Valneva SE (NASDAQ:VALN) shared final immunogenicity and safety data on Wednesday from the Phase 2 study, VLA15-221, of the Lyme disease vaccine candidate, VLA15.Lyme disease is a bacterial infection transmitted to humans by infected ticks, often presenting with an early “bull’s-eye” rash and flu-like symptoms such as fever, headache, and fatigue.The results showed a strong anamnestic immune response and a favorable safety profile six months after a third booster dose (month 48) in all age groups, confirmin ...

Antibody levels remained well above baseline across all six serotypes and age groups sixth month after third yearly booster doseNo safety concerns observed in any age group by an independent Data Monitoring Committee (DMC)Results confirm benefits of a yearly vaccination prior to each Lyme season Saint-Herblain (France), November 26, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) today announced positive final immunogenicity and safety data from Phase 2 study, VLA15-221, of Lyme disease vaccine candid ...

Antibody levels remained well above baseline across all six serotypes and age groups sixth month after third yearly booster doseNo safety concerns observed in any age group by an independent Data Monitoring Committee (DMC)Results confirm benefits of a yearly vaccination prior to each Lyme season Saint-Herblain (France), November 26, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) today announced positive final immunogenicity and safety data from Phase 2 study, VLA15-221, of Lyme disease vaccine candid ...

Financial Data and Key Metrics Changes - Total revenues reached EUR 127 million for the nine months ended September 30, 2025, representing a growth of almost 9% compared to EUR 112.5 million in the same period of 2024 [4][16] - Product sales increased to EUR 119.4 million, up 6.2% from EUR 112 million in the first nine months of 2024 [14][16] - Operating loss reported at EUR 53.9 million compared to an operating profit of EUR 34.2 million in the prior year, primarily due to the sale of a priority review voucher in 2024 [18] Business Line Data and Key Metrics Changes - IXIARO sales reached EUR 74.3 million, increasing 12.5% year-over-year, driven by sales to the U.S. Department of Defense and increased sales in Europe [14] - Ducoral sales decreased from EUR 22.3 million to EUR 21.5 million, impacted by foreign currency fluctuations and a transition to a new distributor in Germany [14][15] - Exchange sales significantly increased to EUR 7.6 million from EUR 1.8 million, including the supply of doses to combat chikungunya outbreaks [15] Market Data and Key Metrics Changes - The company is focusing on expanding into low- and middle-income countries (LMICs) for IXIARO, leveraging its differentiated product profile [22] - The chikungunya vaccine, VLA1553, is being positioned for growth in endemic regions and travel sectors, although the U.S. market remains suspended pending FDA review [10][46] Company Strategy and Development Direction - The company aims to achieve sustainable profitability post-approval and commercialization of the Lyme disease vaccine, VLA15, expected to be a major growth driver [21][22] - Valneva is actively identifying new opportunities for its R&D pipeline, aiming to build a coherent strategy for future vaccine candidates [24] - The company is focusing on operational efficiency and reducing cash burn, with a cash position of EUR 143.5 million as of September 30, 2025 [19][20] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming Lyme vaccine data, which is anticipated to be a significant catalyst for the company [22][56] - The company is preparing for potential growth in product sales and is focused on strategic investments in R&D [21][24] - There is uncertainty regarding funding for the Zika vaccine candidate, which may affect its development moving forward [51][54] Other Important Information - The company successfully completed debt refinancing, enhancing its financial flexibility [5] - Cash used in operating activities decreased significantly to EUR 28.4 million from EUR 76.7 million in the first nine months of 2024 [20] Q&A Session Summary Question: Timeline for FDA response regarding the chikungunya vaccine - Management indicated there is no predefined process for the FDA response and hopes for collaborative interaction, but no specific timeline can be provided [29] Question: Impact of currency and distributor shift on Ducoral sales - Management acknowledged currency impacts and noted a technical delay in sales due to the transition to a new distributor in Germany, expecting continued growth for Ducoral [30][31] Question: Timing of Lyme phase 3 readout and potential delays - Management stated that Pfizer controls the process and is taking steps to ensure timely results, with no major delays anticipated [36][37] Question: Proposed remedies for the exchange BLA suspension - The response to the FDA focused on medical evidence and positive risk-benefit ratios, with ongoing pharmacovigilance reviews [40] Question: Launch timeline for VLA15 and IXIARO growth drivers - Management confirmed timelines for VLA15 support a launch in late 2027, while IXIARO's growth is expected to continue through expansion in endemic regions and travel markets [45][46] Question: Funding considerations for the Zika vaccine candidate - Management highlighted uncertainty around funding and regulatory pathways, indicating that substantial funding would be necessary to proceed with development [53][54]

Valneva (NasdaqGS:VALN) Q3 2025 Earnings Call November 20, 2025 09:00 AM ET Company ParticipantsThomas Lingelbach - CEOPeter Bühler - CFOMaury Raycroft - Equity ResearchJosh Drumm - VP of Global Investor RelationsVamil Divan - Managing DirectorTheodora Rowe Beadle - Equity Research AssociateConference Call ParticipantsRomy O'Connor - Equity Research Analyst for Life Sciences and HealthcareOperatorGood day, and thank you for standing by. Welcome to the Valneva Nine Month 2025 Financial Results Conference Cal ...

Valneva Reports First Nine Months 2025 Financial Results and Provides Corporate Updates November 20, 2025 Disclaimer This presentation does not contain or constitute an offer of, or the solicitation of an offer to buy or subscribe for, Valneva SE shares to any person in the USA or in any jurisdiction to whom or in which such offer or solicitation is unlawful. Valneva is a European company. Information distributed is subject to European disclosure requirements that are different from those of the United Stat ...

Core Insights - Valneva SE reported consolidated financial results for the first nine months of 2025, showing total revenues of €127.0 million, an increase of 8.9% compared to €116.6 million in the same period of 2024 [2][10][17] - The company experienced a net loss of €65.2 million in the first nine months of 2025, contrasting with a net profit of €24.7 million in the same period of 2024, primarily due to the absence of one-time proceeds from the sale of a Priority Review Voucher [2][28] - Valneva's financial position was strengthened through successful debt refinancing, which improved financial terms and reduced operating cash burn [2][10] Financial Performance - Total revenues for the first nine months of 2025 were €127.0 million, up from €116.6 million in 2024, driven by product sales of €119.4 million, which increased by 6.2% from €112.5 million [2][18] - Adjusted EBITDA loss was €37.7 million in the first nine months of 2025, compared to a profit of €48.6 million in the same period of 2024, influenced by the previous year's one-time sale of the Priority Review Voucher [27][28] - Cash and cash equivalents stood at €143.5 million as of September 30, 2025, down from €168.3 million at the end of 2024 [32] Product Sales and Portfolio - Valneva's commercial portfolio includes three travel vaccines: IXIARO/JESPECT, DUKORAL, and IXCHIQ, with IXIARO/JESPECT sales increasing by 12.5% to €74.3 million in the first nine months of 2025 [3][6] - DUKORAL sales decreased slightly to €21.5 million, impacted by currency fluctuations and a transition in distribution to CSL Seqirus [7][20] - IXCHIQ sales rose significantly to €7.6 million, aided by supply for a chikungunya outbreak, although U.S. license suspension affected traveler segment sales [8][9] Research and Development - Valneva is advancing its Lyme disease vaccine candidate, VLA15, with the Phase 3 VALOR study on track, and results expected in the first half of 2026 [11][12] - The company is also developing a tetravalent Shigella vaccine candidate, S4V2, which has received Fast Track designation from the FDA, indicating its potential to address unmet medical needs [13][14] - Positive Phase 1 results were reported for the Zika vaccine candidate, VLA1601, although further development will depend on securing funding [15][16] Cost Management - Operating expenses were managed effectively, with research and development expenses increasing to €59.7 million, primarily due to costs associated with the Shigella vaccine candidate [22] - Marketing and distribution expenses decreased to €28.6 million, reflecting reduced advertising and promotional spending [23] - General and administrative expenses were reduced to €29.5 million, attributed to lower recruitment and insurance costs [24]

Valneva Conference Call Summary Company Overview - **Company**: Valneva (NasdaqGS:VALN) - **Industry**: Vaccine development and infectious diseases - **Headquarters**: Vienna, Austria; incorporated in France - **Employees**: Approximately 700 - **Manufacturing Locations**: Scotland and Sweden - **Current Products**: Three proprietary vaccines marketed in Europe and North America Key Points Clinical Pipeline - Valneva is developing a Lyme disease vaccine (VLA15) in collaboration with Pfizer, with data readout expected in the first half of 2026 [2][4] - The Phase 3 study involves approximately 9,500 participants, with a 2:1 ratio of North America to Europe, and a 1:1 ratio of placebo to treatment [4] - The vaccine regimen consists of three doses followed by a booster 18 months later [4] Data Readout and Timeline - Pfizer revised the guidance for the top-line data readout from year-end 2025 to the first half of 2026 due to the seasonal nature of Lyme disease cases [5][10] - Despite the delay in data readout, commercialization is still expected to begin in late 2027, ahead of the 2028 tick season [10][30] Efficacy Expectations - Valneva anticipates a potentially higher efficacy profile for VLA15 compared to previous Lyme vaccines, with expectations of 50% efficacy after priming doses and up to 75% after the booster [21][22] - The vaccine's design includes modern, stringent assays to differentiate it from prior vaccines [20] Safety Profile - Previous clinical trials showed no concerning safety signals, and modifications were made to the vaccine to mitigate potential risks associated with arthritis observed in earlier vaccines [23][24] Regulatory Pathway - Regulatory submissions to the FDA and EMA are expected in mid-2026, with approval anticipated in early to mid-2027 [25][30] - The vaccine has fast-track designation and is expected to undergo priority review [39][40] Market Opportunity - Pfizer estimates the global market opportunity for the Lyme vaccine to exceed $1 billion annually, with Valneva set to receive tiered royalties between 14% and 22% [44][45] - Milestone payments are expected upon first commercial sales, with potential sales milestones of up to $100 million [46] Other Products and Developments - Valneva is also working on IXCHIQ, a chikungunya virus vaccine, which is currently suspended by the FDA due to safety concerns, with no clear path forward defined yet [49][50] - IXIARO, a Japanese encephalitis vaccine, is experiencing growth driven by increased travel to endemic areas, with expectations for improved gross margins as production scales up [61] Future Expectations - The company anticipates significant updates regarding the Shigella vaccine program by the end of the year, with initial efficacy data expected in early 2026 [67][75] - Valneva projects annual product sales between EUR 155 million and EUR 170 million, indicating a healthy base business [78]

Core Insights - Valneva SE, a specialty vaccine company, is engaging with institutional investors through presentations and 1-on-1 meetings at upcoming conferences in the U.S. and Europe [1][4] Group 1: Upcoming Events - Valneva will host moderated "fireside chat" presentations to discuss key value drivers and upcoming catalysts, particularly the Phase 3 trial outcomes for VLA15, its Lyme disease vaccine candidate partnered with Pfizer [2] - If the Phase 3 trial is successful, Pfizer plans to submit applications for U.S. and European market authorization in 2026, with a potential vaccine launch in the second half of 2027 [2] - The company will participate in several conferences, including the Guggenheim 2nd Annual Healthcare Innovation Conference on November 10, Stifel 2025 Healthcare Conference on November 11, and Jefferies London Healthcare Conference on November 19 [3] Group 2: Company Overview - Valneva specializes in developing, manufacturing, and commercializing prophylactic vaccines for infectious diseases, focusing on unmet medical needs [5] - The company has advanced multiple vaccines from early R&D to approvals and currently markets three proprietary travel vaccines [6] - Valneva's commercial business revenues support the advancement of its vaccine pipeline, which includes the only Lyme disease vaccine candidate in advanced clinical development and the world's most clinically advanced Shigella vaccine candidate [7]

Core Viewpoint - Valneva SE has secured a non-dilutive debt facility of up to $500 million, enhancing its financial flexibility and allowing it to focus on advancing its vaccine pipeline, particularly the Lyme disease vaccine candidate VLA15, which is expected to be commercialized by Pfizer in 2027 [1][2][3]. Financial Updates - The initial tranche of $215 million will be used to fully repay existing debt, while up to $285 million may be drawn for future business development [1][5]. - The new debt facility extends repayment from Q1 2026 to Q4 2030, lowers the interest rate, and provides access to additional capital [5][6]. - Valneva's financial outlook for 2025 has been revised, with product sales now expected between €155-170 million (previously €170-180 million) and total revenues expected to reach €165-180 million (previously €180-190 million) [7]. Business Development - The Phase 3 clinical trial for the Lyme disease vaccine candidate remains on track, with Pfizer aiming to submit a Biologics License Application to the U.S. FDA and a Marketing Authorization Application to the European Medicines Agency in 2026 [4][8]. - The VALOR trial outcomes are expected to be announced in the first half of 2026, with a potential vaccine launch by Pfizer in the second half of 2027 [8]. Strategic Partnerships - The partnership with Pharmakon Advisors is highlighted as a significant support for Valneva, reflecting confidence in the company's products and management [3][9]. - Valneva's approach focuses on developing vaccines for unmet medical needs, with a strong pipeline that includes the only Lyme disease vaccine candidate in advanced clinical development [10][12].