Biocon shares gain 4% after USFDA gives VAI tag to its Malaysia unit

Shares of Biocon were in high demand on Monday after the pharmaceutical company’s subsidiary Biocon Biologics’ Johor Bahru facility in Malaysia was classified as "Voluntary Action Indicated" (VAI) by the United States Food and Drugs Administration. Biocon share price rose 4.52 per cent at Rs 376.95 per share on the BSE in intraday trade. 

 

“The USFDA has classified Biocon Biologics’ Insulins facilities in Johor Bahru, Malaysia as Voluntary Action Indicated (VAI). This relates to the cGMP inspection conducted by the agency between September 15 – 27, 2024. The inspection scope had included several biologics manufacturing units comprising one (1) Drug Substance and one (1) Drug Product manufacturing units, one (1) Medical Device Assembly unit, one (1) Analytical Quality Control Laboratory, two (2) Microbiological Control Laboratories and two (2) Warehouses,” the company’s spokesman said in a statement.

 

Biocon Biologics remains committed to global standards of quality and compliance, the statement read. 

 

Financially, for the second quarter of financial year 2024-25 (Q2FY25), Biocon reported an 84.3 per cent year-on-year decline in net profit for Q2FY25, totaling Rs 27.1 crore, compared to Rs 172.7 crore in Q2FY24.

 

The company posted a profit before tax (PBT) of Rs 98.4 crore, marking a 54.08 per cent decrease from Rs 214.3 crore in Q2FY24.

 

Total revenue for the period stood at Rs 3,623 crore, showing a slight increase from Rs 3,620.2 crore in Q2FY24. Biocon’s earnings before interest and taxes (EBIT) amounted to Rs 718 crore, reflecting a 20 per cent margin.

 

Additionally, revenue from the biosimilars business grew by 10.8 per cent, reaching Rs 2,182 crore, up from Rs 1,969 crore in the same period last year.

 

The company has a total market capitalisation of Rs 44,812.40 crore. Its shares are trading at a price to earnings multiple of 1,066.43  times and at an earning per share of Rs 0.35. 

 

At 9:42 AM, the stock price of the company advanced by 4.03 per cent at Rs 375.20 a piece on the BSE. By comparison, the BSE’s Sensex was up 0.87 per cent to 76,708.48 level.

 

Biocon is a global biopharmaceutical company dedicated to creating affordable treatments for cancer, diabetes, and autoimmune diseases. It operates through two subsidiaries: Biocon Biologics and Syngene. Biocon's product offerings encompass generics, biosimilars, novel biologics, and research services.