Amicus Therapeutics Inc. (NASDAQ:FOLD) Third Quarter 2022 Results Conference Call November 7, 2022 08:30 AMm. ET
Participating companies
Bradley Campbell – President, Chief Executive Officer
Sébastien Martel – Business Director
Jeff Castelli – Director of Development
Daphné Quimi – Chief Financial Officer
Andrew Faughnan – Managing Director, Investor Relations
Conference Call Participants
Ritu Baral – Cowen
Anupam Rama – JP Morgan
Joseph Schwartz – SVB Values
Tazeen Ahmad – Bank of America
Sara – UBS
Dae Gon Ha – Stifel
Salveen Richter – Goldman Sachs
Yun Zhong – BTIG
Gil Blum – Needham
Operator
Good morning, girls and gentlemen, and welcome to the call and webcast of Amicus Therapeutics’ third quarter 2022 monetary effects convention. At this time, all participants are in listen-only mode. at that time. As a reminder, this convention call is being recorded.
Now I would like to speak with your host, Mr. Andrew Faughnan, Executive Director of Investor Relations. You can get started.
Andres Faughan
Thank you, Shannon. Good morning. Thank you for signing up for our convention call to discuss Amicus Therapeutics’ third quarter 2022 corporate effects and monetary highlights. The leaders of today’s call are Bradley Campbell, president and CEO; Daphne Quimi, Chief Financial Officer; Sébastien Martel, commercial director; and Dr. Jeff Castelli, Director of Development. Mitchell Goldman, Chief Medical Officer, and Ellen Rosenberg, General Counsel, will sign up for questions and answers.
As indicated on slide 2, we may have forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 regarding our business, plans and prospects. Our forward-looking statements do not deserve to be construed as a representation through us that any of our plans will be realized. Some or all of the forecasts made in connection with this call may turn out to be erroneous and possibly affected by erroneous assumptions we may make, or by known or unknown knowledge. Dangers and uncertainties. You are cautioned not to place undue reliance on forward-looking emails that refer only to the date hereof. All forward-looking emails qualify in their entirety through this notice and we assume no legal responsibility to revise or update this presentation and convention call to reflect instances subsequent to the date hereof.
For a complete discussion of such forward-looking statements and the threats and uncertainties that would likely result from them, please refer to the forward-looking statements and threat points segment of our Quarterly Report on Form 10-Q for the quarter ended September 30, 2022. filed this morning with the Securities and Exchange Commission.
At this time, I am pleased to move to Bradley Campbell, President and Chief Executive Officer. Bradley?
Bradley Campbell
Great, thank you Andrew and welcome everyone to our third quarter 2022 earnings convention call. Today I am pleased to review the continued progress we have made in our business this year, and as we did in this morning’s press release, let me highlight several key achievements for the quarter.
Above all, Galafold continues its strong functionality and remains the cornerstone of our success. We remain very pleased with the global adoption of Galafold despite the significant currency hurdles we have noticed this year, with the first 3 quarters of the year reporting gains. expansion of 8% or 16% on an operating basis.
In the third quarter, our key signs of expansion and functionality met our targets across geographies and, as Sébastien will highlight, we continue to see strong trends in several of our metrics, adding new patient outflows and in-person visits between our team domain and our physicians. We reiterate our target of 15% to 20% expansion in Galafold’s revenue at consistent exchange rates.
We are also pleased to announce that Galafold’s portfolio of intellectual assets continues to grow this quarter. This year, we strengthened our intellectual asset heritage with the granting of 19 new patents. In the United States, there are now 46 patents published on the Orange List similar to Galafold, 30 of which provide coverage through 2038 and beyond, adding five patents for composition of the matter. We see this patent portfolio, as well as our orphan drug exclusives, offering broad, long-term intellectual asset rights through the late 2030s with this new precision medicine.
As we discussed throughout the year and as expected, we saw 3 Abbreviated New Drug Applications, or ANDA registrants, and obtained their certifications in paragraph 4. Given our heritage of strong and cutting-edge intellectual property, we are well placed to deal with any potential demanding generic situations for our patents, and we announced this morning that later today, we intend to file infringement lawsuits against 3 ANDA applicants seeking approval to commercialize a generic edition of Galafold. We intend to continue to protect and enforce our extensive intellectual asset rights and, for the future, we expect continued expansion for Galafold this year and are confident that with our strong intellectual asset protection, it has a long way to go in the coming decade.
Second, we continue to advance our global regulatory filings and advertising plans for AT-GAA, our new next-generation remedy for Pompe disease. As we announced last week, the U. S. Food and Drug Administration has been in the U. S. Department of Agriculture. Application for license, or BLA for cypaglucosidase alfa, the biological component of AT-GAA which we also refer to as ATB200. The agency said that due to COVID-19 travel restrictions, it was unable to conduct the required inspection of the WuXi Biologics production site in China for the review cycle and is deferring action on the application until the inspection is completed.
That said, the good news is that, according to FDA guidelines, a deferral can only be granted in such cases, quoting, as long as no deficiencies have been known and the application in a different way meets the requirements for approval, final quotation, so we said, we think it’s a matter of when, not if AT-GAA is approved. In addition, the company is now actively engaged with the FDA at this level and under the direction of the Agency, the company has requested a Type A Assembly with the Office of Pharmaceutical Quality to discuss and agree on plans and logistics for pre-approval inspection.
At Amicus, in conjunction with our production partner WuXi Biologics, we are in a position to inspect the production facility in China, and as soon as we have more clarity, we will provide an update on when we may be waiting for approval. As a reminder, we continue to expect both AT-GAA parts to be approved in combination.
Importantly, in Europe we are now quite complex in reviewing the EMA’s application for marketing authorisation for AT-GAA. CHMP’s opinion is expected at the December meeting, preparing for the launch of an announcement in 2023. As a reminder, the EMA has indicated that it does not require an inspection of the WuXi production site as a condition for approval.
We are also incredibly pleased with the point of interest and participation we are seeing in our expanded access systems globally. We now have systems in position in the US, UK, France, Germany and Japan, with increasing numbers of patients participating in each. In fact, throughout our ongoing clinical studies and access systems, only about 190 patients have been receiving AT-GAA lately, representing more than 5% of the total number of Pompe patients treated worldwide. We expect this number to continue to grow as we have technical approvals in the U. S. USA and Europe.
In anticipation of those near-term approvals, our global launch plans continue to move forward, adding our pre-launch activities, targeted investments, and a handful of additional staff to assist in the launch, as well as our ongoing investments in building a launch inventory. We are now on track to succeed in this long-awaited milestone of AT-GAA crossing the regulatory endline and providing some other remedy option for others living with Pompe disease in the U. S. With additional regulatory programs planned in the coming months. .
Third, Amicus has maintained a strong monetary position as we continue to execute Galafold’s global expansion and prepare for AT-GAA’s global launch. our path to profitability. Our purpose is to achieve non-GAAP profitability in the current part of 2023. This is based on a number of factors, adding the timing of AT-GAA’s approval and publication, but based on existing operating plans and projections, we will take part in it next year.
In addition, today we close a market percentage or ATM providing up to $250 million. We consider this to be a smart measure of monetary control and do not intend to use the ATM this year. In 2023 and beyond, we will apply judgment on any ATM usage and all proceeds will be used to ensure Galafold’s continued business expansion and maximize AT-GAA’s planned launches.
I will emphasize that we are focused on our top 3 goals: number one, to continue to advance Galafold to as many patients in as many geographies as possible; secondly, to obtain approvals and launch AT-GAA globally; and third, to the monetary strength of Amicus.
On slide 5, we see that we are on track to achieve our key strategic priorities for this year, including, first, bringing more people with Fabry disease to Galafold with adaptive variants in new and existing markets. As I mentioned, we are on track to achieve our double-digit global product earnings expansion goal of 15% to 20% in consistent currencies. This reflects the strong momentum and demand for this precision medicine on a global scale.
We remain committed to advancing AT-GAA regulatory approvals and the planned launch of AT-GAA, leveraging our seasonal global commercial, medical and market groups and our participation in all mandatory spaces for a successful and effective drug launch. We are fully ready and anticipate a successful launch of the AT-GAA.
We continue to invest wisely in advancing our best-in-class drugs and next-generation genetic functions and our next-generation companion for Fabry disease, and once again, we will continue to have a strong monetary position while conscientiously managing our expenses. Our investments in the company.
With that, let me now turn to Sébastien Martel, our Chief Commercial Officer, who will provide further highlights of Galafold’s functionality for the quarter. Sebastien?
Sebastian Martel
Thank you Bradley. Hello everyone on the call. I’ll start by giving you more main points about our Galafold functionality for the quarter.
On slide 7, for the third quarter of 2022, Galafold said its earnings reached $81. 6 million, thanks to sharp increases in new patients, partially offset by strong headwinds in foreign currencies. The geographic distribution of earnings for the quarter consisted of $51 million or 63% of earnings generated outside the U. S. The U. S. government, and the remaining $30 million or 37% of the U. S. U. S. Excluding currency effects, this corresponds to two-thirds of the third we expect as we continue to grow in any part of the business. We are excited to see continued strong expansion in patient numbers in countries such as the United States, Japan, Canada, Spain, Portugal and Poland, to name a few.
Going back to slide 8, our effects for the first nine months of the year highlight the strength of our efforts in the global industry. same period in 2021 at constant exchange rates. The negative effect of foreign currencies was 8. 3% during the period. As a result, Galafold recorded earnings expansion of 7. 9% in the first 3 quarters of the year.
To add some color to our geographic performance, in the first nine months of the year, our U. S. sales increased 16. 8%, while our U. S. outdoor sales increased 16% at constant exchange rates. This year, Galafold continues to be the fastest developing product in 2022 for Fabry disease in the world and the largest contributor to the expansion of the global Fabry market. I am pleased to report that our monthly net patient results continue to show positive signs; in fact, the three-month trfinish is the highest in the last two years, and if you look at the net patient expansion at Galafold globally, which is perhaps the most accurate measure of the underlying business, we see an expansion of more than 19% in the Number of patients at Galafold at the end of the third quarter of this year compared to the same period last year, all indications of Galafold’s continued and developing demand.
We ended the 3. er quarter with more than a portion of the global market place percentage of accommodable treated patients, and while the global mix is still around 55% replacement and 45% naïve across many geographies, we are seeing increased adoption in naïve populations as we achieve top marketplaceplaceplace percentage in countries where we have been approved for longer. there are still many opportunities to continue moving patients to Galafold and continue to grow the market as we enter the diagnosed untreated segments as well as the newly diagnosed segments. All of this is underpinned by the impressive compliance and compliance rates we continue to see above 90%, reiterating our confidence that patients taking Galafold will remain at Galafold.
We continue to expect non-linear quarterly expansion due to asymmetric order patterns and exchange rate fluctuations. It is vital to note that Galafold’s price continues to be identified through payers, as we have a very clever track record of effective negotiation and renegotiation. Returns outside the United States. Our tireless commitment remains to ensure access to Galafold for anyone who wants it.
On slide 9, what we’ve noticed so far this year is that Galafold adoption continues to hold up very well and we’re seeing expansion in all of our core markets, as well as the maximum of our smaller markets, while we’re on track to succeed in our full annual revenue. Guidance expansion from 15% to 20% at constant exchange rates. Overall, we have a wonderful position during three-quarters of the year.
Turning to slide 10, we know that Galafold has the prospect of surpassing $500 million in annual revenue over the next 3 key drivers of expansion: first, continuing to penetrate existing markets; secondly, expand into new geographical areas; and third, to expand the label. I am pleased to know that we are continuously making progress in our expansion into new markets. To cite just a few examples, we recently obtained marketing authorization in Turkey. We filed an application for marketing authorisation in Hong Kong earlier this year and are in the process of submitting it in New Zealand. We have also recently effectively renegotiated pricing and reimbursement agreements for Galafold in Poland and Spain.
In the longer term, we continue to see significant expansion in the Fabry market globally, driven through patient diagnostics through a variety of measures, adding superior screenings, neonatal screenings and other diagnostic projects that we also continue and invest in.
Finally, we have orphan exclusivity in the US and Europe on top of our forty-five patents now indexed in the Orange Book that give us an IP policy until the late 2030s, 30 of which offer a policy to 2038 and beyond, adding five composition patent curtains, all of which gives us the opportunity to supply Galafold International for a long time to come.
Turning to AT-GAA on slide 11, we describe the launch arrangements as we are in a position to launch another successful product. Unlike when we introduced Galafold, when we contracted and built the commercial infrastructure from scratch, we now provide in more than 40 countries around the world, aggregating all primary markets. This same team will be largely involved in launching AT-GAA with only a handful of new FTE needed. We have enjoyed in all the mandatory spaces for a successful drug launch in the regulatory, commercial, supply chain, reimbursement and payer access experience, and last, but perhaps most importantly, we have key relationships with physicians. We are very confident in ourselves in our world-class organization and can leverage their expertise. and relationships to provide AT-GAA to others with Pompe disease worldwide.
From the team, medical education, Phase III data published in the prestigious Lancet Neurology Journal, our expertise with reimbursement and worldwide access, and supporting all the strategic creation plans we are making with building and actions with our partners at WuXi Biologics, we are very well placed for a successful Amicus launch.
With that, let me now turn to Dr. Jeff Castelli, our Director of Development, to highlight our AT-GAA program and pipeline upgrades. Jeff?
Jeff Castelli
Thank you Sébastien, and good morning everyone. On slide 13, we’ll start with our AT-GAA program.
Pompe is a serious and fatal neuromuscular disease and one of the most common lysosomal disorders, and we recognize that Pompe presents a diversity of health disorders for those affected by the disease and that it is very important to have healing options. Several publications and studies on the history of herbs highlight the initial benefits of the remedy, usually followed by an ongoing long-term decline for many people.
On slide 14, we provide a summary of the number one and secondary key endpoints from our phase III study. As a reminder, PROPEL was a randomized, double-blind study comparing the efficacy and protection of AT-GAA in treatment-naïve ESRD patients. adult participants with experience with late-onset Pompe disease, or LOPD, compared with the approved treatment, alpha avalglucosidase. PROPEL is the only controlled clinical trial to date that included patients experienced with ERT and patients without prior treatment with ERT, with experienced patients who again provided one of the patient teams with the greatest unmet clinical need. Motor function, muscle strength, lung function, patient-reported outcomes, and biomarkers, adding the two maximum endpoints identified in Pump: six-minute walking distance and GCF, shown here on the slide, favored AT-GAA over alpha avalglucosidase in the general population. We believe that this consistency of effect on the main manifestations of Pompe disease illustrates the perspective of an effect on AT-GAA for patients.
Furthermore, in the population experienced with ERT, where 95 participants followed popular care for an average of more than 7. 5 years, usually related to continuous progression for maximum patients at this level of treatment, we actually saw an accumulation in walking. six-minute distance and FVC stabilization after switching to AT-GAA, which achieved nominal statistical superiority at either endpoint over the existing remedy and showed clinically significant final results never before observed in this population.
Returning to slide 15, as part of the developing evidence framework supporting AT-GAA, the Amicus team presented more positive long-term knowledge from the phase I/II study of AT-GAA at the 2022 World Muscle Society conference. As noted here on this slide, the latest knowledge continues to constitute very significant and sustained innovations in functional outcomes, as well as persistent discounts on key biomarkers of muscle injury and disease substrate. The sustained innovations observed give great hope that AT-GAA has the potential for the new global population of care for others living with LOPD.
On slide 16, we show the main effects of an oblique comparison of the ERT remedy Pompe that was also recently presented at the World Muscle Society conference. This research used published knowledge from the Phase I/II and Phase III studies for the 3 ERTs recently had or under regulatory review for the early-start pump. A multipoint network meta-regression explaining the point-of-study effects of covariance was performed using individual patient point knowledge from PROPEL and aggregate knowledge from other studies. The 4 graphs presented here on the slide estimated the relative effects and 95% credible periods of each remedy comparison and reference case investigation in which all covariances for the PROPEL trial target population were explained. profile compared to other ERTs, especially for other people who in the past earned some ERT points. erapia
On slide 17, we highlight key updates to the AT-GAA program. First on regulatory progress, as shared in the past, last year the U. S. FDA was not allowed to do so. The U. S. Food and Drug Administration accepted BLA for revision for cypaglucosidase alfa and NDA for miglustat, the two parts of AT-GAA. As Bradley summarized above, following the FDA’s recent deferred action that was only due to COVID-related inspection delays, the company is now actively engaged with the FDA and, under the agency’s leadership, has requested a Type A assembly with the Office of Pharmaceutical Quality to expand plans and logistics for pre-approval inspection. We continue to wait for the two parts of the AT-GAA to be approved in combination and once we have more clarity, we will be able to give more details on the estimated approval schedule.
We also shared in the past that the MA was sent to the European Medicines Agency and is now in the final stages of review. Following an upcoming oral explanation in November, the CHMP’s opinion is expected at the December meeting. It should be noted that the EMA has indicated in writing that, based on thorough and pre-production inspections of the WuXi facility, an inspection is not required prior to AT-GAA approval.
We now have several expanded access systems, adding in the United States, the United Kingdom, Germany, France, Japan and other countries. This includes the EAMS framework, which we announced in the past that obtained a positive clinical recommendation from Early from the UK. Access to medicines plan under MHRA. We are seeing great enthusiasm for AT-GAA under EAMS, with several doctors applying for access to Pompe’s primary centres in the UK and dozens of patients now receiving AT-GAA under this programme. With this expansion in our access systems, as noted by Bradley, we are pleased to announce that approximately 190 international patients are now being treated with AT-GAA as part of our expanded access and clinical extension examination systems.
For the younger Pompe community, we are proceeding to enroll the ongoing open study in youth up to the age of 18 living with LOPD and plan to expand it to Pompe disease patients in formative years later this year. Importantly, in reaction to the numerous requests for remedy we continue to receive for young people living with LOPD and IOPD, our expanded access systems continue to grow.
With that, I would now like to speak with Daphne Quimi, our CFO, to review our monetary results, forecasts and outlook. Daphne?
Daphne Quimi
Thank you Jeff and good morning everyone. Our monetary review begins on slide 20 with a review of our third-quarter earnings functionality and currency impacts.
For the third quarter, we achieved overall earnings of $81. 7 million, a 3% increase compared to the same era in 2021. This includes an operating profit expansion of 14% offset by a negative currency effect of 11%. the majority of Galafold’s profits are generated outside the U. S. In the U. S. , we see significant exposure to currencies in our reported earnings figures. The euro, the pound sterling and the Japanese yen are the currencies to which we are most exposed and, since the beginning of the year, they have fallen by 14%, 18% and 20% respectively. Applying the average exchange rates of October 2022, the exchange rate would have an effect on Galafold’s reported sales for the year 2022 would be a negative effect of approximately 9%. or $28. 5 million.
Slide 21 shows our revenue stream for the third quarter ended September 30, 2022. Cost of goods sold as a percentage of net sales was 16% in the quarter, compared to 15% in the prior year period. GAAP total operating expenses were $102. 1 million in the third quarter, compared to $110. 2 million in the third quarter of 2021. The minimum reflects the new prioritization of the portfolio of genetic treatments.
On a non-GAAP basis, general operating expenses were $85. 5 million in the third quarter, compared to $93. 6 million in Q3 2021. We describe non-GAAP operating expenses such as studies and development, stock-based general and administrative expenses, reimbursement expense, impairment loss on assets, adjustments to the fair price of contingent consideration, and depreciation and amortization.
Net loss for the third quarter of 2022 $33. 3 million or $0. 12 consistent with a consistent percentage, compared to a net loss of $50. 3 million or $0. 19 consistent with a consistent prior-year percentage consistent with the prior year. Driven through Galafold’s profit expansion and expense management, we continue to move towards profitability in the current part of next year. As of September 30, 2022, we had approximately $281 million consistent with outstanding percentages.
We are updating our full-year 2022 non-GAAP operating expense guidance from $470 million to $485 million to $430 million to $440 million, through prudent expense control while maintaining AT-GAA production and pre-launch activities. It should be noted that in 2023 and beyond, we continue to expect non-GAAP operating expense grades to decline below grades seen in 2021.
Turning now to slide 22, we continue to operate from a strong monetary position and our goal remains to achieve non-GAAP performance in the current part of 2023, as explained in our press release. Profitability depends on a number of factors, adding the timing of AT-GAA’s approval and launch. We will focus the majority of our investments in our entry-level pricing franchises on Fabry disease and Pompe disease through the process of driving Galafold’s global growth, gaining approval and launch of AT-GAA globally, as well as efficiency, cost savings and prudence. Expense management.
As a smart monetary management measure, we concluded a market equity program, or ATM, of up to $250 million. We do not intend to use the ATM this year. In 2023 and beyond, we will be strategic and judicious about any ATM use.
Some comments on our monetary position and monetary forecasts for 2022. Cash, cash equivalents and marketable securities were $354. 7 million as of September 30, 2022, and $482. 5 million as of December 31, 2021. Our full-year earnings guidance for Galafold is $350 million to $365 million in consistent currencies, in addition to our GAAP operating expense guidance of $430 million to $440 million.
With that, let me turn the call over to Bradley for final comments.
Bradley Campbell
Great, thank you Daphne, Jeff, Sébastien for highlighting all the smart progress of the quarter. Thank you to everyone at Amicus and to all our painters around the world, who paint so tirelessly for others living with rare illnesses.
With that, Operator, we can now open the question form.
Q&A session
Operator
[Operator Instructions]
The first comes from the Ritu Baral line with Cowen. Your line is now open.
Ritu Baral
Hi, guys. Thank you for answering the question.
Bradley Campbell
Hello Ritu.
Ritu Baral
Hello. This is on the AT-GAA approval schedule. Suppose you have indicated today that you are going to request a type A meeting.
Bradley Campbell
Correct.
Ritu Baral
Can you tell us when you plan to apply for the Type A meeting?Do you want to have a data e-book like the same ready beforehand, or can it be done more punctually, and what can be just the?Then I have a quick follow-up.
Bradley Campbell
Of course, smart questions. The application has already been sent, so it has already been sent and was under the direction of the Agency. I think it’s vital: it’s the right way for us to have formal conversations, and we’ve been careful to point that out with the Office of Pharmaceutical Quality. When we issued the press release last week, we explained why we were convinced that this was an active step in finding a solution related to conducting the inspection. I think having this formal vehicle is helping to make a point of honor in that.
As for when we might have an update, and then I’ll come back to your next question, when we might have an update, we still expect to have an update in the next few weeks. As I mentioned last week, as soon as we have more clarity, we will be there to provide some expectations about when we might see approval; But again, we think it’s a very important step that we have this discussion and in fact the request has already been sent to the agency.
Ritu Baral
I understand, and my considerations of quick follow-up Europe. Did you ask the 180-day questions and were there surprises or other content of the exam problems in the US?Do you have the U. S. for the EMA exam? Thank you.
Bradley Campbell
Yes, thank you Ritu. Jeff, do you want to let us know about the progress we are making in Europe and where we are with the oral explanation and expectations for December?
Jeff Castelli
Yes, thank you Brad and thank you Ritu.
We are in a very complex review phase with the CHMP. I would say that there were no surprises regarding the other topics of discussion. Well, we’ll have some explanations soon, and we’re still very confident that we have an approved record, and we expect that opinion at the December meeting, but very consistent with a lot of U. S. review issues. U. S.
Ritu Baral
Thank you very much.
Operator
Our next one comes from Anupam Rama’s lineage with JP Morgan. Your line is now open.
Anupam Rama
Hi guys, thank you so much for answering the questions. If I don’t forget correctly, they provided some sort of guidance for the coming year at an investor convention in January. With the CHMP resolution on the horizon, could you give recommendations and actions related to the AT-GAA, or do we just think it will focus on Galafold and spending?Thanks a lot.
Bradley Campbell
Yes, thank you Anupam. That’s a wonderful question. I think we can, as you said, give a little color to Galafold and his expenses. Let us have a little more certainty about the timing of approvals, which, as you said, deserve to have more clarity here soon, that is, in Europe and, hopefully, also in the United States. We’ll definitely give some metrics to track in terms of launch and launch progress, but we’ll be keeping an eye out to find out exactly what they look like. We will do our best to give the street a concept of how to make sure we are following the progress of the launch.
Anupam Rama
Thank you very much for answering our question.
Bradley Campbell
Thank you Anupam.
Operator
The next one comes from Joseph Schwartz’s line with SVB Securities. Your line is now open.
Jose Schwartz
Hello thank you very much. I guess I will also ask about the prestige of the inspection. How do you perceive why the FDA has not been receptive to a hybrid inspection until now?Is an in-person inspection the only way forward and what plans and logistics will you propose?to the FDA so that WuXi, the procedure there, is inspected?Do you have an explanation for why they will be receptive to specific solutions?
Bradley Campbell
Yes, thanks Joe. A few things. First of all, I cannot speak for the Agency, but we have said that despite what we believe are various types of inspections that the Agency can use to satisfy this LIP for AT-GAA, they have indicated to us that they would like to inspect the user. Now, whether it’s a user from Maryland or a user from a hybrid computer, I don’t know, but they’ve said they’d like to inspect the user.
Specifically, what we’re working on right now is precisely that, which lays out the logistics and a plan for the company to inspect WuXi’s China facility in person, and I think the biggest difference here is some of the feedback we’ve given over the summer as we technify this new PDUFA date, is that we now have an active discussion and now a formal discussion through this request for a Type A meeting, and again, under the direction of the Agency.
I think what has replaced here is that, first, we are actively discussing logistics, especially how to deal with the COVID scenario in China, and it is at the request of the Agency that we have this formal assembly and now they are actively participating in this dialogue, so we are very confident that we now have a committed discussion, that we have main points about a plan and logistics that are being discussed, and our hope here is that in the next few weeks we can finalize that and then we can provide more clarity to the outside on when an approval might take place.
Jose Schwartz
Fine thank you. So what can you do this time while waiting for FDA approval to be provided to Pompe doctors and patients in a compliant manner, to make sure you can really get started and not lose too much space at the festival once it’s approved?in the U. S. ? USA?
bradley campbell
Yes, I think what Jeff emphasized on the call is the most important way to achieve that, is through medical education at ongoing medical conferences. We have a giant presence at the World Muscle Society, where we have presented a lot of new information. .
I don’t know, Jeff, do you need to remind us only at a higher level, the specific Pompe knowledge that was presented there, and then some kind of published general medical education publication, etc. ?
Jeff Castelli
As I briefly summarized the call, we had a very active presence at World Muscle, providing the long-term insights from the four-year Phase I/II trial. other ERT products, and we are proceeding to plan the next meetings, you know, World LVN, and then other meetings early next year, to continue to provide a lot of new evidence and knowledge about AT-GAA.
Of course, we have the right education about the disease. Our teams, whether it’s the sales team and the medical team, are in a position to send fabrics and messages, so we can do everything I would do before an approval, and we will continue. to prepare for launch. We are in a position in many ways, but we will be even more so with the additional time.
Bradley Campbell
The only other thing I would add here, Joe, is that I think this is a progression program and a highly anticipated regulatory process, so the smart news here is that I think the network (doctors, patients, etc. ) are very aware that AT-GAA is going through this process, so I think there’s also a lot of anticipation in the burden of medical education activities that Jeff highlighted.
Jose Schwartz
Thank you for answering my questions.
Bradley Campbell
thank y
Operator
The next one comes from Tazeen Ahmad’s line with Bank of America. Your line is now open.
Tazeen Ahmad
Hello, thank you very much for answering my question.
I just need to hear your opinion. I know you’re not talking about the main points of what a label language would look like, but in the event that you get the patient’s specifications to change data, how do you think that would affect your ability to gain opposite traction?to its key competitor, which actually markets without that language, and in the long run, how do we deserve to think about the separation between the United States and the former United States?AT-GAA sales? Thank you.
Bradley Campbell
Of course. I could move on to Sebastien in a moment about the separation between the two: between geographies in terms of sales, but in terms of the first consultation about the ability for us to succeed with AT-GAA and what some of the label scenarios might suggest, I think the most important thing is the differentiated set of knowledge that Jeff highlighted during the call. We’re the only manufacturer that’s been reading in an active control framework that adjusts the population and, as we said before, that’s probably 90%. of the opportunities in the coming years, so I think this set of differentiated knowledge and, over time, the long-term knowledge that we have noticed in the phase I/II study. As we build this evidence framework, I think it provides us with a really differentiated product, especially in this replacement population that we can build on.
The other thing I’d like to remind other people is that while I know we’ve spent a lot of time on what could be scenarios in the United States, we obviously have several jurisdictions that we’re applying for approval for, and just because one jurisdiction has a label, doesn’t mean that every jurisdiction will have that label. So I think it’s going to be vital to see how it evolves over the course of, as we’re seeing some of those approvals in the coming months, so I think other people deserve to be careful with that as well.
Then the last thing I’m going to upload and hand over to Sébastien, again, we intend to continue building the evidence framework in many Pompe populations, so possibly there will be an opportunity in the future, of course, if to get some explanation of why you have a population expressed on your label to carry over time and expand labels.
With that, Sebastian, communicate a little about the distribution of opportunities between the U. S. and Canada. It is in the U. S. and some of the world’s other major markets.
Sebastian Martel
Yes, thank you Bradley. There are many tactics to look at this. You can look at it from the patient or look at it from a sales arrangement. I’ll start with the breakdown of sales across major geographies. The United States accounts about 40% of sales, Europe about 35% of sales and the rest of the world about 25%.
Now, the picture is different when you look at real patients, basically because of the differences in value between the [indistinguishable]. Europe accounts for more than 40% of patients recently treated with [indistinguishable], while the United States accounts for only about 25% of patients. Therefore, Europe represents a great opportunity in terms of percentage of patients.
Bradley Campbell
Great, thanks Sebastian.
Operator
The next one comes from Ellie Merle’s line with UBS. Your line is now open.
Sara,
Hi, I’m Sarah for Ellie. Thank you for answering our question.
I think we have two rapids. Regarding the Type A assembly with the FDA, I guess everything we know traditionally, you know, now that the application is being submitted, how long can it take to start conversations and how long, perhaps, will that procedure take?So, hunting in the ex-US expansion in Galafold, what are the key regions that you think are driving expansion in 2023 and perhaps also the speed of geographical expansion in 2023?Thank you.
Bradley Campbell
Of course, thanks Sarah. Su first consultation related to the Type A meeting, as I mentioned, the request has already been received, so the procedure has already begun. Our hope is that, technically, there’s a formal clock we can get together as soon as possible, and again, as soon as we have more colors there, we’ll move on to providing that update. In terms of how long the procedure takes, again, we expect it to be quick. Let’s go through those discussions, and as soon as we can, we’ll provide more color.
Then in the ex-U. S. expansion opportunities for Galafold, all I’m going to say at a higher level, so maybe Sebastian, can provide an express color, Sebastian explained the call how Galafold is really the biggest contributor to Fabry’s profit expansion in the world, which I think is quite surprising to contemplate the fact that we are limited to the modifiable population. The other thing I’ll say is that when we look at the numbers and look at the metrics that we’ve given, what we’re literally seeing is a continued momentum coming out of what was probably the depth of COVID’s impact, and so, as Sebastien noted on the call, to see that the net number of new patients over 3 months is the highest in two years, I think it gives us a lot of confidence that we’re seeing an uptick in expansion and momentum, which is so vital to this key franchise.
But Sebastian, get some talk about the geo-expansion drivers for Galafold next year.
Sebastian Martel
Yes, as I noted earlier, what we’ve noticed this year is pretty much the same kind of rate of expansion in the U. S. U. S. and outside the U. S. Digit expansion in the countries where we have been longer, and that explains: in the markets in which we have been longer, it is due to the growing participation we have in putting patients without prior treatment in treatment. There are also countries where we have introduced more recently, and there you see a much higher proportion of switches initially, however, overall, we continue to see double expansion rates in most of the markets that we are launching lately.
We are seeing a very strong expansion in some markets in the rest of the world, so if I take some Latin American markets, for example, Colombia, Brazil, in Eastern Europe, the Polish market has also noticed a wonderful expansion for Galafold and, as I pointed out outside, we continue to launch, or at least log into market places where Galafold has not yet launched. therefore, I have spoken in particular of Turkey. Turkey is a giant market of a total number of patients. The actual number of patients treated in Turkey is close to each of the five most sensitive European markets. There are still a small number of markets where we have received approval and are running the pricing and reimbursement process, so they will be new launches in 2023. But again, the major marketplaceplaces, and even I would say that the 10 most sensible marketplaceplaces continue to show a very significant expansion.
Bradley Campbell
Great, thanks Sebastian.
Operator
Our next one comes from Dae Gon Ha’s lineage with Stifel. Your line is now open.
Dae Gon Ha
Hi, hey guys. Thank you for answering the question. I’ll limit myself to one.
Returning to AT-GAA, there have been rumors of unverified reports that China could reopen, given the impact on the tech sector and this economy. I guess if you can talk about two other scenarios, one is what you think at the time of its reopening, and two, in a bearish case where they don’t, what’s the genuine assumption here given that the U. S. Chamber of Commerce is in the wake of the U. S. Chamber of Commerce?The US could still inspect WuXi in the era of 0 COVID policy, what does it deserve What would we be thinking about in this case?Thanks a lot.
Bradley Campbell
Two things, first of all, I think we’re hearing the same thing you’re hearing, which would possibly be on the margins, things are improving, or there’s still hope that there might also be a very different or more permissive policy. around COVID. That said, the plan we are currently running does not require any adjustments to the official COVID policy, so we are executing plans with the Agency that would allow them to conduct the inspection in the existing environment. That is possibly the case with the bear, however, I think we are conservative there. Again, the goal is for this to be anything that can happen in a limited time.
I know the key query is what exactly that time frame looks like, and I wish we had more colour there, however we are actively running it and, again, we feel that in the coming weeks we are going to have even more focus there. , and then we can provide a major upgrade. But again, this assumes that the existing COVID and quarantine restrictions remain in place and we are racing to execute a plan that will allow the Agency to inspect under those conditions.
Dae Gon Ha
Great, thank you very much.
Bradley Campbell
Thanks.
Operator
The next one comes from Salveen Richter’s line with Goldman Sachs. Your line is now open.
Salveen Richter
Hello, thank you for answering my inquiry. I know that in relation to the launch of Pompe, there are doubts about the cadence, but can you tell us how you think the launch will be extended in terms of competitive dynamics with Sanofi and how you think patients will be classified among medicines?
Bradley Campbell
Yes, first of all, I think from a European point of view, while Sanofi has gone through the review procedure and the appeal procedure for the new active substance, I think it has particularly shortened the time between its launch and ours, so I think it gives us, I think, intelligent confidence that we will really release quite a bit depending on the time frame in which we are located, So I think it’s a very different scenario.
With respect to the US, as we mentioned, I think what’s critical about AT-GAA is that we have a very distinct set of knowledge, and if you take a look at a series of market research surveys and a number of sales studies that have been published there, I think you see an alignment around the indicated, or sorry, the populations that have been studied, and therefore some alignment around AT-GAA in the transferred population and the other products in the naïve population, so I think the body of knowledge that Jeff highlighted on today’s call is key for us, that we can show improvement in patients moving from enzyme replacement therapy to the six-minute walk and to forced critical ability, and we think it’s the knowledge that’s going on to be compelling to doctors and I’m looking for the opportunity to go out and advertise the product in the other aspect of an endorsement.
Salveen Richter
Thanks.
Operator
Our next one comes from Yun Zhong’s lineage with BTIG. Your line is now open.
Yun Zhong, his line is open. Please your mute button.
Yun Zhong
Hello thanks. Sorry, I didn’t hear my name. Hello, thank you very much for answering the question.
Can you remind us whether the European launch will only be supported through the Irish site or whether it will also be supported through the WuXi site?Also, what was your plan in terms of coordination between the two sites, and given that you had this challenge?Did the inspection replace your plan in terms of coordination between the two sites going forward?
Bradley Campbell
Yes, wonderful question, just as a reminder, as you suggested, we have the existing production facility in WuXi City, China, and that’s where we manufacture the ATP200, which is biological development, all around. U. S. launch USA and Europe; however, WuXi has also finished the structure and we are now completing the engineering cycles for the manufacture of ATP200 at a site in Dundalk, Ireland. This site really has more capacity than the site in China, so we anticipate that the curtains of this site will enter the advertising source chain during the 24th era, and that has been the intention. But once this site is integrated, you’ll most likely get the most products for Europe and the United States, and the rest of the world for that. issue, with probably a minority of products coming from China.
We’re not too far from having manufacturing in two sites, which is vitally important, but also to build capacity, and the goal was for that capability to connect in the chain of advertising sources when you started getting into the meat. . of the expansion of the global release, which would return to the genre of this timeline of 24. I hope it clarifies the plan there, and has not replaced in the context of the existing scenario with signing and inspection.
Yun Zhong
Thank you very much.
Operator
Our next one comes from Gil Blum’s line with Needham
Gil Blum
Hello, hello everyone. Congratulations on your progress.
Do you think any of those 190 patients at AT-GAA could be transferred to an advertising product once approved?Thank you.
Bradley Campbell
Yes, that is a wonderful question, and the answer is actually yes. As soon as we download regulatory approvals, we look to convert our clinical trials or expanded access patients as temporarily as possible. What we have given is just a kind of ballpark figure. in terms of the distribution of those patients, so probably a part of the 190 are in Europe with a large proportion of those coming from the UK, Germany and the EU5. The UK with the EAMS program is now the largest number of patients in AT-GAA today, and in the US, we said about 20 patients in the US are in our ongoing clinical trials and other programs of access, and again, that would be a population that we would be looking to replace very temporarily.
With Galafold, the goal is to be able to switch patients from a progressing drug or an extended-access drug within 90 days, and here we would have a similar goal.
Gil Blum
Thanks.
Operator
Thank you. That’s your last question. That concludes the call of today’s convention. Thank you and have a wonderful day.