The Bangalore based leading biotechnology company Biocon has announced Q3 performance. The company’s biopharmaceuticals segment delivered a growth of nine per cent year on year (YoY) at Constant Exchange Rate (CER) during 9M FY14. During the quarter it has touched net sales of Rs 2,187 crores and net profit Rs 301 crores and EBITDA at Rs 550 crores. For Q3 FY14, at CER, the segment performance declined by two per cent YoY.
Commenting on the quarterly performance and highlights, Kiran Mazumdar-Shaw, Chairman and Managing Director commented, “Q3 FY14 has been a very eventful quarter for us, with several research milestones across our novel molecules and biosimilars portfolio. The key highlight was the DCGI approval for our biosimilar Trastuzumab, which paved the way for its commercial launch in India as CANMAb. CANMAb is not only the world’s first biosimilar Trastuzumab, but is also the most affordable worldwide. We have also strengthened our R&D pipeline with two new alliances giving us access to novel technology platforms.”
She continued, “The performance of the Biopharmaceuticals segment has been steady as we continue our efforts to optimise the product basket. We have witnessed sustained business momentum in research services, and a return to growth for our branded formulations vertical. Our investment efforts in Malaysia continue and we are on track to commission our insulin facility in FY15. We expect to close this financial year with a strong performance across business verticals.”
As indicated earlier, the small molecules portfolio is currently being optimised to balance margin accretion with growth platforms. The company has seen good momentum in Immunosuppressants and Orlistat, while the changing product mix for statins have helped balance out the headwinds in the industry.
Biocon’s biosimilar Insulins portfolio continues to deliver strong growth. Its generic rh-Insulin is now approved in over 50 countries. Along with our partner Mylan, we continue with the groundwork to initiate a global phase III trial for our generic insulin glargine.
The company has announced the launch of CANMAb. Its biosimilar Trastuzumab in India is the first biosimilar Trastuzumab to be commercialised anywhere in the world; and comes with robust data from a two year long phase III biosimilarity trial conducted in India on over 130 patients. Keeping the emerging market needs in perspective, Biocon has launched the drug in two strengths (150 mg and 440 mg). The 150 mg presentation will help eliminate drug wastage and enable additional savings for patients, when used in conjunction with the standard 440 mg vial. CANMAb will be sold in India through Biocon’s Oncotherapeutics division under the branded formulations vertical and will be available to patients in early February 2014.
Its branded formulations vertical grew up by 15 per cent YoY in Q3 FY14, vis-à-vis the industry growth of five per cent YoY, closing the period with 99 crores in sales. The impasse between the trade and the pharma companies has largely been resolved, and we have seen growth return to the market driven by chronic therapies.
The growth for this quarter has been led by our flagship brands of Basalog, Insupen, BioMab EGFR and Abraxane. In addition, the company seen very enthusiastic uptake of Cytosorb, a novel therapy in sepsis management that we had launched last quarter.
We have signed a licensing and co-development agreement with Advaxis Inc. for ADXS-HPV, a novel cancer immunotherapy to treat Human Papilloma Virus (HPV)-associated cervical cancer in India and key emerging markets.
The company has commenced global trials for our oral insulin (IN 105) programme in the US. And their partnership with BMS on this asset continues, in line with their decision to retain this asset. The company entered into a strategic collaboration with Quark Pharmaceuticals this quarter, to develop a range of siRNA based novel therapeutics. This co-development alliance will leverage Quark’s proprietary technology platform to target various unmet medical needs. The lead candidate in this programme is QPI-1007, a novel siRNA drug candidate for ophthalmic conditions.
The research services segment grew 22 per cent YoY and 15 per cent YoY at Constant Exchange Rate (CER) for 9M FY14 and Q3 FY14 respectively, with widespread growth across our service platforms. Commenting on this performance, Peter Bains, Director Syngene International said, “We are pleased with the strong growth delivered by research services through 9MFY14. This reflects sustained business momentum and an increasing penetration of our integrated service offerings. As pharma and biopharma continue to evolve their R&D models, we see a sustained emphasis on collaborative externalisation. In addition, there is increasing interest from allied sectors such as nutrition, consumer and animal health and agrichemicals to create partnerships between our research and development capabilities and their product pipelines. I am also pleased to report that Syngene has successfully cleared its first US FDA audit of its quality systems, with no observations or 483s. The audit was triggered by an application from one of our existing clients, and gives further credence to the world class quality systems, underpinning our service platforms.”
The outlook for FY14 remains positive while we strive to balance our revenue growth and R&D spend. Our portfolio and cost optimisation initiatives continue, helping us manage our margins more effectively. Biocon continue to invest in R&D pipeline, and the several milestones achieved over the course of this year are indicative of the growth opportunities ahead of us. Its Malaysia facility is on track for commissioning in FY15.
EP News Bureau– Mumbai
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