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 (NasdaqGS:VALN) Q3 2025 Earnings Call November 20, 2025 09:00 AM ET Speaker2Good day, and thank you for standing by. Welcome to the Valneva 9 Month 2025 Financial Results Conference Call and Webcast. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, please press star 1 and 1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw yo ...

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 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].

Core Viewpoint - Bragar Eagel & Squire, P.C. is investigating potential claims against Valneva SE regarding possible violations of federal securities laws and unlawful business practices following adverse events related to its chikungunya virus vaccine, IXCHIQ [2][3][4] Group 1: Legal Investigation - The law firm is encouraging Valneva stockholders who have suffered losses to contact them for discussions about their legal rights [1][5] - The investigation is focused on whether Valneva has engaged in unlawful business practices that may have affected stockholder interests [2] Group 2: Recent Events Impacting Valneva - On February 25, 2025, the CDC announced an investigation into five hospitalizations for cardiac or neurologic events following vaccination with IXCHIQ, leading to a 13.57% drop in Valneva's ADR price, closing at $6.75 on February 28, 2025 [3] - On August 22, 2025, the FDA suspended the marketing application for IXCHIQ due to safety concerns, resulting in an 18.99% decline in Valneva's ADR price, closing at $9.43 on August 25, 2025 [4]

Group 1 - U.S. stock futures are lower, with Dow futures down approximately 0.2% [1] - EHang Holdings Ltd reported a significant decline in FY2025 sales guidance, reducing it from $123.299 million to $69.797 million, leading to an 8.5% drop in pre-market trading to $16.27 [1] - Molecular Partners AG experienced a 13.5% decline to $3.65 due to a wider quarterly loss [3] - Daqo New Energy Corp. saw a 9.2% decrease to $21.70 following its second-quarter results [3] - Harmony Gold Mining Company Ltd fell 6.7% to $14.67 in pre-market trading [3] - ECARX Holdings Inc. dropped 4.7% to $1.61 after its second-quarter results [3] - Valneva SE shares fell 4.6% to $9.00, with a notable 19% drop on Monday after the FDA suspended the license for IXCHIQ [3] - Rigetti Computing, Inc. decreased by 3.5% to $13.96 in pre-market trading [3]

Group 1 - U.S. stocks experienced mixed performance, with the Dow Jones index declining over 200 points on Monday [1] - Keurig Dr Pepper Inc. shares fell sharply by 7.8% to $32.38 following the announcement of its acquisition of JDE Peet's [1] - Valneva SE shares dropped 21% to $9.19 after the FDA suspended the license for IXCHIQ [3] Group 2 - DeFi Development Corp. saw its shares dip 18% to $16.51 after announcing a $125 million offering of 4.2 million shares at $12.50 per share [3] - Venu Holding Corporation's shares fell 13.3% to $15.56 after announcing an offering of 1.7 million shares [3] - Axogen, Inc. shares declined 10.2% to $14.60 due to an FDA Major Amendment designation delaying the Avance Nerve Graft decision to December 5, 2025 [3]

Company Overview - Valneva SE is a specialty vaccine company focused on developing, manufacturing, and commercializing prophylactic vaccines for infectious diseases, addressing unmet medical needs [7] - The company has advanced multiple vaccines from early R&D to approvals and currently markets three proprietary travel vaccines [8] Recent Developments - The FDA has suspended the license for Valneva's chikungunya vaccine IXCHIQ due to four new reports of serious adverse events (SAEs) consistent with chikungunya-like illness, effective immediately [1][2] - This suspension follows the FDA's earlier decision to lift a recommended pause for individuals aged 60 and older, based on an investigation of reported SAEs [2] Financial Impact - IXCHIQ sales contributed €7.5 million to Valneva's total product sales of €91 million in the first half of 2025, with a significant portion attributed to a one-time delivery of vaccine doses for a chikungunya outbreak in La Reunion [4] Commitment to Safety and Access - Valneva is committed to maintaining high safety standards and will continue to engage with health authorities regarding IXCHIQ [3] - The CEO emphasized the company's commitment to providing access to IXCHIQ globally, especially in low-and-middle-income countries affected by chikungunya outbreaks [4] Industry Context - Chikungunya virus (CHIKV) is a mosquito-borne disease that has been identified in over 110 countries, with significant medical and economic burdens expected to grow due to climate change [5][6] - The World Health Organization (WHO) has highlighted chikungunya as a major public health problem, indicating the ongoing need for effective vaccines [6]

Core Insights - Valneva SE has received marketing authorization from Health Canada for its single-dose chikungunya vaccine, IXCHIQ, for individuals aged 12 years and older, complementing previous authorizations in Canada and Europe [1][3][10] - The vaccine demonstrates a sustained immune response for 24 months in 97% of participants, indicating its long-term efficacy [2][5] - The approval is significant as chikungunya outbreaks are increasing globally, particularly in endemic regions, highlighting the need for accessible vaccination [3][4][5] Company Overview - Valneva is a specialty vaccine company focused on developing, manufacturing, and commercializing vaccines for infectious diseases, with a strong track record in advancing vaccines from R&D to market [7] - The company currently markets three proprietary travel vaccines and is advancing multiple vaccine candidates, including those for Lyme disease and Zika virus [7] Industry Context - Chikungunya virus is a mosquito-borne disease causing severe joint pain and other debilitating symptoms, with over 3.7 million cases reported in the Americas from 2013 to 2023 [6] - The World Health Organization has identified chikungunya as a major public health issue, exacerbated by climate change and the geographical spread of mosquito vectors [6] - Valneva's partnership with CEPI aims to enhance access to IXCHIQ in low- and middle-income countries, addressing the growing public health threat posed by chikungunya [4][5]