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Drugmaker Lupin expects to end the year with a much better performance on product approvals in the United States, said Nilesh Gupta, Lupin’s Managing Director.
The company expects to close with about 25 product approvals in the US this year, compared with 20-odd last year, Gupta told BusinessLine , adding that it was also about the quality of the products that were getting approvals.
The US is Lupin’s biggest market and like other Indian companies, there was concern earlier this year over the slow down in approvals for the region. But that seems to have turned a corner, the Lupin chief indicated, adding that the year would see about 18 to 20 product launches.
Lupin clocked total revenues of ₹3,555 crore for the third quarter ended December 31, 2015, almost 12 per cent up from the ₹3,177 crore in the corresponding period last year.
The company’s net profit stood at ₹529 crore for the Q3 under review, down almost 12 per cent from ₹601 crore in the corresponding period last year. However, the quarterly net profit was up about 30 per cent compared with the ₹408 crore it earned in second quarter of the current year, leading Gupta to comment that the business was on its “path to recovery”.
Of its key markets, Lupin’s US sales were $208 million during the said quarter, compared with $217 million in the third quarter of fiscal 2015. Its India formulations business grew 17.1 per cent, recording sales of ₹871 crore, up from ₹743 crore in Q3 FY2015.
The other key highlight was that Lupin’s research-spend stood at about 12 per cent of net sales, at ₹391 crore in the quarter under review, Gupta pointed out, and this included investments towards biosimilars and new chemical entities.
Lupin filed five ANDAs (abbreviated new drug approvals) in the US and received nine approvals from the US Food and Drug Administration during the quarter. Cumulative ANDA filings with the US FDA stood at 225, as on December 31, 2015, with the company having received 133 approvals to date. The company has 37 First-to-Files (FTF) products which includes 17 exclusive FTF opportunities, it said. Cumulative filings with European authorities now stand at 64 with the company having received 55 approvals to date, it added.
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