Amicus Therapeutics, Inc. (FOLD)
Q2 2010 Earnings Call
August 5, 2010 5:00 PM ET
Jenene Thomas – Director, Investor Relations
John Crowley – Chairman and CEO
Matt Patterson – Chief Operating Officer
Jack McAdam – Vice President, Finance and Accounting
David Lockhardt – Chief Scientific Officer
Pol Boudes – Chief Medical Officer
Geoff Meacham – JPMorgan
Ritu Baral – Canaccord
Joseph Schwartz – Leerink Swann
Previous Statements by FOLD
» Amicus Therapeutics, Inc. Q1 2010 Earnings Call Transcript
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Good afternoon. And welcome to the Amicus Second Quarter Earnings Call Conference Call. My name is Sahil, and I’ll be your conference facilitator today. All lines have been placed on mute to prevent any background noise. After Amicus’s remarks, there will be a question-and-answer session period. (Operator Instructions).
I would now like to turn the conference over to Ms. Jenene Thomas, Director of Investor Relations.
Good afternoon. And thank you for joining our second quarter 2010 financial results conference call. This conference call contains certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 relating to the business, operations and financial condition of Amicus. Including but not limited to preclinical and clinical development of Amicus’s candidate drug products. The timing and reporting of results from preclinical studies and clinical trials evaluating Amicus’ candidate drug products, the projected cash position for the company and business development and other transactional activity.
Words such as but not limited to look-forward to, belief, expect, anticipate, estimate, intend, likely, should and could, and similar expressions or words identify forward-looking statements. Although Amicus believes the expectations reflected in such forward-looking statements are based upon reasonable assumptions. There can be no assurance that these expectations will be realized.
Actual results could differ materially from projected in Amicus’ forward-looking statements, due to numerous known and unknown risks and uncertainties, including the risks factors described in our annual report on Form 10-K for the year-ended December 31, 2009.
Amicus does not undertake any obligation to publicly update any forward-looking statements to reflect events or circumstances after the date on which any such statement is made or to reflect the occurrence of unanticipated events.
This afternoon, I’m joined on this call by members of our executive team, including John Crowley, our Chairman and CEO; Matt Patterson, our Chief Operating Officer; Jack McAdam, our Vice President of Finance and Accounting; David Lockhardt, our Chief Scientific Officer; and Pol Boudes, our Chief Medical Officer are available represent to you in the Q&A portion of the call that will follow our formal remarks.
At this time, it is my pleasure to turn the call over to John Crowley, Chairman and CEO of Amicus Therapeutics.
Great. Thanks Jenene, and good afternoon to everybody. I will go ahead and start today’s call with some brief opening remark. And then I hand it over to Matt and to Jack McAdam for a review of the programs in the financial information.
We had a very strong second quarter here at Amicus. It was highlighted by our continued solid progress on our number one strategic priority, which is, you all know is the execution of our Phase 3 physical study of Amigal for the U.S. registration. Enrollment in this trial is ongoing. And today we’re reiterating our guidance that we do expect to complete enrolment of this study by the end of this year, which means that we expect to receive and announced the Phase 3 results in the middle of 2011.
This progress is certainly the result of a very significant global effort by the entire Amicus team and we remain confident in the likelihood of the successful outcomes of that study. We are also on track with our other two main objectives in the Fabry program for this year that is the commitment of the European, the E.U. registration study, which we refer to the Study 012.
And also a study evaluating the use of Amigal when co-administered with enzyme replacement therapy and that Matt will go into more details on those in a moment. We continue to have great momentum on our Fabry program and remain enthusiastic about our chances of having a real impact on the treatment option that people living with Fabry disease.
On a different and related note and I’ll go into more of this and some additional commentary toward the end of the call. But we’re also extremely encouraged by what we’ve seen as the significant increase and attention and commitment to the rare disease space and drug development in the very loose and product area more broadly.
We have seen specifically its an important initiative underway, looking at various ways to improve the current regulatory environment for rare disease drug development, as well as a marked increase level of interest from new companies considering investment in the development of these therapies.
And again, I’ll share with you some more thoughts towards the end of the call. But I think these trends are positive for Amicus, as a leader in the rare disease space and certainly for people and their family to leave with these rare devaluating disorder.
Let me turn to brief updates on the program. Now over to Matt.
Thanks, John, and good afternoon, everyone. First, as John mentioned we’re very pleased with the progress in the second quarter. Number one priority remains advancement of our global Phase 3 program with Amigal for Fabry. Starting with Study 011our U.S. registration trial.
As you know, for competitive reasons, we don’t comment on specific enrollment numbers. However, as John noted, we are reiterating our guidance that we expect to complete enrollment in this study by end of this year and as a result we continue to expect to report results in mid 2011.