This quarter, the performance for Biocon was largely led by Biologics, which grew 136% compared to the same quarter last year. Small Molecules and Research Services also fared well as the segment grew by 23% and 25% respectively in the last quarter.The revenue for Biologics segment more than doubled to Rs 3,670 million in the quarter, driven by the the commercial launch of biosimilar Pegfilgrastim in the U.S. and strong sales of Insulins as well as biosimilar MAbs in key emerging markets.
Mylan commenced commercial sales of Fulphila, the first biosimilar Pegfilgrastim approved in the U.S. Till now Mylan has been able to capture 3% of market share in the U.S. where the overall market size for the biosimilar pegfilgrastim is USD 4.2 billion. Further, Trastuzumab continues to do well in emerging markets with launches in newer geographies and increased prescription share in markets where it has already been commercialized. During the quarter, the company with its partner launched the product as the first biosimilar Trastuzumab in Turkey. In Algeria, Trastuzumab continues to enjoy a wide acceptance among patients and prescribers, while in Brazil it has witnessed a strong uptake since Zedora (Trastuzumab) was launched in March 2018.
European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued positive opinions recommending approvals of Fulphila, a biosimilar Pegfilgrastim, and Ogivri, a biosimilar Trastuzumab, co-developed by Biocon and Mylan. The CHMP positive opinions will now be considered by the European Commission and the decisions on approvals are expected later in 2018.
The Branded Formulations – India (BFI) business performance was muted due to the higher base of Q2FY18 which benefited from channel restocking post GST implementation. The lower sales seen in major divisions was offset by growth in Comprehensive Care and Nephrology.
The Company has reported revenue growth of 35% in the second quarter of FY19 at Rs.13,754 million and on a sequential basis the revenue rose by 15%. EBITDA for the second quarter was Rs. 3,940 million up by 69.03% from Rs 2,331 million. EBITDA margin for the quarter stood at 28.65% and the core operating margin (i.e. EBIDTA margin, net of licensing, impact of forex and R&D remained healthy at 33%. The company in conference call has guided that the margin will continue to be at higher level.