The Board of Directors of Ranbaxy Laboratories Limited (RLL) at their meeting held today, took on record the unaudited results for the quarter ended March 31, 2008.

Key Highlights:

·     Consolidated sales at USD 409 Mn, (Rs 16,231 Mn), records a growth of 15%. 

·     Profit after Tax  was at USD 39 Mn (Rs 1,530 Mn), +19%. 

·    Earnings before Interest, Depreciation, Tax & Amortization (EBIDTA) reflects a margin to sales of 17% ( 2007 : 13.4%) .

Commenting on the business results, Mr. Malvinder Mohan Singh, CEO and MD, Ranbaxy, said, ""Following a good start to the year, we expect business to ramp up even further as we move through the successive quarters . In this regard, our market and product balancing strategy will play to our advantage. Separately, the enhanced visibility of earnings from our FTF pipeline and a highly progressive alliance and collaboration strategy will contribute to the definitive build up in earnings and profitability over the many coming years." 

Ø   Developed markets led by North America, record 17% growth in sales, contribute 40% to global sales. Emerging Markets comprise 53% to global sales and grew 12%.

Ø  North America sales at USD 110 Mn, +20%. Sotret, the Company's leading brand in the dermatology segment, consolidates market leadership position with 53% market share.

Ø Asia Pacific (incl. India) & CIS records combined sales of USD 140 Mn, +22%, led by buoyant growth in key countries such as India, CIS, Malaysia, Japan & the Middle East.

Ø   The Company settled all matters relating to possible patent litigation with GlaxoSmithKline relating to Sumatriptan Succinate Tablets, the generic version of GlaxoSmithKline's Imitrex Tablets. The molecule has a market size of approximately USD 1 Bn at innovator prices (Source :IMS).

Ø   The Company entered into a series of agreements with AstraZeneca for 3 molecules .i.e. Esomeprazole capsules, Felodopine ER capsules and Omeprazole 40 mg tablets. Two of these agreements concern Esomeprazole magnesium capsules (Nexium), the second largest selling drug in the United States with sales of USD 5.5 Bn (Source : IMS). The Company has also been designated as the U.S. distributor for the authorized generic versions of Felodipine ER Capsules and Omeprazole 40mg Tablets. 

Ø   The Company announced the scheme of the New Drug Discovery Research (NDDR) de-merger wherein shareholders in Ranbaxy will be entitled to receive one equity share of Re.1 each of Ranbaxy Life Science Research Limited (RLSRL) for every four equity shares of Rs.5 each held in Ranbaxy. The Appointed Date for the purpose of the demerger has been fixed as 1st January 2008.

Ø    The Company received approval for Amlodopine Tablets 2.5mg & 5mg from Ministry of Health and Labour Welfare (MHLW-Japan) for marketing the generic version of the product. This is the first independent product approval received by Ranbaxy in Japan and has the unique distinction of being the first product developed by any foreign generic pharmaceutical company outside Japan. Amlodipine tablets has a market size of approximately USD 2 Billion (Jan-Dec' 2007 - IMS - Japan).   

Consolidated Results (Ranbaxy Laboratories Limited and Subsidiaries)

Quarter ended March 31, 2008 (Q1)

For Q1, the Company achieved Consolidated Sales of Rs. 16,231 Mn [USD 409 Mn] (2007: Rs. 15,644 Mn, USD 355 Mn), a growth of 4% in rupee terms. Profit before interest, depreciation, tax and amortization was Rs. 2,552 Mn [USD 64 Mn] (2007: Rs. 1,908 Mn, USD 43 Mn), an increase of 34%. This represents a margin of 15.7% to sales  compared to 12.2% to sales in the corresponding previous period. Profit before tax was at Rs 1,729 Mn [USD 44 Mn] (2007: Rs 1,642 Mn, USD 37 Mn), an increase of 5%. Profit after Tax without considering foreign exchange gains/losses on translation & extra-ordinary items was at Rs 1,196 Mn (USD 30 Mn), up15 %. Reported Profit after tax was at Rs.1,368 Mn [USD 34 Mn], up 6% (2007: Rs. 1,287 Mn, USD 29 Mn).

Earnings per share on a fully diluted basis were Rs. 3.66 (2007: Rs. 2.64).

Global Sales

For Q1, consolidated sales were at USD 409 Mn, an increase of 15%. The Company's market mix remained steady with the emerging markets contributing 53% to global sales and recording a growth of 12%. The developed markets contributed 40% to global sales and recorded a growth of 17%. North America was the key contributor to developed markets whereas growth in the emerging markets was led by India, CIS & other countries in the Asia Pacific region. The API business recorded sales of USD 30 Mn, +27%.

North America 

North America, comprising USA & Canada, recorded sales of USD 110 Mn, +20%.

USA recorded sales of USD 99 Mn for the Quarter, a growth of 16% over the previous year. New product introductions by the Company and the continuing volume growth led to an overall improved performance across the generics, branded generics and OTC segments of the business. 5 new products were introduced in the quarter: 4 generic products and 1 OTC. In the branded generics segment, the Company's flagship brand Sotret, further consolidated its market share position and remained the leader in its respective product category with 53% market share. In the 30mg dosage strength, Sotret currently has 68% market share. With the increase in the sales force to support the existing and recently acquired dermatology brands from BMS, the Company's branded business is well poised to further enhance its growth momentum.

The overall market share of Ranbaxy in the US generic market (in the molecules Ranbaxy is present) was ~11.3% for QTD Feb '08, as against 10.3% in the trailing quarter.

The Company continues to strengthen its US product pipeline and presently has 98 ANDA's pending approval with the US FDA. These products, at an innovator market size, are valued at USD 55 Bn and comprise a well-balanced mix of plain vanilla generics, niche & potential First to File products. The Company believes that it has a First to File status on approximately 19 Para IV ANDA filings, with an innovator market size in excess of USD 27 Bn.

The Company entered into 2 key settlements for its First -to-File (FTF) products during the quarter.

Last week, Ranbaxy entered into a multi-pronged settlement with AstraZeneca, concerning Esomeprazole magnesium capsules (Innovator brand- Nexium). The agreement will allow Ranbaxy to launch the generic version of Nexium under a license from AstraZeneca, on May 27, 2014. Ranbaxy will be the only company to market this product with a 180 days exclusivity, in the US market.

Separately, Ranbaxy and AstraZeneca have also entered into an agreement under which Ranbaxy will formulate a significant portion of AstraZeneca's U.S. supply of Nexium from May 2010, including provisions for the manufacture of Esomeprazole magnesium, the Active Pharmaceutical Ingredient (API) from May 2009.

Under the third component of the settlement, Ranbaxy has been designated as the U.S. distributor for the authorized generic versions of Felodipine Capsules and Omeprazole 40mg Tablets. 

In January this year, Ranbaxy settled all matters relating to possible patent litigation with GlaxoSmithKline relating to Sumatriptan Succinate Tablets, the generic version of GlaxoSmithKline's Imitrex® Tablets. The settlement will allow the Company to distribute a generic version of Sumatriptan Succinate Tablets (in the 25 mg,50 mg and 100 mg strengths) in the US market at the end of this year.

During the quarter, Ranbaxy received approval from the U.S. FDA to manufacture and market Cefuroxime Axetil Oral Suspension USP, 125 mg/5mL and 250 mg/5mL. The Company would be the sole generic supplier in the market place and is the only one to offer both the suspension and tablet dosage forms of the molecule. Total annual market sales for the product stood at USD 29 Mn. The Company was also granted a tentative approval from the U.S. FDA for Esomeprazole Magnesium Delayed-Release Capsules, 20 mg (base) and 40 mg (base), the generic version of  Nexium (Astra Zeneca). 

Canada continued its robust growth momentum recording sales of USD 10 Mn, a growth of 80% in the quarter. The Company currently ranks 9^th in the generics market and has performed exceedingly well since it began operation in 2005. The key products that contributed to sales during the quarter were Zoplicone, Citalporam & Ciprofloxacin. Rabiprazole ultra generic was also launched during the quarter.

Europe

In Q1 2008, Europe (including Romania) registered sales of USD 83 Mn, 11% lower than the corresponding previous period. The Company's key markets in Western Europe, i.e. Germany, UK & France recorded sales of USD 34 Mn in the quarter, at similar levels to those in the corresponding previous period. Sales in Germany for the quarter were at USD 11 Mn, an increase of 9% over the corresponding previous period. UK & France recorded sales of USD 11 Mn & 12 Mn, a decline of 7% & 6% respectively over the corresponding previous period. In UK, the Company launched 2 new products in March .i.e. Glimeperide & 3 additional strengths of Gabapentin that are expected to contribute positively to sales in the coming quarters. The French operations after having undergone a re-structuring in 2007, coupled with 20 new product introductions over the last few quarters, is expected to register a progressively improving performance.

Romania, recorded sales of USD 26 Mn for the quarter, a decline of 29% over the corresponding previous period. Sales were impacted as a result of the uncertainty in the market place due to the proposed healthcare reforms and the re-introduction of branded prescribing, which has been introduced from April 1, 2008. The Company's existing brand recognition and brand building capabilities will augur well as a result of the re-introduction of branded prescribing in the market.

In Rest of Europe, sales for the quarter were at USD 23 Mn, a growth of 7% over the corresponding previous period. Italy & Spain, the recently entered into newer markets recorded combined sales of USD 7 Mn, + 12%.  Italy witnessed 5 new product launches and was the fastest growing generic Company in the marketplace.

Asia Pacific & CIS

 The region recorded sales of USD 140 Mn for the Quarter, 22% better than previous year. All countries recorded a good growth in the region led by India, CIS, Middle East, China, Japan & Malaysia. 

India

The sales for the quarter were at USD 75 Mn, a 16% increase over the corresponding previous period. During the Quarter, the Company launched 12 new products across several therapies like antibiotics, cardiovascular, asthma, urologicals, ortho, gastrointestinal & anti-cancer. Of them, Coltazole-OD (Cilastozole), Contiflo ICON (Tamsulosin) and Storfib Tab (Atorva + Fenofibrate 145) are the new products launched for the first time in the country. Coltazole-OD (Cilastozole) & Contiflo ICON (Tamsulosin) are based on the Company's NDDS  (Novel Drug Delivery System s) platforms.

Ø   During the Moving quarter (Dec 07- Feb 08, source ORG-IMS report), the market share of the Company moved up to 5.05% from 4.82% (Dec 06-Feb 07) with 23% growth. This is a further improvement over the market share of 4.97% on MAT -moving annual total basis. Ranbaxy maintained its 2^nd rank in the domestic market during this period.

Ø    Contribution of Chronic therapy portfolio for Ranbaxy to total sales has further improved to 24% (February, 2008 MAT) against 21% over the corresponding period last year. Ranbaxy's Chronic Portfolio has grown at a higher rate of 28% against 21% for the market.

Ø    Amongst "New Products Introduction" category  (Source ORG-IMS report), Ranbaxy has the highest numbers of brands featuring amongst the Top-30 leading launches in the industry over the last two years. These brands are: Synasma (Doxophylline), Volitra (Topical NSAID formulation) & Gembax (Gemifloxacin)

Ø  The contribution of the Novel Drug Delivery System (NDDS) portfolio  to total Ranbaxy sales stood at 9% and the Company remained among the top rung companies with 7% market share in the NDDS segment (February, 2008 MAT)

Ø   Ranbaxy launched BONISTA, a Teriparatide injection (recombinant human parathyroid hormone) for the treatment of Osteoporosis,  in collaboration with Virchow Biotech Pvt Ltd, Hyderabad, India. Ranbaxy is the first company to launch this bio-generic product in the world. The Osteoporosis segment in India currently has a market size of around Rs. 219 crores and  grew more than 29% in value terms in 2006-07.

Ø   The Company also entered into an exclusive in-licensing agreement with CD Pharma, the Indian affiliate of US based VSL Pharmaceuticals for a first of its kind breakthrough drug in the dental segment. The patented product INERSAN will be sold in India & Nepal and is used in the treatment of dental problems such as Periodontitis, Gingivitis & Halitosis.

CIS: Russia & Ukraine

The region recorded sales of USD 24 Mn (+29%) for the Quarter. Russia recorded sales of USD 13 Mn, a growth of 41% in the quarter, while sales in Ukraine were at USD 11 Mn, a growth of 17%. In Russia, both the ethical & OTC segments continued to perform well with key products such as Coldact, Pylobact, Cifran & Simvor maintaining their leading market standing in their respective therapeutic categories. In Ukraine, key products that contributed to sales were Loxof, Ketanov & Cifran.  

Asia Pacific (excl. India)

The Asia Pacific region recorded sales of USD 25 Mn, an increase of 37% over the previous period. All countries in the region have shown buoyant growth led by Malaysia, China & Japan. Malaysia recorded sales of USD 6 Mn, +40%, contributed by products such as Fluhalt, Storvas & Enhancin. Sales in China during the quarter was USD 4 Mn, a growth of 32% versus the corresponding previous period, led by a mix of both existing and new products.

The Company's business in Japan recorded sales of USD 5 Mn, a robust growth of 51%. The Company has attained the unique distinction of having the first product i.e. Amlodopine, developed by any foreign generic pharmaceutical company outside Japan and subsequently being granted approval by MHLW (Japan). Amlodipine tablets has a market size of approximately USD 2 Billion (Jan-Dec' 2007 - IMS - Japan). The Government of Japan is encouraging generic substitution, reflected in the increasing genericization of medicines which is expected to grow to 30% in volume terms by 2012. The Company is well poised to capitalize on this opportunity in the future.

Middle East registered sales of USD 7 Mn, 13% better than the corresponding previous period. Bahrain, Lebanon & UAE have shown a strong performance and have contributed to sales for the quarter. 

Rest of the World (RoW)

Africa: Recorded sales of USD 31 Mn , a growth of 28%. South Africa recorded sales of USD 11 Mn, a growth of 68%. Key markets in East Africa such as Kenya & Ethiopia also performed well contributing to growth in the quarter.

The Company's core business sales in Africa (excluding the ARV business)   recorded a growth of 29% with sales at USD 21 Mn.

Brazil:  Sales stood at USD 10 Mn for the Quarter, recording a growth of 75% over the corresponding previous period. The Company is currently ranked 6^th in the generic market and has a 3.9% market share ( 3.1% in the corresponding previous period). Rest of Latin America (excl. Brazil) registered sales for the quarter at USD 6 Mn, a robust growth of 77%.

Global Consumer Healthcare (GCHC): Sales for the Quarter were USD 10 Mn, a growth of 28% over the corresponding previous year. The Company's leading brand Revital crossed the Rs 100 Crore sales mark based on Secondary MAT Mar '08 and recorded a healthy growth of 21%. The market share of the product increased 4% to 82% (ORG - SSA MAT Feb 08). The Company also announced its entry into the Chyawanprash segment, launching its sugar-free product under the Brand name 'Chyawan Active'. The product will be initially introduced in North India and later in other parts of the country. Ranbaxy's 'Chyawan Active' is an Ayurvedic Proprietary Medicine developed by the Company's Herbal Drug Research team.

Research & Development

Ranbaxy entered into a collaborative research agreement with the Department of Biotechnology (DBT), New Delhi, in the area of New Drug Discovery Research (NDDR). Under the alliance, Ranbaxy will develop novel drugs, using the inhibitor design for novel targets/pathways /proteins etc. DBT will support the project with a financial grant, for a period of 3 years in the first phase of the collaboration. On identification of a lead molecule, DBT and Ranbaxy will jointly support its clinical development. The research will be conducted under the aegis of DBT's key initiative in the area of tuberculosis and three major areas have been identified in the program pertaining to the Development of Diagnostics, Vaccines & Drugs.  

During the Quarter, the Company filed one ANDA with the US FDA and received one approval. This takes the cumulative filings to date to 240 with 142 approvals. In the European Union (EU), the Company made 9 national filings in 3 Reference Member States (RMS) and received 11 approvals in 6 RMS. 

With respect to the anti-malaria molecule, RBx -11160, Phase II studies with the combination product are ongoing in Thailand & India. The studies are expected to be completed by Jun 08. Reproductive toxicity studies are underway and are scheduled to be completed by end of 2008 / Q1 2009.

RBx-14255, the anti-bacterial molecule belonging to the Ketolide class, has completed exploratory toxicity studies. The IND enabling studies will be initiated in Q2 2008. The molecule has exhibited a favorable pharmacokinetic profile in mice & dogs and in the action potential duration studies appears to be safer than Telithromycin, a comparable drug.

The agreement with GSK is progressing well. In the COPD segment, the identified compound for this therapeutic category has been scaled up and IND directed toxicology & safety pharamacology studies have been initiated. In the anti-bacterial therapeutic segment several compounds that show much improved developability have been identified and are currently being profiled in order to identify a pre-clinical candidate.

Sourced From: Ranbaxy Laboratories Ltd