Big League Breakthrough

Being a copycat isn’t always such a bad thing. Generic drugmakers, whose sole mission is to clone branded drugs, are enjoying a boom thanks to outrage over some obscene price increases for branded drugs and a less bureaucratic Food and Drug Administration, which implies faster approvals of generics. Generics can cut branded drug prices as much as 80%.

ANI Pharmaceuticals (NSDQ: ANIP), a small but sophisticated generic manufacturer, is an expert at copying hard-to-make branded drugs. Its revenue grew 55% in the first nine months of 2016 and is expected to increase 65% by 2018 when ANI introduces a copy of a popular drug, Acthar, and launches itself into the big leagues. Acthar, a corticotrophin gel made by Mallinckrodt Pharmaceuticals, has a $1 billion annual market. A growing list of new generic launches plus sales from this drug will propel ANI’s earnings 33% in 2018.

Target: $100

Buy ANI Pharmaceuticals up to $72.

Making generic drugs isn’t easy. First, you face a slew of competitors toiling in their labs, preparing for the day that the patent on a branded drug expires. A generic market can get crowded quickly, which means prices can drop precipitously once two or three companies win approval to sell a generic version of the same drug.

So the trick is to minimize competition by picking hard-to-replicate drugs to copy. ANI’s list of generics includes controlled substances, hormones, steroids and complex formulations of extended-release drugs.

This expertise is crucial for making a generic version of Acthar, a steroid gel that has managed to avoid generic competition for more than 60 years. The drug, made from the pituitary gland of pigs, was first approved by the FDA in 1952 and has been prescribed only for rare instances of a condition known as infantile spasms. Recent approvals extend Acthar’s use to treating multiple sclerosis.

The price of Acthar has skyrocketed from $1,600 per dose to more than $38,000, making it the poster child of price hike abuse. Other generic drug manufacturers have shied away from the challenge of producing this drug, but ANI is making steady progress.

ANI bought the rights to the generic corticotrophin from Merck in January 2016 and has secured enough pig pituitary glands for commercial scale production, a necessary step toward FDA approval. On its third-quarter conference call in October, management noted the company is ahead of its own internal timeline for getting a generic Acthar approved.

As a point of reference, ANI sells about $130 million in generic drugs in a year. So capturing just a portion of the $1 billion in branded Acthar sales should make for healthy profits.

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