The Board of Directors of Zydus Lifesciences Limited approved the unaudited financial results for the quarter and nine months ended December 31, 2025, at their meeting held on February 9, 2026. The company subsequently held its Q3FY26 post-results earnings call on February 10, 2026, pursuant to regulations 30 and 46(2)(oa) of the SEBI Listing Regulations.

Board Meeting and Regulatory Compliance

The meeting commenced at 11:10 a.m. and concluded at 1:15 p.m., with results reviewed by the Audit Committee and taken on record by the Board pursuant to Regulation 33 of SEBI Listing Regulations. The financial results were prepared in accordance with Indian Accounting Standards (Ind AS) and underwent limited review by statutory auditors Deloitte Haskins & Sells LLP.

Consolidated Financial Performance Q3FY26

The company demonstrated robust consolidated performance during Q3FY26. Total revenue from operations reached ₹68,645 million, representing significant 30.30% year-over-year growth from ₹52,691 million in Q3FY25. Net profit for the quarter stood at ₹10,421 million compared to ₹10,235 million in the corresponding quarter of the previous year, marking a 1.82% increase. EBITDA for the quarter stood at ₹18.20 billion, up 31% year-on-year with an EBITDA margin of 26.50%.

Business Segment Performance

North America Operations

The North America business, comprising the United States and Canada, registered revenues of ₹28,000 million during the quarter, up 16% year-on-year. The base US business continued to grow driven by sustained volume expansion and new products launched over the last 12 months. The company filed 18 ANDAs, received 8 approvals and launched 4 new products during the quarter. On the US specialty front, the company launched BEIZRAY (albumin-solubilized docetaxel injection), its first oncology 505(b)(2) product.

India Branded Formulations

The India branded formulation business sustained its growth trajectory with a robust 14% year-on-year growth, outperforming the market growth. The growth was driven by persistent traction in innovation products and pillar brands, with the chronic segment continuing to grow at a faster pace. Contribution of chronic portfolio increased to 45.30% as per IQVIA MAT December 2025.

International Markets and Consumer Wellness

International markets formulation business posted revenues of ₹7.90 billion with strong year-on-year growth of 38%. The Consumer Wellness business recorded revenues of ₹9.60 billion, up 113% year-on-year with full quarter consolidation of Comfort Click business.

Strategic Developments and Innovation Pipeline

During the earnings call, Managing Director Dr. Sharvil Patel highlighted key strategic developments. The company plans to file Saroglitazar Magnesium with the USFDA for PBC indication, marking a pivotal milestone for growth in the specialty pharmaceutical space. In January 2026, the company received final approval from the USFDA for Zycubo (copper histidinate), becoming the first and only therapy approved for the treatment of Menkes disease.

The company has licensed two large molecules, Pembrolizumab and Ranibizumab biosimilars, leveraging the recently acquired biologics manufacturing facility in the US. The company expects to launch Ranibizumab in the second half of the year and aims for meaningful Bio CDMO business development over the next 2-3 years.

Exceptional Items and Future Outlook

The quarter's results were affected by exceptional items totaling ₹849 million, primarily attributed to the one-time impact of New Labour Codes implementation. The company expects R&D expenses to remain at 7.50%-8.00% of revenue for FY26, with Q4 EBITDA margins expected to be 23% plus despite minimal Lenalidomide revenue.

Management expressed confidence in continued double-digit growth across key business segments, with the US generics business showing 11% volume growth and international markets expected to maintain 20% plus growth trajectory.

Source: Earnings Call Transcript

Zydus Lifesciences Limited has secured final approval from the United States Food and Drug Administration (USFDA) for Ammonium Lactate Cream, 12%, marking another milestone in the company's US pharmaceutical portfolio expansion.

Product Details and Therapeutic Applications

Ammonium lactate cream, 12% is a topical prescription medication specifically indicated for treating dry, scaly skin conditions. The cream addresses two primary conditions:

• Xerosis: General dry, scaly skin condition
• Ichthyosis vulgaris: An inherited dry skin condition

As an alpha-hydroxy acid formulation, the medication works by increasing skin hydration and providing multiple therapeutic benefits including relieving itching, softening skin, and decreasing skin scaling.

Manufacturing and Distribution Strategy

The product will be manufactured at Zydus's established topical manufacturing facility in Changodar, Ahmedabad, leveraging the company's existing infrastructure and quality systems.

Market Opportunity

The approval represents entry into a significant market segment, with Ammonium lactate cream recording annual sales of USD 15 mn in the United States according to IQVIA MAT December 2025 data. This market size indicates substantial commercial potential for the newly approved generic version.

Regulatory Portfolio Expansion

*As on 31-Dec-2025

This latest approval brings Zydus Lifesciences' total USFDA approvals to 430, while the company has filed 505 Abbreviated New Drug Applications (ANDAs) since commencing its US filing process in FY 2003-04. The consistent approval rate demonstrates the company's regulatory expertise and manufacturing quality standards.

Strategic Significance

The Ammonium Lactate Cream approval strengthens Zydus Lifesciences' dermatology portfolio in the US market. The topical medication addresses common skin conditions, potentially providing steady revenue streams from both prescription and healthcare provider channels. The company's established manufacturing capabilities and distribution partnership position it well for market entry and commercialisation of this therapeutic product.