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 that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs. It currently provides three proprietary travel vaccines: IXIARO, DUKORAL, and IXCHIQ. The IXIARO is an inactivated Vero cell culture-derived Japanese encephalitis vaccine indicated for active immunization against Japanese encephalitis in adults, adolescents, children, and infants aged two months and older. The DUKORAL is a drinkable vaccine that helps prevent diarrhea caused by heat-labile toxin-producing ETEC, as well as cholera. The IXCHIQ is a single-dose, live-attenuated vaccine for the prevention of disease caused by chikungunya virus. The company also offers additional vaccines, including VLA1553, VLA15, VLA160, VLA200, VLA1601 and others. Valneva was founded on May 28, 2013 and is headquartered in Saint-Herblain, France.

Valneva Reports Full Year 2023 Revenue and Cash, Provides First 2024 Guidance 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 December 31, 2023 Excludes recent sale of the Priority Review Voucher (PRV) for $103 million (€95 million)1                                                                                                                                                                                                                                                                                                                                           Reflects significant payments related to the Phase 3 Lyme disease study, for which Valneva's cost contributions are expected to be completed in the first half 20242 First full year 2024 guidance Product sales expected between €150 million and €180 million, reflecting continued revenue growth for proprietary products and IXCHIQ®'s launch-year sales, despite anticipated supply constraints for third-party products and IXIARO® Other income anticipated between €95 million and €105 million, including the PRV sold in early 2024 for €95 million Expected R&D expenses between €65 million and €90 million Saint-Herblain (France), February 15, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) a specialty vaccine company, today reported its revenue and cash balance for the full year 2023 and provided first full year 2024 sales and R&D expense guidance. The Company will publish its 2023 audited consolidated financial statements on March 20, 2024.

Valneva Reports Full Year 2023 Revenue and Cash, Provides First 2024 Guidance

French vaccine maker Valneva said on Monday it sold the priority review voucher (PRV) it received from the U.S. Food and Drug Administration (FDA) for $103 million.

Valneva sells chikungunya vaccine priority review voucher for $103 mln

Saint-Herblain (France), February 5, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced it sold the Priority Review Voucher (PRV) it received from the U.S. Food and Drug Administration (FDA) for $103 million (€95 million).

Valneva Announces Sale of Priority Review Voucher for $103 Million

Saint-Herblain (France), January 10, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) today announced that the first participant has been vaccinated in the Phase 2 clinical trial evaluating the safety and Immunogenicity in children of two different dose levels of Valneva's single-shot chikungunya vaccine. The Company reported positive pivotal Phase 3 data in adolescents two months ago confirming the immunogenicity and safety profile observed in adults1.There is currently no approved chikungunya vaccine for children and Valneva's vaccine IXCHIQ® is currently the only licensed chikungunya vaccine2 to address this unmet medical need in adults aged 18 years and older who are at increased risk of exposure to the virus. Once available, the Phase 2 pediatric data are intended to support a Phase 3 pivotal study in children with the objective to extend the label in this age group following initial regulatory approvals in adults and possibly in adolescents.

Valneva Vaccinates First Participant in Pediatric Trial of Single-Shot Chikungunya Vaccine

Saint-Herblain (France), January 4, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announces that members of its management team including Thomas Lingelbach, CEO and Peter Bühler, CFO will hold investor meetings during the 42nd Annual J.P. Morgan Healthcare Conference, January 8 – 10, 2024 in San Francisco and virtually at the Oddo BHF Forum on January 15,2024.

Valneva to Conduct Investor Meetings during the J.P. Morgan Healthcare Conference and Oddo BHF Forum

Saint-Herblain (France), December 29, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the Company is modifying its financial guidance for 2023. Product sales guidance remains unchanged, as do anticipated R&D expenses. The €90 million to €110 million of other income related to proceeds from potential sale of the Company's priority review voucher (PRV), which was previously expected before year-end, is now expected in early 2024.

Valneva Provides Updated 2023 Financial Guidance

Anne-Marie Graffin is appointed as Chair of the Board of Directors Saint-Herblain (France), December 20, 2023 –Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that its shareholders approved the resolutions recommended by the Management Board at its Extraordinary General Meeting (EGM) held on December 20, 2023. These included the immediate transition from the Company's two-tier governance model to a one-tier model led by a Board of Directors.

Valneva Shareholders Approve EGM Resolutions Including the Transition to a Board of Directors

Pfizer

Pfizer and Valneva Complete Recruitment for Phase 3 VALOR Trial for Lyme Disease Vaccine Candidate, VLA15 9,437* participants enrolled at sites across the U.S., Europe and Canada in areas where Lyme disease is endemic Trial conclusion expected by year-end 2025 Pfizer aims to submit regulatory filings in the U.S. and Europe in 2026 New York, NY, and Saint-Herblain (France), December 4, 2023 – Pfizer Inc. (NYSE: PFE) and Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) today announced that they have completed recruitment for the Phase 3 trial Vaccine Against Lyme for Outdoor Recreationists (VALOR) (NCT05477524) for Lyme disease vaccine candidate VLA15. The trial builds on previous positive Phase 1 and 2 trial results and includes both adult and pediatric participants, with the aim to confirm the efficacy, safety, lot consistency, and immunogenicity of VLA15.

Pfizer and Valneva Complete Recruitment for Phase 3 VALOR Trial for Lyme Disease Vaccine Candidate, VLA15

Valneva Reports Positive 24-Month Antibody Persistence Data for its Single-Shot Chikungunya Vaccine IXCHIQ ®

Valneva Reports Positive 24-Month Antibody Persistence Data for its Single-Shot Chikungunya Vaccine IXCHIQ®

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

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.

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