Sanofi India Limited has received an order from the State Tax Officer, Tiruvallur Assessment Circle, dropping a Goods and Services Tax (GST) demand of ₹1.07 crore for FY23. The ruling concludes ongoing proceedings with no additional dues or penalties remaining for the company.

The order, received on September 21, 2026, accepts the company’s submissions regarding anomalies found in GSTR filings for the fiscal year 2022-23. The tax authority initiated these proceedings under Section 73 of the TNGST/CGST Act, 2017, citing significant differences in the filed returns.

Regulatory Context

The disclosure was made in compliance with Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015. The order specifically addresses the tax demand along with associated interest and penalty, which have now been waived.

Operational Impact

The company stated that the resolution of this matter has no material impact on its financial, operational, or other activities. With the acceptance of its submissions, Sanofi India Limited has closed this specific regulatory chapter for the referenced period.

Sanofi reported a 17.8% increase in second-quarter 2026 net sales to €11.6 billion, driven primarily by volume growth in its immunology franchise and momentum from recent pharmaceutical launches. The company upgraded its full-year 2026 guidance, projecting around 10% sales growth at constant exchange rates.

New CEO Belén Garijo highlighted the company’s focus on mid- and long-term growth through strategic initiatives, including improving R&D productivity and exploring disciplined M&A opportunities. Management emphasized that the strong quarterly performance was underpinned by disciplined cost management and robust demand across key indications.

Financial Performance

Q2 2026 results demonstrated significant operational leverage. Net sales grew 17.8% year-on-year to €11.6 billion. This growth was largely volume-driven, supported by positive adjustments in gross-to-net deductions. Excluding the impact of Dynavax and Blueprint sales from the prior year, organic sales growth stood at approximately 15%.

Gross margin expanded by 3.7 percentage points, aided by the reversal of inventory provisions following regulatory approval for Sarclisa’s subcutaneous formulation. Underlying gross margin increased by 1.7 percentage points, reflecting favorable product mix and efficiency gains.

Operating expenses rose 13.1%, primarily due to recent acquisitions. However, as a percentage of sales, operating expenses declined by 1.5 percentage points, showcasing cost discipline. Business operating income (BOI) surged 35.8%, with BOI margin expanding by 3.8 percentage points. Business earnings per share (EPS) grew strongly at 33.3%.

Portfolio Highlights

Dupixent sales exceeded €5 billion in the quarter for the first time, growing 37% year-on-year. The growth was driven by robust patient adoption across indications and geographies, with more than 1.5 million patients currently under treatment globally. The US market benefited from favorable gross-to-net adjustments, though management noted these are not expected to recur at similar levels later in the year.

The launch portfolio, which now represents 13% of total sales, grew over 60% in Q2. Key contributors included:

• Altuviiio: Strong momentum in hemophilia A, remaining the top choice for patient switches in the US.
• Ayvakit: Expansion in systemic mastocytosis driven by increased patient numbers and treatment duration.
• Sarclisa: Performance in multiple myeloma bolstered by recent subcutaneous regulatory approval.

Rare disease sales reached nearly €1.9 billion, up 24%, driven by Ayvakit and Altuviiio. Vaccines sales declined 5% to €1.15 billion, impacted by high influenza comparables from 2025. This decline was partially offset by solid performance from Beyfortus, which grew 54% to €108 million, and HEPLISAV-B, which grew 43% on a pro forma basis.

What the Numbers Show

The divergence between top-line growth and operating expense expansion reveals significant operational efficiency. While operating expenses increased by 13.1% due to acquisition-related costs, they declined as a percentage of sales by 1.5 percentage points. This indicates that revenue growth outpaced cost inflation, allowing business operating income to expand by 35.8%. Furthermore, the 3.7 percentage point gross margin expansion was partly non-recurring, linked to inventory provision reversals; excluding this item, underlying margin improvement was 1.7 percentage points, suggesting sustainable efficiency gains from product mix rather than one-off accounting adjustments.

Outlook and Strategy

Management upgraded its 2030 ambition for Dupixent sales to approximately €25 billion at constant exchange rates. The company expects vaccine sales growth to be slightly negative for full-year 2026, mainly crystallizing in H2 due to seasonality. For Q3 specifically, a low- to mid-teens sales decrease is anticipated.

Belén Garijo outlined a comprehensive enterprise strategy focused on scientific rigor and fact-based decision-making in R&D. The company is conducting an outside-in portfolio review, having already discontinued several programs to focus resources on assets with the highest potential. Discussions regarding the alliance with Regeneron are ongoing, with a focus on rebuilding trust and identifying future collaboration opportunities.