(BFM Stock Exchange) – The pharmaceutical group has in its portfolio of products in clinical development AMLITELIMAB, a molecule which should make it possible to treat atopic dermatitis. The phase III results of this candidate-drug are expected in the second half of 2025 and good figures are imperative for Sanofi which tries to energize its internal R&D.

For almost two years, Sanofi has been operating an important strategic turn. The pharmaceutical group has decided to build their efforts in terms of R&D to succeed in launching innovative drugs.

The company wants to produce new “blockbusters” to reduce its dependence on the Dupixent, the fruit of successful collaboration with the American Regeneron. This anti-inflammatory has obtained many indications, for example in the treatment of asthma, and remains the major growth engine of the company.

Last year, Dupixent generated revenues of 13.07 billion euros for Sanofi, up 23.1% excluding exchange effects, and UBS estimated that this figure could reach 21.5 billion euros in 2030.

The company is looking for other growth relays, while the exclusives linked to the patents of Dupixent will begin to end in the early 2030s.

For this, the company has decided to intensify its investments, leaving it to obeys its short -term profitability. This is, in hollow, the message that the company had delivered to the market in the fall of 2023, which had resulted in a historic dive of the title of 18.93% on a single session.

A few days later, during an “R&D Day”, Sanofi had presented a “pipeline” (drugs under development) rich in twelve molecules likely to generate between 2 billion and more than 5 billion euros in annual income, in sales.

This represents a total potential ranging from 33 billion to more than 60 billion euros. “If this objective (income, editor’s note) was achieved, the innovative medication launches would generate a turnover greater than that necessary to replace the sales of Dupixent at the expiration of his patents,” said UBS.

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A stop in May

Sanofi had started regaining credit from the market. In September 2024, the group had published the results of two phase III clinical trials, the last step before potential marketing, evaluating the Tolebrutinib molecule for the treatment of different forms of multiple sclerosis.

Only one of the two studies had reached its main evaluation criteria, which had been sufficient to delight the market. “These have been the first strong phase III results for Sanofi for some time, which has played on the feeling of market,” said an analyst.

Sanofi’s revival on the Sanofi stock market has been stopped this year, and the title drops 12% since January 1, underperforming CAC 40 (+4.2% over the same period). A good part of this sub-performance is explained by external causes, such as potential customs duties on American imports of pharmaceutical products, the risk of price reductions of certain drugs in the United States, or the appointment of an oncologist hostile to the pharmaceutical lobby at the head of an important body dependent on the food and drug administration, the American health authority.

Beyond these elements, the story that Sanofi has been trying to tell for the market for two years now has been blurred by disappointing clinical results in late May for almost two years. These results focused on two phase III trials evaluating itepekimab to treat “chronic obstructive bronchopneumopathy” (BPCO), a disease nicknamed “smoker’s bronchitis”, which takes the form of chronic inflammation of the bronchi.

Only one of these two phase III tests had reached its evaluation criteria. “The first study obtained very good results but for the second is very bad. What is disturbing, because the two studies have almost the same population, which raises the question of whether the results of the first study are not an” one-off “(an exceptional, non-reproducible result, editor’s note)”, underlined an analyst. The Sanofi action had then lost almost 5%.

The group has not abandoned the development of itepekimab but it risks having to conduct additional studies, which means more time and money to spend.

AMLITELIMAB, a master card to play

Sanofi has other cards in his hand, one of which should soon be played: amlitemab. This molecule is currently evaluated to treat atopic dermatitis as part of a phase III clinical trial, or asthma via a phase II trial (intermediate phase).

Results eagerly awaited by the market relate to atopic dermatitis. AMLITELIMAB had shown promising data during phase II test, SANOFI believing in passing that this candidate-drug had the potential to become “the best treatment of his category” on this disease.

Recall that atopic dermatitis is a disease that causes chronic skin inflammation responsible for itching and which largely affects children, especially infants. Skin lesions or even infections may appear. According to an article published in the “Journal of European Academy of Dermatology and Venereology”, at least 171 million people were affected by this form of eczema in 2019, or 2.23% of the world’s population.

Sanofi, for its part, believes that the market for advanced treatments for atopic dermatitis should be multiplied by four in 20235 compared to 2022 to be approximately $ 30 billion.

The pharmaceutical group indicated in April that the first clinical data of phase III trials evaluating amlitemab would be available in the second half of 2025, while complete data will wait 2026. Bank of America estimates that the first data should be communicated in the third quarter of 2025.

Sanofi does not really have the right to make mistakes on these results. Jefferies notes that the disappointing results on the itepekimab means that the pharmaceutical group necessarily has “more eggs in the amlitemab basket”.

The disappointment on the itepekimab has “probably reinforced the attention of investors for the results of phase III of the amlitemab in atopic dermatitis, now largely considered as the key program to compensate for the loss of exclusivity of the dupixent (which is also indicated in atopic dermatitis, editor’s note)”, explains the bank.

“After the mixed results of phase III tests of itepekimab in COPD we now consider the phase III test of amlitemab in atopic dermatitis like a ‘must-have (an essential success, editor’s note)’,” warns Bank of America, in a mid-June published note.

“We judge that positive data for the phase III test evaluating amlitemab is important to validate the recovery of Sanofi R&D and to help advance the debate on the future group’s sales profile after patent losses on Dupixent,” insists the American establishment.

What conditions for success?

What are the conditions for AMLITELIMAB to be successful? Answer: arrive at convincing results in the treatment of the severity of atopic dermatitis.

This severity is measured by two indicators, namely the Easi score (“eczema area and severity index”), which assesses the severity of clinical signs and the body surface affected by atopic dermatitis, as well as the “IGA” score (“Investigator Global Assessment”), the overall evaluation score of the dermatologist.

In clinical trials, the “EASI-75” indicator indicates a reduction at least 75% of the EASI score while the IGA 0/1 indicator means that the IGA score has limited to 0 or 1, the two lower levels of this score (which goes from 0 to 4).

During the Phase IIB trial, the amlitemab had shown that 45.5% of patients treated with this medication presented an “IGA 0/1” after 24 weeks of treatment, and 54.5% reached “Easi-75”. This represented respective differences compared to the placebo of 34% and 36%.

Bank of America believes that if AMLITELIMAB manages to repeat these results during phase III (which relates to a much wider population in terms of patients) this would constitute “the best possible scenario”.

The American establishment sees the bar at 30% (positive efficiency gap compared to the placebo) for the “Easi-75” and 25% for “IGAO 0/1”. Jefferies evokes rates at the bottom of those reached by Dupixent in several clinical trials or 32% for the “Easi-75” and) 27% for the “IGA 0/1” indicator

In fact, both Bank of mercia and Jefferies are optimistic about phase III results for Amlitemab, the two establishments with purchasing advice.

Bank of America estimates that AMLITELIMAB sales in atopic dermatitis could reach 4 billion euros, in peak, on an annual basis.

Jefferies retains an annual sales peak figure of 8 billion euros that the bank itself qualifies “optimistic” and which concerns, this time, all the potential indications for the amlitemab.

Beyond the two design offices, 17 of the 23 analysts which cover the title Sanofi are purchased, according to Investing.com, and none advises to sell it.

“After a decrease of 20% compared to its highest in March 2025, Sanofi is exchanged with one of the lowest course ratios on profit expected in 2025 among large pharmaceutical groups,” observed AlphaValue on Tuesday.

“Some success in terms of R&D and a reduction in the volatility of the political/regulatory environment could trigger a significant rise in the course of action,” concluded the independent design office.