Sanofi
For the period ended Dec 31, 2025. Filed Feb 17, 2026.
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The yearly report of a company based outside the US. It covers much of what a 10-K does, and may follow accounting rules other than US ones.
FY2025 · Filed Feb 17, 2026
Contents
B. Significant Changes
Updates to Note D.22.
340B Drug Pricing Program in the United States
The US Health Resources and Services Administration (HRSA) withdrew its 340B Rebate Model Pilot Program in February 2026
but is expected to announce a new 340B Rebate Model Pilot Program later in 2026.
Other Changes
On January 29, 2026, Sanofi announced its intention to execute a share buyback program in 2026 of €1 billion. On February 2,
2026, Sanofi entered a mandate with an investment service provider for this program. Under the terms of the mandate, Sanofi
will repurchase its own shares for a total consideration of up to €1 billion, between February 3, 2026 and December 31, 2026, at
the latest.
On February 10, 2026, Sanofi announced that ithad completed the acquisition of Dynavax Technologies Corporation (Dynavax).
The acquisition includes Dynavax’s adult hepatitis B vaccine HEPLISAV-B, which is currently marketed in the US and is
differentiated by its two-dose regimen over one month. It also includes Dynavax’s shingles vaccine candidate (Z-1018), which is
currently in phase 1/2 studies, and additional vaccine pipeline projects.
On February 12, 2026, Sanofi announced that Sanofi's Board of Directors met on February 11, 2026, and decided not to renew the
Director mandate of Paul Hudson. As a result, Paul Hudson’s last day as Chief Executive Officer will be on February 17, 2026 at the
end of business. The Board thanks him for his valuable contributions to the transformation and development of the Group over
the last six years. Following the proposal of the Appointments, Governance and CSR Committee, the Board of Directors
appointed Belén Garijo as Chief Executive Officer. She will take up her duties after the Group's Annual General Meeting on
April 29, 2026. The Board will also propose to the shareholder vote the candidacy of Belén Garijo as a director of the Group(1).
Olivier Charmeil, Executive Vice President, General Medicines, and member of the Executive Committee since 2011, will assume
the role of Interim Chief Executive Officer during this transition.
On February 16, 2026, Sanofi announced that a universal respiratory syncytial virus (RSV) immunization program using Beyfortus
(nirsevimab) was associated with a statistically significant reduction in RSV-related hospitalizations in the second RSV season
among infants immunized during their first season, according to a new study published in The Lancet Infectious Diseases. The
NIRSE-GAL study, conducted in Galicia, Spain, is the first prospective real-world population study to evaluate the impact of a
universal Beyfortus immunization program during two consecutive RSV seasons. The study findings, comparing the number of
hospitalizations in immunized infants during their second RSV season versus the number of expected hospitalization cases based
on data from recent seasons, are being presented at RSVVW ’26 (Respiratory Syncytial Virus Vaccines for the World) conference
in Rome, Italy.
On February 17, 2026, Sanofi announced the nomination of Manuela Buxo as Executive Vice-President, Specialty Care, effective
March 1, 2026. Manuela will succeed Brian Foard, who has decided to leave the company as of February 28, 2026, having
accepted an external leadership opportunity.
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PART I
ITEM 9. The Offer and Listing
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.