Zydus Lifesciences arm gets FDA priority review for liver disease drug application

Pharmaceutical company Zydus Lifesciences Ltd on Wednesday (May 27) said its wholly-owned subsidiary, Zydus Therapeutics, has received priority review designation from the US Food and Drug Administration (FDA) for the New Drug Application (NDA) of saroglitazar.

The proposed indication is for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have shown an inadequate response to UDCA, or as monotherapy in patients who are unable to tolerate UDCA. The US FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of November 27, 2026.

Fourth quarter results

Zydus Lifesciences reported a consolidated net profit of ₹1,272.5 crore for the March quarter, up 8.7% year-on-year and ahead of the CNBC-TV18 poll estimate of ₹997.5 crore. Its revenue rose 16.2% year-on-year to ₹7,587 crore from ₹6,528 crore, also beating the CNBC-TV18 poll estimate of ₹7,086 crore.

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Earnings before interest, tax, depreciation and amortisation (EBITDA) increased 20.2% to ₹2,554 crore from ₹2,125.5 crore in the year-ago quarter, while EBITDA margin expanded to 33.7% from 32.6%.

The EBITDA performance was sharply above the CNBC-TV18 poll estimate of ₹1,632.6 crore, while the margin exceeded expectations of 23%. Excluding forex gains, EBITDA stood at ₹1,909 crore with a margin of 25.2%, both still higher than what the Street had anticipated.

The company’s standalone financials included an exceptional item gain of ₹1,068 crore during the quarter related to impairment in the value of investment in Zydus VTEC Ltd, a wholly-owned subsidiary. The quarter also included a one-time expense of ₹397.5 crore towards the Mirabegron litigation settlement.

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The company said its India formulations revenue rose 14% year-on-year to ₹1,752.8 crore from ₹1,537.4 crore, driven by strong growth in chronic therapies and super-speciality segments such as oncology and nephrology. The India business accounted for 24% of consolidated revenue.

Shares of Zydus Lifesciences Ltd ended at ₹1,085.95, up by ₹7, or 0.65%, on the BSE today, May 27.