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Amicus Therapeutics, Inc. (FOLD)
Q3 2008 Earnings Call Transcript
November 3, 2008, 5:00 pm ET
John Crowley – President and CEO
Matt Patterson – COO
Jim Dentzer – CFO
Matt Osborne – Lazard
Greg Wade – Pacific Growth
Terry Coyne – JP Morgan
Steve Harr – Morgan Stanley
Previous Statements by FOLD
» Amicus Therapeutics, Inc. Q4 2008 Earnings Call Transcript
» Amicus Therapeutics, Inc. Q2 2008 Earnings Call Transcript
» Amicus Therapeutics Inc. Q1 2008 Earnings Call Transcript
During this call, Amicus may make various remarks about the company’s future expectations, plans, and prospects that constitute forward-looking statements for purposes of the Safe Harbor Provisions under the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors including those discussed in the company’s most recent Annual Report on Form 10-K and our periodic reports on Form 10-Q. These documents are available from the SEC, the Amicus website, or from our Investor Relations representatives.
In addition, any forward-looking statements represent our estimates only as of today and should not be relied upon as representing our estimates as of any subsequent date. While we may like to update forward-looking statements at some time in the future, we specifically disclaim any obligations to do so even if our estimates change.
Before we begin, we would ask everyone to go to the Investor Relations section of the company’s website, amicustherapeutics.com, and print out the press release and related financial tables. These will be particularly useful when the company reviews the financial results and reconciliation to non-GAAP financial measures discussed today.
And now at this time, I’d like to turn the conference over to Mr. John Crowley, President and CEO of Amicus Therapeutics. Please go ahead sir.
Okay, thank you and good afternoon everyone, and welcome to our third quarter 2008 conference call. I am joined in this call by other members of the executive team here at Amicus, including Matt Patterson, our COO, who will provide an update on our lead lysosomal storage disease clinical program; by Jim Dentzer, our CFO, who will provide an overview of the financial results for the quarter; and also available is David Lockhart, our Chief Scientific Officer, who will be available to participate in the Q&A portion of the call that will follow our formal remarks here.
Let me begin by saying that in the third quarter we focused very intensely on continued advancement of our core programs. In our lead program Amigal for Fabry disease, we recalled it in August – we announced successful completion of our Phase – of our end of Phase 2 meeting with the FDA. Since that time, we have continued to make excellent progress in our discussions with both the FDA and the EMEA in Europe in order to further define our global development plan for Phase 3 for Amigal. These discussions are ongoing and we remain optimistic and on track to provide you with an update by the end of the year. Importantly too, I’ll note that where we are in this process is consistent with our expectation and most significantly we continue to expect to begin Phase 3 development for Amigal for February in the first half of 2009.
In our Gaucher and Pompe clinical programs, we continue to focus on running our ongoing Phase 2 clinical trial in each of those diseases, and we expect to report the Gaucher Phase 2 data in 2009. Separately in our Pompe program, we continue our pre-clinical work to evaluate the potential for the combination of our chaperone AT2220 and enzyme replacement therapy. This exploratory effort looking at the combination underscores the versatility of our chaperone platform, and I will ask Matt to elaborate a bit more on where we are and the next steps in just a minute.
During the third quarter, we also announced that we leased a small-scale research facility in San Diego, which will be used to support ongoing research into new application of our chaperone platform technology beyond the lysosomal storage disorders. In particular, the work done in the new San Diego facility will focus on diseases with high unmet medical need and larger patient populations, particularly, in the areas of neurodegenerative and other genetic disorders.
In 2009, we expect to provide more specifics on the R&D program that we will focus on, in addition to the ongoing work in our pre-clinical program in Parkinson’s. So as we continue to execute on our lead clinical and pre-clinical programs, we look forward to achieving several important near-term milestones.
And finally, I’ll finish my upfront comments here by reminding everyone of our strong financial position based on a healthy balance sheet and our strategic alliance with Shire that funds 50% of our worldwide development cost for our three lead programs and the lysosomal storage disorders, and provides for success-based milestone payments for these lead programs. Jim will add some more detail later in the call, but obviously this is a very important subject at this time in the market.
With that brief overview, I will turn the call over to Matt Patterson and ask that Matt further review in more detail our lead clinical programs in the lysosomal storage disorders. Matt, it’s over to you.
Thanks, John, and good afternoon everyone.
I’ll start with Amigal for Fabry and just elaborate a little bit on the introduction John has provided. As John mentioned, our focus over the last quarter has been to continue our discussions with both the FDA and the European authorities regarding our global Phase 3 development plan for Amigal.