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Amicus Therapeutics Announces Third Quarter 2013 Financial Results

Reiterates Full-Year 2013 Net Cash Spend Guidance of $47 Million to $53 Million

Broad Strategic Update to be Provided by Year-End 2013

CRANBURY, N.J., Nov. 12, 2013 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq:FOLD), a biopharmaceutical company at the forefront of therapies for rare and orphan diseases, today announced financial results for the third quarter ended September 30, 2013. A broad strategic update on the Company's development programs and business development activities will be provided by year-end 2013.

John F. Crowley, Chairman and Chief Executive Officer of Amicus Therapeutics stated, "During the third quarter we continued to advance next-generation enzyme replacement therapies in Fabry, Pompe and MPS I utilizing our CHARTâ„¢ platform. In addition, our ongoing Phase 3 studies of migalastat HCl monotherapy continued to advance toward further results in Fabry patients with amenable mutations. Our balance sheet also remains strong through our collaborations with GSK and Biogen, and with careful cost management. We look forward to providing what we believe will be important and positive updates on our portfolio and our future strategic direction in the coming weeks."

Financial Highlights for Third Quarter Ended September 30, 2013
  • Cash, cash equivalents, and marketable securities totaled $60.5 million at September 30, 2013 compared to $99.1 million at December 31, 2012.
  • Cash reimbursements received from GlaxoSmithKline (GSK) for shared development of migalastat HCl totaled $1.0 million compared to $3.7 million in the third quarter 2012.
  • Total revenue of $39,000 consisted of research revenue received from Biogen Idec under the Parkinson's disease collaboration, which Amicus and Biogen entered on September 1, 2013. No revenue was recognized in the third quarter of 2012.
  • Total operating expenses decreased to $15.2 million from $16.9 million in the third quarter 2012 primarily due to lower expenses in research and development.
  • Net loss was $14.6 million, or $0.29 per share, compared to a net loss of $16.3 million, or $0.34 per share, for the third quarter 2012.

2013 Financial Guidance and Financial Outlook

Amicus continues to expect full-year 2013 net cash spend to total between $47 million and $53 million, including cash reimbursements received from GSK. Amicus and GSK are responsible for 40% and 60% of global development costs for migalastat HCl, respectively, in 2013 and beyond. The Company projects that the current cash position and anticipated Fabry program reimbursements from GSK are sufficient to fund operations into the fourth quarter of 2014.

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