Amicus Therapeutics, Inc. (FOLD)
Q1 2010 Earnings Call
May 06, 2010 05:00 am ET
Jenene Thomas - Director of IR
John Crowley - Chairman and CEO
Matt Patterson - COO
John McAdam - VP of Finance and Accounting
David Lockhart - CSO
Pol Boudes - CMO
Ritu Baral - Canaccord
Joseph Schwartz - Leerink Swann
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Good afternoon and thank you for joining me Amicus first 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, timing and reporting of results for preclinical studies and clinical trials evaluating Amicus’s candidate drug products. The projected cash position for the company on its business development and other transactional activity.
Words such as; but not limited to, look forward to, believe, expect, anticipate, estimate, intend, likely should, incur and similar expressions or words identify forward-looking statements. Although Amicus believe the expectations reflected in such forward-looking statements are based upon reasonable assumptions there can no be assurance that this expectations will be realized. Actual results could differ materially from those projected in the forward-looking statements due to numerous known and unknown risks and uncertainties included in risk factors described in our Annual Report on Form 10-K for the year ended December 31, 2009.
Amicus does not undertake any obligations to publicly update any forward-looking statements through such events or circumstances after the date on which any statement is made or to reflect the occurrence financial dictated events. I am joined on the call by members of the executive team including John Crowley our Chairman and CEO, Matt Patterson our Chief Operating Officer, John McAdam our Vice President of Finance and Accounting and we have David Lockhart our Chief Scientific Officer and Pol Boudes our Chief Medical Officer who will be available to participate in the Q&A portion of the call that will follow up on Amicus remarks. At this time it is my pleasure to turn the call over to Margin. John Crowley, Chairman and CEO of Amicus Therapeutics.
Hi thanks Jenene let me go ahead and begin with some opening remarks and I will share with you all some of my perspectives on some of the key events of the quarter and then I will turn call over the Matt Patterson to provide some more detail on the program activity as well as turning the call after that over the Jack MacAdam who can walk us through the financial results for the quarter.
Let me begin by saying we are very pleased with our progress during the first quarter we meet all of our milestones that we set out to achieve. And also we are able to provide some important new data to update. Most notably we presented back in February at the worldwide by some disease meeting positive data update with our ongoing Phase II extension study with setting with Amigal which is our lead product candidate for Fabry disease. These data which Matt will highlight here in a moment give us added confidence and continued confidence quite frankly in our Phase III program for this product. And of course the Amigal Phase III program remains our number one priority here at Amicus.
We believe we have a very experienced team across all functional areas. A team that’s focused and committed to continuing the solid execution of the program and we plan to achieve our goal of enrolling this study which we recall our O11 study. The US approval study by the end of this year. In addition we are also readying for the commencement of the Study 012 that is our European registration study as well as pursuing a Phase II study of Amigal in combination with existing enzyme replacement therapy.
So you can see we have many reasons to remain enthusiastic about Amigal and its potential to change the treatment paradigm for people living with Fabry disease in the near future. A second milestone for us in the quarter we completed as you all know a register direct offering that yielded net proceeds of about $17 million. This was an important event for us because it not only strengthens our financial position it also allows us to dedicate additional resources to the Amigal global Phase III program in particular we can now begin that 012 study the European registration study earlier than we had planned.
Another update, a key update for us in the quarter, we continue to remain very excited about our CNS franchise and particularly encouraged by our advanced and Parkinson's and Alzheimer's program. We were pleased to report to the additional data from our advanced pre-clinical program for Parkinson's during the quarter and we look forward to continuing this program with the potential to select an IND candidate in that Parkinson's program by the end of this year.
Another increasingly important part of our CNS franchise, centers around Alzheimer's program if you recall we announced back in January at the JPMorgan conference that Alzheimer's was our second CNS target and drug discovery program. As you saw from our press release that crossed the wire a short while ago, we have received recently a grant from the Alzheimer's Drug Discovery Foundation, we were honored to have been selected for this grant and we look forward to continuing the further exploration of our chaperone technology for the treatment of Alzheimer’s disease and look forward to continuing to work with the ADDF the Alzheimer’s Foundation on our novel approach to this devastating disease.