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Valneva SE (VLAP.PA)

Paris - Paris Prix différé. Devise en EUR
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0,07000,0000 (0,00 %)
À la clôture : 5:35PM CEST
Plein écran
Clôture précédente0,0700
Ouverture0,0680
Offre0,0000 x 0
Vente0,0000 x 0
Var. jour0,0632 - 0,0700
Sur 52 semaines0,0566 - 0,1400
Volume393 875
Volume moyen0
Cap. boursière243,339M
Bêta (mensuel sur 5 ans)S.O.
Rapport P/E (sur 12 mois)S.O.
BPA (sur 12 mois)S.O.
Date de bénéficesS.O.
Dividende et rendement à termeS.O. (S.O.)
Date ex-dividendeS.O.
Objectif sur 1 anS.O.
  • Globe Newswire

    Valneva annonce une modification des termes de son accord de financement avec Deerfield et OrbiMed

    Saint-Herblain (France), 15 janvier 2021 – Valneva SE (“Valneva” ou “le Groupe”), société spécialisée dans les vaccins contre des maladies infectieuses générant d’importants besoins médicaux, a annoncé aujourd’hui une modification des termes de son accord de financement avec les fonds américains spécialisés dans le secteur de la santé Deerfield Management Company et OrbiMed. Compte tenu de l’impact de la pandémie de COVID-19 sur l’industrie du voyage, et après une levée temporaire de l’engagement de revenus minimum au second semestre 2020, Valneva, Deerfield et OrbiMed se sont mis d’accord pour modifier cet engagement en 2021 et 2022, en remplaçant le revenu minimum de €115 millions sur 12 mois glissants par des revenus trimestriels minimum représentant un total de €64 millions sur l’exercice 2021 et un total de €103,75 million en 2022. Les parties se sont également mis d’accord pour fixer une obligation de trésorerie minimale de €50 millions pour 2021 et 2023 et de €35 millions les années suivantes. En février 2020, Valneva a annoncé un accord de financement avec des fonds gérés par Deerfield et Orbimed1. La transaction inclut un emprunt à taux fixe de $60 millions ainsi que la possibilité de tirer jusqu’à $25 millions supplémentaires au cours des douze mois suivant le versement initial. Valneva a, à ce jour, tiré $60 millions sur les $85 millions mis à sa disposition dans le cadre de cet accord de financement. Début janvier 2021, Valneva a annoncé une position de trésorerie, incluant les équivalents de trésorerie, de €204,4 millions à fin décembre 20202, supérieure à ses prévisions d’une trésorerie 2020 se situant entre €180 millions et €200 millions3. Á propos de Deerfield Deerfield est une société de financement engagée dans le développement des soins de santé par l'investissement, l'information et la philanthropie. Á propos d’OrbiMed OrbiMed est une société d'investissement spécialisée dans le secteur de la santé disposant de $13 milliards d'actifs sous gestion. OrbiMed investit dans le monde entier dans le secteur de la santé, de la start-up aux grandes sociétés multinationales, au travers de fonds d’investissements privés, de fonds d’investissements publics et de fonds de redevances/crédit. OrbiMed dispose de bureaux à New York, San Francisco, Shanghai, Hong Kong, Mumbai et Herzliya. OrbiMed cherche à être un fournisseur de capitaux de choix, en apportant des solutions de financement sur mesure ainsi que les ressources et le soutien d'une équipe mondiale afin de contribuer à construire des entreprises de santé de premier plan. Á propos de Valneva SEValneva est une société spécialisée dans les vaccins contre les maladies infectieuses générant d’importants besoins médicaux. Le Groupe possède un solide portefeuille de vaccins en développement dont des candidats vaccins uniques contre la maladie de Lyme, la COVID-19 et le chikungunya. Valneva possède par ailleurs deux vaccins sur le marché, IXIARO®/JESPECT® contre l’encéphalite japonaise et DUKORAL4 dans la prévention du choléra et, dans certains pays, de la diarrhée causée par l’ETEC®. Valneva compte plus de 500 employés et exerce ses activités depuis l’Autriche, la Suède, la Grande-Bretagne, la France, le Canada et les Etats-Unis. Contacts Investisseurs et MediaLaetitia Bachelot-FontaineDirector Investor Relations & Corporate CommunicationsM +33 (0)6 4516 7099investors@valneva.com Teresa PinzolitsCorporate Communications SpecialistT +43 (0)1 20620 1116communications@valneva.com Information importante Ce communiqué de presse contient certaines déclarations prospectives relatives à l'activité de Valneva. En outre, même si les résultats réels ou le développement de Valneva sont conformes aux énoncés prospectifs contenus dans ce communiqué de presse, ces résultats ou évolutions de Valneva peuvent ne pas être représentatifs du futur. Dans certains cas, vous pouvez identifier les énoncés prospectifs par des termes comme « pourrait », « devrait », « s'attend à », « anticipe », « croit », « a l'intention », « estime », « vise », « cible » ou des mots similaires. Ces énoncés prospectifs sont basés en grande partie sur les attentes actuelles de Valneva à la date du présent communiqué et sont assujettis à un certain nombre de risques et incertitudes connus et inconnus ainsi qu'à d'autres facteurs qui pourraient faire que les résultats réels, le rendement ou les réalisations réels diffèrent considérablement des résultats futurs, des performances ou réalisations futurs, exprimés ou sous-entendus par ces énoncés prospectifs. En particulier, les attentes de Valneva pourraient être affectées par, entre autres, des incertitudes liées au développement et à la fabrication de vaccins, à des résultats d'essais cliniques inattendus, des actions réglementaires inattendues ou des retards, à la concurrence en général, aux fluctuations monétaires, à l'impact de la crise mondiale et européenne du crédit, et à la capacité à obtenir ou à conserver un brevet ou toute autre protection de propriété intellectuelle. Compte tenu de ces risques et incertitudes, il ne peut y avoir aucune assurance que les énoncés prospectifs formulés dans le présent communiqué seront effectivement réalisés. Valneva fournit les informations contenues dans ce communiqué de presse à la date de celui-ci et décline toute intention ou obligation de mettre à jour ou de réviser publiquement tout énoncé prospectif, que ce soit en raison de nouvelles informations, d'événements futurs ou pour d’autres raisons. [1] Valneva Announces New $85 Million Financing Arrangement with Leading US Healthcare Funds Deerfield and OrbiMed 2 Valneva Reports FY 2020 Cash of Over €200 Million [3] Valneva Reports Nine Month Results Marked by Further Major Corporate Achievements 4 Le vaccin DUKORAL® ne bénéficie pas de l’indication ETEC en France Pièce jointe 2021_01_15_VLA_Deerfield-Orbi_Debt_Amendment_PR_FR_Final

  • Globe Newswire

    Valneva Announces Amendment to Deerfield and OrbiMed Debt Facility Terms

    Saint-Herblain (France), January 15, 2021 – Valneva SE (“Valneva” or “the Company”), a specialty vaccine company focused on prevention against diseases with major unmet needs, today announced an amendment to the terms of its existing debt facility with US-based healthcare investment firms Deerfield Management Company and OrbiMed. Noting the COVID-19 pandemic impact on the travel industry, and following a temporary waiver of the revenue covenant for the second half of 2020, Valneva, Deerfield and OrbiMed have agreed to modify this covenant for 2021 and 2022, replacing the twelve month rolling €115 million with quarterly minimum revenues representing an annual total of €64 million in 2021 and an annual total of €103.75 million in 2022. The parties have also agreed to modify the minimum cash requirement to €50 million for 2021 and 2023 and to €35 million for the following years. In February 2020, Valneva announced a broad debt financing arrangement with funds managed by Deerfield Management Company and OrbiMed1. The transaction included an initial $60 million fixed rate debt and flexible terms to draw down an additional $25 million in the next twelve months. To date, Valneva has drawn down $60 million from this $85 million financing arrangement. At the beginning of January 2021, Valneva reported preliminary and unaudited cash and cash equivalents of €204.4 million at the end of December 20202, exceeding its guidance of between €180 million and €200 million3. About Deerfield Deerfield is an investment management firm committed to advancing healthcare through investment, information and philanthropy. About OrbiMed OrbiMed is a leading healthcare investment firm, with $13 billion in assets under management. OrbiMed invests globally across the healthcare industry, from start-ups to large multinational corporations, utilizing a range of private equity funds, public equity funds, and royalty/credit funds. OrbiMed maintains offices in New York City, San Francisco, Shanghai, Hong Kong, Mumbai and Herzliya. OrbiMed seeks to be a capital provider of choice, providing tailored financing solutions and global team resources and support to help build world-class healthcare companies. About Valneva SE Valneva is a specialty vaccine company focused on prevention of infectious diseases with significant unmet medical need. The Company has several vaccines in development including unique vaccines against Lyme disease, COVID-19 and chikungunya. Valneva’s portfolio includes two commercial vaccines for travelers: IXIARO®/JESPECT® indicated for the prevention of Japanese encephalitis and DUKORAL® indicated for the prevention of cholera and, in some countries, prevention of diarrhea caused by ETEC. Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the U.S. with over 500 employees. Valneva Investor and Media ContactsLaetitia Bachelot-FontaineGlobal Head of Investor Relations & Corporate CommunicationsM +33 (0)6 4516 7099investors@valneva.com Teresa PinzolitsCorporate Communications SpecialistT +43 (0)1 20620 1116communications@valneva.com Forward-Looking Statements This press release contains certain forward-looking statements relating to the business of Valneva, including with respect to the progress, timing and completion of research, development and clinical trials for product candidates, the ability to manufacture, market, commercialize and achieve market acceptance for product candidates, the ability to protect intellectual property and operate the business without infringing on the intellectual property rights of others, estimates for future performance and estimates regarding anticipated operating losses, future revenues, capital requirements and needs for additional financing. In addition, even if the actual results or development of Valneva are consistent with the forward-looking statements contained in this press release, those results or developments of Valneva may not be indicative of their in the future. In some cases, you can identify forward-looking statements by words such as "could," "should," "may," "expects," "anticipates," "believes," "intends," "estimates," "aims," "targets," or similar words. These forward-looking statements are based largely on the current expectations of Valneva as of the date of this press release and are subject to a number of known and unknown risks and uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievement expressed or implied by these forward-looking statements. In particular, the expectations of Valneva could be affected by, among other things, uncertainties involved in the development and manufacture of vaccines, unexpected clinical trial results, unexpected regulatory actions or delays, competition in general, currency fluctuations, the impact of the global and European credit crisis, and the ability to obtain or maintain patent or other proprietary intellectual property protection. In light of these risks and uncertainties, there can be no assurance that the forward-looking statements made during this presentation will in fact be realized. Valneva is providing the information in these materials as of this press release, and disclaim any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. [1] Valneva Announces New $85 Million Financing Arrangement with Leading US Healthcare Funds Deerfield and OrbiMed 2 Valneva Reports FY 2020 Cash of Over €200 Million [3] Valneva Reports Nine Month Results Marked by Further Major Corporate Achievements Attachment 2021_01_15_VLA_Deerfield-Orbi_Debt_Amendment_PR_EN_Final

  • Globe Newswire

    Valneva in Advanced Discussions with European Commission to Supply up to 60 Million Doses of Inactivated, Adjuvanted COVID-19 Vaccine Candidate

    Saint-Herblain (France), January 12, 2021 – Valneva SE, a specialty vaccine company focused on prevention of infectious diseases with significant unmet medical need, today announced it is in advanced discussions with the European Commission (EC) for the supply of up to 60 million doses of its COVID-19 vaccine, VLA2001. VLA2001 is currently the only inactivated vaccine candidate in clinical trials against COVID-19 in Europe. Valneva’s vaccine candidate is based on a proven approach and will leverage the Company’s existing manufacturing platform being used for its US Food and Drug Administration (FDA) and European Medicines Agency (EMA) approved Japanese encephalitis vaccine. VLA2001 entered Phase 1/2 clinical studies in December 20201 and Valneva expects to report initial safety and immunogenicity data in April 2021. Upon analysis of the data, Valneva will select the best dose and commence the second part of the Phase 1/2 clinical development. If clinical development is successful, an initial approval may be granted in the second half of 2021. Thomas Lingelbach, Chief Executive Officer of Valneva, said, “Today’s announcement helps to ensure that millions of Europeans potentially have access to a proven and well-established inactivated vaccine approach, upon approval of VLA2001. We are grateful to the European Commission for their support and eager to partner with them to address the ongoing pandemic. We are deeply committed to providing broad access to our inactivated SARS-CoV-2 vaccine candidate and, as we proceed with clinical development, we will simultaneously continue working with partners, including the European Commission and the UK Government, to help us reach that goal. We increasingly see wider recognition that our vaccine will be one that the world cannot do without.” In September 2020, Valneva announced a major COVID-19 vaccine partnership with the UK government for the supply of up to 190 million doses of its inactivated vaccine candidate, VLA20012. Under the partnership agreement, if vaccine development is successful, Valneva will provide the UK government with 60 million doses in the second half of 2021. About the Novel Coronavirus SARS-CoV-2 and COVID-19 DiseaseSARS-CoV-2 is a new coronavirus identified in late 2019 and belongs to a family of enveloped RNA viruses that include MERS and SARS, both of which caused serious human infections of the respiratory system. The virus, which causes a disease named COVID-19, has never before been found in humans. Since this outbreak was first reported, the virus has caused approximately 2 million reported deaths globally. It has been declared a pandemic by the World Health Organization (WHO). About VLA2001VLA2001 is Valneva’s vaccine candidate against the SARS-CoV-2 virus. VLA2001 consists of inactivated whole virus particles of SARS-CoV-2 with high S-protein density, in combination with two adjuvants, alum and CpG 1018. This adjuvant combination has consistently induced higher antibody levels in preclinical experiments than alum-only formulations and shown a shift of the cellular immune response towards Th1. VLA2001 is produced on Valneva’s established Vero-cell platform, leveraging the manufacturing technology for Valneva’s licensed Japanese encephalitis vaccine, IXIARO®. The process, which has already been upscaled to final industrial scale, includes inactivation with BPL to preserve the native structure of the S-protein. CpG 1018 is a component of the US FDA-approved HEPLISAV-B® vaccine.VLA2001 is expected to conform with standard cold chain requirements (2 degrees to 8 degrees Celsius). About VLA2001-201VLA2001-201 is the first-in-human Phase 1/2 study evaluating three dose levels of VLA2001 (low, medium, high) for safety, tolerability and immunogenicity in a two-dose schedule with intra muscular vaccinations three weeks apart. Overall, 150 healthy young adults aged 18 to 55 years will be recruited. The study includes an open-label dose-escalation phase and will be conducted as a randomized, double-blind, multicenter study. On January 8th 2021, a Data Safety Monitoring Board (DSMB) gave approval to progress into the study’s full randomization phase. VLA2001-201 is conducted in two parts: Part A (Day 1 to Day 36) and Part B (Day 37 to Day 208). Following an evaluation of Part A data (i.e., data up to Day 36) from the present study, further clinical studies may be initiated. About Valneva SEValneva is a specialty vaccine company focused on prevention of infectious diseases with significant unmet medical need. The Company has several vaccines in development including unique vaccines against Lyme disease, COVID-19 and chikungunya. Valneva’s portfolio includes two commercial vaccines for travelers: IXIARO®/JESPECT® indicated for the prevention of Japanese encephalitis and DUKORAL® indicated for the prevention of cholera and, in some countries, prevention of diarrhea caused by ETEC. Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the U.S. with over 500 employees. Investor and Media ContactsLaetitia Bachelot-FontaineDirector Investor Relations & Corporate CommunicationsM +33 (0)6 4516 7099investors@valneva.com          Teresa PinzolitsCorporate Communications SpecialistT +43 (0)1 20620 1116communications@valneva.com Forward-Looking StatementsThis press release contains certain forward-looking statements relating to the business of Valneva, including with respect to the progress, timing, design, data read-outs, anticipated results and completion of clinical trials for VLA2001. In addition, even if the actual results or development of Valneva are consistent with the forward-looking statements contained in this press release, those results or developments of Valneva may not be indicative of future results. In some cases, you can identify forward-looking statements by words such as "could," "should," "may," "expects," "anticipates," "believes," "intends," "estimates," "aims," "targets," or similar words. These forward-looking statements are based on the current expectations of Valneva as of the date of this press release and are subject to a number of known and unknown risks and uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievement expressed or implied by these forward-looking statements. In particular, the expectations of Valneva could be affected by, among other things, uncertainties involved in the development and manufacture of vaccines, unexpected clinical trial results, unexpected regulatory actions or delays, competition in general, currency fluctuations, the impact of the global and European credit crisis, the ability to obtain or maintain patent or other proprietary intellectual property protection and the impact of the COVID-19 pandemic. In light of these risks and uncertainties, there can be no assurance that the forward-looking statements made during this presentation will in fact be realized. Valneva is providing the information in this press release as of the date hereof and disclaims any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. 1 Valneva Initiates Phase 1/2 Clinical Study of Inactivated, Adjuvanted COVID-19 Vaccine 2 Valneva Announces Major COVID-19 Vaccine Partnership with U.K. Government Attachment 2021_01_12_VLA2001_EC_Discussions_PR_EN_Final