Biocon shares surge 8.5% as USFDA classifies Bengaluru unit as VAI

Biocon Ltd shares rose sharply by over 8.5% on Monday after the company received a ‘Voluntary Action Indicated’ (VAI) status from the United States Food and Drug Administration (USFDA) for its Bengaluru unit.

The biopharmaceutical firm announced that its Biocon Biologics facilities located at Biocon Park in Bengaluru have been classified as VAI by the USFDA.

The US health regulator conducted a Current Good Manufacturing Practice (cGMP) inspection along with a Pre-Licensing Inspection (PLI) at the Biocon Biologics facilities in Bengaluru from 15 July to 26 July this year.

The scope of the inspection covered six separate biologics manufacturing units, comprising four drug substance and two drug product manufacturing plants. Additionally, five Analytical Quality Control Laboratories, four Microbiology Laboratories, and two warehouses were inspected, Biocon stated in a press release.

The facilities were found compliant with global standards for quality and compliance, according to Biocon.

Biocon Ltd shares traded 8.50% higher at ₹348.55 per piece on the BSE as of 2:31 pm on November 11. The stock opened at ₹326.00 a share on the BSE and rose to touch an intraday high of ₹350.80.

The stock has gained nearly 30% so far in 2024 and surged 50% over the past year.

Also read: Biocon Q2 falls short of estimates; net profit dives 84% but revenue up 4%

For Q2 FY25, Biocon Ltd reported an 84.2% drop in net profit on a year-on-year basis to ₹27.1 crore, compared to ₹172 crore last year, missing CNBC-TV18’s poll estimate of ₹54.7 crore.

Revenue from operations grew marginally by 3.7% to ₹3,590.4 crore in the quarter, from ₹3,462 crore a year ago. The CNBC-TV18 poll had forecast revenue of ₹3,660.1 crore.

The company’s Earnings before Interest, Tax, Depreciation, and Amortisation (EBITDA) for Q2 FY25 declined by 7.6% to ₹685.5 crore from ₹741.3 crore in the same quarter last year, falling short of the poll estimate of ₹736 crore.