Sanofi's Q1 Surge Driven by Dupixent and Emerging Blockbusters: Unchanged Outlook Reflects Strategic Resilience

Sanofi (SASY.PA) delivered a robust Q1 2025 performance, with its flagship drug Dupixent and newer therapies like ALTUVIIIO and Beyfortus propelling sales and earnings growth. Despite headwinds from generic competition and macroeconomic pressures, the company reaffirmed its full-year 2025 outlook, underscoring its confidence in a transformative pipeline and disciplined capital allocation. Here’s why investors should take note.

Dupixent: The Engine of Growth

Dupixent, Sanofi’s anti-inflammatory biologic, remains the bedrock of its success. In Q1, sales surged 20.3% year-on-year to €3.5 billion, driven by expanding use in indications like atopic dermatitis, asthma, and chronic sinusitis. The drug’s long-term potential is staggering: Sanofi projects it could reach €22 billion in annual sales by 2030, cementing its status as one of the industry’s most valuable assets.

The molecule’s versatility is its secret. Regulatory wins in 2024, such as EU approval for pediatric eosinophilic esophagitis (EoE), and ongoing trials in conditions like bullous pemphigoid and chronic rhinosinusitis with nasal polyps (CRSwNP) continue to widen its addressable market.

Newer Drugs: Building a Pipeline of Blockbusters

Sanofi’s strategy to diversify beyond Dupixent is paying off. Two newer therapies—ALTUVIIIO and Beyfortus—are already delivering blockbuster returns:

1. ALTUVIIIO (long-acting therapy for hemophilia A):
2. Q1 sales of €800 million (up 43.8% at CER), with CEO Paul Hudson declaring it “on track to become a blockbuster by year-end.”

3. A subcutaneous formulation offering patients fewer injections than existing therapies, ALTUVIIIO is capturing market share in a $5 billion rare disease market.

4. Beyfortus (RSV monoclonal antibody for infants/elderly):

5. Vaccines division sales rose 11.4% to €1.3 billion, with Beyfortus contributing significantly. It hit blockbuster status in 2024 ($1.7 billion) and is expanding into new geographies, including the U.S.

Financial Fortitude Amid Challenges

Sanofi’s Q1 IFRS net sales rose 9.7% to €9.9 billion at constant exchange rates, while Business EPS (a non-IFRS metric) jumped 15.7% to €1.79, reflecting strong operational discipline. R&D spending increased 6.9% to €1.8 billion, funding late-stage trials for therapies like amlitelimab (asthma) and tolebrutinib (multiple sclerosis).

However, headwinds persist. Generic competition for Aubagio (a multiple sclerosis treatment) in key markets like Germany and Italy reduced sales by ~€100 million in Q1. Flu vaccine sales also lagged due to lower demand. Sanofi mitigated these pressures by accelerating its €5 billion share buyback program (72% completed by Q1) and advancing plans to divest its consumer health division (Opella) by Q2 2025.

Why the Forecast Remains Unchanged

Sanofi’s 2025 guidance—mid-to-high single-digit sales growth and a low double-digit rebound in Business EPS—is grounded in three pillars:
1. Dupixent’s momentum: With ~10% of its peak sales potential captured, the drug’s global expansion and new indications will drive growth.
2. Pipeline execution: Six regulatory approvals in Q1 (e.g., Qfitlia for hemophilia, Kevzara for polymyalgia rheumatica) and mid-stage data enabling late-stage trials (e.g., itepekimab for atopic dermatitis) position Sanofi to deliver 7–10 new launches by 2030.
3. Strategic capital reallocation: Offloading the Opella division by Q2 2025 will free up resources for high-margin biopharma assets, while the share buyback program enhances shareholder returns.

Conclusion: A Pharma Leader in Transition

Sanofi’s Q1 results and unchanged outlook reflect a company successfully pivoting toward biopharma innovation. With Dupixent’s dominance, emerging blockbusters like ALTUVIIIO, and a pipeline rich in immunology and rare disease therapies, the company is well-positioned to achieve its €22 billion Dupixent target by 2030 and €10 billion in vaccines sales.

While risks like generic erosion and regulatory hurdles linger, Sanofi’s financial flexibility—backed by a 15.7% EPS surge and a €1.8 billion R&D budget—provides a safety net. Investors should take note: Sanofi’s blend of near-term execution and long-term pipeline vision makes it a compelling play in the healthcare sector.

In short, Sanofi is not just surviving—it’s thriving as a modern biopharma leader. The unchanged forecast isn’t just a number; it’s a roadmap to sustained dominance in immunology and beyond.