Good day, ladies and gentlemen, and welcome to Amicus Therapeutics Full-year 2018 Financial Results and Corporate Update Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session. Instructions will follow at that time. [Operator Instructions].
As a reminder, this conference call is being recorded. I would now like to turn the conference over to your host, Sara Pellegrino, Vice President of Investor Relations and Corporate Communications. You may begin..
Sara Pellegrino:.
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On this call, as referenced on slide two, we may make forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 relating to our business as well as our plans and prospects. Our forward-looking statements should not be regarded as representation by us that any of our plans will be achieved.
Any or all of the forward-looking statements made on this call may turn out to be wrong and can be affected by inaccurate assumptions we might make or by known or unknown risks and uncertainties. You are cautioned not to place undue reliance on any forward-looking statements, which speak only to the date hereof.
All forward-looking statements are qualified in their entirety by the cautionary statement and we undertake no obligation to revise or update this presentation or conference call to reflect events or circumstances after the date hereof.
For a full discussion of such forward-looking statements and risks and uncertainties that may impact them, we refer you to the forward-looking statements on slide two of our full-year 2018 results slide deck as well as the forward-looking statements and risk factors section of our annual report on Form 10-K for the year ended December 31, 2018, to be filed later today with the Securities and Exchange Commission.
At this time, it is my pleasure to turn the call over to John Crowley, Chairman and Chief Executive Officer of Amicus.
John?.
Great. Thank you, Sara. Good morning and welcome everyone to our full-year 2018 results conference call.
This is the third year we are holding our full-year results on the last day of February on Global Rare Disease Day, a true reflection of our dual mission of making a positive and meaningful impact for people living with rare diseases, as well as our important mission to drive shareholder value for all Amicus shareholders..
Indeed, Amicus strives every day to bridge these gaps through the commercialization and development of our portfolio of medicines for rare metabolic disorders, as well as our strength in patient advocacy, our corporate citizenship and our other support services.
And beyond just the medicines we develop and deliver, our Healing Beyond Disease initiative brings team Amicus into the rare disease communities to help bridge these gaps in very unique and extraordinary ways..
Indeed, Amicus strives every day to bridge these gaps through the commercialization and development of our portfolio of medicines for rare metabolic disorders, as well as our strength in patient advocacy, our corporate citizenship and our other support services.
And beyond just the medicines we develop and deliver, our Healing Beyond Disease initiative brings team Amicus into the rare disease communities to help bridge these gaps in very unique and extraordinary ways..
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The first is the extraordinary success we have had with the launch of our precision medicine Galafold for Fabry disease. At the end of last year, more than 650 people living with Fabry disease with amenable GLA variants, also referred to as genetic mutations, were taking this precision medicine as their only treatment for Fabry disease..
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We are also even more confident now with our pathway to drive Galafold sales toward $500 million by 2023 and to $1 billion plus addressable Galafold market in 2028, with the potential to positively impact thousands of people living with Fabry disease who are amenable to this novel precision medicine.
The second pillar is AT-GAA for Pompe disease, our novel biologic combined with a pharmacological chaperone.
In February, at the WORLD Symposium in Orlando, we presented Phase I/II data out to 24 months in persons living with Pompe disease, some of whom were confined to wheelchairs, some still with the ability to walk and the group who had previously been on treatment and others new to treatment.
The effect of AT-GAA continues to impress and to be persistent and durable. The vast majority of patients in this study receiving AT-GAA have improved in their muscle strength and muscle function.
And earlier this week, as I will highlight later on the call, we announced that the US FDA granted breakthrough therapy designation, or BTD, for AT-GAA in late onset Pompe disease, a significant accomplishment for team Amicus and the patients, physicians and collaborators who have worked with us to advance AT-GAA to be the next potential standard of care as quickly as possible, again, with a potential $1 billion to $2 billion peak sales opportunity..
And now, with the announcement this week of our new Global Research and Gene Therapy Center of Excellence located in Philadelphia, adjacent to UPenn, we further advance our commitment to world-class science through gene therapies that will make a meaningful difference in the lives of people living with these life-threatening conditions and that have the potential to one day lead to cures.
And again, we see our gene therapy programs at Amicus potentially leading to more than $1 billion in peak recurring annual revenue..
And now, with the announcement this week of our new Global Research and Gene Therapy Center of Excellence located in Philadelphia, adjacent to UPenn, we further advance our commitment to world-class science through gene therapies that will make a meaningful difference in the lives of people living with these life-threatening conditions and that have the potential to one day lead to cures.
And again, we see our gene therapy programs at Amicus potentially leading to more than $1 billion in peak recurring annual revenue..
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Turning to slide five, as I highlighted in our press release this morning, we have five key strategic priorities for this year, 2019, and we are well on track to achieving or exceeding all of them..
Second, Pompe continues to be incredibly important for Amicus. And with the recent BTD, there is a lot of momentum right now for this program and an enormous amount of activity here at Amicus..
Second, Pompe continues to be incredibly important for Amicus. And with the recent BTD, there is a lot of momentum right now for this program and an enormous amount of activity here at Amicus..
Third, we now have two gene therapy programs in the clinic in two different types of Batten disease. We expect very important data in the middle of this year in the CLN6 Batten program in additional patients at two years following a one-time administration of our gene therapy.
We also expect to complete enrollment of the ongoing CLN3 Batten disease clinical study. The initial child with CLM3 Batten disease in that study continues to participate with no serious adverse events to-date, following a single one-time administration of the gene therapy at the end of last year.
Our fourth goal is to achieve preclinical proof-of-concept for our Fabry and Pompe gene therapy programs, likely at science meetings and in peer-reviewed publications. A lot of work is now well underway in collaboration with Dr. Wilson and his scientists at UPenn, together with our Research and Gene Therapy team in Philadelphia.
And five, again, we will always maintain a strong financial position here at Amicus. So, with that as the overview, let me now hand the call over to Bradley Campbell, our President and Chief Operating Officer, to highlight the Galafold launch.
Brad?.
Thanks, John. Good morning, everyone. Let me begin on slide seven with a snapshot of the Galafold launch through December 31..
Our full-year revenue in 2018 was $91.2 million, which is a year-over-year increase of approximately 147% from fiscal year 2017. And as we move through our first quarter, we continue to see exceptionally strong momentum in new markets, including the United States and Japan, as well as in our more mature markets.
Let me provide a little qualitative color in the different regions around the world. We do continue to see growth across the EU 5, and Europe more broadly. And in more mature markets such as Germany and the UK, we see an increasing proportion of previously untreated patients come on to Galafold.
This is right in line with our strategy for initial adoption in switch patients followed by uptake in previously untreated patients..
We have obtained broad reimbursement coverage and continue to make great progress with payers, experiencing shorter and shorter times toward moving from prescription to patients receiving drug. And finally, across all markets, we continue to see an exceptionally high rate of compliance and adherence to this oral treatment option..
This would be a fantastic achievement for Amicus and will represent a meaningful impact on how Fabry disease is treated around the world.
On slide nine, we continue to believe that Fabry may be one of the most under and misdiagnosed human genetic disorders in the world, with continued growth expected in the Fabry population through newborn screening and other diagnostic initiatives.
We believe we can get to, as John mentioned, $500 million in potential sales by 2023, with a $1 billion plus addressable market opportunity in 2028. With that, let me hand the call back to John to provide an update on our pipeline programs..
John Crowley:.
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First, by definition, to receive a breakthrough therapy designation, there must be preliminary clinical evidence indicating that the drug may demonstrate substantial improvement on a clinically-significant endpoint over available therapies. And in the case of Pompe disease, we believe significant unmet need remains despite an approved therapy.
For AT-GAA, the BTD is based on clinical efficacy results from the ongoing Phase I/II clinical study, including improvements in six-minute walk distance in late onset Pompe patients in comparison to natural history of treated patients.
And now, with this BTD for AT-GAA, it will facilitate multi-disciplinary, comprehensive discussions of the AT-GAA development program with the FDA, including planned clinical trials and plans for expediting manufacturing development strategy..
This BTD, together with our results from the ongoing Phase I/II study and the ongoing PROPEL pivotal study, support our strategy to advance AT-GAA as quickly as possible with a potential to become the new standard of care for people living with Pompe disease.
In addition to the more frequent and intense dialog with the FDA on this program and also all of the initiatives that may advance this medicine to Pompe patients as quickly as possible with this BTD, we also believe that the BTD represents an important acknowledgment of the great unmet need that exists for patients with Pompe disease, despite an approved ERT.
And also, the significance of the data that we have shown to-date as compared to the natural history of people on the ERT standard of care. The baseline remains that the pivotal PROPEL study will be the basis to support full approval of AT-GAA.
We remain laser-focused on enrolling the PROPEL study and doing what we need to do to further build out our body of data for AT-GAA.
Based on regulatory feedback from both the FDA and the European Medicines Agency, we expect that the AT-GAA development plan, including a planned pediatric study, will support a broad indication for ERT switch and treatment-naïve Pompe patients in adults, as well as in children..
For the remainder of this year, we will concentrate on the PROPEL study enrollment, on the additional Phase I/II and natural history data, on supportive studies, including our open-label pediatric study initiation, as well as the advancement of our agreed-upon CMC requirements and the continued important related manufacturing work for AT-GAA with our partners at WuXi Biologics..
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Through our partnership with Nationwide, we have 10 programs in the neurologic LSDs, two of which are now in the clinic.
Indeed, on Rare Disease Day, we can reflect on all of the diseases for which there are no available treatments and think about the new programs in our pipeline and the potential to offer hope to people who, in too many cases, particularly children living with these diseases, believe that they no longer have hope..
As outlined on the next slide, number 15, 2019 is a very important year of execution for us in gene therapy across these programs and this R&D engine for future growth.
By the end of the year, in terms of data, we anticipate having additional two-year data in our CLN6 Batten disease study, as well as proof-of-concept for our Fabry and Pompe gene therapy programs..
As outlined on the next slide, number 15, 2019 is a very important year of execution for us in gene therapy across these programs and this R&D engine for future growth.
By the end of the year, in terms of data, we anticipate having additional two-year data in our CLN6 Batten disease study, as well as proof-of-concept for our Fabry and Pompe gene therapy programs..
This, as many of you know, is a burgeoning hub for medical breakthroughs.
The establishment of this center for Amicus is an important next step in the evolution of our science, research and gene therapy capabilities, which greatly advances our commitment to world-class science that makes a meaningful difference in the lives of people living with rare metabolic diseases. The new facility in Philadelphia is being led by Dr.
Jeff Castelli, our Chief Portfolio Officer and the newly appointed Head of Gene Therapy, as well as our Chief Science Officer, Dr. Hung Do. Together Jeff and Hung will serve at the headquarters for the global Amicus Science organization and the gene therapy leadership team.
We are honored to be a part of the exciting Philadelphia research community and we look forward to fostering collaborations to significantly contribute to our role in advancing further medical innovation..
This, as many of you know, is a burgeoning hub for medical breakthroughs.
The establishment of this center for Amicus is an important next step in the evolution of our science, research and gene therapy capabilities, which greatly advances our commitment to world-class science that makes a meaningful difference in the lives of people living with rare metabolic diseases. The new facility in Philadelphia is being led by Dr.
Jeff Castelli, our Chief Portfolio Officer and the newly appointed Head of Gene Therapy, as well as our Chief Science Officer, Dr. Hung Do. Together Jeff and Hung will serve at the headquarters for the global Amicus Science organization and the gene therapy leadership team.
We are honored to be a part of the exciting Philadelphia research community and we look forward to fostering collaborations to significantly contribute to our role in advancing further medical innovation..
At Amicus, we have key organizational strength as well that provide us with a strategic advantage to build the next great leading global biotechnology company in rare diseases. And, again, this fits with the notion that we are building one of the great and enduring companies in biotechnology.
Over the next several quarters in 2019, on these calls, I plan to highlight different teams at Amicus that are driving us toward our vision, beginning with our commercial organization on this call.
In future quarters, I plan to highlight our technical operations and quality organizations, our global clinical development and regulatory affairs teams, and our science and research teams and, of course, throughout our patient advocacy focus..
The reach and breadth of our footprint is remarkable when you think that just a few short years ago, in 2015, Amicus in total had fewer than 200 employees operating out of our one location here in New Jersey.
Then we took the decision to commercialize Galafold on our own and have now built an organization of more than 600 total global employees, including more than 150 Amicus employees who support the Galafold business around the world.
And with the strength of our clinical development and patient advocacy and medical affairs team, we have now laid, we believe, the groundwork for developing and delivering a global rare disease portfolio that will create even more value with each additional product we can deliver globally for people living with rare diseases..
Among these individuals, there is extensive experience from leading organizations within the orphan disease space and from biotechnology more broadly, who have built very successful multi-product franchises around these diseases, with significant unmet need.
This diversity created an optimal combination that not only prepared us to launch Galafold, but have now established Amicus within the LSD field and position us for our longer-term success and move us toward our greater vision.
Third, as we see here on slide 22, is part of our success that is truly the result of the qualities of Galafold in our efforts to drive the science. Again, Galafold is a truly differentiated product..
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Again, the credibility and relationships this team has built within the Fabry and lysosomal storage disease space through these efforts will support our future programs and we think will continue to be a strategic advantage for Amicus and a very differentiating feature for our company.
And finally, slide 23, we have a corporate responsibility and a broad commitment to market access, which has been the key to our success based on our core value that our medicines must be fairly priced and broadly accessible.
For Galafold, this means we have generally priced at parity to ERT within each market, which then saves the system the cost associated with the infusions. We believe this has translated into a meaningful value proposition for reimbursement authorities and that it has led to rapid access and reimbursement for Galafold in markets around the world.
In the United States, we introduced the Amicus promise. And in that PROMISE, we pledged that we would never raise the price of our medicines – Galafold in this case – above consumer inflation annually, which again has been very well received by payers.
And we are supporting patients throughout their Galafold journey through our in-house Amicus Assist patient services group, including various financial assistance mechanisms for qualifying persons to help ensure broad access to Galafold.
We have also made a commitment, an AMICUS pledge, to reinvest a portion of our revenue from Galafold back into the Fabry disease community, specifically to Fabry research and development until there is a cure for this disease. This pledge is already underway through our Fabry gene therapy program with UPenn, which we initiated last year..
So, with that, and thank you for indulging me in just highlighting a very important organizational strength of Amicus. Let me now pass the call over to Daphne to discuss the financials for the full year.
Daphne?.
So, with that, and thank you for indulging me in just highlighting a very important organizational strength of Amicus. Let me now pass the call over to Daphne to discuss the financials for the full year.
Daphne?.
Thank you, John. And good morning, everyone. Our financial overview begins on slide 25 with our income statement for the 12-month period ending December 31, 2018. For the full-year 2018, we recorded Galafold revenue of $91.2 million, a 147% increase over 2017.
Cost of goods sold includes manufacturing costs as well as royalties associated with sales of our product. Cost of goods sold as a percentage of net sales was 15.8% for the full year ended December 31, 2018 as compared to 16.9% for the prior full-year period.
We continue to make significant investments in R&D and manufacturing, with the ongoing pivotal study and commercial scale-up in our Pompe program, as well as the expansion of our gene therapy portfolio and capabilities.
During the full year of 2018, we recorded $270.9 million in R&D expense, which, as a reminder, includes the upfront payment of $100 million for the Celenex asset acquisition. This compares to $149.3 million for the prior full-year period.
Total selling, general and administrative expense for the full year of 2018 was $127.2 million as compared to $88.7 million for the prior full-year period. The increase represents the expanded geographic scope of the ongoing Galafold commercial launch, including initial launch activities in Japan and the United States.
Net loss for the full-year 2018 was $349 million or $1.88 per share compared to a net loss of $284 million or $1.85 per share for the prior full-year period. At December 31, 2018, we had approximately 189.4 million shares outstanding. Moving onto slide 26, a few comments about our current cash position and 2019 financial guidance.
Cash, cash equivalents and marketable securities totaled $504.2 million on December 31, 2018 compared to $358.6 million at December 31, 2017. In addition, net cash spent was $196.3 million for the full year of 2018, which was below full-year 2018 net cash spend guidance of $200 million to $225 million.
Looking at the remainder of 2019, we are reaffirming our full-year Galafold revenue guidance of $160 million to $180 million. Taking into account our anticipated investments as well as anticipated Galafold revenue, we expect to have approximately $300 million in cash on the balance sheet at the end of 2019.
This projected year-end cash balance reflects all ongoing investments in our operations, including Pompe manufacturing scale-up, as well as facilities, including our new Global Research and Gene Therapy Center of Excellence in Philadelphia.
With our current cash position and the continued revenue from sales of Galafold, we have sufficient capital to fund ongoing operations into at least mid-2021. As we have noted in the past, potential business development collaborations, pipeline expansion and investment in manufacturing capabilities could impact our future capital requirements.
This summarizes our key financials for full-year 2018. Additional details can be found in our annual report on Form 10-K, which will be filed later today..
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John Crowley:.
As you can see on this slide, we are well on our way to achieving our 2023 vision to treat 5,000 patients..
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Thank you. [Operator Instructions]. And our first question comes from Anupam Rama from JPMorgan. Your line is now open..
John Crowley:.
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Sorry. Hello.
Can you hear me?.
Hi. We can hear you now. Yes..
Sorry. Sorry about that..
John Crowley:.
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Anupam Rama:.
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John Crowley:.
If you remember, we had shown data out to two years in the first two patients treated. One patient who looked – was quite older when she received it and she looked to have generally stabilized on the Hamburg scale.
And then the other patient, who is her younger sister, who received it when she was quite young, I think she was about two-and-a-half old or so, she actually completely stabilized over that couple-of-year period. We think that data is incredibly exciting.
And it is part of what gives us great hope that this gene therapy has the potential to really change the trajectory of the disease..
If you remember, we had shown data out to two years in the first two patients treated. One patient who looked – was quite older when she received it and she looked to have generally stabilized on the Hamburg scale.
And then the other patient, who is her younger sister, who received it when she was quite young, I think she was about two-and-a-half old or so, she actually completely stabilized over that couple-of-year period. We think that data is incredibly exciting.
And it is part of what gives us great hope that this gene therapy has the potential to really change the trajectory of the disease..
If you remember, we had shown data out to two years in the first two patients treated. One patient who looked – was quite older when she received it and she looked to have generally stabilized on the Hamburg scale.
And then the other patient, who is her younger sister, who received it when she was quite young, I think she was about two-and-a-half old or so, she actually completely stabilized over that couple-of-year period. We think that data is incredibly exciting.
And it is part of what gives us great hope that this gene therapy has the potential to really change the trajectory of the disease..
Jay, Jeff anything to add?.
Jay, Jeff anything to add?.
Jay Barth:.
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Yeah, Just to be clear, Anupam, we want to see striking results, so that when we look at the data, when we see the evaluations on the patients, when we look at videos internally at least, it is night and day from what you would expect from a course of this just awful, awful disease..
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Awesome. Thanks for taking the question, guys..
Great. Thank you, Anupam..
Thank you. And our next question comes from Tazeen Ahmad from Bank of America. Your line is now open..
Tazeen Ahmad:.
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John Crowley:.
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Yeah. Thanks, Tazeen, for the questions. What I think would be most helpful is to first highlight what we see as the big growth drivers over the next few years, which I think gets you to the 2023 time point, and share a little bit of the sort of distribution of those patients.
And then, I can talk a little bit about the long-term market growth we see, the $1 billion plus market opportunity over the next decade..
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So, hopefully, that gives you a flavor of how we see the market progressing over time and our opportunities within that market..
Okay. Great. Thanks, Brad..
Thanks, Tazeen..
Thank you. And our next question comes from Irina Margine from Cowen. Your line is now open..
Hi, guys. Good morning. And thank you for taking my questions.
I was wondering, just to follow up on the previous question, maybe if you could comment on the magnitude of update you are seeing with Galafold among naïve patients in the US? And how that might differ from dynamic in the EU? Is willingness to treat in anyway difference between the different geographies? Thank you..
Bradley Campbell:.
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Irina Margine:.
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John Crowley:.
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Yes, yes..
John Crowley:.
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Jay Barth:.
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Thanks so much, guys..
Thank you..
Thank you. And our next question comes from Mike Ulz from Baird. Your line is now open..
Michael Ulz:.
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Bradley Campbell:.
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Great, thank you..
Thank you, Mike..
Thank you. And our next question comes from Mohit Bansal from Citi. Your line is now open..
Mohit Bansal:.
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John Crowley:.
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Mohit Bansal:.
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John Crowley:.
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Very helpful. Thank you very much..
Thank you, Mohit. Have a great day. Operator Thank you. And our next question comes from Whitney Ijem from Guggenheim. Your line is now open..
Hi. Good morning. First, I just wanted to follow up on CLN6.
For the mid-year update, just to clarify, will we get data out to two years only or will we get additional follow-up for the patients that have it beyond two years?.
John Crowley:.
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Okay, got it.
And then, are there specific medical meetings that we should have on our radar for that update mid-year?.
John Crowley:.
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Okay. And then, just last quick one, back on Galafold and kind of longer-term market opportunity, I think you had a slide in one of your decks earlier this year talking about, I guess, the rate of misdiagnosis in different categories based on screening studies. And two that were of particular note were MS and IBS.
So, is FOLD sort of – or is Amicus doing any sort of active outreach or screening in those settings to find patients?.
Yeah, very much.
Brad?.
Bradley Campbell:.
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Great, thanks..
Thanks, Whitney..
Thank you. And our next question comes from Kristen Kluska from Cantor Fitzgerald. Your line is now open..
Kristen Kluska:.
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John Crowley:.
In terms of the breakout, expect, of those 200 people at our Global Research and Gene Therapy Center of Excellence, the vast majority of those will be scientists.
We also expect to have some members of our technical operations team in Philadelphia working primarily on the early stage process development, getting that science ready for manufacturer and, ultimately, then hand off either to a CMO or to our later stage process development in our own Amicus manufacturing team..
In terms of the breakout, expect, of those 200 people at our Global Research and Gene Therapy Center of Excellence, the vast majority of those will be scientists.
We also expect to have some members of our technical operations team in Philadelphia working primarily on the early stage process development, getting that science ready for manufacturer and, ultimately, then hand off either to a CMO or to our later stage process development in our own Amicus manufacturing team..
In terms of the breakout, expect, of those 200 people at our Global Research and Gene Therapy Center of Excellence, the vast majority of those will be scientists.
We also expect to have some members of our technical operations team in Philadelphia working primarily on the early stage process development, getting that science ready for manufacturer and, ultimately, then hand off either to a CMO or to our later stage process development in our own Amicus manufacturing team..
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Great. Thank you, John..
Thanks, Kristen. Have a good day..
Thank you. And our next question comes from Salveen Richter from Goldman Sachs. Your line is now open..
Yes. Hi. Thanks for taking the questions. [indiscernible] for Salveen. Congrats on all the progress. Very encouraging. I had a couple of questions.
One of them, for the AT-GAA program, what is the CMC requirements that are still sort of in process of being completed for the Phase III and what is the work that you basically expect to do there in the next couple of years?.
John Crowley:.
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John Crowley:.
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Jay Barth:.
And along with that, we showed in the naïve patients, who have not been treated before, a quite robust increase in their FEC and their pulmonary function tests. And I really think that shows the ability of AT-GAA to have a pretty profound effect on their function. And we saw that also in the motor function.
Of course, the six-minute walk increasing in both groups. So, I think all the results are pretty much as we expected and as good as they could be for these different populations..
And along with that, we showed in the naïve patients, who have not been treated before, a quite robust increase in their FEC and their pulmonary function tests. And I really think that shows the ability of AT-GAA to have a pretty profound effect on their function. And we saw that also in the motor function.
Of course, the six-minute walk increasing in both groups. So, I think all the results are pretty much as we expected and as good as they could be for these different populations..
And along with that, we showed in the naïve patients, who have not been treated before, a quite robust increase in their FEC and their pulmonary function tests. And I really think that shows the ability of AT-GAA to have a pretty profound effect on their function. And we saw that also in the motor function.
Of course, the six-minute walk increasing in both groups. So, I think all the results are pretty much as we expected and as good as they could be for these different populations..
And along with that, we showed in the naïve patients, who have not been treated before, a quite robust increase in their FEC and their pulmonary function tests. And I really think that shows the ability of AT-GAA to have a pretty profound effect on their function. And we saw that also in the motor function.
Of course, the six-minute walk increasing in both groups. So, I think all the results are pretty much as we expected and as good as they could be for these different populations..
Got it. Thank you. Very helpful.
Would the ERT-naïve basically data will be a better comparison with the natural history? Is that the thinking?.
Jay Barth:.
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Got it. Thank you..
Operator:.
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Great. Thank you, operator. Thank you everybody for listening. Have a great day..
Operator:.
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