Dr. Reddy’s Laboratories is targeting a conditional November return for generic semaglutide supplies, as regional sales diverged in the quarter and biosimilar programs advanced toward U.S. milestones.
Revenue for the quarter ended Sept. 30 was $905 million (₹86.7 billion), down 1.5% from a year earlier and up 7.4% from the previous quarter. North American revenue dropped 23% to ₹24.9 billion, which the company attributed largely to lower lenalidomide sales. India revenue increased 17% to ₹18.5 billion.
Profit after tax attributable to equity holders was ₹9.25 billion, compared with ₹14.372 billion a year earlier. G V Prasad, co-chairman and managing director, described the quarter as delivering “double-digit base business growth,” with EBITDA margins above 20%. The company said its base business, excluding North American lenalidomide, grew at a double-digit rate across businesses other than Europe and active pharmaceutical ingredients.
CEO Erez Israeli said on an Oct. 23 earnings call that direct and partner supplies of generic semaglutide could resume in November if validation succeeds. The company kept its fiscal 2027 target at six million to seven million pens. A possible run rate of 12 million to 15 million pens over the 12 months beginning in April 2027 remains tentative and depends on approvals, market performance and partner market share. Generic semaglutide has been approved in 10 countries, the company said. EconoTimes previously reported the November supply target.
The company linked the supply interruption to a quality problem in finished product that surfaced after it expanded its synthetic active pharmaceutical ingredient (API) operation. It said further process work and validation were needed before commercial deliveries could resume. Dr. Reddy’s recorded a ₹2.397 billion provision for related inventory and costs in the first quarter of fiscal 2027. It also disclosed a separate Canadian recall in August, involving an impurity over the allowed level and a packaging and labeling problem; the company said that recall was unrelated to the API issue.
The U.S. Food and Drug Administration (FDA) approved the company’s rituximab biosimilar, and Dr. Reddy’s launched a nivolumab biosimilar in India. The company also reported India’s first biosimilar approval for intravenous abatacept. It filed its U.S. biologics license application for the drug in December 2025. Israeli said an initial launch could involve smaller quantities, with fuller growth after codes and registrations are in place, a process management estimated at about six months. Management’s goal date for a U.S. regulatory decision is Dec. 22, 2026.
