2012 Generics Revenue: $5.95 billion
Before taking the CEO role at Mylan ($MYL), Heather Bresch led the integration of Matrix Laboratories and Merck KGaA's generics business. The experience seems to have prepped her well to lead Mylan, which has been an active dealmaker under her guidance.
Bresch's latest deal is the $1.6 billion buyout of Agila Specialties, the specialty injectables unit of India's Strides Arcolab. The deal will make Mylan one of the world's largest producers of sterile injectables, which treat diseases from heart disease to cancer. It took the company some maneuvering to get the transaction moving forward, however. Indian officials worried that Mylan might stop producing some of Agila's low-cost drugs for the domestic market, so Mylan pledged to maintain current production levels of essential treatments for the next 5 years. All Mylan has to do now, the U.S. Federal Trade Commission says, is sell off 11 injectable drugs in markets where the deal might hurt competition.
When that deal closes, Mylan will pick up 9 manufacturing facilities in India, Brazil and Poland, 8 of which the FDA has approved. It will also gain one of the largest sterile capacities in India, as well as one of the largest freeze-drying capacities worldwide. Combined, Mylan and Agila will boast more than 700 injectable products with a pipeline of 350 more -- not bad, with the generic injectables market tagged for compound growth of 13% through 2017.
Mylan reportedly explored bids for other companies, such as Elan ($ELN) and Actavis ($ACT). But the company has made some important moves outside of M&A as well, teaming up with branded drugmakers to capitalize on growth in other rapidly expanding markets. Last August, along with Ranbaxy and Strides, Mylan inked a deal with Gilead Sciences to help increase production and lower costs of its HIV-fighting drugs in developing countries. And just a couple of weeks later, it announced a partnership with Pfizer ($PFE) to produce branded generics in Japan, with up to 350 off-patent drugs in the mix. Between Pfizer's brand recognition and Mylan's manufacturing and distribution resources, the two hope to grab a major share of the world's sixth-largest generics market.
All in all, Bresch steered the company to a 7% increase in generics sales for 2012. Some of that came from new product launches, which brought in revenues of $784 million on the year. A few of those launches were especially significant. For one, Mylan rolled out the first equivalent product to Forest Laboratories' Lexapro, the blockbuster antidepressant that raked in $2.9 billion in sales the year before it went off patent. Lexapro generics hit so hard that Forest's profits fell 40% the quarter its drug lost protection. Mylan also brought to market a generic of Actos, Takeda's diabetes med.
And then there was Mylan's generic version of Novartis' ($NVS) Diovan HCT, which combines the heart drug valsartan and with a diuretic, hydrochlorothiazide. Mylan launched that product in September of last year, and in December, it was ready and waiting to hit the market with the non-combo Diovan. It challenged Ranbaxy's 180-day exclusivity period to make a copycat of the Novartis star, eager to steal a piece of revenues that had registered at $1.9 billion the year prior. But a court dismissed Mylan's plea, leaving a potential Diovan generic in Ranbaxy's hands alone--and that knockoff is still missing in action.
Mylan hopes to keep those big launches coming, and it already has its eye on at least one for 2014: a generic of Teva's ($TEVA) multiple sclerosis drug Copaxone, which scored more than $4 billion in 2012 sales. In July, an appeals court nixed a patent protecting the drug until 2015, meaning it will be up for copy next May. By the time that happens, Mylan says, its version will be ready to go.
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