Acorda Therapeutics, Inc. (ACOR): New Analyst Report from Zacks Equity Research - Zacks Equity Research Report

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Summary:
Acorda's first quarter results were mixed with the company missing on earnings but beating on revenues. First quarter earnings came in at $0.02 per share, below the Zacks Consensus Estimate of $0.04 but better than the year-ago loss of $0.03 per share. Total revenues for the quarter were $80.5 million, up 12.0% from the year-ago quarter and above the Zacks Consensus Estimate of $79.0 million. Ampyra is expected to grow modestly in 2014 with a price increase driving growth. Meanwhile, we were disappointed about the CRL for Plumiaz. Acorda is also facing a delay in the commencement of its phase III study for a once daily formulation of Ampyra. Given the lack of near-term catalysts, we remain Neutral on the stock.

Overview:

Ardsley, NY based Acorda Therapeutics, Inc. is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel treatments that improve neurological function in people suffering from multiple sclerosis (MS), spinal cord injury (SCI) and other nervous system disorders.

The company's lead marketed product is Ampyra (dalfampridine), which was approved by the U.S. Food and Drug Administration (FDA) in Jan 2010 for the improvement of walking in MS patients. Ampyra is available outside the U.S. under the trade name Fampyra. Acorda has a license and collaboration agreement with Biogen Idec for the development and commercialization of Fampyra outside the U.S. Fampyra is approved in the EU, Canada, Australia, Israel and New Zealand. Biogen has launched Fampyra in a number of EU countries.

Ampyra is being studied for other indications as well including post-stroke deficits (phase III study to commence in the second half of 2014).

The second marketed product at Acorda is Zanaflex (capsules and tablets), approved by the FDA for spasticity. However, Zanaflex is facing generic competition.

Acorda's third marketed product is Qutenza, which was acquired from NeurogesX, Inc. Quenteza is approved for the treatment of postherpetic neuralgia. Astellas Pharmaceuticals Europe, which has rights to Qutenza in the EU and other markets, is currently evaluating Qutenza in painful diabetic neuropathy. The study is expected to finish this year.

Pipeline candidates include glial growth factor 2 (GGF2 second phase I study ongoing for chronic heart failure with results due in 2015), rHIgM22 (treatment of MS phase I ongoing with results due in 2015), and AC105 (spinal cord injury phase II study ongoing). Acorda is also working on evaluating the use of chondroitinases for the treatment of brain and spinal cord injuries and neurotraumatic indications. GGF2 has fast track designation in the U.S. for the treatment of heart failure.

In Dec 2012, Acorda acquired privately-held Neuronex, Inc. The acquisition of Neuronex added Plumiaz (proposed trade name of diazepam nasal spray) to Acorda's neurology pipeline. Acorda had filed a 505(b)(2) type NDA for Plumiaz for the management of seizure in certain epilepsy patients. However, the FDA issued a complete response letter (CRL).

In Jul 2013, Acorda added two neuropathic pain management assets to its portfolio. The company acquired these assets, Qutenza and NP-1998, from NeurogesX. NP-1998 is a phase III ready product for treating patients suffering from neuropathic pain.

Acorda recorded total revenues of $336.4 million in 2013, up 10.0%. Revenues consisted of product sales of $310.3 million, and royalty (ex- U.S. sales of Fampyra) and license revenues (recognition of the upfront payment received from Biogen in 2009) of $17.1 million and $9.1 million, respectively. Royalty received from Actavis, Inc. for the sale of authorized generic Zanaflex capsules ($7.8 million) was also included in revenues. Ampyra net revenues in 2013 were $302.6 million, up approximately 13.7%. Zanaflex capsules and tablets generated revenues of $15.1 million in 2013 (including $3.2 million sold to Actavis).


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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of The NASDAQ OMX Group, Inc.



This article appears in: Investing , Stocks

Referenced Stocks: MS , SCI , CRL , ACOR

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