Q1 2024 Amicus Therapeutics Inc Earnings Call
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Operator: Good morning, ladies and gentlemen, and welcome to the Amicus Therapeutics First Quarter, 2024 Financial Results Conference Call and Webcast. At this time, all participants are in a listen-only mode. Later, we will conduct a question and answer session, and instructions will follow at that time. As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Mr. Andrew Faughnan, Vice President of Investor Relations. You may begin.
Speaker Change: Good morning, ladies and gentlemen, and welcome to the Anika Therapeutics first quarter 'twenty 'twenty four financial results conference call and webcast.
Speaker Change: At this time all participants are in a listen only mode. Later, we will conduct a question and answer session and instructions will follow at that time.
Speaker Change: A reminder, this conference is being recorded.
Speaker Change: I would now like to turn the conference over to your host Mr. Andrew Faughnan, Vice President of Investor Relations you may begin.
Andrew Faughnan: Good morning. Thank you for joining our conference call to discuss Amicus Therapeutics' first quarter 2024 financial results and corporate highlights. Leading today's call is Bradley Campbell, President and Chief Executive Officer, Sbastien Martel, Chief Business Officer, Dr. Jeff Castelli, Chief Development Officer, and Simon Harford, Chief Financial Officer. Also joining for Q&A are Dr. Mitchell Goldman, Chief Medical Officer, and Ellen Rosenberg, Chief Legal Officer.
Andrew Faughnan: Thank you Jill.
Andrew Faughnan: Good morning. Thank.
Andrew Faughnan: Thank you for joining our conference call to discuss amicus Therapeutics first quarter 2024 financial results and corporate highlights leading today's call. We are Bradley Campbell, President and Chief Executive Officer, Sebastien Martel, Chief Business Officer, Dr. Justice, Sally Chief Development Officer, Simon Harford, Chief Financial Officer, joining for Q&A, Dr. Mitchell Goldman Chief Medical Officer, and Ellen Rosenberg.
Andrew Faughnan: As referenced on slide two, we might 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 processes. Our forward-looking statements should not be regarded as representations by us, but any plan, any of our plans will be achieved. Any or all the forward-looking statements made in 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.
Ellen Rosenberg: Our chief legal officer.
Ellen Rosenberg: Sounds like you we might make forward looking statements within the meaning of the private Securities Litigation Reform Act 1995 relating to our business as well as our plans and prospects are forward looking statements should not be regarded as a representation by us that any plans any of our plans will be achieved and hear all the forward looking statements made on this call may turn out to be wrong and can be affected by.
Ellen Rosenberg: Inaccurate assumptions, we might make or by known or unknown risks and uncertainties. You are cautioned not to place undue reliance on any forward looking statements, which speak only to the date hereof. All forward looking statements are qualified in their entirety by this cautionary statement and we undertake no obligation to revise or update this presentation and conference call to reflect events or circumstances.
Andrew Faughnan: You are cautioned not to place undue reliance on any forward-looking statements, which 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 full discussion of such forward-looking statements and the risks and uncertainties that may impact them, we refer you to the forward-looking statements and risk factors section of our annual report on Form 10-K for the year ended December 31, 2023, and the quarterly report on Form 10-Q for the quarter ended March 31, 2024, to be filed with the At this time, it's my pleasure to turn the call over to Bradley Campbell, President and Chief Executive Officer.
Ellen Rosenberg: After the date hereof for a full discussion of such forward looking statements and the risks of uncertainties that may impact them. We refer you to the forward looking statements and risk factors section of our annual report on Form 10-K for year ended December 31, 2023, and our quarterly report on Form 10-Q for the quarter ended March 31, 2024 to be filed with the securities.
Ellen Rosenberg: And exchange Commission today.
Ellen Rosenberg: At this time, it's my pleasure to turn the call over to Bradley Campbell, President and Chief Executive Officer Bradley.
Bradley L. Campbell: Great, thank you, Andrew, and welcome, everyone, to our first quarter 2024 conference call. I'm pleased to report a strong start to the year across our global business. We continue to build on the momentum of significant top-line revenue growth on our way to our first full year of non-gap profitability while advancing our mission of bringing hope to patients and families affected by rare diseases. As we did in this morning's press release, let me just highlight several key points before I turn it over to the team to go into more detail.
Bradley L. Campbell: Great. Thank you Andrew and welcome everyone to our first quarter 2024 conference call I'm pleased to report a strong start to the year across our global business. We continued to build on the momentum of significant topline revenue growth on our way to our first full year of non-GAAP profitability, while advancing our mission of bringing hope to patients and.
Ellen Rosenberg: These affected by rare diseases.
Speaker Change: We did in this morning's press release, let me just highlight several key points before I turn it over to the team to go to more detail.
Bradley L. Campbell: First, we continued our excellent commercial execution and delivered strong total revenue of $110 million, representing 28% growth year-over-year. Galliford continues its strong performance, and we remain very pleased with the continued commercial uptake globally. For the first quarter, Galliford revenue was $99 million globally, representing 16% growth year over year on a constant currency basis, coming in at the high end of our initial guidance for the year.
Speaker Change: First we continued our excellent commercial execution and delivered strong total revenue of $110 million, representing 28% growth year over year.
Speaker Change: <unk> continued its strong performance and we remain very pleased with the continued commercial uptake globally for the first quarter gallon fold revenue was $99 million globally, representing 16% growth year over year on a constant currency basis coming in at the high end of our initial guidance for the year.
Bradley L. Campbell: For Galliford, we continue to observe strong trends across our key performance indicators in all key geographies in the first quarter, including continued demand through new patient starts from both the switch and naive populations in all of our leading markets, and sustained patient compliance and adherence rates of over 90%. All of this is across the backdrop of the significant growth in diagnosed and treated patients that we've highlighted previously. We see Gallup Holdings serving as the foundation of our business for the next decade and more.
Speaker Change: For <unk>, we continue to observe strong trends across our key performance indicators in all key geographies in the first quarter, including continued demand through new patient starts from both the switch and naive populations in all of our leading markets.
Speaker Change: Sustained patient compliance and adherence rates of over 90%.
Speaker Change: All of this is across the backdrop of a significant growth in the diagnosed untreated patients that we've highlighted previously.
Speaker Change: We see <unk>, serving as the foundation of our business for the next decade and more.
Bradley L. Campbell: Based on Galliford's strong performance in the first year, we are pleased to be raising our full year 2024 revenue growth guidance from 11 to 16 percent to now 13 to 17 percent. Second, let me highlight the strong global commercial launch of Pumbility and Opfolda, our novel two-component therapy for late-outset pompate, now available in Germany, Austria, the UK, the U.S., and also now in Spain. POMOP, as we like to call it, is a huge driver of growth for us this year, and our progress against our key performance indicators that we've shared previously continues to demonstrate the strength of this long-term strategy.
Speaker Change: Based on <unk> strong performance in the first year, we are pleased to be raising our full year 2020 for revenue growth guidance from 11% to 16, 2% to now 13% to 17%.
Speaker Change: Second let me highlight the strong global commercial launch of <unk>. Our novel two component therapy for late onset Pompe disease.
Speaker Change: Now launched in Germany, Austria, the U K the U S and also now in Spain.
Speaker Change: Tom Op as we like to call. It is a huge driver of growth for us this year and our progress against our key performance indicators that we've shared previously continues to demonstrate the strength of this launch.
Bradley L. Campbell: Our number one focus for this year is to maximize the number of patients on therapy by year-end, and in light of that, it's great to report that the rate of new commercial patients coming on to POMOF in 2024 is double that of last year. In fact, for the month of April, we saw the largest number of new commercial patients start on POMBILITY and Upfolda since our launch. And as of the end of last month, we had 155 patients on treatment or scheduled.
Speaker Change: Our number one focus for this year is to maximize the number of patients on therapy by year end and in light of that its great to report that the rate of new commercial patients coming onto <unk> in 2024 is double that of last year.
Speaker Change: In fact for the month of April we saw the largest number of new commercial patients start on possibility in that folder since our launch and as of the end of last month, we had 155 patients on treatment or scheduled for treatment.
Bradley L. Campbell: We're incredibly pleased with the patient and physician demand for this new therapy globally and continue to hear inspiring anecdotes from clinicians around the world on how their patients are responding to pompility and upfolda, which will help continue to build the momentum throughout the year and beyond. Sbastien will provide more details in a moment, but the switch dynamics in the U.S., Europe, and the U.K. also continue to look strong, and we're seeing great progress on the reimbursement front globally, including moving patients more quickly through the insurance process in the U.S. as we anticipated we would.
Speaker Change: We're incredibly pleased with the patient and physician demand for this new therapy globally and continue to hear inspiring anecdotes from treaters around the world on how their patients are responding to probability of that program, which will help continue to build the momentum throughout the year and beyond.
Speaker Change: Sebastian will provide more details in a moment, but switch dynamics in the U S. Europe and UK also continued to look strong and were seeing great progress on the reimbursement front globally, including moving patients more quickly through the insurance process in the U S. As we anticipate it would be what.
Bradley L. Campbell: We've also just launched in Spain and are off to a great start there. And throughout the remainder of 2024, we'll focus on increasing patient access as we gain reimbursement, and then launch in additional countries throughout Europe. Before I turn it over to the team, let me also comment on the new guidance we're providing. As we said upon approval and coming into this year, we needed about six to 12 months of trends before we had enough information to provide revenue guidance.
Speaker Change: We've also just launched in Spain are off to a great start there and throughout the remainder of 2024 will focus on increasing patient access as we gain reimbursement and then launch in additional countries throughout Europe.
Speaker Change: Before I turn it over to the team. Let me also comment on the new guidance, we're providing.
Speaker Change: As we set upon approval and coming into this year, we needed about six to 12 months of trends before we had enough information to provide revenue guidance.
Bradley L. Campbell: Now, with more than six months since launch in the three largest Pompei markets and the great trends we're seeing, we feel we now have enough information to accurately forecast their performance. You'll see in the press release and in the slides, for the first time, we've announced that we expect to deliver $62 to $67 million in global sales, which will again be a significant contributor to our growth and set us on a great course to achieve our ambition for Pondility and Upfolda to become the new standard of care in treating this devastating, We are incredibly pleased to be providing a real choice for patients, and physicians and challenging therapeutic expectations for people living with palpated, Finally, as we continue our excellent commercial execution across both therapies and prudently manage our resources, we are confident we are well on track to achieve full-year non-gap profitability in 2024.
Speaker Change: Now with more than six months since launch and the three largest pompeii market and the great trends. We're seeing we feel we now have enough information to accurately forecast our performance for the year.
Speaker Change: Youll see in the press release and in the slides for the <unk>.
Speaker Change: First time, we've announced that we expect to deliver $62 million to $67 million in global sales, which will again be a significant contributor to our growth and set us on a great course to achieve our ambition for possibility in a foldout become a new standard of care in treating this devastating disease.
Speaker Change: We are incredibly pleased to be providing a real choice for patients.
Speaker Change: And physicians and challenging therapeutic expectations for people living with Pompe disease.
Speaker Change: Finally, as we continue our excellent commercial execution across both therapies and prudently manage our resources. We are confident we are well on track to achieve full year non-GAAP profitability in 2024.
Bradley L. Campbell: Ahead on slide four, as we lay out the beginning of the year, we continue to focus on delivering against our three, excuse me, our four key strategic priorities, including sustaining double-digit Galliford revenue growth on the back of strong sales. Again, we've raised that expected annual growth rate of Galliford to thirteen to seventeen percent to the comfort exchange rate, successfully executing on multiple commercial launches of probability and uphold, advancing our ongoing studies to support our medical and scientific leadership in FABRA and Pompe disease, and maintaining our strong financial position as we carefully manage our expenses and investments to achieve non-gap profitability for the full year. With that overview, let me now hand the call over to Sbastien to further highlight our commercial performance. Sbastien?
Speaker Change: I had on slide four as we laid out at the beginning of the year, we continue to focus on delivering against our three excuse me, our four key strategic priorities, including sustaining double digit <unk> revenue growth on the back of strong sales again, we've raised our expected annual growth rate of golf ball to 13% to 17% at constant exchange rates.
Speaker Change: Successfully executing on multiple commercial launches of <unk> and our product.
Speaker Change: Advancing our ongoing studies to support our medical and scientific leadership in Fabry, and Pompe disease, and maintaining our strong financial position as we carefully manage our expenses and investments to achieve non-GAAP profitability for the full year.
Speaker Change: With that overview, let me now hand, the call over to Sebastian to further highlight our commercial performance Sebastian.
Sbastien Martel: Thank you, Bradley, and good morning to everyone on the call. I will start by providing you with more details on our Gallup performance so far this year. As you can see on slide 6, for the first quarter of 2024, Gallup World reported revenue of $99.4 million, primarily driven by strong patient demand, particularly from our leading market. We ended the first quarter with more than 60% of the global market share of treated and amenable patients, but we know there are still many more potential patients for our therapy.
Sebastian: Thank you Bradley and good morning to everyone on the call I'll start by providing you with more details on our Gulf wind performance. So far this year.
Sebastian: You can see on slide six for the first quarter of 2024, <unk> reported revenue reached $99 $4 million, primarily driven by strong patient demand, particularly from our leading markets.
Sebastian: We ended the first quarter with more than 60% of the global market share of treated amenable patients, but we know there's still many more potential patients who are on therapy.
Sbastien Martel: As Bradley highlighted, given Gallup's strong performance in the first quarter, we're increasing our full year 2024 revenue growth guidance from 11% to 16% to now 13% to 17% growth. Turning on to slide seven, our results in the first quarter highlight the strengths of our global commercial efforts.
Sebastian: As Brian highlighted even gone up with strong performance in the first quarter, we are increasing our full year 2020 for revenue growth guidance from 11% to 16% to now 13% to 17% growth.
Speaker Change: Turning on to slide seven our results in the first quarter highlights the strength of our global commercial efforts the demand for <unk> globally continues to be strong with patients added in all major markets delivering operational growth of 16% over the same period in 2023.
Sbastien Martel: The demand for Galafold globally continues to be strong, with patients added in all major markets, delivering operational growth of 16% over the same period in 2028. We're very pleased to see that Galliford grew at the high end of our initial guidance range in Q1 2024. And Galapagos continues to be the fastest growing treatment for Fabry disease globally. Our leading markets, such as the US, the UK, top EU countries, and Japan, remain the biggest drivers of patient demand and give great confidence in the growth this product will have over the long term. With the global mix, which is about 42% switch and 58% naive now, we're seeing stronger uptake in naive populations.
Speaker Change: We're very pleased to see that <unk> grew at the high end of our initial guidance range in Q1 2024.
Sebastian: <unk> continues to be the fastest growing treatments for <unk> globally.
Sebastian: Our leading markets such as the U S. The UK EU.
Sebastian: New countries and Japan.
Sebastian: The biggest drivers of patient demand and gives great confidence in the growth. This product has over the long term.
Sebastian: With the global mix, which is about 42% switch and 58%, 9% now we're seeing stronger uptake in naive population. So we continue to achieve high market shares in countries, where we have been approved the longest theres still plenty of opportunity to continue to switch patients over to <unk> and to keep growing the market as we penetrate the Dino.
Sbastien Martel: So we continue to achieve high market shares in countries where we've been approved the longest. But there is still plenty of opportunity to continue to switch patients over to Galafold and to keep growing the market as we penetrate the diagnosed, untreated, and newly diagnosed sectors. All of this is underpinned by sustained compliance and adherence rates that continue to exceed 90%, reiterating our belief that those who go on Galapagos predominantly stay on Galapagos. As mentioned on past calls, due to a variety of factors, including uneven ordering patterns and effects from frustrations, the rate of growth within the year is typically nonlinear.
Sebastian: Untreated newly diagnosed segments.
Sebastian: All of this is underpinned by sustained compliance and adherence rates that continue to exceed 90% reiterating our belief that those who go and get a cold predominantly stay on hold.
Sebastian: As mentioned on past calls due to a variety of factors, including uneven ordering patterns and FX fluctuations the rate of growth within the year is typically non linear we expect that to continue in 2024.
Sbastien Martel: We expect that to continue in 2024. So within the table on the right-hand side of the slide, we've provided a five-year historical snapshot of the percentage of Gallup old sales that occur each quarter during a given year. The average of quarterly sales distribution over the last five years corresponds precisely to what we achieved for the full year 2023. We would expect a similar trend to occur this year.
Sebastian: So within the table on the right hand side of this slide we've provided a five year historical snapshots of the percentage of <unk> sales that occur each quarter during a given year.
Sebastian: The average quarterly sales distribution over the last five years correspond precisely to what we achieved for the full year 2023.
Sebastian: We would expect the similar trends this year and so as an example, we expect Q2 sales in the current year to be around 24% of food yourselves.
Sbastien Martel: And so, as an example, we expect Q2 sales in the current year to be around 24% of food year sales. On slide 8, we know that there's significant patient demand for Galapagos and that the segment of the global fabric market made of patients with amenable mutations has the potential to reach up to 1 billion in annual revenue by the end of the decade. We anticipate sustained growth in 2024 and beyond to be driven by several key cooperatives.
Sebastian: On slide eight we know that there is significant patient demand for <unk> in the segments of the global property market made of patients with amenable mutations has the potential to reach up to 1 billion annual revenue by the end of the decade.
Sebastian: We anticipate sustained growth in 2024 and beyond to be driven by several key growth drivers.
Sbastien Martel: First, the fabric market is growing robustly, with a significant portion of growth coming from finding new patients and reaching the diagnosed and treated population. As we've mentioned previously, there were more than 2,500 individuals on Galapagos at the end of 2023, and about 1,400 of those individuals were naive to any treatment before coming to Galapagos. Second, we've seen many new patients go to treatment through newborn and family screening, and we continue to increase patient identification capabilities through ongoing medical education and support of noble screening initiatives, including the use of artificial intelligence through our partnership with OMR. Fabry is one of the most underdiagnosed rare diseases, so the more patients that can be identified, the more patients can be eligible for GAP.
Sebastian: First the fabry market is growing robustly.
Sebastian: And with a significant portion of growth coming from finding new patients and reaching the diagnosed untreated population as we've mentioned previously they were more than 2500 individuals in California at the end of 2023.
Sebastian: And about 1400 of these individuals were naive to any treatment before get fooled.
Sebastian: Second we have seen in many new patients gone through treatment through newborn and family screening and we continue to increase patient identification capabilities through ongoing medical education and support of Novo screening initiatives, including the use of artificial intelligence through our partnership with <unk> one.
Sebastian: He is one of the most underdiagnosed.
Sebastian: More patients that can be identified that more patients can be eligible for gaslog.
Sbastien Martel: We're also seeing many diagnosed and treated patients transition to treatment as the need for earlier treatment, especially in females, becomes better appreciated. The other piece is continuing to drive Gallup World's market share of treated and amenable patients through continued commercial execution. As noted, Gallup currently has more than 60% of the global amenable market, but we're seeing in our most mature markets that we can reach up to about 85 or 90% of market share.
Sebastian: We're also seeing many diagnosed untreated patients transition to treatment.
Sebastian: The need for earlier treatment, especially in female becomes better appreciated.
Sebastian: The other piece is continuing to drive <unk> market share of treated amenable patients through continued commercial commercial execution.
Sebastian: As noted <unk> currently has more than 60% of the global amenable market, but we're seeing most mature market that we can reach up to about 80, 590% of market share. So we know that there is the potential to reach those levels in the global market share as well.
Sbastien Martel: So we know that there is the potential to reach those levels in global market share as well. And again, all of these efforts are supported by solid compliance and endurance rates through physician and patient education and support programs.
Sebastian: And again all of these efforts are supported by solid compliance and adherence rates through physician and patient education and support programs.
Sbastien Martel: Additionally, we'll continue to make progress on expanding Galafold into new markets and extending the labels. There are still some markets in Natan, the Middle East, and the Asia-Pacific region where Galafold is either newly reimbursed, or we expect reimbursement. Also important to note here, we often have exclusivity in the US and Europe, in addition to our now 58 Orange Book-listed patents, 42 of which provide protection into 2038 and beyond, including 12 composition
Sebastian: Additionally, we will continue to make progress on expanding our platform into new markets and extending the labels theres still some markets and the time, the Middle East Asia Pacific region, where Gannett these either newly reimbursed we expect reimbursement.
Sebastian: Also important to note here, we have orphan exclusivity in the U S and Europe. In addition to our now 58 Orange book listed patents 42 of which provide protection through 2038 and beyond including 12 composition of matter patents.
Sbastien Martel: This provides us with the opportunity to provide access to Gallupol globally for a long time to come. We intend to continue to protect and enforce a broad intellectual property right. And looking ahead, we expect steady double-digit growth for Galapagos throughout 2024, and we remain confident that with our strong IP protection, Galapagos has a long runway well into the next decade. Turning now to Pompe disease, on slide 10, we outline our global launch progress with Pombilichia rupolda. For the first quarter of 2024, Pombilithi Anupalda reported revenue of $11 million.
Sebastian: This provides us the opportunity to provide access to <unk> globally for a long time to come we intend to continue to protect and enforce our broad intellectual property rights.
Sebastian: And looking ahead, we expect steady double digit growth for Gaslog throughout 2024, and we remain confident that with our strong IP protection going forward has a long runway well into the next decade.
Sebastian: Turning now to compare this is on slide 10, we outline our global launch progress with Bombardier General pull down.
Sebastian: For the first quarter 2024, <unk> and pull that reported revenue reached $11 million.
Sbastien Martel: This represents an increase of 30% compared to the fourth quarter of 2023 and provides a strong foundation for 2020. In the first quarter, we actually achieved the same level of sales as we did in the last six months of 2020. In the U.S., we continue to see a majority of patients switching from Nexviazine, about 73%, and the remaining 27% from Lumida. This means we're switching patients proportionally from both products. We're also seeing a broadening and deepening of prescriptions with more sites coming online and multiple new.
Sebastian: This represents an increase of 30% compared to the fourth quarter of 2023.
Sebastian: And provides a strong foundation for 2024.
Sebastian: In the first quarter, we actually achieve the same level of sales as we did in the last six months of 2023.
Sebastian: In the U S. We continue to see a majority of patients switching from next year's time about 73% and the remaining 27% from <unk>.
Sebastian: <unk> wood switching patients proportionately from both products.
Sebastian: We're also seeing a broadening and deepening of prescriptions with more sites coming online and multiple new prescriptions.
Sbastien Martel: Outside of the U.S., we're seeing patients from all three segments, some switching from myozyme and from nexiodyme at a proportional rate to the respective market shares, and some from the naive population. That's exactly what we want to see at this stage.
Sebastian: Outside of the U S. We're seeing patients from all three segments. Some switching from <unk> and from next year dime, but a proportional rate to the respective market shares and some from the 90 population.
Speaker Change: That's exactly what we want to see at this stage.
Sbastien Martel: A few updates on the launch in Europe. We're happy to announce that POMIDI TENOPODA is now reimbursed and launched in Spain, ahead of our internal expectations. We're very pleased with the fast reimbursement process here and increased access to this therapy throughout the European Union. In Germany, we're delighted with the ongoing success in one of our largest European models. Recently, the federal joint committee, the DBA, designated Pombilithia naphroda with minor additional benefits versus Anglicocidase alpha or myozyme based on an extremely stringent review of the data in the PROPEL trial.
Sebastian: A few updates on the launch in Europe.
Sebastian: Happy to announce that competitor in a pool that is now reimbursed and launched in Spain.
Sebastian: Going ahead of our internal expectations, we're very pleased with the fast reimbursement process here and increased access to this therapy throughout Europe.
Sebastian: European Union.
Sebastian: In Germany, we're delighted with the ongoing success in one of our largest European markets recently.
Sebastian: <unk> joined committee the DBA.
Sebastian: This is Nathan <unk> pulled out with minor additional benefits versus agriculture data followed my enzyme based on an extremely stringent review of the data in the propel trial.
Sbastien Martel: This is a great achievement, as POMBILITY and OPFOLDA is the only POMPEI treatment to receive this designation, and it reflects the value HTAs are seeing in this therapy. This also reinforces our belief that this therapy has the potential to reset treatment expectations and that improvement is possible. And finally, we remain very pleased with the uptake of Pombilich and Opoda in the UK.
Sebastian: This is a great achievement as committee channel pull down is the only pump that treatment to receive this designation.
Sebastian: It reflects the value <unk> are seeing in this therapy.
Sebastian: This also reinforces our belief that this therapy has the potential to reset treatment expectations and that improvement is possible.
Sebastian: And finally, we remain very pleased with the uptake of commodity and a pull there in the UK.
Sbastien Martel: We are heading towards capturing the majority of market share. Currently, we're close to passing one third of market share within the UK, with the benefit of EAMS from Billie Giannopolda, which has actually been available for two years in the UK. And we believe that the current market share is indicative of how this product can perform over a two-year period, and it's a great example of mobility to support that potential demand and uptake.
Sebastian: We're heading towards capturing the majority of market share.
Sebastian: Currently we're close to passing one third of market share within the U K.
Sebastian: With the benefit of beams Committee channel buildup.
Sebastian: Actually been available for now two years in the UK and we believe that the current market shares, indicating how this product can perform over a two year period and is a great example of comedy channel pull that potential demand and uptake.
Sbastien Martel: Given increased visibility on patient trends and pricing and reimbursement, we're now able to provide full-year revenue guidance for POMBILITY and OPFOLDA. For the year 2024, we anticipate revenue of $62 to $67 million for POMBILITY and OPFOLDA. To put this in perspective, this is roughly 75% more sales than the first full year of sales from Galapagos, which was a great launch by all accounts. Moving on to slide 11.
Sebastian: Given increased visibility on patient trends in pricing and reimbursement, we're now able to provide full year revenue guidance for <unk>.
Sebastian: So the Euro 2024, we anticipate revenue of $62 million to $67 million for <unk> to put this in perspective. This is roughly 75% more sales in the first full year of sales from <unk>, which was a great launch by all accounts.
Sebastian: Moving on to slide 11.
Sbastien Martel: As Bradley mentioned earlier, there are about 155 patients on treatment or scheduled for treatment as of late April. That's about 130 currently on therapy and about 20 who are scheduled. We continue to be very pleased with ongoing demand for this therapy, as the rate of new commercial patients coming onto mobility and upfolda continues to increase the cost of free markets. Of note, Q1 was the best quarter yet for new commercial patient starts, doubling the rate of new patient starts from 2023. In particular, April was the strongest month to date for new patient starts and new commercial patients.
Sbastien Martel: As Brian mentioned earlier, there are about 155 patients on treatment or scheduled for treatment as of late April that's about 130 <unk> currently on therapy and about <unk> are scheduled.
Sebastian: We continue to be very pleased with the ongoing demand for this therapy.
Sebastian: Our rate of new commercial patients coming onto <unk> general pull down continues to increase across all three markets.
Sbastien Martel: Of note Q1 was the best quarter, yet for new commercial patients tons doubling the rate of new patient starts from 2023 in particular April was the strongest month to date for new patient starts on new commercial patients. This is important as it.
Sbastien Martel: This is important as it further supports our thesis that launch momentum will continue to build throughout the year as we move more quickly through the prescription-to-treatment process in the U.S. and as we launch in new countries in Europe. Our launch has leveraged our highly experienced cross-functional team, and we've had great outreach with key opinion leaders. We're seeing an increase in depth and breadth of prescribers across all three markets, and, in particular, a growing number of prescribers who were not part of our clinical studies or expanded access program.
Sbastien Martel: Further supports our thesis that launch momentum will continue to build throughout the year as we move more quickly with a prescription to treatment process in the U S and as we launch in new countries in Europe.
Sbastien Martel: Our launch of leverage our highly experienced cross functional team and we've had great outreach with key opinion leaders, we're seeing an increase in the depth and breadth of prescribers across all three markets and in particular, a growing number of prescribers, we're not talking about clinical studies or expanded access programs.
Sbastien Martel: All core treating centers have been engaged, and we've had very positive feedback from HCPs and other stakeholders as to our business approach, our support, and patient co-payment. Finally, we find an important metric to track is our progress with access and reimbursement. We have a highly experienced team who are engaging in positive conversations with payers to demonstrate the value of POMPILITY and UPFOLDER. In the U.S., and with the start of the new year, many large payers have already put POMPILITY and UPFOLDER on their respective formularies. And we've also seen strong acceptance by Medicare and Medicaid. The overall time from prescription to infusion is now down to around 70 days; the last few commercial patients have actually come in even quicker.
Sbastien Martel: All core treating centers have been engaged and we've had very positive feedback from hcp's and all the stakeholders as to our business approach our support and patient focus.
Sbastien Martel: Finally, we signed an important metric to track our progress with access and reimbursement we have a highly experienced team who are engaging and positive conversations with payers to demonstrate the value of ampligen are pulled out in the U S and with the start of the year Minion arch payers are already good competitor and a pull down to their respective formularies.
Sbastien Martel: And we've also seen strong acceptance by Medicare and Medicaid.
Sbastien Martel: The overall time core from prescription to infusion is now down to around 70 days.
Sbastien Martel: The last few commercial patients and actually come in even quicker.
Sbastien Martel: We believe that this will continue to improve.
Sbastien Martel: We believe that this will continue to improve. Today, we have launched in Germany, Austria, the UK, the US, and now Spain, but we remain in active pricing and reimbursement discussions with additional major markets as we focus on securing broad patient access throughout the European Union. More than 10 reimbursement dossiers have been submitted. Overall, we're starting off the year strong, and we're very pleased with the building momentum on patient. Throughout 2024, our focus will be on maximizing the number of patients on therapy by year-end.
Sbastien Martel: Today were launched in Germany, and Australia, and the U K the U S and now, Spain, but we remain in active pricing and reimbursement discussions with additional major markets as we focus on securing broad patient access throughout the European Union.
Sbastien Martel: More than 10 reimbursement dossier have been submitted.
Sbastien Martel: Overall, we're starting of the year strong and we're very pleased with the building momentum on patient demand.
Sbastien Martel: Throughout 2024, I'll focus will be on maximizing the number of patients on therapy by year end.
Sbastien Martel: So, in summary, we're very pleased with the launches of Compedity and Upholder across the first wave of countries. The strength of our clinical data and the depth of experience and talent we have at Amicus gives us great confidence in our ability to make a real difference for people living with Compedity. We believe Amicus is in a great position with our second successful launch. And with that, I will hand the call over to Jeff Castelli, our Chief Development Officer, to discuss the ongoing clinical studies and regulatory updates. Jeff?
Sbastien Martel: So in summary, we're very pleased with the launch of the committee general pullback across the first wave of countries. The strength of our clinical data on the depth of experience and talent. We have at amicus gives us great confidence in our ability to make a real difference for people living with competitive fees.
Sbastien Martel: We believe this is in a great position with our second successful launch and with that I will hand, the call over to Jeff Castelli.
Jeffrey P. Castelli: Chief Development officer to discuss the ongoing clinical studies and regulatory updates Jeff.
Jeffrey P. Castelli: Thank you, Sebastian. Good morning, everyone.
Jeffrey P. Castelli: Thank you Sebastian and good morning, everyone.
Jeffrey P. Castelli: Moving on to slide 12, we remind everyone that we continue to build the body of evidence for pumbility and opphalta through our ongoing clinical studies and our registry, as we also continue to execute on expanding commercial access through regulatory submission as we enter the second phase of launch. In addition to the 10 different reimbursement dossiers that we're in the process of submitting or have submitted, as Sebastian mentioned, we also have multiple ongoing or planned regulatory submissions for marking approval in New Geography throughout this year.
Jeffrey P. Castelli: Moving on to slide 12, we remind everyone that we continue to build the body of evidence for <unk>, Florida through our ongoing clinical studies and our registry as we also continue to execute on expanding commercial access through regulatory submissions.
Jeffrey P. Castelli: As we entered the second phase of launch.
Jeffrey P. Castelli: In addition to the 10 different reimbursement dossiers that we're in the process of submitting our have submitted that Sebastian mentioned, we also have multiple ongoing or planned regulatory submissions for marketing approval in new geographies.
Jeffrey P. Castelli: As we speak, our regulatory dossiers are being reviewed in Switzerland, Australia, and Canada, and we're working towards a submission in Japan in the second half of this year. Importantly, for the younger Pompeii community, we continue to enroll the ongoing Open Label ZIT study for children living with late-onset Pompeii disease and the Open Label Rosella study for children.
Jeffrey P. Castelli: This year.
Jeffrey P. Castelli: As we speak our regulatory dossiers are being reviewed in Switzerland, and Australia, and Canada, and we're working towards a submission in Japan in the second half of this year.
Jeffrey P. Castelli: Importantly for the younger Pompeii community, we continue to enroll the ongoing.
Jeffrey P. Castelli: Often labelled study for children living with late onset Pompe disease, and the open label <unk> study for children living with infantile onset pompe disease.
Jeffrey P. Castelli: for Children Living with Infantile Onset Pompadour. We see this as an important...
Jeffrey P. Castelli: We see this as an important opportunity to support label expansions into these patient segments in the years ahead and to address the significant unmet needs in these patients. Through our ongoing studies in the Amicus Pompei Registry, we continue to generate evidence on the differentiated mechanism of action and the long-term impact of Pompidou-Napfoda across endpoints and different patient populations.
Jeffrey P. Castelli: We see this as an important opportunity to support label expansion and to these patient segments in the years ahead and to address the significant unmet needs in these patients.
Jeffrey P. Castelli: Through our ongoing studies in the amicus Pompeii registry, we continue to generate evidence on the differentiated mechanism of action and the long term impact.
Jeffrey P. Castelli: Florida across end clients and different patient populations.
Jeffrey P. Castelli: As a reminder, in February, we once again had a significant presence and a very successful set of interactions at the 20th Annual World Symposium. We had 11 posters and an oral presentation highlighting our continued work across FABRE and Pompeii. Finally, as highlighted in the pipeline slide in the appendix for our earlier stage pipeline, we continue to focus on novel approaches for Fabbrae and Pompeii, including delivery of our engineered GLA and GAA transgenes, as well as the next generation Fabbrae shackles. With that, I would like to turn the call over to Simon Harford, our Chief Financial Officer, to review our financial results, guidance, and outlook.
Jeffrey P. Castelli: As a reminder in February we once again had a significant presence in very successful set of interactions at the 20th annual World Symposium.
Simon Nicolas Reade Harford: We had 11 posters in an oral presentation, highlighting our continued work across fabry and Pompe disease or medical conference presence is an important part of our education efforts.
Simon Nicolas Reade Harford: Finally, as highlighted in the pipeline side in the appendix for our earlier stage pipeline. We continue to focus on novel approaches for Fabry and Pompe.
Simon Nicolas Reade Harford: Including delivery of our engineered GLA and GAA transgene as well as the next generation Fabry chaperone.
Jeffrey P. Castelli: With that I would like to turn the call over to Simon Harford, Our Chief Financial Officer to review, our financial results guidance and outlook Simon.
Simon Nicolas Reade Harford: Thank you, Jeff. Our financial overview begins on slide 14, with our income statement for the first quarter ending March 31st, 2024. For Q1, we achieved total revenue of $110 million, which is a 28% increase over the same period in 2023. At constant exchange rates, revenue also grew 28%. The global geographic breakdown of total revenue during the quarter consisted of $73 million, or 66% of revenue generated outside the United States, and the remaining $37 million, or 34%, coming from within the U.S.
Simon Nicolas Reade Harford: Thank you Jess our financial overview begins on slide 14, with our income statement for the first quarter ending March 31 2024.
Simon Nicolas Reade Harford: Cost of goods sold as a percentage of net sales was 12% in Q1 due to validation costs in the quarter as compared to 8% for the prior year period. Total GAAP operating expenses increased to $125 million for the first quarter of 2024 as compared to $117 million in the first quarter of 2023. An increase of 6% due primarily to a facility's lease restructuring charge. On a non-GAAP basis, total operating expenses increased to $86 million for the first quarter of 2024, as compared to $81 million in the first quarter of last year. We define non-GAAP operating expenses, research and development, and SG&A expenses, excluding stock-based compensation, loss on impairment of assets, changes in fair value of contingent consideration, restructuring charges, and depreciation.
Simon Nicolas Reade Harford: For Q1, we achieved total revenue of $110 million, which is a 28% increase over the same period in 2023.
Simon Nicolas Reade Harford: Constant exchange rates revenue also grew 28%.
Simon Nicolas Reade Harford: The global geographic breakdown of total revenue during the quarter consisted of $73 million or 66% of revenue generated outside the United States and the remaining $37 million or 34% coming from within the U S.
Simon Nicolas Reade Harford: Cost of goods sold as a percentage of net sales was 12% in Q1 due to validation costs in the quarter as compared to 8% for the prior year period.
Simon Nicolas Reade Harford: Total GAAP operating expenses increased to $125 million for the first quarter of 2024 as compared to $117 million in the first quarter of 2023, an increase of 6% due primarily to a facility lease restructuring charge.
Simon Nicolas Reade Harford: On a non-GAAP basis total operating expenses increased to $86 million for the first quarter of 2024 as compared to $81 million in the first quarter of last year.
Simon Nicolas Reade Harford: We define non-GAAP operating expenses research and development and SG&A expenses, excluding stock based compensation.
Simon Nicolas Reade Harford: Loss on impairments of assets changes in fair value of contingent consideration restructuring charges and depreciation.
Simon Nicolas Reade Harford: On a gap basis, the net loss for the first quarter of 2024 was 48 million, or 16 cents per share, compared to a net loss of 53 million, or 18 cents per share, for the first quarter of last year. In Q1 2024, there was a non-GAAP net loss of $4.6 million, driven by the negative impact of foreign exchange. This was in line with our expectations of a small loss in Q1, as absolute dollar revenue is traditionally lower in the first quarter. Cash, cash equivalents, and marketable securities were $240 million as of March the 31st 2024 compared to $286 million as of the end of December 23.
Simon Nicolas Reade Harford: Turning now to slide 15, we are guiding to full year 2024 total revenue growth of 25 to 30 percent. This is driven by the increase in our full year 2024 Gala Fold Revenue Growth Guidance, from 11% to 16% previously to 13% to 17% currently at a constant exchange rate. It is also driven by guidance of $62 to $67 million for Pondbility op folder sales for the full year. On Fulia, 2024 non-gap operating expense guidance remains at $345 to $365 million.
Simon Nicolas Reade Harford: From 11% to 16% previously to 13 to 17 per cent currently at constant exchange rates.
Simon Nicolas Reade Harford: It is also driven by guidance of $62 million to $67 million for <unk> for the food we.
Simon Nicolas Reade Harford: On fully at 2024, non-GAAP operating expense guidance remains at $345 million to $365 million.
Simon Nicolas Reade Harford: With our commitment to full-year non-gap profitability during the first full year of launch of POMVILITY-OPFOLDER, we are keeping operating expense growth in low single digits year over year at the midpoint of guidance. As a reminder, we continue to have R&D commitments, including registry studies in both Fabry and Pompeii, the ongoing Pompeii Phase III study in countries not yet reimbursed, as well as next With our total revenue guidance of $25 to $30, we remain comfortably on track to achieve our first full year of non-gap profitability in 2024, as profitability grows quarter by quarter for the remainder of the year. And with that, I will turn the call back over to Bradley for our closing remarks. Bradley?
Simon Nicolas Reade Harford: Without commitment to fool, we non-GAAP profitability during the first full year of launch of <unk> folder, we are keeping operating expense growth in low single digit Sierra over yeah at the mid point of guidance. As a reminder, we continue to have R&D commitments, including <unk>.
Simon Nicolas Reade Harford: <unk> studies in both Fabry I'm Pompeii, the ongoing Pompeii phase three study in countries not yet reimbursed as well as next generation manufacturing for palm ability.
Simon Nicolas Reade Harford: Without total revenue guidance of 25 to 30 per cent, we remain comfortably on track to achieve off first fully of non-GAAP profitability in 2024 as profitability grows quarter by quarter for the remainder of the <unk>.
Simon Nicolas Reade Harford: With that let me turn the call back over to Bradley for a closing remarks Bradley.
Bradley L. Campbell: Thank you, Simon, Jeff, and Sebastian, for the further color. So, as you can see, we've been highly focused on execution this year across the business, and we've laid a strong foundation for what will be another important year of commercial execution. We're confident in our leadership position in Fabre and Pompe disease and that Amicus can continue to drive sustainable long-term value and deliver life-changing therapies to people in need. With that operator, we can now turn the call over to questions. Great
Bradley: Thank you Simon Jeff Sebastian after the further color. So you can see we have been highly focused on execution. This year across the business and we've made a strong foundation for what will be another important year of commercial execution. We're confident in our leadership position in February in Pompeii disease, and an anarchist can continue to drive sustainable longterm <unk>.
Bradley L. Campbell: <unk> and deliver life changing therapies to people in need.
Bradley L. Campbell: With that operator, we can now turn the call over to questions.
Operator: Great, thank you. Ladies and gentlemen, if you have a question, please press star 11 on your touchtone telephone. At this time, we request that you only ask one question, and if you have additional questions, please enter back into the queue. Stand by as we bring up our first question. The first question comes from Anupam Rama with J.P. Morgan. Go ahead. Your line is open. Hey guys, thanks so much for taking the question.
Speaker Change: Alright, Thank you ladies and gentlemen, if you have a question. Please press star one one on your Touchtone telephone.
Anupam Rama: At this time, we request that you only ask one question and if you have additional questions. Please enter back into the queue.
Anupam Rama: And I have to bring up our first question.
Anupam Rama: Yeah, thanks, Anupam. I appreciate the question.
Anupam Rama: The first question comes from <unk> with J P. Morgan go ahead. Your line is open.
Anupam Rama: Hey, guys. Thanks, so much for taking the question.
Anupam Rama: You guys were constructing sort of the guidance for possibility up old.
Anupam Rama: And you started looking at St models, where did you see the biggest.
Anupam Rama: Disconnect between your guidance Street models, given that you know almost 30 million divergence there. Thanks so much.
Bradley L. Campbell: I think, you know, the most important thing is that when we came into the launch, and then into this year as well, we were pretty clear that we needed six to 12 months of trends to be able to provide accurate guidance. And I think you've seen, historically, once we provide guidance, we do a great job of, you know, executing against that, as we saw again here with Gallup Hold. The biggest driver of what we really needed to understand coming into the year was timing to get new patients through the insurance process in the US. And I think we have a clear view of that now.
Anupam Rama: Yeah. Thanks I. Appreciate the question I think you know the most important thing is that when we came into the launch and then into this year as well we were pretty clear that we needed six to 12 months of trends to be able to provide accurate guidance I think you've seen historically and once we provide guidance, we do a great job of executing against that is <unk>.
Bradley L. Campbell: Get in here with Gallup hold the biggest drivers of what we really needed to understand coming into the year was timing to get new patients through the insurance process in the U S and I think we have a clear view of that now I think that's probably the biggest disconnect from where just the rate of revenue coming into the year versus what that perhaps the street was initially modeling of course, we wanted to see.
Bradley L. Campbell: I think that's probably the biggest disconnect from just the rate of revenue coming into the year versus what perhaps the street was initially modeling. Of course, we wanted to see the rate of new commercial starts, which, you know, as we've seen now, is built in momentum, which we expected to see. And then there's also timing of launches in Europe. And as we go through the reimbursement process, and as, you know, Sebastian highlighted on the call, we're starting to see some real wins there.
Bradley L. Campbell: The the rate of new commercial starts which as we've seen now is building momentum, which we expected to see and then it's also timing of launches in Europe and as we go through the reimbursement process and as you know Sebastian highlighted on the call. We're starting to see some real wins, there we needed to kind of understand that cadence and an outcome as well I think maybe the lab.
Bradley L. Campbell: We needed to kind of understand that cadence and outcome as well. I think maybe the last piece is, again, factoring in that time from prescription to infusion. You also get a higher distribution of revenue coming from European patients, which of course is a lower price. So I think that probably, you know, those two things have a bit of a multiplying capacity. But now, look, we have the information we need. I think the big picture here is that this is shaping up to be a very successful launch.
Bradley L. Campbell: Last piece is again factoring in that time from prescription to infusion you also get a higher distribution of revenue coming from the European patients, which of course is a lower price, but I think that probably you know those two things that are a bit about multiplying capacity, but now look we have the information we need I think the big picture here.
Bradley L. Campbell: Is that this is shaping up to be a very successful launch as Sebastian said almost double the first year that we did for the first full year of Gallup old and I think the big picture for US is that this will be a huge driver of growth this year and it really set this up for our ambition to become a standard of Karen in Pompeii, which of course is that sort of billion dollar product.
Bradley L. Campbell: As Sebastian said, it's almost double the first year that we did for the first full year of Gallifold. And I think the big picture for us is that this will be a huge driver of growth this year. And it really sets us up for our ambition to become the standard of care in Pompeii, which of course is that sort of billion-dollar product opportunity that we're aiming for. And I think now we can do what we do best, which is execute against our guidance and drive growth in both of these products, and then deliver on our financial performance as well with that non-GAAP profit.
Bradley L. Campbell: [noise] opportunity that were 84 and I think now we can do what we do best which is execute against her guidance and drive growth in both of these products and then deliver on our financial performance as well with that non-GAAP profitability.
Speaker Change: Thanks, so much for taking the question.
Bradley L. Campbell: <unk>.
Operator: Thank you. And bye for our next question. The next question comes from Joseph Schwartz with Lyric. Joe, go ahead. Your line is open.
Speaker Change: Alright, thank you.
Speaker Change: And I for our next question.
Operator: The next question comes from Joseph Schwartz with Lyric Channel go ahead. Your line is open.
Operator: Right, this is Will on behalf of Joe. Thanks for taking our question today. One for us on kind of manufacturing. We've seen the biosecure headlines. So could you just remind us of how you feel about your ability to navigate the situation?
Joseph Patrick Schwartz: Right It will on for Joe. Thanks for taking my question today, one for US just on kind of manufacturing we've seen the bio secure headline. So could you just remind us of how you feel about your ability to navigate the situation has been new manufacturing facility come online in Ireland and.
Will: Can you just remind us of where you are in that process and your ability to kind of.
Speaker Change: Each supplying them and stockpiling throughout the year. Thank you yeah, great question, Thanks, well and I'm glad you raised those headlines they sort of came in right. When we were doing the call here, but for both of you haven't seen it I think and point.
Bradley L. Campbell: Has the new manufacturing facility come online in Ireland yet? And can you just remind us of where you are in that process and your ability to kind of They sort of came in right when we were doing the call here? But for those of you who haven't seen it, I think Endpoint reported what we had anticipated coming out, which is that the new markup from the Senate of the biosecure bill proposes a 2032 sort of grandfathering phase. So, effectively, contracts that are existing, from what we understand and from what the article reported, would actually be grandfathered in out to 2032.
Bradley L. Campbell: Reported what we had anticipated coming out which is the new markup from the Senate Ah Ah of the Bio's secure Bill proposes a 2032 sort of grandfathering phase so effectively contracts that are existing from what we understand from what the article reported contracts that are existing would actually be grandpa.
Bradley L. Campbell: So that would give us plenty of time to find a second source of manufacturing if that bill ever comes to pass. And I know that that's been a big focus for investors and analysts. It's been a big focus for us as well. But behind the scenes, we have grown increasingly confident that now Congress understands the importance of that transition period. And I think that an eight-year, you know, proposition would be plenty of time for us to find a second source.
Bradley L. Campbell: In how to 2032, so that would give us plenty of time to find a second source of manufacturing if that they'll ever comes to pass and so I know that that's been a big focus for investors and analysts it's been a big focus for us as well, but <unk> seems we have grown increasingly confident that now congress understands the importance of that.
Bradley L. Campbell: Transition period, and I think that eight year, you know proposition would be plenty of time for us to find a second source in the meantime, I think we've taken great made great progress against any kind of supply challenges. So as a reminder, or target is 18 to 24 months.
Bradley L. Campbell: In the meantime, I think we've taken great strides, made great progress against any kind of supply challenges. So, as a reminder, our target is 18 to 24 months of supply throughout the supply chain. And right now, we're trending at about 24 months on the high end of that range.
Bradley L. Campbell: Supply throughout the supply chain and right now we're training at about 24 months of the high end of that range. We also had begun moving product out of China into a central depot in Europe and now we've started moving that product further into the market. So sitting in the U S U K and in Europe more than 65% today.
Bradley L. Campbell: We also had begun moving product out of China into a central depot in Europe, and now we've started moving that product further into the market. So sitting in the US, UK, and Europe, more than 65 percent today of our global supply sits either in Europe or in the UK or the US. So I think we've done a great job in continuing to mitigate away from sitting in China. And then to your last point, yes, we are making great progress in Ireland.
Bradley L. Campbell: [noise] of our global supply six either in Europe or in in the UK or the U S. So I think we've done a great job and continuing to mitigate away away from sitting in China, and then to your last point, yes, making great progress in Ireland P. P. Q batches are well under way, we continue to think that that product will come into the supply chain at the back half of next year.
Bradley L. Campbell: PPQ batches are well underway, and we continue to think that that product will come into the supply chain in the back half of next year or early 2026. So I think we've done a great job in all three of those areas, and we have high confidence that anything that comes out of the Biosecure Act, we have plenty of time to be able to react against that. Great, thank you; I appreciate the caller. Thank you. One moment.
Bradley L. Campbell: Or early 2026, so I think we've done a great job in in all three of those areas and we have high confidence that anything that comes out of the box of curiosity, we have plenty of time to be able to to react against that.
Speaker Change: Great. Thank you I appreciate the color.
Speaker Change: Thank you one moment for our next question.
Operator: Thank you. One moment for our next question. Our next question comes from Leanna Merle with UBS. Go ahead, your line is open.
Speaker Change: The next question comes from the <unk> with you B S. Go ahead. Your line is open.
Operator: Hey guys, thanks so much for taking my question. In terms of your guidance, can you help us understand the assumptions that go into it for POMOP, specifically the mix between U.S. and ex-U.S. revenues and patient starts? What markets outside the U.S. do these sales include? And can you remind us what proportion of EAP and clinical trial patients are now reimbursed versus the proportion that are not yet reimbursed? Thanks. Yes, so it is.
Speaker Change: Oh hold on thank you so much for taking my question.
Speaker Change: Adam can you help us understand the assumption all internet for palm up specifically.
Speaker Change: Between <unk> and <unk>.
Operator: <unk> <unk> can you remind us what proportion M. B E. A T M clinical trial two cents an hour reimbursed persons the proportions and I can't remember.
Speaker Change: Yes so.
Bradley L. Campbell: So there are two camps here. First, what goes into the rate of new patient capture. I would say continuing to build momentum in the current launch countries. So, UK, US, Germany, now Spain, and Austria as well. We do expect a number of European countries to come on board throughout the back half of the year. A number of the EU5 or EU4, I guess, remaining countries as well as some of the smaller Northern European countries.
Speaker Change: So to cancel their first is what goes into the rate of new patient capture I would say continuing to build momentum in the current launch countries. So U K U S, Germany, and now, Spain, Austria as well, we do expect a number of European countries to come onboard throughout the back half of the year.
Bradley L. Campbell: A number of the E. U five are you for I guess remaining countries as well as some of the smaller northern European countries. I think all of those will will contribute to the patient captured right and that's why we've talked about I think maximizing the number of patients you know the more patience, we get onto the end of the year of course, the better the run rate going into next year. So that's a big piece of it.
Bradley L. Campbell: I think all of those will contribute to the patient capture rate. And that's why we've talked about, I think, maximizing the number of patients. The more patients we get on to the end of the year, of course, the better the run rate going into next year. So that's a big piece of it.
Bradley L. Campbell: In terms of the distribution of revenue between the U.S. and Europe, remember, we had more patients in the clinical trial for EAP drug coming out of Germany and the U.K. than we did in the U.S., so I'd say for the majority of this year, it's going to be weighted more heavily towards Europe, and especially as we have more launch countries in the back half of the year. Over time, though, we would expect the revenue, the proportion of revenue, to be something like 40-ish percent coming out of the U.S. and the balance coming out of the ex-U.S., so you'll see that move towards that 40 percent over time. And then, Jeff, do you just want to talk about the remainder of the EAP clinical trial patients in Europe and what we have left to convert there? Yeah, thanks, Brad.
Bradley L. Campbell: In terms of distribution of revenue between the U S and Europe remember, we had more patients on clinical trials E. A P drug coming out of Germany, and the UK than we did in the U S. So I'd say for the majority of this year, it's gonna be it's gonna be still weighted more heavily towards Europe and is.
Jeff: Especially as we have more launch countries in the back half of the year over time, though we would expect the revenue the proportion of revenue to be something like fortyish percent coming out of the U S and the balance coming out it back to you have so you'll see that you know move towards that 40%.
Bradley L. Campbell: Overtime, and then Jeff do you want to just wanted to talk about the remainder of the clinical trial a P patients in Europe, and and what we have left to convert there.
Jeffrey P. Castelli: So, in terms of remaining patients in Trials Expanded Access, there are about 65 or 70 of them that are adults, and about 40 of those are in Europe. The rest are sort of from the rest of the world, be it Japan, Australia, Canada, et cetera. And then of those 40 in Europe, about 20 are in those sort of 10 countries that we are expecting reimbursement for this year. But again, that will be staggered towards the second half of the year.
Jeff: Yeah. Thanks, Brian So in terms of remaining patience and trials extended access there's about 65 or 70 of them that are adult.
Jeffrey P. Castelli: About 40 of those are in Europe. The rest are sort of rest of the world and Japan, Australia candidate cetera, and then others 40 in Europe about 20 or in those sort of 10 countries that we are expecting reimbursement this year, but again that will be staggered towards second half of the year.
Jeffrey P. Castelli: We also have a number of pediatric patients, and those actually continue to increase as we continue to enroll Brazil and Zip. But I think from a commercial perspective, you know, thinking about those 65 to 70 adults, 40 in Europe, 20 in countries that would come on board later this year.
Jeffrey P. Castelli: I also have a number of pediatric patients those actually continue to increase as we continue to enroll as <unk>, but I think from a commercial perspective, you know thinking about those 65 to 70 adults 40 in Europe 20 in countries that would come on later this year.
Speaker Change: Mmm great. Thanks.
Operator: Please stand by while we prepare the next question. The next question comes from Ritu Baral with T.D. Cohen.
Speaker Change: Thank god. Thank you.
Speaker Change: It sounds I'm only prepare the next question.
Ritu Subhalaksmi Baral: Next question comes from <unk> with T. D. Cohen go ahead. Your line is open.
Operator: Go ahead. Your line is open. Hi, this is Athena Anh for Ritu.
Speaker Change: Hi, This is Athena on for <unk>. Another question on <unk>, if the island plant changes hands, what <unk>, what percentage of the raw material going to Ireland, Some Chinese stores.
Athena Anh: And what pieces are still source kind of supply. Thank you.
Bradley L. Campbell: Yeah, it's a fair question. We are, as you might imagine, also looking at ways to find materials from outside of China as well. And again, I think that the eight-year extension period would give us plenty of time to be able to do that. In fact, many of the raw materials actually come from European-based companies already. And I think Congress has now clearly understood that, yes, this, you know, initiative might be important, but given the number of patients, the millions of patients who take a medicine, not just Pompeii, but across many other diseases, take a medicine that has some component parts manufactured elsewhere, they need to have that transition period. So that eight-year period would be plenty of time to do that.
Athena Anh: Yeah. It's a fair question. We are as you might imagine we are also looking at ways to find material from outside of China, as well and again I think that eight year extension period would give us plenty of time to be able to do that the the many of the raw materials actually come from European based company has already and I think.
Bradley L. Campbell: That I think Congress is clearly now understood that yes. This this you know initiative might be important but given the number of patients the millions of patients who take a medicine notch on pay but across many other diseases, taking medicine that has some component parts manufactured elsewhere that they need to add that transition.
Bradley L. Campbell: Period, so so that eight year period would be plenty of time to do that.
Speaker Change: Alright, thank you.
Bradley L. Campbell: Okay.
Speaker Change: Thank you.
Operator: Please stand by for our next question. The next question is from Jeffrey Hung with Morgan Stanley. Go ahead, Jeff, your line is open. Hi, good morning. This is.
Speaker Change: That's our next question.
Operator: Jeff will talk a little bit more about the details. So the registry, I would say, serves two really important purposes. The first is, as is almost always the case in rare diseases, it is a commitment, a post-marketing commitment. So we do have an obligation to do it.
Jeff Hung: The next question is from Jeffrey hung with Morgan Stanley Go ahead check your line is open hi.
Operator: Hi, Good morning. This is Catherine on for jazz. Thank you. So much you would take care of question.
Jeff Hung: Just had one in the attic is Pompeii registry could you talk more to what your goals are here and any expectation that you have on how many patients he might be able to enroll on an annual basis, especially when it comes circle with maximizing possibility helpful to patients on treatment by ear and any color here would be appreciated. Thank you.
Jeffrey P. Castelli: But I think the real value that comes out of the registry is all the real-world evidence that you start to generate and that you could then use to further provide proof to physicians and patients on how they're responding to the palm-out treatment. And this is one unique opportunity we have, and then I'll let Jeff provide more details in terms of the numbers that you were asking for. One unique opportunity we have is that we do have a registry coming out of the UK EAMS program.
Jeffrey P. Castelli: Sure. Thanks for the question and I'll just hit one overview statement, then I'll I'll, let Jeff talk a little bit more to the detail. So the registry I would say it serves to really important purposes. The first is added is almost the case and rare diseases. It is a commitment postmarketing commitment. So we do have an obligation to do it but I think the real value that comes out of the registry.
Jeffrey P. Castelli: He has all the real world evidence that you start to generate that you could then use to further provide proof that physicians and patients how they're responding to the <unk> treatment and one unique opportunity we have and then I'll, let Jess provide more details in terms of the numbers that you were asking for one unique opportunity. We have is we do have a registry coming out of the U K M's program.
Jeffrey P. Castelli: Remember, those patients have been on the drug for a year to two years. And so that is sort of a real-world, near-term opportunity to provide data out to the prescribers and to the patients out there. So Jeff, maybe talk a little bit more about the numbers, both the EAMS and then the broad registry. Yeah, thanks, Brad.
Jeffrey P. Castelli: Remember those patients had been on drug for a year to two years and so that that is a sort of a real world near term opportunity to provide data out to the to the prescribers and to the patient out there, but Jeff maybe talk a little bit more about the numbers at both the <unk> the broad registry.
Jeffrey P. Castelli: And thanks, Catherine, for the question. So in terms of the Pompeii Registry, I mean, the real vision there, as Brad said, it's to cover the regulatory requirement for safety, but then also, similar to Galliford, just to continue to collect real world data and all these patients. So our plan is to have that registry available in most of the countries that we go commercial in, to have hundreds of patients. I can't recall the exact high level number on the upside that it has, but it's hundreds of patients.
Jeff: Yeah. Thanks, Brian Thanks customer the question. So in terms of the Palm Bay Registry I mean, the real visionary <unk>. It's the cover the regular requirement for safety, but then also similar to <unk> just to continue to collect real world data and all these patients so.
Jeffrey P. Castelli: Plan is to have that registered available in most of the countries that we could go commercial in to have hundreds of patience I can't recall the exact high level number on the upside that it has been it's hundreds of patients.
Jeffrey P. Castelli: Importantly, it's really for commercial patients. So we continue to have patients in access and trials, and they remain in those programs, and we continue to collect data in those programs. Generally, then, when they become commercial patients, the way for us to continue to follow those patients would be through a registry. So right now, we have a registry targeted at the U.S., UK, Germany, Spain, you know, where we are going commercial. So that's the way to think about it. It doesn't really impact commercial uptake or anything. It's more of a way to capture data for commercial patients long-term safety, but that important, kind of long-term, real-world data on quality of life, durability.
Jeffrey P. Castelli: Importantly, it's really for commercial patients. So we continue to have patience and access and trials and they remain at those programs and we continue to collect data in those programs. Generally then when you know they become commercial patients the way for us to continue to follow those patients would be through a registry. So right now we have the registry targeted in the U S.
Jeffrey P. Castelli: U K, Germany, Spain, where we are going commercial so that's the way to think about it it doesn't really impact commercial uptake or anything it's more of a way to capture data and those commercial patience longterm those safety that that importantly, kind of long-term Ah real world data on quality of life, the ability et cetera.
Jeffrey P. Castelli: Uh-huh.
Speaker Change: Thank you. Thank you ma'am, while we prepare our next question.
Operator: Thank you. One moment while we prepare our next question. The next question comes from Kristen Kluska with Cancer Fitzgerald. Go ahead. Your line is open. Hi, good morning.
Christian Cluster: The next question comes from Christian cluster with Cantor Fitzgerald go ahead. Your line is open.
Kristen Brianne Kluska: Hi, good morning, Sir Dallas.
Kristen Brianne Kluska: We haven't really seen much of a slowdown in terms of the ability to continue finding naive patients. So can you comment on your expectations Medicaid into this movie So where do you see any early.
Kristen Brianne Kluska: The swelling down okay.
Bradley L. Campbell: Thanks, Kristen. Yeah, I think that's a really important point. And we highlighted previously, in our presentation, just the remarkable growth in this market. Just as a quick reminder, when we launched seven or eight years ago, we estimated about 11,000 diagnosed patients, sorry, 10,000 diagnosed patients, about half of them were treated. Now we're treating 11,000 patients globally between Galliford and the other therapies, but there are further 6,000 diagnosed untreated patients. We actually think that this is going to continue to grow the diagnosis rate. You know, it's a combination of low cost, readily available genetic testing and also much more intelligent screening. And then, of course, the work that we're doing, which others are doing as well, looking at artificial intelligence.
Kristen Brianne Kluska: Thanks Christian Yeah, I think that's a really important point and we highlighted previously and our presentation just the remarkable growth in this market just as a quick reminder, when we launched seven or eight years ago. We estimated about 11000 diagnose patients sorry, 10000 diagnose patients about half of whom were treated now we're treating 11000 patients glue.
Bradley L. Campbell: <unk> between <unk> and the other therapies, but there are further 6000 diagnosed untreated patients. We actually think that this is gonna continue to grow the diagnosis rate you know, it's a combination of low cost readily available genetic testing also much more intelligence screaming and then of course, the work that we're doing which others are doing as well.
Operator: So we think that, number one, you're going to continue to treat those diagnosed untreated patients as they move through their disease course. And, of course, we've seen that already with Galliford. And then we think you're going to just keep finding more and more patients. If you look at the statistics, this is the most underdiagnosed genetic disease, and there could be double or triple the number of patients living with Fabre who are not diagnosed today.
Bradley L. Campbell: Looking at artificial intelligence. So we think that number one you're gonna you're gonna continue to treat those diagnosed untreated patients as they move through their disease course of course, we've seen that already with golf old and then we think you're gonna just keep finding more and more patients. If you look at the statistics. This is the most under diagnosed genetic disease and there could be.
Operator: Be double or triple the number of patients living with fat Bray, who are not diagnosed today. So that's a really important part of the story of a Gallup poll and if you think about what we offer with gallon fold with which is an oral medication, which you know is shown to be clearly impacting so many patients around the world, we think that would be a great.
Operator: So that's a really important part of the story of Galliford. And if you think about what we offer with Galliford, which is an oral medication that has shown to be clearly impacting so many patients around the world, we think that would be a great option for patients that are newly diagnosed with the disease.
Operator: Right option for patients that are newly diagnosed with the disease.
Speaker Change: Thank you.
Operator: One moment for our next question. The next question comes from Tazeen Ahmad with BofA Securities. Go ahead. Your line is open.
Speaker Change: Thank you.
Speaker Change: One moment for our next question.
Tazeen Ahmad: The next question comes from <unk> Securities Go ahead. Your line is open.
Bradley L. Campbell: Okay, great. Good morning. Thanks for taking my question. Brad, I just wanted to ask you about Pompeii. When you came up with your guidance for the year, what proportion of that guidance is an assumption that you're making about how long patients are staying on the Sanofi products before switching? We had conversations between us and you as well as with physicians that indicated that docs could conceivably start to switch patients as early as two years from the previous drug, but how is that working out in a real-world setting so far, and what part of your guidance is that? Yeah, thanks Tazeen, and look at this.
Tazeen Ahmad: Okay granted the morning. Thanks for taking my question Brown I would just wanted to ask you about Pompeii. When you came up with your identity here, what what what's a person at that guidance as an assumption that you're making about how long patients are staying on the canopy products.
Bradley L. Campbell: For switching had conversation mm between <unk> physicians and indicated that dogs can feasibly searches, which patients as early as two years.
Bradley L. Campbell: From your previous drug, but how is that working out in the real world settings, So far and what part of your guidance does that concern okay.
Bradley L. Campbell: Yeah, thanks, Tazeen. I'm looking forward to seeing you at the conference next week.
Brad: Yeah, Thanks to Xena and looking forward to see Ya Conference next week. So yeah. That's a great question, we what we had heard coming into the launch was that physicians were thinking they needed kind of at least a year of treatment before they would think about switching a patient and then patients said look.
Bradley L. Campbell: So yeah, it's a great question. What we had heard coming into the launch was that physicians were thinking they needed kind of at least a year of treatment before they would think about switching a patient. And then patients said, look, if I'm not doing well, I'd be willing to switch within six months. And I think if you look at the switch dynamics that we highlighted for the United States, we're seeing 75%, roughly, of our switch patients are coming from nexviazine, and 25% are coming from lumizine. I think that's a pretty fair reflection because Nexviazine was launched a little over two years ago.
Bradley L. Campbell: If I'm not doing well I'd I'd be willing to switch within six months and I think if you look at the switch dynamics that we highlighted for the United States. We're seeing you know 75% roughly of our switch patients are coming from exercise I'm in 25 per cent are coming from the Amazon I think that's a pretty fair reflection because.
Bradley L. Campbell: You know an exercise I'm launched a little over two years ago. So you're starting to see a bolus of patients go through that kind of one plus year period I do think that there was some physicians sure who will be thinking more about that two year period and my my view and our expectation is the better we demonstrate outcomes.
Bradley L. Campbell: So you're starting to see a bolus of patients go through that kind of one plus year period. I do think that there are some physicians, sure, who will be thinking more about that two year period. And my view and our expectation is that the better we demonstrate outcomes in those patients who do switch, the more likely that physicians are going to start to think that, hey, I should be thinking about doing this sooner, and I should be proactive.
Bradley L. Campbell: In those patients who do switch the more likely that physicians are gonna start to think that pay I should be thinking about doing this sooner and even though I should be proactive and I think that's what we've talked about is kind of the the real battle here is for that quote unquote stable middle and that's when we win that the hearts and minds of those face.
Bradley L. Campbell: And I think that's what we've talked about, the kind of real battle here is for that quote unquote stable middle. And when we win that, the hearts and minds of those patients and physicians, I think that's where the momentum continues to build. So we're seeing great trends right now. I think what we are seeing is what we expected to see in that kind of one to two year switch period.
Bradley L. Campbell: [noise] physicians I think that's where that momentum continues to build so we're seeing great trends right now I think what we're seeing is what we expected to see and that kind of one to two year switch period.
Bradley L. Campbell: And then outside the US, remember where Nexavirazine hasn't been on the market for nearly as long. And in many cases, we're launching kind of head to head. We're seeing switches from majority lumazine because that's the majority of the population, but we're also seeing nexavirazine switches, and we're seeing strong uptake in naive patients. So I think as long as those trends continue, and we think they'll actually accelerate, that will clearly support our guidance, and then there will be much more room to grow.
Bradley L. Campbell: And then outside the U S remember, where <unk> hasn't been on the market for nearly as long and in many cases, we're launching kind of head to head we're seeing switches from majority <unk> because that's the majority of the population, but we're also seeing next wise I'm switches and we're seeing strong uptake in in naive patients. So I think as long as those trends continue and we think they'll actually excel.
Bradley L. Campbell: Alright.
Bradley L. Campbell: That that would clearly support our guidance amid much more room to grow from there.
Bradley L. Campbell: Okay.
Operator: Thank you. One moment for our next question. The next question comes from Deghanha with Stifle. Go ahead, your line is open. Hello, this is Benazir on behalf of Dagon. Thank you for taking our question. Can you speak to your appetite on
Speaker Change: Thank you.
Benazir: One moment for our next question.
Benazir: The next question comes from tick on Huh with Stifle go ahead. Your line is open.
Benazir: This is <unk>. Thank you for taking my question can you pick your appetite on you know business development opportunities both with the pipeline.
Benazir: Kind of wondering if the volatile markets and depressed valuations are drawn your attention and if so what therapeutic areas, but you'll be considering.
Operator: Thank you for the question. Yeah, Sebastian, do you want to just give an overview of what we've talked about previously in terms of how we're thinking about business development opportunities?
Benazir: Thank you for the question Yeah, Sebastian you Wanna, just give an overview of what we've talked about previously in terms of how we're thinking about business development opportunities.
Benazir: That should I believe you on me.
Sbastien Martel: Thank you for the question. So, you know, as we discussed, we've got plenty of growth still generated from Galafold, as we just discussed, and we're in the midst of the launch rollout of POMAP. Hence, you know, the very strong growth rate that we've provided today in terms of overall sales growth for Amicus as a whole. Yet, you know, we've been doing our homework from the BDNMNA side of things, and we have been developing a framework for addressing, you know, what potential disease areas or even specific indications might be of interest.
Speaker Change: Sorry about that [laughter].
Sebastian: Thank you for the questions. So you know as you know we've got plenty of plenty of growth.
Sbastien Martel: She'll generated from got Ahold as we just discussed and we're in the midst of the launch roll out of <unk>, hence the the very strong growth rate that we've provided today in terms of overall sales growth for this as a whole.
Sbastien Martel: Yeah, we've been doing our homework from obedient M&A a side of things.
Sbastien Martel: Been.
Sbastien Martel: Developing a framework on dressing what potential disease areas or even specific indications might be of interest I think we overtime have developed.
Sbastien Martel: I think we, over time, have developed a very solid infrastructure from a commercial and medical standpoint, as well as from a development and regulatory standpoint. And we could clearly be able to leverage that. We've been looking at what we call adjacencies when it comes to indication, so thinking of Fabry as a rare renal or rare cardiac disease, thinking of Pompe as a rare neuromuscular, or more broadly speaking, rare neural.
Sbastien Martel: You know a very solid infrastructure commercial and medical standpoint.
Sbastien Martel: As well as from a development and regulatory standpoint, and we could clearly be able to leverage that we've been looking at would be called I. Just some cheese when it comes to indication. So thinking of somebody is <unk> counteract disease thinking of <unk>.
Sbastien Martel: So these are some of the therapy areas that are of interest to us. When it comes to stage of development, we are, you know, more focused and more interested in looking at later stage opportunities. And by that, I actually even include, you know, potentially marketed assets, recently approved drugs or products that are still in the launch phase, or product programs that are currently undergoing phase three trials. So, you know, we would be initially more focused on assets that could, you know, provide a fair amount of accretion fairly quickly, as opposed to investing in the early stage tech platform type of opportunities.
Brody: Brody speaking.
Sbastien Martel: New roles. So these are some of the therapy <unk> of interest to us when it comes to.
Operator: Excellent. Thank you so much. Thank you. One moment for our next question. The final question comes from Salveen Richter with Goldman Sachs. Go ahead. Your line is open.
Salveen Jaswal Richter: The stage of development. We are you know more focused and more interested to look at later stage opportunities and by data.
Operator: I'm actually even includes potentially marketed assets recently approved drugs or <unk> in the in the launch face or product programs in our currency undergoing a phase three trials. So that you know we would be initially multiple <unk> acids.
Salveen Jaswal Richter: <unk>, you know provide a fair amount of accretion.
Operator: Fairly quickly as opposed to investing in the early stage take that form type of opportunities.
Salveen Jaswal Richter: Excellent. Thank you so much.
Salveen Jaswal Richter: Thank you one moment the next question.
Salveen Jaswal Richter: Final question comes from Sylvia Rector with Goldman Sachs Go ahead. Your line is open.
John: Hi, This is John.
Salveen Jaswal Richter: So much for taking a question can.
Salveen Jaswal Richter: Can you comment.
Salveen Jaswal Richter: N D E.
Operator:
Salveen Jaswal Richter: And are there any details.
Salveen Jaswal Richter: And the U S can you discuss the efforts.
Salveen Jaswal Richter: [noise], yes. Thank you for the two questions I would say for sure you know we continue to hear incredibly positive anecdotes coming from physicians and patients in the United States in particular around their experiences possibility October I won't.
Bradley L. Campbell: Yes, thank you for the two questions. I would say for sure that we continue to hear incredibly positive anecdotes coming from physicians and patients in the United States, in particular, around their experiences with Ponvodiabfolder. I won't speak to the other product, but I think that will be a huge driver of word of mouth and confidence in this product. We're just seeing things that I think are really inspiring and will inspire others as well.
Bradley L. Campbell: Speak to the to the other products, but I think that will be a huge driver of word of mouth and confidence in this product. We're just seeing things that that I think are are really inspiring and will inspire others as well one place to look for some of that is Dr. Mark Roberts did have a presentation at a world Congress this year, where.
Bradley L. Campbell: One place to look for some of that is Dr. Mark Roberts did a presentation at the World Congress this year, where he presented some case studies coming out of the EAMS program. He was one of the EAMS physicians in the UK, so that's a good place to look.
Bradley L. Campbell: He presented on some case studies coming out of the <unk> program. He was one of the physicians in the U K. So that's a good place to look there was also another <unk> site that published a poster I believe last year that also looked at a number of of patients who were responding to or excuse me and how they were responding to the.
Bradley L. Campbell: There was also another EAMS site that published a poster, I believe last year, that also looked at a number of patients who were responding to, or excuse me, and how they were responding to the therapy. So I think there is, and that's something that we will continue to focus on as well, building that body of evidence, both through the registry, as Jeff highlighted, but then also through, you know, physicians who are having those experiences.
Bradley L. Campbell: Therapy. So I think there is and that's something that we will continue to focus on as well as kind of building that body of evidence both through the registry is Jeff highlighted but then also through you know physicians were having those experiences I think that would be a a significant driver up momentum going forward. The second question in terms of the insurance process. So really there's two key components.
Bradley L. Campbell: I think that will be a significant driver of momentum going forward. The second question is in terms of the insurance process. So really, there are two key components. The first component, and this is really the long tent in the pole, is when you first launch, you're not in any of the formularies, and so you typically go through what's called a letter of authorization process that takes time. And it's a process that we know well from Galliford, but you just have to work through that system.
Bradley L. Campbell: That's probably the longest part. And then at the beginning of the year, you start to go on to formularies, both for hospitals and major insurers, and we do that. We're also seeing patients go through Medicare and Medicaid very successfully. So all those things are happening kind of when we thought they would. The second piece of the puzzle is then just purchasing the drug and getting the drug, and then scheduling the infusion.
Bradley L. Campbell: The first component and this is really the long 10 to Nepal is when you first launch you don't you're not on any of the formularies and so you typically go through what's called a letter of authorization process that takes time and it's a process that we know well from Gallup hold that you just have to work through that system, that's probably the longest part.
Bradley L. Campbell: And then when you come in at the beginning of the year you start to come onto formularies, both for hospitals and major insurers and we're doing that we're also seeing patients go through Medicare and Medicaid very successfully so all of those things are happening kind of when we thought they would the second piece of the puzzle has been just purchasing the drug and getting the drug and then scheduling the infusion.
Bradley L. Campbell: And so, you know, that takes a little bit of time as well. Our goal is that, at steady state, this can get down to kind of 30 to 45 days, which is what we see with Galliford. And, just as an aside, the two most recent commercial patients in the U.S. were in that timeframe. So that's a place that we know we can get to, and we're glad to see the progress so far this year.
Bradley L. Campbell: And so you know that takes a little bit of time as well. Our goal is that you know steady state. This can get down to kind of 30 to 45 days, which is what we see with Gallup hold EM and just as an aside the two most recent commercial patients in the U S were in that timeframe. So that's a place that we know we can get too and and we're glad to.
Bradley L. Campbell: See the progress so far this year.
Speaker Change: Thank you.
Operator: That was your last question. This concludes today's conference call. Have a great day.
Speaker Change: Thank you.
Speaker Change: What is your last question.
Speaker Change: This concludes today's conference call have a great day.
Operator: [music].
Operator: Mmm.
Operator: [music].