Biocon Limited

Biocon commenced FY26 with robust performance, reporting an operating revenue of INR 3,942 crores, a 15% year-on-year increase. Core EBITDA grew 11% YoY to INR 1,003 crores, maintaining a 25% margin. Profit before tax, excluding exceptionals, saw a significant 72% YoY rise to INR 97 crores, indicating improved operational leverage. The Biosimilars segment was a primary growth engine, with revenue up 18% YoY to INR 2,458 crores and EBITDA increasing 36% YoY to INR 645 crores. The CRDMO business (Syngene) also contributed strongly, achieving INR 875 crores in revenue, an 11% YoY increase, and an EBITDA of INR 224 crores, up 19% YoY.

The company achieved several significant regulatory milestones, including the U.S. FDA approval for Kirsty™ (biosimilar Insulin Aspart), making it the first and only interchangeable rapid-acting insulin in the U.S. This approval reinforces Biocon's leadership in the US Insulins market. Additionally, Biocon launched Yesafili™ (biosimilar Aflibercept) in Canada and secured approvals for biosimilar Denosumab from both the European Commission and U.K. MHRA, marking its entry into the bone health therapy area. The oncology portfolio, including Ogivri® and Fulphila®, maintained a strong 27% market share in North America.

Biocon successfully completed a Qualified Institutions Placement (QIP) of INR 4,500 crores, significantly strengthening its financial position. Approximately USD 200 million from the QIP proceeds were utilized to repay Goldman Sachs OCD by the end of June, with further repayments to Kotak and Edelweiss planned later this fiscal. This strategic debt reduction is expected to lead to a decrease in interest burden from Q2 FY26 onwards. Post these repayments, Biocon's stake in Biocon Biologics is projected to increase to 78% on a fully diluted basis.

The Generics segment reported INR 697 crores in revenue, a 6% year-on-year increase, with product sales growing 13% YoY. However, profitability was impacted by ongoing operating costs of approximately INR 60 crores per quarter, totaling an estimated INR 240 crores for the full year, associated with new facilities (Immunosuppressants, Peptides, Cranbury NJ) capitalized last fiscal. Management indicated that significant Lenalidomide sales, which boosted Q4 FY25, would not continue for the first three quarters of FY26. Despite these headwinds, management expects margins to ramp up from H2 FY26 due to new product launches and increased capacity utilization.

Biocon continues to invest in expanding its manufacturing capabilities and product pipeline. The injectables facility focused on GLP-1s has been commissioned, with commercial supply anticipated to begin in FY27. The Malaysia facility for drug product line expansion has doubled its capacity and is expected to be operational 'very imminently,' supporting growing global insulin demand. Syngene's Bayview biologics facility in the U.S. is also on track for commissioning later this year, enhancing CRDMO capabilities and providing direct access to the US biologics market.

The company anticipates strong double-digit growth for its Generics business for the full year, driven by multiple product launches in the coming quarters^⏳, including Liraglutide in Europe and the US (pending FDA approval). Biocon plans to file Semaglutide in emerging markets and Canada in Q2 FY26, with approvals expected by late calendar '26 or '27. Management expressed confidence in the biosimilars business, aiming to surge into a leadership position in the next five years, leveraging its broad portfolio in oncology, diabetes, and autoimmune diseases.