Acorda Therapeutics (NYSE: ACOR) is a biotechnology company specializing in therapies designed to improve the quality of life for multiple sclerosis (MS) patients. The company has two major products currently approved for sale. Acorda launched Zanaflex capsules in 2005 to relieve spasms in MS patients, and received FDA approval for Ampyra in 2010 to improve walking in MS patients. Ampyra is currently Acorda's biggest revenue generator, with $141 million in 2010 sales.
Ampyra is the driver of Acorda's revenue for the near-term future, and its sales growth as it ramps up to its peak potential will significantly impact Acorda's value. In addition, Acorda is pursuing patent extension opportunities that could protect it from generic competition for the next decade.
In 2010, revenue growth was driven by the approval of Ampyra by the FDA to improve walking in adults with multiple sclerosis (MS). In 2010, its first year of commercial sales, Ampyra earned $141 million in revenue. Acorda's other major drug, Zanaflex, which is used to relieve spasms in MS patients, earned $55 million, a decrease of 6%. For 2011, Acorda expects net revenue to increase to $205-230 million.
The FDA approval of Ampyra to treat MS has transformed Acorda's business. As sales for Ampryria ramp up to the $871 million that analysts expect for 2015, these sales will make up the vast majority of Acorda revenue. In 2010, Ampyra garnered $141 million in sales and analysts expect as much as $230 million in sales for 2011. How Acorda ramps up sales of Ampyra and where peak sales fall relative to analyst estimates will impact Acorda's valuation.
As a treatment for a rare disease, Ampyra has been granted 7 years of "Orphan Drug" exclusivity by the FDA for the treatment of MS. However, the major patents for Ampyra, which are necessary to prevent competitors from developing the drug for other disease markets, expire in 2011 and 2013. In 2010, Acorda applied for extensions on the patents, which would grant the company 5 additional years of exclusivity. Acorda's ability to gain these extensions will impact its ability to prevent competition in markets outside of the MS field.
There are currently no generic versions of Ampyra, and FDA Orphan Drug regulations will prevent competition from entering the MS market until at least 2017.