A suivre aujourd’hui… Valneva

A suivre aujourd'hui... Valneva

(AOF) – Valneva has announced the establishment of an “At-the-Market (ATM)” program on the Nasdaq. Under this program, the vaccine specialist may, subject to French regulatory limits, issue to eligible investors, including unsolicited investors who have expressed interest, a total gross amount of up to $75 million in the form of American Depositary Shares (ADS) .

Valneva currently intends to use the net proceeds from this ATM Program primarily for research and development of vaccine candidates, working capital and general corporate purposes at its discretion, in combination with its existing cash and cash equivalents.

By way of example, assuming the issuance of the total amount of $75 million (or €72.5 million) of ADSs at an assumed offer price of $20.83 per ADS (or €10.03 per common share), the last published sales price of ADSs on the Nasdaq on August 11, 2022 – a holder of 1% of the outstanding capital stock of the company as of the date of this press release, would own 0.99% of the outstanding capital stock of the company after the completion of the transaction.

AOF – MORE INFORMATION

Key points

– Specialist in the development of prophylactic vaccines against infectious diseases with limited therapeutic options;

– Turnover of 348 million euros from Europe by 56%, ahead of America (27%), then Asia-Oceania (9%) and Africa-Middle East (8%);

– Business model: diversified portfolio of vaccines for the general public, financing of clinical developments by a specialized infrastructure, 2 commercial vaccines (Ixiaro and Dukoral against Japanese encephalitis and cholera) and vaccine distribution rights for third parties;

– Capital held at 13.02% by the Grimaud la Corbière group and 8.19% by BPI France, Frédéric Grimaud chairing the 5-member supervisory board and Thamas Lingelbach the board of directors;

– Solid balance sheet with €307m in equity compared to €42m in debt, reinforced by net cash of almost €350m in April 2022.

bets

– Medium-term strategy based on the financing of R&D through the sale of the Ixiaro and Dukoral vaccines, expansion of the manufacturing network (3 sites, in Scotland, Sweden and Austria) and alliances that promote the assets of the cluster;

– Innovation strategy inherent to the business model, rich in a portfolio of 398 patents and supported by 173 million euros in R&D expenses, with 3 main assets and 3 preclinical programs: the only vaccine in clinical development against Lyme, the the only single-shot chikungunya vaccine, the only inactivated and adjuvanted whole virus COVID-19 vaccine, vaccine candidates against human metapneumovirus, parvovirus and norovirus;

– Environmental strategy: energy efficiency, minimization of waste, optimal use of water and reduction of 5%, vs 2016, of CO2 emissions by 2025;

– Good visibility of the activity thanks to the agreements on vaccines with: the British government (orders of 100 million doses of anti-Covid vaccines and options of 190 million for 2025, that is, 1,400 million euros in total), with Pfizer to co-develop and sell the one against Lyme disease ($308 million), with the American authorities for Ixiario against Japanese encephalitis ($70 million), with Bavarian Nordic for the commercialization and distribution of specialized vaccines, with Batavia Biosciences to develop a Economic vaccine against poliomyelitis, with the Butantan institute against chikingunya for low-income countries.

challenges

– In 2022, launch of phase 3 trials for the vaccine against Lyme disease and pending the approval of the US authority for the sale of the chikingunya vaccine and that of the European Union for Covid 19 (60 million dose);

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

– Uncertainties about the commercial success of the Covid 19 vaccine in the United Kingdom, given the strong competition already established;

– Objectives 2022: without Covid vaccine, turnover between 430 and 590 million euros and R&D spending between 65 and 75 million euros.

An inevitable race for new blockbusters

The patent for Merck’s flagship product, the cancer drug Keytruda, which accounts for more than 35% of its sales, expires in 2028. Despite the loss, since 2019, of the patents for its three flagship products (Avastin, Herceptine, Rituxan) Roche was able to renew its portfolio by bringing new molecules to market. However, the discovery and launch of new drugs are becoming more expensive. AstraZeneca spends about $6 billion a year on R&D in a pharmaceutical industry where the life of a patent is only ten to fifteen years. This leads laboratories to withdraw from certain activities. Thus J&J, Pfizer, GSK and, no doubt, Novartis soon prefer to refocus on specialty drugs and abandon any ancillary activities.

#suivre #aujourdhui.. #Valneva

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