQ[142] Summary of Significant Accounting Policies The interim condensed consolidated financial statements for H1 2025 are prepared in accordance with IAS 34, with no significant impact from newly adopted standards, and an ongoing assessment of IFRS 18 - The interim condensed consolidated financial statements for H1 2025 are prepared in accordance with IAS 34 Interim Financial Reporting as adopted by the EU[145] - New standards, amendments, and interpretations adopted since January 1, 2025 (IAS 21 Amendments, Editorial Corrections) had no significant impact[149] - The Group is currently assessing the impact of IFRS 18 (effective January 1, 2027) on future reporting periods[151][153] Critical Accounting Judgements and Key Sources of Estimation Uncertainty Management applies judgments, estimates, and assumptions in accounting, confirming sufficient cash for operations for at least 12 months, with no new significant estimation uncertainties since December 31, 2024 - Management makes judgments, estimates, and assumptions in applying accounting policies, which are reviewed on an ongoing basis[154][155] - The Group believes existing cash and cash equivalents are sufficient to fund operations for at least 12 months after the report's publication[156] - No additional key sources of estimation uncertainty with significant risk of material adjustment have been added since December 31, 2024[156] Segment Information Valneva's Executive Committee, as the chief operating decision maker, considers the entire operating business as a single segment: 'development and commercialization of prophylactic vaccines' - Valneva's Executive Committee, as the chief operating decision maker, considers the entire operating business as a single segment: 'development and commercialization of prophylactic vaccines'[157] Revenues Total revenues increased by €26.7 million in H1 2025, driven by strong product sales across IXIARO/JESPECT, DUKORAL, and IXCHIQ, alongside higher other revenues from collaborations and licensing Disaggregated Revenue Information (H1 2025 vs H1 2024) | in € thousand | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :-------------- | :----------------------------- | :----------------------------- | | IXIARO® | 54,705 | 41,891 | | DUKORAL® | 17,394 | 14,945 | | Third party products | 11,418 | 10,490 | | IXCHIQ® | 7,504 | 952 | | PRODUCT SALES | 91,020 | 68,279 | | Royalties received | 1,570 | 1,602 | | Milestone payment - licenses (1) | 4,564 | (123) | | Other services | — | 343 | | OTHER REVENUES FROM CONTRACTS WITH CUSTOMERS | 6,152 | 1,847 | | Other non-IFRS 15 revenue | 389 | 687 | | REVENUES | 97,562 | 70,813 | - Product sales increased by €22.7 million (33%) in H1 2025 compared to H1 2024, with favorable performance across all commercialized products[161] - IXIARO/JESPECT sales increased by 31% due to higher sales in both Travel and Military channels, including a return to regular supply patterns for the U.S. DoD[162] - DUKORAL sales increased by 16%, supported by supply to Mayotte and growth in most travel markets[163] - IXCHIQ product sales increased by €6.6 million, benefiting from its launch in late Q1 2024 and supply to La Réunion during an outbreak[163] - Other revenues from collaborations, licensing, and services increased to €6.2 million (from €1.8 million), mainly from the chikungunya vaccine development partnership in India[165] Product Sales by Sales Channel (H1 2025 vs H1 2024) | in € thousand | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :-------------- | :----------------------------- | :----------------------------- | | Direct product sales | 70,599 | 57,423 | | Indirect product sales | 20,421 | 10,856 | | TOTAL PRODUCT SALES | 91,020 | 68,279 | Revenue by Geographical Market (H1 2025 vs H1 2024) | in € thousand | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :-------------- | :----------------------------- | :----------------------------- | | United States | 23,470 | 20,137 | | Germany | 14,682 | 7,611 | | Canada | 14,464 | 16,034 | | France | 9,670 | 2,955 | | Austria | 7,064 | 5,873 | | United Kingdom | 6,863 | 5,554 | | Nordics | 5,892 | 6,502 | | Other Europe | 7,015 | 4,048 | | Rest of World | 8,442 | 2,099 | | REVENUE TOTAL | 97,562 | 70,813 | - Total revenues increased by €26.7 million in H1 2025, with positive contributions from the United States (increased U.S. military sales), Germany (higher market demand), and France (IXCHIQ sales to La Réunion)[169] Expenses by Nature Operating expenses slightly decreased to €118.9 million in H1 2025, influenced by reductions in consulting and inventory costs, offset by increases in employee benefits and building expenses Operating Expenses by Nature (H1 2025 vs H1 2024) | in € thousand | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :-------------- | :----------------------------- | :----------------------------- | | Consulting and other purchased services | 28,620 | 31,309 | | Cost of services and change in inventory | (273) | 4,147 | | Employee benefit expense other than share-based compensation | 44,426 | 40,956 | | Share-based compensation expense | 4,500 | 3,770 | | Raw materials and consumables used | 7,363 | 7,802 | | Depreciation and amortization and impairment | 10,811 | 9,496 | | Building and energy costs | 7,344 | 6,048 | | Supply, office and IT costs | 4,457 | 3,694 | | License fees and royalties | 1,877 | 1,816 | | Advertising costs | 5,267 | 6,979 | | Warehousing and distribution costs | 2,221 | 1,743 | | Travel and transportation costs | 843 | 1,847 | | Other expenses | 1,490 | 1,733 | | OPERATING EXPENSES | 118,947 | 121,339 | - Operating expenses slightly decreased to €118.9 million in H1 2025 from €121.3 million in H1 2024[170] - Decrease in 'cost of services and change in inventory' (€4.4 million) due to improved manufacturing performance and smaller inventory provisions[172] - Decrease in 'consulting and other purchased services' (€2.7 million) due to increased in-house recruiting, reduced consultant use, and renegotiated loan-related insurance premiums[173] - Increase in 'employee benefit expenses' (€3.5 million) due to inflation-related higher salaries and social security contributions, and 'share-based compensation expense' (€0.7 million) from an additional stock option program[174][176] - Increase in 'building and energy costs' (€1.3 million) due to an onerous lease provision and increased running costs for the new Scottish facility[177] - Decrease in 'advertising costs' (€1.7 million) following lower investments after the U.S. launch of IXCHIQ in early 2024[177] Other Income/(Expenses), Net Other income and expenses, net, decreased to €4.6 million in H1 2025, primarily due to the non-recurrence of the €90.8 million net gain from the Priority Review Voucher sale in H1 2024 and lower R&D tax credits - The net gain from the sale of the Priority Review Voucher (PRV) in H1 2024 was €90.8 million (gross proceeds $103 million), which did not recur in H1 2025[174][175][178] Remaining Other Income and Expenses, Net (H1 2025 vs H1 2024) | in € thousand | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :-------------- | :----------------------------- | :----------------------------- | | Research and development tax credit | 2,792 | 3,610 | | Grant income | 1,951 | 1,822 | | Gain/(loss) on disposal of fixed assets and intangible assets, net | (230) | 48 | | Gain/(loss) from revaluation of lease agreements | — | 723 | | Taxes, duties, fees, charges, other than income tax | (215) | (171) | | Miscellaneous income/(expenses), net | 258 | 324 | | OTHER INCOME AND EXPENSES, NET | 4,555 | 6,357 | - Other operating income and expenses, net, decreased by €1.8 million (28%) to €4.6 million in H1 2025, mainly due to lower R&D tax credits (€0.8 million decrease in Austria) and the absence of one-off gains from lease agreement revaluation recorded in 2024[179][180] - Grant income of €1.8 million was recognized in H1 2025 from additional CEPI funding, compared to €0.1 million from Scottish Enterprise[181] Finance Income/(Expenses), Net Net finance expense significantly decreased to €2.7 million in H1 2025, primarily due to a substantial foreign exchange gain from the revaluation of USD-denominated liabilities as the USD depreciated against the EUR Finance Income/(Expenses), Net (H1 2025 vs H1 2024) | in € thousand | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :-------------- | :----------------------------- | :----------------------------- | | FINANCE INCOME | | | | Interest income from other parties | 1,028 | 787 | | Other financial income | 38 | — | | TOTAL FINANCE INCOME | 1,065 | 787 | | FINANCE EXPENSES | | | | Interest expense on loans | (11,084) | (11,296) | | Interest expense on refund liabilities | (96) | (266) | | Interest expenses on lease liabilities | (404) | (418) | | Other interest expense | (1) | (2) | | TOTAL FINANCE EXPENSES | (11,585) | (11,981) | | FOREIGN EXCHANGE GAIN/(LOSSES), NET | 7,783 | (1,652) | | FINANCE INCOME/(EXPENSES), NET | (2,737) | (12,845) | - Net finance expense decreased to €2.7 million in H1 2025 from €12.8 million in H1 2024[184] - A foreign exchange gain of €7.8 million was recorded in H1 2025 (compared to a loss of €1.7 million in H1 2024), primarily due to the non-cash revaluation of USD-denominated liabilities as the USD depreciated against the EUR by 12.81%[185] - Interest expense on refund liabilities decreased to €0.1 million due to significant payments to Pfizer in H1 2024[184] Impairment Testing Impairment testing for the IXCHIQ Cash-Generating Unit (CGU) as of June 30, 2025, found no impairment requirement, as its recoverable amount significantly exceeded the carrying value of its assets - Impairment testing was performed for the IXCHIQ Cash-Generating Unit (CGU) as of June 30, 2025, due to potential label restrictions following serious adverse events (SAEs) in La Réunion[188] - No impairment requirement resulted for the IXCHIQ CGU, as its recoverable amount was considerably higher than the carrying value of its assets[188] - Cumulative impairments amounted to €21.9 million as of June 30, 2025 (December 31, 2024: €22.1 million), with the slight decrease related to currency revaluation effects[189] Inventories Gross inventories increased to €98.1 million, driven by higher work in progress for IXCHIQ and DUKORAL, while the total write-down provision also increased to €36.3 million Inventories (June 30, 2025 vs December 31, 2024) | in € thousand | June 30, 2025 | December 31, 2024 | | :-------------- | :------------ | :---------------- | | Raw materials | 27,619 | 28,086 | | Work in progress | 49,215 | 36,832 | | Finished goods | 18,739 | 19,493 | | Purchased goods (third party products) | 2,478 | 4,762 | | GROSS AMOUNT OF INVENTORIES BEFORE WRITE-DOWN | 98,051 | 89,173 | | Less: write-down provision | (36,320) | (35,510) | | INVENTORIES | 61,731 | 53,663 | - Gross inventories before write-down increased to €98.1 million (from €89.2 million), primarily due to an increase in work in progress related to IXCHIQ and DUKORAL, partially offset by a decrease in purchased goods[192] - Total write-down provision on inventory increased to €36.3 million (from €35.5 million), including €17.2 million for VLA2001 COVID vaccine raw materials and €16.5 million for IXIARO, DUKORAL, and IXCHIQ raw materials and work in progress[193][194][195] Trade Receivables Trade receivables, net, decreased by €12.9 million to €24.1 million due to sales timing and improved cash collections, while contract assets increased to €1.9 million Trade Receivables, Net (June 30, 2025 vs December 31, 2024) | in € thousand | June 30, 2025 | December 31, 2024 | | :-------------- | :------------ | :---------------- | | Trade receivables | 22,297 | 35,182 | | Less: loss allowance of receivables | (52) | (52) | | Contract assets | 1,877 | 75 | | TRADE RECEIVABLES, NET | 24,122 | 35,205 | - Trade receivables, net, decreased by €12.9 million to €24.1 million (from €35.2 million) primarily due to the timing of sales near period-end and improved cash collections[198][200] - Contract assets increased to €1.9 million (from €0.1 million), related to the master collaboration and license agreement with Serum Institute of India (SII) for IXCHIQ[200] - Trade receivables past due (more than 30 days late) reached €0.9 million (December 31, 2024: €2.0 million)[199] Other Assets Other assets decreased to €46.2 million, primarily due to a reduction in R&D tax credit receivables and tax receivables following payments received Other Assets (June 30, 2025 vs December 31, 2024) | in € thousand | June 30, 2025 | December 31, 2024 | | :-------------- | :------------ | :---------------- | | R&D tax credit receivables | 28,827 | 31,208 | | Advance payments | 319 | 399 | | Tax receivables | 3,182 | 3,686 | | Prepaid expenses | 7,997 | 8,878 | | Contract costs | 3,710 | 3,710 | | Consumables and supplies on stock | 782 | 767 | | Miscellaneous current assets | 57 | 11 | | OTHER NON-FINANCIAL ASSETS | 44,874 | 48,659 | | Deposits | 196 | 198 | | Miscellaneous financial assets | 1,114 | 1,058 | | OTHER FINANCIAL ASSETS | 1,310 | 1,256 | | OTHER ASSETS | 46,184 | 49,915 | | Less non-current portion | 8,627 | 8,041 | | CURRENT PORTION | 37,557 | 41,874 | - R&D tax credit receivables decreased due to a €5.1 million payment received in March 2025[203] - Tax receivables decreased due to the receipt of VAT claims[203] Cash and Cash Equivalents Cash and cash equivalents stood at €161.3 million as of June 30, 2025, including €20.1 million from ATM transactions, exceeding the €35.0 million minimum liquidity requirement Cash and Cash Equivalents (June 30, 2025 vs December 31, 2024) | in € thousand | June 30, 2025 | December 31, 2024 | | :-------------- | :------------ | :---------------- | | Cash in hand | — | 1 | | Cash at bank | 161,307 | 168,269 | | CASH AND CASH EQUIVALENTS | 161,307 | 168,271 | - Cash and cash equivalents were €161.3 million as of June 30, 2025, including €20.1 million of net proceeds from At The Market (ATM) transactions[205] - The Group's minimum liquidity requirement for 2025 under the Deerfield & Orbimed Loan Agreement is €35.0 million[205] Borrowings Total borrowings decreased to €168.4 million, primarily related to the Deerfield & Orbimed Loan Agreement, which has a book value of $190.1 million (€162.2 million) and specific liquidity and revenue covenants Total Borrowings (June 30, 2025 vs December 31, 2024) | in € thousand | June 30, 2025 | December 31, 2024 | | :-------------- | :------------ | :---------------- | | NON-CURRENT | | | | Debentures and other loans | 122,362 | 166,521 | | CURRENT | | | | Debentures and other loans | 46,023 | 20,852 | | TOTAL BORROWINGS | 168,385 | 187,373 | - Total borrowings decreased to €168.4 million (from €187.4 million), with €162.2 million related to the Deerfield & Orbimed (D&O) Loan Agreement[208] - The D&O Loan Agreement has a book value of $190.1 million (€162.2 million) as of June 30, 2025, with interest-only periods extending to Q1 2026 for the initial tranche and Q1 2027 for subsequent tranches, at an interest rate of 9.95%[211] - The loan is secured by substantially all of Valneva's assets and guaranteed by its subsidiaries. Minimum liquidity requirement is €35.0 million for 2025, and a twelve-month rolling minimum revenue requirement of €115.0 million is effective for 2025[212] Borrowings by Currency (June 30, 2025 vs December 31, 2024) | in € thousand | June 30, 2025 | December 31, 2024 | | :-------------- | :------------ | :---------------- | | Borrowings denominated in EUR | 3,539 | 3,540 | | Borrowings denominated in USD | 164,847 | 183,833 | | TOTAL BORROWINGS | 168,385 | 187,373 | - No material difference between the carrying amount and fair value of borrowings was found as of June 30, 2025[216] Trade Payables and Accruals Total trade payables and accruals decreased to €21.1 million, with all amounts classified as current and their carrying amounts reflecting fair values Trade Payables and Accruals (June 30, 2025 vs December 31, 2024) | in € thousand | June 30, 2025 | December 31, 2024 | | :-------------- | :------------ | :---------------- | | Trade payables | 5,682 | 12,639 | | Accrued expenses | 15,433 | 22,883 | | TOTAL | 21,116 | 35,522 | | Less non-current portion | — | — | | CURRENT PORTION | 21,116 | 35,522 | - Total trade payables and accruals decreased to €21.1 million from €35.5 million[217] - All trade payables and accruals are current and their carrying amounts are considered to be the same as their fair values[217] Contract Liabilities Contract liabilities decreased to €0.5 million, with €2.5 million in revenue recognized from the license and technology transfer obligation under the SII agreement for IXCHIQ Development of Contract Liabilities (June 30, 2025 vs December 31, 2024) | in € thousand | June 30, 2025 | December 31, 2024 | | :-------------- | :------------ | :---------------- | | BALANCE AS AT JANUARY 1 | 3,010 | 5,697 | | Revenue recognition | (3,220) | (462) | | Redemption | — | (4,777) | | Addition | 720 | 2,500 | | Exchange rate differences | 10 | 53 | | BALANCE AS AT CLOSING DATE | 520 | 3,010 | | Less non-current portion | — | — | | CURRENT PORTION | 520 | 3,010 | - Contract liabilities decreased to €0.5 million (from €3.0 million), with €0.4 million related to upfront payments for analytical support and drug substance manufacturing[219] - Revenue of €2.5 million was recognized in H1 2025 from the license and technology transfer obligation under the SII agreement for IXCHIQ[220] Refund Liabilities Refund liabilities slightly increased to €26.4 million, with €18.4 million related to the Pfizer Collaboration and License Agreement and €6.6 million to the expected payment to GlaxoSmithKline Development of Refund Liabilities (June 30, 2025 vs December 31, 2024) | in € thousand | June 30, 2025 | December 31, 2024 | | :-------------- | :------------ | :---------------- | | BALANCE AS AT JANUARY 1 | 26,141 | 39,941 | | Additions | 4,023 | 4,013 | | Other releases | (1,505) | (19,901) | | Interest expense capitalized | 96 | 360 | | Exchange rate difference | (2,332) | 1,728 | | BALANCE AS AT CLOSING DATE | 26,423 | 26,141 | | Less non-current portion | (6,587) | (6,491) | | CURRENT PORTION | 19,836 | 19,650 | - Refund liabilities increased slightly to €26.4 million (from €26.1 million)[223] - €18.4 million (all current) is connected to the Collaboration and License Agreement with Pfizer, with €2.1 million in additions in H1 2025[223] - €6.6 million (non-current) relates to the expected payment to GlaxoSmithKline (GSK) due to the termination of strategic alliance agreements[224] Cash Flow Information Cash used in operations significantly decreased to €10.4 million in H1 2025, an improvement driven by better working capital management compared to the prior year Cash Generated/(Used) in Operations Reconciliation (H1 2025 vs H1 2024) | in € thousand | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :-------------- | :----------------------------- | :----------------------------- | | PROFIT/(LOSS) FOR THE PERIOD | (20,818) | 33,976 | | Gain from sale of Priority Review Voucher, net | — | (90,833) | | Total adjustments to reconcile profit/(loss) for the period to cash generated from/(used in) operations | 17,780 | 23,973 | | TOTAL CHANGES IN NON-CURRENT OPERATING ASSETS AND LIABILITIES | 456 | (1,117) | | Total changes in working capital | (7,788) | (31,153) | | CASH GENERATED/(USED) IN OPERATIONS | (10,369) | (65,154) | - Cash used in operations significantly decreased to €10.4 million in H1 2025 from €65.2 million in H1 2024[226] - Changes in working capital contributed to a €7.8 million cash outflow in H1 2025, an improvement from a €31.2 million outflow in H1 2024[226] Contingencies and Litigations Valneva maintains a €5.2 million provision for potential legal costs related to challenges by former Intercell shareholders regarding the 2013 merger, with the final outcome pending court decision - Valneva holds a provision of €5.2 million to cover reassessed risk and potential legal costs related to challenges by former Intercell shareholders regarding cash compensation and share exchange ratio following the 2013 merger[227][228] - The final outcome of the litigation depends on the court's decision on specific legal points[228] Related-Party Transactions Bpifrance is a related party, from whom Valneva borrowed €3.5 million, and aggregate key management compensation amounted to €4.2 million in H1 2025 - Bpifrance is considered a related party due to its influence and Board membership until June 25, 2025[230] - Valneva borrowed €3.5 million from Bpifrance, representing 80% of French Tax Authorities receivables for Research Tax Credits (2021, 2022, 2023)[231][233] - Aggregate compensation of key management amounted to €4.2 million in H1 2025 (H1 2024: €3.5 million), mostly salaries and share-based payment expenses[234] Events After the Reporting Period No events requiring adjustment or disclosure occurred between the reporting date (June 30, 2025) and the authorization date for financial statement issuance (August 11, 2025) - No events requiring adjustment to, or disclosure in, the financial statements occurred subsequent to the reporting date (June 30, 2025) and up to the date of authorization for issuance of the financial statements (August 11, 2025)[231] Responsibility Statement The content for the Responsibility Statement was not provided in the original document