Drug maker Zydus Lifesciences Ltd on Tuesday (March 18) said it has received the final approval from the United States Food and Drug Administration (FDA) to manufacture and market apalutamide tablets, 60 mg, the generic equivalent of Erleada tablets, 60 mg.
Apalutamide is an androgen receptor inhibitor indicated for the treatment of patients with metastatic castration-sensitive prostate cancer. Apalutamide tablets will be produced at Zydus Lifesciences Ltd (SEZ), Ahmedabad.
According to IQVIA MAT January 2025, apalutamide tablets had annual sales of $1099.8 million in the United States. The group now has 420 approvals and has so far filed 483 (as of December 31, 2024) ANDAs since the commencement of the filing process in FY2003-04.
Also Read: Zydus Lifesciences’ API unit in Ankleshwar, Gujarat clears USFDA inspection with nil observations
Q3 numbers
For the third quarter, the company’s profitability was aided by a surge in its forex gain, which stood at ₹183 crore during the quarter, compared to a gain of ₹21 crore during the same quarter last year.
Revenue during the quarter grew by 17% for the company to ₹5,269 crore, while its net profit stood at ₹1,023 crore from ₹789 crore last year, implying a growth of 30%.
US formulation sales for Zydus Life during the quarter stood at $285 million, which is a growth of 29% on a YoY basis. The figure is also higher than the $270-million estimate. The US contributes nearly 47% to Zydus Life’s overall topline.
Zydus Life’s earnings before interest, tax, depreciation and amortisation (EBITDA) stood at ₹1,387 crore at the end of the December quarter. The company had reported an EBITDA of ₹1,102 crore in the base quarter. The EBITDA margin expanded by nearly 200 basis points to 26.3% from 24.5% last year.
Also Read: Zydus Life receives final approval from USFDA for Eluxadoline Tablets
The company’s net-debt-to-equity ratio as of December 13 stood at a negative 0.14 times, compared to a negative 0.47 times at the end of the December quarter last year.
Shares of Zydus Lifesciences Ltd ended at ₹901.15, up by ₹7.85, or 0.88%, on the BSE.
First Published: Mar 18, 2025 6:14 pm IS
