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 ...

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 ...

Financial Data and Key Metrics Changes - Revenues for Q3 2025 were $17.2 million, a decrease of $24.5 million compared to Q3 2024, while revenues for the nine months ended September 30, 2025, were $74.8 million, down $54.7 million year-over-year [14] - Total operating expenses for Q3 2025 were $33.7 million, down from $52.4 million in Q3 2024, and for the nine months ended September 30, 2025, total operating expenses were $119.8 million compared to $191.8 million in the prior year [14][15] - The net loss for Q3 2025 was approximately $13.5 million or $0.49 per diluted share, compared to a net loss of $6.9 million or $0.26 per diluted share in Q3 2024 [16] Business Line Data and Key Metrics Changes - The ARCT-032 program for cystic fibrosis is progressing with a planned 12-week study to begin in the first half of 2026, following positive interim data from the ongoing phase 2 clinical trial [5][9] - The ARCT-810 program for ornithine transcarbamylase deficiency is preparing for regulatory meetings in 2026 to discuss pivotal trial strategies for both pediatric and adult populations [9][10] Market Data and Key Metrics Changes - The Costave COVID-19 vaccine program has faced delays in the BLA filing due to regulatory changes by the FDA, impacting commercial visibility in the U.S. [13] - The Japanese partner, Meiji Seika Pharma, has launched a two-dose vial of Costave updated for the JN.1 variant in Japan, marking the first distribution of this presentation [10] Company Strategy and Development Direction - The company is focused on advancing its mRNA therapeutics and vaccines pipeline, with a commitment to addressing the unmet medical needs in cystic fibrosis and OTC deficiency [9][18] - Cost reductions are being implemented to extend the runway for the cystic fibrosis and OTC programs, while expecting continued support from CSL for commercialization in Asia and Europe [13][17] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the ongoing clinical trials and the potential for ARCT-032 to address significant unmet medical needs in cystic fibrosis [7][8] - The company remains in a strong financial position with a cash runway extended into 2028, allowing for the achievement of near-term milestones [17] Other Important Information - The company plans to add additional sites for the upcoming 12-week study to accelerate enrollment, particularly targeting countries with higher prevalence of class one CF patients [78] - The FDA's stance on CT imaging as a potential endpoint for approval is still under discussion, with management indicating that it may serve as a supportive endpoint rather than a primary one [54] Q&A Session Summary Question: Have you been able to do some PK/PD modeling for the third-dose cohort? - Management confirmed that the third cohort is being evaluated similarly to the first two cohorts, with additional data collection planned for the 12-week study [21] Question: What are the optionalities for the OTC pivotal programs? - Management indicated that separate discussions with regulatory agencies will be held for adult and pediatric populations, focusing on different biomarkers for each group [24] Question: Do you expect improvements in mucus over time in the CF study? - Management noted that mucus plugs form in smaller airways and that improvements are expected over time, with the 12-week study designed to assess this [28] Question: What metrics will drive the go/no-go decision for the 15-mg dose? - Management stated that safety and tolerability will be key metrics, along with observing a dose response in mucus plug reduction [37] Question: When should we expect to see data from the 15-mg cohort? - Data from the 15-mg cohort is expected in the first quarter of next year, with plans to transition quickly to the 12-week study thereafter [44] Question: What is the age range for the pediatric population in the OTC program? - Management indicated that the age cutoff for pediatric patients will be determined in discussions with regulatory agencies [80]

Core Viewpoint - Changchun High-tech announced that its subsidiary, Changchun Baike Biotechnology Co., Ltd., received the "Drug Clinical Trial Approval Notice" from the National Medical Products Administration for its adsorbed acellular DTPa-Hib combined vaccine [1] Group 1 - The approved Hib vaccine is in a lyophilized form, which, when used in conjunction with the liquid form of the DTPa vaccine, reduces the number of injections required [1] - This combination aims to improve vaccination compliance among infants and young children [1]

Core Viewpoint - Tonix Pharmaceuticals Holding Corp. is actively participating in the World Vaccine Congress–Europe 2025, showcasing its advancements in vaccine development, particularly the TNX-801 Mpox vaccine, which is aimed at enhancing vaccine effectiveness against infectious diseases [1][3]. Company Overview - Tonix Pharmaceuticals is a fully-integrated biotechnology company with marketed products and a diverse pipeline of development candidates, focusing on central nervous system disorders, immunology, rare diseases, and infectious diseases [4]. - The company has received FDA approval for Tonmya, a first-in-class non-opioid analgesic for fibromyalgia, marking the first new prescription medicine approval for this condition in over 15 years [4]. - Tonix's development portfolio includes treatments for acute migraine, acute stress reaction, major depressive disorder, organ transplant rejection, autoimmune diseases, and infectious diseases [4]. Upcoming Conference Details - Dr. Sina Bavari will present on the safety, durability, and protection of the single-dose TNX-801 Mpox vaccine on October 15, 2025 [3]. - A panel discussion moderated by Dr. Zeil Rosenberg will focus on enhancing vaccine effectiveness, using Mpox as a model, featuring experts from Tonix and other institutions [3].

Summary of Novavax Conference Call Company Overview - **Company**: Novavax - **Industry**: Biotechnology, specifically vaccine development Key Points and Arguments 1. **Company Transformation**: Novavax has transitioned from a single-product company focused on COVID-19 vaccines to a more diversified biotech firm, reducing expenses and strengthening its balance sheet while maintaining capabilities for future growth [8][78]. 2. **Vaccine Approval**: The company received full approval for its COVID-19 vaccine for individuals aged 65 and older, supported by data from clinical trials involving nearly 30,000 individuals and a safety database of over 5 million vaccinated individuals [11][12]. 3. **Partnership with Sanofi**: Novavax has partnered with Sanofi for the commercialization of its COVID-19 vaccine, with Sanofi taking over responsibilities and expected to drive significant growth in the vaccine market [22][28]. 4. **Financial Milestones**: The transition to Sanofi will trigger milestone payments of $50 million and an additional $75 million upon successful tech transfer, highlighting the financial benefits of the partnership [23][24]. 5. **Market Potential**: The global vaccine market is projected to grow from $57 billion in 2023 to over $75 billion by 2030, with Novavax positioned to benefit from this growth through its partnerships and innovative technology [36][48]. 6. **Combination Vaccines**: There is a strong consumer and physician preference for combination vaccines, which Novavax aims to develop in collaboration with Sanofi, leveraging their expertise in flu vaccines [45][47]. 7. **Royalties and Cash Flow**: For every billion dollars in sales of the COVID vaccine, Novavax expects to receive approximately $200 million in royalties, with additional opportunities from combination vaccines [52][54]. 8. **Research and Development Pipeline**: Novavax is expanding its R&D pipeline, focusing on multiple assets, including oncology, RSV, and pandemic flu vaccines, with the potential for significant market opportunities [34][70]. 9. **Cost Management**: The company has made significant strides in cost-cutting and debt management, targeting non-GAAP profitability by 2027, with a projected reduction in operating costs by 85% from peak levels [78][79]. 10. **Matrix M Adjuvant**: Novavax's proprietary Matrix M adjuvant is expected to facilitate the development of combination vaccines and enhance immune responses while reducing the required antigen amount [59][60]. Additional Important Content - **Post-Marketing Commitments**: Novavax is committed to ongoing studies to evaluate the safety and efficacy of its vaccines post-approval, which is standard for vaccine manufacturers [20][21]. - **Regulatory Landscape**: The company is actively preparing for future clinical trials and regulatory submissions, emphasizing the importance of safety and immunogenicity data [61][62]. - **Public Health Impact**: Novavax aims to address significant unmet medical needs, particularly in areas like C. diff and shingles, which could provide substantial public health benefits [72][74]. This summary encapsulates the critical insights from the Novavax conference call, highlighting the company's strategic direction, financial outlook, and market opportunities in the evolving vaccine landscape.

As the US government ends contracts to make vaccines using new technology, at least a dozen countries are interested in developing their own vaccines to prepare for the next pandemic https://t.co/ym4QJQ4adX ...

Financial Performance - H1 2025 - Total revenues reached €97.6 million, representing a 38% year-over-year growth[10] - Product sales amounted to €91 million, driven by IXIARO®/JESPECT®, DUKORAL®, and IXCHIQ®[62] - IXCHIQ® sales showed significant growth, increasing by 688% to €7.5 million[62] - The company experienced a significant reduction in operating cash burn, targeting a 50% reduction compared to 2024[10] - Adjusted EBITDA was a loss of €6.0 million[64] Product Performance - H1 2025 - IXIARO®/JESPECT® sales increased by 30.6% to €54.7 million[62] - DUKORAL® sales increased by 16.4% to €17.4 million, including €1.1 million from doses supplied to Mayotte[62, 63] - Third-party product sales increased by 8.8% to €11.4 million[62] Financial Outlook - 2025 - The company projects product sales between €170 million and €180 million[70] - Total revenues are expected to be in the range of €180 million to €190 million[70] - R&D expenses are projected to be between €90 million and €100 million, partially offset by grant funding and R&D tax credits[70]

Core Viewpoint - Valneva SE reported strong financial results for the first half of 2025, with total revenues of €97.6 million, a 37.8% increase compared to the same period in 2024, while confirming its financial guidance for the year [5][6][28]. Financial Performance - Total revenues reached €97.6 million in H1 2025, up from €70.8 million in H1 2024, marking a 37.8% increase [6][28]. - Product sales amounted to €91.0 million, a 33.3% increase from €68.3 million in H1 2024 [6][10]. - The company reported a net loss of €20.8 million in H1 2025, compared to a net profit of €34.0 million in H1 2024, which included a one-time gain from the sale of a Priority Review Voucher [6][38]. - Cash and cash equivalents stood at €161.3 million as of June 30, 2025, slightly down from €168.3 million at the end of 2024 [43]. R&D and Regulatory Updates - Valneva is focused on the Phase 3 data readout for its Lyme disease vaccine candidate, VLA15, which is in collaboration with Pfizer [3][19]. - The company has made significant progress in clinical and regulatory areas, including the launch of IXCHIQ® in response to a chikungunya outbreak [7][15]. - IXCHIQ® sales increased to €7.5 million in H1 2025, compared to €1.0 million in H1 2024, benefiting from supply to La Réunion [16][17]. Commercial Developments - Valneva finalized a $32.8 million supply contract for IXIARO® with the U.S. Department of Defense [7][13]. - An exclusive agreement was signed with CSL Seqirus for the marketing and distribution of Valneva's vaccines in Germany [11]. - The company expects product sales to grow to €170-180 million in 2025, contributing to positive cash flow [6][40]. Cost Management - Operating cash burn was significantly reduced to €10.9 million in H1 2025 from €66.3 million in H1 2024, reflecting improved sales and cost management [6][40]. - Research and development expenses increased to €32.4 million in H1 2025, driven by costs related to the Shigella vaccine candidate [32].