Amicus Therapeutics Inc (FOLD) 2011 Q2 法說會逐字稿

Good day, ladies and gentlemen, and welcome to the Amicus Therapeutics second quarter 2011 results. (Operator Instructions) As a reminder, this conference call is being recorded. I'd like to turn the call to your host, Ms. Sara Pellegrino. You may begin.

Good afternoon and thank you for joining our conference call to discuss our second quarter of 2011 financial results. Speaking on today's call we have John Crowley, our Chairman and Chief Executive Officer; Bradley Campbell, our Senior Vice President, Business Operations; and Daphne Quimi our Corporate Controller. They are also joined by executive team members David Lockhart, Our Chief Scientific Officer and Pol Boudes, our Chief Medical Officer, who are available to participate in the Q&A session.

As a reminder, this conference call will contain 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 candidate drug products and the projected cash position for the Company. Words such as, but not limited to, "believe", "expect", "anticipate", "estimate", "intend", "likely", "should" and "could" and similar expressions are words identifying forward-looking statements.

Although Amicus believes the expectations reflected in such forward-looking statements are based upon reasonable assumptions, there can be no assurance that its expectations will be realized. Actual results could differ materially from those projected in Amicus' 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, 2010 and our other public filings with the Securities and Exchange Commission. Amicus does not undertake any obligation to publicly update any forward-looking statements to reflect 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 John Crowley, Chairman and Chief Executive Officer of Amicus.

Great. Thank you, Sara, and welcome, everybody, this evening to our second quarter of 2011 conference call. I'm happy to lead today's call and to be back again at Amicus and to provide you with an update on our Phase III Amigal study for Fabry disease, which, as many of you know, we refer to as our Study 011, as well as some other significant and I think very positive developments here at Amicus.

Through this part of the conversation, I'll be joined here shortly by Bradley Campbell, our Senior Vice President, Business Operations. Brad will provide some additional comments and color on the progress of our development pipeline. I'm also joined by Daphne Quimi, our Corporate Controller, and Daphne, as before, will go through our second quarter financial results and guidance and then we'll open up the call to questions. And as Sara indicated, we also have Dr. Pol Boudes, our Chief Medical Officer, as well as Dr. David Lockhart, our Chief Scientific Officer here as well.

Again, let me state that it is terrific even in these turbulent market times, to be back at Amicus. I think this is a Company we all have tremendous confidence in and to be here at a time of such positive momentum is a truly exciting experience for all of us as we keep driving the programs forward, including our top priority, the Phase III study of Amigal.

Let me begin by reiterating, as we began the year talking about some of our key corporate strengths and key messages. First, of course, is the strength of our partnership with GSK Rare Diseases and also and closely related that it is our continued strong financial position here at Amicus. We believe we have several opportunities to create shareholder value, principally through leveraging our core technology platform and chaperones, as well, again, with our lead program Amigal for Fabry disease.

I'm thankful that the organization has been strong and consistent even in my absence over these last months. I am, as many of you saw with our press release, I'm particularly thankful to Matt Patterson, for his tremendous leadership of Amicus over the past several months in the acting CEO role and to Matt's many contributions over the nearly seven years that he's been here. For all of his work in the last few months to keeping the Company on track towards completing the Phase III Amigal study, as well as advancing the rest of our clinical studies and leveraging our pipeline.

Again, Matt will be leaving Amicus, as we announced in the press release, at the end of this month to pursue other opportunities in the industry. I've had the pleasure to work with Matt since we first came into this Company together at the end of 2004. He has been a tremendous asset to the Company, a tremendous friend, to me and to many others here, and I know I speak for everyone at Amicus by knowing, by stating that Matt will be missed, but I'm very confident that he is headed towards further great successes in his future endeavors.

Again, we're upbeat about the current pace of screening. Let me talk a little bit about the 011 study here. Again, this is our pivotal study for U.S. registration of Amigal for Fabry disease here in the United States. This has been an effort now for the better part of a year-and-a-half for our Phase III study. It is one of the most complex and I think exciting studies ever done in the rare disease space. I can tell you that both Amicus and GSK, working closely together, confidently expect that we will close recruitment in the third quarter, or early fourth quarter of this year and that the final patient will come onto drug and enroll sometime in the fourth quarter of this year.

I think, like many studies in the rare diseases, the enrollment has been challenging. We've learned much. We've kept to very strict Phase III entry criteria and given, particularly some of the evolving Fabry market dynamics, especially those related to enzyme supply issues over the last two years. I'm extremely proud of all of the work that's gone into the team's efforts here and to the nearly 40 clinical sites around the world that have worked with us in partnership to find the appropriate Fabry patient to screen them and to enroll them into this study.

We continue to remain true to our strategy in this program and are confident that the Phase III protocol design that we established gives this study, and quite frankly by extension all of our Fabry programs and technology, the best potential for success. We do very much look forward to the tail end of completion of this study. We expect to complete recruitment soon, which we will announce in a separate press release and again, expect to enroll the final patient in the fourth quarter of this year.

The close of recruitment of this study, as well as the final enrollment, are both very significant milestones for Amicus. Let me remind everybody that this was an entry criteria where people of course had to have Fabry disease; they also had to be naive to enzyme replacement therapy. They had to have appropriate mutations to respond to Amigal as a monotherapy. They had to have a 4x neuronal elevation of GL3, the substrate that builds up in Fabry disease. All of that, we think will, has led to a very robust study and one, again, that we're eager to complete enrollment on here shortly.

I'll highlight, too, the consistent with the physician feedback, that the 4x GL3 elevation and the strict entry criteria have been barriers to the study, even greater barriers than the kidney biopsy that was included, but we're very, very pleased with the progress. We're pleased, again, with the types of patients who are in this study and advancing this study toward completion remains our top priority. It fits in with the mission here at Amicus to address unmet patient needs and particularly in the current landscape around all the supply issues and we think Amigal could potentially offer significant benefits for people living with Fabry disease.

I'll also remind everybody that 17 people with Fabry disease remain in our Phase II extension study and that data is extremely important to us now, all patients having completed at least three and some now more than four years on that drug, even though every one of those patients in this voluntary extension has been given the opportunity to stop their Amigal treatment and to move back to enzyme, or to move to, enzyme therapy if they were naive. So we think that continues to provide strong confidence in the experience that patients and physician are having with this drug.

With that, let me turn the call over to Bradley Campbell. I'll ask Brad to give us an update on our progress with the second Phase III Amigal study, Study 012, our Phase II study to evaluate pharmacological chaperones coadministered with enzyme replacement therapy, the combination therapy approach that we've talked to many of you about and that we continue to be very excited about, as well as our pipeline in diseases of neurodegeneration, particularly Parkinson's and Alzheimer's.

So, Brad, let me turn it to you.

Thanks, John. Just to reiterate the point, we do remain extremely encouraged by the current momentum on 011. This is really a critical milestone for us and we're excited to complete that in fourth quarter.

So, building on the momentum, we remain on track in the third quarter to dose the first patient in Study 012, which is our second Phase III study of Amigal for Fabry disease. As a reminder, this is the 18-month, randomized, open-label, Phase III study, which is the first to compare the safety and efficacy of Amigal and enzyme replacement therapy, or ERT. The primary outcome of efficacy is renal function as measured by glomerular filtration rate, or GFR. In our primary analysis, we'll use descriptive statistics to compare the mean change in GFR between Amigal and ERT.

During the second quarter we continued to open sites for our Study 012 outside the U.S. and began screening male and female patients with Fabry who are on ERT and have genetic mutations that may be addressable with Amigal. Unfortunately, recruiting patients that are already on at least 80% of a labeled dose of ERT has continued to be a challenge with the extended global Fabry shortage, especially at sites in the U.S. Despite this difficulty, we are on track to dose the first patient this quarter and we've been proactive with GSK in moving forward as quickly as possible.

Our ex-U.S. sites with access to Replagal are less impacted by the shortage and have been initiated first, where we continue to target additional sites around the world. And really, in our experience it's the number of sites which is the key driver for enrollment timelines, so we may open as many as 50 sites globally to support the study.

In addition, study 012 was recently amended to randomize approximately 50 patients, with 30 to switch to Amigal and 20 to remain on ERT. As the first pivotal study to evaluate long-term clinical data and compare Amigal to ERT, Study 012 is an important component of our global registration study for Amigal. It's also expected to support our Phase IV post-approval requirements under the U.S. accelerated approval pathway and we're eager for the first patient to be treated. We'll issue an announcement on that, as soon as it happens, to let you know.

Also on the horizon for this year we expect important milestones surrounding coadministration of pharmacological chaperones in ERT. This is really a component of the expansion of our technology platform and one that we believe has the potential to build significant shareholder value.

As a reminder, we're currently running two Phase II coadministration studies that are the first in man. These are designed to build on the preclinical proof of concept data in animal models of both Fabry and Pompe disease. Our preclinical work has consistently demonstrated that a pharmacological chaperone can selectively bind to and stabilize infused ERT, prevent the loss of ERT in the circulation, increase tissue uptake of ERT and increase substrate reduction over ERT alone.

In Study 013, which is our Phase II study of Amigal coadministration with ERT for Fabry disease, patient enrollment is already underway and we anticipate preliminary results in the fourth quarter of this year. While Amigal monotherapy is a promising oral treatment candidate for Fabry patients who have amenable genetic mutations, we believe that Amigal ERT coadministration might benefit the remainder of Fabry patients regardless of their mutation.

When coadministered with ERT, Amigal binds to the recombinant enzyme being infused, so genetic mutations are not a factor. So, in one form or another, we hope that Amigal may be able to treat all individuals with Fabry disease and the preliminary results of Study 013 should help us better understand the potential for this treatment going forward.

Turning now to our program for Pompe disease, we continue to believe that there is significant unmet medical need to improve patient outcomes with current ERT treatment in Pompe. For Study 010, which is our Phase II study of AT2220 coadministered with ERT, we do remain on track to dose the first patient during the third quarter. Study 010 is designed to further explore our previous preclinical findings that demonstrate AT2220 combines to and stabilizes infused ERT, increase glycogen substrate degradation, and reduce immunogenicity.

Following the same principle of Study 013 for Fabry, Study 010 will investigate drug-drug interactions between AT2220 and ERT. The primary outcome measures will be safety and a comparison of ERT activity in plasma, with and without coadministration of AT2220.

So both of these Phase II coadministration studies in Fabry and Pompe will provide important findings, generally, on whether the addition of a pharmacological chaperone prior to ERT can reduce either the dosage or reduce the frequency of ERT infusions, two things that would make a significant impact for patients.

Before we wrap up today's call I want to comment briefly, also, on our preclinical programs for diseases of neurodegeneration. As a reminder, based on the observed genetic association between Parkinson's and Gaucher disease, we're evaluating AT3375 in late-state preclinical proof of concept studies for Parkinson's disease and we continue to anticipate that these results will be available during the second half of this year.

As a reminder, 3375 is a pharmacological chaperone targeted at glucocerebrosidase, or GCase, which is the enzyme deficient in Gaucher disease. Remember, the mutations in the GBA1 that encode for GCase are the most common genetic risk factor known for Parkinson's, so not only are Gaucher carriers who have one mutant copy of GCase approximately 5 times more frequent in the Parkinson's Disease population, the Gaucher patients have an estimated 20-fold increased risk of developing Parkinson's Disease.

So our ongoing preclinical studies of 3375 are designed to support an IND filing for potential entry into the clinic next year.

Finally, we're also continuing our preclinical work in genetic subpopulations of Alzheimer's disease and we'll update you on the progress as appropriate.

So now that I've gone through our main development programs, I'll turn the call over to Daphne Quimi, who is our Corporate Controller, who will revenue our financial results for the second quarter of 2011. Daphne?

Great. Thanks, Bradley, and good afternoon everyone. Before I review the second quarter 2011 financial results, I will comment briefly on our cash position and financial guidance.

To summarize our outlook, we remain confident in the overall strength of our financial position, as we approach major milestones for our development programs. As of June 30, 2011, cash, cash equivalents, and marketable securities totaled $83 million, compared to $93.8 million at March 31, 2011.

Our current cash position, including anticipated payments from GSK in connection with the collaboration, is expected to be sufficient to fund our operations and capital expenditure requirements through at least the end of 2012.

As a reminder, we are eligible to receive up to $170 million from GSK upon the successful achievement of development and commercialization milestones as well as tiered, double-digit royalties on global sales of Amigal for Fabry disease.

For 2011, we expect operating expenses to total $50 million to $55 million, net of anticipated cost-sharing related to the GSK collaboration and within the guidance range of $45 million to $55 million that we introduced in early January.

Turning to the financial results, I will be referring to Table 1 in our press release, which is available on our corporate website at www.AmicusTherapeutics.com. Additional details can also be found in our Form 10-Q to be filed later this week.

Total revenue for the second quarter of 2011 was $4.0 million, compared to no revenue in the prior year period. Our total revenue consists of research and collaboration revenues recognized under tour collaboration with GSK for Amigal.

Research revenue reflects reimbursement from GSK related to our agreement to share total development costs for Amigal. Each quarter, GSK reimburses us for the portion of our actual spend that exceeds our obligation. As a reminder, Amicus and GSK are equally sharing development costs for Amigal in 2011, and GSK will be responsible for 75% of these costs in 2012 and beyond. Amicus and GSK reconcile each party's spend for the Amigal program on a quarterly basis, to ensure that costs are shared in accordance with this arrangement.

For the second quarter of 2011, research revenue was $2.4 million, down from $4.3 million in the prior quarter. Quarter-over-quarter, GSK incurred a higher percentage of total Amigal costs relative to Amicus, so we were reimbursed a lower amount. Research revenue is expected to fluctuate, quarter-to-quarter, relative to our proportion of total Amigal expenses and the percentage we are responsible for paying under the agreement.

Collaboration revenues for the second quarter of 2011 was $1.66 million and reflected the recognized portion of the $33.2 million upfront payment received from GSK upon signing the agreement. The total upfront consideration, consisting of a $30 million license fee and a $3.2 million premium on GSK's equity investment, is being recognized on a straight line basis. At June 30, 2011, we have recognized approximately $4.2 million as collaboration revenue.

Total operating expenses for the second quarter of 2011 were $18.8 million, compared to $12.7 million in the prior year period. The increase was primarily attributed to higher expenses for research and development, as well as stock options.

Research and development, or R&D, expenses, were $11.6 million in the second quarter including $651,000 of stock-based compensation expense, compared to $8.1 million in R&D expenses including $605,000 of stock-based compensation expense in the prior year period. The year-over-year increase in R&D was primarily a result of higher contract research and manufacturing costs within the Fabry program.

General and administrative, or G&A, expenses for the second quarter of 2011 were $6.7 million, including $3.2 million of stock-based compensation expense, up from G&A expenses of $4.0 million in the prior year period. The increase corresponds to an additional stock option compensation expense to modify the term of our Chief Executive Officer's stock option grants in connection with his amended employment agreement.

During the second quarter of 2011 we recorded non-operating income of $2.15 million, consisting of interest income and a recorded gain for the change in the fair value of our warrant liability.

Net income for the second quarter consisted on interest income of $5,000, compared to net interest expense of $20,000 in the comparable quarter last year, due to less outstanding debt on our secured loan.

For the second quarter of 2011 we reported non-operating gain of $2.1 million related to the change in the fair value of our warrant liability, compared to a gain of $1.4 million for the second quarter of last year. Warrants issued in connection with our March 2010 registered direct offering of common stock were recorded as a liability at their fair value on issuance dates. The fair value of these warrants increases or decreases with the change in our stock price and we report the change at each reporting date until the warrants are exercised or expire.

Net loss attributable to common stockholders for the three months ended June 30, 2011 was $12.6 million or $0.37 per share, compared to a net loss of $11.3 million or $0.41 per share for the same period in 2010. Weighted-average common shares outstanding were 34.5 million and 27.6 million for the three months ended June 30, 2011 and June 30, 2010, respectively.

This summarizes our key financials for the second quarter of 2011. I will also be available to answer questions during the Q&A session of this call. With that, I turn things back to John.

Great, thanks, Daphne. So, hopefully, you all get a sense for the tremendous amount of activity and work going on at Amicus.

We're very excited for a number of the upcoming milestones between now and the end of this year. Some of those include completing recruitment in the Phase III Amigal study in the third or early fourth quarter and then the final enrollment in the fourth quarter of this year. Also looking forward to the dosing of the first patient in our second Amigal Phase III study, as well as our Phase II study of AT2220 coadministered with enzyme replacement therapy in the third quarter.

We also look forward to, between now and the end of the year, announcing preclinical proof of concept study results of AT3375 for Parkinson's, as well as reporting preliminary results of our Phase II coadministration study that Brad talked about of Amigal and ERT in the fourth quarter, again that being a really important extension of the platform technology with this combination therapy approach.

Again, Amicus is a very special place and I am pleased and honored to be back as CEO and with that, we'd like to open the call to questions, so please do so.

(Operator instructions) Ritu Baral, Canaccord Adams

Hi. Thanks, everyone, for taking the question and for holding the call today. Can you guys talk to enrollment trends in the 011 trial, what you're seeing as far as enrollment across geographies, any particular mutation trends that you're seeing? And also, if you could, give us an update on the dropout rate?

Yes. Let me go ahead and take that and Brad, feel free to add any color re 02. Over the last, I'd say year, has been really when we've been enrolling the patients. We've had a few outliers, I think as you know, maybe almost 18 months ago. There've been a couple of ebbs and flows with recruitment.

We look at the funnel in two ways. We look at it, first, patients presenting for the study to qualify, who go into the recruitment funnel and then once they come out of that and we've classified and quantitated their GL3 levels, their genotype, and then they actually move into enrollment at the bottom end of the funnel. There have been periods where the top end has been pretty rich in patients presenting and periods where we've seen more emphasis on the bottom end of moving patients into the study. I'm really pleased with where we are now. I think we have a good balance.

We continue to move. It's been slower that we would have liked, for sure. But I think sticking to that strict entry criteria, I'm pleased with both ends of that funnel right now and I think that gives us the confidence to state that we're going to finish recruitment here very shortly and then actually get that final patient on drug in the fourth quarter.

We have enrolled more patients ex-U.S. than U.S., but that's not unexpected and I think consistent with our prior statements and how the study, quite frankly, was designed. With respect to mutations, we're not going to comment on that, except, as we've always known, that we expect many patients with varied missense mutations. Again, quite a few, several hundred, that we know would qualify under the HEC assay that we've developed with the genotyping for the entry criteria into the study.

So I think those are, to give us a little bit more flavor, Ritu, for some of the dynamics in the study. The momentum has continued. This slope of the enrollment curve is slower than we had predicted maybe six months ago, but I think we're at the very tail end of that.

And then the -- I'm sorry, I forgot the second part of your question.

The dropout rate.

Oh, yes. The dropout rate has been less than we thought, so that gives you further confidence in the enrollment.

So you would still describe the trial as being substantially enrolled, as you did feel last call?

Oh yes, very, very much so.

And for the 012 trial, do you believe that they're -- I'm sorry. Does the trial design dictate a sort of set stratification or a set percentage between patients formerly on Fabrazyme or patients on Replagal?

No it doesn't, Ritu. There's no set stratification.

Got it and --.

We did that, as you might expect, specify anticipating challenges with the Fabrazyme enrollment, so it really -- or with the Fabrazyme shortage, excuse me. So, while the shortage really impacts us from a site perspective, in terms of who can come onboard, whether or not they have access to Replagal, it doesn't impact us from a study design perspective.

Got it. Are there a certain sort of data trends that you would expect having a predominance of patients formerly on Replagal, or compared to Replagal?

Not necessarily. I mean, I think this will be the single largest study comparing active arms of both ERT's plus chaperone. So I think we're very much looking forward to seeing the data and as you know, there's clearly wide debate in the industry over whether there are differences between Fabrazyme and Replagal, but we don't expect anything significantly that would impact the outcome of the study.

Got it and a final question. Are you -- can you give us an update as far as what activities you're conducting as far as pricing sensitivity, exercises, or patient community outreach to date?

Yes. We continue to work very, very closely with the patient community, as you know, Ritu. We started early on at Amicus with a patient advocacy department. We have a senior director of patient advocacy and a staff under her, together with our medical affairs department and honestly, a good part of Amicus that's very, very patient-focused.

So we continue to maintain an open dialog. We have, for instance, in addition to our scientific and medical advisory boards here at Amicus, we also have a Fabry patient advisory board who we rely upon in trying to gauge a sense of the needs of the patient community and help inform our studies. So I think that's a really important part of our overall business strategy.

With respect to pricing, we've done a lot of early commercial work. We have a joint team that looks at that now with GSK. Obviously very early to try to indicate where our pricing is going to be, but I can assure you within our teams and then beginning the discussions with third party payers, we'll make sure we've done a significant amount of research before the price is set. And again, of course, this is going to be GSK's drug commercially, to market worldwide, but we expect to have a significant amount of input in the commercial strategy.

Great. Thanks for taking the questions, everyone.

Yes, of course. I look forward to seeing you here shortly.

Thanks.

Joseph Schwartz, Leerink Swan

Hi, thanks. I was wondering. Would you think that the pace of enrollment in the second Phase III 012 study would be more rapid relative to the 011 study? On the one hand there's no biopsy or urine GL3 requirement and there's no placebo arm, I think, but on the hand you may have to convince some patients who have worked hard to get ERT to go off. How would you think through those issues?

Yes. I'll tell you, Joe, you described it absolutely right. That's the balance that we're facing. Our assumption had always been, going back awhile, that this would be a more straightforward study to enroll, given the factors that you just laid out.

The one confounding factor has been the enzyme supply shortage and that's been very, very frustrating and scary, honestly, for families living with Fabry disease today. We continue to work with physicians. It means this, at least in the early days, is a very heavily ex-U.S.-focused study where there is still a significant amount of Replagal available and a fair amount of Fabrazyme as well.

So we'll have to wait and see. It certainly had a negative impact to data and we'll have to see, as the supply issue becomes more clear, as honestly, peoples' confidence in our drug as the Study 011 study becomes fully recruited and then enrolled. I think that'll give people further reason to believe that Amigal is likely to be a safe drug and based on the data, a potentially efficacious drug as well.

So we continue to think and work pretty hard on all those issues and work very hard with our clinical sites, especially the ex-U.S. sites outside the United -- for the 012 study.

And that's one place, too, that GSK has been a big help, because their global footprint allows us to access geographies that we may not necessarily been able to do on our own. And so, as I mentioned in my talk, really one of the most important ways to combat that challenge is to have more sites onboard to help you find every patient that might be willing and interested in coming in who has availability of full dose either of Fabrazyme or Replagal. So that partnership has been important there, in addition to the kinds of activities that John alluded to earlier, in terms of reaching out to the patient community, the physician community, etc.

Yes. It's an important study for us, Joe. It's one -- it's certainly our Phase IV commitment to the U.S. FDA. But also, too, I think ultimately for commercial and marketing purposes, it's data that'll be important to us in distinguishing the characteristics of the chaperone approach to treating Fabry disease versus the current standard of care with ERT, so it's one we remain very committed to and continue to focus on very hard.

How many sites will overlap between the 011 and the 012 study and will there be an all-new IRB process required? Or do you think you can get some traction based on your going through that process already with a lot of sites who seem to find that somewhat cumbersome?

Yes, I mean, I think the overlap right now, if I could guess, although I don't have the numbers, is probably something like 50-50. There are some sites who continue to be leaders in the space, who have access to ERT, who are enthusiastic about participating in the study.

There are other sites in new geographies, for example, where we've been able to expand into thanks to the help, in part, of GSK, where they weren't previously part of the 011 study. And certainly, having a relationship with those physicians, knowing they're IRBs and their contracts are in process, helps and in some cases you can leverage those operational efficiencies.

But the reality is every time you go through the process it is a new process, and so it cuts down the timeline to some extent and certainly there's value in having an existing relationship, but it's still a process to go through that. And again, that's why we're, early on, identifying the need to bring more sites onboard than you might in a normal study outside of this space.

Okay, a last question. What does it mean that the EMEA will require descriptive statistics and do you think there's any way that they might accept 011 data for filing?

Joe, it's Paul, meaning descriptive statistics, it means it's a comparative. So it's like an equivalence trial, but you don't need to define your margin or it's equivalence.

Actually, it works significantly to our favor, not being held to a predefined standard here in the FDA -- or, I'm sorry, the EMEA essentially saying "Bring the data to us". And I think that'll play greatly to our advantage.

Great.

The second part of your question about whether or not we think the EMEA will accept the 011 data, that's obviously something we've mentioned before, that we will continue to pursue with them. It's our hope, based on the current environment and the shortages of Fabrazyme and the challenges that are out there in the space, that they may be more receptive to that and we'll pursue that aggressively with GSK. And if we have an update on that, we'll let you know.

Great. Thanks for the color.

(Operator instructions) Anupam Rama, JPMorgan Securities, Inc.

Hi, this is Anupam Rama in for Jeff Meachum, just a quick question on timelines for the study 012, the first patient being enrolled in 3Q. But what are some of the goals for enrollment completion and when we might see data? And then I didn't actually see in the press release what your expectations are for timing of data for the 011 study. Is that now more of a second half '12 thing or could we see it earlier? Thanks.

Yes. Let me kind of take that piecemeal. I think in terms of specific goals related to 011, we haven't -- we've been real careful, for competitive and other reasons, Anu, not to actually put out any specific quantitative targets or criteria related to that. I'll just reiterate that we continue to see momentum.

We continue to see patients presenting for the study, enrolling in the study. I think the slope of that enrollment curve, given a number of different factors, is one that's a little bit different than it was six months ago. And with that, we'll just reiterate that guidance, that we expect the recruitment, meaning people, presenting for the study and qualifying for the study to complete here in Q3 or early Q4 and the last patient into that 60-person study coming onto drug sometime in the fourth quarter.

And then the specific guidance with respect to the 011 data we'll provide once we have that final patient into the study on drug. So, we'll be able to give that, certainly, by the end of the year.

Great. Thanks for taking out question.

You bet.

(Operator instructions) I'd like to turn it back over to management for closing.

Great. I don't have anything else. Thanks, everybody, for listening. Sara, anything else? We're good. Wonderful, thank you, have a good night.

Ladies and gentlemen, thanks for participating in today's program. This concludes the program. You may all disconnect.