Sanofi (NASDAQ:SNY) opened 2026 with what interim CEO Olivier Charmeil described as a “strong start,” pointing to double-digit sales and earnings growth in the first quarter driven by Dupixent, newer product launches and recent acquisitions. Management kept full-year guidance unchanged and highlighted ongoing efforts to extend the durability of its largest franchise while advancing a pipeline that includes late-stage dermatology and respiratory programs.
Q1 performance led by Dupixent and launches
Charmeil said first-quarter performance reflected “strong performance across our company,” with pharma launches led by Ayvakit, ALTUVIIIO and Sarclisa. Vaccines posted “modest” growth, supported by an expanded PPH portfolio that now includes hepatitis B vaccine Heplisav-B following the Dynavax acquisition that closed in February.
Sanofi’s launch portfolio represented 14% of total sales in the quarter, Charmeil said. He highlighted:
- ALTUVIIIO sales of EUR 325 million, up 42%
- Beyfortus sales of EUR 284 million, reflecting continued global expansion
- Sarclisa sales up 30% to EUR 167 million, driven by higher demand and increased frontline use
- Ayvakit sales of EUR 170 million
- Heplisav-B sales contribution of EUR 46 million since consolidation
Charmeil said the launch portfolio grew 44% versus last year, or roughly 22% excluding acquisitions.
Dupixent approaches EUR 4.2 billion; lifecycle management outlined
Dupixent sales in the quarter “approach[ed] EUR 4.2 billion,” according to Charmeil, who attributed the year-over-year growth to continued penetration across indications and geographies, and to an easier comparison in the U.S. He said Sanofi expects volume-driven growth to continue with “some normalization in the second half of the year” as comparisons become tougher and recent launches annualize.
Charmeil said Dupixent is the “number one prescribed biologic medicine across top specialists in the U.S.” With a U.S. approval in February for allergic fungal sinusitis, Dupixent is now approved in nine indications and reaches more than 1.4 million patients, he added.
Management also used the call to detail a three-part plan to sustain value creation for Dupixent: “defend, extend and innovate.” Charmeil said Sanofi has issued and pending patents with expirations “from 2031 to 2045,” and expects to protect innovations beyond the U.S. compound patent expiration in March 2031. The company is also exploring extending dosing to every four weeks via a higher-dose asthma approach (development ongoing) and a co-formulation approach with clinical studies expected to start in the second half of 2026.
During Q&A, executives declined to disclose some specifics around the longer-acting strategy. R&D head Houman Ashrafian said the “technology’s pretty straightforward,” is “with a partner,” and is “precedented,” and later confirmed the co-formulation uses “high hyaluronidase with a partner,” without naming the partner.
On U.S. pricing dynamics, Specialty Care head Manuela Buxo said Q1 was helped by a low base due to “higher gross to net price adjustments in Q1 2025,” adding that gross-to-net can fluctuate quarter to quarter and is “usually…highest” in Q1 due to insurance benefit resets. She said Sanofi has a “robust GTN strategy” to support profitable growth while maintaining access.
Financial results and 2026 guidance reiterated
CFO François-Xavier Roger said net sales grew 13.6% to EUR 10.5 billion in the first quarter, with like-for-like sales up 12%. At constant exchange rates, he said gross profit and margins rose on favorable product mix and operational efficiencies.
Operating expenses increased 7%, which Roger attributed to higher SG&A tied to 2025 business development and M&A activity, including Blueprint and Dynavax, as well as “some one-off items.” As a percentage of sales, OpEx declined by 1.9 percentage points, which he said reflected the company’s efficiency programs.
Roger said business operating income (BOI) rose 10.9%, with BOI margin “slightly down” due to higher profit sharing and the “phasing of capital gains,” which he said were approximately EUR 230 million last year versus EUR 40 million this year. Business EPS increased 14% on operational leverage.
Sanofi reaffirmed its outlook for “high single-digit sales growth” at constant exchange rates in 2026, with business EPS expected to grow “slightly faster than sales,” Roger said. He cautioned that comparisons become tougher in the second half due to Dupixent’s new indication launches and the consolidation of Ayvakit starting in July 2025.
Roger said the company now expects about EUR 400 million of capital gains from divestments in 2026. He also noted an agreement signed in March to divest Medley, Sanofi’s Brazilian generics business, under what he called “very favorable market conditions,” with closing expected “at the earliest around the end of 2026,” subject to antitrust approvals.
Roger also said Sanofi expects to complete its EUR 1 billion share buyback program “in the coming days.”
Pipeline updates: dermatology, respiratory, immunology, and rare disease
Ashrafian highlighted several regulatory and clinical updates, including multiple Dupixent label expansions (EU, Japan, and U.S.), EU approval for Rezurock in third-line chronic graft-versus-host disease, and a U.S. label expansion for Tzield to delay onset of stage 3 type 1 diabetes in children as young as one year of age.
He also discussed mixed results for venglustat, with a positive phase II result in type 3 Gaucher disease and a phase III Fabry disease study that did not meet its primary endpoint. He said a new phase III study for frexalimab in kidney transplantation has been initiated.
In dermatology, Ashrafian presented updated comments on amlitelimab, stating that across pivotal studies the drug showed continuous improvement versus placebo through week 24 without evidence of plateau, with supportive phase II data through week 52. On safety, he said amlitelimab was “well-tolerated” with low rates of conjunctivitis, pyrexia, chills, and headache, and no Kaposi sarcoma cases in phase III studies; however, he acknowledged one case in the ATLANTIS phase II study and one in the ESTUARY phase III extension study. He said both cases were cutaneous and patients were recovering after discontinuation, adding that malignancy rates were similar to placebo. In response to analyst questions, Ashrafian said Sanofi has seen “no impact on enthusiasm” from physicians and patients based on the AAD data presentation.
In respiratory, Ashrafian described “statistically significant and clinically meaningful” phase II results for lunsekimig in moderate-to-severe asthma and chronic rhinosinusitis with nasal polyps, with improvements in exacerbations and lung function in asthma and multiple endpoints in nasal polyps. He said phase III plans would be discussed “soon,” and later added that Sanofi does not anticipate waiting for results from the ongoing AIRLYMPUS study before moving forward; he said any phase III progression would depend on regulatory conversations and internal portfolio decisions.
Business development priorities and alliance economics
On capital allocation, Roger said Sanofi previously indicated it could invest up to EUR 15 billion in BD and M&A while maintaining a double-A rating, and added that capacity could be higher for commercialized assets. He reiterated a focus on immunology, rare disease, and vaccines, while not ruling out “white spaces.”
Roger also addressed the step-down of Dupixent alliance R&D reimbursement from Regeneron, saying Sanofi expects a negative impact on BOI of “probably a good EUR 400 million” in 2026 and “maybe EUR 700 million” in 2027. He said the balance is expected to be “fully reimbursed around Q2 2026,” with impacts extending “up to Q2 2027,” while maintaining that BOI should still increase in margin and absolute value in both 2026 and 2027.
Charmeil, who is serving as interim CEO before incoming CEO Belén Garijo joins in May following the annual general meeting, said he has prepared a program to ensure she can be “up and running from day one.” He added that updating investors on Dupixent loss-of-exclusivity planning was a commitment made previously and “has nothing to do with the change of CEO.”
About Sanofi (NASDAQ:SNY)
Sanofi (NASDAQ:SNY) is a multinational pharmaceutical company headquartered in France that researches, develops, manufactures and markets prescription medicines, vaccines and consumer healthcare products. The company operates across multiple therapeutic areas, including immunology, rare diseases, oncology, cardiovascular and metabolic diseases, and vaccines through its Sanofi Pasteur division. Sanofi sells products to hospitals, clinics, governments and retail pharmacies, with a broad global footprint and significant presence in Europe, North America and emerging markets.
Key commercial offerings include specialty biologics and established small-molecule medicines.
