Amicus Therapeutics' CEO Hosts GSK Expanded Fabry Collaboration Call (Transcript)

Amicus Therapeutics, Inc.

Amicus and GSK Expanded Fabry Collaboration Call

July 17, 2012 05:00 pm ET


John Crowley – Chairman & Chief Executive Officer

David Lockhart – Chief Scientific Officer

Pol Boudes, MD – Chief Medical Officer

Chip Baird – Chief Financial Officer

Bradley Campbell – Chief Business Officer

Sara Pellegrino – Associate Director, Investor Relations


Ritu Baral – Canaccord Genuity

Anupam Rama – JP Morgan

Kim Lee – ThinkEquity

Bill Tanner – Lazard Capital Markets



Good day, ladies and gentlemen, and welcome to your Amicus and GSK Expanded Fabry Collaboration Call. (Operator instructions.) As a reminder, today’s conference is being recorded. And now I would like to introduce your host for today, Sara Pellegrino.

Sara Pellegrino

Good afternoon and thank you for joining our conference call to discuss the expansion of our collaboration with GSK to develop and commercialize co-formulations of migalastat for Fabry disease. Speaking on today’s call we have John Crowley, our Chairman and Chief Executive Officer; Bradley Campbell, our Chief Business Officer; and David Lockhart, our Chief Scientific Officer. They are joined by Chip Baird, our Chief Financial Officer, and Pol Boudes, our Chief Medical Officer, who are available to participate in the Q&A Session.

As a reminder, the presentation contains forward-looking statements within the meaning of the Private Securities Litigation 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 and business development and other transactional activities. Words such as but not limited to “look forward to,” “believe,” “expect,” “anticipate,” “estimate,” “intend,” “plan,” “would,” “should,” and “could,” and similar expressions and 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. All forward-looking statements are qualified in their entirety by this cautionary statement and Amicus undertakes no obligation to revise or update this presentation to reflect events or circumstances after the date hereof.

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, and good evening everybody and thanks for joining. This is very, very good news that we’re happy to announce this evening. As Sara indicated I’m joined by a number of members of the Executive Team here at Amicus, and before I turn it over to Brad and David in particular to take us through a number of different slides that hopefully everybody has now available to them – and we’ll reference those throughout this presentation – let me just reiterate why this is such a significant deal for Amicus and for continued collaboration and strengthening of that collaboration with GSK.

Again, three major components to this transaction: first is the agreement that we will jointly develop with our partners at GSK a next generation proprietary enzyme replacement therapy in Fabry disease that co-formulates and utilizes our core platform technology – the use of the chaperone migalastat; so a proprietary ERT developed by GSK, and we’ll talk more about the history of that development here and how it came to be and the significance of that ERT now combined. So a propriety co-formulated ERT that’s been in development for some time.

Secondly, we have a new division of responsibilities as a result of this extended collaboration. Amicus will now have responsibility for all commercial operations relative to all of these Fabry products – so the monotherapy use of migalastat, the use of migalastat in combination with other existing ERTs as well as the sales and marketing of this future proprietary ERT as it hopefully makes its way through the clinic. And then the third component and further strengthening our relationship with GSK – GSK is increasing its ownership in Amicus to 19.9% and purchasing 2.95 million shares of our common stock at a premium to today’s market close. They’ll be purchasing that at $6.30 for a total investment of a little over $18.5 million.

So those are the three components and I’ll comment just briefly now on the rationale from Amicus’ perspective and some of the history of how this came to be. I’ll take you first to our vision and one that I reiterated earlier this year at the JP Morgan conference, and that’s that Amicus would be a company at the forefront of rare and orphan diseases and very significantly utilizing our core platform technology including the extension of that along a continuum of innovation, taking our molecules from small molecule monotherapy as we already have now in advanced development in Fabry disease; looking for co-administration therapies but also very, very aggressively developing that technology co-formulated with enzyme replacement therapy. And David will share more of the scientific rationale for that.

But it fits very much in with our business-led, science-driven motto here at Amicus, and it is in line, too, with the vision that I articulated and we have continued to articulate throughout this year that our long-term vision in building Amicus is to be fully integrated by a pharmaceutical company in the rare diseases. And with this, this now allows us to begin preparing for the commercial launch of our products in Fabry disease as they hopefully make their way through the clinic, leading of course with our 011 study, our monotherapy study which remains on track for data delivery here in Q3.

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