Biocon shares jump 4% as USFDA classifies Biocon Biologics site in Malaysia as voluntary action indicated; all you need to know

Biocon Biologics Limited (BBL) is a subsidiary of Biocon.

Shares of the company, reacting to the development, on Monday, January 13, surged as much as 4.36% to ₹376.70 apiece on the NSE in the early trade.

According to the FDA, voluntary action indicated (VAI) classification means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.

Biocon Biologics is a fully integrated global biosimilars player. "With established capabilities in the development, manufacturing, and commercialisation of high-quality biosimilars, we want to enable equitable access to cost-effective, lifesaving biosimilars for patients worldwide. Biocon Biologics offers a comprehensive portfolio of 20 biosimilars—one of the widest and deepest in the industry," the company's website says.

Having completed the acquisition of Viatris’ global biosimilar business, the company says it is leveraging end-to-end capabilities from lab to market, which not only widens its reach worldwide but pushes it to greater heights in the biosimilar business.

Biocon Q2 FY25 Results

The company had posted a net profit of ₹126 crore for the July-September period last fiscal.

Revenue from operations stood at ₹3,590 crore in the September quarter as compared with ₹3,462 crore in the year-ago period.

"Biocon Group's overall Q2FY25 financial and operational performance provides a foundation for improved performance as we move into the second half of the fiscal," Biocon Group Chairperson Kiran Mazumdar-Shaw said.

The group had a robust performance in the biosimilar business driven by strong market share gains in US oncology and insulin franchises, she noted.

Syngene has returned to sequential growth and has good visibility of a pickup in momentum in the coming quarter led by its discovery services and biomanufacturing CMO business, she said.

Meanwhile, in October 2024, Biocon Biologics said it had refinanced $1.1 billion (₹9,347 crore) in long-term debt through dollar bonds and a new syndicated facility.

"This strategic refinancing underscores our commitment to enhance financial flexibility, fuels Biocon Biologics' long-term growth, and is core to the consolidation phase of our business," Biocon Biologics CEO and Managing Director Shreehas Tambe said.

The company expects the transaction to strengthen capital structure and allow it to redeploy investments into the business, including advancing our differentiated pipeline of biosimilars, he added.

"It will also enable us to diversify our investor base to include marquee global funds and healthcare investors who seek to participate in Biocon Biologics' growth story," Tambe said.