The Quarter in Detail
The bulk of net product revenues at Acorda came from Ampyra, which generated $92.4 million in the reported quarter, up 27% from the year-ago period. Ampyra revenues, however, declined 15.9% on a sequential basis.
Acorda is currently facing several patent challenges from generic companies looking to bring their generic versions of Ampyra to market. The trial is scheduled for Sep 2016. Acorda is also working on preparing responses for the two inter partes review (IPR) petitions.
Ampyra is marketed in ex-U.S. markets under the trade name Fampyra by Biogen BIIB. Fampyra royalties slipped 4.2% from the year-ago period to $2.3 million.
Zanaflex capsules and tablets recorded revenues of $2.6 million in the first quarter of 2015, down 16.1% from the year-ago period.
Acorda’s research and development (R&D) expenses increased 111% to $30.6 million. Selling, general and administrative (SG&A) expenses came in at $48.8 million, up 4.1% from the year-ago period.
Acorda continues to expect 2015 Ampyra revenues in the range of $405 million to $420 million.
The company continues to expect R&D spend of $150 million – $160 million and SG&A spend of $180 million – $190 million. Higher R&D spend reflects investment in phase III studies on dalfampridine and CVT-301.
Acorda is currently evaluating a twice-daily formulation of Ampyra in a phase III study for post-stroke deficits. Additionally, Acorda expects to start a second phase I study on rHIgM22 for remyelination in multiple sclerosis (MS) in the second quarter.
Acorda is also enrolling patients in the phase III study on CVT-301 for relief of OFF episodes in Parkinson’s disease (PD) patients.
Meanwhile, an update on Plumiaz nasal spray for the treatment of patients with epilepsy who experience cluster seizures should be out within a month. The company had received a complete response letter (CRL) for Plumiaz last year.
Acorda’s first quarter results were mixed with the company missing on the bottom-line but surpassing revenue expectations. Ampyra sales were, however, down on a sequential basis. With Ampyra facing several patent challenges, focus increases on the company’s pipeline development efforts and ability to bring new products to market. The Ampyra patent challenge situation will remain an overhang with a trial scheduled for Sep 2016.