(AOF) – Valneva fell more than 20% to € 9.5 after reaching € 9.162 a little earlier. This is the lowest level since the end of January 2021. Franco Austria’s biotechnology is receiving very bad news. The European Commission wants to cancel 60 million Covid vaccine orders (24.3 million this year, with the option to administer the remaining dose in 2023). In fact, the European Medicines Agency (EMA) has not yet given a green light to vaccines, and the Committee for Medicinal Products for Human Use (CHMP) must govern by the end of June.
However, according to an agreement signed between Barneva and the European Commission at the end of last year, Brussels will end it if Barneva has not received this approval to sell the EMA by April 30, 2022. There is a clause that allows you to do so.
Valneva will need to obtain marketing approval for 30 days starting May 13, 2022, or propose a plan to “improve the situation in an acceptable way.”
On May 2, the group provided answers to a third set of questions submitted by CHMP. If these are approved by the Commission, Valneva may receive positive feedback from the EMA by the end of the second quarter of 2022.
The company will work with the European Commission and the Member States participating in the Agreement to agree on such a plan and make VLA2001 available to Member States wishing to obtain the vaccine.
If the Commission finally terminates the contract at the end of the ongoing process, it is a very likely scenario for Invest Securities, and Valneva has spent or committed the full amount of these installments, so Valneva will pay the installments received. There is no need to return it. In this case, no refund of such payment is required.
After discussions with the Commission and affected Member States, Valneva will review the financial guidance for the 2022 fiscal year.
The group has also received an emergency use authorization for the vaccine from the United Arab Emirates Department of Health and Prevention.
-Specialist in the development of preventive vaccines for infectious diseases with limited treatment options.
-Sales of € 348 million are higher than Europe-56%, Americas (27%), Asia-Oceania (9%) and Africa-Middle East (8%).
-Business model: a diverse portfolio of vaccines for the general public, funding for clinical development with specialized infrastructure, two over-the-counter vaccines (Ixiaro and Ducoral for Japanese encephalitis and cholera), and vaccine distribution rights for third parties.
-Capital is held by Grimaudla Corbière Group 13.02%, BPI France 8.19%, Frédéric Grimaud, chair of the five Audit & Supervisory Boards, and Thomas Lingelbach, Executive Committee.
-A solid balance sheet of € 307 million equity against € 42 million in debt, fortified by approximately € 350 million in net cash in April 2022.
-A medium-term strategy based on R & D funding through partnerships to promote Ixiaro and Ducoral vaccine sales, expansion of manufacturing networks (three sites in Scotland, Sweden and Austria), and the Group’s assets.
-Business model-specific innovation strategy, rich portfolio of 398 patents, supported by R & D spend of 173 million euros, three key assets and three preclinical programs: the only clinical development for Lime Vaccine, Only Single Vaccine Candidate for human metapneumovirus, parvovirus and norovirus against Chikungunya fever, the only inactivated and adjuvanted whole virus COVID-19 vaccine.
-Environmental strategies: energy efficiency, waste minimization, optimal use of water, and 5% reduction in CO2 emissions by 2025 compared to 2016.
-Good visibility of activities (100 million orders out of 190 million anti-covid vaccines and options by 2025, totaling 1.4 billion euros), thanks to the vaccine agreement with the British government. Joint vaccine with Pfizer for Lime’s disease ($ 308 million), Ixialio’s US authorities for Japanese encephalitis ($ 70 million), Bavarian Nordic for the sale and distribution of specialty vaccines, and the development of cheap vaccines for polio. Development and sales with Batavia Biosciences, with the Butantan Institute for chikingunya for low-income countries.
-In 2022, Phase 3 trials of the vaccine against Lyme disease will begin, waiting for US authorities to approve the European Union approval (60 million doses) for Covid 19 for the sale of the vaccine for chicken yam.
-Sensitivity to travel for the sale of vaccines already on the market (against Japanese encephalitis and cholera);
-Uncertainty about the commercial success of the vaccine against Covid19 in the UK, given the already established fierce competition.
-Target for 2022: Sales excluding Covid vaccine, € 430 million to € 590 million, R & D expenditure € 65 million to € 75 million.
Oncology supports laboratory performance
According to GlobalData, oncology generated $ 163 billion in revenue in 2021, up 11.9% (out of $ 613 billion across the industry). Its average annual growth rate has reached 15.4% in the last 20 years.This increasingly competitive segment is dominated by a few big names such as MSD (Merck & Co. Inc), Roche and BMS.
Immuno-oncology, a specialty that has been driving this market for 10 years, supports research. GlobalData estimates that this segment could reach 180 billion in 2026. Major players are aiming to strengthen in this niche. Pfizer recently acquired Canada’s biotechnology Trillium Therapeutics for $ 2.3 billion. Following this surgery, the American group gained two promising molecules in the treatment of blood cancer.