Valneva SE, a specialty vaccine company, focuses on the development and commercialization of prophylactic vaccines for infectious diseases with unmet needs. Its commercial vaccines for travelers include IXIARO, an inactivated Vero cell culture-derived Japanese encephalitis vaccine indicated for active immunization against Japanese encephalitis; DUKORAL, an oral vaccine for the prevention of diarrhea caused by Vibrio cholera and/or heat-labile toxin producing Enterotoxigenic Escherichia coli bacterium; and VLA2001, a vaccine candidate against SARS-CoV-2. The company also develops VLA15, a vaccine candidate that has completed Phase II clinical trial against Borrelia; and VLA1553, a vaccine candidate, which is in Phase III clinical trial against the chikungunya virus. It sells its products in the United States, Canada, Germany, Austria, Nordics, the United Kingdom, other European countries, and internationally. Valneva SE has collaborations with Pfizer, Inc. to co-develop and commercialize its Lyme disease vaccine; and Instituto Butantan for the development, manufacturing, and marketing of single-shot chikungunya vaccine. The company was founded in 1998 and is headquartered in Saint-Herblain, France.
IPO Year: 2021
Exchange: NASDAQ
Website: https://valneva.com
| Date | Price Target | Rating | Analyst |
|---|---|---|---|
| 8/3/2022 | $34.00 | Buy | H.C. Wainwright |
H.C. Wainwright initiated coverage of Valneva SE with a rating of Buy and set a new price target of $34.00
6-K - Valneva SE (0001836564) (Filer)
6-K - Valneva SE (0001836564) (Filer)
6-K - Valneva SE (0001836564) (Filer)
6-K - Valneva SE (0001836564) (Filer)
6-K - Valneva SE (0001836564) (Filer)
6-K - Valneva SE (0001836564) (Filer)
6-K - Valneva SE (0001836564) (Filer)
6-K - Valneva SE (0001836564) (Filer)
6-K - Valneva SE (0001836564) (Filer)
6-K - Valneva SE (0001836564) (Filer)
Total revenues of €49.2 million compared to €32.8 million in the first quarter of 2024Cash and cash equivalents of €153.0 million at end of March 2025Further clinical and regulatory progress2025 financial outlook confirmed Saint-Herblain (France), May 7, 2025 – Valneva SE (NASDAQ:VALN, PARIS:VLA), a specialty vaccine company, today reported its financial results for the first quarter ending March 31, 2025, provided key corporate updates and confirmed its 2025 financial guidance. The condensed consolidated interim financial results are available on the Company's website (Financial Reports – Valneva). Valneva will provide a live webcast of its first quarter 2025 results conference call begi
Met 2024 growth targets for product sales (+13% vs 2023) and total revenues (+10% vs 2023)Strong year-end cash position of €168.3 million including sale of Priority Review Voucher1, successful private placement and 67% reduction in operating cash burnSubstantial clinical and regulatory progress in 2024; further data readouts, product approvals and label extensions anticipated in 20252025 outlook reflects solid revenue growth and positive commercial cash flows to support strategic R&D investments with lower operating cash burn Saint-Herblain (France), March 20, 2025 – Valneva SE (NASDAQ:VALN, PARIS:VLA), a specialty vaccine company, today reported its consolidated financial results for the y
Nine-Month Key Financial Highlights Total revenues of €116.6 million, including product sales of €112.5 millionNet Profit of €24.7 million, including proceeds from the Priority Review Voucher (PRV)1 sale Operating profit of €34.2 million compared to an operating loss of €57.2 million in the first nine-months of 2023 Cash position of €156.3 million Includes €61.2 million in gross proceeds from recent private placement2Lower cash burn expected in the second half of 2024 as cost contributions to the agreed R&D budget for partnered Lyme disease program were completed in the second quarter of the year Full-year 2024 Financial Guidance Narrowed Expected total product sales according to guidan
First-Half Sales Performance in Line with Full-Year 2024 Guidance Total revenues of €70.8 million, including product sales of €68.3 million, in line with anticipated supply and sales phasingNet Profit of €34.0 million, including proceeds from PRV sale Operating profit of €46.7 million compared to an operating loss of €35.0 million in the first half of 2023 Cash position of €131.4 million Substantially lower cash burn expected in the second half of 2024 as Valneva completed its cost contributions to the agreed R&D budget for its partnered Lyme disease program in the second quarterSignificantly extended cash runway with update of debt financing agreement1 Full-year 2024 Financial
Valneva Reports First Quarter 2024 Financial Results and Provides Corporate Updates Q1 financial highlights Total revenues of €32.8 million, including sales of €32.1 million, on track to meet anticipated full year guidance Cash position of €176.6 million, including €95 million from sale of Priority Review Voucher (PRV)1. Significantly extended cash runway with recent update of debt financing agreement2Substantially lower cash burn expected in 2024 as Valneva expects to complete its cost contributions for the Lyme disease Phase 3 study in the second quarter Net Profit of €58.9 million, reflecting PRV sale 2024 financial guidance confirmed Expected tot
Total revenues of €153.7 million, including product sales of €144.6 million Product sales surpassed pre-pandemic (2019) sales by 12% and 2022 sales by 26%Excluding COVID-19 vaccine sales, product sales grew by 63% compared to 2022 Cash position of €126.1 million at year-end 2023 enhanced by €95 million from sale of Priority Review Voucher (PRV)1 Extended the interest-only period of existing debt financing agreement to January 2026 significantly extending cash runway2Operational business considered sufficiently funded (excluding debt repayment) until commercial revenues from Lyme program enable sustained profitability Excellent progress across R&D pipeline Appr
Product sales of €106.1 million, an increase of 42.6% compared to the first nine months of 2022 IXIARO® and DUKORAL® sales benefited from a continued recovery of the travel industryTotal revenues of €111.8 million in the first nine months of 2023 Cash position of €171.3 million as of September 30, 2023 Includes $50 million of the $100 million available following upsize of credit facility with leading U.S. Healthcare Funds Deerfield and OrbiMed in August 20231Includes a significant payment made to Pfizer in the third quarter of 2023 related to the companies' Phase 3 Lyme disease study "VALOR" Chikungunya: progressing towards potential licensure of the world's first chikungunya vacci
Product sales more than doubled in the first half of 2023 to €69.7 million compared to €33.3 million in the first half of 2022 Driven by IXIARO® and DUKORAL® sales, both of which benefited from a continued recovery of the travel industry as well as from price increasesBringing total revenues to €73.7 million in the first half of 2023 Strong cash position of €204.4 million as at June 30, 2023 Excludes up to an additional $100 million made available as part of a recent upsized financing arrangement with leading U.S. Healthcare Funds Deerfield and OrbiMed1 Chikungunya: progressing towards delivery of the world's first chikungunya vaccine Biologic License Application (BLA) current
Saint-Herblain (France), August 31, 2023 – Valneva SE (NASDAQ:VALN, PARIS:VLA), a specialty vaccine company, today announced that members of its senior leadership team are scheduled to participate in 1-on-1 meetings with institutional investors at the following investor conferences in September 2023. The Company will discuss its single-dose vaccine candidate against the chikungunya virus (VLA1553), currently under priority review by the U.S. FDA with a Prescription Drug User Fee Act (PDUFA) action date planned for end of November 20231, as well as its Lyme disease vaccine candidate (VLA15), which is currently in Phase 3 clinical trials led by Valneva's development partner Pfizer. The Comp
Product sales increased 98.6% to €32.1 million in the first quarter of 2023 compared to €16.2 million in the first quarter of 2022 Driven by IXIARO® and DUKORAL® sales both of which more than quadrupled year-over-yearTotal revenues of €33.5 million in the first quarter of 2023 compared to €21.8 million in the first quarter of 2022 Strong cash position of €254.5 million at March 31, 2023 Chikungunya: progressing towards delivery of the world's first chikungunya vaccine Prescription Drug User Fee Act (PDUFA) review goal date confirmed for end of August 2023 by the U.S. Food and Drug Administration (FDA) Additional regulatory submission process to be initiated in the second quarter of 2023
Saint-Herblain, France, June 26, 2025 – Valneva SE, (NASDAQ:VALN, PARIS:VLA), a specialty vaccine company, today announced an exclusive agreement with CSL Seqirus, one of the world's largest influenza vaccine companies, for the marketing and distribution of Valneva's three proprietary vaccines in Germany. Under the agreed terms, CSL Seqirus will start commercializing Valneva's single-dose chikungunya vaccine IXCHIQ® from July 2025, and Valneva's Japanese Encephalitis vaccine IXIARO® and cholera/ETEC1 vaccine DUKORAL® from January 2026. This new agreement with CSL Seqirus replaces the marketing and distribution agreement Valneva signed with Bavarian Nordic in 20212, which is due to conclude
Saint-Herblain (France), June 25, 2025 – Valneva SE (NASDAQ:VALN, PARIS:VLA), a specialty vaccine company, today announced that all the resolutions recommended by the Board of Directors were approved by the shareholders at its Annual General Meeting held today in Lyon, France. Among the adopted resolutions were the approval of the 2024 financial statements, delegations for the Board of Directors to increase Valneva's share capital and/or issue financial instruments, the appointment of Dr. Gerd Zettlmeissl to the Board for a three-year term and the reappointment of Mr. James Sulat for a one-year term. Dr. Gerd Zettlmeissl is a vaccine expert and Biotech Entrepreneur with more than 30 years
Saint-Herblain (France), June 26, 2024 – Valneva SE (NASDAQ:VALN, PARIS:VLA), a specialty vaccine company, today announced that all the resolutions recommended by the Board of Directors were approved by the shareholders at its Combined General Meeting (CGM) held today in Lyon, France. Among the adopted resolutions were approval of the 2023 financial statements, delegations for the management board to increase Valneva's share capital and/or issue financial instruments, and the appointment of a new director to its Board. Ms. Danièle Guyot-Caparros was appointed to Valneva's Board of Directors for a three-year term. Ms. Guyot-Caparros has a proven track record in finance and business
Saint-Herblain (France), May 21, 2024 – Valneva SE (NASDAQ:VALN, PARIS:VLA), a specialty vaccine company, today announced the appointment of Dr. Hanneke Schuitemaker, Ph.D. as Chief Scientific Officer (CSO) and Executive Committee member, effective June 3, 2024. Valneva decided to complement its Executive Team with an accomplished R&D leader to oversee the further evolution of the Company´s R&D portfolio. Specifically, Dr. Schuitemaker will focus on accelerating Valneva's pre-clinical and translational R&D activities in support of the Company's strategic ambition to provide first-, best- or only-in-class vaccine solutions. Dr. Schuitemaker brings more than two decades of experience in vacc
Saint-Herblain (France), June 21, 2023 – Valneva SE (NASDAQ:VALN, PARIS:VLA), a specialty vaccine company, today announced that all the resolutions recommended by the Management Board were approved by the shareholders at its Annual General Meeting (AGM) held today in Lyon, France. Among the adopted resolutions were approval of the 2022 financial statements, delegations for the management board to increase Valneva's share capital and/or issue financial instruments, as well as the appointment of a new Supervisory Board member and the reappointment of two of them. Dr Kathrin U Jansen, Ph.D., a German national with over 30 years of vaccine R&D experience, was appointed to Valneva's Supervisory
Saint-Herblain (France), November 17, 2022 – Valneva SE (NASDAQ:VALN, PARIS:VLA), a specialty vaccine company, today announced the appointment of Dipal Patel as Chief Commercial Officer (CCO) and Management Board member. With this newly created role, Valneva strengthens its management team with a recognized commercial industry leader as the Company advances its chikungunya vaccine candidate towards potential market entry in 2023. Ms. Patel is an established commercial leader with over 23 years of experience in the pharmaceutical sector covering commercial strategy, execution, market access and lifecycle management. Over her career, she has held roles of increasing responsibilities across mu
Saint-Herblain (France), June 24, 2022 – Valneva SE (NASDAQ:VALN, PARIS:VLA), a specialty vaccine company, today announced that all the resolutions recommended by the Management Board were approved by the shareholders at its Annual General Meeting (AGM) held yesterday in Paris. Among the adopted resolutions were approval of the 2021 financial statements, delegations for the management board to increase Valneva's share capital and/or issue financial instruments, and the appointment, for a three-year term, of two new Supervisory Board members. Bpifrance Participations was appointed to Valneva's Supervisor Board and will be represented by Maïlys Ferrère. Ms. Ferrère, a French national, is
Saint-Herblain (France), May 31, 2022 – Valneva SE (NASDAQ:VALN, PARIS:VLA), a specialty vaccine company, announced today the appointment of leading vaccine experts Dr. Thomas Decker and Dr. Michael Pfleiderer to its Scientific Advisory Board (SAB). Dr. Thomas Decker is a professor of Immunobiology at the Max Perutz Labs of the University of Vienna. His experience as an immunobiologist stems from more than 30 years of research and teaching in Germany, Sweden, Austria and the USA, with a focus on the molecular aspects of immunity to infection. During his career, Dr. Decker also served as a consultant for several pharmaceutical companies. He was Chair of the Department of Microbiology and Gen
ShouTi Inc., a clinical-stage global biopharmaceutical company developing novel oral therapeutics to treat a wide range of chronic diseases, today announced the appointment of Sharon Tetlow to the company's board of directors. Ms. Tetlow will also serve as chair of the audit committee. "On behalf of the board and management team at ShouTi, I am pleased to welcome Sharon to the board," said Daniel Welch, Chairman of the Board, ShouTi. "Sharon is an accomplished life sciences finance executive whose deep financial strategy and compliance expertise will be instrumental in leading our audit committee. With an outstanding track record of advising biopharmaceutical companies, Sharon's perspectiv
Saint Herblain (France), July, 11 2025 – Valneva SE (NASDAQ:VALN, PARIS:VLA), a specialty vaccine company, today announced that the European Medicines Agency (EMA) will lift the temporary restriction on vaccinating people aged 65 years and above after concluding a thorough review of Valneva's single-dose chikungunya vaccine IXCHIQ® by EMA's safety committee (PRAC). The committee initiated its review at the beginning of May following the occurrence of serious side effects mainly in elderly people with several underlying medical conditions. In a press release published today on its website1, EMA underlined that the vaccine is already contraindicated for people with a weakened immune system a
Saint-Herblain, France, June 26, 2025 – Valneva SE, (NASDAQ:VALN, PARIS:VLA), a specialty vaccine company, today announced an exclusive agreement with CSL Seqirus, one of the world's largest influenza vaccine companies, for the marketing and distribution of Valneva's three proprietary vaccines in Germany. Under the agreed terms, CSL Seqirus will start commercializing Valneva's single-dose chikungunya vaccine IXCHIQ® from July 2025, and Valneva's Japanese Encephalitis vaccine IXIARO® and cholera/ETEC1 vaccine DUKORAL® from January 2026. This new agreement with CSL Seqirus replaces the marketing and distribution agreement Valneva signed with Bavarian Nordic in 20212, which is due to conclude
Saint-Herblain (France), June 25, 2025 – Valneva SE (NASDAQ:VALN, PARIS:VLA), a specialty vaccine company, today announced that all the resolutions recommended by the Board of Directors were approved by the shareholders at its Annual General Meeting held today in Lyon, France. Among the adopted resolutions were the approval of the 2024 financial statements, delegations for the Board of Directors to increase Valneva's share capital and/or issue financial instruments, the appointment of Dr. Gerd Zettlmeissl to the Board for a three-year term and the reappointment of Mr. James Sulat for a one-year term. Dr. Gerd Zettlmeissl is a vaccine expert and Biotech Entrepreneur with more than 30 years
IXCHIQ® was well tolerated by children aged one to eleven years regardless of the dose or previous chikungunya infection (CHIKV)Antibody levels remained high after six months in both dose groups, although more robust with the full doseSix-month data confirm full dose selection for pivotal Phase 3 trial Saint-Herblain (France), June 5, 2025 – Valneva SE (NASDAQ:VALN, PARIS:VLA), a specialty vaccine company, today announced positive six-month antibody persistence and safety data for its Phase 2 clinical trial evaluating the safety and immunogenicity of two different dose levels of its single-shot chikungunya vaccine, IXCHIQ®, in 304 children. Partially funded by the Coalition for Epidemic Pre
Saint-Herblain (France), June 4, 2025 – Valneva SE (NASDAQ:VALN, PARIS:VLA), a specialty vaccine company ("the Company"), today announced the availability of documentation for its Combined General Meeting ("the Meeting") to be held on June 25, 2025 at 2:00 p.m. CEST at the Sofitel Lyon Bellecour Hotel, 20 quai du Docteur Gailleton, 69002 Lyon (France). The Preliminary Notice of Meeting – including the agenda, the draft resolutions proposed by the Board of Directors, and instructions for participation and voting to the Meeting – was published in the Bulletin des Annonces Légales Obligatoires (BALO) on May 21, 2025. The information and preparatory documents related to this Meeting are avail
Saint-Herblain (France), May 26, 2025 – Valneva SE (NASDAQ:VALN, PARIS:VLA), a specialty vaccine company, today announced that its senior management will present and hold investor meetings at several upcoming investor conferences in the United States and Europe in June 2025. Key topics for discussion include Valneva's commercial stage vaccines and its differentiated portfolio of vaccine candidates, including VLA15, the world's leading Lyme disease vaccine candidate. VLA15 is partnered with Pfizer and currently being evaluated in a pivotal Phase 3 trial for which the Company expects first data at the end of 2025. Institutional investors who would like to meet 1on1 with management at any of
Saint Herblain (France), May, 12 2025 – Valneva SE (NASDAQ:VALN, PARIS:VLA), a specialty vaccine company, today announced that the U.S. Food and Drug Association (FDA) and the U.S. Centers for Disease Control and Prevention (CDC), in a joint communication to the medical community, have recommended a pause in the use of Valneva's single-dose live attenuated chikungunya vaccine IXCHIQ® in elderly individuals while ongoing investigations into reported serious adverse events (SAEs) are completed. This update follows an earlier recommendation from the U.S. Advisory Committee on Immunization Practices (ACIP) to include a precaution related to the use of IXCHIQ® in persons aged 65 and over and a si
Saint Herblain (France), May, 07 2025 – Valneva SE (NASDAQ:VALN, PARIS:VLA), a specialty vaccine company, today announced that the European Medicines Agency (EMA) has started a review of Valneva's single-dose live attenuated chikungunya vaccine IXCHIQ® based on reports of serious adverse events (SAEs) in elderly people. As a temporary measure, while this review is ongoing, EMA has suspended the use of the vaccine for individuals over 65 years old. EMA has maintained current recommendations for IXCHIQ® for people from 12 to 64 years of age. The decision was taken following a plenary meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) on May 5, 2025 and is based on reports of 17
Total revenues of €49.2 million compared to €32.8 million in the first quarter of 2024Cash and cash equivalents of €153.0 million at end of March 2025Further clinical and regulatory progress2025 financial outlook confirmed Saint-Herblain (France), May 7, 2025 – Valneva SE (NASDAQ:VALN, PARIS:VLA), a specialty vaccine company, today reported its financial results for the first quarter ending March 31, 2025, provided key corporate updates and confirmed its 2025 financial guidance. The condensed consolidated interim financial results are available on the Company's website (Financial Reports – Valneva). Valneva will provide a live webcast of its first quarter 2025 results conference call begi
Saint Herblain (France), April 26, 2025 – Valneva SE (NASDAQ:VALN, PARIS:VLA), a specialty vaccine company, today announced that France's national public health agency, the Haute Autorité de Santé (HAS), has updated its recommendation for use of Valneva's single-dose chikungunya vaccine IXCHIQ® for the prevention of disease caused by the chikungunya virus (CHIKV) following reports of serious adverse events (SAEs) in elderly people with comorbidities during the ongoing vaccination campaign in La Reunion and Mayotte. Valneva has been responding to the French government's call for vaccine supply of IXCHIQ® in La Reunion1 as the island is going through a major chikungunya outbreak with ~ 40,000
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