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Acorda Therapeutics (ACOR) Tops Q4 EPS by 32c

February 12, 2015 6:20 AM EST

Acorda Therapeutics (NASDAQ: ACOR) reported Q4 EPS of $0.46, $0.32 better than the analyst estimate of $0.14. Revenue for the quarter came in at $117.9 million versus the consensus estimate of $110.8 million.

Highlights:

  • AMPYRA® (dalfampridine) Fourth Quarter Net Revenue of $109.9 Million; Full Year Net Revenue of $366.2 Million
  • Full Year AMPYRA 2015 Net Revenue Guidance of $405-$420 Million
  • Full Year 2015 Guidance for R&D Expense of $150-$160 Million
  • Full Year 2015 Guidance for SG&A Expense of $180-$190 Million

Guidance for 2015

The following guidance does not include potential expenditures related to the acquisition of new products or other business development activities.

  • The Company expects AMPYRA 2015 full year net revenue of $405-$420 million.
  • In 2015, the Company expects ZANAFLEX franchise and ex-U.S. FAMPYRA revenue of approximately $25 million, which includes sales of branded ZANAFLEX products and royalties from ex-U.S. FAMPYRA and authorized generic tizanidine hydrochloride capsules sales.
  • R&D expenses for the full year 2015 are expected to be $150-$160 million, excluding share-based compensation. The increase in R&D expenses in 2015 is primarily related to Phase 3 studies of dalfampridine and CVT-301. Additional expenses include continued development of PLUMIAZTM (diazepam) Nasal Spray, clinical trials for cimaglermin and rHIgM22, as well as ongoing preclinical studies.
  • SG&A expenses for the full year 2015 are expected to be $180-$190 million, excluding share-based compensation.

AMPYRA Update

  • More than 65% of new AMPYRA patients currently enroll in First Step, which provides two months of AMPYRA at no cost. The program is in its fourth year, and data show that First Step participants have higher compliance and persistency rates over time compared to non-First Step patients.
  • More than 100,000 people with multiple sclerosis in the United States have tried AMPYRA since its launch in 2010.
  • The Company received eight Paragraph IV Certification Notice Letters advising that companies have submitted Abbreviated New Drug Applications (ANDA) to the U.S. Food and Drug Administration (FDA) requesting permission to manufacture and market a generic version of AMPYRA. Acorda has filed patent infringement suits against all ANDA filers to date, triggering a 30-month statutory stay period that restricts FDA from approving an ANDA until July 2017 at the earliest, unless a district court issues a decision adverse to all of Acorda’s asserted Orange Book patents prior to that date.
  • In February 2015, a hedge fund filed an inter partes review (IPR) petition with the U.S. Patent and Trademark Office, challenging one of the five AMPYRA Orange Book-listed patents. The Company will oppose the request to institute the IPR, and if it is allowed to proceed, the Company will oppose the full proceeding. The 30-month statutory stay period based on patent infringement suits filed by Acorda against ANDA filers is not impacted by this filing, and remains in effect.

Pipeline Update

  • In February 2015, the Company announced safety and tolerability data from the first Phase 1 clinical trial of rHIgM22, a remyelinating antibody for treatment of multiple sclerosis. The trial, which followed participants for up to six months after receiving a single dose of rHIgM22, found no dose-limiting toxicities at any of the five dose levels studied. Based on these data, the Company plans to initiate a second Phase 1 trial of rHIgM22 in 2015.
  • In December 2014, the Company initiated a Phase 3 clinical trial studying the use of dalfampridine administered twice-daily (BID) to improve walking in people who have experienced an ischemic stroke.
  • The Company initiated a Phase 3 clinical trial studying the use of CVT-301 to treat OFF episodes in Parkinson’s disease in December 2014.
  • The Company announced it is deferring further development of NP-1998 for neuropathic pain in 2015.
  • The Company is continuing to work with the FDA to define the additional clinical work necessary for the approval of PLUMIAZ.

For earnings history and earnings-related data on Acorda Therapeutics (ACOR) click here.



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