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Amicus Therapeutics Inc. (NASDAQ:FOLD)

Q1 2008 Earnings Call

May 13, 2008 5:00 pm ET

Executives

John Crowley - President and CEO

Jim Dentzer - CFO

Matt Patterson - COO

Analysts

Terry Coyne - JPMorgan

Matt Osborne - Lazard Capital Markets

Alan Leong - Biotech Stock Research

Joe Aguilera - BioRevolution Capital

Operator

Good afternoon, my name is Sarah and I will be your conference facilitator today. 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 remarks, there will be a question-and-answer period. (Operator Instructions).

During this call we 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 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 like to update forward-looking statements at some point in the future, we specifically disclaim any obligation to do so even if our estimate changes.

Before we begin, we would ask everyone to go to the Investor Relations section of the company's website, amicustherapeutics.com, and printout the press release and related financial tables. These will be useful when the company reviews the financial results and for the reconciliation of the non-GAAP financial measures discussed today.

At this time, I would like to turn the conference over to Mr. John Crowley, President and Chief Executive Officer. Mr. Crowley, are you ready to begin?

John Crowley

Yes, I am. Thank you.

Operator

You are welcome, sir. You may begin your conference.

John Crowley

Great. Thank you and good afternoon to everyone, and welcome to the Amicus Therapeutics first quarter 2008 conference call. I am joined in the call today by Jim Dentzer, our Chief Financial Officer; by Matt Patterson, our Chief Operating Officer; and David Lockhart, our Chief Scientific Officer. After the initial remarks, we will try to accommodate as many questions as the time permits.

Let me begin by saying that as many of you know, Amicus Therapeutics is a bio-pharmaceutical company and that we focus on developing small molecule drugs, known as pharmacological chaperones for the treatment of a broad range of human genetic diseases. We see this chaperone technology as a new and powerful platform with potentially broad applications and also a technology that we are utilizing today to discover and develop new medicines in a broad range of fields.

We see two-three core areas of value for our shareholders. First, there are three lead chaperone programs which targets the lysosomal storage disorders, Fabry, Gaucher and Pompe disease, are all in clinical development with Fabry already having established proof of concept in man and validating the pharmacological chaperone platform.

Second, we also see that in developing these three lead candidates, we have a great strategic and worldwide development partner and we derive significant amount of value we think for our shareholders with through our partnership with Shire Human Genetic Therapies.

Third, I will highlight here the outset that we remain in a very strong financial position as Jim will discuss in greater detail in just a few moments.

So a number of accomplishments we would like to take you through for the first quarter of 2008 and I will begin with some of the highlights in our Fabry disease program. Several of these advancements include back in March where clinical investigators for the Amigal drug for Fabry disease presented a complete results for multiple Phase 2 trials of Amigal in Phoenix of the American College of Medical Genetics meeting. The positive results of these studies built on the preliminary results first discussed at our R&D day back in December. Some of the highlights to that data include first that Amigal was generally safe and well-tolerated at all doses evaluated with no-drug related serious adverse events reported.

We also demonstrated with Amigal an increase in the target enzyme level in 24 of 26 patients. Amigal was shown to reduce the accumulated substrate known as GL-3 in a majority of patients by multiple measures. We presented this data for the first time back in December and as many of you know we were very encouraged by this data as were a number of the investigators who we shared it with, some of whom were there with us that day and I can not underemphasize how significant it was to be able to take this platform technology with this first drug, Amigal and for the first time to put it in demand and to have the first demonstration that a small molecule Pharmacological chaperone can do what it was intended to. That is to selectively target, bind too and elevate the enzyme deficient and people living with these diseases. We think that was an enormous step forward for the technology for Amigal in particular and also for Amicus more broadly.

We also realized that data there were a number of questions that came out of this presentation of the initial data in our R&D day back in December. These questions generally centered around first dosing of Chaperone, particularly Amigal. Second the appropriateness of kidney GL-3 as measured in the year and on as circuit marker in Fabry disease. Third, questions around the regulatory path forward for Amigal for Fabry disease. I can assure you we have worked diligently together with our partners at Shire over the past four months to address these outstanding questions and let me provide just a little bit more color about some of the works that we have done to clarify this questions.

First on dosing. As you all know we have previously evaluated multiple doses and regimens in our Phase 2 Amigal studies. Coming out of the primary treatment periods for Amigal in this Phase 2, we saw that indeed we can hit the enzyme target, again elevated and also decreased for substrates that accumulates in Fabry patients. We have also seen encouraging trends in a variety of clinical measures in these patients. So we believe we have a dose and a dose regimen that we can move into Phase 3 studies.

In addition, with respect to the appropriateness of end points, over the past few months we have continued to consider in detail the Phase 2 clinical results with the study investigators and also done a series of additional preclinical studies to evaluate further the most optimized dose and dose regimen. Based on these evaluations we have amended the extension protocols to evaluate potentially optimized doses and dose regimens of Amigal. We expect data from these patients to be available in Q4, '08 to Q1, of '09 prior to our finalization of the Phase 3 protocols for Amigal for Fabry disease.

Second, we have worked extensively to understand and characterize the appropriateness of utilizing kidney GL-3, as measured in urine as a primary surrogate in point for Fabry disease. We continue to believe that this is the best, most objective, and least invasive surrogate measure available. Based on the consensus of many experts in the field and based on multiple prior published studies.

Thirdly, regarding the regulatory path forward for Amigal, Amicus together with Shire, have already initiated the process for obtaining feedback from the US and European regulatory agencies, regarding our plan for Phase 3 clinical evaluation of Amigal and the path for regulatory approval. We expect to complete these interactions and to provide an update on this path forward in the second half of 2008, and we also expect to initiate the global Phase 3 registration for Amigal for Fabry disease in the first half of 2009.

In parallel with the regulatory process, as I alluded to earlier, all 23 patients who voluntarily elected to go into the extension study with Amigal for Fabry and to have remained on the study continue to be treated with Amigal today in this voluntary Phase 2 extension study.

These are the patients who are moving to the potentially optimized doses and regimens and for whom we will have the results later this year or in early 2009. Of course, we continue to collect long-term safety and efficacy data from these 23 patients, some of whom have been on Amigal for the treatment of their Fabry disease for more than two years.

I should note too that every one of these patients has the option of going back to being treated with enzyme replacement therapy, but each one of them continued to voluntarily elect to take Amigal in their treatment for Fabry.

So for Fabry, to summarize significant number of events happening to advance this program to better understand the path forward as we prepare to move into Phase 3 with our partners at Shire.

Turning to Gaucher disease; in Gaucher, again at the American College of Medical Genetics meeting at March, the clinical investigators presented the full data from a four week Phase 2 study in patients who were switched from enzyme replacement therapy to our pharmacological chaperone for Gaucher disease, known as Plicera.

Highlights of this data include that first, Plicera was generally safe and well-tolerated at all doses, and that it increased the target enzyme activity in 20 of 26 patients. Five of the six patients without a clear increase were either in the lowest dose cohort or the cohort dosed least frequently. As expected in this short-term study, the levels of the relevant hematological markers of Gaucher disease remained stable.

Based in part on the work done in the Fabry program, both clinically and preclinically, around the dose optimization, Amicus has also amended the protocol for the ongoing six-month Phase 2 clinical trial of Plicera in individuals who are naive to enzyme replacement therapy . This study will now evaluate two-dose regimens, the first cohort will receive Plicera at 225 milligram, three days on and four days off of that drug and the second cohort will take Plicera at 225 milligram, seven days on and seven days off. We expect the results of this study to be available in 2009.

In addition, during the second half of 2008, Amicus expects to initiate a longer-term study in individuals switching from enzyme replacement therapy to Plicera, building on the knowledge and understanding that we developed in that first four weeks switch study.

Turning towards third lysosomal disease program, our program in Pompe. A number of advancements there. In Pompe, clinical investigators presented encouraging results at the ACMG Meeting from an Ex Vivo Response Study in cells obtained from patients with Pompe disease as well as three Phase 1 clinical trials of AT2220 in healthy volunteers.

Some of those highlights to bring to your attention here, the first is that in Ex Vivo response study, it was one designed to test the effective AT2220, that is our chaperone for Pompe, on various Pompe mutation. What the data showed was that of the 26 patients, the cells from 24 showed a dose responsive increase in GAA, the Pompe enzyme. The GAA level suggesting that a majority of Pompe patients may be amenable to chaperone therapy for the treatment of their Pompe disease.

In addition of the ACMG meeting, we also presented complete data from the Phase 1 trails and the total of 72 healthy volunteers in Pompe disease, and this showed that AT2220 was generally safe and well tolerated at all doses evaluated.

In the second quarter of 2008, Amicus plans to initiate a Phase 2 clinical trial of AT2220 in patients with Pompe disease. In addition, we are also conducting pre-clinical studies to evaluate the safety and therapeutic effects of administering AT2220 as a combination to the treatment with Myozyme.

Based on these pre-clinical results, we plan to consider initiating a clinical trail of an AT2220 Myozyme combination treatment in Pompe disease and this would be focused specifically at Pompe patients for whom AT2220 as a mono-therapy may not be appropriate.

In summary, we have made significant progress over the last quarter in each of our three lead programs. In other programs, we continue to accelerate our investment and research and development and to assess to potential for using this pharmacologic chaperone platform to treat a broader range of human genetic diseases beyond lysosomal storage disorders. As part of this effort, Amicus continues to conduct preclinical experiments in Parkinson's disease and that work I should notice funded in part by a grant from the Michael J. Fox Foundation.

We also continue to invest in new research aimed at evaluating disease targets for other neurodegenerative and metabolic disorders. With all those advancements and all the work that have done both scientifically and medically to advance these programs, I will take a break now and turn the call over to Jim who will give you a review of the financial results of the quarter and then I will take the call back and just provide some final commentary before we move to our Q&A session.

Hey Jim, pass the call to you.

Jim Dentzer

Thanks John and welcome everyone. I will provide a brief summary of the financial results for the first quarter. First let me note that in 2008 we are focusing our capital to advance our portfolio of three clinical development stage programs and fund investments into expanding the application of our chaperone technology platform to additional disease areas. Overall we used $7 million of cash in the quarter ending with a $155 million in cash and marketable securities. I will now briefly review the first quarter results.

In our press release, you will see that our GAAP financials are provided in table 1. The next two tables table 2 & table 3 are reconciliation of the GAAP and non-GAAP financial results. As noted on the reconciliation tables, the difference between GAAP and non-GAAP comprises charges for three non-cash items of stock based compensation, preferred stock accretion and changes in fair value for ones. Note that the charges for preferred stock and warrants do not impact the current period as they were converted to common stock in connection with the IPO.

Now let's move on to the P&L. On a non-GAAP basis, the net loss for the quarter was $6.4 million as compared to $8.9 million for the same period in 2007. The reduction in operating loss was driven primarily by revenue resulting from our collaboration with Shire. Recall that we signed a strategic alliance with Shire in November of 2007, which included a $50 million upfront licensing fee, $150 million in clinical and regulatory milestones, $240 million in sales milestones, tiered double digit royalties for each products sold ex-US by Shire and a 50-50 cost sharing on global development expenses for all three clinical programs in Gaucher, Fabry and Pompe diseases.

In addition, Amicus retains all US rights to these programs as well as rights to our other programs in our pipeline. Total revenue for the first quarter 2008 was $3.2 million comprising $0.7 million of collaboration revenue on the upfront payment and $2.5 million in research revenue for the reimbursement of R&D cost associated with each of our three lead programs.

Now to the R&D investment we spent $6.9 million on R&D in the quarter. While this is essentially flat compared to 2007, we expect that R&D will ramp up through 2008 as we initiate and enroll additional clinical trials, invest in clinical drug supply and expand our discovery research activities.

Our SG&A expense was $5.2 million compared to $2.9 million in 2007. This was primarily due to increased headcount and other administrative costs associated with being a public company. Our interest income for the first quarter was $1.7 million as compared to $0.7 million in the first quarter last year. This increase is primarily due to higher cash balances attributable to our 2007 initial public offering and the upfront payment we received from Shire.

Now turning to our balance sheet, we ended the first quarter 2008 with approximately $155 million in cash and marketable securities as compared to $162 million at the end of 2007. In short we have a strong financial position to support our pipeline development.

Our financial and related guidance for 2008 is as follows. We will continue to recognize the $50 million upfront payment from Shire on a straight line basis over an 18 year period from the date of the agreement last November. We do not expect to raise cash from any equity financings in 2008. We reiterate our guidance for 2008 net cash burn in the range of $40 million to $60 million. As a reminder our net cash burn guidance includes reimbursement of R&D costs, but excludes milestones from Shire.

With that I will turn things back to John for his closing comments.

John Crowley

Great thank you Jim, so hopefully you all get a sense that we have done a very significant amount of work through advance, the technologies, the programs and to better position Amicus to be able to execute on all the future studies that we need to do. For many of us like me who have been involved in these disease areas for over a decade it is quiet satisfying to see that patients may finally have an option for another therapeutic approach to their diseases.

When we think about Amicus, it is helping to shift the paradigm potentially for treatment of these diseases and to advance the science and medicine, we feel really good about the work that we have been able to do and that has all been grounded in data together with our consultation and the way the discussions with the experts in this field.

We have got a lot of work ahead of us for the balance of 2008 and as we move into 2009. In the months ahead, we will be looking to advance the global regulatory path for Amigal for Phase 3 development, we will be announcing the data from Phase 2 extension study on those 23 patients who continue to take Amigal for their Fabry disease.

We will be initiating additional studies in both Gaucher and Pompe disease, we will be exploring the potential use of our Pompe chaperone AT2220 as a combination therapy with Myozyme. Finally, we will be working to identify additional therapeutic areas to apply our pharmacologic chaperone technology.

We look forward to keeping all of you updated on our clinical and scientific progress and developments as we execute on the business plan, and I thank you. As I reminder I am joined here today not only by Jim, but by David Lockhart and Matt Patterson.

With that, operator, I will be happy to take questions.

Question-and-Answer Session

Operator

(Operator Instructions) First, we will go to Geoff Meacham with JPMorgan.

Terry Coyne - JPMorgan

Hello. This is Terry Coyne for Geoff today. Thanks a lot for taking the question. My question is on the, I am wondering if you can expand a little more on your specific plans for the Phase 2 Pompe trial. You can give us some details about what that trial could look like?

John Crowley

No. The only guidance I will give here is to say that by the end of this quarter, so within the next month or two, we will be initiating that study and at that time we will be able to comment on the study design.

Terry Coyne - JPMorgan

Okay. Are there any plans to look at the Fabry and Gaucher programs in combination with ERT in the near term? Or is that something that you are just going to look at with the Pompe program for now?

John Crowley

Well, we have chosen to begin looking at the potential for combination therapy. There are several different ways, of course, to look at combination therapy. So we think it is most appropriate to begin looking in Pompe disease, both by the nature of that enzyme replacement therapy, Myozyme that treats Pompe today for many patients, but also the nature of the disease. So we think that is best in terms of meeting unmet patient needs, but also establishing the potential for proof-of-concept of a combination approach..

So we will begin and continue to advance that pre-clinical work, but we are also mindful of the potential in Fabry and Gaucher. We just think given the nature of that disease in the patient population that Pompe has a better place to begin looking at the combo therapy. Again, I will highlight that as combo therapy, in addition to our initially pursuing in the clinic, the mono therapy, chaperone AT2220. Based on the Ex Vivo study that we shared at the ACMG, we are very encouraged by that data and we do believe that a good majority of patients with Pompe disease will be amenable to the chaperone as a mono therapy. We simply want to make sure that we are leveraging the technology as best we can to meet as much of the unmet medical need with patients as we can.

Terry Coyne - JPMorgan

Okay, thanks a lot.

Operator

Thank you. Next we will go to Matt Osborne at Lazard Capital Markets.

Matt Osborne - Lazard Capital Markets

Hello. Thanks for taking the question. John can you comment on the dosing regimen that are being explored, both for Plicera and Amigal? Was there a signal that you saw that is allowing you to consider different doses and can you describe a little bit more with, should we consider these as maintenance type dosing regimens that you will be exploring in both the extension Phase and the change in the Plicera study?

John Crowley

Sure. Let me begin by reiterating in Fabry disease with Amigal. We believe we have a safe and effective dose, safe for all patients, effective for a majority of the patients studied, and that dose again was a 150 mg given in an every other day fashion. What we were able to do is to look at the clinical data, particularly the people who have limited to non-responses with the chaperone. Try to think, are there different ways to approach it where we can get those patients to be good responders. So we looked at the clinical data. We conducted a series of preclinical experiments and then also we did some advanced PK/PD modeling, and our partners at Shire and their pharmacokineticists were particularly helpful here and there is a -- building on the on-again, off again with the 150 mgs every other day.

For Fabry disease, we are going to explore dose regiments where it is three days on and four days off, we are getting patients, and taking them to 250 mgs and then again up to 500 mgs. A total of four months of treatment; a two months in the first dose and dose regimen at 250, and then the next two months at the next dose.

So it was based on clinical data, preclinical data in pharmacokinetic modeling, and the intend is to evaluate potentially optimized doses. I am not sure that it will help the patients who already have a good response, but it may give us a chance to take the people with who are limited to non-responders and move them up to be good responders. The nice thing is, it is in this same patient population that we have already studied extensively and we are doing it in parallel with our regulatory discussions in the US and in Europe.

Matt Osborne - Lazard Capital Markets

Okay, and the same on Plicera. Was there a signal that you saw and can you describe and remind us what the original dosing was?

John Crowley

The Plicera, there is a lot of commonalities across the chaperone programs, particularly around uniqueness of dosing. So the decision to amend the protocols with Plicera was based in part on the preclinical and clinical work we had done with Amigal. So we leveraged a lot of those leanings. Plus some very specific work we did with Plicera in Gaucher disease. We explored in the switching study, a number of different dose regimens. In this current study I will highlight again that its 225 mgs three days on and four days off, and 225 mgs seven days on and seven days off. We think there is very strong rationale for why that may be a more optimized dose for these patients who are naive to enzyme replacement therapy.

Matt Osborne - Lazard Capital Markets

Okay, and can you remind us, how long it took you to enroll, this Phase 3 trial in the naïve therapy from start to finish?

John Crowley

Well, we are not commenting on enrollment of ongoing studies. I will say that in the switching study that we reported the data on back in March, the total time for enrollment of those 30 patients across 11 clinical centers just in the United States was about 6 months from start to finish.

Matt Osborne - Lazard Capital Markets

Okay, great. Last question on Amigal; what effort is ongoing if at all to establish kidney GL-3 as measured in the urine as a surrogate, what gives you the confidence so far, that this is a useful surrogate in the absence of a controlled clinical trial.

John Crowley

One of the things that we have done is to, not just extensively review the literature and their papers going back to 1971, describing kidney GL-3 as measured in urine, and why that is an appropriate objective measure of overall kidney function, multiple papers. We are happy to provide investors with those references and continue to speak to the experts about the appropriateness of that endpoint. For instance, I would refer you to a 2006 paper comparing the efficacy of Fabrazyme and Replagal in the presence of antibodies in the primary biochemical surrogate endpoint referred to their was kidney GL-3 as measured in urine. So that is part of our overall rationale. Its not again something we invented, this has been around for many decades. We think it is the most appropriate and objective measure surrogate marker in the disease.

Matt Osborne - Lazard Capital Markets

Can you look at the Shire patients or patients who are on Replagal and look back and see if there is a surrogate there as well with measuring urine GL-3 to their results on Replagal now, is that another way you could correlate your GL-3 with clinical outcomes? Is that something you are considering with Shire looking at now?

John Crowley

Let me begin by highlighting, we worked very closely with Shire, and I should also highlight that both for Fabrazyme and for Replagal, it is been very clearly demonstrated that with treatment, effective treatment with enzyme replacement therapy, that kidney GL-3 as measured in urine decreases. So yes, I will leave it at that.

Matt Osborne - Lazard Capital Markets

Okay, great, thank you.

Operator

Thank you. (Operator instructions) Next we will move to Alan Leong at Biotech Stock Research.

Alan Leong - Biotech Stock Research

I am going to ask a couple of side questions. The upcoming results like lets say your pre-clinical results that you are working on for Pompe Disease, first in typical conferences that you might be presenting it and if you still looking at doing at presenting the results initially thorough a PR release?

John Crowley

Yes, we have got a pretty robust publication and release strategy and we have presented at many conferences over the past year. So, you can look to conferences like the American Society of Human Genetics, American College of Medical Genetics, the Neuroscience Conference. There are number of other geographic specific conferences in genetic diseases and you can expect going forward that we will continue to present data posters symposia at all those major events.

Alan Leong - Biotech Stock Research

So I got to keep my eyes open all over the place this year. Thanks a lot.

John Crowley

Yes as well as multiple LSD conferences, LSD specific conferences.

Alan Leong - Biotech Stock Research

LSD conferences. Thanks.

John Crowley

Sure.

Operator

Thank you. We will take our next question from Joe Aguilera at BioRevolution Capital.

Joe Aguilera – BioRevolution Capital

Congratulations on your IPO and your Shire deal. Just a few questions, John first of all on the Phase 3 for the Fabry, how many patients do we expect to have and how long do you think that Phase 3 might take, roughly?

John Crowley

Yes, let me begin by saying that we think there are a number of potential paths that could make sense for Phase 3. There is a particular path that we believe maybe the more optimal way to show the safety and efficacy of this drug and in a relatively high level. I will ask Matt Patterson to comment what our thinking is there.

Matt Patterson

Sure. I will be happy to, John. We have spent a lot of time working with the experts in the field and with our partners at Shire to come up with a Phase 3 strategy that we think makes sense. The study design that we have in mind that we intend to propose and discuss with the authorities this year is a design that built on the switching concept, switching from enzyme replacement therapy concept we have spoken about before, and specifically the vision is that a trial could be performed in patients who are currently on enzyme replacement therapy, have know responsive mutations to the chaperone and could be randomized into a study that allows the comparison of them remaining on ERT, or going on to Amigal.

So it'd be a non-inferiority study that compares the two treatments, and looks at endpoints overtime, but as John has described, uses of primary endpoint to surrogate endpoint of Kidney GL-3 as measured in the urine and it would on a comparison on that endpoint that would be the basis for a license applications globally.

As far as patient numbers, it is a little difficult to estimate that with great specificity, but I think it is reasonable to think that it will be slightly larger than LSD studies, Fabry studies done in the past. I think a number range of 75 to 100 would be reasonable.

Joe Aguilera – BioRevolution Capital

So how are you going to get enough patients for all these very limited disease markets?

Matt Patterson

Well, we work globally. Remember the child design as such that we would work with patients who are on enzyme replacement therapy globally and that is several thousand patients today. So, we would work globally with centers that we have worked with through our Phase 2 and in collaboration with our partner at Shire, and certainly you would involve many different centers globally to ensure you could enroll the trial on a reasonable timeframe and that is our expectation.

John Crowley

In fact one of the reasons why we like the non-inferiority designs is because it is in essence a switch study. So these disease has a pretty large existing patient population already on ERT. So, we do not have to just carry the world for that level or that number of patients who are naive to ERT. So, we think actually this trial design, in addition to potentially demonstrating very strongly the safety and efficacy of the drug, also we will address any concerns around the ability to rapidly unroll the study.

Joe Aguilera – BioRevolution Capital

When would the next milestone be with Shire. What would be the announcement and who would you have to meet to get that milestone, how much would be the first milestone?

John Crowley

Sure we do not comment, by the nature of our agreement with Shire, we can not comment on the specific milestones, triggers or amounts expect to say that there is $150 million in clinical and regulatory milestones that are achievable by Amicus and that some of those milestones are achievable within the next 12 to 18 months.

Joe Aguilera – BioRevolution Capital

Are you expecting to replace basically Genzymes products with Amicus or to compliment them? Can we really, maybe you can talk about that, John?

John Crowley

Well, I will just say that, we think going forward, as we continue to prove the safety and efficacy of these drugs and that they hopefully come to market that physicians and patients will be able to evaluate what is the most appropriate drug for their use. We do think that ours is a paradigm shifting technology for many patients with these diseases and that in each of these three diseases at least a majority of patients should be amenable to taking these chaperone drugs as a mono therapy for their standard of care.

Joe Aguilera – BioRevolution Capital

So if the patients fail, let's say Genzymes, they will be able to take ours, hopefully. Correct?

John Crowley

I am sorry. I did not get that.

Joe Aguilera – BioRevolution Capital

If they fail Genzymes products, then they will be able to take out products?

John Crowley

Well, I think there is a number of different ways to look at it. I think patients who are diagnosed with these diseases, who have identified mutations that are amenable to these therapies could well take this as their first and lifelong treatment, and I think for existing patients, it will be patients who will be switched. The majority of our patients we expect to switch overtime as the standard of care evolve to chaperones as the mono therapy. So, I think that is it. If there are no other question, operator?

Operator

There are no further questions at this time sir.

John Crowley

Terrific, great. Well, thank you all for listening and we are going to get back to work. Have a great day.

Operator

This concludes today's conference. Thank you for participating and have a nice day.

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Source: Amicus Therapeutics Inc. Q1 2008 Earnings Call Transcript
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