Sanofi’s Painful Reset

How a New CEO Is Burying Three Blockbuster Hopes

A leadership change, three failed late-stage programs, and a ticking patent clock: how Sanofi is trying to reposition itself before its own blockbuster Dupixent comes into the crosshairs of biosimilar competition

When a pharmaceutical company shelves three advanced clinical development programs within a matter of months, replaces its CEO, and overhauls the leadership of its R&D organization on top of that, it's rarely a coincidence — usually it's the visible outcome of a deeper strategic crisis. That's exactly what French pharmaceutical company Sanofi is going through in 2026: a comprehensive course correction fueled directly by a string of disappointing trial results and growing concern about life after patent protection for its own blockbuster, Dupixent.

The Leadership Change: A Board Loses Patience

In February 2026, Sanofi's board decided not to renew CEO Paul Hudson's mandate — according to industry observers, a direct consequence of a string of high-profile clinical setbacks that had shaken confidence in the company's development pipeline. He was succeeded in April 2026 by Belén Garijo, previously CEO of German pharmaceutical and life sciences group Merck KGaA. Sanofi explained the personnel decision by saying Garijo would bring greater rigor to the execution of the company's strategy, with improving R&D productivity, governance, and innovation among her stated priorities.

Garijo didn't stop at a single leadership change: shortly after taking office, she also replaced R&D chief Houman Ashrafian. As his successor, she brought in former Roche executive Paulo Fontoura, who was set to take over leadership of pharmaceutical research and development in September 2026. Sanofi also reorganized its executive committee in July 2026 — according to the company, with the goal of managing business development and mergers and acquisitions in a more integrated way. Garijo herself announced that the new leadership team would be expected to make more disciplined decisions and execute them with greater consistency.

The Trial Track Record: Three Setbacks, One Common Pattern

The pressure that led to the leadership change can be traced to a series of concrete clinical disappointments that marked the final stretch of Hudson's tenure.

Amlitelimab in atopic dermatitis — the most prominent case: the monoclonal antibody (compound code SAR445229, originally KY1005), which entered Sanofi's portfolio through the $1.1 billion acquisition of Kymab completed in 2021, was once touted as having up to $5 billion in annual revenue potential in atopic dermatitis (eczema). On July 24, 2026, Sanofi announced it would not submit the compound for global regulatory approval in this indication. The company's official statement said, in essence, that the totality of efficacy and safety evidence generated to date did not support further development of amlitelimab in atopic dermatitis — the drug would not represent a meaningful improvement over the existing standard of care. While the Phase 3 long-term extension study ESTUARY (clinical trial identifier NCT06407934) had shown sustained clinical response without relapse in patients aged 12 and older, efficacy fell short of Sanofi's own blockbuster Dupixent, as several analysts noted. Development in asthma had already been discontinued earlier following a failed Phase 2 result; a study in celiac disease was, as of this writing, still ongoing, with results expected in the second half of 2026. Financially, the decision resulted in a €952 million impairment charge — part of a total impairment of €1.031 billion in the second quarter of 2026.

Itepekimab in COPD — the second major setback: the IL-33 antibody, co-developed with Regeneron, was originally intended to treat chronic obstructive pulmonary disease (COPD) as well as chronic rhinosinusitis. After a thorough analysis of results from the two Phase 3 trials AERIFY-1 (clinical trial identifier NCT04701983) and AERIFY-2 (clinical trial identifier NCT04751487), which read out in May 2025, and taking into account the shifting competitive landscape, Sanofi and Regeneron decided not to proceed with development in COPD — with the consequence that all studies in chronic rhinosinusitis were discontinued as well.

Balinatunfib in psoriasis and Crohn's disease — the third case: the oral TNF inhibitor missed its goal in a midsize Phase 2 study in plaque psoriasis. Interim analyses of two ongoing Phase 2 studies in Crohn's disease (clinical trial identifier NCT06637631) ultimately led to discontinuation of the clinical development program as well.

CEO Belén Garijo spoke at length about her strategy for the first time during the Q2 2026 earnings call on July 30. Her first months as CEO, she said, had been spent assessing the company's challenges and developing an "accelerated transformation roadmap," with improvements to research and the pipeline among its priorities. She described the recent decisions on amlitelimab, itepekimab, and the other programs as the first steps in a broader pipeline prioritization effort. Her stated principle: invest where the science is strongest, where unmet medical need is greatest, and where sustainable long-term value can be created. Backed by Fontoura, she also intends to simplify the company's decision-making processes.

The Real Urgency: The Dupixent Patent Cliff

The reason these pipeline setbacks weigh so heavily on Sanofi lies in the company's dependence on a single product. Dupixent (dupilumab), co-developed and co-commercialized with Regeneron, has long since become far more than just an important product in Sanofi's portfolio — it's by far the company's largest revenue driver. In the first half of 2026, Dupixent accounted for roughly 42 percent of Sanofi's total revenue, according to industry analyses, with first-half sales of €9.32 billion. In the second quarter of 2026 alone, quarterly sales surpassed €5 billion for the first time. By 2030, annual sales are projected to reach as much as €25 billion.

That very revenue concentration is what makes the approaching patent expiration one of the single largest risk factors facing the entire pharmaceutical industry in the early 2030s. Dupixent's primary U.S. compound patent expires in March 2031, according to company disclosures; two key method-of-use patents were previously noted as expiring in October 2030. Sanofi has publicly announced a "robust" and "vigorous" patent defense plan intended to protect the franchise beyond the base patent's expiration. At the same time, the race among biosimilar manufacturers is already well underway: several South Korean companies — including Celltrion, Samsung Bioepis, Chong Kun Dang, and Daewoong Pharmaceutical — are actively developing Dupixent biosimilars, with Chong Kun Dang already receiving Phase 1 clearance from the EMA and the UK's MHRA in January 2026.

Unlike classical small-molecule drugs, where a patent expiration often triggers an 80 to 90 percent loss of market share within months, competitive pressure on biologics like Dupixent typically unfolds more slowly — biosimilars generally cannot be automatically substituted at the pharmacy counter in most markets, requiring a physician's prescribing decision instead. Even so, industry analysts classify Dupixent as one of the central examples of the so-called "patent cliff" phenomenon set to hit the industry at a historically unprecedented scale between 2025 and 2032: estimates put branded revenue at risk industry-wide in that period at between $236 billion and $350 billion.

The Counter-Strategy: Acquisitions as an Answer to the Pipeline Gap

Even before the current leadership change, Sanofi had already begun trying to close the looming revenue gap through targeted acquisitions — a strategy Garijo is now continuing, apparently with more discipline. In June 2025, the company announced the acquisition of Blueprint Medicines, a company specializing in systemic mastocytosis (a rare immunological disease), with the deal closing in July 2025. The acquisition brought Sanofi the already-approved drug Ayvakit/Ayvakyt (avapritinib) as well as a promising earlier-stage development pipeline in immunology, including the next-generation compound elenestinib (in a registrational Phase 2/3 study) and BLU-808, an oral KIT inhibitor with potential across several immunology indications. According to the company, the acquisition is expected to be accretive to gross margin, operating income, and earnings per share starting in 2026.

In parallel, Sanofi expanded its vaccine portfolio through the acquisition of Dynavax as well as, earlier, Vicebio — in the second quarter of 2026, revenue in the polio, pertussis, and hepatitis B vaccine category grew 77.2 percent, driven largely by the inclusion of the newly acquired product. The company additionally secured access to an Alzheimer's disease drug candidate through the acquisition of Vigil, and gained a further early-stage immunology position through a collaboration with Dren Bio (compound DR-0201).

Despite the pipeline setbacks, recent figures show a more nuanced picture: Sanofi reported second-quarter 2026 group revenue of €11.6 billion — above the analyst consensus of €11.2 billion — and raised its full-year 2026 revenue growth guidance from a previous high single-digit target to around 10 percent at constant exchange rates. At the same time, vaccine sales of €1.15 billion missed the consensus estimate of €1.20 billion, pointing to persistently softer demand in that segment. Sanofi's stock responded to the mixed news with a slight decline despite otherwise solid headline numbers — a sign that the market had already priced in much of the depth of the pipeline problems, beyond what the raw revenue figures alone would suggest.

What This Means for the Industry

The Sanofi case illustrates a pattern likely to recur with increasing frequency across the pharmaceutical industry in the years ahead: companies whose revenue is heavily concentrated in a single, aging blockbuster product face mounting pressure once pipeline replenishment falls short — both from investors and, structurally, at the leadership level. The fact that three late-stage programs failed within a matter of months before the previous CEO was forced to leave the company also shows how tightly clinical development risk and corporate governance have become intertwined: a board that once accepted research setbacks as an unavoidable industry risk now responds with a complete change of leadership.

For Sanofi itself, the central strategic question remains unresolved: how much time the company actually has left. The Dupixent patent cliff is coming into clear view, just as the three most promising internal successor candidates have dropped out of the race. Whether the newly acquired compounds from the Blueprint, Dynavax, and Vigil deals — combined with internal research now run with greater discipline under Fontoura — can close the resulting gap in time will only become clear in the trial readouts of 2027 and 2028: precisely the window in which the Dupixent patent cliff will already be looming large.

Sources

1. Sanofi, Press Release, Jul 30, 2026 – Q2 2026: double-digit sales growth and strong business EPS growth; 2026 guidance upgraded
2. Sanofi, SEC Form 6-K, Jul 24, 2026 – Sanofi announces decision not to submit amlitelimab in atopic dermatitis for global regulatory reviews
3. Fierce Biotech, Jul 30, 2026 – Sanofi CEO 'looking deeply' at pipeline as clearout continues
4. Fierce Biotech, Jul 28, 2026 – Sanofi abandons plan to seek approval for eczema drug from $1.1B Kymab buyout
5. Quartz, Jul 24, 2026 – Sanofi drops amlitelimab eczema drug in pipeline overhaul
6. Labiotech.eu – Sanofi pipeline 2026: new leadership, same strategy?
7. Investing.com, Jul 30, 2026 – Why is Sanofi stock sliding today?
8. Sanofi, Q2 2026 Press Release (PDF) – SANOFI PRESS RELEASE Q2 2026
9. DCAT Value Chain Insights – Generics/Biosimilars Outlook: Major Patent Cliff Looms Large
10. Labiotech.eu – The next pharma patent cliff: how 2026-2032 will reshape revenue
11. DrugPatentWatch – Patent Cliff or Patent Opportunity? Mapping Blockbuster Drug Expirations for Strategic Supply Chain Readiness
12. Korea Biomedical Review – Korean biosimilars gear up for wave of blockbuster patent expiries
13. Life Science Daily News – Biologics on the Brink: The Patent Cliff Facing Big Pharma
14. Sanofi, Press Release, Jun 2, 2025 – Sanofi to acquire Blueprint Medicines, expanding portfolio in rare immunological disease and adding early-stage pipeline in immunology
15. Sanofi, Press Release, Jul 18, 2025 – Sanofi completes acquisition of Blueprint Medicines
16. Sanofi, SEC Form 6-K, FY2025 (Capital allocation/acquisitions: Blueprint, Dren Bio, Vigil, Vicebio)

Adrian Kempf 
Pharma Communications Writer, Graphic & Media Designer Kirchzarten im Dreisamtal, Germany

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