The company’s biopharmaceuticals business represents about 75% of Biocon’s total revenue, and for the first quarter 2015 it reported sales of 5.47bn Rupees ($91m), a rise of 1% compared to the same period last year.
Speaking on a conference call, Managing Director Kiran Mazumdar-Shaw said the quarter had been challenging. “We have been impacted by external factors largely related to the Middle East and North Africa [MENA] due to the political tensions that remain in those regions.”
The company would not break down geographical details of its sales further but spokesman Rumman Ahmed told in-Pharmatechnologist.com: “Biocon used to get Export Credit Guarantee Corporation of India (ECGC) cover for the MENA region,” but “because of the turmoil in the region ECGC cover is not readily available, which means payments become an issue and that is the credit risk Biocon is trying to address.”
However, both Ahmed and Mazumdar-Shaw said the firm was looking at addressing this issue in order to resume supplies to the region and reduce the impact of such external factors in the coming quarters.
Quality Systems
Biocon was optimistic about the future, despite the flat sales, as for the quarter its branded formulations business recorded record revenues, the firm filed its first ANDAs targeting the US generics market, and it progressed further with its insulin biosimilar for Sanofi’s Lantus.
However, Mazumdar-Shaw told investors the firm’s approach to quality and its systems in place would “be a very big competitive advantage” and a driver going forward.
“Many, many Indian companies have been really challenged with US FDA inspections but I think the fact we have successfully completed several FDA inspections within the group is a testimony to the quality systems that we have in our company,” she said. “[This] is going to be a huge value differentiator for us going forward.”
With a number of Indian facilities making headlines recently due to cGMP violations – for example Ranbaxy, Apotex and Ipca - we asked the company for more insight into Biocon’s quality systems.
“Biocon’s quality system procedures undergo continuous improvements and upgrades based on internal reviews, regulatory guidelines, inputs from multiple regulatory authorities and customers’ audits,” Ahmed told us. “The company ensures harmonized Quality Systems across all manufacturing sites based on global requirements.”
Furthermore, the company uses an experienced talent pool and “employs experts with robust experience in the Pharma and Biotech industry,” and is part of the “importance in maintaining the Indian pharma industry’s reputation as a global supplier of high quality but affordable drugs.”