Ranbaxy Laboratories declared the results for the quarter ended December ’08 and held a tele conference call on 22nd January 2008 to discuss the financial performance as well as future plans. The key takeaways from the meet are as follows:
- Consolidated net sales for the year FY’08 reported growth of 8% to Rs 7250.70 crore and net loss of Rs 914.60 crore.
- Consolidated sales for the quarter ended December’08 reported growth of 6% to Rs 1909.60 crore and net loss of Rs 679.80 crore.
- During Q4’08, the Company adopted AS30 (Financial Standard 30 – Financial Instruments: Recognition and Measurement) to stay current in its accounting practices and to ensure high level of transparency. As a result of this, change in fair valuation during Q4’08, of forex options taken by the Company to safeguard its receivables, is accounted for in the P&L.
- The results were significantly impacted by three major factors viz., AS30 impact of USD 161 million, forex impact of USD 179 million, US related provisions of USD 59 million. While these three items were non-cash in nature, they primarily contributed to the overall loss of Rs. 914.60 crore (USD 198 million) for the year.
- Emerging markets portfolio achieves sales of Rs. 3911.40 crore, an increase of 9% over corresponding pervious year and accounted for 54% of sales.
- Developed markets sales up by 7% to Rs. 2833.40 crore and accounts for 39% of sales.
- In Jun’08, Ranbaxy and Daiichi Sankyo, the third largest pharmaceutical company in Japan, signed a landmark deal, with Daiichi Sankyo acquiring majority stake in Ranbaxy. Later in the year, Daiichi Sankyo completed the transaction for acquisition of 63.92% stake in the Company.
- The Company received Rs. 3584.90 crore against preferential equity and warrants issued to Daiichi Sankyo, significantly bolstering Net Worth.
- The Company made its first set of authorized generic launches in the US. Both Omeprazole 40 mg Capsules and Felodipine ER Tablets have performed well in the market, with Omeprazole garnering 43% market share.
- Following the USFDA Import Alert in September’08, Pharmaceutical and Medical Devices Agency, Japan (PMDA) audited three dosage form and one Active Pharmaceutical Ingredient (API) facility of the Company during October-November’08.
- The dosage form facilities audited were Paonta Sahib, Batamandi and Dewas while the API facility was Toansa.
- All these inspections were successful and as a result, the company has received approvals for Levofloxacin 100mg Tablets and Bicalutamide 80mg Tablets.
- Ranbaxy and Pfizer Inc. entered into an agreement to settle most of the patent litigation worldwide involving Atorvastatin (Lipitor), the world’s most-prescribed cholesterol-lowering medicine. This decision will allow for an earlier introduction of a generic formulation in several countries. Ranbaxy will have a license to sell generic versions of Atorvastatin and the fixed-dose combination of Atorvastatin-Amlodipine Besylate in the United States. The Company will retain the right to the marketing exclusivity of 180 days in the United States.
- Ranbaxy reached several agreements with AstraZeneca settling patent infringement litigation for Nexium® (Esomeprazole Magnesium). The settlement allows Ranbaxy to supply API and formulation to AstraZeneca, and later to exclusively sell a generic version of Nexium® under license from AstraZeneca with 180 days exclusivity in USA.
- The Company settled all matters relating to possible patent litigation with GlaxoSmithKline (GSK) relating to Sumatriptan Succinate Tablets, the generic version of GSK’s Imitrex Tablets. The settlement allows Ranbaxy to distribute a generic version of Imitrex Tablets in USA. Ranbaxy is currently awaiting approval from USFDA for launch.
- Ranbaxy launched on day-1 of patent expiry, Amlodipine tablets 2.5mg & 5mg in Japan.
- Romania sales declined by 11% to Rs 110.80 crore for the quarter and by 7% to Rs 464.40 crore for FY’08 and company is expects good in FY’09.
- During the year, Ranbaxy licensed in or received approval, for the first time in India of certain innovative and differentiated products such as Inersan, Bronist and Gliadel Wafer.
- The noval Anti-malaria deug, Arterolane Maleate and Piperaquine Phaosphate, has successfully completed Phase II studies in Thailand and India. The company has received approvals from DCGI to commence Phase-III studies in India.
- Company has 2 supply contracts from AOK tender in Germany.
- Capex for FY’09 would be around USD 100 million.
- R & D expenditure will be around USD 100 million for FY’09
- 7 ANDAs were filed in the FY’08
- ANDA for Sumatriptan Succinate is filed from the Ohm Laboratories and the drug is manufactured in the Ohm manufacturing unit.
- The US FDA ban on 30 drugs of from Dewas and Paonta Sahab units was felt only for four months of calendar year 2008; and the adverse impact will continue to be felt till the ban is lifted.