Acorda Therapeutics (ACOR) Provides Prelim. Q4, FY15 AMPYRA Sales Results; Guides FY16 Sales

Acorda Therapeutics, Inc. (Nasdaq:ACOR) reported AMPYRA (dalfampridine) Extended Release Tablets, 10 mg unaudited net sales for the fourth quarter of 2015 of $121 million. Unaudited 2015 full-year net sales were $436 million, an increase of approximately 19% from 2014. Final results are subject to completion of the Company’s year-end audit.

*** The Street is looking for total Q4 revenue of $126.5 million and FY15 revenue of $485.8 million.

“We expect a series of important clinical milestones in 2016 for all three of our late-stage programs,” said Ron Cohen, President and CEO of Acorda. “We are aiming to complete pivotal trials for CVT-301 in Parkinson’s disease and PLUMIAZ in seizure clusters this year; if successful, we plan to file New Drug Applications for both in 2017. We project that these two therapies could generate combined peak sales of over $700 million. We also expect to perform an interim analysis in our Phase 3 trial of dalfampridine for post-stroke walking deficits. This analysis, combined with results from our development efforts on a once-daily formulation of dalfampridine, will establish the next steps for the program.”

Dr. Cohen continued, “AMPYRA’s growth in 2015 allowed us to remain cash flow positive while still investing in our late stage pipeline. We expect to remain active on the business development front, focusing on late stage or marketed products that leverage the strength of our neurology development and commercial capabilities.”

The Company provided 2016 guidance for AMPYRA net revenue of $475-$485 million, research and development (R&D) expense of $165-$175 million, and sales, general and administrative (SG&A) expense of $195-$205 million. This guidance excludes share-based compensation.

At year-end 2015, the Company had cash, cash equivalents and investments of $353 million (unaudited).

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