Pharma Stock Jumps 4.5 per cent After Japan’s Nod for Injectable Biosimilar

A key injectable biosimilar gets the green light from Japan, driving a 4.5 per cent surge in stock price.

Biocon Biologics Ltd, a subsidiary of Biocon Limited, has received approval from Japan's Pharmaceuticals and Medical Devices Agency (PMDA) for Ustekinumab BS subcutaneous injection [YD], a biosimilar to Stelara® (Ustekinumab). This biosimilar will be used for treating Psoriasis Vulgaris and Psoriatic Arthritis (PsA) and will be marketed in Japan by Yoshindo Inc., Biocon’s exclusive partner.

Strategic Licensing Agreement
The approval follows a settlement and licensing agreement Biocon Biologics entered with Janssen Biotech Inc. and Johnson & Johnson in August 2024. This agreement enabled Biocon Biologics to commercialize Ustekinumab in Japan upon regulatory approval, marking a significant milestone for its biosimilars portfolio.

Stock Performance
The news has positively impacted Biocon's stock performance. As of 10:10 AM on Tuesday, the stock was trading at Rs 370, up 3.39 per cent. Over the past year, the stock has delivered an impressive return of 26.81 per cent, showcasing strong investor confidence.

Q3 FY25 Financial Highlights
Biocon reported flat year-on-year revenue at Rs 3,623 crore, with adjusted revenue growth of 7 per cent year-on-year, excluding divested businesses. However, quarterly profit margins faced pressure:

• Core EBITDA stood at Rs 992 crore, reflecting a 10 per cent year-on-year decline.
• Reported EBITDA margins dropped to 20 per cent.
• The company posted a net loss of Rs 16 crore compared to a profit of Rs 238 crore last year.

Segment Performance

• Generics: Revenue declined 8 per cent year-on-year, impacted by pricing pressures. Recovery is anticipated in H2 FY25 with new launches.
• Biosimilars: Revenue grew 11 per cent year-on-year, driven by strong U.S. and European market performance. Core EBITDA margins stood at 32 per cent.
• Research Services (Syngene): Sequential growth of 13 per cent with expanding demand for Discovery Services.

Future Outlook
Biocon Biologics plans multiple biosimilar launches and anticipates significant market share gains. Ongoing cost improvement programs and investments in R&D are expected to strengthen the company’s competitive edge. Despite regulatory and pricing challenges, Biocon is optimistic about its long-term growth trajectory.

Disclaimer: The article is for informational purposes only and not investment advice