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.

Oslo, Norway, and Saint-Herblain, France, July 22, 2024—The Coalition for Epidemic Preparedness Innovations (CEPI) and Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, have expanded their partnership to support broader access to the world's first chikungunya vaccine, IXCHIQ®, in Low- and Middle-Income countries (LMICs), as well as post-marketing trials and potential label extensions in children, adolescents and pregnant women.

CEPI Expands Partnership with Valneva with a $41.3 Million Grant to Support Broader Access to the World's First Chikungunya Vaccine

Pfizer

On Wednesday, Pfizer Inc PFE and Valneva SE VALN announced that the participants of the Phase 3 VALOR trial have completed the primary vaccination series (three doses) of Lyme disease vaccine candidate VLA15.

Pfizer/Valneva's Vaccine Study For Tick-Borne Infection Completes Primary Vaccination Series, Plans Approval In 2026

New York, NY and Saint-Herblain (France), July 17, 2024 – Pfizer Inc. (NYSE: PFE) and Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) today announced that the participants of the Phase 3 trial “Vaccine Against Lyme for Outdoor Recreationists” (VALOR) have completed the primary vaccination series (three doses) of Lyme disease vaccine candidate VLA15. Participants will be monitored for the occurrence of Lyme disease cases until the end of the Lyme disease season in 2025.1 ,

Phase 3 VALOR Lyme Disease Trial: Valneva and Pfizer Announce Primary Vaccination Series Completion

Valneva (VALN) gets European Commission???s marketing authorization in Europe for Valneva?

Valneva (VALN) Gets EC's Approval on Chikungunya Vaccine

Saint Herblain (France), July 1, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the European Commission (EC) has granted marketing authorization in Europe for Valneva's single-dose vaccine, IXCHIQ®, for the prevention of disease caused by the chikungunya virus in individuals 18 years of age and older. The approval was unanimously endorsed by Member States following a stringent assessment by the European Medicines Agency (EMA)1. The EC decision marks the third approval the Company has received for IXCHIQ® following approval from the U.S. Food and Drug Administration (FDA) in November 2023 and Health Canada last month2. The Company expects to deliver the first doses in Europe in the fourth quarter of 2024.

Valneva Receives Marketing Authorization in Europe for the World's First Chikungunya Vaccine, IXCHIQ®

Saint-Herblain (France), June 26, 2024 – Valneva SE (Nasdaq: VALN; Euronext 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.

Valneva Announces Successful Outcome of its Combined General Meeting and Appointment of a New Director to its Board

Valneva's (VALN) IXCHIQ, the world's only licensed chikungunya vaccine, is a critical tool in combating this public health threat.

Valneva's (VALN) CHIKV Vaccine Gets Health Canada's Approval

Saint-Herblain (France), June 24, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that Health Canada has approved IXCHIQ®, Valneva's single-dose vaccine for the prevention of disease caused by the chikungunya virus in individuals 18 years of age and older. This decision marks the second approval the Company has received for IXCHIQ® following approval from the U.S. Food and Drug Administration (FDA) in November 2023. The European Medicines Agency (EMA) also recently recommended marketing authorization of the vaccine in Europe, and a formal decision is expected in the third quarter of 2024.

Valneva Announces Health Canada Approval of the World's First Chikungunya Vaccine, IXCHIQ®

Saint-Herblain (France), June 5, 2024 – Valneva SE (Nasdaq: VALN; Euronext 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 26, 2024 at 2:00 p.m. CEST at the Sofitel Lyon Bellecour Hotel, 20 quai du Docteur Gailleton, 69002 Lyon (France).

Valneva Announces Availability of Documentation for its Combined Shareholder Meeting and Provides Corporate Update

Saint-Herblain (France), June 4, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that management will participate at several upcoming investor conferences in the United States and Europe during June 2024.

Valneva to Present and Hold Investor Meetings at Upcoming Conferences in June

Saint-Herblain (France), June 3, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the results of two Phase 2 clinical trials of Lyme disease vaccine candidate, VLA15, were published in the peer-reviewed medical journal, The Lancet Infectious Diseases. These trials, as well as a third Phase 2 trial in pediatric participants, supported the design of the current pivotal Phase 3 trial, ‘Vaccine Against Lyme for Outdoor Recreationists' (VALOR).

Valneva Announces Publication of Lyme Disease Phase 2 Trials in the Lancet Infectious Diseases

Saint Herblain (France), May 31, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending authorization of Valneva's single-dose vaccine for the prevention of disease caused by the chikungunya virus in individuals 18 years of age and older.

Valneva Receives EMA's Positive CHMP Opinion for its Chikungunya Vaccine

The European Medicines Agency (EMA) recommended the use of Valneva's single-shot vaccine for chikungunya virus, the regulator said on Friday.

EU regulator recommends use of Valneva's chikungunya vaccine

Saint-Herblain (France), May 21, 2024 – Valneva SE (Nasdaq: VALN; Euronext 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 Appoints Dr. Hanneke Schuitemaker, Ph.D. as Chief Scientific Officer

Results Intended to Support Filing for Potential Label Extension for Use in Adolescents Saint-Herblain (France), May 13, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today reported further positive pivotal Phase 3 data in adolescents for its single-shot chikungunya virus (CHIKV) vaccine. Following the initial analysis up to Day 29 post-vaccination, the most recent analysis of study VLA1553-321 evaluated the safety and immunogenicity six months (Day 180) after vaccination with a single dose of the vaccine.

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

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 agreement2 Substantially 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 total revenues between €170 million and €190 million, including: €160 million to €180 million of sales driven by growth of Valneva's proprietary products Expected R&D investments between €60 million and €75 million, mostly dedicated to ongoing chikungunya development activities, the Zika trial and advancement of pre-clinical programs Expected Other income between €100 million and €110 million, reflecting €95 million in proceeds from the PRV sale Strong R&D execution Single-shot chikungunya vaccine IXCHIQ® recommended by ACIP and adopted by U.S. CDC3; Regulatory processes with the European, Canadian and Brazilian authorities on track; Six-month data for Phase 3 adolescent study of IXCHIQ® to be reported shortly and label extensions to be submitted based on results; Enrolment of children for pediatric Phase 2 study on track; Primary vaccinations for all participants in the VALOR Lyme disease Phase 3 trial expected to be completed in Q2; Phase 1 clinical trial for second-generation Zika vaccine candidate initiated4.

Valneva Reports First Quarter 2024 Financial Results and Provides Corporate Updates

Saint-Herblain (France), March 26, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced the initiation of a Phase 1 clinical trial to investigate the

Valneva Initiates Phase 1 Trial of Second-Generation Zika Vaccine Candidate

Saint-Herblain (France), March 25, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, announced today the filing, on March 22, 2024, of its 2023 Universal Registration Document (URD) with the French Financial Markets Authority (AMF) under the filing number D.24-0157 and its Form 20-F with the U.S. Securities and Exchange Commission (SEC).

Valneva Announces Filing of 2023 Universal Registration Document and US Form 20-F

Saint-Herblain (France), March 21, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced it will present on its single-shot chikungunya vaccine, IXCHIQ®, moderate a roundtable on the Zika and chikungunya viruses, and participate in a panel discussion on efforts to eradicate chikungunya at the 24th World Vaccine Congress, which will take place between April 1-4, 2024 at the Walter E. Washington convention center in Washington, D.C. The Company will have a display in the exhibit area of the congress at booth #433.

Valneva to Present on its Chikungunya Vaccine IXCHIQ®, Participate in Multiple Events at the 24th World Vaccine Congress in Washington D.C.

Valneva SE (VALN) Q4 2023 Earnings Call Transcript

French biotech company Valneva on Wednesday raised its product sales guidance and said it now expects revenues of between 170 million euros and 190 million euros ($184.72 million to $206.45 million) in 2024, as it anticipates sales growth of its travel vaccines and the launch of Ixiaro.

French biotech company Valneva raises product sales 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 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 runway2 Operational business considered sufficiently funded (excluding debt repayment) until commercial revenues from Lyme program enable sustained profitability Excellent progress across R&D pipeline          Approval of single-shot chikungunya vaccine IXCHIQ® in the United States (U.S.) The world's first and only vaccine to address this significant unmet medical need U.S. CDC recently adopted ACIP recommendations3 Regulatory reviews ongoing in Europe, Canada and Brazil Completion of recruitment for Lyme disease Phase 3 study conducted in collaboration with Pfizer All execution milestones on track Advancing second-generation ZIKA vaccine candidate into Phase 1 clinical trial Addressing a re-emerging medical need Updated FY 2024 guidance Valneva raises its 2024 product sales4 guidance to between €160 million and €180 million due to an improved outlook regarding the IXIARO® supply constraints that were anticipated in February 2024.As such, 2024 total revenues are now expected to reach between €170 million and €190 million compared to €153.7 million in 2023, driven by continued sales growth of the Company's proprietary travel vaccines and the launch-year sales of IXCHIQ®.Sales are expected to grow this year despite an estimated 20-30% reduction in third-party sales as a result of anticipated supply constraints.In 2024, the Company anticipates lower R&D expenses than previously communicated, narrowing guidance to €60 million to €75 million, based on additional visibility for its chikungunya- and Zika- related expenses. Additionally, Valneva expects non-dilutive contributions from institutions for R&D costs in connection with its ongoing chikungunya activities and the product tech transfers to Valneva's brand-new state-of the art facility (“Almeida”) in Scotland.

Valneva Reports Full Year 2023 Results and Provides Business Updates and Outlook

Saint-Herblain (France), March 18, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced an agreement with funds managed by leading U.S. healthcare investment firms Deerfield Management Company and OrbiMed to extend the interest-only period of its existing loan by eighteen months.

Valneva Announces Extension of the Interest-Only Period of Its Debt Facility with Deerfield and OrbiMed

Saint-Herblain (France), March 4, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that its senior management will participate at upcoming investor conferences in the United States and Europe. CEO Thomas Lingelbach will present Valneva at the TD Cowen 44th Annual Health Care Conference, taking place March 4 - 6, 2024, in Boston, MA. Mr. Lingelbach and CFO Peter Bühler will also meet with institutional investors during the Van Lanschot Kempen Life Sciences Conference, held April 16 - 17, 2024, in Amsterdam, The Netherlands.

Valneva to Present at Upcoming TD Cowen and Van Lanschot Kempen Healthcare Investor Conferences

U.S. CDC Advisory Committee (ACIP) Recommends Use of Valneva's Single-Dose Chikungunya Vaccine IXCHIQ ®

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