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Amicus Therapeutics Announces Second Quarter 2013 Financial Results

Full-Year 2013 Net Cash Spend Guidance Reduced to $47 Million to $53 Million – Current Cash Expected to Fund Operations into 4Q14

Multiple Next-Generation Enzyme Replacement Therapies Advancing for Lysosomal Storage Diseases

CRANBURY, N.J., Aug. 7, 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 second quarter ended June 30, 2013. The Company also summarized recent and upcoming milestones and reduced full-year 2013 net cash spend guidance.

Key Program Highlights and Upcoming Milestones:
  • Phase 2 chaperone-ERT co-administration study for Pompe disease expected to begin 2H13
  • Fabry chaperone-ERT co-formulated product anticipated to enter clinic in 1H14
  • Next-generation ERTs for Pompe disease and Mucopolysaccharidosis Type I (MPS I) advancing in preclinical studies
  • 12-month (Stage 2) data from Phase 3 Study 011 of migalastat HCl monotherapy for Fabry disease anticipated 4Q13 and top-line data from Study 012 expected 2H14 - U.S. new drug application (NDA) submission expected to include data from all clinical studies

John F. Crowley, Chairman and Chief Executive Officer of Amicus Therapeutics stated, "During the second quarter we continued to build out our CHART platform of chaperone-ERT combinations across the lysosomal storage diseases. We expect to initiate our next Phase 2 Pompe co-administration study in the second half of this year, as well as initial clinical studies of our chaperone-ERT co-formulated product for Fabry disease in 2014. Our long-term vision is to move multiple next-generation ERTs into the clinic over the next several years. We also remain committed to advancing migalastat HCl monotherapy toward a potential U.S. approval for Fabry patients who have amenable mutations."

Financial Highlights for Second Quarter Ended June 30, 2013
  • Cash, cash equivalents, and marketable securities totaled $74.2 million at June 30, 2013 compared to $99.1 million at December 31, 2012.
  • Cash reimbursements received from GlaxoSmithKline (GSK) for shared development of migalastat HCl totaled $1.3 million compared to $4.3 million in the second quarter 2012.
  • No revenue was reported due to a change in revenue recognition accounting under the expanded GSK collaboration. Total revenue of $10.6 million was recognized in the second quarter 2012.
  • Total operating expenses decreased to $16.0 million from $20.0 million in the second quarter 2012 due to lower expenses in research and development as well as general and administrative.
  • Net loss was $15.3 million, or $0.31 per share, compared to a net loss of $9.3 million, or $0.20 per share, for the second quarter 2012.

2013 Financial Guidance

Amicus expects full-year 2013 net cash spend to total between $47 million and $53 million, compared to previous net cash spend guidance of $52 million and $58 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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