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
- 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.