Adds investor comment, updates share price

By Alessandro Parodi and Bhanvi Satija

LONDON, Feb 12 (Reuters) - French drugmaker Sanofi SASY.PA ousted CEO Paul Hudson on Thursday, ending a six-year tenure marked by a stalled drive to replace blockbuster drugs going off patent and rising pressure from U.S. anti-vaccine policy and rhetoric.

The company said it had appointed Belén Garijo, the head of German drugmaker Merck KGaA MRCG.DE, as the new chief executive. The 65-year-old Spanish executive will take over in late April and would be Sanofi's first female CEO.

Sanofi shares fell some 3.5% on Thursday, with some analysts pointing to Garijo's relatively low profile and mixed record at Merck. Brokerage Jefferies said in a note that she wasn't "on many shortlists as potential successor."

"She has shown cost discipline at Merck, which is positive. However... she needs to improve her R&D track record," said Markus Manns, portfolio manager at Sanofi investor Union Investment, adding this was key for Garijo's future employer.

"The CEO change at Sanofi is a sign that the R&D transformation has failed or is happening too slowly."

Hudson, 58, who was pushed out only two months before his tenure was up for renewal, did not respond to a Reuters request for comment. He had admitted on a call with analysts late last month that his plans had not moved as quickly as anticipated.

HUDSON LATEST PHARMA CEO TO EXIT

His departure marks the latest in a recent string of European pharmaceutical CEO exits after new leadership at UK-based GSK GSK.L in January and Danish weight-loss drugmaker Novo Nordisk last August.

Sanofi, among the world's largest vaccine makers, released a string of underwhelming trial updates in 2025, which cast a shadow over the company and helped drive its shares down around 25% over the past year, lagging Europe's STOXX pharmaceutical index.

Hudson had also pursued bolt-on acquisitions in search of new medicines to help drive growth once its blockbuster asthma drug Dupixent loses key patents in the early 2030s. The lack of a successor to Dupixent, also used to treat eczema, heaped on the pressure.

"The market had been discussing a potential change as Paul Hudson's contract was up for renewal in April," Berenberg analyst Luisa Hector said, adding he had made positive changes in his six years though fell short on drug development.

"The final component of R&D fix is still work in progress."

'WE HAVE TO BE A LITTLE BIT PATIENT'

Hudson had been hired with a mandate to revive the company's drug pipeline and share price - which initially buoyed Sanofi - but has struggled to reduce its dependence on Dupixent and the turnaround stalled.

"If you'd have asked me back in 2020, will (a turnaround) take between five and seven years for Sanofi, I'd say absolutely not. We'll go faster, we're smarter, we're stronger. It was not to be the case," he told analysts on January 29.

"So we have to be a little bit patient."

Shareholders have seen a 33% return on their investment, including dividends, since September 2019 when Hudson took over, according to LSEG data, but that's well below UK-based rivals AstraZeneca AZN.L and GSK GSK.L, which saw returns of 133% and 65% respectively during the same period.

SANOFI SEEKS 'NEXT GROWTH CYCLE' UNDER NEW CEO

Sanofi has also faced rising pressure on its key vaccine business, especially in the United States. In January it said that vaccine sales would be "slightly negative" this year, partly due to U.S. policy changes under President Donald Trump.

Hudson had said in January that 2026 could offer a good time for dealmaking in the vaccine sector after Sanofi forecast high-single-digit overall sales growth this year.

Sanofi said in a statement that Hudson would step down as of February 17, while Garijo will take the role at the end of the group's shareholder meeting on April 29. Sanofi board member Olivier Charmeil will serve as acting CEO during the transition.

Garijo previously worked for 15 years at Sanofi and was a board member at French cosmetics giant L'Oreal OREP.PA.

"She has the experience and profile to accelerate the pace, strengthen the quality of execution of strategy and lead the next growth cycle of the company," Sanofi Chair Frederic Oudea said in a statement.

(Reporting by Alessandro Parodi in Gdansk and Bhanvi Satija in London; Editing by Matt Scuffham, Adam Jourdan, Joe Bavier, Emelia Sithole-Matarise and Nick Zieminski)

((Alessandro.Parodi@thomsonreuters.com;))