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Positive 12- and 24-Month Data From First Phase 3 Fabry Monotherapy Study (Study 011) – Results from Second Phase 3 Fabry Monotherapy Study (Study 012) Expected 3Q14
3-in-3 Strategy to Advance 3 Next-Generation Enzyme Replacement Therapies (ERTs) Into Clinic in Next 3 Years
CRANBURY, N.J., May 5, 2014 (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 first quarter ended March 31, 2014. The Company also provided program updates and reiterated full-year 2014 operating expense guidance.
John F. Crowley, Chairman and Chief Executive Officer of Amicus Therapeutics, Inc., stated, "Last week was a momentous occasion for Amicus as we announced very positive 12- and 24-month data from our first Phase 3 Fabry monotherapy study. The feedback from investigators and, most especially, Fabry patients, has been so very enthusiastic. Moving migalastat forward toward commercialization is an important objective for this company and will have our relentless focus in the months ahead. During the first quarter we also made great progress with the execution of our 3-in-3 strategy to advance 3 next-generation ERTs into the clinic over the next three years, with lead programs in Fabry, Pompe, and MPS I. We believe that the strength of our programs and the breadth of our technology platforms will create significant value for our shareholders throughout 2014 and hopefully for many years to come."
Financial Highlights for First Quarter Ended March 31, 2014
Cash, cash equivalents, and marketable securities totaled $71.6 million at March 31, 2014 compared to $82.0 million at December 31, 2013.
Total operating expenses decreased to $16.1 million compared to $17.3 million for the first quarter 2013 due to decreases in personnel and contract research costs.
Net cash spend was $10.4 million, compared to $14.4 million for the first quarter 2013.
Net loss was $15.9 million, or $0.25 per share, compared to a net loss of $17.5 million, or $0.35 per share, for the first quarter 2013.
2014 Financial Guidance
Cash, cash equivalents, and marketable securities totaled $71.6 million at March 31, 2014 compared to $82.0 million at December 31, 2013. Amicus continues to expect full-year 2014 net cash spend between $54 million and $59 million. The current cash position is projected to fund operations into the second half of 2015.