Acorda Therapeutics, Inc. (Nasdaq:
) today announced that AMPYRA
(dalfampridine) Extended Release Tablets, 10 mg unaudited net sales for the fourth quarter of 2013 were $84 million, and unaudited AMPYRA 2013 full-year net sales were $302 million. These results are preliminary and subject to completion of the Company’s year-end audit.
The Company provided 2014 guidance for AMPYRA net sales revenue of $328-$335 million. In prior years, AMPYRA sales have been variable between quarters, with the first quarter lower than subsequent quarters. AMPYRA has Orphan Drug Status until January 2017, and a broad patent portfolio that extends exclusivity in the United States until 2027.
The Company also provided operating expense guidance for 2014. This guidance excludes share-based compensation and costs associated with expenditures related to the potential acquisition of new products or other business development activities. Guidance for research and development (R&D) expense is $60-$70 million and sales, general and administrative (SG&A) expense is $180-$190 million. R&D expense is increasing based on advances in the Company’s pipeline. In 2014, the Company expects to support at least four clinical trial programs for products in various stages of development. SG&A expense in 2014 includes commercialization expenses for Diazepam Nasal Spray.
“More than 85,000 people with multiple sclerosis have tried AMPYRA since launch, and thousands have experienced improvement in their walking. The success of this valuable contribution to the treatment of MS has also supported our investment in developing new neurological therapies. We now have five active clinical programs, including one exploring the use of AMPYRA in a new indication,” said Ron Cohen, M.D., Acorda’s President and CEO. “This year, we plan to initiate a Phase 3 trial of a once-daily formulation of dalfampridine in post-stroke deficits. We are also preparing for the potential commercial launch of Diazepam Nasal Spray, a treatment for people with epilepsy who experience cluster seizures. Our commercial success, together with a deep pipeline and strong balance sheet, are positioning Acorda for long-term growth.”