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.
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 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
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).
Acorda Therapeutics, Inc. (ACOR): Read the Full
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