Terming the September quarter performance of the biopharmaceutical major Biocon as one that has delivered a strong revenue growth and profitability, Kiran Mazumdar-Shaw, chairperson and managing director, Biocon, tells Business Today that the early greenshoots of the unlocking of value in biosimilars have begun to reflect from this quarter.Referring to the three approvals for the biosimilars (two in the US and one in EU) that Biocon and Mylan have received with one of these already launched in the US, she explains, "Mylan has already launched (the biosimilar pegfilgrastim) Fulphila in the US market and thanks to that, this quarter's performance has been strong."
"Going forward, if this is how things shape up, obviously a robust business will be created with bright future prospects for Biocon and Mylan," she adds. On asking a strong signal coming in from the Q2 numbers of the early signs of value-unlocking, Shaw refers to profitability figures that were the highest ever. "The biosimilars have delivered handsomely for us this quarter," she says.
"We delivered a strong revenue growth of 35 per cent this quarter (the revenue figure being Rs 1,375 crore), driven by robust performance across our biologics, small molecules and research services segments. Net Profit, excluding net exceptional income of Rs 171 crore, grew by 167 per cent on account of strong topline growth, including biosimilar Pegfilgrastim sales in the US, and margin expansion," says Shaw in the BSE filing.
She further says that they are greatly encouraged by the USFDA's acceptance of an IND submitted by their partner Equillium Inc. for Itolizumab, a novel monoclonal antibody, for an orphan indication."The positive opinions from the European CHMP for Biocon and Mylan's Pegfilgrastim and Trastuzumab augur well for the future growth of our biosimilars business," she says.
Here are the key pointers from the results:1. Biocon partner Mylan commenced commercial sales of Fulphila, biosimilar Pegfilgrastim, in the US.
2. EMA's CHMP issued positive opinions recommending approvals of Fulphila, biosimilar Pegfilgrastim, and Ogivri, biosimilar Trastuzumab
3. Biocon partner Equillium's Investigational New Drug (IND) application for EQ001 (Itolizumab) for an orphan indication of acute graft-versus-host disease (aGVHD) was accepted by the USFDA in July 20184. Biocon's Drug Substance facility in Bangalore completed US FDA inspection with no observations
5. Biocon's Sterile Drug Product and Devices facilities in Bangalore received Certificates of GMP Compliance from EU
6. Biocon's API facility in Hyderabad successfully completed GMP audits from TGA, Australia and COFEPRIS, Mexico.