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Q4 2008 Amicus Therapeutics, Inc. Earnings Conference Call - Final.

Article Excerpt
OPERATOR: Good afternoon. At this time I would like to welcome everyone to the Amicus Therapeutics conference call. All lines have been placed on mute to prevent any background noise. After Amicus's remarks there will be a question-and-answer period. (Operator Instructions).

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 Web site or from our Investor Relations representative.

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 look to update forward-looking statements at some point in the future, we specifically disclaim any obligation 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 Web site 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.

Now I am happy to turn the call over to John F. Crowley, President and CEO. Please go ahead, Sir.

JOHN CROWLEY, CEO, PRES, AMICUS THERAPEUTICS, INC.: Great. Thank you and good afternoon, everyone, and welcome to our fourth quarter full year 2008 conference call.

I am joined on this call by other members of our management team, including Matt Patterson, Chief Operating Officer. Matt will provide an update on our lead lysosomal disease programs.

I am also joined by Jim Dentzer, Chief Financial Officer, and Jim will be providing an overview of the financial results for the quarter and for the full year 2008.

David Lockhart is also here, our Chief Scientific Officer. And David, as always, will be available to participate in the Q&A portion of the call that will follow our remarks.

Let me begin by saying we are very pleased with 2008. We think it was an excellent year for Amicus. We achieved our planned development milestones; and by doing so, we've made significant regulatory and clinical progress in each of our three lead programs in the lysosomal storage diseases, and this is consistent with our guidance.

In addition, we also continued to invest in the pharmacological chaperone platform more broadly. In particular, we generated very encouraging preclinical data demonstrating the potential breadth and versatility of our science. And we'll talk more about that in a short while as Matt goes through his section.

And finally, we maintained a strong financial profile ending the year with $121 million in cash and marketable securities.

So in 2008, we continued to build a strong foundation through solid execution on multiple fronts. We expect 2009 to be a very transformational year for Amicus. This year, we expect to achieve several key development milestones in our lead programs and to transition to a late-stage biopharmaceutical company as we move to initiate our first Phase 3 clinical study.

I will highlight our 2008 advancements with respect to our three lead programs; and then I will turn this call over to Matt to go into greater detail on each of these programs.

In 2008, we made significant progress toward the finalization of a thorough and well-designed global Phase 3 program for our product candidate Amigal, our chaperone for Fabry disease. Through multiple interactions with regulatory authorities in both the United States and in Europe, we were able to secure some very important agreements and helpful guidance in the United States.

In particular the FDA has agreed that Amigal for Fabry can pursue an accelerated approval pathway, based on a Phase 3 clinical trial comparing Amigal to placebo, using a surrogate primary endpoint of kidney GL-3 levels. We have been and continue to be very encouraged by the interactions to date, and look forward to our final discussions with the agency in the coming months and to initiating our Phase 3 program in the second quarter.

Turning briefly to Gaucher, we are very pleased also with the progress in that program. We expect to have surpassed our target enrollment in our ongoing Phase 2 clinical study, a six-month clinical trial in patients naive to enzyme replacement therapy. And we now expect to report this results in the third quarter of this year for that study. It is our goal to complete this study and to, in parallel, work with our partners at Shire to advance this program in to Phase 3 as rapidly as possible.

I will comment here finally in the introductory remarks about our Pompe program and also note continuing excellent progress on that front. Our Phase 2 trial of AT2220 is ongoing; and we expect to report results in the second half of this year.

In addition, we've recently reported on some interesting preclinical data, evaluating the potential for the combination of our chaperone AT2220, and an enzyme replacement therapy to be a potential new...

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