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Acorda Therapeutics Inc. (ACOR - Analyst Report) reported third quarter earnings (including share-based compensation charges but excluding other special items) of 24 cents per share, below the year-ago earnings of 28 cents but well above the Zacks Consensus Estimate of 12 cents per share.
Quarterly revenues fell 16.8% to $77.4 million, beating the Zacks Consensus Estimate of $76 million.
Quarter in Detail
Bulk of the net product revenues at Acorda came from Ampyra sales. Ampyra sales came in at $69.8 million, reflecting a year-over-year increase of 28%. Ampyra revenues also increased 5% on a sequential basis.
Acorda has a licensing agreement with Biogen Idec (BIIB - Analyst Report) for the development and commercialization of Ampyra outside the US. In July 2011, Biogen received conditional approval for Fampyra (ex-US trade name of Ampyra) in the EU, as a treatment for improved walking in adult patients with multiple sclerosis.
Fampyra royalties on ex-US sales were $1.5 million in the reported quarter, in comparison to $0.3 million a year-ago. Acorda also has a supply agreement with Elan Corporation (ELN - Snapshot Report) for manufacturing Ampyra.
Zanaflex capsules and tablets recorded sales of $1.9 million in the third quarter, down 82.2%. We note that, in February 2012, Acorda launched an authorized generic version of Zanaflex in collaboration with Watson Pharmaceuticals.
While revenues from the sale of the authorized generic version of Zanaflex were $0.5 million, royalties from Watson Pharma for the sale of the authorized generic version amounted to $1.4 million.
Acorda’s research and development (R&D) expenses increased 32.4% to $12.0 million. The increase was attributable to Acorda’s efforts to develop its pipeline. Selling, general and administrative (SG&A) expenses came in at $40.1 million, up 15.6 % from the year-ago period.
Guidance for 2012
Acorda maintained its Ampyra revenue guidance of $255 million - $275 million. The company continues to expect combined royalty revenues from the Zanaflex franchise and Fampyra sales in ex-US markets of at least $25 million.
Acorda also reiterated its SG&A expense guidance. SG&A spending is forecast in the range of $145-$160 million. The guidance excludes stock-based compensation expenses.
The company lowered its R&D spending guidance, which is expected to be approximately $45 million (previous guidance: $50 million - $60 million) in 2012. The guidance excludes stock-based compensation expenses.
In August 2012, Acorda announced results from a post-marketing commitment study evaluating a 5 mg dose of Ampyra for improvement in walking in patients suffering from multiple sclerosis (MS). The study failed to meet the primary endpoint.
The company is also evaluating safety and efficacy of Ampyra in a proof-of-concept study in adults with cerebral palsy. Results from the study in expected in mid-2013. We note in the first phase of the trial no safety issues were observed.
Another proof-of-concept study of Ampyra in patients with post-stroke deficits was initiated in the second quarter of the year. The company expects initial results in the second quarter of 2013.
Meanwhile, the company is preparing to commence a phase II study of AC105 in patients with acute spinal cord injury. Results of GGF2, which is currently in a phase I study in heart failure patients, should also be out by the end of this year.
We currently have a Neutral recommendation on Acorda. Acorda carries a Zacks #4 Rank (short-term ‘Sell’ rating).
While we are pleased with the improvement in Ampyra sales, it remains to be seen whether the performance is sustainable. Moreover, we remain concerned about the company s dependence on Ampyra for growth.