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Amicus Therapeutics, Inc. (FOLD)

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Amicus Therapeutics Inc. (FOLD)

Amicus Agreement with GSK Call

October 29, 2010 08:30 am ET

Executives

Jenene Thomas - IR

John Crowley - Chairman & CEO

Matt Patterson - COO

Analysts

Ritu Baral - Canaccord

Geoff Meacham - JPMorgan

Greg Wade - Wedbush

Joseph Schwartz - Leerink Swann

Presentation

Operator

Good morning and welcome to Amicus conference call and webcast today. My name is Alison and I will 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 call over to Jenene Thomas, Director of Investor Relations.

Jenene Thomas

Good morning and thank you for joining our conference call to discuss our exclusive worldwide agreement with GSK to develop and commercialize Amigal for Fabry Disease. I am joined on this call by members of our executive team include John Crowley, our Chairman and CEO; Matt Patterson our Chief Operating Officer; David Lockhart our Chief Scientific Officer; Pol Boudes, Chief Medical Officer and Daphne Quimi, our Corporate Controller.

Before I turn the call over to John I have to remind you of the following. 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’s drug products candidate and the projected cash position for the company including achievement of development and commercialization milestone payments and sales royalties under out collaboration with GlaxoSmithKline and business development and other transactional activities.

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 Amicus’s 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, 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 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 Mr. John Crowley, Chairman and CEO of Amicus Therapeutics.

John Crowley

Great. Thanks Jenene, and welcome all, good morning. These are the days when its good to be a Biotech CEO. Let me begin by just reading a couple of bullet points from the Amicus vision statement that we developed about five years ago and most of us came to this company and I think it will help us frame that the context and background for this field. We wrote at that time that we believe we must constantly build momentum in the fight against human genetic diseases. We seek to deliver the highest quality therapies for persons afflicted with these diseases. We support the disease communities and their families. We are passionate about what we do and we embrace constant innovation. This is a time when we look back on innovation and the work that we've done over the last many years in Amicus and with the risk taking involvement, innovation and the nature of developing cutting edge technologies, it also means that the other side of risk taking, sharing and the reward. We think that this deal here with our new partners at GlaxoSmithKline GSK is both positive and transformational for Amicus and our shareholders and especially for the people who we're developing medicines for.

Let me lay out for you the four fundamental reasons why we think this deal was positive and transformational. At first you think it’s a strong validation of our pharmacological chaperone technology, which is a technology we believe will promise for many rare diseases. Secondly, we think that this deal will enhance the likelihood of the clinical success of Amigal and hopefully its commercial success as well by leveraging the extensive resources and experience GSK in manufacturing regulatory affairs, clinical and commercial operation. The third we think there is a very strong strategic component of this deal. We think this collaboration with GSK will firmly position Amicus as a leader in research and development of technologies and products for rare diseases a leader in the field of rare disease drug development we think that this deal also will enable us to judiciously drive our pipeline and also to opportunistically seek products that we think we will complimentary in development.

Fourthly we think there is a very strong added financial component to this deal and the financial strength that it gives Amicus. With this deal we believe we have cash resources to fund our operations and capital investments at least through the approval, the US approval of Amigal and we will give more detailed financial guidance on our quarterly earnings call in a couple of weeks. Let me comment briefly before I turn it over to Mat Patterson to just go through it at a high level the terms of the deal.

Let me just comment briefly on why GFK is the right partner for Amicus and at this time. This was a very competitive process, there were multiple parties in discussions and multiple opportunities we evaluated broadly with similar economics at the end of the day. However with GFK we think that there are a number of reasons why it is a good strategic fit for Amicus. First we believe with GFK we share a common vision for developing new treatments for rare diseases and this strategic fit was very important part for the deal for us. Secondly GFK has extremely impressive global clinical and regulatory and commercial expertise and for this reason as well we think they will be a strong partner for us. Thirdly GFK of course has tremendous scientific expertise and I could tell you the rigor that they put into the due diligence process both on the science side as well as the clinical manufacturing and other related activities in drug development were extremely impressive to us. Also fourthly that GSK has a very strong commitment to the rare diseases. Many of you may have seen a little over a week ago GSK issued a press release where they outlined their approach to delivering advancements in the treatment of rare diseases noting the establishment this year of a discrete rare disease business unit headed by Mark a member of their corporate executive team who reports to their CEO Andrew I would encourage you to take a look at that [reality] because I think it puts in good perspective again why we think GSK will such a strong partner for Amicus.

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