Acorda Therapeutics (ACOR) Prelim. AMPYRA Sales Rose 21% in 2014

Acorda Therapeutics (NASDAQ: ACOR) announced that AMPYRA (dalfampridine) Extended Release Tablets, 10 mg unaudited net sales for the fourth quarter of 2014 were $109 million, and unaudited AMPYRA 2014 full-year net sales were $366 million, an increase of approximately 21% from 2013. Final results are subject to completion of the Company’s year-end audit.

“We were very pleased with AMPYRA’s 2014 net sales, and our 2015 guidance of $405-$420 million reflects our confidence in the continued growth of the brand,” said Ron Cohen, M.D., Acorda’s President and CEO. “We believe the strength of the franchise demonstrates outstanding execution by our commercial, sales and medical education teams, and the growing acceptance of AMPYRA as a standard of care in MS.”

Dr. Cohen added, “We added substantial value to our pipeline and capabilities in 2014 with the acquisition of CVT-301 and the ARCUS technology. We are now entering 2015 with two active Phase 3 programs. CVT-301 is being developed for people with Parkinson’s disease who experience OFF episodes, which include impaired ability to move, muscle stiffness and tremor. Dalfampridine is being developed for people with chronic post-stroke walking deficits, which affect approximately 3.5 million people in the U.S. alone.”

The Company provided 2015 operating expense guidance of $150-$160 million for R&D expense and $180-$190 million for SG&A expense. This guidance excludes share-based compensation and certain non-cash expenses related to the Civitas acquisition.

Michael Rogers, Acorda’s Chief Financial Officer, said, “Our increased R&D budget for 2015 is primarily related to our two Phase 3 programs, as well as the advancement of our earlier stage clinical programs. It also includes the manufacturing plant and R&D operations of our new Chelsea, Massachusetts location. Given our increasing R&D investment needs, we are setting a high priority on managing SG&A costs in 2015. Despite the added infrastructure accompanying our acquisition of Civitas, SG&A guidance for 2015 remains the same as for 2014. We expect to remain cash flow positive in 2015.”

Following the acquisition of Civitas Therapeutics, the Company announced that it was evaluating and prioritizing its clinical stage pipeline. As a result, Acorda is deferring further development of NP-1998 for neuropathic pain in 2015. The Company is continuing to work with the FDA to define the additional clinical work necessary for the approval of PLUMIAZ™ (diazepam) Nasal Spray.

Dr. Cohen will provide a corporate overview at the 33rd Annual J.P. Morgan Healthcare Conference today at 11:00 a.m. Pacific Time in San Francisco. The presentation is available via webcast at www.acorda.com.

This press release includes certain forward-looking financial measures that were not prepared in accordance with accounting principles generally accepted in the United States (GAAP). Non-GAAP financial measures are not an alternative for financial measures prepared in accordance with GAAP. However, the Company believes the presentation of these non-GAAP financial measures when viewed in conjunction with our GAAP results, provide investors with a more meaningful understanding of our ongoing and projected operating performance. The Company believes these non-GAAP financial measures help indicate underlying trends in the company's business and are important in understanding projected operating performance.

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