Acorda's third quarter results were better-than-expected with
Ampyra sales picking up. Earnings of $0.34 per share surpassed the
Zacks Consensus Estimate of $0.04 by a wide margin and the year-ago
earnings of $0.20. Revenues increased 24.8% to $105.9 million,
surpassing the Zacks Consensus Estimate of $95 million. We expect
Acorda to expand its pipeline and product portfolio through
in-licensing deals and product acquisitions. While we are positive
on the company's plans to reprioritize its pipeline, the CRL for
Plumiaz was disappointing and we remain concerned about the patent
challenges from several companies looking to launch their generic
versions of Ampyra. We remain Neutral on the stock. Investor focus
will remain on the company's plans for its pipeline which should be
out in January.
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
The company's lead marketed product is Ampyra (dalfampridine),
which was approved by the 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 to commence by year end).
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 has rights
to Qutenza in the EU and other markets.
Pipeline candidates include glial growth factor 2 (GGF2 second
phase I study ongoing for chronic heart failure with results due in
the second half of 2015) and rHIgM22 (treatment of MS phase I
ongoing with results due in early 2015). 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
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%. 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).
Acorda Therapeutics, Inc. (ACOR): Read the Full
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