Concord Biotech has achieved a significant regulatory milestone by receiving FDA approval for its abbreviated new drug application (ANDA) for mycophenolate mofetil oral suspension USP, 200 mg/mL. According to CNBC TV18, the product is an antimetabolite immunosuppressant indicated for the prophylaxis of organ rejection in adult and paediatric recipients aged three months and older of allogeneic kidney, heart or liver transplants, in combination with other immunosuppressants. The company estimates the US market for mycophenolate mofetil is approximately $30 million, positioning this approval as strategically important for enhancing product offerings and supporting long-term growth across US and international markets.
Concord Biotech reported a significant decline in fourth-quarter earnings, with net profit falling 36.8% year-on-year to ₹88.8 crore from ₹140.4 crore in the corresponding quarter last year. According to reports from CNBC TV18, the R&D-driven biopharmaceutical company's revenue from operations declined 24.1% to ₹326.1 crore compared with ₹429.9 crore a year ago. The earnings decline was primarily attributed to lower revenue and margin contraction during the quarter, with the decline in profit mainly due to lower revenue and weaker operating performance during the quarter.
The company experienced significant margin pressure during the quarter, with EBITDA falling 37.8% year-on-year to ₹118.5 crore from ₹190.6 crore in the same period last year. As reported by CNBC TV18, the EBITDA margin narrowed to 36.4% from 44.3% in the year-ago period, indicating that profitability came under pressure as costs remained elevated compared to revenue growth. This margin compression reflects the impact of lower revenue and operational efficiency challenges faced by the biopharmaceutical company during the quarter.
Despite the challenging quarter, the board recommended a dividend of ₹7.55 per equity share of face value ₹1 each for FY26, subject to shareholder approval at the upcoming annual general meeting. According to CNBC TV18, the company has fixed July 24, 2026, as the record date for determining eligible shareholders for the dividend payout. This dividend declaration comes despite the company's profit decline, suggesting management's confidence in maintaining shareholder returns even amid operational challenges.
The market responded positively to the FDA approval news, with shares of Concord Biotech ending at ₹1,166.80, up by ₹106.20 or 10.01% on the BSE on June 2, as reported by CNBC TV18. The stock performance reflects investor optimism about the company's regulatory milestone and growth prospects, particularly following the FDA approval for mycophenolate mofetil. The market reaction suggests increased confidence in the company's ability to capitalize on the new product approval and strengthen its position in the US market.
