Sanofi dans une mauvaise passe

Sanofi dans une mauvaise passe

(AOF) – Sanofi’s share (-3.33% to 84.75 euros) ended Thursday’s session at the bottom of the star index of the Paris stock exchange. On Tuesday, the pharmaceutical company announced the suspension of recruitment for clinical trials of tolebrutinib, an experimental treatment for multiple sclerosis (MS). On the same day, UBS downgraded its view on the value from Buy to Neutral and lowered its price target from €118 to €103. He expects earnings growth to slow in 2023 due to difficulties with amcenestrant, a breast cancer treatment, and tolebrutinib.

Therefore, Sanofi has announced the suspension of recruitment for clinical trials of tolebrutinib, an experimental treatment for certain forms of multiple sclerosis and myasthenia gravis.

The FDA’s Independent Data Monitoring Committee (iDMC), responsible for overseeing clinical trials of tolebrutinib, has called for a worldwide suspension of recruitment for all of these trials.

At the end of June, the US health authority had already requested a partial suspension of trials in the United States after several cases of liver damage linked to treatment.

Per iDMC’s recommendation, all participants currently receiving tolebrutinib in all studies will continue treatment according to trial protocols, Sanofi said.

The group assures that it is working side by side with the regulatory authorities to be able to resume active contracting during the fourth quarter of 2022.

Sanofi is committed to providing the FDA with the requested information by the end of September 2022.

In addition, the company adds, the regulatory deadlines for this indication remain unchanged with a recurring MS presentation scheduled for 2024.

AOF – MORE INFORMATION

Key points

– 5

the

world pharmaceutical group, created in 1994, first in Europe, and 1

Ahem

worldwide in vaccines;

– Balanced sales of 37.8 billion euros from 4 divisions: general medicine for 34%, specialized medicine (immunology, neurology and oncology) for 35%, vaccines for 20% and consumer care;

– Growing share of emerging countries (34% of sales) behind the United States (38%) and Europe (28%);

– 4-point business model: a streamlined organization, a restructured portfolio containing more organic products, transformed R&D, and strong ambitions in terms of profitability and financial strength; –

– Divided capital (excluding L’Oréal: 9.48% of the shares and 16.95% of the voting rights), Serge Weinberg chairing the 16-member board of directors, with Paul Hudson as CEO;

– Healthy balance sheet with net debt reduced to €8.8 billion and free cash flow of €8.1 billion.

bets

– Plan 2020-2025 “Play to win” with the aim of creating an agile group and number 2 in the world, and articulated in 2 phases: 2020/22: 30% operating margin, 2,500 million euros in cost savings / 2023/ 25: Reduction of 1/3 of product families and productivity driven by R&D and digital in factories, operating margin of 32%;

– Innovation strategy: 5 research areas: immunology and inflammation, oncology, neurology (particularly sclerosis), rare hematological diseases and rare diseases, vaccines / 91 ongoing projects, including 29 in phase 3 and 5 awaiting approval by the authorities / developed in collaboration -Kymera for immunology, Translate Bio in RNA for vaccines- or through acquisitions -Kiadis, Biopharma, Kymab for oncology/ supported by technological platforms: small molecules, antibodies, hemogenetic proteins, genomics;

– Planet Mobilization environmental strategy with the goal of 2030 carbon neutrality in 2030, 100% sustainable electricity consumption compared to 50% in 2021 and 100% sustainable car fleet compared to 22% / in 2027, elimination of plastic packaging for vaccines / in 2025, eco-design of all new products / launch of lines of credit indexed to sustainable development;

– Impact of the 5 “priority” drugs: Amcenestrant (breast cancer), Fitusiran (RNA for hemophilia), Efanesoctocog (hemophilia), Nirsevimab and Nisevimab (respiratory viruses) and Tolebrutinib (multiple sclerosis):

– After Origimm, specialized in skin disease research, Kadmon and Owkin, agreement to acquire Amunix in immuno-oncology, reinforcing the R&D portfolio of biological agents.

challenges

– Image tarnished by the delay of the vaccine against Covid 19;

– IPO of EUROAPI, a group created from the group’s activities in the production of active pharmaceutical ingredients or APIs in Europe, the shareholders receive 1 EUROAPI share for 23 shares and the capital is divided between Sanofi for 30% and BPIFrance for 12%;

– 2022 target of growth of at least 10% in earnings per share;

– 2021 dividend of €3.33.

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.

#Sanofi #dans #une #mauvaise #passe

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