Acorda reports fourth quarter net revenue of $133.1 million for full year ended December 31, 2010

Acorda TherapeuticsFeb 17 2011

Acorda Therapeutics, Inc. today announced its financial results for the fourth quarter and full year ended December 31, 2010.

"In just its first ten months since launch, approximately 40,000 people, or 10% of the MS population in the United States, received a prescription for AMPYRA. This reflects the enormous medical need for a medication to improve walking in people with MS, one of the most pervasive and worrying disabilities associated with this condition," said Ron Cohen, M.D., Acorda Therapeutics' President and CEO. "AMPYRA's success in 2010 provides us with a solid base to continue to build this business in 2011."

Financial Results

AMPYRA^® (dalfampridine) Extended Release Tablets, 10 mg net revenue - For the quarter ended December 31, 2010, the Company reported AMPYRA net revenue of $52.3 million. For the full year ended December 31, 2010, the Company reported net revenue of $133.1 million. Acorda began shipping AMPYRA to specialty pharmacies on March 1, 2010. AMPYRA revenue is recognized following shipment of the product from the Company's distribution facility to its network of specialty pharmacies.

ZANAFLEX CAPSULES^® (tizanidine hydrochloride) and ZANAFLEX^® (tizanidine hydrochloride) tablets net revenue - For the quarter ended December 31, 2010, the Company reported combined net revenue of ZANAFLEX CAPSULES and ZANAFLEX tablets of $12.1 million, compared to combined net revenue of $12.1 million for the same quarter in 2009. For the full year ended December 31, 2010, the Company reported combined net revenue of ZANAFLEX CAPSULES and ZANAFLEX tablets of $48.5 million, compared to combined net revenue of $50.0 million in 2009.

ZANAFLEX revenue is recognized using a deferred revenue recognition model, meaning ZANAFLEX CAPSULES and ZANAFLEX tablets shipments to wholesalers are recorded as deferred revenue and only recognized as revenue when end-user prescriptions of ZANAFLEX CAPSULES and ZANAFLEX tablets are reported.

ZANAFLEX CAPSULES and ZANAFLEX tablets shipments - Total ZANAFLEX CAPSULES and ZANAFLEX tablets shipments for the quarter ended December 31, 2010 were $15.8 million, compared to total shipments of $18.4 million for the same quarter in 2009. For the full year ended December 31, 2010, total ZANAFLEX CAPSULES and ZANAFLEX tablet shipments were $57.3 million, compared to total shipments of $66.7 million in 2009.

Research and development expenses for the quarter ended December 31, 2010 were $8.0 million, including $1.6 million of share-based compensation, compared to $10.6 million including $1.1 million of share-based compensation for the same quarter in 2009. Research and development expenses for the full year ended December 31, 2010 were $30.6 million, including $5.3 million of share-based compensation, compared to $34.6 million including $3.7 million of share-based compensation in 2009. Research and development expenses for the full year ended December 31, 2010 included costs related to AMPYRA post-marketing studies, clinical costs associated with the close-out of the Company's MS extension study sites, launch stock inventory received prior to regulatory approval and the development of the Company's pipeline products, including the initiation of a Phase 1 clinical trial for Glial Growth Factor 2 (GGF2).

Sales, general and administrative expenses for the quarter ended December 31, 2010 were $41.8 million, including $3.6 million of share-based compensation, compared to $22.9 million including $2.3 million of share-based compensation for the same quarter in 2009. Sales, general and administrative expenses for the full year ended December 31, 2010 were $133.3 million, including $12.5 million of share-based compensation, compared to $90.3 million including $8.6 million of share-based compensation in 2009. The increase in expenses was primarily due to increases in AMPYRA launch activities.

The Company reported net income of $3.7 million for the quarter ended December 31, 2010, or $0.10 per basic EPS and $0.09 per diluted EPS, compared to a net loss of $22.5 million, or $0.59 per basic and diluted EPS for the same quarter in 2009. The Company reported a net loss of $11.8 million for the full year ended December 31, 2010, or $0.31 per basic and diluted EPS, compared to a net loss of $83.9 million, or $2.22 per basic and diluted EPS, in 2009.

As of December 31, 2010, Acorda held cash, cash equivalents and short-term investments of $240.0 million.

AMPYRA Update

• As of December 31, 2010, approximately 40,000 people with MS have filled a prescription for AMPYRA, representing approximately 10% of all MS patients in the United States.
• Approximately 7,000 healthcare professionals had written at least one prescription for AMPYRA as of December 31, 2010.
• As part of its post-marketing commitment to the U.S. Food and Drug Administration (FDA), the Company has initiated a clinical trial of a 5 mg tablet, as well as a renal impairment trial.
• The Company is currently working with external formulation companies to develop a once-daily formulation of AMPYRA.
• New clinical data analyses on AMPYRA will be presented at the upcoming American Academy of Neurology (AAN) meeting in April 2011.
• On January 21, 2011 Biogen Idec announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) decided against approval of FAMPYRA^® (prolonged-release fampridine 10 mg tablets) to improve walking ability in adult patients with multiple sclerosis (MS). Biogen Idec is appealing for a re-examination of the decision by the CHMP.

ZANAFLEX CAPSULES and ZANAFLEX Tablets Franchise

• Under the terms of the Paul Royalty Fund (PRF) agreement, the Company paid the second of two $5.0 million payments to PRF in December 2010.
• The litigation against Apotex Inc. in connection with its application for approval of a generic version of ZANFLEX CAPSULES continues to proceed, and a trial date has been set for April 25, 2011.

Pipeline

• Acorda initiated a single dose Phase 1 clinical trial for Glial Growth Factor 2 (GGF2) in patients with heart failure. Preclinical studies demonstrate that GGF2 acts directly to repair cardiac muscle and improve its contractile function, and may offer a unique therapeutic option for treatment of the disease.
• The Company's remyelinating antibody, rHIgM22, has completed GMP manufacturing and pilot toxicology studies. GLP toxicology studies are ongoing, and if results are acceptable the Company expects to file an Investigational New Drug (IND) application.

Guidance for 2011

• The Company currently expects AMPYRA full year net revenue to increase to $205-$230 million.
• Sales, general and administrative (SG&A) expenses for the full year 2011 are currently expected to be $130-$140 million excluding share based compensation charges. SG&A will be primarily driven by commercial and administrative costs related to AMPYRA.
• Research and development (R&D) expenses for the full year 2011 are currently expected to be $40-$45 million excluding share based compensation charges. R&D expenses in 2011 include post-marketing studies for AMPYRA and continuing development expenses for our pipeline products, including Phase 1 clinical trials for GGF2.