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Amicus Therapeutics Inc (FOLD -1.68%)
Q1Â 2020 Earnings Call
May 9, 2020, 8:30 p.m. ET
Contents:
- Prepared Remarks
- Questions and Answers
- Call Participants
Prepared Remarks:
Operator
Good morning, ladies and gentlemen, and welcome to the Amicus Therapeutics' First Quarter 2020 Financial Results Conference Call and Webcast. [Operator Instructions]
I would now like to turn the conference over to your host, Mr. Andrew Faughnan, Director of Investor Relations, you may begin.
Andrew Faughnan -- Director of Investor Relations
Good morning.
Thank you for joining our conference call to discuss Amicus Therapeutics' first quarter 2020 financial results and corporate highlights. Speaking on today's call, we have John Crowley, Chairman and Chief Executive Officer; Bradley Campbell, President and Chief Operating Officer; and Daphne Quimi, Chief Financial Officer. Also joining for Q&A are Dr. Jay Barth, Chief Medical Officer; Dr. Hung Do, Chief Science Officer; and Dr. Jeff Castelli, Chief Portfolio Officer and Head of Gene Therapy.
As referenced on slide 2, 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 our 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. Our forward-looking statements are qualified in their entirety by this cautionary statement, and we undertake no obligation to revise or update this presentation and conference call to reflect events or circumstances after the date hereof.
For a whole disclosure of such forward-looking statements and the risks and uncertainties that may impact them, we refer you to the Forward-Looking Statements & Risk Factors section of our annual report on Form 10-Q [Phonetic] for the year ended December 31, 2019, and the quarterly report on Form 10-Q for the quarter ended March 31, 2020, 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. John?
John F. Crowley -- Chairman of the Board, Chief Executive Officer
Great. Thank you, Andrew, and welcome, everyone, to our first quarter 2020 results conference call.
Let me just begin by stating that I hope everyone and their families are well and safe. I know this is an extraordinary time and it certainly has been for our Amicus team and for our families. Since we first announced that Amicus would be moving to a work from home environment back on March 11, the senior leadership team and I at Amicus had focused on two important themes: empathy and performance. The core of empathy has been about protecting the safety, health and well-being of our global Amicus workforce and by extension our families. And while emphasizing a range of programs and initiatives to protect and support our workforce, we have also been relentlessly focused on ensuring business continuity and performance against all of our key objectives.
So, with that as background on today's call, I'm pleased to be highlighting the significant progress we've made at Amicus during the first quarter and now into the second quarter of this quite memorable year. While adapting to all of the changes brought about by this world pandemic, for Amicus, the start of 2020 has been a period of growth and execution across our science, clinical, regulatory, and commercial efforts as we continue to build one of the next great global biotechnology companies poised to impact many people around the world living with rare diseases.
As we did in this morning's press release, I'd like to highlight four key accomplishments. First, Galafold continues its strong launch performance and remains the cornerstone of our success. With $60.5 million dollars in first quarter revenue, the Galafold launch continues to exceed expectations. First quarter revenue represents the performance across the global business, including new patient starts from both switch and treatment-naive patients throughout the quarter in all major regions, including those hardest hit by COVID-19. Of course, we will continue to monitor any future impact from this pandemic, but we are encouraged by the trends that we are seeing.
Second, our R&D timelines remain on track. We continue to expect the Phase III PROPEL study of AT-GAA in late onset Pompe disease to read out top line data on schedule in the first half of 2021. We disclosed also today that the US FDA has now authorized us to proceed with a rolling BLA submission for this program, and our plans remain to start the rolling BLA in the second half of this year. Within our gene therapy pipeline, we continue to move forward our lead Batten disease program in CLN6 and CLN3, as well as our most advanced preclinical gene therapy program.
Third, the Amicus Global technical operations team has done just a tremendous job maintaining our supply chain during these times. Thanks to the extensive contingency planning in advance in place and the quick work early in this pandemic, we have been able to get drug to patients where needed, and we have taken further measures to ensure that that remains true into the future. We expect to be able to continuously supply all Amicus therapies and potential therapies to patients in all geographies around the world.
And fourth, maintaining the strength of our balance sheet remains a core priority for Amicus. We are announcing today that through a recent further financial exercise and a series of cost savings initiatives, our cash runway now leads us well into the second half of 2022. Our team continues to carefully shepherd our financial resources as we continue on a path to profitability. Daphne will discuss this in more detail later in the call.
Turning to slide 4. We are well on track then to achieve our five key strategic priorities for 2020. These include, one, Galafold, our precision medicine for Fabry; we will continue to drive Galafold to more patients living with Fabry disease with amenable variance in existing and in new markets. We look to achieve global product revenue of $250 million to $260 million this year.
Two, we are increasing the clinical, regulatory, manufacturing and pre-commercial activities surrounding our Pompe program as we advance toward this approval. Three, we are advancing our industry-leading rare disease gene therapy portfolio. Stemming from our new Global Research and Gene Therapy Center of Excellence in Philadelphia, we will be advancing the clinical development, manufacturing and regulatory discussions for both our CLN6 and CLN3 Batten programs.
Four, in addition, we are progressing our Pompe gene therapy toward IND and we will disclose up to two additional IND candidates this year. A lot of work is under way with our manufacturing partners for the manufacturing, scale-up of the Pompe gene therapy as well as our other potential IND candidates. And we look forward to sharing the additional IND candidates from our Penn collaboration later this year.
And again, we continue to maintain a strong financial position as we carefully manage our expenses and investments, and we remain fully funded through all major milestones ahead, again now with cash well into the second half of 2022.
So with that as an introduction, let me go ahead now and hand the call over to Bradley Campbell, our President and Chief Operating Officer, to further highlight the Galafold performance, our R&D timelines and the supply chain. So Brad, go ahead, please.
Bradley L. Campbell -- President and Chief Operating Officer
Thanks, John.
And as we sit here at what I think is our first truly virtual earnings call, let me just echo John's statement. I hope everybody out there is safe and well along with your families and your colleagues.
As John said, I will go through in more detail the Galafold performance for the quarter, also our R&D timelines and milestones. And I will provide more detail on the actions we've taken to ensure the strength and continuity of the supply chain.
But let me start on slide 6, which goes through the continued growth of Galafold for the first quarter of 2020, and we'll give a global snapshot of the Galafold commercial progress. For the first quarter, total product revenue was $60.5 million, which is an increase of 78% from the first quarter in 2019. Galafold revenue has been driven by strong patient demand as well as continued strong adherence. We've had some favorable reimbursement dynamics and there has been only a minimal contribution from some ordering patterns as healthcare organizations in select countries have adjusted to the impact of the COVID-19 virus, and importantly, global compliance and adherence rates continued to exceed 90%.
The geographic breakdown of revenue during the quarter, similar to we've seen in previous quarters, was $42.8 million or 71% of revenue generated outside the United States and the remaining $17.7 million or 29% coming from within the US over the quarter. We now have over 40 countries around the world with regulatory approvals, and we have commercial sales in over 30 of those countries now, with patients for the first time this quarter coming on to reimburse product in Colombia and Romania and we do have more markets that we expect on the horizon later this year. And this expanding global footprint is important, not just to support the continued growth of patients with access to Galafold, but it lays an incredibly strong foundation, which is highly leverageable to support the anticipated launch of Pompe and our future products as well.
Turning now to slide 7. We have had a very strong Q1 even in the face of COVID-19 pandemic, and part of that was clearly strong momentum coming into the year after a great finish in 2019. But, as the COVID crisis has rolled through our various geographies, we've also seen some dynamics that we think could be unique to Galafold as an oral therapy for Fabry in these very unique times.
For example, we've seen some patients switch to Galafold or start on Galafold because they've been reluctant to go into a hospital or clinical setting for alternative care. We've also seen our first patients prescribed Galafold via telemedicine, a phenomenon that actually was highlighted in the recently released [Indecipherable] report which show that 50% of rare disease patients now have experienced some form of telemedicine, which is up from 20% before the crisis.
And then finally -- and I'll provide more detail later -- our supply chain remains fully intact and so our customers have confidence that they can access Galafold. And all that we think has led to continued uptake. And we've seen new patient starts all through the crisis, even in the hardest hit countries including the UK, France, Italy, Spain, Japan, the United States, and many others. So, we think these dynamics may continue to provide some tailwinds even as the global pandemic inevitably may cause some headwinds, which we will continue to closely monitor as the full impact of the pandemic currently remains unknown.
From a numbers perspective, you can see that the first quarter sales, as I mentioned, increased 78%, which does include a 3% negative impact from foreign exchange. And so if you look at it from an operational performance perspective, sales actually increased by 81% compared to the same quarter last year. And on the left-hand side, here we do show the quarterly performance over the past several quarters, and we do continue to expect consistent growth quarter-to-quarter, but again in a relatively non-linear way as we've seen in years past.
So, on slide 8, now with several years of performance behind us, we can confidently say that we are on a path to that $500 million sales opportunity in 2023. And as I've outlined previously, to get to that $500 million, we would expect about a five year compounded annual growth rate of 40% from 2018 to 2023, and we're well through that period now. We do expect that we'll generate about $1 billion in cumulative revenue between 2020 and 2022 alone, which of course will go a long way toward funding our R&D and opex over that period.
And we continue to have even further confidence in the billion-dollar revenue opportunity at peak as we continue to see significant and sustained growth in the Fabry market globally, which is driven by continued diagnosis from high-risk screening, newborn screening, other diagnostic initiatives, which we're now investing in as well. And we have orphan exclusivity in the US and Europe and other geographies, which alone take us to the end of the 2020s in addition to our Orange Book-listed patents that give us IP coverage into late 2030s. So lots of opportunity and time to provide access to Galafold globally for a long period to come.
On slide 9, we do want to highlight all the things that we're doing to ensure that continuous supply chain. This isn't something we've focused on before, but we will reiterate again here that our supply chain has maintained continuous supply during the COVID-19 pandemic for both Galafold and AT-GAA. For Galafold, part of our existing strategy had already been to hold multiple years of inventory in API and drug product, so we don't believe manufacturing will be an issue for us. And as the COVID-19 pandemic became increasingly severe, we have successfully now pushed inventory as far as possible down the supply chain to the country and even to the pharmacy level, and again, this is made much easier by the fact that this is a small molecule with long stability and easy to ship around the world.
And similarly for AT-GAA, our base plan had already been to build inventory ahead of our anticipated launch and to move drug products outside of China into the UK, and work had already been under way, and now following the spread and impact of the COVID pandemic, we're taking similar actions for Galafold where we've now pushed inventory into the supply chain as far as possible and coordinating on a site-by-site basis for delivery.
We would also note here that WuXi who is our manufacturing partner for ATB200, the biologic, has not had a single interruption to their manufacturing operations, and we continue to successfully manufacture ATB200 and AT-GAA as we build commercial inventory.
In summary, we expect to be able to continue to supply Galafold and AT-GAA in all of our global geographies for all of our patients living with Fabry and Pompe disease, and additionally, we do have sufficient inventory now of AT-GAA to complete all of our ongoing clinical studies in the Pompe program with a high degree of confidence that the studies, including the Phase III PROPEL study, importantly, will continue uninterrupted and be completed on schedule. And I'll go through that in more detail here in a moment.
So turning now to slide 11. Let me go through some of our R&D updates. AT-GAA for Pompe disease, you'll remember, is the first ever second generation therapy as well as the first ever therapy for Pompe disease to receive breakthrough therapy designation. There is a tremendous momentum behind what we believe may be the next standard of care for a broad population of people living with Pompe disease which does represent a $1 billion to $2 billion global opportunity. We're on track, as John mentioned, to complete the Pompe Phase III PROPEL study on our original timelines to enroll the pediatrics studies and advance manufacturing to support a 2021 BLA and MAA filings.
And importantly, we're reiterating that PROPEL study timelines are on track even if in the face of the COVID crisis. And this is really thanks to the incredible efforts of our clinical team where we literally have a patient by patient plan that we've created, along with our investigators, to protect the integrity of the study. We'd remind everyone that we did over-enroll the study which provides further confidence. And importantly, a little bit more color. As of today, we've administered 97% of the expected 2,250 infusions up to this point, which is well within the design study parameters. And we'll continue to ensure that patients are getting their infusions.
Today, for the first time, we announced that the US FDA has granted our rolling BLA submission of AT-GAA and we're on track to initiate that rolling BLA in the second half of this year, which will support a full approval under the fast track designation. Additionally, in response to the many requests we're getting for compassionate use that we've received, in particular for children with infantile onset Pompe disease or IOPD, we've now initiated the Expanded Access Program that we first discussed on our call for the full year earlier in March.
And from a manufacturing perspective, we've successfully completed all three of the production campaigns, including the bioreactor runs and now the related downstream purification activities under the PPQ process at WuXi, which will serve as the foundation for the CMC section for the BLA submission. And importantly, as you know, this is a significant step forward and a major de-risking event for this program.
We do continue to be extremely excited about AT-GAA as well as our pre-clinical Pompe gene therapy program to build what we believe could be the largest and the most valuable franchise in the industry with the potential to offer solutions to all patients living with Pompe disease globally.
Now, on slide 14, I'll briefly highlight here our industry-leading portfolio gene therapies for rare diseases. And I would say, thanks to the careful efforts of our science and facilities teams, even during this time, we've been able to maintain our critical science and lead program activities across our gene therapy portfolio, including of course CLN6 and CLN3 Batten disease as well as the Pompe and Fabry gene therapy and our earlier discovery programs [Indecipherable].
Starting with our Batten disease franchise in CLN6. As a reminder, we've previously reported positive interim data in our clinical study that we think demonstrates meaningful impact of our AAV gene therapy in this extremely devastating form of Batten disease. And this year, we do expect additional data from the CLN6 Phase I/II study and we do plan to advance our regulatory discussions, so we can finalize clinical and regulatory path for that program. We also believe that the initial CLN6 data provide important read-through for our clinical study in CLN3 Batten disease, which as you know, is the most common form of childhood neurodegeneration, and our plans this year are to advance regulatory discussions to finalize that clinical and regulatory path as well as report initial data from the ongoing Phase I/II study in the second half.
And importantly, in recognition of its potential to address a significant unmet medical need, our CLN3 gene therapy program has been granted fast track designation by the US FDA. That fast track designation affords us greater access to the agency for purposes of expediting the drug's development, review and potential approval.
And then finally on slide 15. Let me just remind you of all the great things that are going on as part of the research collaboration with the University of Pennsylvania, which will be an important driver of growth for Amicus for decades to come. This collaboration with the Wilson Lab at Penn combines Amicus protein engineering and glycobiology experience along with Penn's world-class gene transfer technologies to develop novel gene therapies designed for optimal cellular uptake targeting dosing, safety and manufacturability. As part of this collaboration, we have rights to 15 plus diseases, including eight that are currently in active preclinical programs.
Also, I'll note that we announced several Amicus presentations to be presented at the American Society of Gene and Cell Therapy at their 23rd Annual Meeting, which is being held virtually next week. Our sponsored studies there have included one oral presentation and two posters, and we would encourage you to take a look at some of the new data that we'll provide in a virtual way through that conference. We do expect additional preclinical data this year in multiple of our gene therapy programs and we're continuing to guide to the disclosure of one to two additional IND candidates by year-end.
And with that, let me now turn the call over to Daphne who can go through our financial results, our guidance and our financial outlook. Daphne?
Daphne Quimi -- Chief Financial Officer
Great. Thank you, Bradley, and good morning, everyone.
Our financial overview begins on slide 17, with our income statement for the quarter ending March 31, 2020. For the first quarter, we achieved Galafold revenue of $60.5 million, which is a 78% increase over the first quarter of 2019. This includes year-over-year operational revenue growth measured at constant currency exchange rates of 81%, offset by negative currency impact of 3%.
Cost of goods sold as a percentage of net sales was 10.8% in the first quarter as compared to 11.9% for the prior-year period. Cost of goods sold as a percent of revenue was favorable as Galafold revenue continues to grow in the United States where we do not owe royalties as well as other countries where we are subject to lower royalties.
Total operating expenses were $132 million for the first quarter of 2020 as compared to $111.3 million for the first quarter of 2019. On a non-GAAP basis, total operating expenses were $116.7 million for the first quarter of 2020 as compared to $96.2 million in the first quarter of 2019. The increase in research and development costs was primarily due to investment in our gene therapy programs, for the initiation of the tech transfer to our contract manufacturers and clinical research within our early stage programs and within the Pompe program to advance and enroll clinical studies.
Our investment in research and development includes the impact of the implementation of the cost reduction measures that were previously announced as does the decrease in selling, general and administrative expenses. The non-GAAP quarterly expense is expected to decline throughout 2020. We define non-GAAP operating expense as research and development and selling, general and administrative expenses, excluding share-based compensation expense, changes in fair value of contingent consideration and depreciation.
Net loss for the first quarter was $88.9 million or $0.35 per share as compared to a net loss of $120.3 million or $0.56 per share for the prior-year period. As of March 31, 2020, we had approximately 257 million shares outstanding.
Turning now to slide 18. As John mentioned, we are now fully funded well into the second half of 2022 through major milestones in our portfolio and continued global growth. We have been able to further extend our cash runway by continuing to drive efficiencies, cost savings and careful expense management.
On slide 19, going forward, again to emphasize, we expect total non-GAAP operating expenses in 2020 to remain relatively flat from 2019 as we leverage the commercial infrastructure that is already in place for the AT-GAA launch and other products in our pipeline. We transition the costs associated with the development of AT-GAA to multiple gene therapy programs in our pipeline and maintain financial discipline while meeting our objective. To reiterate, all high priority research programs in gene therapy are moving ahead on schedule, especially CLN6, CLN3, Pompe and Fabry gene therapy programs. And we continue to fully support the work with Jim Wilson and Penn.
A few comments about our current cash position and 2020 financial guidance. Cash, cash equivalents and marketable securities were $339 million at March 31, 2020, compared to $453 million at December 31, 2019. We are reaffirming our full year Galafold revenue guidance of $250 million to $260 million and our non-GAAP operating expense guidance of $410 million to $420 million.
And with that, let me turn the call back to John for closing remarks.
John F. Crowley -- Chairman of the Board, Chief Executive Officer
Great. Thank you, both Daphne and Bradley.
So, as you can see, we have been relentlessly focused on performance across the business despite all of the unprecedented pains and challenges brought about by the global pandemic. We have a great global team of passionate entrepreneurs who have led and will continue to lead us through this. And I'm confident that as the world emerges from this crisis, Amicus will emerge even stronger.
So operator, with that, we're happy to take any questions.
Questions and Answers:
Operator
[Operator Instructions] Your first question comes from the line of Anupam Rama with JP Morgan.
Anupam Rama -- JP Morgan Chase & Co. -- Analyst
Hey guys, thanks for taking the question and congrats on all the progress. Just a quick question on the cash runway guidance which is now second half of 2022. I'm just wondering what that assumes in terms of sort of reopening here in the US and globally due to COVID-19 pandemic and what are the push-pull levers we should be thinking about on the expense side, if for whatever reason there is a second wave of infection and the pandemic is along longer than what some of us assume? Thanks so much.
John F. Crowley -- Chairman of the Board, Chief Executive Officer
Sure. So what we've communicated to all of our employees globally on it is that we're going to put their health, safety and well-being first and foremost. Thankfully, we've been able to operate Amicus through this telepresence mode really effectively. So, the greatest risk to the business frankly would be to rush back and to put people at risk. So we're not going to do that. We've said to our employees that June would be the earliest that there would be any reintegration back. We are now undergoing a project carefully evaluating that, looking at all the local guidelines around the world in all the geographies we work in. So, what I've emphasized to the employees is that our return to any semblance of what we were before from a work cadence will be flexible and will be staggered and will be an integration over time.
Frankly, we've also taken this time to launch an internal initiative we're calling R3 or R cubed where I've asked all of our employees to rediscover, reimagine and reinvent what Amicus looks like on the other side of this to really take the best practices, the best efficiencies, including the cost savings efficiencies. So, right now, that takes into account as we extend the runway to the second half of 2022. Again, this was a multi-week financial exercise across the entire organization, looking at all of our functional operating expenses, looking at a reprioritization of our earlier-stage preclinical programs and a further measuring of our capital expenditures.
Obviously, there is certain -- very evident savings from the crisis itself: travel, entertainment expenses, the T&E part of the budget; conferences; frankly, hiring as we've had very limited additional hiring through this period. So all of that taken together allow us to buy a couple of quarters now to extend the runway well into the second half of 2022, which puts us very close to that bridge to profitability ahead. And if the crisis were to reemerge and we had to go back to kind of our shelter-in-place routine, we don't expect that that would have any negative bearing from an expense standpoint as well. Does that answer the question, Anupam? Okay, hopefully.
Operator
Your next question comes from the line of Ellie Merle with Cantor Fitzgerald.
Ellie Merle -- Cantor Fitzgerald -- Analyst
Hey, guys. Thanks so much for taking the question. Just on the manufacturing front for gene therapy, can you give us more color on how the scale-up is going for Batten and sort of the latest on your expectations for dosing more patients and using the commercial-scale manufacturing and just any impact you're seeing in terms of sort of supply or raw materials through the scale-up process just due to COVID? Thanks.
John F. Crowley -- Chairman of the Board, Chief Executive Officer
Sure. I'm going to let Brad handle that. It seems like your dogs are as excited as ours are about the Amicus [Indecipherable].
Ellie Merle -- Cantor Fitzgerald -- Analyst
[Indecipherable].
John F. Crowley -- Chairman of the Board, Chief Executive Officer
No, no, that's all part of working from home. It's fine, of course. So Bradley, I'll let you take that question, and obviously Jeff as well, please chime in.
Bradley L. Campbell -- President and Chief Operating Officer
Yeah, sure. So manufacturing for gene therapy continues to go very well as you are asking your question. We're in the middle of the tech transfer activities to Brammer who will be our manufacturer for the CLN6 and CLN3 programs. And that is in the hyperstack platform, which is how they are being manufactured with NCH. And so that process is going very well. It's a platform that Brammer has a lot of experience with and we're well under way there. The intention is that the next patients and who will be dosed in CLN6 will be using that commercial material or the commercial platform, I should say, from Brammer, and that's on track for 2021.
In terms of your question around raw materials and inputs into the supply chain for gene therapy, likewise, we had purchased starting materials, plasmas, etc., ahead of time and secured manufacturing sweet time for all of our supply chain for gene therapy. And so we have had no interruptions so far, and we don't anticipate any interruptions in the gene therapy manufacturing or supply chain.
John F. Crowley -- Chairman of the Board, Chief Executive Officer
Great. Thank you, Bradley.
Operator
Your next question comes from the line of Whitney Ijem with Guggenheim.
Whitney Ijem -- Guggenheim -- Analyst
Good morning, guys. Thanks for taking the question. I wanted to follow up on the Galafold, some of the comments around the Galafold trends, I guess, that you're seeing so far in light of COVID kind of around patients being hesitant to go into healthcare centers and that sort of being a tailwind for oral. I guess, curious are there any kind of like leading indicators or things in terms of patients engaging with you guys virtually or on the website or anything like that you guys are tracking that you can talk about to see if that sort of trend or potential tailwind for a switch is continuing going forward.
John F. Crowley -- Chairman of the Board, Chief Executive Officer
Great. Thanks, Whitney. I will ask Brad to comment in a moment. But, again, just to emphasize, we had really strong trends coming into 2020 before the COVID-19 crisis. So this great performance in Q1 was driven by fundamental patient demand, again, going back to the nature and characteristics of the medicine. We think the fact that of course that it's an oral medicine that can be taken at home is yet one further benefit, particularly in this COVID-19 crisis, and we've seen that play out now in a number of settings, a number of geographies. So, not the key driver of this great performance but a factor.
Brad, if you want to add more color and maybe how we think about it going forward in the months ahead.
Bradley L. Campbell -- President and Chief Operating Officer
Yeah, I think that's well said, John. I think, look, we have been well under way in establishing Galafold as an important treatment option in Fabry disease, and we think the best treatment option for patients with amenable mutations. And I think that strength, foundation, experience now with the physicians and patients, it really sets us up for this success and strength going forward.
To your specific question around some of those dynamics around being an oral product, it's interesting. Outside the US, of course, we can't have direct interaction with patients. It's really all through physicians. But we do have very close relationships with physicians and have done a good job ahead of time setting up the ability to interact with them virtually. It's moved from instead of face-to-face meetings to text or phone call or video chat, just as we all have, and that's how we hear of some of these really encouraging anecdotes of physicians being able to meet some of their patients' needs by moving them to the oral option, and that's both switch patients who may have been getting enzyme replacement therapy, and again, for the reasons I highlighted, might want to pursue an oral option and for new patients. We continue to have new patient starts even in the hardest hit countries. So that system is working well. And again, as John said, that we think provides us some incremental tailwinds which is exciting.
In the US, where you can have a regulatory compliant interaction with patients more directly, what we've seen is that we actually have had more virtual patient meetings, which is really exciting, and that seems to be a form and an environment that actually patients are drawn to. So we're going to look to continue to explore that. And again, in the US, with our physicians and with some patients, we do know of examples of where specifically patients that wanted to switch or start on Galafold because it's an oral option. So, again, important trends. We'll continue to watch them. We'll continue to watch how the pandemic plays out. But so far, again, great in terms of Q1.
Operator
Thank you, sir. Your next question comes from the line of Ritu Baral with Cowen.
Ritu Subhalaksmi Baral -- Cowen and Company -- Analyst
Hi guys, thanks for taking the question. I wanted to ask about potential Pompe competition and sort of the commercial landscape coming up. How would you position AT-GAA if the upcoming Genzyme data hits FVC superiority within its naive patient population? How would that compare to potential superior six minute walk data that you might generate? How are you thinking about commercializing a Pompe drug in the age of COVID, just understanding the risk of this patient population to respiratory diseases? And orphan drug lunches are usually so incredibly high [Indecipherable] and you've got such a great team with like patient relationships with Jane and her organization within Amicus. How are you thinking about the situation?
John F. Crowley -- Chairman of the Board, Chief Executive Officer
Thanks, Ritu. I think this launch, like any other, but particularly in Pompe, is going to be driven by the strength of the data. So the PROPEL study will be incredibly important. We've got a lot of data that we've already accumulated. Again, to remind everybody, the first patient treated with AT-GAA was just over four years ago. And to remind everybody, we have a very unique dataset. I'm not going review at all here. At the moment, we've spoken to it at multiple scientific conferences, where for AT-GAA we've seen profound impacts on people, whether they were treatment-naive or whether they were switching from the ERT standard of care.
So while we think it's great that there are other drugs in development, we think we have a very unique medicine that we have developed. And we're going to let the clinical data speak for itself, and ultimately the clinical data will have to drive the success of the launch. We are well-positioned. Importantly, with the PROPEL study, we have dozens of sites in multiple countries around the world. Really, every key opinion leader is now getting experience with AT-GAA which we think will also help as we hopefully are able to launch this medicine around the world. So I'm not going to speculate as to what any other program may or may not show. Ultimately, the success of the launch of AT-GAA will rest on the strength of the AT-GAA data.
Operator
Your next question comes from the line of Joseph Schwartz with SVB Leerink.
Joseph Patrick Schwartz -- SVB Leerink -- Analyst
Great. Thanks so much. I was wondering if you could talk about the extent of CLN3 data that you expect to report later this year. Just given the slower progression of disease activity in this subtype, how sensitive are the endpoints you're using and where do you expect to detect the biggest impact versus natural history in CLN3 versus what you've seen in CLN6?
John F. Crowley -- Chairman of the Board, Chief Executive Officer
Sure, Joe. Thanks. I hope you're well. Again, it will be a limited dataset on a handful of patients who were treated at the low and then the high dose with CLN3. I am going to ask Jeff Castelli, our Head of Gene Therapy, just to comment a little further about the CLN3 program. Again, this will be preliminary data, with most of the patients to begin being treated in 2021 with the Brammer-made commercial material that we think will be the basis of approval. But, Jeff, feel free to add any color.
Jeffrey P. Castelli -- Chief Portfolio Officer and Head of Gene Therapy
Sure. Thanks John. As John noted, we will have the data later this year for CLN3 in the first handful of patients that we've enrolled. That would be one year post gene transfer data for most of those patients. CLN3 is slower progressive than CLN6, although it still does progress quite rapidly. The main endpoint that we'll be focusing on from an efficacy perspective is the unified Batten disease rating scale, which measures various aspects of motor function in language, cognition, vision, so it's a very diversified scale with lots of components, so a lots of different things to look at, but it will just be an early look at one-year data and then importantly, it will be an update on the safety data this case as well.
Operator
Your next question comes from the line of Mohit Bansal with Citigroup.
Mohit Bansal -- Citigroup -- Analyst
Great. Thanks for taking my question and very good morning. Hope everyone is staying safe out there. My question is regarding -- so some of the companies in our coverage area have talked about a little bit of advanced purchasing, especially for orals in the light of COVID. Have you experienced anything like that for Galafold which could potentially -- we need to keep in mind while we are modeling second quarter and subsequent quarters? Thank you.
John F. Crowley -- Chairman of the Board, Chief Executive Officer
Great. Thanks, Mohit. Yeah, the results, the $60.5 million that we reported today was driven by fundamental demand and kind of the natural rhythm of sales. Very, very minimal impact that we could see from any advanced work in the channel. I'll ask maybe Bradley and Daphne if you want to add any more specifics to that.
Bradley L. Campbell -- President and Chief Operating Officer
Yeah, John. I think you said it well, and I was careful in my intro comments to highlight that. So, first and foremost, it was strong patient demand and strong compliance, which we continue to see around the world, which is great. We did have some favorable reimbursement dynamics as well. Fewer bridge programs in the United States. So reauthorization went really well. So that's all, again, underlying patient demand. As John said, there was very minimal contribution from some ordering patterns. There were a few hospitals here and there and a few countries here and there who ordered a little bit more, but that was a minor contribution. The fundamental driver of the quarter was really that momentum, the patient demand, and some of those reimbursement dynamics that I mentioned.
Operator
Thank you. Your next question comes from the line of Tazeen Ahmad with Bank of America.
Tazeen Ahmad -- Bank of America -- Analyst
Good morning. Thanks for taking my questions. One for Brad. Can you just walk us through how you're thinking about the Pompe market? Maybe specifics about range of pricing that we should assume. You do have the benefit of having another drug on the market, one that's been around for a long time. So, I'm hoping you could share some of the learnings, maybe observations about Lumizyme in terms of how big of a sales force you might need and again just your thoughts on pricing. And then I have a follow-up question. Thanks.
John F. Crowley -- Chairman of the Board, Chief Executive Officer
Yeah. Thanks, Tazeen. I'll turn it over to Brad. I'll just start with -- again, we will apply the same principles that we did for Galafold as we will for all of our medicines that they must be fairly priced and broadly accessible, and that would be a fundamental premise that we apply here. And with that, Brad, if you want to talk about broadly how we're thinking about ensuring access for patients for AT-GAA once it's hopefully on a path to launch.
Bradley L. Campbell -- President and Chief Operating Officer
Sure. Thanks, John. Yeah, thanks, Tazeen, for the question. Yeah, I think we've learned a lot from Galafold and I think the focus on access rather than premium pricing I think served us very well. We focused on providing a great value proposition for both patients and physicians, of course, but also to payers and that's allowed us to go very quickly through the reimbursements and launch cascade in Europe and really throughout the world. And so we'll apply those similar learning's here.
I do think there is some advantage to being kind of a second mover in the sense that, again, like with Galafold in the case of Fabry disease, here in Pompe, we don't have to convince payers that Pompe is a serious disease that is worth reimbursing for a relatively high-cost rare disease drug. Here, we have to show payers and physicians and patients that our value proposition is better than the alternative. And as John mentioned earlier, that will come down to the data, but of course, we feel very confident in our ability to demonstrate that based on the data we saw in Phase II.
From an infrastructure perspective, there too, we are very successful with our, we think, very efficient rare disease sales force. Of course, Sanofi has the Fabry drug as well as the Pompe alternative right now. And so we understand kind of the ratio of our team to their team. We think we have a smaller team out there in the field and that served us very well. And so we're confident that with really only very little additions to our global commercial organization, we will be able to successfully launch and commercialize this drug.
One other thing that I think is important if you think about how we were with Galafold launch versus where we'll be with the AT-GAA launch. We'll have a lot more patients on AT-GAA at the time of launch, and we hope to be launching in the US, which is one of the largest markets early as well as the UK and Europe, and so, we think that we will have an opportunity to access a much higher number of clinical trial patients earlier in the launch cascade than we did with Galafold. So I think for all those reasons, we feel well prepared and eagerly looking forward to seeing the data.
Operator
Your next question comes from the line of Debjit Chattopadhyay with H.C. Wainwright.
Debjit D. Chattopadhyay -- H.C. Wainwright & Co. -- Analyst
Hey, good morning, and congrats on the execution, and thanks for taking the question. So, I understand the US market is 29% of the revenue base. But given the 33 million unemployment print this morning and since we are all dependent on employer-provided insurance, wondering what your current payer mix is and how much of the unemployment disruption is built into your $250 million to $260 million full year guide. Thank you.
John F. Crowley -- Chairman of the Board, Chief Executive Officer
Great. Thanks, Debjit. I'll ask Brad to comment on the payer mix and how we're thinking about that.
Debjit D. Chattopadhyay -- H.C. Wainwright & Co. -- Analyst
Yeah, it's a good question. So far, we've actually had a lower exposure to government payers from a mix perspective than we had anticipated. But we have great access programs for both private insurers as well as government payers. And frankly where patients can't afford the drug, we provide free access to the drug. And so, one of the things we've said is we've never had a patient go through the process and be ultimately rejected by a payer. So we feel very good that patients are getting access to Galafold and have been -- we haven't seen any disruption so far in patient access even due to some of the unemployment.
Of course, you have to remember that Fabry is big population for us, but it's a very small portion of the US population. And so those kinds of numbers that feel quite large from a US unemployment perspective, the exposure in the Fabry population so far for us has been minimal. And so our guidance I would say remains the same. Where we sit here, we are reiterating and feel very confident in the guidance. Of course, we'll continue to monitor, and should things change, we'll provide those updates accordingly. But right now, we feel very good about where we are.
Operator
Your next question comes from the line of Mike Ulz with Baird.
Debjit D. Chattopadhyay -- H.C. Wainwright & Co. -- Analyst
Hey guys, thanks for taking the question, and congrats on the strong quarter as well. Just a quick question for you on the PROPEL study. It seems like things are progressing fairly well there. Despite COVID-19, you're seeing 97% of infusions occurring on schedule. Just curious, if you're expecting any issues in terms of the data collection for that study or are there some steps you're taking to help mitigate that potential risk? Thanks.
John F. Crowley -- Chairman of the Board, Chief Executive Officer
Yeah. Thanks, Mike. As Bradley indicated, we have a really custom, patient-by-patient, site-by-site plan that we've implemented. And the areas of focus are twofold. One is to ensure that infusions happen in patients who are able to access drug within the appropriate windows. And secondly are the assessments. To remind everybody, we do assessments of course at baseline but also three, six, nine, and then the 12-month assessments as well. So, we continue to ensure that patients are getting those assessments, and that's part of the confidence that we have in the integrity of the study.
In some cases, we've had to go to some pretty extraordinary lengths to make sure that those assessments are administered but that's an important part of maintaining the integrity of the study. So we feel good about where we are there as well. And I think that would continue with all the contingency plans we've put in place to ensure that we're able to collect the data appropriately. So we've not thankfully seen any interruption that would impact the integrity of the study. But it's something we'll continue to follow very closely.
Operator
Thank you. Your next question comes from the line of Salveen Richter with Goldman Sachs.
Andrea Tan -- Goldman Sachs -- Analyst
Thanks for taking our questions. This is Andrea on for Salveen. Maybe one question for Brad. With respect to Galafold, could you provide updated metrics on the split between the switch and naive patients, and how this patient mix is perhaps tracking with your expectations within the context of new and established markets?
Bradley L. Campbell -- President and Chief Operating Officer
Yeah. Happy to take that. And good question. So, the dynamics that we've been highlighting through most of our calls are continuing kind of on track, and so right now, we're about 65-35 or two-thirds, one-third switch versus naive. So the naive portion is slowly growing, which is what we would anticipate.
In most markets, the dynamic we see is that the initial uptake is stronger in the switch population. And again, that's logical because they are the ones that are coming in every other week into the healthcare system to get an infusion. And so they are the ones that are kind of readily available in the system. And then, typically over time, we see more and more naive patients come onto therapy. I will say that in our more mature markets like Europe, the growth driver this year is 50:50 really between switch and naive, and even in some markets, we will start to tip toward more naives than switches as we penetrate the existing market, and again, that would anticipate that that will really grow the market over time.
And so we will expect and we do expect in the three to five year timeline that we are driving significant growth in treated market in Fabry disease. So those trends continue. And as I highlighted on the call, we are seeing new patient starts, both switch and naive, along the portions that we've seen in previous quarters.
Operator
Thank you. You have a follow-up question from the line of Ritu Baral with Cowen.
Ritu Subhalaksmi Baral -- Cowen and Company -- Analyst
Hey, guys. I just wanted to get back in with my commercialization question. Just as far as launching into an at risk Pompe population at risk for respiratory diseases when COVID could still be a risk at the general population, just how you're thinking about a virtual orphan drug launch assuming your data [Indecipherable] approval is in 2021.
John F. Crowley -- Chairman of the Board, Chief Executive Officer
Sure, Ritu. I'll comment and then I'll ask Brad to add some color. Again, given the extraordinary demand for a next generation product in Pompe, I wouldn't think that it has any impact on the launch ahead. Of course, again, we're looking at a launch perhaps in late '21 or early '22, and hopefully, the COVID crisis will have largely, if not entirely, passed by then. But with that in mind, I would really use the PROPEL study as a reference together with the infantile study that we just launched. Patients are seeking better treatment options. The greatest risk is [Indecipherable] [0:53:13] not beyond the best available therapy.
So, again, these are physician scientists. They are extremely motivated, the key opinion leaders across the world. We've seen them go to great lengths just to maintain the integrity of a clinical study. And I would think with further data and approvals, they would go to just as greater, even greater lengths, to ensure that patients have access to a potential next generation therapy.
So Bradley, do you want to maybe add any color or then even a bit more about how we're thinking about a global launch of AT-GAA?
Bradley L. Campbell -- President and Chief Operating Officer
Yeah. Thanks, John. Just a few more comments there. I think that was well said in terms of the demand and our ability to keep the supply chain intact and keep patients getting their infusions. A couple other things that I would highlight, one of which I mentioned earlier, which is one great thing about the development program for AT-GAA is we will have quite a number of patients on AT-GAA at the time of launch and dozens of centers around the world and even more countries than we have with Galafold. So if you think about kind of the rate of uptake with Galafold versus with AT-GAA, I think we have many more sites, many more patients, and many more geographies, who will be on AT-GAA at the time of launch, which I think gives you a good start.
I also would say, we are looking at a whole host of opportunities to think about what may be on the other side of this pandemic. It's very likely that the adoption and acceptance of virtual interactions will go up as we've all gotten used to operating this world. We expect our physicians and patients will as well. You may have heard in one of the previous questions, in the US as an example, we're doing more virtual patient meetings, and that seems to be very, very strong, and so we'll continue to look at that. We're interacting with physicians in different ways. We would never think that that would substitute with direct interactions, but we're going to use this time to see how we can augment that, and really be a value add to our customers through this process.
And I did mention it before, but I will here, another important part of this is our case management team and our medical affairs team globally who work very closely with our supply chain to make sure that patients are answering the questions they have, physicians are answering the questions they have, and again, that experience with Galafold which has been very strong will help us in any kind of setting, whether it's in a -this normal or the new normal or whatever it is that really strong support function that we've built up through the Galafold launch will continue, and we think that will serve us well with the launch of Pompe.
Operator
Your next question is a follow-up from Debjit with H.C. Wainwright.
Debjit D. Chattopadhyay -- H.C. Wainwright & Co. -- Analyst
Hey, thank you for letting back in again. So with regards to the Pompe gene therapy IND, we have very little information regarding whether it's liver directed or muscle directed, etc. How should we be thinking about autophagy in terms of expression uptake, etc. And also in CRIM-negative patients, if it's not a liver-directed gene therapy, how do you circumvent that? Thank you.
John F. Crowley -- Chairman of the Board, Chief Executive Officer
Great. Thanks, Debjit. We of course have more data coming out at the conference next week. So I'm going to ask Hung to comment broadly about the technology approach that we're taking. So Hung, if you want to feel that, and Jeff, chime in if you have any other color.
Hung Do -- Chief Science Officer
Sure. I think that we have described, at least in some detail, that our Pompe gene therapy program will use mostly a broad [Indecipherable] type of vector which allows for transduction of not just liver but also muscle and other tissues as well. And so, we know that this particular vector -- again, this is a vector that was designed by Jim Wilson and his group at UPenn and we know that it seems to transduce quite well.
And we don't know, at least, we don't have data to indicate that autophagy will be a problem for its ability to transduce. We know that that virus is able to deliver the gene and it's able to get out of the [Indecipherable] to basically go about transfer the gene pretty well in all of the animal studies that we've done up to this point. Jeff, do you want to comment anymore on that?
Jeffrey P. Castelli -- Chief Portfolio Officer and Head of Gene Therapy
Sure, Hung. Thanks. I think that's a really good answer. The only thing I'd reemphasize is that the approach we're taking with our capsules [Phonetic] and promoters will certainly transduce liver. It's just that in addition to that liver transduction, we'll transduce other tissues like muscle that might have better durability. So we would expect any tolerization that might come from the liver to also help in the case of, for instance, a CRIM-negative infant that might have some immunogenicity to the actual GAA protein produced by the cells.
Operator
Thank you. At this time, I would like to turn the conference back to Mr. John Crowley, Chairman and CEO, for closing remarks.
Jeffrey P. Castelli -- Chief Portfolio Officer and Head of Gene Therapy
Great. Thanks, operator. That was a great conference call. Thanks for all the terrific questions. I hope everybody and your family stays well and healthy. Have a great day.
Operator
[Operator Closing Remarks]
Duration: 59 minutes
Call participants:
Andrew Faughnan -- Director of Investor Relations
John F. Crowley -- Chairman of the Board, Chief Executive Officer
Bradley L. Campbell -- President and Chief Operating Officer
Daphne Quimi -- Chief Financial Officer
Jeffrey P. Castelli -- Chief Portfolio Officer and Head of Gene Therapy
Hung Do -- Chief Science Officer
Anupam Rama -- JP Morgan Chase & Co. -- Analyst
Ellie Merle -- Cantor Fitzgerald -- Analyst
Whitney Ijem -- Guggenheim -- Analyst
Ritu Subhalaksmi Baral -- Cowen and Company -- Analyst
Joseph Patrick Schwartz -- SVB Leerink -- Analyst
Mohit Bansal -- Citigroup -- Analyst
Tazeen Ahmad -- Bank of America -- Analyst
Debjit D. Chattopadhyay -- H.C. Wainwright & Co. -- Analyst
Andrea Tan -- Goldman Sachs -- Analyst
