Strides Arcolab has reported a sharp fall in net profit by 92.7 per cent at Rs.2.2 crore as against Rs.30. 1 crore for the same period last year. The EBITDA is Rs.32.5 crore and the profit decline is reported because of the exchange loss of Rs.12.5 crore. The nine month net sales has indicated a 11.3 per cent increase at Rs.208.9 crore for Q3 ending September 2013 compared to Rs.187.7 crore during the same period of last year.

The company stated that the Q3’13 consolidated pharma earnings before interest, tax, depreciation and amortization (EBITDA) grew by 82 per cent to Rs.39 crore in Q3 2013 against Rs.22 crore in Q3 2012.

The company statement indicated that its management opted to report standalone financials, which captures the pharma business. It opted out of reporting consolidated financials as the Agila business is in transition consequent to the sale of Agila business to Mylan Inc., as announced in February 2013.

“Inspite of a subdued quarter and delay in product approvals for the US market, the company is confident of meeting its guidance for the year,” said Arun Kumar, vice chairman and group CEO, Strides Arcolab Limited.

Over the 2013 nine month phase, the company rebranded its biotech business as Stelis Biopharma which inked a Research Collaboration Agreement with Bio-Scaffold International Pte Ltd to develop scaffolds loaded with BMP and stem cells for various medical applications. The product development is progressing as per schedule for commercialization in early 2015, according to the press note issued.

During the nine months period of 2013, Strides has made 46 filings with US FDA with 18 pending approvals. It received US FDA approval for Italian semi solids and Ointment facility (Beltapharm). Further, the company also received ANDA approval from US FDA for Tenofovir Disoproxil Fumarate and Emtricitabine tablets.

The company had received a warning letter from US FDA for its injectable facility in Bengaluru (Sterile formulation facility). It took various voluntary remedial actions to address the concerns raised by the US FDA and has responded suitably within the stipulated timelines. The transaction with Mylan announced in February 2013 is expected to close in Q4’13.