Amicus Therapeutics' CEO Discusses Second Quarter Results - Earnings Call Transcript

Amicus Therapeutics (FOLD)

Q2 2012 Earnings Call

August 7, 2012, 5:00 pm ET


John Crowley – Chairman, CEO

Bradley Campbell – Chief Business Officer

Chip Baird – CFO

David Lockhart – Chief Scientific Officer


Ritu Baral – Canaccord

Anupam Rama – JP Morgan

Joseph Schwartz – Leerink Swann

Kim Lee - ThinkEquity



Good day, ladies and gentlemen, and welcome to the Amicus Therapeutics second quarter 2012 results conference call. At this time, all participants are in a listen-only mode and later, we will conduct a question and answer session and instructions will be given at that time. (Operator instructions). This call is being recorded. I would now like to introduce your host for today's conference, Sara Pelligrino. Now you may begin.

Sara Pelligrino

Good afternoon and thank you for joining our conference call to discuss our second quarter 2012 financial results. Speaking on today's call we have John Crowley, our Chairman and Chief Executive Officer, Bradley Campbell, our Chief Business Officer, David Lockhart, our Chief Scientific Officer, and Chip Baird, our Chief Financial Officer.

They are all available to participate in the Q&A session, as well. Pol Boudes, our Chief Medical Officer, is on vacation this week.

Today's prepared remarks coincide with the slide presentation that is now available on our corporate website at The slides are located in the Investors section under Events and Presentations right below the webcast link.

On Slide 2, we have a reference to forward-looking statements in this conference within the meaning of the Private Securities Reform Act of 1995 relating to the business, operations and financial conditions of Amicus including but not limited to preclinical and clinical development of Amicus' 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.

Words such as but not limited to , 'believe', '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 its expectations will be realized.

Actual results could differ materially from those projected in Amicus' forward-looking statements due to numerous known and unknown risks and uncertainties including the risk factors described in our annual report on Form 10-K for the year ended December 31, 2011 and other other filings with the Securities and Exchange Commission.

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.

At this time, it is my pleasure to turn the call over to John Crowley, Chairman and Chief Executive Officer of Amicus.

John Crowley

Great, thank you, Sara. Good evening, everybody, and as Sara indicated, we will be using the slides that are up and available to everybody on the call. We got feedback after our last conference call that that was very helpful and hopefully that will be a format that we will continue to follow here at Amicus. So with that in mind, I'll reference Slide number 3 to begin just to give you a sense of the agenda for this call.

I will provide an overview of some of the general Amicus corporate highlights, go through that together with the Fabry program. I'll then turn it over to Brad Campbell, who will take us through the highlights of the Chaperone-ERT Program highlights.

Chip Baird, our Chief Financial Officer, will go through the 2Q 2012 financial results together with updated guidance for full year 2012 and then I'll take the call back for some concluding remark.

So if I can draw your attention now to Slide 4, I'll just provide a couple of updates on Q2 highlights including the very recent development that you've seen in the press release that we sent out just about an hour ago based on a very recent and very positive type-C meeting interaction with the FDA which we think is going to bode very well for this program, so we'll provide some more update and color on that.

But just generally with our Phase 3 Program, we're happy to report that in the second quarter, we completed the six month primary treatment arm and again remember that the study 011, our Phase 3 study for US approval, it's a randomized placebo-controlled study again with a six-month double-blind primary treatment period and then if you'll recall, a six-month open label follow-up period.

We are updating our patient disposition today letting everybody know that at the end of that six-month primary treatment arm, we had 63 of the 67 patients completed. We did have four dropouts, none due to any FAEs or any concerns with the drug. They came off for various other reasons as we expected.

There was a lower than expected dropout rate for this study so we think another point that would further enhance our likelihood of success here. So we end the study with 63 patients. Of those 63 who completed the primary treatment arm, we had a 100% conversion of those patients to voluntarily elect to continue on the study.

So again, half the patients having been randomized to migalastat, half randomized to placebo, patients blinded of course to either. At six months, those patients who had been on migalastat continuing on migalastat. Those patients who had been on placebo continuing onto – coming onto migalastat again blinded to that.

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