To continue today … Valneva – 09/19/2022 at 08:18

(AOF) – Valneva SE, a company specializing in vaccines, and IDT Biologika have reached an agreement to end their cooperation on Covid-19 after vaccine materials have been delivered to Valneva and taking into account current demand levels and existing stocks. In accordance with a November 2021 commercial manufacturing agreement for the manufacture of the vaccine, IDT Biologika mass-produced 2001 VLA at its biosafety level 3 facilities in Germany, and Valneva purchased the batches produced by IDT on this day.

Due to reduced order volumes from the European Commission, Valneva has stopped production of the vaccine and will, as compensation, pay IDT up to €36.2 million in cash and the equivalent of €4.5 million in kind (equipment purchased by Valneva).

Valneva has begun providing doses of VLA 2001 to member states in Europe that have requested the vaccine. Valneva maintains a stockpile of VLA 2001 for potential additional supplies to these member states should they request an increase.

At the same time, the company continues its discussions with other governments around the world, with the goal of selling approximately eight to ten million doses of the remaining stock on international markets over the next six to twelve months.

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the main points

Specializes in developing preventive vaccines against infectious diseases with limited treatment options;

The turnover of 348 million euros is derived from Europe with 56%, before the Americas (27%), then Asia-Oceania (9%), Africa and the Middle East (8%);

Business model: portfolio of diversified vaccines for the general public, funding of clinical developments through specialized infrastructure, two commercial vaccines (Ixiaro and Dukoral against Japanese encephalitis and cholera) and vaccine distribution rights to third parties;

– the capital owned by 13.02% of the Grimaud la Corbière Group and 8.19% of BPI France, Frédéric Grimaud chairs the 5-member supervisory board, and Thamas Lingelbach the board of directors;

Strong balance sheet of €307 million in equity against €42 million of debt, boosted by net cash of around €350 million in April 2022.

Challenges

– a medium-term strategy based on research and development funding through the sale of Exaro and Dokoral vaccines, expansion of the manufacturing network (3 sites in Scotland, Sweden and Austria) and partnerships that enhance the group’s assets;

– An innovation strategy rooted in the business model, rich with a portfolio of 398 patents and backed by 173 million euros in research and development costs, with 3 main assets and 3 pre-clinical programmes: the only vaccine in clinical development against Lyme, the only vaccine to be obtained from single shot against chikungunya, the only inactivated and adjuvant vaccine against the full virus COVID-19, the candidate vaccine against human metapinomaviruses, parvovirus and norovirus;

– Environmental strategy: energy efficiency, waste reduction, water optimization and reduction of carbon dioxide emissions by 5%, compared to 2016, by 2025;

– Good visibility of activity thanks to vaccine-specific agreements with: the British government (orders for 100 million doses of Covid-19 vaccines and options of 190 million by 2025, i.e. €1.4 billion in total), with Pfizer to co-develop and sell one against Lyme disease ( $308 million), with US authorities for Ixiario against Japanese encephalitis ($70 million), with Bavaria Nordic to market and distribute specialized vaccines, with Batavia Biosciences to develop an inexpensive polio vaccine, with the Putantan Institute against Chikungunya in low-income countries.

Challenges

– In 2022, the launch of phase 3 trials of the Lyme disease vaccine and pending approval by the US authority to sell Chikungunya and the European Union vaccine against Covid 19 (60 million doses);

Travel allergy from sales of vaccines already on the market (against Japanese encephalitis and cholera);

– Uncertainty about the commercial success of a vaccine against Covid 19 in the UK, given the already strong competition;

– 2022 targets: excluding the Covid vaccine, sales volume between 430 and 590 million euros and research and development expenditures between 65 and 75 million euros.

The inevitable race for new movies

The patent for Merck’s star product, the cancer drug Keytruda, which accounts for more than 35% of its sales, expires in 2028. Despite losing patents since 2019 for its three-star products (Avastin, Herceptine, Rituxan) Roche has been able to replenish its portfolio By bringing new molecules to the market. However, discovering and releasing new drugs is increasingly expensive. AstraZeneca spends about $6 billion annually on research and development in the pharmaceutical industry where the patent life is only ten to fifteen years. This leads the laboratories to withdraw from some activities. Thus, J&J, Pfizer, GSK and no doubt Novartis would soon prefer to refocus on specialty drugs and forgo any additional business.

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