Valneva SE

Valneva SE is a specialty vaccine company. The firm focuses on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. It takes a highly specialized and targeted approach to vaccine development and then applies its deep understanding of vaccine science to develop prophylactic vaccines addressing these diseases. It operates through the following segments: Commercialized products, COVID, Vaccine candidates and Technologies and services. The Commercialized products segment markets vaccines, currently IXIARO and DUKORAL vaccines, as well as third-party products. The COVID segment engages in the development, manufacturing and distribution related to COVID-19 vaccine candidate, VLA2001. The Vaccine candidates segment engages in proprietary research and development programs aiming to generate new approvable products in order to generate future cash flows from product sales or from commercialization through partnering with pharmaceutical companies, excluding COVID-19 vaccine candidate, VLA2001. The Technologies and services segment provides services and inventions at a commercialization stage. The company was founded on April 7, 1999 and is headquartered in Saint-Herblain, France.

Earnings data Q1 2021

Earnings data Q2 2021

Earnings data Q4 2021

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Valneva SE is a specialty vaccine company, which focuses on the development, manufacturing, and commercialization of prophylactic vaccines for infectious diseases. It operates through the following segments: Commercialized Products, COVID, Vaccine Candidates, and Technologies and Services. The Commercialized Products segment markets vaccines, currently IXIARO and DUKORAL vaccines, as well as third-party products. The COVID segment develops, manufactures, and distribute related to COVID-19 vaccine candidate, VLA2001. The Vaccine Candidates segment focuses on proprietary research and development programs aiming to generate new approvable products to generate future cash flows from product sales or from commercialization through partnering with pharmaceutical companies. The Technologies and Services segment offers services and inventions at a commercialization stage. The company was founded on April 7, 1999 and is headquartered in Saint-Herblain, France.

French drugmaker Valneva said on Monday that the application for its vaccine candidate against mosquito-borne viral disease chikungunya was accepted by the European Medicines Agency (EMA) which would now examine the drug in a fast-track procedure.

Valneva says EU regulator accepts its chikungunya vaccine application

Saint-Herblain (France), November 27, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the European Medicines Agency (EMA) has performed a technical validation of the Marketing Authorization Application (MAA) for Valneva's single-shot chikungunya vaccine candidate VLA1553 and has determined that all essential regulatory elements required for scientific assessment were included in the application. The MAA was granted accelerated assessment1 last month by EMA's Committee for Medicinal Products for Human Use (CHMP) based on the vaccine candidate's “major interest for public health and therapeutic innovation”2.

EMA Accepts Valneva's Chikungunya Vaccine Marketing Authorization Application for Accelerated Assessment

Saint-Herblain (France), November 15, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced the availability of documentation for its Extraordinary General Meeting (“General Meeting” or “EGM”) which will be held on December 20, 2023 at 2:00 p.m. CET at the Radisson Blu Hotel, 6 place Aristide Briand, 44000 Nantes, France.

Valneva Announces the Availability of Documentation for its Extraordinary General Meeting including Planned Changes to its Future Board of Directors

Saint-Herblain (France), November 13, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today reported positive pivotal Phase 3 immunogenicity data in adolescents for its single-dose chikungunya virus (CHIKV) vaccine candidate VLA1553. These results complement the initial Phase 3 safety data the Company reported for the trial in August 20231.

Valneva Reports Positive Pivotal Phase 3 Immunogenicity Data in Adolescents for its Single-Shot Chikungunya Vaccine Candidate

French drugmaker Valneva said on Friday the U.S. Food and Drug Administration (FDA) has approved its Chikungunya single-dose vaccine in individuals aged 18 and above.

FDA approves Valneva's Chikungunya vaccine for adults

Saint-Herblain (France), November 10, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the U.S. Food and Drug Administration (FDA) has approved IXCHIQ®, Valneva's single-dose, live-attenuated vaccine indicated for the prevention of disease caused by chikungunya virus (CHIKV) in individuals 18 years of age and older who are at increased risk of exposure to CHIKV. This indication is approved under accelerated approval based on anti-CHIKV neutralizing antibody titers. Continued approval for this indication is contingent upon verification of clinical benefit in confirmatory studies.

Valneva Announces U.S. FDA Approval of World's First Chikungunya Vaccine, IXCHIQ®

The U.S. Food and Drug Administration (FDA) on Thursday approved Valneva's single-shot vaccine for individuals 18 years of age and older who are at increased risk of exposure to chikungunya virus.

US FDA approves Valneva's chikungunya vaccine

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 industry Total 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 20231 Includes 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 vaccine Biologic License Application (BLA) currently under priority review by the U.S. Food and Drug Administration (FDA) with a PDUFA date at the end of November New Drug Submission (NDS) under review by Health Canada Marketing Authorization Application (MAA) submitted to the European Medicines Agency (EMA) in October 20232; accelerated assessment granted by EMA's Committee for Medicinal Products for Human Use (CHMP). Updated 2023 financial guidance reflects lower R&D expenditure Expected total revenues and other income between €220 million and €260 million, including: €130 million to €150 million of product sales €90 million to €110 million of other income (assuming a sale of the Priority Review Voucher received upon a potential approval of VLA1553 before year-end) Expected R&D expenses now between €60 million and €70 million (previously between €70 million and €90 million); mainly driven by lower than anticipated costs related to the closeout of the COVID-19 activities Financial Information (Unaudited results, consolidated per IFRS)         € in million Nine months ending September 30,   2023 2022 Total revenues 111.8 249.9 Product sales 106.1 74.4 Net loss (69.3) (99.1) Adjusted EBITDA3 (46.0) (38.0) Cash                  171.3                  261.0 Saint-Herblain (France), November 9, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today reported consolidated financial results for the first nine months of the year, ended September 30, 2023.

Valneva Reports Nine-Month 2023 Financial Results and Provides Corporate Updates

Pfizer

Saint-Herblain (France), November 7, 2023 – Valneva SE (Nasdaq: VALN; Euronext 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 the Jefferies London Healthcare Conference, to take place November 14-16, 2023 in London, UK.

Valneva to Present and Hold Investor Meetings at the Jefferies London Healthcare Conference

Saint-Herblain (France), October 25, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announces the submission of a marketing application with the European Medicines Agency (EMA) for approval of the Company's single-shot chikungunya vaccine candidate, VLA1553. Valneva was also granted accelerated assessment1 for the application by EMA's Committee for Medicinal Products for Human Use (CHMP) based on the vaccine candidate's “major interest for public health and therapeutic innovation”.

Valneva Submits Chikungunya Vaccine Marketing Application to EMA and Announces CHMP Accelerated Assessment

Valneva's 1H 2023 revenue declined compared to the previous year, but product sales more than doubled, driven by the recovery in the travel market. The phase 3 trial for VLA15, a Lyme disease vaccine candidate, is progressing well, with plans for official submissions to the FDA and EMA in 2026. Valneva's chikungunya vaccine, VLA1553, awaits PDUFA action by the end of November 2023, with the potential for a Priority Review Voucher valued at $100M.

Valneva's Vaccination Valor: A Buy Rating Justified

Saint Herblain ( France), September 25 , 202 3 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced the signing of a new $32 million contract with the United States (U.S.) Department of Defense (DoD) for the supply of its Japanese encephalitis (JE) vaccine, IXIARO®.

Valneva Announces New IXIARO® Supply Contract with the U.S. Government Worth a Minimum of $32 Million

Valneva SE (NASDAQ:VALN ) Q2 2023 Earnings Conference Call September 21, 2023 9:00 AM ET Company Participants Joshua Drumm - VP, IR Thomas Lingelbach - CEO Peter Buhler - CFO Conference Call Participants Maury Raycroft - Jefferies Samir Devani - Rx Securities Simon Scholes - First Berlin Damien Choplain - Oddo BHF Evan Wang - Guggenheim Securities Suzanne Van Voorthuizen - VLK Max Herrmann - Stifel Operator Good day, and thank you for standing by. Welcome to the Valneva Half Year 2023 Financial Results Call and Webcast.

Valneva SE (VALN) Q2 2023 Earnings Call Transcript

French vaccine maker Valneva on Thursday reported a smaller half-year loss, as a rebound in global tourism boosted sales of its travel vaccines Ixiario and Dukoral.

Valneva's half-year loss narrows on strong travel vaccine demand

Product sales more than doubled in the first half of 202 3 to €69.7 million compared to

Valneva Reports Half Year 2023 Financial Results and Provides Corporate Updates

Pfizer and French pharmaceutical peer Valneva announced on Thursday that a phase 2 study for its VLA15 Lyme disease vaccine candidate showed a "strong immune response" in both children and adolescents one month after receiving a booster shoot.

Pfizer, Valneva announce 'positive' results for Lyme disease vaccine candidate booster shot

Saint-Herblain (France) & New York , September 7, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) and Pfizer Inc. (NYSE: PFE) announced today positive pediatric and adolescent immunogenicity and safety data for their Lyme disease vaccine candidate, VLA15, when given as a booster. These results from the VLA15-221 Phase 2 study showed a strong anamnestic antibody response for all serotypes in pediatric (5 to 11 years of age) and adolescent participants (12 to 17 years of age), as well as in adults (18 to 65 years of age), one month after administration of a booster dose (month 19).

Valneva and Pfizer Report Positive Pediatric and Adolescent Phase 2 Booster Results for Lyme Disease Vaccine Candidate

Saint- Herb lain (France ) , August 31 , 2 02 3 – Valneva SE (Nasdaq: VALN; Euronext 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.

Valneva to Participate in Investor Conferences in the United States and Europe in September 2023

Saint - Herblain ( France), August 29 , 2 02 3 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that Health Canada has completed screening validation of the Company's regulatory application for marketing approval of its single-shot chikungunya vaccine candidate VLA1553 in persons aged 18 years and above, and has determined that the New Drug Submission (NDS) application is sufficiently complete to permit a substantive review. Based on Health Canada's performance standard to process an NDS application, the Company believes the regulatory review could be completed by mid-2024.

Health Canada Accepts Valneva's Chikungunya Vaccine License Application for Review

Saint- Herb lain (France ) , August 28 , 2 02 3 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today reported positive initial Phase 3 safety data in adolescents for its single-dose chikungunya virus (CHIKV) vaccine candidate VLA1553. Immunogenicity data for the trial are expected in November 2023.

Valneva Reports Positive Initial Phase 3 Safety Data in Adolescents for its Single-Shot Chikungunya Vaccine Candidate

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MATFORS, Sweden, Aug. 23, 2023 (GLOBE NEWSWIRE) -- NorthX Biologics AB, (‘NorthX'), a leading Nordic development and manufacturing organisation with a focus on advanced biologics, CGT (cell and gene therapy) and vaccines, today announces that it has appointed Dr Janet Hoogstraate as its new Chief Executive Officer with immediate effect. This move follows the company's strategic merger with Valneva Sweden's Clinical Trial Manufacturing Unit announced July 3, 2023

NorthX Biologics Welcomes Dr Janet Hoogstraate as New CEO Following Merger with Valneva Clinical Trials Manufacturing Unit

Up to an additional $100 million made available in two tranches Saint - Herblain ( France ), August 1 7 , 202 3 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced an agreement to increase the principal amount of its existing $100 million senior secured debt financing agreement with funds managed by leading U.S. healthcare investment firms Deerfield Management Company and OrbiMed. The add-on loan facility provides Valneva with immediate access to $50 million, with an additional $50 million available at the Company's discretion until December 31, 2023.

Valneva Announces Extension of Existing Loan Agreement

Saint - Herblain ( France), August 14 , 2 02 3 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the U.S. Food and Drug Administration (FDA) has revised the Prescription Drug User Fee Act (PDUFA) action date for the Biologics License Application (BLA) for VLA1553, Valneva's chikungunya virus vaccine candidate, from the previously communicated end of August to the end of November.

Valneva Announces PDUFA Date Extension for Chikungunya Virus Vaccine Candidate

Positive Phase 3 data from Bavarian Nordic's chikungunya virus (CHIKV) vaccine candidate, PXVX0317, reinforces bullish view on Valneva's VLA1553 due to its superior clinical profile. Valneva's VLA1553 demonstrated impressive seroresponse rates and durability, with future data releases from Bavarian Nordic's additional Phase 3 trial expected to provide a comprehensive comparison between the two vaccines. Valneva has submitted a regulatory application to Health Canada for VLA1553 approval and received Fast Track.

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