Earnings Labs

Amicus Therapeutics, Inc. (FOLD)

Q1 2010 Earnings Call· Fri, May 7, 2010

$14.49

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Transcript

Operator

Operator

Good afternoon and welcome to Amicus Therapeutics first quarter earnings call. My name is Huey and I will be your conference facilitator today. All lines have been placed on mute to prevent any background noise. After Amicus remarks there will be a question-and-answer session period. (Operator Instructions) I would now like to turn the program over to our speaker Jenene Thomas Director of Investor Relations.

Jenene Thomas

Management

Good afternoon and thank you for joining me Amicus first quarter 2010 financial results conference call. 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, timing and reporting of results for preclinical studies and clinical trials evaluating Amicus’s candidate drug products. The projected cash position for the company on its business development and other transactional activity. 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 the forward-looking statements due to numerous known and unknown risks and uncertainties included in 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 statement is made or to reflect the occurrence financial dictated events. I am joined on the call by members of the executive team including John Crowley our Chairman and CEO, Matt Patterson our Chief Operating Officer, John McAdam our Vice President of Finance and Accounting and we have David Lockhart our Chief Scientific Officer and Pol Boudes our Chief Medical Officer who will be available to participate in the Q&A portion of the call that will follow up on Amicus remarks. At this time it is my pleasure to turn the call over to Margin. John Crowley, Chairman and CEO of Amicus Therapeutics.

John Crowley

Chairman

Hi thanks Jenene let me go ahead and begin with some opening remarks and I will share with you all some of my perspectives on some of the key events of the quarter and then I will turn call over the Matt Patterson to provide some more detail on the program activity as well as turning the call after that over the Jack MacAdam who can walk us through the financial results for the quarter. Let me begin by saying we are very pleased with our progress during the first quarter we meet all of our milestones that we set out to achieve. And also we are able to provide some important new data to update. Most notably we presented back in February at the worldwide by some disease meeting positive data update with our ongoing Phase II extension study with setting with Amigal which is our lead product candidate for Fabry disease. These data which Matt will highlight here in a moment give us added confidence and continued confidence quite frankly in our Phase III program for this product. And of course the Amigal Phase III program remains our number one priority here at Amicus. We believe we have a very experienced team across all functional areas. A team that’s focused and committed to continuing the solid execution of the program and we plan to achieve our goal of enrolling this study which we recall our O11 study. The US approval study by the end of this year. In addition we are also readying for the commencement of the Study 012 that is our European registration study as well as pursuing a Phase II study of Amigal in combination with existing enzyme replacement therapy. So you can see we have many reasons to remain enthusiastic about Amigal and its…

Matt Patterson

Chief Operating Officer

Thanks John and good afternoon everyone. Let me start off with an updates on the number 1 priority program the global Phase III program for Amigal. As a reminder, we have several for the Amigal program this year. The first is to complete enrollment and study 011 which is the registration trial for the US. The second is to commence study 012 which is the registration trial for the European Union. Finally we planned to commence Phase II study of Amigal in combination with ERT. Based on solid progress during Q1 we continue to expect each of these goals. We expect to complete enrollment and study 011 by the end of the year largely because of the focused global effort we started last year and continued to manage aggressively. We previously planned to start studying 012 late in the year but as John mentioned after the completion of the recent financing, we now plan to start that trial sooner which we believe will add volume and momentum to the program overall. Finally, based on continued encouraging pre-clinical results and we still planned on advancing chaperone-ERT combo study into the clinic starting that study this year and that is in Fabry disease. Let me spend a minute discussing why we remain confident in the Amigal Phase III reprogram. In addition to our agreements with regulatory authorities, we remained very confident this program for two major reasons. First we have designed the Phase-III studies with specific entry criteria that enrich the study population in ways that we believe increase the profitability for positive results from the study. For example, subjects enrolled in study 011 must have both a genetic mutation that is known to respond to Amigal as well as an elevated base line level of the sub straight which we will…

Jack McAdam

Management

Thanks, Matt. And good afternoon everyone. Before I review the first quarter financial results I’ll comment briefly on our cash balance and financial guidance. We entered the first quarter with $81.4 million in cash and marketable securities. In January, we provided financial guidance and at this time we reiterate our expectations that cash spend in 2010 will be $40 to $50 million and that current cash and marketable securities will be sufficient to fund operations into the second half of 2011. Now to move to the financial results. I’ll be refereeing to Table 1 in our press release. Net loss for the quarter was $13.2 million as compared to a net loss of $12.5 million for the same period in 2009. Reductions in operating expenses resulting from our Q4 2009 restructuring and refocused operating priorities largely offset the $4.6 million year-over-year revenue impact to permitting the Shire collaboration agreement. R&D expense in the first quarter of $8.9 million which included $0.7 million of stock compensation was lower the $11.9 million of R&D expense in the prior year quarter. The decrease is primarily due to lower personnel cost associated with our Q4 2009 work force reduction, a decrease in consulting costs and decreased activity with the negotiate program. Our first quarter 2010 G&A expense of $3.9 million which included $1 million of stock compensation was lower than the $5.2 million of G&A expense incurred in the first quarter of 2009. The decrease in G&A was largely attributable to lower personal cost associated with that 2009 workforce reduction as well as decreases in third quarter party with third party legal and consulting fees. Interest income for the first quarter was $0.01 million as compared to $0.05 million in the comparable quarter last year. This decrease was driven by lower effective interest rates and decreased cash and cash equivalent balances. As John mentioned earlier during the first quarter we raised $17.1 million of net proceeds through a registered direct offering of 4.95 million shares of common stock and wants to purchase an additional 1.85 million shares of common stock We allocated $3.3 million of our net proceeds to the warrants which we then classified as a liability on our balance sheet. Each quarter the warrant liability would be mark-to-market with changes recorded as the non-cash, non-operating line item in our P&L. The change in fair value of our warrant liability during the first quarter of 2010 was $0.02 million. So that covers the financial update for the first quarter. If there are any other areas you would like to cover, we’d be happy to address them in the Q&A portion of the call. And with that I will turn things back to John.

John Crowley

Chairman

I will be very brief and wrap it up before we move to the Q&A session. So hopefully as you can see a lot of activities a lot of momentum continuing and we continue to hit all the milestones that we laid out. We continue focus as our number one priority the enrolment of the Fabry 011 study and the momentum around the Amigal molecule and a lot of different clinical programs which will be an important component to building near term shareholder value for sure. But we also continue to significantly invest in the platform both in rare diseases but then also increasingly in our CNS programs in Parkinson’s and Alzheimer’s which will also be a pivotal part of building long term shareholder wealth. So, with that let me remind folks that our Chief medical officer Pol Boudes and our chief scientific officer David Lockhart are also here with Matt, Jack and I and we are happy to take any of your questions.

Operator

Operator

Thank you, sir. Ladies and gentlemen, (Operator Instructions). Our first question in queue comes from Ritu Baral with Canaccord. Please go ahead. Pardon me your line is open.

Ritu Baral - Canaccord

Analyst · Canaccord. Please go ahead. Pardon me your line is open

Can you give me some little more granularity on the European study, I guess have you started picking fights and would you have a partner investigator at this point?

John Crowley

Chairman

We have done a lot of work on that, a lot of sites we planned that I will certainly overlap with the 011 study lead to. That’s something we are certainly deep in the process of developing protocols, we have the relationships with all of the sites that we would expect to use as a result of all of our again more than 40 sites globally being used for the 011 study. So, all of that prep work is been in place for sometime.

Ritu Baral - Canaccord

Analyst · Canaccord. Please go ahead. Pardon me your line is open

And as far as the combo studies that you will be doing, the ERT combo studies. How does the on going shortages is various enzyme therapies affecting your plans through that study both planning wise and enrollment and design wise?

John Crowley

Chairman

Yes, we expect these to be pretty small studies for proof of concept extending from the preclinical to now the clinical proof of concept. So, with the combo studies, I don’t expect that to have a significant impact the drug shortage, there is still a number of patients that still have access to Fabrazyme or Replagal certainly. So, I don’t expect that have an impact and some we take into consideration as well, but I don’t think that will repeat the progress on the combo studies.

Ritu Baral - Canaccord

Analyst · Canaccord. Please go ahead. Pardon me your line is open

Great. And I guess when can we expect the first CNS drug to be in patients or like an IND filed and accepted?

John Crowley

Chairman

Yeah, well Parkinson’s, has been a program of ours for well over three years now going on 40 years and this year we are in the final stages of the late preclinical development leading to candidate selection. We hope by the end of this year early next year. So, we are not yet giving guidance to when a lead molecule would be in the clinic but we continue to build on the preferred concept studies and then prepare for what would be IND related activity for the right time.

Operator

Operator

Thank you. Our next question in queue comes from Joseph Schwartz with Leerink Swann. Please go ahead with your question.

Joseph Schwartz - Leerink Swann

Analyst · Leerink Swann. Please go ahead with your question

Hi, thanks for taking my question. I was wondering, if I’m reading this right that looks like for the 26 or 23 patients, excuse me. For the 23 patients that were in the open label extension study as of the license from world meeting in February may have dropped off given that you have 19 today, I was wondering what happened to those four patients? Was it a safety or efficacy reasoning that led them to leave Amigal treatment and where did they go?

John Crowley

Chairman

No, certainly not safety. Again we have certainly not safety we have not seen a single serious adverse event with it. There were different reasons for each of those four and Matt if you want to provide more granularity on that?

Matt Patterson

Chief Operating Officer

It's a little bit of mixed bag Joe but as I recall couple of them were capital too and didn’t really have much of a response wasn’t really responders to the drug anyway so they their dropping out was a logical thing and maybe they continue to form it and they needed to even and I think couple of others were just termed personal reasons and desire to longer participate in the study and the activity associated with it or in one case I think at least it was a desire to try to get on ERT but it's a bit of mixed bag, I can work and give you more detail.

John Crowley

Chairman

But what the nice thing is it was a really interesting kind of almost negative control for us because a number of I think maybe three of the four patients had non responsive mutations and we had actually recommended some time ago that they not continue with the therapy. They wanted to and their physicians consented to it we agreed to continue them on the drug Joe, but after collecting more data they agreed it didn't make sense, wasn't in the patients' interest to continue so working with doc’s we move them out of the study. But again it really kind of confirms the important pharmacogenetic nature of what we do and identifying responsive mutation and give us yet even more confidence for why we have got the right patients now in the Phase III study and none of those patients would qualify for our Phase III study for instance.

Joseph Schwartz - Leerink Swann

Analyst · Leerink Swann. Please go ahead with your question

Can you give us a finer sense of how enrollments are going in the 011 study or how many types are pass the IRB stage actively in the patients?

John Crowley

Chairman

Yeah. Then you know for a whole host of reason primarily competitive. We don’t provide that level of granularity except to say that we’re still confident and we’re reiterating the guidance that the study will be fully enrolled by year end. Again, there are more than 40 sites in six continents and we’re managing all of that with our clinical team here in the United States and we do it in partnership with CRO outside of the United States and we continue to see good progress in all the different parameters that we look at in terms of site selection, IRB clearance, contract work and ultimately patient randomization still. So far, we continue to on track.

Operator

Operator

Thank you. Our next question is queue comes from Geoff Meacham with JPMorgan. Your line is now open.

Geoff Meacham - JPMorgan

Analyst · JPMorgan. Your line is now open

Hi. This is Christian Gordy on behalf of Geoff Meacham. Thanks for taking my question. I have a couple of question. Starting with 011 trails, is there a plan for any interim analysis for 011?

John Crowley

Chairman

To no, we don’t have any plans for an interim look.

Unidentified Analyst

Analyst · JPMorgan. Your line is now open

In terms of the Phase II combo trial, I know you just stated it’s a proof of concept, could you elaborate a little bit on the design of the trials, the number of patients in that trial that’s there?

John Crowley

Chairman

Yeah. We, we haven’t yet finalized that. So we’re not going to comment on that Christian but it is a study where the goal would be to extend it from pre-clinical to clinical proof of concept. In terms of hitting the end target, elevating the deficient enzyme, we do that with a model therapy. Here, what we want to do is show was a patient gets their ERT, that we can show and that the pharmacokinetics change in that we can potentially get more of it to target itself. So I will look at a number of different parameters both on safety and efficacy.

Operator

Operator

Thank you. (Operator Instructions) At this time there appears to be further questions in the queue. Ladies and gentlemen thank you for your participation and have a wonderful day. You may now all disconnect.

John Crowley

Chairman

Great thank you all have a nice day.