Sanofi's Strong Growth Obscures Launch Portfolio Headwinds and Intensifying Dupixent Competition

Sanofi Reports Strong Q2 2026 Financials and Upgrades Guidance

Sanofi reported robust financial results for Q2 2026, with sales increasing by 17.8% at constant exchange rates (CER) to €11.6 billion and business earnings per share (EPS) growing 33.3% at CER to €2.09. This performance was primarily driven by strong growth in Pharma launches, including Ayvakit, ALTUVIIIO, and Sarclisa, which saw sales rise 48.3% to €1.3 billion, and Dupixent, which achieved €5.2 billion in sales, up 37.6%. Based on these strong first-half results, Sanofi upgraded its full-year 2026 guidance, now expecting sales to grow by approximately 10% at CER, with business EPS growing slightly faster. The company also highlighted pipeline advancements, including seven regulatory approvals and two positive Phase 3 readouts, alongside strategic decisions to discontinue certain programs.

• Strong Q2 Financial Performance: Sanofi delivered significant financial growth in Q2 2026, with net sales reaching €11.6 billion, marking a 17.8% increase at constant exchange rates (CER). Business earnings per share (EPS) also saw a substantial rise of 33.3% at CER, reaching €2.09. This robust performance was largely fueled by the strong uptake of new Pharma launches, which contributed €1.3 billion in sales, and the continued exceptional growth of Dupixent, surpassing €5 billion in quarterly sales for the first time at €5.2 billion.
• Upgraded 2026 Guidance and Long-Term Outlook: Following a strong first half, Sanofi has upgraded its full-year 2026 financial guidance, now projecting sales growth of approximately 10% at CER, with business EPS expected to grow slightly faster than sales. Looking further ahead, the company anticipates Dupixent sales to reach around €25 billion by 2030, complemented by approximately €10 billion from other Pharma launches, underscoring a confident trajectory for profitable and sustainable growth.
• Strategic Pipeline Advancements and Prioritization: Sanofi's pipeline saw significant activity, including seven regulatory approvals across immunology, rare diseases, oncology, and neurology. Two positive Phase 3 readouts were reported for Nexviazyme in infantile-onset Pompe disease and amlitelimab maintenance in atopic dermatitis. Concurrently, the company made strategic decisions to discontinue the global regulatory submission for amlitelimab in atopic dermatitis, as well as the clinical development programs for itepekimab and balinatunfib, reflecting a focus on pipeline prioritization.

Why New Options are Crucial for Infantile-Onset Pompe Disease

While enzyme replacement therapy (ERT) with alglucosidase alfa has significantly improved survival in infantile-onset Pompe disease (IOPD), substantial limitations and challenges persist. Many patients experience variable responses and long-term complications, highlighting the urgent need for more advanced therapeutic options that can overcome the hurdles of current treatment.

• Variable Efficacy and Long-Term Decline: Patient response to ERT is markedly heterogeneous, with many patients demonstrating suboptimal responses or clinical decline after years of treatment. Despite clear cardiovascular improvements, ERT has shown limited efficacy on skeletal muscle, and case reports describe patients initially achieving motor milestones only to lose them after the third year of therapy.

• Immunogenicity and Treatment Response: A patient's immune response is a critical factor influencing treatment effectiveness. The development of high and sustained antibody titers (HSAT), which can occur in CRIM-positive patients, is correlated with a poor clinical response to ERT and subsequent clinical decline. A patient's cross-reactive immunologic material (CRIM) status at baseline is a key determinant of outcomes.

• Narrow Therapeutic Window: The rapid and fatal progression of IOPD necessitates extremely early diagnosis and intervention. Even slight delays in starting ERT can profoundly alter the disease course, and many infants die before therapy can be initiated. For long-term survivors, a complicated new phenotype involving the central nervous system has been observed, presenting a new challenge for disease management.

• High Economic Burden: The financial cost of current ERT presents a significant disadvantage. One analysis estimated the lifetime incremental cost of treatment at €7.0 million, resulting in an incremental cost-effectiveness ratio of approximately €1.0 million per quality-adjusted life-year (QALY) gained.

Unpacking Nexviazyme's Positive Phase 3 Safety Data

Clinical trial data from the pivotal 49-week COMET study, which compared avalglucosidase alfa to alglucosidase alfa in 100 participants, demonstrated a favorable safety profile for Nexviazyme. The incidence of potentially treatment-related adverse events was similar between the groups (45% for avalglucosidase alfa vs. 49% for alglucosidase alfa), while infusion-associated reactions (26% vs. 33%) and serious treatment-emergent adverse events (16% vs. 25%) were numerically lower in the avalglucosidase alfa arm. Notably, all five trial withdrawals occurred in the alglucosidase alfa group, four of which were due to adverse events. While overall antidrug antibody responses were similar, high and persistent antibody titres (≥12,800) and neutralizing antibodies were more common with alglucosidase alfa (33% of participants) compared to avalglucosidase alfa (20% of participants).

The safety profile of avalglucosidase alfa remains consistent over the long term and in real-world settings. Extended data from the COMET trial through 145 weeks of treatment identified no new safety concerns, with similar rates of potentially treatment-related adverse events in patients continuing avalglucosidase alfa (53%) and those who switched from alglucosidase alfa (57%). Real-world evidence from a German multicenter study of 39 patients who switched enzyme replacement therapies found that such transitions were generally feasible, with rare occurrences of infusion-related or serious adverse events. Further case series have confirmed that avalglucosidase alfa is well-tolerated in specific populations, including Japanese patients with both late-onset and infantile-onset Pompe disease (IOPD), and even in a severe IOPD patient who received a short-term, high-dose, high-frequency regimen without adverse reactions.