(AOF) – Valneva has reached an agreement with the United Kingdom government (“HMG”) regarding the termination of the supply agreement for its candidate vaccine against Covid-19 (VLA2001). “The settlement agreement resolves certain points relating to the obligations of Valneva and HMG following the termination of the supply agreement and also clarifies others contained in the agreement relating to the clinical trials of VLA2001 at United Kingdom, which remains in force, ”explained the biotech.
The company adds that it “retains certain obligations under the provisions of the supply contract which survive its termination”.
As a reminder, Valneva announced on September 13 that it had received a termination notice from the British government. This termination, which Valneva accepted on the basis of the UK government exercising its discretionary right to terminate the agreement for convenience, became effective on October 10.
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Key points
– Specialist in the development of prophylactic vaccines against infectious diseases with limited therapeutic options;
– Turnover of €348m €bn drawn from Europe for 56%, ahead of the Americas (27%), then Asia-Oceania (9%) and Africa-Middle East (8%) ;
– Business model: portfolio of diversified 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 management board;
– Solid balance sheet with €307m in equity against €42m in debt, reinforced by net cash of nearly €350m in April 2022.
Challenges
– Medium-term strategy based on financing R&D through sales of the Ixiaro and Dukoral vaccines, extension of the manufacturing network (3 sites, in Scotland, Sweden and Austria) and partnerships promoting the group’s assets;
– Innovation strategy inherent in the business model, rich in a portfolio of 398 patents and supported by €173 million in R&D costs, with 3 main assets and 3 preclinical programs: the only vaccine in clinical development against Lyme, the only single-shot vaccine against chikungunya, 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 out of 190 million by 2025, i.e. €1.4 billion 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 marketing and distribution of specialized vaccines, with Batavia Biosciences to develop an inexpensive vaccine against polio, 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 awaiting the approval of the American authority for the sale of the vaccine against chikingunya and that of the European Union for the Covid 19 (60 million doses);
– Sensitivity to travel of sales of vaccines already on the market (against Japanese encephalitis and cholera);
– Uncertainties about the commercial success of the vaccine against Covid 19 in the United Kingdom, given the strong competition already established;
– 2022 objectives: excluding Covid vaccine, turnover between €430 and €590 million and R&D expenditure between €65 and €75 million.
Oncology supports laboratory performance
Oncology generated $163 billion in revenue in 2021 (out of an industry total of $613 billion), up 11.9%, according to GlobalData. Its average annual growth has reached 15.4% over the past twenty years. This segment, which is increasingly competitive, is dominated by a few heavyweights such as MSD (Merck & Co. Inc), Roche, BMS
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immuno-oncology, the specialty that has been driving this market for ten years, supports research. GlobalData estimates that this segment could reach 180 billion in 2026. The major players are looking to strengthen themselves in this niche. Pfizer recently acquired Canadian biotech Trillium Therapeutics for $2.3 billion. Following this operation, the American group got hold of two promising molecules in the treatment of blood cancer.