Amicus Therapeutics, Inc. (FOLD) Earnings Call Transcript & Summary
May 24, 2021
Earnings Call Speaker Segments
Eliana Merle
analystWe have Amicus Therapeutics here with us today. With us from Amicus is John Crowley, Chairman and CEO. Thank you so much for joining us at the UBS Healthcare Conference.
Eliana Merle
analystAnd maybe just to kick it off, John, just for some background, those who are newer to the story. Can you give us a quick overview of Amicus' rare disease portfolio and, I guess, key goals for the company in the coming years?
John F. Crowley
executiveGreat. Of course, Ellie. Thank you, and thank you for having me. I apologize I have to join by telephone here. I guess I didn't have the latest version of Google Chrome updated. But thank you, everybody, for listening. To remind everybody, Amicus is a global biotechnology company, and we focus in the rare diseases, and we have since the founding of the company. We have a range of technologies that we bring to bear. The cornerstone of our success is our small molecule precision medicine for people living with Fabry disease with certain, what we call, amenable variants or mutations of that disease. And that's been a very successful program and now product for us, medicine for patients. In the third year of its global launch. It's been a very successful launch with much more opportunity to help people ahead, and I know we'll get into that in more depth. And again, a program that we expect now in its third year of full global launch to generate revenue of about $300 million to $315 million. On its way to the next milestone in the next couple of years of $500 million in revenue, and we think with the potential for about $1 billion in peak revenue, and again, the opportunity to help transform the lives of thousands of people living with any one of these amenable variants in Fabry disease. So continuing the successful launch of that program, that medicine, Galafold, is incredibly important for us. And we're also very excited about what will be our second medicine for people living with a rare disease, and that's a medicine we designate now as AT-GAA for people living with Pompe disease. That's all people living with Pompe disease. And as you know, Pompe is a rare, devastating musculoskeletal neuromuscular disease affecting people from infancy all the way through adulthood. We've completed our Phase III study, and we're now in the process of preparing our global regulatory submissions, including our BLA submission here in the United States after our successful pre-BLA meeting a few weeks ago with FDA. And that will be complete and into the FDA here in the next few weeks. And then we expect filings in Q3 in Europe and in other important geographies around the world. And again, another medicine that we think has the potential to become the new standard of care for everybody living with Pompe disease. And we are prepared for a launch by the end of this year, by December of this year, as early as December. And we expect approval most likely in the first part of 2022 in the United States. So those are our 2 most advanced programs. And then we've assembled over the last couple of years what is now, we believe, the largest portfolio with gene therapy medicines for rare diseases, including 2 late-stage clinical programs in 2 different subtypes of a fatal brain disease in children, known as Batten disease. And again, much of this anchored in our original relationship with a nationwide children's hospital and now our significant partnership with Dr. Jim Wilson in UPenn. So those are the kind of the outline of the portfolio and programs at Amicus. And all of this value underpinned by our strong financial strength, and I'm sure we'll get into that as well. So that is Amicus. We've made much progress, particularly now in the transition to a global commercial company, and we continue to have a very, very big vision for the years ahead.
Eliana Merle
analystThanks, John. Maybe just starting with Galafold. What do you see as the key drivers of growth over the next 2 to 3 years? And maybe how does this differ from, say, your initial expectations when you first launched the product years back and sort of your confidence in getting to your long-term sales target of $500 million and then $1 billion versus the $260 million sold in 2020?
John F. Crowley
executiveYes. Again, Ellie, thank you. It's been a terrific medicine for patients, and it's been a very successful launch of this medicine. It has met or exceeded our expectations in every major geography around the world where we've been able to launch. The -- just to remind everybody, again, Galafold is an oral precision medicine for people living with amenable mutations or variants of Fabry disease. And there are over 1,000 mutations on the same gene in Fabry that can lead to a buildup of the substrate that causes disease in Fabry, a buildup that we see in many key organs of disease as well. So important that this is a small molecule, that it's able to get -- penetrate to all key tissues of disease. We've seen great results in substrate reduction and results, of course, with respect to its effect more broadly on the disease. The launch expectations, again, were very high for this product. We've always believed that this would not be a niche program, that it would become the standard of care for people living with these amenable variants. And that's what we continue to see. If you look at the first countries where we were able to launch this, in Germany for instance, and then following the next year of being able to launch in Italy and France, in Spain, some of the major countries, the United Kingdom, in the EU, we've seen tremendous uptake. The focus has been on the -- initially on the switch population. Again, these are people who were receiving enzyme replacement therapy, where we thought this oral precision, small medicine could not only be a more convenient way to treat the disease, but also had the potential to show differentiated approaches with these patients. And in Europe, for instance, as we've seen the effects on the cardiac outcome for patients living with this disease, something we're very excited about as well. And across these countries that we're able to see is very rapid switching from patients moving from the infused therapy to the oral precision medicine. In Germany and the United Kingdom, for instance, we're now to the point where about 90% of the patients who were taking enzyme replacement therapy, who have amenable mutations, have switched to Galafold. In most all countries in Europe now and the larger geographies, we've seen greater than 50% switch. So still room for continued growth with these patients, but again, in terms of meeting our expectations, it's met or exceeded our expectations. We're seeing more and more treatment-naive patients coming on to the medicine. In fact, in Germany, last year, the majority of new patient starts were treatment-naive patients as we've really, really concentrated now with more than 90% of the switch patients on the medicine. One dynamic that's been incredibly helpful is the compliance rates. We see annual compliance rates north of 90% for compliance and adherence to this medicine, which is extraordinary for any medicine. And frankly, I don't know another small medicine -- small molecule medicine that has that rate of compliance and adherence. So what we see when patients come on to Galafold, and particularly, when they switch from the enzyme replacement products, they stay on Galafold, and that's a very important dynamic. And just to remind everybody, we've got approvals now in 40 countries and commercial sales in over 30 of those countries. So we continue to look at opportunities to get this to more patients. But while it's been a successful launch, we have more patients to switch particularly in Japan and the United States, where we were only approved in 2018, so now in the third full year of launch there. So more opportunity to switch patients, many more treatment-naive patients to be able to address and new geographies that we're able to open. We're expecting very shortly our launch here in Brazil, for instance. So lots more opportunity, but again, this has been a really successful launch for us and a product with a very significant runway on its intellectual property as well. We have over 2 dozen Orange Book listed-patents around Galafold, about a dozen of which go out to 2038. So we think this will be a franchise for us that continues for quite some time.
Eliana Merle
analystGot it. That's really helpful. And just digging a little bit deeper into some of the geographic expansion. You mentioned about 90% of the amenable patients in Germany are treated with Galafold. I guess as you think about further penetration outside of Germany and EU, in some of the countries like U.S., Brazil, what are some of the hurdles to achieving this 90% share of the amenable patients for Galafold?
John F. Crowley
executiveIt's really the same plan in every country. And with Germany, that's 90% of the switch patients. So people who had been taking one of the enzyme replacement products in Germany, so about 90% of those have switched. So still some room to go in switch. But importantly, there is still significant populations of treatment-naive patients and that varies by country. Here in the United States, for instance, there are more treatment-naive patients than there are treated patients. So that's a significant opportunity to help people. And again, many new geographies to open. And especially, too, given Fabry is a very unique disease, it was thought to be a very rare, rare disease a number of years ago. What we're finding out is that it's actually one of the most common rare diseases. Some of the -- a number of published studies looking at the epidemiology of Fabry have shown repeatedly that rather than what was thought to be a population of 1 in 30,000 or 1 in 40,000, it's actually much more like a population of 1 in 2,000 or 1 in 3,000 or even more common than that. So in order of magnitude, greater population. And a lot of the work that we're doing and others in the field, but particularly with Amicus, what we're doing is looking at patient populations in certain treatment centers that present with symptoms similar to Fabry disease where we've shown and others have shown in the field very high rates of undiagnosis, under diagnosis or misdiagnosis, for instance, going into pain clinics. There was a study in Germany, looking at multiple sclerosis clinics where they actually found that about 5% of the MS patients in these clinics didn't have multiple sclerosis. They had Fabry disease. So again, a multi-systemic, multi-organ disease with Fabry disease that presents with a range of symptoms, cardiac involvement, certainly renal involvement, CNS involvement, a lot of pain, peripheral neuropathies, and more and more we're realizing this is Fabry disease. And a significant majority of these newly diagnosed patients who were misdiagnosed actually have amenable mutations. So it's very exciting that we could potentially help these patients. And this will be a multiyear effort to try to continue to find more and more patients. There are quite a few. If we just treat the known patients today with Galafold, we'll come increasingly close to that billion-dollar potential and then certainly, being able to expand it with newly diagnosed patients. And again, with a really strong compliance and adherence rate as well.
Eliana Merle
analystGot it. That's helpful. And I guess just thinking longer term in the Fabry market in terms of competition, both with gene therapy products in development. But then also how your own gene therapy product for Fabry could transform kind of the treatment paradigm and where you see that going?
John F. Crowley
executiveI think gene therapy holds a lot of potential in Fabry disease. It's going to be a lot of work with existing therapies now. I think you've seen regulators setting a very high bar for what they want to see, and I think that's appropriate for being able to show safety and efficacy. This is unlikely to be a disease with a very small patient population where you get rapid approval. I think these are going to have to be rigorous studies. I think the first patient population would be the population with nonamenable mutations or nonamenable variants where they don't have the option of Galafold today. I think that would be the first opportunity for gene therapy. Although, ultimately, I think you do have the potential for the treatment -- I'm sorry, the Galafold-treated patients as well. And here with gene therapy, this is a great example of Amicus building on our global experience in clinical research, clinical operations, regulatory around the world. We know Fabry disease and the science and the patient communities, the physician communities very, very well. We're able to combine that with exceptional science. And I know we'll come to it, Ellie, but just to remind everybody. What we're doing in gene therapy is a differentiated approach. We're not simply looking at the very best vectors. While that's important, we're also looking at this in terms of the protein itself. And very important, in Fabry disease, for instance, what we've done, our science teams have done at Amicus is to engineer the protein structure with a disulfide bond. And what that does is, when the protein is expressed by the gene therapy, you're actually getting a protein that's inherently more stable. And this is a notoriously unstable protein, and we believe that's leading to much greater activity. We just showed at the gene therapy conference, the ASGCT meeting a couple of weeks ago, some really strong preclinical data showing significant reduction of the GL-3 substrate in multiple tissues with this Amicus-engineered version of the protein. One thing we also saw was a decrease in the DRGs as well. So we think there are ways that we could potentially make better proteins that are being expressed by the vectors. And we're combining it with the state-of-the-art vectors -- proprietary vectors from Jim Wilson and his team at UPenn. That's completed. That program now has completed all of its preclinical work. It's now in the IND-enabling studies. We're also working with the Thermo Fisher team on the manufacturing scale up. We think one advantage of our Fabry gene therapy is not only potentially better efficacy and safety because we can deliver this at lower doses than people might otherwise have to, to reach all key organs and tissues of disease. So not only potentially more efficacious and safer, but we can manufacture it at a fundamentally different scale than others in the field. And that's what we're working on now, the analytics, the manufacturing, together with the IND-enabling studies. And that's a program that we'll be talking a lot more about in the quarters ahead.
Eliana Merle
analystRight. And where are you in sort of the IND-enabling work? And when should we expect a potential IND filing and first patient dosed?
John F. Crowley
executiveYes. More to come on that in the months and quarters ahead, but I think you could be looking at potentially sometime second half of 2022 for that to be in patients as well. But that continues to progress again on all fronts, the analytics, the manufacturing and all the IND-enabling preclinical work as well.
Eliana Merle
analystGot it. That's helpful. And then just turning to Pompe. I mean what -- after sort of the Phase III data, the miss by sort of a hair in the primary end point, can you talk a bit about your confidence in a U.S. and ex U.S. approval in light of the study? And sort of why you think this was meaningful data in the context of the treatment paradigm?
John F. Crowley
executiveYes. A number of reasons, Ellie. I'll begin first with the unmet need in Pompe disease. Despite having an approved therapy for nearly 15 years, only one approved therapy, people on that therapy, the approved enzyme therapy, the literature is very clear that after any benefit in the first couple of years, you almost universally see a plateau and then that inexorable decline in muscle strength and pulmonary function continues. So we know our AT-GAA approach is differentiated with the way that we have engineered the protein, the way that it's expressed and manufactured and then it's further enhanced with the combination of a small molecule chaperone, which we think adds stability. So again, the focus here is on targeting and on efficacy, and it's been for many years. So with that unmet need in Pompe, we go to the data, and we've accumulated enormous amounts of data across this program, including, importantly, in the PROPEL study. And I think in the note you put out last week, I think you framed it pretty very well, that the design of that study was intentionally very complex. We incorporated the feedback from both European and United States regulators, and it sought to study both the treatment-naive and, importantly, the switch population. And when we look at that, we see that the data overwhelmingly demonstrate the clinically meaningful and significant improvements of people over the approved ERT. So happy to go through the data, but again, what we saw was in the switch population, a nominally statistically significant improvement on both key end points of 6-minute walk and forced vital capacity. And very important, too, for people to remember, we weren't going against placebo. We were going against an approved billion-dollar, standard-of-care medicine, and we sought to show superiority in both of those populations. And again, in the switch population, we showed -- demonstrated superiority on forced vital capacity, on 6-minute walk, on every one of the secondary end points as well, favoring AT-GAA. We showed, we think, a very good safety profile. So we think that body of data overwhelmingly shows the benefits of this medicine over Lumizyme. So -- and again, that's the view we had. We've taken it to regulators in the United States. When we think about the regulatory precedent, again, very important, specific to Pompe disease, the FDA approved Lumizyme on forced vital capacity when it was the first key secondary, as it was in our study for the overall population. And then again, the use of forced vital capacity as an approvable end point in Pompe disease, again, reminding everybody, not just in the switch population, but in the overall population, showing statistically significant superiority. So we already had begun the rolling BLA in the United States in the fourth quarter. The FDA has indicated we can continue to complete that BLA submission. We think it's strengthened by the Breakthrough Therapy Designation for the program, the Fast Track designation. And again, I'll just highlight that this was the only randomized controlled data generated, only randomized controlled study in a switch population, and more than 80% of the addressable market in the next several years are patients that we would intend to switch from Lumizyme. So we continue to do a lot of work to advance this program to other populations: the adolescents, the children, the infants with the disease as well. And we're really excited that this has the potential to be a new standard of care, especially based on the forced vital capacity in what's already a $1 billion market and growing to be a $2 billion market throughout this decade.
Eliana Merle
analystGot it. Very helpful. And just turning to sort of the submission timeline and steps, maybe just with the BLA as well as the MAA in Europe. Just how should we think about the time lines both in terms of the clinical package as well as the manufacturing package? And I guess, when we should expect a potential decision by and theoretical launch? And just if you had to identify any key risks to the time lines or the approvability, I guess, what would those key risks or considerations be?
John F. Crowley
executiveYes. I think what you want to do is maintain control over everything that we can do within our shop to make sure that the submissions and, ultimately, the filing and review are successful. So we think this will be a very high-quality submission. Again, we'll submit the BLA/NDA, given the -- both the small molecule and the large molecule here. Those will be submitted in the coming weeks. So by the end of this quarter, by the end of June, we expect that to be submitted to FDA. And then we'll immediately follow with the EMA submission, which we expect in the third quarter of this year and then many other geographies to follow after that. Our teams at Amicus are preparing for launch as early as the latter part of the fourth quarter of this year. I think the expectation would be that in the first part of 2022 and early 2022, that we would be launching in the United States. But we'll be ready to launch as soon as December. And then we would expect, at some point, then in 2022 to launch throughout the European Union. We are exploring the potential for an early approval in the United Kingdom, now that they do have a separate regulatory process there. So there is a potential actually that the United Kingdom could be our first approved geography. So we continue to explore that as well. And then, of course, looking at Japan and some of the other major markets. And the good news is, we've done this before. We have gone to toe to toe, and in the Fabry world, it was against 2 major competitors. Here, it will be against one major competitor. And again, the focus is going to be on those patients on enzyme replacement therapy today, that existing billion-dollar market, where we have exceptional data and where we are the only medicine to have studied in a controlled fashion head-to-head in that population. And we think that will position us very, very well for a launch of the medicine.
Eliana Merle
analystAnd then I guess just key risk. Like if anything goes wrong with the filing, what do you think it would be?
John F. Crowley
executiveYes. The clinical data are what they are. We think they're quite strong and going all the way back to our Phase II studies as well. We not only are the only -- this is not the only -- this is the only program in Pompe disease that studied the switch population. We're also in our Phase II, the only program ever that studied people in wheelchairs with Pompe disease or people on ventilators. And in the adult population, that's up to 1/3 of the population. So that will be data that will be incorporated in our review. So I think very strong on the clinical side, very clear. We don't have to conduct any further studies, that we've got a robust data set there. This is a very complex manufacturing process. We've been partnered now for 7 years with WuXi Biologics on this program. This material is coming from their Chinese facility. They're nearing completion on an identical facility in Dublin, Ireland. That will be online in the next year or 2, so that will provide a good part of the commercial supply going forward. And I've got a lot of confidence in our partners at WuXi. We've been joined at the hip with them on the -- on all the manufacturing and analytical work here. So look, there is a long litany of things on the CMC side that always could go wrong, but I've been really pleased. Because we've focused from day one on the quality of the manufacturing. I was always worried that we would get -- we'd have great science, great clinical data, but get tripped up on the manufacturing. This is a notoriously difficult molecule to scale, to keep control of those carbohydrates. And we -- and hats off Chris Chen and his team at WuXi, have really done a remarkable job in the scale-up and the consistency of the material. So we've completed all the PPQ runs, all those analytics are complete. So look, there's a lot of things that could always go wrong, but I think we've controlled for everything that we possibly can, and I'm hopeful this will be a successful review.
Eliana Merle
analystGot it. That's helpful. And just in terms of competition, I mean, there is a lot of talk obviously about Sanofi's neoGAA and could potentially be launching ahead of AT-GAA. How are you thinking about patients that, say, might have switched from Lumizyme to neo and their willingness to, say, switch from neo to AT-GAA? And how are you planning for potential commercial strategies around perhaps neo switches to your product?
John F. Crowley
executiveYes. Again, the neo product is still under review in the United States and in Europe. It's not approved anywhere in the world. I really don't want to comment too much on it, Ellie. The disease is the competition. The 2 -- yes, the only thing I'll say, the 2 things we do know is that we have a very differentiated molecule from the neo product and a very differentiated data set. Again, if the focus is on switch patients, we did the controlled study in the switch population. And this -- our molecule is the only one to have controlled data in a pivotal study on a switch population. And this is a very sophisticated physician scientist community. I think, as they become more and more familiar with the AT-GAA data, I think, hopefully, they'll become more and more comfortable with the notion of switching patients to our product, given the breadth of the data that we have. But ultimately, patients will have, I believe, choices. And the data, as it should, will drive the day, and I think that's where our focus will be.
Eliana Merle
analystAnd I guess just from sort of a commercial cadence and thinking about uptake. I mean how should we think about things like how often Pompe patients see their physician? Sort of, would this be something that physicians call their patients proactively to discuss switching once approved? Or is it something that could take maybe a slower cadence? And is it just going to be the patients that are declining on ERT that you think would be switched? Or would it be patients that even are stable or still improving on ERT that would be considering a switch?
John F. Crowley
executiveAgain, look, I think it's great. Patients are going to have choices for the first time ever in Pompe disease. Here, it's clear, there is a significant unmet need. You may have patients that are stable for a time, but the literature, the data are very clear that over the long time, patients will decline on the standard of care treatment. And what we saw with -- again, you look at our switch data, where patients have been on the standard of care for over 7 years on average in our pivotal study, what we showed is that they can walk further and their breathing stabilized when they switch to AT-GAA. I think this will be profoundly important, not only for regulators in the months ahead, but ultimately, for physicians and patients. So my expectation is, you will see a strong rate of switch. I think you'll have patients who immediately switch. I think you'll have patients and physicians who, through dialogue, learn more about the data and other experiences. We saw this with Galafold. We saw, to the extent that patients were perhaps curious, but not willing to switch quite immediately, and doctors maybe with the same mindset. As they looked more at the data, as we generated more data and as more patients in a post-approval setting began to switch, we saw more and more confidence. And I think that's exactly what you'll see here. So we think in the years after approval, I think we'll build to that billion-dollar potential in revenue in thousands of patients who will switch to our medicine. And we're going to be prepared to talk about that from day 1, together with treatment naive and the patients who would be newly diagnosed.
Eliana Merle
analystGot it. Makes sense. And maybe just pivoting to some of your gene therapy programs. How should we think about the time lines and potential path to market in both of the Batten franchises in CLN6 and CLN3? And where you are in some of the manufacturing work post completing the tech transfer and before you can, say, dose patients in the registration studies?
John F. Crowley
executiveSure. And just to remind everybody, we've developed, again, what we think is the largest portfolio of gene therapy rare disease programs in the industry. And they're led by our soon-to-be pivotal-stage programs in CLN6 and CLN3 Batten disease. Batten disease is just a devastating brain disease in children. For children diagnosed with CLN6, for instance, generally around their third, fourth, fifth year, they'll begin to lose the ability to walk, to speak, to think. They'll go blind and oftentimes by 8, 10, 12 years old, they die from the disease. Nobody survives childhood with CLN6 Batten disease when they're diagnosed in those first few years of life. So just devastating fatal disease. Our activities, since we acquired this program in the fall of 2018 and it became very clear to us by the fall of 2019, that we were seeing in CLN6 very significant effects on patients, particularly the younger children, where we were intervening. It looked to stave off or to completely mitigate the effects of the disease. So very, very exciting, but it also became clear to us, Ellie, that the manufacturing, the production, the analytic work needed to be in a very different place, and the FDA was evolving its thinking pretty dramatically here. And candidly, I think, appropriately so for patients and for quality of medicine here. And we were ahead of the curve. So we were working with a number of vendors. We quickly settled on our partners at Brammer, Thermal Fisher. We acquired a significant amount of capacity at the Thermo Fisher facilities and quite a bit of their expertise, and we've now completed the tech transfer there. We've completed the engineering runs, and we're manufacturing now GMP commercial-grade material in commercial scale. A lot of -- we've advanced the analytical work significantly. We still have more work to do there, and that work continues. And we would expect then by next year that we will be dosing patients in CLN6, CLN3, subject to our continued discussions with the regulators around all the work that we're doing to set up the clinical study as well. So those are our lead programs. We have other Batten disease programs, some of which we've disclosed, some of which we've not yet disclosed. And again, a good part of what we're building is based on our relationship with Jim Wilson and UPenn. And to remind everybody, we have the broadest, deepest relationship with the UPenn team in the Wilson Lab. We have the rights to about 50 -- exclusive global rights to about 50 rare disease programs out of UPenn, including the programs in Fabry and Pompe gene therapy, the MPS -- a number of the MPS disorders that we have and others; about a dozen active gene therapy programs at Amicus, including the CLN6, CLN3 programs. So you'll see us talking a lot more about these programs going forward. And one thing that's exciting is that, again, the combination of the Amicus protein engineering and glycobiology teams at Amicus, our 60 bench scientists at Amicus, working in partnership with their colleagues across the street in Philadelphia in the Wilson Lab at UPenn, combining the Amicus expertise in engineering with the Wilson expertise in gene vector technology, I think is going to provide some remarkable medicines in the years ahead. So we're very, very excited. It's a portfolio that we get little to no credit for today, but we're looking at exciting ways to advance those programs and unlock quite a bit of that value.
Eliana Merle
analystGot it. Yes. Very exciting work. [Operator Instructions] But I guess while we maybe wait for any questions from the audience, I did want to ask a little bit more on this emerging gene therapy portfolio. You have a lot of programs in preclinical development. How are you thinking about manufacturing going forward? And when you could potentially have your own in-house manufacturing ready and live to dose in patients? And is this even necessary given your partnerships with some of the companies like Brammer, where you're working on manufacturing now, such as with the CLN programs?
John F. Crowley
executiveYes. I really believe, Ellie, if you're going to be one of the world's leading gene therapy research and development companies, you need to be one of the world's leading gene therapy manufacturing companies. In gene therapy, the process is the product. And for Amicus, the whole -- everything we're doing in the technical operations of gene therapy builds on our experience out of our Pompe program, that we have worked with WuXi and that Pompe enzyme replacement therapy program to develop scale and manufacture what's arguably the most complex glycosylated medicine ever created. And I think we've done it exceptionally well. So those skills, that discipline, all the quality control that goes into that, we've got a team of more than 50 tech ops experts at Amicus that are now increasingly focused on gene therapy. We can -- again, I mentioned we have a great relationship with the Thermo Fisher, Brammer team. That will continue for the long term. We see that as driving our programs in CLN6, CLN3. We're working with them on Fabry, Pompe, other gene therapy programs. And in parallel with that, we've already designed and we are just about ready to begin construction on what will be about a 35,000 square feet state-of-the-art gene therapy manufacturing facility that will be designed largely for clinical manufacturing. That will be a supplement and a complement to our work at Thermo Fisher. And it will also help us build the expertise in gene therapy manufacturing. We also, in that same complex, have acquired the land for a greenfield manufacturing site that would be a commercial site, again, as a complement to the manufacture from Thermo Fisher. So we've got plans in place. In fact, it's already permitted to go a facility. And some of the long-lead-time equipment has already been ordered for that manufacturing facility. So increasingly, in the years ahead, I think Amicus -- you'll see Amicus recognized as one of the world's leading manufacturers of gene therapy as well.
Eliana Merle
analystVery exciting. Well, I think we're at 10:45 here, and I don't see any questions on the line. But John, thank you so much for your time. Great hearing your insights and vision for the company. And yes, thanks, everyone, on the line for joining, and we will speak to you all soon.
John F. Crowley
executiveGreat. Thank you, Ellie. Thanks, everybody. Have a good day.
Eliana Merle
analystThanks. You, too. Bye.
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