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.

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 ®

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

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.

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