Founded by 2 Gujaratis, US drug major Amneal eyes speciality biz in India

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Two Indian-American brothers hailing from Gujarat, Chirag and Chintu Patel, have built a $1.8-billion drug major Amneal Pharmaceuticals in the US from scratch in around a decade and a half. After its recent merger with Impax Laboratories last month, the combined entity, with revenues of $1.75-1.85 billion, is close to pipping Indian giant Sun Pharmaceutical ($2 billion revenue in 2016-17) as the fifth-largest generics maker in the US. Amneal expects revenues to touch $2.6 billion by 2020.  

The brothers, who spent the first two decades of their lives among a 45-member joint family in India, are, however, cautious about entering the Indian market. "The Indian generics market is already crowded with affordable drugs. For us, competing with already established companies here will be difficult. We want to bring in technology-led innovative drugs that will target unmet medical needs in India like sickle cell anaemia or some niche oncology product," said Chirag Patel, co-chief executive officer, co-chairman, and co-founder of Amneal. The company already has six sites in India – four for formulations and two for active pharmaceutical ingredients (APIs) – in Gujarat, Telangana, and Andhra Pradesh that supply to the US and European markets. 

Amneal plans to enter India with speciality drugs three or four years from now. However, whenever it does enter, it will set up its own network in the country. It has been investing 20 per cent of its turnover in research and development (R&D), amounting to around $1 billion in the past five years. It will now focus on complex generics, biologics, and hospital products. 

The journey began when the Patel family migrated to the US in 1987. Kanu Patel, the father, was an industrial pharmacist by training who worked as a drug regulatory inspector in India. "We came to the US with nothing. We started working from Day 1 and continued to study," Chintu Patel says. Both brothers agree that the education and business environment in the US fosters and rewards the entrepreneurial spirit. Chirag began his business pursuits with technology start-ups while Chintu followed in his father's footsteps as a pharmacist. 

During his time as a pharmacist, generic substitution rates were less than 40 per cent in the US and Chintu witnessed first-hand the struggle patients had in choosing between buying food and medicine. Amneal was born sensing this need gap for affordable medicines and is now one of the fastest growing global generics players in the world with more than 160 US Food and Drug Administration approvals for marketing generic drugs. 

With capital from the principals of private investment group Tarsadia Investments and more than 10 merger and acquisition deals since 2007 (see chart), Amneal is rapidly growing to be the fifth-largest US generics pharmaceutical company by prescription volume, with 5,000 employees in North America, Europe, and Asia. 

Sun Pharma had clocked revenues of $2 billion in 2016-17 but the Street expects its 2017-18 revenues to be lower given the headwinds it is facing in the US market. The combined gross revenues of Amneal and Impax have thus edged past Sun Pharma's revenues in the US. 

In October this year, the New Jersey-based privately-held generics maker Amneal merged with California-based Impax in an all-stock deal. Amneal will own 75 per cent and Impax shareholders will own 25 per cent of the combined entity that will retain the name Amneal Pharmaceuticals. 

As a result of the merger, the combined entity is expected to generate $200 million in cost savings per year. Amneal will not only pare debt, but the combined entity now has one of the largest pipelines in the US with approximately 165 products in active stages of development and around 150 pending abbreviated new drug applications (ANDAs). Most of the pipeline products are first-to-file opportunities that will face limited competition in the market at the time of launch. 

The Patel brothers have exhibited astute business sense, be it in acquiring ANDAs from Merck, investing heavily in R&D, or in developing low-cost manufacturing bases in India. The company has chosen the inorganic route to grow at a rapid pace. Now that it is looking at the China and India markets over the medium term, the next leg of growth for Amneal is set to unfold. 


Timeline:

2002: Amneal Founded

2005: Manufactures first Rx product and files first ANDA

2006: First ANDA approved

2007: Acquires ANDAs from Merck. Acquires ANDAs and facility from KVD. Acquires Akyma and launches Amneal label

2008: Acquires InterPharm and opens India R&D centre

2009: Becomes 12th largest generics company in the US (in TRx) 

2010: Opens consolidated, expanded distribution & sales operations in Glasgow, Kentucky. Acquires manufacturing facility in Piscataway, New Jersey

2011: Acquires packaging facility in East Hanover, New Jersey. Becomes the 7th largest generics company in the US (in TRx)

2012: US FDA approves new API and FDF facilities in India 

2013: Acquires 1,000+ MAs from Pfizer. Acquires assets from Actavis and Warner Chilcott. Acquires 60% of Creo Pharma

2014: Acquires CoPharma, Pharmagenus, and Bioeq. Opens international HQ

2015: Acquires Actavis Australia, Epsilon India, and inhalation manufacturing site in Ireland

2016: Adds distribution facility in Glasgow, Kentucky 

2017: Completes expansion of both New York manufacturing facilities. Divests Amneal Australia operation. Divests CoPharma and Pharmagenus.