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]

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 the same period in 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] - 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][19] Business Line Data and Key Metrics Changes - IXIARO sales increased by 12.5% to EUR 74.3 million, driven by sales to the U.S. Department of Defense and increased sales in Europe [14] - DUKORAL 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] - IXCHIQ sales surged to EUR 7.6 million from EUR 1.8 million, aided by the supply of doses during a chikungunya outbreak [15] Market Data and Key Metrics Changes - The gross margin on commercial products, excluding IXCHIQ, improved to 57.2% from 48.6% in the prior year, driven by better manufacturing performance [16] - IXIARO's gross margin reached 63.2%, up from 58.8%, while DUKORAL's gross margin improved to 52.3% from 34.8% [16] Company Strategy and Development Direction - The company aims to focus on strategic investments in R&D and anticipates continuous growth in product sales, particularly from the Lyme disease vaccine, VLA15, expected to be a significant growth driver [21][22] - Valneva is working on expanding IXCHIQ into low- and middle-income countries (LMICs) and is exploring new partnerships to enhance market access [22][24] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming Lyme vaccine data, which could lead to sustained profitability post-commercialization [21][22] - The company is focused on reducing cash burn and maintaining a strong cash position to support future growth initiatives [4][19] Other Important Information - The company successfully completed debt refinancing, enhancing financial flexibility [5] - Cash at the end of September 2025 was reported at EUR 143.5 million, down from EUR 168.4 million at the end of 2024 [19] Q&A Session Summary Question: Timeline for FDA response regarding IXCHIQ - Management indicated there is no predefined process for the FDA response and hopes for a collaborative interaction, although no specific timeline can be provided [29][30] Question: Impact of currency and distributor shift on DUKORAL - 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 DUKORAL [31][32] Question: Timing for Lyme phase III readout - Management stated that Pfizer controls the process and is taking steps to ensure timely results, with no major delays anticipated [36][38] Question: IXCHIQ BLA suspension and proposed remedies - The response to the FDA focused on medical evidence and a positive risk-benefit ratio, with ongoing pharmacovigilance reviews [40][41] Question: Launch timeline for VLA15 - Management confirmed that timelines communicated by Pfizer support a launch in the autumn of 2027, contingent on regulatory submission next year [46] Question: Future growth drivers for IXCHIQ - Management sees growth opportunities in travel and endemic countries, with ongoing discussions for market access in various territories [47][48] Question: Funding considerations for Zika vaccine candidate - Management highlighted uncertainties around funding and regulatory pathways, indicating that substantial funding would be necessary to proceed with development [54][55]

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] - 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 the previous year [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 some European countries [14] - Ducoral sales decreased from EUR 22.3 million to EUR 21.5 million, impacted by foreign currency fluctuations and lower sales during the 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 a chikungunya outbreak [15] Market Data and Key Metrics Changes - The company is focusing on expanding into low- and middle-income countries (LMICs) and new territories for IXIARO, leveraging its differentiated product profile [20][21] - The Lyme disease vaccine, VLA15, is expected to be a major growth driver, with regulatory submissions anticipated in 2026 and a potential launch in autumn 2027 [20][31] Company Strategy and Development Direction - The company aims to achieve sustainable profitability post-approval and commercialization of the Lyme disease vaccine, which is seen as a significant growth catalyst [20][21] - Valneva is actively identifying new opportunities for its R&D pipeline, aiming to build a coherent strategy for future vaccine candidates [22] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming Lyme disease vaccine data, which is expected to be a pivotal moment for the company [20][37] - The company is focused on reducing cash burn and ensuring sufficient runway to reach key inflection points, with cash at September 30 reported at EUR 143.5 million [18][19] Other Important Information - The company successfully completed debt refinancing, enhancing financial flexibility [5] - Research and development expenses increased to EUR 59.7 million, partly due to costs related to the Shigella vaccine candidate [17] Q&A Session Summary Question: Timeline for FDA response regarding exchange - Management indicated there is no predefined process for the FDA response and hopes for a collaborative interaction [24][25] Question: Impact of currency and distributor shift on Ducoral sales - Management noted that the transition to a new distributor in Germany caused a technical delay in purchases, but growth for Ducoral is expected to continue [25][26] Question: Timing for Lyme phase 3 readout - Management stated that Pfizer controls the process and is taking steps to ensure an early readout, with no major delays anticipated [27][28] Question: Remedies proposed to FDA for exchange BLA suspension - The response to the FDA focused on medical evidence and positive risk-benefit ratios, with ongoing pharmacovigilance reviews [29] Question: Launch timeline for VLA15 - Management confirmed that timelines communicated by Pfizer support a launch in the autumn of 2027, contingent on regulatory submissions next year [30][31] Question: Funding considerations for Zika vaccine candidate - Management highlighted uncertainty around funding and regulatory pathways, indicating that substantial funding would be necessary to proceed with development [33][36]

Core Insights - The article emphasizes the importance of enabling Javascript and cookies in browsers to prevent access issues [1] Group 1 - The article suggests that users may face blocks if they have ad-blockers enabled [1]

Financial Performance - Total revenues for the first nine months of 2025 reached €127.0 million, an 8.9% increase compared to the same period in 2024, despite headwinds and reduced third-party sales [11] - Product sales amounted to €119.4 million, a 6.2% increase from €112.5 million in the first nine months of 2024 [51] - IXCHIQ® sales saw significant growth, reaching €7.6 million, a 330% increase compared to €1.8 million in the same period of 2024 [51] - The company experienced a significant reduction in operating cash burn, with €28.4 million compared to €76.7 million in the first nine months of 2024 [11] - Valneva anticipates product sales between €155 million and €170 million for 2025 [59] Product & Pipeline Updates - IXIARO®/JESPECT® sales increased by 12.5%, reaching €74.3 million compared to €66.0 million in the first nine months of 2024 [51] - DUKORAL® sales decreased slightly by 3.4%, with sales of €21.5 million compared to €22.3 million in the first nine months of 2024 [51] - Valneva completed all vaccinations in the VALOR Phase 3 study for VLA15 (Lyme disease vaccine) and expects efficacy read-out in H1 2026 [16, 27] - The global market for Shigella vaccine is expected to exceed $500 million annually [48] Strategic Initiatives - Valneva successfully refinanced its debt, enhancing financial flexibility to Q4 2030 [11] - The company secured a new $32.8 million IXIARO® contract with the U.S Department of Defense [16] - Valneva responded to the French government's call for IXCHIQ® to combat chikungunya outbreaks in La Réunion and Mayotte [16]

Financial Performance - Revenues for the nine months ended September 30, 2025, increased to €126,971 thousand, up 8.4% from €116,637 thousand in 2024[1] - Product sales rose to €119,397 thousand, a 6.9% increase compared to €112,475 thousand in the same period last year[1] - Operating loss for the period was €53,945 thousand, compared to an operating profit of €34,214 thousand in 2024[1] - Net loss for the period was €65,173 thousand, a significant decline from a profit of €24,740 thousand in the previous year[2] - Total comprehensive loss for the period amounted to €64,429 thousand, compared to a comprehensive income of €25,342 thousand in 2024[2] Cash and Assets - Cash and cash equivalents decreased to €143,462 thousand from €168,271 thousand at the beginning of the year[5] - Non-current assets decreased to €179,900 thousand from €201,020 thousand as of December 31, 2024[4] - Total equity as of September 30, 2025, was €150,477 thousand, down from €181,253 thousand at the end of 2024[4] - Current liabilities increased to €150,481 thousand from €114,580 thousand at the end of 2024[4] Research and Development - Research and development expenses rose to €59,729 thousand, up 23.0% from €48,567 thousand in the same period last year[1]

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 announced positive results from its Phase 1 clinical trial for VLA1601, a second-generation vaccine candidate against the Zika virus, demonstrating improved immune response and safety [1][5][7] Group 1: Clinical Trial Details - The Phase 1 trial, VLA1601-102, involved approximately 150 participants aged 18 to 49 in the U.S., who received two doses of the vaccine at varying dosages [2] - The trial evaluated the safety and immunogenicity of VLA1601, which is an aluminum-adjuvanted inactivated vaccine, with additional adjuvants tested in the low-dose group [2][4] - Data up to Day 57 indicated that VLA1601 was generally safe and well tolerated across all treatment arms, with no safety concerns identified [3] Group 2: Immunogenicity Results - VLA1601 induced an immune response across all treatment arms, with the strongest response observed in the double-adjuvanted groups, showing significantly higher neutralizing antibody titers compared to the single-adjuvant group [4] - The second-generation vaccine candidate showed higher peak seroconversion rates (>93% vs 86%) and a greater peak Geometric Mean Fold Increase of titers (>56 fold vs >7 fold) compared to the first-generation vaccine [5] Group 3: Development Context - VLA1601 is developed using the manufacturing platform of Valneva's licensed Japanese encephalitis vaccine IXIARO®, which has been optimized for other vaccine candidates [6][9] - The Chief Medical Officer of Valneva highlighted the growing public health challenge posed by Zika virus due to climate change, but noted that further development of VLA1601 will depend on securing significant funding opportunities [7]

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]