Over 158 applications for generic products pending with US FDA for approval: Lupin

Drug firm Lupin remains bullish over its US business with over 158 applications for generic products pending with the US drug regulator for approval, as per the company’s annual report for 2019-20.

Sharing information with company’s shareholders, Lupin MD Nilesh Gupta and CEO Vinita Gupta said the company’s US business stabilised last fiscal and saw an increase of 5 per cent on the back of products like Levothyroxine and Oseltamivir.

“We now have over 158 abbreviated new drug applications (ANDAs) pending approval with the US Food and Drug Administration (USFDA), a rich pipeline addressing a total market of over USD 71.7 billion comprising of inhalation, first-to-files and injectable products,” they said.

During the year, the company filed 21 ANDAs, two of which were confirmed exclusive first-to-files, Nilesh and Vinita Gupta said.

“We expect to continue our ramp-up of Levothyroxine and look forward to the launch of our first major inhalation product, Albuterol in the coming fiscal (pending FDA approval),” they added.

During 2019-20, the US business contributed 38 per cent to the company’s revenues, aggregating USD 800 million (about Rs 6,000 crore), a 3 per cent growth over 2018-19.

The Mumbai-based company’s domestic business continues to be the second largest vertical, contributing 34 per cent to the topline, which stood at Rs 15,142.8 crore in 2019.

“Our India business continues to outperform the Indian pharmaceutical market with 13 per cent year-on-year growth,” Nilesh and Vinita Gupta said.

Lupin’s top priority for 2019-20 was to get the company back on growth path from the decline witnessed in 2018-19 fiscal, the company leaders noted.

“We have made significant progress in this effort, as well as in optimising our costs on several fronts. We are confident that our performance will reflect the same over the next few quarters as the global situation normalises,” they added.

Lupin Executive Director, Global CFO and Head Corporate Affairs Ramesh Swaminathan said the company is conscious of the headwinds being faced by the industry.

“However, we see the emergence of an improved business environment, especially in the second half of 2020-21 and are confident that the measures taken by us in recent times would help us to come out stronger than ever,” he noted.

With the changing dynamics of the generic market, the company believes that cost optimisation and prudent capital allocation will continue to be a key business imperative, Swaminathan said.

“We aim to continue creating a leaner and more efficient organisation. In FY20, we made significant strides in our cost optimisation initiatives encompassing value engineering, procurement efficiencies and R&D productivity. However, input price rises on other molecules and sales mix changes eroded visibility of the same, to some measure,” he noted.

“These initiatives have however created a strong foundation and our cost optimization momentum will continue with increased rigor in FY21,” Swaminathan said.

Lupin said its net debt as on March 31, 2020 stood at Rs 1,511.8 crore as compared with Rs 5,243.8 crore as on March 31, 2019.