|View printer-friendly version|
|Acorda Therapeutics Reports Fourth Quarter and Full Year 2010 Financial Results|
HAWTHORNE, N.Y., Feb 17, 2011 (BUSINESS WIRE) -- Acorda Therapeutics, Inc. (Nasdaq: ACOR) 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."
AMPYRA(R) (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(R) (tizanidine hydrochloride) and ZANAFLEX(R) (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.
ZANAFLEX CAPSULES and ZANAFLEX Tablets Franchise
Guidance for 2011
Webcast and Conference Call
Ron Cohen, President and Chief Executive Officer and David Lawrence, Chief Financial Officer will host a conference call today at 8:30 a.m. ET to review the Company's fourth quarter and full year 2010 results.
To participate in the conference call, please dial 866-783-2138 (domestic) or 857-350-1597 (international) and reference the access code 85537670. The presentation will be available via a live webcast at:
A replay of the call will be available from 11:30 a.m. ET on February 17, 2011 until midnight on March 17, 2011. To access the replay, please dial 888-286-8010 (domestic) or 617-801-6888 (international) and reference the access code 24273931. The archived webcast will be available for 30 days in the Investor Events section of the Acorda website at www.acorda.com.
Important Safety Information
AMPYRA can cause seizures; the risk of seizures increases with increasing AMPYRA doses. AMPYRA is contraindicated in patients with a prior history of seizure. Discontinue AMPYRA use if seizure occurs.
AMPYRA is contraindicated in patients with moderate or severe renal impairment (CrClless-than or equal to 50 mL/min); the risk of seizures in patients with mild renal impairment (CrCl 51-80 mL/min) is unknown, but AMPYRA plasma levels in these patients may approach those seen at a dose of 15 mg twice daily, a dose that may be associated with an increased risk of seizures; estimated CrCl should be known before initiating treatment with AMPYRA.
AMPYRA should not be taken with other forms of 4-aminopyridine (4-AP, fampridine), since the active ingredient is the same.
Urinary tract infections were reported more frequently as adverse reactions in patients receiving AMPYRA 10 mg twice daily compared to placebo.
The most common adverse events (incidence greater-than or equal to 2% and at a rate greater than the placebo rate) for AMPYRA in MS patients were urinary tract infection, insomnia, dizziness, headache, nausea, asthenia, back pain, balance disorder, multiple sclerosis relapse, paresthesia, nasopharyngitis, constipation, dyspepsia, and pharyngolaryngeal pain.
For full U.S. Prescribing Information and Medication Guide for AMPYRA, please visit: www.AMPYRA.com.
About AMPYRA (dalfampridine)
AMPYRA is a potassium channel blocker approved as a treatment to improve walking in patients with multiple sclerosis (MS). This was demonstrated by an increase in walking speed. AMPYRA, which was previously referred to as Fampridine-SR, is an extended release tablet formulation of dalfampridine (4-aminopyridine, 4-AP), which was previously called fampridine, and remains known by that name outside the US. In laboratory studies, dalfampridine has been found to improve impulse conduction in nerve fibers in which the insulating layer, called myelin, has been damaged. AMPYRA is being developed and commercialized in the United States by Acorda Therapeutics, and by Biogen Idec in markets outside the U.S. based on a licensing agreement with Acorda. AMPYRA is manufactured globally by Elan based on a supply agreement with Acorda.
AMPYRA is now available by prescription in the United States. For more information about AMPYRA, including patient assistance and co-pay programs, healthcare professionals and people with MS can contact AMPYRA Patient Support Services at 888-881-1918.
AMPYRA Patient Support Services is available Monday through Friday, from 8:00 a.m. to 8:00 p.m. Eastern Time at 888-881-1918. For full U.S. Prescribing Information and Medication Guide, please visit: www.AMPYRA.com.
About Acorda Therapeutics
Acorda Therapeutics is a biotechnology company developing therapies for multiple sclerosis, spinal cord injury and related nervous system disorders. The Company is commercializing and marketing AMPYRA(R) (dalfampridine) Extended Release Tablets, 10 mg, in the Unites States. AMPYRA is a potassium channel blocker approved as a treatment to improve walking in patients with multiple sclerosis (MS); this was demonstrated by an improvement in walking speed. AMPYRA was developed using Elan's Matrix Drug Absorption System (MXDAS(R)) technology and is manufactured by Elan based on a supply agreement with Acorda.
Acorda also markets ZANAFLEX CAPSULES(R) (tizanidine hydrochloride), a short-acting drug for the management of spasticity. The Company's pipeline includes a number of products in development for the treatment, regeneration and repair of the spinal cord and brain.
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, regarding management's expectations, beliefs, goals, plans or prospects should be considered forward-looking. These statements are subject to risks and uncertainties that could cause actual results to differ materially, including Acorda Therapeutics' ability to successfully market and sell Ampyra in the United States and to successfully market Zanaflex Capsules; third party payors (including governmental agencies) may not reimburse for the use of Ampyra at acceptable rates or at all and may impose restrictive prior authorization requirements that limit or block prescriptions; the risk of unfavorable results from future studies of Ampyra; the occurrence of adverse safety events with our products; delays in obtaining or failure to obtain regulatory approval of Ampyra outside of the United States and our dependence on our collaboration partner Biogen Idec in connection therewith; competition; failure to protect Acorda Therapeutics' intellectual property or to defend against the intellectual property claims of others; the ability to obtain additional financing to support Acorda Therapeutics' operations; and, unfavorable results from our preclinical programs. These and other risks are described in greater detail in Acorda Therapeutics' filings with the Securities and Exchange Commission. Acorda Therapeutics may not actually achieve the goals or plans described in its forward-looking statements, and investors should not place undue reliance on these statements. Forward-looking statements made in this release are made only as of the date hereof, and Acorda Therapeutics disclaims any intent or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.
SOURCE: Acorda Therapeutics, Inc.