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)
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
Excellent progress on clinical programs Lyme Disease Vaccine Candidate VLA15 Further positive Phase 2 results reported, including first pediatric data Phase 3 expected to commence in the third quarter of 2022 Inactivated COVID-19 Vaccine Candidate VLA2001 Conditional Marketing Authorization granted by the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom (UK)Emergency use authorization granted by the National Health Regulatory Authority (NHRA) of the Kingdom of Bahrain and first vaccinations confirmed Rolling review ongoing with the European Medicines Agency (EMA); Valneva has provided responses to the latest list of questions (LOQ) Single-Shot Chiku
Saint Herblain (France), January 6, 2025 – Valneva SE (NASDAQ:VALN, PARIS:VLA), a specialty vaccine company, today announces that members of its management team will meet one-on-one with existing shareholders and hold meetings with other institutional specialist investors during the 43nd Annual J.P. Morgan Healthcare Conference, January 13-15, 2025 in San Francisco. Valneva's CEO Thomas Lingelbach and CFO Peter Bühler will discuss the Company's commercial portfolio of vaccines, which is expected to generate €160 - €170 million in revenues in 2024, and highlight upcoming catalysts from its clinical development pipeline, including the pivotal data readout for its Lyme disease vaccine later th
Saint-Herblain (France), December 4, 2024 – Valneva SE (NASDAQ:VALN, PARIS:VLA), a specialty vaccine company, today announces the publication of an article on the global health and economic burden of mosquito-borne disease chikungunya in The British Medical Journal (BMJ), one of the world's leading peer-reviewed medical journals. The article, titled, "The Global Health and Economic Burden of Chikungunya from 2011 to 2020: A Model-Driven Analysis on the Impact of an Emerging Vector-Borne Disease," shows that chikungunya has a higher disease burden than was previously estimated, and costs related to the disease are substantial. According to the BMJ article, chikungunya could significantly imp
Antibody levels remained high at 96% seroresponse in line with the two-year persistence data This long-lasting antibody persistence was comparable in older (65+) and younger adults Saint-Herblain (France), December 3, 2024 – Valneva SE (NASDAQ:VALN, PARIS:VLA), a specialty vaccine company, today reported positive antibody persistence data three years after vaccination with a single dose of its chikungunya vaccine IXCHIQ®. The results are in line with Valneva's expectations for this vaccine, confirming a strong and long-lasting antibody persistence across all age groups investigated. The three-year persistence data are also in line with positive twelve-month and two-year persistence data t
To potentially include adolescents and antibody persistence up to two years Saint Herblain (France), November 26, 2024 – Valneva SE (NASDAQ:VALN, PARIS:VLA), a specialty vaccine company, today announced that it has submitted a label extension application to the U.S. Food and Drug Administration (FDA) to potentially extend the use of its chikungunya vaccine IXCHIQ®, which is currently approved in adults, to adolescents aged 12 to 17 years. The application also includes adding the two-year antibody persistence data to the product label, which is a key differentiator for IXCHIQ®. This FDA application follows the submission of label extension applications to the European Medicines Agency (EMA)
Saint Herblain (France) and Schlieren (Zurich), November 13, 2024 – Valneva SE (NASDAQ:VALN, PARIS:VLA), a specialty vaccine company, and LimmaTech Biologics AG, a clinical-stage biotech company developing vaccines for the prevention of life-threatening diseases, announced today that the first participant has been vaccinated in a Phase 2b controlled human infection model (CHIM) study of Shigella4V2 (S4V2), the world's most clinically advanced tetravalent bioconjugate shigellosis vaccine candidate, for which Valneva obtained an exclusive worldwide license from LimmaTech1. In the CHIM study S4V03 (Identifier: NCT06615375), S4V2 will be tested for safety and preliminary efficacy in approximate
Saint-Herblain (France), November 12, 2024 – Valneva SE (NASDAQ:VALN, PARIS:VLA), a specialty vaccine company, today announced that its senior management will present and participate in 1-on-1 meetings with institutional investors at upcoming investor conferences in the United States and Europe. Chief Executive Officer Thomas Lingelbach and Chief Financial Officer Peter Bühler will host moderated "fireside chat" presentations to discuss the Company's key value drivers and upcoming catalysts, which include multiple clinical data events in 2025, most notably key Phase 3 conclusions for VLA15, the Company's Lyme disease vaccine candidate, which is partnered with Pfizer. If successful, Pfiz
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
Saint-Herblain (France), October 21, 2024 – Valneva SE (NASDAQ:VALN, PARIS:VLA), a specialty vaccine company, announces today that members of its senior leadership team will present datasets on the world's first and only approved chikungunya vaccine, IXCHIQ®, at several leading scientific conferences during the fourth quarter of 2024. At the International Society of Vaccines Annual Congress taking place in Seoul, South Korea, Valneva will present on the two-year antibody persistence and safety data of its single-dose chikungunya vaccine in adults aged 18 years and above today at 5:00 pm Korea Standard Time (KST). The Company will also display a poster at the event complementing the presenta
Saint Herblain (France) and Schlieren (Zurich), October 16, 2024 – Valneva SE (NASDAQ:VALN, PARIS:VLA), a specialty vaccine company, and LimmaTech Biologics AG, a clinical-stage biotech company developing vaccines for the prevention of life-threatening diseases, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Shigella4V (S4V), the world's most clinically advanced tetravalent bioconjugate shigellosis vaccine candidate, for which Valneva obtained an exclusive worldwide license from LimmaTech. Fast Track designation is granted by the FDA to products under development that have the potential to treat serious conditions and fill an unmet med
Live event and webcast TODAY at 10 AM ET Saint Herblain (France), October 10, 2024 –Valneva SE (NASDAQ:VALN, PARIS:VLA), a specialty vaccine company, is hosting an investor day today in New York City to discuss the Company's key value drivers over the next 12-18 months and beyond. Valneva's Chief Executive Officer Thomas Lingelbach, Chief Financial Officer Peter Bühler, and other members of the Company's senior leadership team will highlight the Company's substantial opportunity for its Lyme disease vaccine candidate led by partner Pfizer, Valneva's growing commercial vaccine business, and opportunities for continued value creation from the Company's promising R&D pipeline. Presentation
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
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