Sanofi (NASDAQ:SNY) executives told investors the company delivered “strong performance” in 2025 as it continued its shift toward what CEO Paul Hudson described as an “R&D-driven, AI-powered biopharma company.” Management highlighted the completion of the Opella transaction, which it said enabled reinvestment into business development and M&A opportunities while also completing a €5 billion share buyback program.
2025 results and Q4 acceleration
Hudson said 2025 sales grew 9.9% and that new launches totaled €5.7 billion in sales. In the fourth quarter, the company reported €11.3 billion in sales, up 13.3%, which CFO François-Xavier Roger said represented Sanofi’s “strongest quarterly sales growth in Q4 2025.” Roger also pointed to business EPS growth of 26.7% in Q4, which he attributed to “disciplined execution on operational leverage.”
Roger said business EPS excluding the share buyback grew 12.2% (in line with guidance), and business EPS including the buyback grew 15%. Free cash flow was €8.1 billion, or 18.5% of sales, with inventory optimization cited as a major driver, including an inventory reduction of nearly 30 days. Net debt ended the year at €11 billion, with a net debt-to-EBITDA ratio of 0.8x.
Key commercial drivers: Dupixent, launches, and vaccines
Hudson said newly launched medicines and vaccines grew 34% in 2025. Beyfortus delivered €1.8 billion in full-year sales, and ALTUVIIIO reached blockbuster status with €1.2 billion in full-year sales. Management also cited “annual pro forma sales” for Ayvakit of $725 million, described as slightly ahead of Blueprint expectations from early 2025.
Dupixent was a central focus of the call. Hudson said Dupixent reached €4.2 billion in Q4 sales and €15.7 billion for the year, supported by growth across anchor indications and expansion into COPD, chronic spontaneous urticaria (CSU), and bullous pemphigoid (BP). He said this contributed to more than a 30% increase in patients over the past year and described Dupixent as the “number one prescribed biologic” across several specialist groups.
In Q&A, Brian (who addressed Dupixent performance) said Dupixent grew 25% year-over-year in 2025 and 32% in Q4, with COPD, CSU, and BP adding growth compared to 2024. He said biologic penetration rates remain low, citing atopic dermatitis at 18% and CSU “in the low teens,” and argued that new competitors can expand the overall market. He also said the company remains on track for longer-term guidance of “greater than €22 billion, around €22 billion sales” by 2030.
On vaccines, Hudson said full-year sales reached €7.9 billion and that Sanofi maintained leadership in influenza and RSV. He cited U.S. market share gains in influenza with Fluzone High-Dose and Flublok, and in Europe with Efluelda and Supemtek. He also said real-world evidence supports Beyfortus effectiveness of 87% to 98%, adding that the product has protected more than 11 million babies in more than 45 countries, preventing an estimated 200,000 hospitalizations to date.
Pipeline progress and regulatory updates
Head of R&D Houman Ashrafian said 2025 included 12 phase 3 readouts and 15 phase 2 readouts, and the company added 10 new molecules to phase 1, including three gene therapies and an entry into ophthalmology. He also cited 20 regulatory approvals and 22 acceptances, including nine priority reviews.
Sanofi highlighted three new products provided to patients in 2025:
- Qfitlia, described as the first RNAi antithrombin medicine in hemophilia approved in the U.S. and China
- Wayrilz, described as the first BTK inhibitor in ITP, approved in the U.S. and the EU
- Nuvaxovid, a recombinant COVID-19 vaccine with full approval in the U.S. and the EU
On late-stage updates, Ashrafian said Amlitelimab delivered additional positive phase 3 results in atopic dermatitis and characterized the program as supporting “monthly and quarterly dosing” with no evidence of a plateau through weeks 24 to 52 across multiple studies. Remaining studies (AQUA and ESTUARY) are expected to read out in the second half of 2026, completing the package for regulatory submission.
Ashrafian also said Tolebrutinib did not meet its primary endpoint in a study for primary progressive multiple sclerosis (PPMS), and the company will not pursue regulatory submission for that indication. He added in Q&A that the company is “waiting for regulatory comments” from outside the U.S., including the EU. On Itepekimab, he said next steps depend on interactions with the FDA to determine requirements for a replication phase 3 study.
Asked about a Kaposi sarcoma case in Amlitelimab development, Ashrafian said immunomodulators carry a theoretical risk of infectious complications and noted Kaposi sarcoma is caused by HHV-8. He said the company had anticipated herpes-virus-related risk in early documentation and that the benefit-risk profile remains aligned with its prior assessment.
Business development, capital returns, and 2026 outlook
Management said it deployed €10.4 billion of proceeds from the Opella divestment into business development and M&A, citing Blueprint, Vicebio, Dren Bio DR-0201, Vigil, and others. Hudson highlighted the December acquisition of Vicebio, which added a bivalent RSV plus human metapneumovirus vaccine candidate using molecular clamp technology. The company also announced a proposed acquisition of Dynavax Technologies Corporation, expected to close in the first quarter, which would add Heplisav-B and a shingles vaccine candidate in phase 1/2.
Roger said Sanofi proposed raising its dividend for the 31st consecutive year to €4.12, up 5%, and announced a €1 billion share buyback program for 2026.
For 2026, management guided to high single-digit sales growth and business EPS growth “slightly faster than sales.” Key assumptions included:
- Portfolio optimization divestments reducing 2026 sales by about €200 million
- Vaccine sales expected to “slightly decline” in 2026
- Minimal tariff impact following an agreement reached with the U.S. administration in December
- Approximately €500 million of capital gains from disposals included in operating income
Roger also discussed changes in collaboration economics: Sanofi expects a roughly €400 million decrease in R&D reimbursement from Regeneron in 2026, which he said would be more than offset by Amvutra royalties estimated at about €1 billion based on the latest consensus, resulting in a net positive impact of around €500 million to business operating income. He added that financial expenses are expected to rise due to increased net debt tied to 2025 and 2026 business development activity.
In closing remarks, Hudson said Sanofi expects profitable growth to continue “over at least five years” and stated that, based on the pipeline and external growth opportunities, the company’s ambition is to pursue earnings growth into the next decade.
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.
