Ranbaxy Laboratories Ltd.

(NSE: EQRANBAXY) is the largest genericpharmaceutical company in India by sales and a top 10 generic company globally.
[1] [2][3]

In 2008, a majority stake in the company was acquired by Japanese PharmaDaiichi Sankyo Company (4568TO),
[4]

the third largest pharmaceutical company in Japan.

[5]

Daiichi-Sankyos strength in proprietary medicine

complements Ranbaxys leadership in the generics segment and both companies acquire a broader product base, therapeutic focus areas and well distributed risks.
[6]

Ranbaxy also reached settlements with the makers of the world's two largest selling drugs - Lipitor (withPfizer (PFE)) and Nexium (with AstraZeneca (AZN)).
[7]

This decision will allow for an earlier introduction of a generic formulation in

several countries. Ranbaxy is also bringing out novel drug-delivery systems and was the first Indian company to license a product in this field to Bayer AG.
[2]

Company Overview
Ranbaxy Laboratories Limited operates as an integrated international pharmaceuticals organization with businesses encompassing the value chain in the marketing, production and distribution of pharmaceuticals products. It operates under two segments: Pharmaceuticals and other business. Pharmaceuticals segment comprises the manufacture and trading of Formulations, Active Pharmaceuticals Ingredients (API) and Intermediate, Generics, Drug discovery and Consumer Health Care products. Other business comprises rendering of financial services. Contents

1 Company Overview

o o

1.1 Business and Financial Metrics 1.2 Business Segments

     

1.2.1 Anti-Infectives[13] 1.2.2 Cardiovascular[13] 1.2.3 Musculoskeletal[13] 1.2.4 Central Nervous[13] 1.2.5 Gastrointestinal[13] 1.2.6 Dermatological[13]

2 Trends and Forces

2.1 Gaining First-to-File exclusive rights to a generic through patent challenges

2.2 Pricing Pressures in US & European generic

markets affect Ranbaxy's revenue

2.3 Regulatory issues raised by regulators in various countries where Ranbaxy operates pose a risk to its markets

3 Competition 4 References The Company manufactures products for anti-infectives, cardiovasculars, musculoskeletal, gastrointestinals, dermatologicals, and central nervous system. Ranbaxy Laboratories Limited encompasses the entire pharmaceutical value chain[8] from manufacturing to marketing generic pharmaceuticals, value added generic pharmaceuticals, branded generics, Active Pharmaceuticals Ingredients (API) and intermediates.[9] As a research driven company, over 6% of its revenues are invested in R&D.[10] Among the pharmaceutical companies in India, Ranbaxy has the largest R&D budget with an R&D spend of over U.S. $100 million.[11] The company has manufacturing operations in eight countries with a ground presence in 49 countries, and its products are available in over 125 countries. It has been aggressively entering into joint ventures and strategically acquiring companies in the past few years. Besides concluding its acquisition of Be-Tabs in South Africa, which makes Ranbaxy the 5th largest generic pharmaceutical company in South Africa, the Company acquired 13 Dermatalogy products fromBristol-Myers Squibb in the U.S in 2007.[2] Ranbaxy acquired RPG Aventis which has since been renamed Ranbaxy Pharmacie Generiques SAS. It also has subsidiaries in Spain, Netherlands, Russia and Australia.

Business and Financial Metrics

Second Quarter 2010 Results (ended June 30, 2010)[12] Ranbaxy reported sales for the second quarter of $458 million (Rs 21,029 million), a growth of 22% over the second quarter of 2009. Earnings before interest, taxes, depreciation & amortization (EBITDA) was $90 million (Rs. 4,168 million), a margin of 20%. Profit after tax was $72 million (Rs. 3,320 Mn), a margin of 16%. Operational Highlights of the Second Quarter 2010
[12]

To sharpen its focus on generics, the Company reached an agreement to transfer its New Drug Discovery Research assets to Daiichi Sankyo India Pharma Pvt Ltd (DSIN).

Ranbaxy launched Atorvastatin in Canada and South Africa. The launch in Canada, was under the Companys global settlement with Pfizer. In South Africa, Ranbaxy was the first to launch a generic version in the market.

Valacyclovir, an FTF product in the US, achieved a peak market share of 74% before the end of exclusivity during the quarter.

The Company introduced Daiichi Sankyos innovative anti-platelet drug Prasita (Prasugrel) in India. During the quarter, Ranbaxy launched 31 new products in India, including 3 in-licensed products.

 

The Company made 32 filings and received 35 approvals for dosage forms during the quarter. During the quarter, emerging markets recorded sales of $230 million, a growth of 6%, and contributed about 50% to global sales. Sales in developed markets amounted to $203 million, a growth of 63%.

Business Segments
Anti-Infectives[13]
This segment launched Valacyclovir Hydrochloride in the United States. The product was also launched in United Kingdom and France.

Cardiovascular[13]
This segment introduced the drug Simvastatin. The Company launched Olvance (Olmesartan Medoxomil) and its fixed dose combination with Amlodipine (Ol-Vamlo), in India. Further expanding its portfolio in Canada, Ranbaxy launched two products, Ran-Simvastatin (Simvastatin) and Ran-Amlodipine (Amlodipine).

Musculoskeletal[13]
In the Musculoskeletal segment, Ketorolac was the primary contributor to sales. In the United States, Ranbaxy entered into an agreement with Validus Pharmaceuticals to market and distribute an Authorized Generic version of Rocaltrol (Calcitriol). Ranbaxy's flagship brand in this segment is Volini.

Central Nervous[13]
The key products in Central Nervous System segment are Gabapentin and Sertraline. The two other products include Oxcarbazepine Suspension and Sumatriptan tablets.

Gastrointestinal[13]
The Company launched Pantoprazole in the Gastrointestinals segment. Ondansetron tablets were launched in Canada.

Dermatological[13]
The Company received Dermatological franchises through the acquisition of brands and marketing rights from Ochoa Laboratories in India for their range of Dermatological products.

Trends and Forces

Gaining First-to-File exclusive rights to a generic through patent challenges
Generic drug companies can challenge a patent's validity or argue that their version does not infringe on the existing drug's patent even before patent expiration. The first company to apply for FDA Approval for a generic, in spite of an existing patent, receives a 180-day period of exclusivity to produce and sell the generic version.
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Ranbaxy has been filing more than 20 ANDAs to the U.S. Food and Drug Administration (FDA) each year.

[15]

It has

one of the largest product pipeline in the US that includes 18 potential First-To-File opportunities with a market size of around US $27 billion, at innovator prices.
[2]

Pricing Pressures in US & European generic markets affect Ranbaxy's revenue

Due to an increase in number of pharmaceutical companies forging into the generics market, there has been downward pricing pressure on generics in the U.S.[16] The generics market in Europe, which had become a safe haven for Indian pharmaceutical companies after competition pulled down margins in the US, has come under pricing pressure too, especially in countries like Germany, the UK and France, the top three generics markets on the continent. These countries have seen margins in the generics segment erode as much as 80-90%.[17] The pricing pressure has been adversely affecting revenue as both US & Europe occupy Ranbaxy's majority market share.

Regulatory issues raised by regulators in various countries where Ranbaxy operates pose a risk to its markets
On September 16, 2008 the U.S.Food and Drug Administration (FDA) issued warning letters to Ranbaxy Laboratories Ltd., and an Import Alert for Drugs from Two Ranbaxy Plants in India affecting over 30 different generic drugs and citing serious manufacturing deficiencies. Following this the World Health Organisation (WHO) observed that several inspections of Ranbaxy's Paonta Sahib site, in June 2008, revealed noncompliance with WHO good manufacturing practices standards.
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Further, India's business daily Mint quoted the Canadian health ministry as saying a

"regulatory letter" was sent to Ranbaxy Pharmaceuticals Canada requesting an action plan and a response to the FDA's move.
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Impending healthcare reforms in Romania, Ranbaxy's largest market in the EU, is leading to a delay

in the government's product and price approval list, and adding to uncertainty amongst customers and

suppliers.

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The outcome of these regulatory issues pose a risk to the company's image as global generic player as

well a risk to its markets worldwide.

Competition
The pharmaceutical industry is characterized by rapid advances in scientific knowledge. The industry is therefore led by large manufacturers and marketers of drugs investing heavily in research & development, having clinical testing, marketing and distribution capabilities.[20] Some of Ranbaxy's main competitors are:

Sun Pharmaceuticals Industries is No. 1 in India in specialty therapy areas like psychiatry, neurology, cardiology, gastroenterology, diabetology and respiratory.
[21]

. It has brands in 30 markets worldwide and also has

a generic presence in the U.S. with Caraco Pharm Labs, Sun Pharmaceutical Industries Inc (subsidiary).[21] Cipla is a leader in the domestic retail pharmaceutical market.[22] It also exports raw materials, intermediates, prescription drugs, over-the-counter products, and veterinary products to some 180 countries around the world.[22]

GlaxoSmithKline is one of the oldest pharma companies in India and with a turnover of Rs. 1500 crore is one of the market leaders in India with a share of 6.2%. and pain management drugs.[24]
[23]

Its main portfolios consist of anti- infectives, dermatologicals

Dr. Reddy's Laboratories is a global pharmaceutical company with its headquarters in India and a presence in more than 100 countries.[25] In India it the largest drug maker by sales.[26]