The Chennai-based global pharma major, Orchid Chemicals & Pharmaceuticals Ltd. (Orchid) has reduced its net loss after exceptional items to Rs 13.20 crore during the second quarter ended September 2009 from Rs 40.66 crore in the corresponding period of last year. Its net sales, however, declined by 10.1 per cent to Rs 304.85 crore from Rs 339.14 crore.

Earnings before interest & tax (EBIT) stood at Rs 49.63 crore compared to Rs 67.22 crore of the corresponding quarter of last year. Profit/(loss) before tax (prior to exceptional item on account of exchange (loss)/gain on the FCCBs) stood at a loss of Rs 6.97 crore as against a profit of Rs 36 crore of the corresponding Q2 of the last fiscal. After considering the exceptional item on account of exchange loss on the FCCBs, the loss before tax for the second quarter (Q2) was at Rs 11.58 crore compared to a loss of Rs 45.58 crore during the corresponding Q2 of the last fiscal. Exceptional items in respect of loss on FCCBs amounted to only Rs 4.60 crore as against Rs 81.58 crore in the last period.

Orchid’s standalone revenues for the first half-year ended September 30, 2009 stood at Rs 623.24 crore compared to Rs 654.77 crore registered during the corresponding period of last fiscal. Earnings before interest & tax (EBIT) stood at Rs 77.24 crore compared to Rs 124.39 crore registered during the corresponding half of the last fiscal. The net loss for the first half stood at Rs 42.96 crore as compared to Rs 72.31 crore. Foreign exchange loss for the period under review amounted to Rs 8.23 crore as compared to Rs 140.37 crore.

“The second quarter of this fiscal witnessed key milestone achievements. The approval of our Piperacillin-Tazobactam injection ANDAs by the US FDA marks the start of yet another robust revenue cycle. The approval of this product in the US market validates the technical and regulatory strengths of Orchid. With the newer product verticals gaining in strength with additional product approvals, the overall asset utilization will also increase resulting in a stronger revenue and profitability pattern from the ensuing quarters”, said K Raghavendra Rao, managing director, Orchid Chemicals & Pharmaceuticals Ltd.

The second quarter (Q2) of this fiscal 2009-10 witnessed the scaling of a new high in the history of Orchid’s regulated generics business with a quick launch of Piperacillin-Tazobactam injections in the US following the much-awaited approval of the ANDAs for these products by the US FDA on September 15, 2009.

The earlier launched products, including Cefepime, Ceftriaxone, Cefazolin, Cefdinir and Cefadroxil in the cephalosporin segment and terbinafine and divalproex in the non-penicillin, non-cephalosporin (NPNC) segment continued to post significant contributions to Orchid’s revenues. In the penicillins segment, Piperacillin+Tazobactam injection in the ANZ and Canadian markets continued to display an increasing trend.

With several launches across varied spectrum of markets and product segments lined up in the coming quarters, Orchid’s revenues from the regulated generics business is poised to grow significantly in the forthcoming months and quarters.

In the API (Active Pharmaceutical Ingredients) segment, Orchid increased its cumulative filings of its US DMF count to 72. The break-up of the total filings is: 25 in the cephalosporin segment, 34 in the NPNC segment, 2 in the penicillin segment and 11 in the carbapenems segment. In the European market space, the cumulative filings of COS (Certificate of Suitability) count remained at 21 which includes 13 in cephalosporin segment, 7 in NPNC segment and 1 in the penicillin segment.

Orchid’s cumulative ANDA filings for the US market remained at 58. This includes 7 Para IV FTF (First–To–File) filings. The break-up of the total ANDA filings is: 29 in cephalosporins, 5 in penicillins, 21 in NPNC and 3 in the carbapenems space. More filings are slated in the ensuing quarters. During the quarter under review (Q2 FY10), Orchid received the final ANDA approvals for 4 of its ANDAs.

With these 4 approvals, the cumulative count of the ANDA approvals moved to 36, out of which 26 are in the cephalosporin segment, 8 in the NPNC segment and 2 in the penicillin segment.

In the Canadian market, Orchid’s cumulative count of ANDS approved remained at 4, out of which 3 are in cephalosporin segment and 1 in the penicillin segment.

In the EU space the cumulative count of Marketing Authorizations filings moved to 23. The break-up of the total MA filings is: 16 in the cephalosporin segment, 1 in the penicillin segment, 4 in the NPNC segment and 2 in the carbapenems segment. A few more dossiers have been lined up for filing in the 3rd & 4th quarters of this fiscal, based on the DCP slots allotted by the respective RMS (Reference Member States) countries.

During the quarter under review, Orchid received its sixth MA approval thereby increasing the cumulative count of MAs approved to 6. These approvals covering both oral and sterile products have already been translated into robust order-book positions.

In the other regulated markets like Canada & ANZ, several dossiers are expected to be approved by the respective regulatory bodies in the ensuing quarters.

The company has exercised the option provided under the companies (Accounting Standards) Amendment Rules, 2006 dated 31st March, 2009 in respect of AS 11. The amount remaining to be amortized in the financial statements as on 30th September, 2009 on account of exercising the above option is Rs 26.50 crore. If the same policy had been followed for the previous half year ended and quarter ended 30th September, 2008 then the profit before tax would have been Rs.60.49 crore and Rs 26.89 crore and profit after tax would have been Rs 52.83 crore and Rs.23.38 crore respectively against the reported figures for the respective period.