Lupin hits 52-week high on US FDA nod for respiratory drug

Pharmaceutical major Lupin surged as much as 6.7% to hit a 52-week high of ₹885 apiece in intraday trade on the BSE after the company received US FDA's (food and drug administration) approval for the manufacturing of its abbreviated new drug application for Tiotropium Bromide Inhalation Powder, 18 mcg/capsule.  

The scrip opened a gap-up at ₹834.95 on Wednesday against the closing price of the previous session at ₹829.65. The scrip closed 5.44% higher at ₹874.75, in line with the broader market. At the current share price, shares of the pharmaceutical major are trading 45.1% higher than the 52-week low of ₹602.80, which the company touched on August 4, 2022.

During the session, Lupin's market capitalisation stood at ₹39,806.60 crore as more than 2.14 lakh shares exchanged hands on the BSE, higher than the two-week average of 0.24 lakh shares. On the NSE, as many as 57.6 lakh shares worth ₹50,081 lakh were traded on Wednesday. In the past one month, three months and one year, the pharmaceutical major has given 6.9%, 13% and 35% in returns, respectively.

According to the company, Tiotropium Bromide Inhalation Powder, 18 mcg/capsule is a generic equivalent of Spiriva HandiHaler (Tiotropium Bromide Inhalation Powder), 18 mcg/capsule of Boehringer Ingelheim Pharmaceuticals, Inc, and will be manufactured at Lupin's Pithampur facility in India.

"We are delighted to receive the final approval for generic Spiriva® HandiHaler from the U.S. FDA. This builds on our commitment to serving the unmet needs of our patients across the world. This is the first generic approval for Spiriva® HandiHaler in the U.S., and is also the first DPI approval from India for the U.S. This is an important milestone in our journey of building our respiratory franchise globally," said Vinita Gupta, CEO, Lupin.

Earlier this month, the company received FDA's approval for its abbreviated new drug application for Diazepam Rectal Gel, 10 mg and 20 mg, Rectal Delivery System, a generic equivalent of Diastat AcuDialTM rectal delivery system, 10 mg and 20 mg, of Bausch Health US, LLC. The company also launched its Darunavir Tablets, 600 mg and 800 mg in the US market this month.

In the March quarter, the company reported an increase in net sales by 12.1% year-on-year (YoY) to ₹4,330.3 crore in the January-March quarter this year owing to robust sales in foreign markets such as the U.S. and Europe. The company's profit before tax stood at ₹235.9 crore as against the net loss of ₹517.9 crore in the same period last year. The company’s EBITDA (earnings before interest, taxes, depreciation and amortisation) margin during the quarter under review was up 690 basis points by 14.2% YoY as against 7.3% in the same period last year.

In FY23, the company's net profit stood at ₹430.1 crore as against the net loss of ₹1,528 crore in FY22. The company's net sales during the year under review stood at ₹16,270.0 crore as against ₹16,192.8 crore in FY22.

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