Valneva SE ( VALN ) NASDAQ Global Select

Cena: 6.0 ( -2.44% )

Aktualizacja 06-13 21:59
NASDAQ Global Select
Branża: Biotechnology

Notowania:


Informacje o spółce:
Sektor: Zdrowie
Branża: Biotechnology
Zatrudnienie: 676
Giełda: NASDAQ Global Select
Ilość akcji w obrocie: 100%
Ilość akcji: 69 386 339
Debiut giełdowy: 2021-05-05
WWW: https://valneva.com
CEO: Mr. Thomas Lingelbach
Adres: 6 rue Alain Bombard
Siedziba: 44800 Saint-Herblain
ISIN: US92025Y1038
Opis firmy:

Valneva SE, specjalistyczna firma szczepionkowa, koncentruje się na rozwoju i komercjalizacji profilaktycznych szczepionek na choroby zakaźne o niezaspokojonych potrzebach. Jego komercyjne szczepionki dla podróżników obejmują IXiro, inaktywowaną japońską szczepionkę przeciwbólową komórek Vero, wskazaną na aktywną immunizację przeciwko japońskiemu zapaleniu mózgu; Dukoral, doustna szczepionka do zapobiegania biegunce spowodowanej przez wibrio cholery i/lub toksyny enterotoksyczne Escherichia coli produkująca toksynę; oraz VLA2001, kandydat na szczepionkę przeciwko SARS-COV-2. Firma opracowuje również VLA15, kandydat na szczepionkę, który zakończył badanie kliniczne fazy II przeciwko Borrelii; oraz VLA1553, kandydat na szczepionkę, który jest w badaniu klinicznym fazy III przeciwko wirusowi Chikungunya. Sprzedaje swoje produkty w Stanach Zjednoczonych, Kanadzie, Niemczech, Austrii, Nordycie, Wielkiej Brytanii, innych krajach europejskich i na arenie międzynarodowej. Valneva SE współpracuje z Pfizer, Inc. w celu współistniejącego i komercjalizacji szczepionki z boreliozy; oraz Instituto Butantan dla rozwoju, produkcji i marketingu szczepionki Chikungunya. Firma została założona w 1998 roku i ma siedzibę w Saint-Herblain we Francji.

Wskaźniki finansowe
Kapitalizacja (USD) 510 191 034
Aktywa: 516 614 000
Cena: 6.0
Wskaźnik Altman Z-Score: -0.5
Słaby (wysokie ryzyko bankructwa)
Dywidenda: 0
P/E: -4.7
Ilość akcji w obrocie: 100%
Średni wolumen: 75 919
Ilość akcji 85 031 839
Wskaźniki finansowe
Przychody TTM 158 536 000
Zobowiązania: 299 145 000
Przedział 52 tyg.: 3.62 - 8.661
Piotroski F-Score: 2
Słaby (niska jakość finansowa)
EPS: -1.3
P/E branży: 26.1
Beta: 1.02
Raport okresowy: 2025-08-12
WWW: https://valneva.com
Zarząd
Imie i Nazwisko Stanowisko Wynagrodzenie Rok urodzenia
Mr. Thomas Lingelbach President, Chief Executive Officer & Director 999 565 1963
Mr. Peter Buhler Chief Financial Officer 607 451 1971
Dr. Juan-Carlos Jaramillo M.D. Chief Medical Officer 586 716 1972
Ms. Dipal Patel Chief Commercial Officer 561 712 1975
Mr. Franck Grimaud MBA Chief Business Officer 436 258 1967
Mr. Frederic Jacotot Vice President of Legal & IP, General Counsel, and Corporate Secretary 331 753 1964
Mr. Vincent Dequenne Chief Operating Officer 0 1967
Dr. Hanneke Schuitemaker Ph.D. Chief Scientific Officer 0 0
Mr. Joshua Drumm Ph.D. Vice President of Investor Relations 0 0
Ms. Laetitia Bachelot-Fontaine Vice President of Global Communications & European Investor Relations 0 0
Wiadomości dla Valneva SE
Tytuł Treść Źródło Aktualizacja Link
Valneva Provides Update on Recommended Use of IXCHIQ® by Elderly Individuals in the United States Saint Herblain (France), May, 12 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the U.S. Food and Drug Association (FDA) and the U.S. Centers for Disease Control and Prevention (CDC), in a joint communication to the medical community, have recommended a pause in the use of Valneva's single-dose live attenuated chikungunya vaccine IXCHIQ® in elderly individuals while ongoing investigations into reported serious adverse events (SAEs) are completed. This update follows an earlier recommendation from the U.S. Advisory Committee on Immunization Practices (ACIP) to include a precaution related to the use of IXCHIQ® in persons aged 65 and over and a similar decision by the European Medicines Agency (EMA) to temporarily suspend the use of the vaccine for individuals over 65 years old pending investigation. globenewswire.com 2025-05-12 05:00:00 Czytaj oryginał (ang.)
Valneva SE (VALN) Q1 2025 Earnings Call Transcript Valneva SE (NASDAQ:VALN ) Q1 2025 Earnings Conference Call May 7, 2025 9:00 AM ET Company Participants Joshua Drumm - Vice President-Global Investor Relations Thomas Lingelbach - Chief Executive Officer Peter Bühler - Chief Financial Officer Conference Call Participants Maury Raycroft - Jefferies Rajan Sharma - Goldman Sachs Vamil Divan - Guggenheim Securities. Samir Devani - Rx Securities Oscar Haffen Lamm - Bryan, Garnier & Co. Simon Scholes - First Berlin Joshua Drumm Thank you. seekingalpha.com 2025-05-09 13:47:36 Czytaj oryginał (ang.)
Valneva SE: Still Undervalued Travel Vaccine Bet With Robust 2025 Guidance Valneva SE offers exposure to a robust travel vaccine portfolio that includes Ixiaro, Dukoral, and Ixchiq. Ixiaro generated roughly €94.1 million in 2024 and remains Valneva's main revenue vertical. Dukoral contributed with €32.3 million in sales in 2024 and provides some revenue diversification alongside Ixiaro in the traveler-vaccine niche. seekingalpha.com 2025-05-08 04:30:39 Czytaj oryginał (ang.)
Valneva Provides Update Following European Medicines Agency Announcement on Use of IXCHIQ® in Elderly Saint Herblain (France), May, 07 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the European Medicines Agency (EMA) has started a review of Valneva's single-dose live attenuated chikungunya vaccine IXCHIQ® based on reports of serious adverse events (SAEs) in elderly people. As a temporary measure, while this review is ongoing, EMA has suspended the use of the vaccine for individuals over 65 years old. EMA has maintained current recommendations for IXCHIQ® for people from 12 to 64 years of age. globenewswire.com 2025-05-07 15:45:00 Czytaj oryginał (ang.)
Europe reviews Valneva's chikungunya vaccine after reports of serious side-effects in older people The European Union's health regulator said on Wednesday it has begun a review of Valneva's chikungunya vaccine after reports of serious adverse events in older adults, including two deaths globally. reuters.com 2025-05-07 12:40:35 Czytaj oryginał (ang.)
Valneva Reports First Quarter 2025 Financial Results and Provides Corporate Updates Saint-Herblain (France), May 7, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today reported its financial results for the first quarter ending March 31, 2025, provided key corporate updates and confirmed its 2025 financial guidance. The condensed consolidated interim financial results are available on the Company's website (Financial Reports – Valneva). globenewswire.com 2025-05-07 05:00:00 Czytaj oryginał (ang.)
Valneva Provides Update on Recommendation for Use of Its Chikungunya Vaccine by French Authorities Saint Herblain (France), April 26, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that France's national public health agency, the Haute Autorité de Santé (HAS), has updated its recommendation for use of Valneva's single-dose chikungunya vaccine IXCHIQ® for the prevention of disease caused by the chikungunya virus (CHIKV) following reports of serious adverse events (SAEs) in elderly people with comorbidities during the ongoing vaccination campaign in La Reunion and Mayotte. Valneva has been responding to the French government's call for vaccine supply of IXCHIQ® in La Reunion1 as the island is going through a major chikungunya outbreak with ~ 40,000 confirmed cases since the beginning of 20252. globenewswire.com 2025-04-26 17:10:00 Czytaj oryginał (ang.)
INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Valneva SE - VALN NEW YORK, April 25, 2025 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of  Valneva SE (“Valneva” or the “Company”) (NASDAQ: VALN). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext. 7980. globenewswire.com 2025-04-25 20:44:00 Czytaj oryginał (ang.)
INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Valneva SE - VALN NEW YORK CITY, NY / ACCESS Newswire / April 23, 2025 / Pomerantz LLP is investigating claims on behalf of investors of Valneva SE ("Valneva" or the "Company") (NASDAQ:VALN). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext. accessnewswire.com 2025-04-23 14:35:00 Czytaj oryginał (ang.)
INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Valneva SE - VALN NEW YORK , April 22, 2025 /PRNewswire/ -- Pomerantz LLP is investigating claims on behalf of investors of  Valneva SE ("Valneva" or the "Company") (NASDAQ: VALN). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext. prnewswire.com 2025-04-22 20:32:00 Czytaj oryginał (ang.)
INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Valneva SE - VALN NEW YORK, April 21, 2025 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of  Valneva SE (“Valneva” or the “Company”) (NASDAQ: VALN).  Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext. 7980. globenewswire.com 2025-04-21 21:07:00 Czytaj oryginał (ang.)
INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Valneva SE - VALN NEW YORK CITY, NY / ACCESS Newswire / April 20, 2025 / Pomerantz LLP is investigating claims on behalf of investors of Valneva SE ("Valneva" or the "Company") (NASDAQ:VALN). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext. accessnewswire.com 2025-04-20 13:30:00 Czytaj oryginał (ang.)
INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Valneva SE - VALN NEW YORK CITY, NY / ACCESS Newswire / April 18, 2025 / Pomerantz LLP is investigating claims on behalf of investors of Valneva SE ("Valneva" or the "Company") (NASDAQ:VALN). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext. accessnewswire.com 2025-04-18 17:30:00 Czytaj oryginał (ang.)
Valneva Provides Update on ACIP Recommendation for its Chikungunya Vaccine IXCHIQ® Among U.S. Travelers Saint Herblain (France), April 18, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that during its regular meeting on April 16, the U.S. Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) updated its recommendation for use of Valneva's single-dose chikungunya vaccine IXCHIQ® for the prevention of disease caused by the chikungunya virus (CHIKV). ACIP maintained its current recommendation for IXCHIQ® for persons aged ≥18 years traveling to a country or territory where there is a chikungunya outbreak. Additionally, it may be considered for persons aged ≥18 years traveling or taking up residence in a country or territory without an outbreak but with elevated risk for U.S. travelers if planning travel for an extended period of time e.g., six months or more. globenewswire.com 2025-04-18 08:00:00 Czytaj oryginał (ang.)
INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Valneva SE - VALN NEW YORK, April 17, 2025 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of  Valneva SE (“Valneva” or the “Company”) (NASDAQ: VALN).  Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext. 7980. globenewswire.com 2025-04-17 18:24:00 Czytaj oryginał (ang.)
INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Valneva SE - VALN NEW YORK CITY, NY / ACCESS Newswire / April 16, 2025 / Pomerantz LLP is investigating claims on behalf of investors of Valneva SE ("Valneva" or the "Company") (NASDAQ:VALN). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext. accessnewswire.com 2025-04-16 17:45:00 Czytaj oryginał (ang.)
Valneva to Participate in Multiple Events at the 25th World Vaccine Congress, including a Presentation on its Chikungunya Vaccine IXCHIQ® Saint-Herblain (France), April 16, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced its presence at the forthcoming 25th World Vaccine Congress, which will take place from April 21-24, 2025 at the Walter E. convention center in Washington, D.C. Under the leadership of the Company´s Chief Executive Officer, Thomas Lingelbach, a team of Valneva´s senior managers will participate in multiple events, including an important presentation on the Company´s vaccine IXCHIQ®, the world's first licensed chikungunya vaccine. globenewswire.com 2025-04-16 15:45:00 Czytaj oryginał (ang.)
INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Valneva SE - VALN NEW YORK CITY, NY / ACCESS Newswire / April 15, 2025 / NEW YORK, April 15, 2025 (ACCESSWIRE) Pomerantz LLP is investigating claims on behalf of investors of Valneva SE ("Valneva" or the "Company") (NASDAQ:VALN). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext. accessnewswire.com 2025-04-15 20:30:00 Czytaj oryginał (ang.)
INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Valneva SE - VALN NEW YORK , April 14, 2025 /PRNewswire/ -- Pomerantz LLP is investigating claims on behalf of investors of Valneva SE ("Valneva" or the "Company") (NASDAQ: VALN). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext. prnewswire.com 2025-04-14 21:45:00 Czytaj oryginał (ang.)
Brazil Approves Valneva's Mosquito-Borne Chikungunya Vaccine The Brazilian Health Regulatory Agency (ANVISA) has granted marketing authorization to Valneva SE's VALN single-dose vaccine Ixchiq for the prevention of disease caused by the chikungunya virus in individuals 18 years of age and older. benzinga.com 2025-04-14 18:28:54 Czytaj oryginał (ang.)
Valneva Reports Preliminary Unaudited 2024 Revenue and Cash and Provides 2025 Outlook Met 2024 growth targets for sales revenue (+13% vs 2023) and total revenues (+10% vs 2023) Strong year-end cash position of €168.3 million Substantial clinical and regulatory progress in 2024, leading to multiple anticipated data readouts, product approvals and label extensions in 2025 2025 outlook reflects solid revenue growth and positive commercial cash flows to support strategic R&D investments with lower operating cash burn Saint-Herblain (France), February 18, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) a specialty vaccine company, today reported its preliminary unaudited full-year 2024 revenue and cash results1 and provided a 2025 outlook. The Company will publish its 2024 audited consolidated financial statements and host an analyst call on March 20, 2025. globenewswire.com 2025-02-18 03:00:00 Czytaj oryginał (ang.)
Valneva Receives Marketing Authorization in the UK for the World's First Chikungunya Vaccine, IXCHIQ® Saint Herblain (France), February 5, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization in the United Kingdom (UK) for the world's first and only chikungunya vaccine, IXCHIQ®. The single-dose vaccine is indicated for active immunization for the prevention of disease caused by chikungunya virus (CHIKV) in individuals 18 years of age and older. The vaccine is manufactured at Valneva's leading vaccine production site in Livingston, Scotland. globenewswire.com 2025-02-05 03:00:00 Czytaj oryginał (ang.)
Valneva Announces New IXIARO® Supply Contract with the U.S. Government Worth a Minimum of $32.8 Million Saint Herblain (France), January 30, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced the signing of a new $32.8 million contract with the United States (U.S.) Department of Defense (DoD) for the supply of its Japanese encephalitis (JE) vaccine, IXIARO®.Under this new one-year contract, the DoD will buy a minimum of $32.8 million worth of IXIARO® vaccines and has the possibility to purchase additional doses during the coming twelve months. Deliveries of IXIARO® doses have continued in 2024 under the supply contract signed in September 20231. The new contract will commence immediately. globenewswire.com 2025-01-30 13:45:00 Czytaj oryginał (ang.)
Valneva Is A 'Buy' As A First-Mover In Chikungunya Valneva Is A 'Buy' As A First-Mover In Chikungunya seekingalpha.com 2025-01-23 17:48:48 Czytaj oryginał (ang.)
Valneva Reports Positive Phase 2 Results in Children for its Chikungunya Vaccine and Announces Phase 3 Dose Decision Saint-Herblain (France), January 22, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) today announced positive results for its Phase 2 clinical trial evaluating the safety and immunogenicity of two different dose levels of its single-shot chikungunya vaccine, IXCHIQ®, in 304 children. Partially funded by the Coalition for Epidemic Preparedness Innovations (CEPI), with support from the European Union, the trial is intended to support a pivotal Phase 3 study in children, which the Company expects to initiate in the fourth quarter of 2025, with the objective to extend the product label to this age group. globenewswire.com 2025-01-22 13:45:00 Czytaj oryginał (ang.)
Valneva Vaccine Shows Sustained Immune Response In Adolescents One Year After Single Shot On Tuesday, Valneva SE  VALN reported Phase 3 data in adolescents for its single-shot chikungunya virus (CHIKV) vaccine, Ixchiq. benzinga.com 2025-01-21 12:44:20 Czytaj oryginał (ang.)
Favorable VLA1553-321 Phase 3 Study Results Boost VALN Stock Valneva reports positive data from its Phase 3 - VLA1553-321 study of the IXCHIQ vaccine. zacks.com 2025-01-21 10:07:19 Czytaj oryginał (ang.)
Valneva Reports High Sustained Immune Response in Adolescents One Year After Single Vaccination with its Chikungunya Vaccine Saint-Herblain (France), January 20, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today reported further positive Phase 3 data in adolescents for its single-shot chikungunya virus (CHIKV) vaccine, IXCHIQ®, which showed a sustained 98.3% sero-response rate one-year after single vaccination. These results support and strengthen the pivotal data previously reported for adolescents (12 to 17 years old) which supported filing for potential label extension to this age group in the U.S.1, Europe, and Canada2. Data from this trial are also expected to support licensure of IXCHIQ® in Brazil, which would be the first potential approval for use in endemic populations. globenewswire.com 2025-01-20 13:45:00 Czytaj oryginał (ang.)
Valneva to Meet with Investors during the J.P. Morgan Healthcare Conference Saint Herblain (France), January 6, 2025 – Valneva SE (Nasdaq: VALN; Euronext 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. globenewswire.com 2025-01-06 13:45:00 Czytaj oryginał (ang.)
Valneva Announces Peer-Reviewed Publication on the Global Health and Economic Burden of Chikungunya in The British Medical Journal Saint-Herblain (France), December 4, 2024 – Valneva SE (Nasdaq: VALN; Euronext 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. globenewswire.com 2024-12-04 03:00:00 Czytaj oryginał (ang.)
Valneva Reports Positive Three-Year Antibody Persistence Data for its Single-Shot Chikungunya Vaccine IXCHIQ® Saint-Herblain (France), December 3, 2024 – Valneva SE (Nasdaq: VALN; Euronext 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 the Company reported in December 20221 and 20232, respectively. globenewswire.com 2024-12-03 03:00:00 Czytaj oryginał (ang.)
Chikungunya Vaccine Label Extension Call Likely to Support VALN Stock The FDA application complements recent label extension submissions to the EMA and Health Canada, highlighting Valneva's strategic push to enhance IXCHIQ's global reach. zacks.com 2024-11-28 12:31:08 Czytaj oryginał (ang.)
Valneva Submits Label Extension Application for its Chikungunya Vaccine, IXCHIQ®, to the U.S. FDA To potentially include adolescents and antibody persistence up to two years Saint Herblain (France), November 26, 2024 – Valneva SE (Nasdaq: VALN; Euronext 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®. globenewswire.com 2024-11-26 13:45:00 Czytaj oryginał (ang.)
European And US Vaccine Stocks Are Under Pressure - Here's WHy Some large European and U.S. vaccine maker stocks have fallen in reaction to Robert F. Kennedy Jr.'s nomination to lead the Department of Health and Human Services. benzinga.com 2024-11-15 13:21:18 Czytaj oryginał (ang.)
Valneva and LimmaTech Announce First Vaccination in Phase 2b Human Challenge Study of Tetravalent Shigella Vaccine Candidate S4V2 Saint Herblain (France) and Schlieren (Zurich) , November 13, 2024 – Valneva SE (Nasdaq: VALN; Euronext 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. globenewswire.com 2024-11-13 13:45:00 Czytaj oryginał (ang.)
Valneva SE (VALN) Q3 2024 Earnings Call Transcript Valneva SE (NASDAQ:VALN ) Q3 2024 Earnings Conference Call November 7, 2024 9:00 AM ET Company Participants Thomas Lingelbach - Chief Executive Officer Peter Buhler - Chief Financial Officer Joshua Drumm - Vice President of Investor Relations Conference Call Participants Maury Raycroft - Jefferies Chiara Montironi - Van Lanschot Kempen Ed White - HC Wainwright Rajan Sharma - Goldman Sachs Samir Devani - Rx Securities Joshua Drumm Thank you for joining us to discuss Valneva's Financial Results for the First Nine Months of 2024 and a Corporate Update. It's my pleasure to welcome you today. seekingalpha.com 2024-11-09 15:10:24 Czytaj oryginał (ang.)
Valneva Reports Nine-Month 2024 Financial Results and Provides Corporate Updates Nine-Month Key Financial Highlights Total revenues of €116.6 million, including product sales of €112.5 million Net 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 placement2 Lower 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 guidance between €160 million to €170 million and currently anticipated total revenues between €170 million and €180 million Expected R&D investments between €65 million and €75 million Expected Other income between €100 million and €110 million, including €95 million from the PRV sale Launch of the world's first chikungunya vaccine in Canada and Europe underway; Further potential approvals expected in Brazil (Q4 2024) and the UK (Q1 2025); Strategic Pipeline Expansion, Strong Clinical and Regulatory Execution         Secured exclusive worldwide license for S4V2 Shigella vaccine candidate, adding an attractive Phase 2 clinical asset to Valneva's R&D pipeline3 - recently granted FDA Fast Track4 Submitted key label extension(s) for IXCHIQ® in Europe and Canada5 Published IXCHIQ® two-year antibody persistence and safety data in the Lancet Infectious Diseases6 further demonstrating the vaccine's highly differentiated immunological profile Awarded new $41.3 million CEPI grant7 to contribute significantly to IXCHIQ® Phase 4 costs and other studies supporting broader access to the vaccine Pfizer completed primary vaccination (three doses) in Phase 3 VALOR Lyme disease trial8 Advancing Phase 1 clinical trial for second-generation Zika vaccine candidate toward expected data readout and further decision on potential development path in 20259 Financial Information (Unaudited results, consolidated per IFRS) € in million Nine months ended September 30,   2024 2023 Total Revenues 116.6 111.8 Product Sales 112.5 106.1 Net profit/(loss) 24.7 -69.3 Adjusted EBITDA10 48.6 -46.0 Cash 156.3 171.3 Saint-Herblain (France), November 7, 2024 – 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, 2024. The condensed consolidated interim financial results are available on the Company's website ( Financial Reports – Valneva ). globenewswire.com 2024-11-07 03:00:00 Czytaj oryginał (ang.)
Valneva to Present on Chikungunya at Several Leading Scientific Conferences Saint-Herblain (France), October 21, 2024 – Valneva SE (Nasdaq: VALN; Euronext 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. globenewswire.com 2024-10-21 15:45:00 Czytaj oryginał (ang.)
Valneva and LimmaTech Awarded FDA Fast Track Designation for Tetravalent Shigella Vaccine Candidate S4V Saint Herblain (France) and Schlieren (Zurich), October 16, 2024 – Valneva SE (Nasdaq: VALN; Euronext 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. globenewswire.com 2024-10-16 15:45:00 Czytaj oryginał (ang.)
Valneva Hosts Investor Day in New York City Live event and webcast TODAY at 10 AM ET Saint Herblain (France), October 10, 2024 –Valneva SE (Nasdaq: VALN; Euronext 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. globenewswire.com 2024-10-10 05:00:00 Czytaj oryginał (ang.)
Valneva to Host Investor Day in New York on Thursday, October 10, 2024 at 10:00 AM ET Saint Herblain (France), October 3, 2024 –Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that it will host an investor day at the Lotte New York Palace Hotel in New York, NY on Thursday, October 10, 2024 at 10:00 AM ET (4:00 pm CET). The meeting will be conducted in a hybrid way – in person and webcast. To register, click here. globenewswire.com 2024-10-03 05:00:00 Czytaj oryginał (ang.)
Valneva Submits Label Extension Applications for its Chikungunya Vaccine, IXCHIQ®, to EMA and Health Canada To potentially include adolescents and antibody persistence up to two years Saint Herblain (France), September 18, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that it has submitted label extension applications to the European Medicines Agency (EMA) and Health Canada to potentially expand the use of its chikungunya vaccine, IXCHIQ®, to adolescents aged 12 to 17 years in Europe and Canada. The Canadian label extension application also includes two-year antibody persistence data, which is a key differentiator for IXCHIQ® that was already included in the initial EMA filing. globenewswire.com 2024-09-18 05:00:00 Czytaj oryginał (ang.)
Valneva Announces the Success of its Private Placement Raising approximately €60 Million Saint-Herblain (France), September 13, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) (“Valneva” or the “Company”), a specialty vaccine company, today announces the successful pricing of its Private Placement (as defined below) for a final amount of €61,180,000. globenewswire.com 2024-09-13 06:30:00 Czytaj oryginał (ang.)
Valneva Announces the Launch of a Private Placement of Ordinary Shares for Approximately 60 Million Euros Saint-Herblain (France), September 12, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) (“Valneva” or the “Company”), a specialty vaccine company, today announces its intention to issue, subject to market conditions, approximately 22.6 million new ordinary shares (the “Offer Shares”) at a price of €2.66 per Offer Share to certain categories of investors via a private placement through an accelerated bookbuilding process starting immediately. globenewswire.com 2024-09-12 20:05:00 Czytaj oryginał (ang.)
Favorable VLA15 Phase 2 Study Results Might Boost VALN Stock Valneva and Pfizer report positive immunogenicity and safety data from their Phase 2 study of the VLA15 vaccine. Phase 3 trials for VLA15 are in progress. zacks.com 2024-09-03 13:40:52 Czytaj oryginał (ang.)
Pfizer and Valneva report positive results in mid-stage trial of Lyme disease vaccine The Phase 2 trial was evaluating the vaccine called VLA15 following a second booster dose given one year after the first one. marketwatch.com 2024-09-03 10:50:00 Czytaj oryginał (ang.)
Valneva and Pfizer Report Further Positive Phase 2 Booster Results for Lyme Disease Vaccine Candidate Saint-Herblain (France) and New York, NY, September 3, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) and Pfizer Inc. (NYSE: PFE) announced today positive immunogenicity and safety data from their VLA15-221 Phase 2 study following a second booster vaccination of their Lyme disease vaccine candidate, VLA15, given one year after receiving the first booster dose. The immune response and safety profile of VLA15 one month after receiving the second booster dose were similar to those reported after receiving the first booster dose, showing compatibility with the anticipated benefit of a booster vaccination prior to each Lyme season. There are currently no approved human vaccines for Lyme disease, and VLA15 is the Lyme disease vaccine candidate which has advanced the furthest along the clinical development timeline, with two Phase 3 trials in progress. The Centers for Disease Control and Prevention (CDC) has estimated that approximately 476,000 people in the U.S. are diagnosed and treated for Lyme disease each year and 129,000 cases are reported annually in Europe.1 , 2 globenewswire.com 2024-09-03 05:00:00 Czytaj oryginał (ang.)
Wall Street Analysts Predict a 150.41% Upside in Valneva (VALN): Here's What You Should Know The consensus price target hints at a 150.4% upside potential for Valneva (VALN). While empirical research shows that this sought-after metric is hardly effective, an upward trend in earnings estimate revisions could mean that the stock will witness an upside in the near term. zacks.com 2024-09-02 15:00:45 Czytaj oryginał (ang.)
How Much Upside is Left in Valneva (VALN)? Wall Street Analysts Think 135.3% The consensus price target hints at a 135.3% upside potential for Valneva (VALN). While empirical research shows that this sought-after metric is hardly effective, an upward trend in earnings estimate revisions could mean that the stock will witness an upside in the near term. zacks.com 2024-08-15 14:56:05 Czytaj oryginał (ang.)