January 29, 2026
Finance

Sanofi Signals Challenges in Replacing Dupixent as Patent Expiry Nears

Q4 Sales Beat Currency-Adjusted Expectations; Growth to Continue Despite Dupixent Exclusivity Loss

Summary

Sanofi SA disclosed fourth-quarter financial results showcasing robust growth fueled by flagship drug Dupixent and new pharmaceutical launches. Despite beating adjusted earnings per share forecasts, the company conveyed concerns about offsetting the sales impact following Dupixent's patent expiry. Management projects sustained profitability over the next five years while planning strategic initiatives including share repurchases and pipeline advancements to mitigate anticipated revenue pressures.

Key Points

Sanofi's Q4 sales grew 7% year over year, reaching $13.159 billion but missing consensus estimates of $13.41 billion.
Dupixent remains the company's top growth driver with sales up 32.2% to 4.2 billion euros and has surpassed 4 billion euros in quarterly sales twice.
Pharmaceutical launches led by Ayvakit and ALTUVIIIO grew 49.4%, hitting 1.1 billion euros in sales.
Sanofi forecasts high single-digit sales growth in 2026 alongside EPS growth and plans a 1 billion euro share buyback program.

Sanofi SA, the French pharmaceutical giant listed on NASDAQ under the ticker SNY, unveiled its financial performance for the fourth quarter, reporting sales of $13.159 billion (equivalent to 11.30 billion euros). While this figure represented a 7% increase from the previous year and a stronger 13.3% growth when measured on a constant currency basis, it fell short of market consensus expectations pegged at $13.41 billion.

CEO Paul Hudson highlighted the quarter’s performance in a statement, noting an acceleration in sales growth to 13.3%, driven significantly by new medicinal products and the sustained momentum of Dupixent. The CEO further emphasized that these factors supported a 26.7% increase in business earnings per share (EPS), a result attributed to disciplined cost management and operating leverage gained through revenue expansion.

The company’s sales in the United States were notably strong, amounting to 5.80 billion euros and reflecting a 22.6% increase. This growth was primarily propelled by Dupixent, launches of novel pharmaceutical products, and influenza vaccines, although some headwinds emerged from other vaccine segments. Particularly, the pharmaceutical agent ALTUVIIIO surpassed the billion-dollar sales milestone in 2025, underscoring its rising market significance.

Pharmaceutical launches overall surged by 49.4%, with sales reaching 1.1 billion euros. This growth was led principally by the contributions of Ayvakit and ALTUVIIIO. Meanwhile, Dupixent generated sales rising by 32.2% to 4.2 billion euros, capping the year with remarkable volume growth across its approved indications. Notably, this marked the second occasion when quarterly sales of Dupixent exceeded the four billion euro threshold globally.

Conversely, the vaccine business experienced a decline of 2.5% in sales, totaling 2 billion euros, primarily due to decreased revenues from Beyfortus and Polio/Pertussis/Hib (PPH) vaccines, although influenza vaccine sales surpassed expectations. Specifically, Beyfortus sales declined by 14.9% to 686 million euros, whereas combined influenza and COVID-19 vaccine sales increased by 31.5% to 575 million euros. The reduction in PPH primary and booster vaccine sales, down 9.5% to 551 million euros, was attributed mainly to demographic trends such as fewer newborns in multiple countries, including China.

On the profitability front, Sanofi recorded a business operating income for Q4 of 2.34 billion euros, reflecting a 12.7% year-on-year increase and 21.7% growth on a constant currency basis. The adjusted EPS reached 1.53 euros (89 cents per American Depositary Share), outperforming the consensus estimate of 84 cents and representing growth of 16.8% versus last year, or 26.7% when adjusted for currency effects.

Looking forward, CEO Hudson articulated an outlook anticipative of continued profitable growth extending for at least the next five years. For 2026, the company projects sales growth in the high single-digit percentage range on a constant exchange rate basis, with business EPS expected to advance at a slightly faster pace than sales prior to considering share repurchases, signifying sustained operating leverage and margin progression.

In line with shareholder return initiatives, Sanofi plans to implement a share buyback program targeting one billion euros worth of repurchases during 2026. Despite these positive perspectives, Chief Financial Officer François-Xavier Roger sounded a cautionary note regarding the imminent loss of exclusivity on Dupixent. Roger indicated that the sales impact from Dupixent's patent expiry will be considerable and "too big to be mitigated" through existing product revenues.

To counterbalance the expected EPS pressures arising from Dupixent's expiry, Roger outlined strategic measures including leveraging the current portfolio, advancing late-stage pipeline candidates through 2031, and pursuing external acquisitions. While the pharmaceutical segment is forecasted to maintain growth, vaccine sales are anticipated to experience a modest downturn in the coming year, partially influenced by shifts in U.S. policy that trace back to changes enacted during the Trump administration.

Following the earnings release, shares of Sanofi were up 0.63% in premarket trading, trading at $46.06 according to Benzinga Pro data, signaling a moderate positive market reception amid the outlined challenges and growth prospects.

Risks
  • Dupixent’s upcoming patent expiration will have a significant negative impact on sales, described as ‘too big to be mitigated.’
  • Vaccine sales are expected to decline slightly in 2026, influenced in part by changes in U.S. vaccination policies.
  • Demographic trends such as reduced birth rates in certain countries (e.g., China) have negatively affected vaccine sales.
  • EPS growth could be pressured despite sales increases, necessitating strategic actions including acquisitions and pipeline progression.
Disclosure
Education only / not financial advice
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