Q1 2022 Amicus Therapeutics Inc Earnings Call

Good morning, ladies and gentlemen, and welcome to the amicus Therapeutics first quarter 'twenty 'twenty financial results conference call and webcast.

Operator: Good morning, ladies and gentlemen, and welcome to the Amicus Therapeutics First Quarter 2022 Financial Results Conference Call and Webcast. At this time, all participants are in a listen-only mode.

Time, all participants are in a listen only mode.

Operator: Later, we will conduct a question and answer session. Instructions will follow at that time. If anyone should require assistance during the conference, please press star and then zero on your touchtone telephone.

We will conduct a question and answer session and instruction will follow at that time.

Anyone should require assistance during the conference. Please.

Press Star and then zero on your Touchtone telephone.

Operator: As a reminder, this conference call is being recorded. I would now like to turn the conference over to your host, Mr. Andrew Faughnan, Executive Director of Investor Relations. You may begin. Thank you, Charlotte. Good morning, everyone.

As a reminder, this conference call is being recorded.

I would now like to turn the conference over to your host Mr. Andrew Faughnan.

Director of Investor Relations you may begin.

Andrew Faughnan: Thank you for joining our conference call today to discuss Amicus Therapeutics' First Quarter 2022 Financial Results and Corporate Highlights. Speaking on today's call, we have John Crowley, Chairman and Chief Executive Officer, Bradley Campbell, President and Chief Operating Officer, Daphne Quimi, Chief Financial Officer, and Dr. Jeff Castelli, Chief Development Officer. Joining for Q&A are Dr. Mitchell Goldman, Chief Medical Officer, and Sbastien Martel, Chief Business Officer. As referenced on slide two, we may make forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 relating to our business as well as our plans and prospects.

Thank you Charlotte and good morning, everyone. Thank you for joining our conference call today to discuss them get therapeutics first quarter 2022 financial results and corporate highlights.

On today's call, we have John Crowley, Chairman and Chief Executive Officer, Bradley Campbell, President and Chief Operating Officer, Daphne Queenie, Chief Financial Officer, and Dr. Jeff Castelli, Chief Development Officer, joining for Q&A, We'll have Dr. Mitchell Goldman Chief Medical Officer, Sebastien Martel, Chief business Officer as referenced on slide two we may make forward looking statements.

Andrew Faughnan: Our forward-looking statements should not be regarded as representations by us that any plans will be achieved. Any or all of the forward-looking statements made on this call may turn out to be wrong and can be affected by inaccurate assumptions we might make or by known or unknown risks and uncertainties.

Within the meaning of the private Securities Litigation Reform Act of 1995 relating to our business as well as our plans and prospects.

Our forward looking statements should not be regarded as representation by us that any plans will be achieved any or all of the forward looking statements made on this call may turn out to be wrong. It can be affected by inaccurate assumptions, we might make or by known or unknown risks and uncertainties. You are cautioned not to place undue reliance on any forward looking statements, which speak only to the date hereof.

Andrew Faughnan: 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 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 our Form 10-K for the year-ended 2021 and for the quarter-ended March 31, 2022, to be filed later today with the Securities and Exchange Commission. At this time, it is my pleasure to turn the call over to John Crowley, Chairman and Chief Executive Officer. John?

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. 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.

Our Form 10-K for the year ended.

'twenty one quarter ended March 31, 2020 to be filed later today with the Securities and Exchange Commission at this time, it's my pleasure to turn the call over to John Crowley, Chairman and Chief Executive Officer John .

John Crowley: Great. Thank you, Andrew, and welcome, everyone, to our first quarter 2022 results conference call. I'm pleased to highlight the successful start to the year across our business and reiterate the Amicus team's focus on our business priorities, despite, as we all know, this tumultuous stock market environment across the biotech sector. Let me begin by emphasizing that we are sharply focused on three primary objectives. 1. To improve the quality of life for all. 2. We will continue to advance GALIFOLD to as many patients in as many geographies as possible, to secure approvals for and launch APGAA and Pompe disease globally. 3.

Great. Thank you Andrew and welcome everyone to our first quarter 2022 results conference call I'm pleased to highlight the successful start to the year across our business and reiterate the amicus team is focus on our business priorities.

As we all know this tumultuous stock market environment across the biotech sector.

We begin by emphasizing that we are sharply focused on three primary objectives. One continued to advance Gallup poll to as many patients and as many geographies as possible too.

To secure approvals for and launch a T G. A a in pompe disease globally.

John Crowley: Ensure the financial strength of Amicus, including the path to profitability, without the need for any further equity-based financing. As we did in this morning's press release, let me elaborate on several key accounts. First, Guelpholt continues its strong performance and remains the cornerstone of our success. With $78.7 million in first quarter revenue, a nearly 19% increase from a year ago, we continue to be very pleased with the uptake of Galafold globally. Its growth thus far this year is meeting or exceeding our objectives in all key geographies.

Three ensure the financial strength of amicus, including the path to profitability without the need for any further equity based financing.

John Crowley: We are excited to announce that the intellectual property portfolio of Gallifold has been strengthened by the issuance of eight new patents this year. Together, there are now 35 Orange Book listed issued patents related to Gallifold in the United States, all of which provide protection through 2038, including the very important and recently issued Composition of Matter Patent.

As we did in this morning's press release, let me elaborate on several key accomplishments.

First yellow fold continues its strong performance and remains the cornerstone of our success.

With $78 $7 million in first quarter revenue of nearly 19% increase from a year ago. We continue to be very pleased with the uptake of <unk> globally.

It's growth thus far this year is meeting or exceeding our objectives in all key geographies.

We were excited to announce also that the intellectual property portfolio with state for Gallup hold has been strengthened by the issuance of eight new patents this year.

There are now 35 Orange book listed issued patents related to Gallo folds in the United States.

Which provide protection through 'twenty 38, including the very important and recently issued composition of matter patent.

John Crowley: This portfolio will provide broad and long-term intellectual property rights well into the late 2030s for this novel precision medicine. We expect significant growth for Gallifold in 2022, and with this strengthened IP protection, believe that it has a long runway into the next decade and beyond, and that it continues to have the potential to achieve $1 billion in peak revenue. Second, we continue to make great progress on our global regulatory filings for ATGAA, our novel next-generation therapy for Pompe disease.

This portfolio will provide broad and long term intellectual property rights well into the late twenties thirties for this novel precision medicine.

We expect significant growth for Gallup fold in 2022 and with the strengthened IP protection believed that it has a long runway into the next decade and beyond and the Gallup poll continues to have the potential to achieve $1 billion in peak revenue.

John Crowley: The U.S. and EU regulatory reviews are progressing very well, and we are extremely pleased with the level of engagement from the regulatory agencies. We have recently completed the late-cycle review with the U.S. FDA and are now in labeling discussions with the agency. We remain confident in ATGAA's approvability and its potential to become the next standard of care in Pompe disease. We continue to expect a manufacturing inspection at the WUSHI facility for the Biologic ATB-200, again the biologic component of ATGAA, and that this will be needed for FDA approval.

Second we continue to make great progress on our global regulatory filings for a T. G. A a or a novel next generation therapy for Pompe disease.

The U S and EU regulatory reviews are progressing very well and we are extremely pleased with the level of engagement from the regulatory agencies.

We now have a recently completed the late cycle review with the U S. F D. A and are now in labeling discussions with the agency.

We remain confident in a T G a as a proof of ability and its potential to become the next standard of care in Pompe disease.

We continue to expect the manufacturing inspection at the Wuxi facility for the biologic a T. B 200 again, the biologic component of a T. G. A a and that this will be needed for FDA approval.

John Crowley: We are carefully watching the COVID-19 situation in China and recognize that it could impact the potential timing of an inspection. We are in communication with the agency regarding the best way to support an inspection. Amicus also continues to evaluate all options with respect to the inspection requirement.

We are carefully watching the COVID-19 situation in China and recognized that it could impact the potential timing of an inspection we are in communication with the agency regarding the best way to support an inspection and it gets also continues to evaluate all options with respect to the inspection requirement we end our PA.

John Crowley: We and our partners at WUSHI have completed all preparatory work, including internal mock inspections, and are fully prepared. Today, we continue to expect the agency to approve both applications together by the July 29 deadline. In the EU, we are actively engaged with the EMA on the Marketing Authorization Applications, or MAAs, for ATGAA. We continue to expect a positive CHMP opinion later this year and commercial launch in 2023. Of note, importantly, the EMA has indicated that it will not require a new inspection of the WuXi manufacturing site.

Or is it Wuxi has completed all preparatory work, including internal mock inspections and are fully prepared today. We continue to expect the agency to improve to approve the applications together by the July 29 action date.

In the EU, we are actively engaged with the EMA on the marketing authorization application or MAA for <unk> H T. G. A a we.

We continue to expect a positive C. H M. P opinion later this year and commercial launch in 2023 of.

Of note importantly, the MAA has indicated that it will not require a new inspection at the Wuxi manufacturing site.

John Crowley: Our global launch plans continue to accelerate, including pre-launch activities, targeted investments in additional personnel to support the launch, and significant investments in launch inventory preparation. We are now closer to having another potential treatment option for people living with Pompe disease, both in the United States and in Europe, with further regulatory applications planned in the months ahead. Of note also, both the EMA and the US FDA have approved the trade names for this novel new treatment paradigm for people living with Pompe.

Our global launch plans continued to accelerate including prelaunch activities targeted investments in additional personnel to support the launch and significant investments in launch inventory preparations.

We are now closer to having another potential treatment option for people living with Pompe disease, both in the United States and in Europe with further regulatory applications are planned in the months ahead.

Of note also both the EMA and the U S. FDA have approved the trade names for this novel New treatment paradigm for people living with Pompe pay so we expect one global brand name.

John Crowley: So we expect one global brand name, which of course, we will not disclose until approval. And third, and importantly, Amicus has maintained a strong financial position and remains committed to achieving profitability in 2023 as we continue to execute on the global expansion of Galafold and prepare for the global launch of ATGAA. We have no need for any equity or equity-linked financing to achieve profitability.

Which of course, we will not disclose until approval.

And third and importantly, amicus has maintained a strong financial position and remains committed to achieving profitability in 2023, as we continue to execute on the global expansion of Gallo fold and prepare for the global launch of a T. G. I E. We have no need for any equity or equity linked financings to achieve.

<unk> profitability.

John Crowley: In order to accomplish this, we will concentrate the vast majority of our efforts and investments in our priority growth franchises in febrile disease and Pompe disease. And we'll do this through the continued global growth and commercialization of Gallifold, advancing the activities to secure global regulatory approvals and commercial launch for ATGAA, and by making judicious strategic investments in next-generation therapies for Fabry and Pompey and in core science and platform technologies in the field of genetic medicine. We are rapidly approaching two pivotal inflection points for Amicus.

In order to accomplish this we will concentrate the vast majority of our efforts and investments in our priority growth franchises in fabry disease in Pompe disease, and we will do this through the continued global growth and commercialization of Gallophone.

We are advancing the activities to secure global regulatory approvals and commercial launch for a T. G. A a.

And by making judicious strategic investments in next generation therapies in Fabry and Pompe pay and then core science and platform technologies in the field of genetic medicine.

We are rapidly approaching two pivotal inflection points for amicus.

John Crowley: First, the global launch of a second rare disease medicine with ATGAA, and secondly, profitability. These are feats that we believe will enable Amicus to truly enter the upper echelon of biotechnology companies. Ahead on slide six, and as we laid out last month, we are focused on achieving our key strategic priorities for the year. These include, one, we will continue to drive Gallifold to more people living with febrile disease with a minimal variance in existing and new markets. We look to achieve double-digit global product revenue growth of 15 to 20 percent with revenue of $350 million to $365 million at constant exchange rates.

First the global launch of a second rare disease medicine with a T G. A a.

And secondly profitability.

These are feats that we believe will enable amicus to truly enter the upper echelon of biotechnology companies.

It head on slide six and as we laid out last month, we are focused on achieving our key strategic priorities for the year. These include one we will continue to drive yellow poll to more people living with fabry disease with a minimal variance in existing and new markets.

We look to achieve double digit global product revenue growth of 15% to 20% with revenue of 350 million to $365 million at constant exchange rates.

John Crowley: This reflects the strong momentum and demand behind this precision medicine globally. Second, we remain steadfast in our commitment to advancing ATGAA regulatory filings and initiating the anticipated launch of ATGAA in the United States. Leveraging our seasoned global commercial team and experience across all areas for an effective drug launch, we are fully prepared and anticipate a successful launch of APGAA. Third, we are strategically advancing our best-in-class, next-generation genetic medicines and capabilities. And finally, again, we continue to maintain a strong financial position as we carefully manage our expenses and investments, and we remain fully funded through all major milestones. With that introduction, let me go ahead now and turn the call over to Bradley Campbell, our President and Chief Operating Officer, to further highlight Gallifold's performance. Bradley

This reflects the strong momentum and demand behind this precision medicine globally.

Second we remain steadfast in our commitment to advancing a T G. A a regulatory filings and initiating the anticipated launch at a T. G. A a in the United States.

Leveraging our seasoned global commercial team and experience across all areas for an effective drug launch we are fully prepared and anticipate a successful launch of a T. G. A a.

Third we are strategically advancing our best in class next generation genetic medicines and capabilities in.

And finally again, we continue to maintain a strong financial position as we carefully manage our expenses and investments.

And we remain fully funded through all major milestones with that introduction. Let me go ahead, now and turn the call over to Bradley Campbell, our President and Chief operating officer to further highlight the Gallup polled performance Bradley.

Bradley Campbell: Great. Thanks, John. Good morning, everyone.

Great. Thanks, John Good morning, everyone.

Bradley Campbell: Let me start by walking you through in more detail our GALFOLD performance for the quarter. On slide 7, for the first quarter again, total product revenue grew 18.5% to $78.7 million globally. This is driven by strong new patient accruals and continued sustained patient compliance and adherence. The geographic breakdown of revenue during the quarter was consistent with what we've seen historically with 55 million, or 69 percent, of revenue generated outside the United States, and the remaining 24 million, or 31%, coming from within the United States.

Let me start by walking you through in more detail our Gulf old performance for the quarter on slide seven for the first quarter again total product revenue grew 18, 5% to $78 $7 million globally. This was driven by strong new patient accruals and continued sustained patient compliance and adherence rates.

The geographic breakdown of revenue during the quarter was consistent with what we've seen historically with $55 million or 69% of revenue generated outside the United States.

And the remaining 24 million or 31% coming from within the United States and this is in line with the roughly 70 30 split that we expect as we continue to grow both parts of the business.

Bradley Campbell: And this is in line with the roughly 70-30 split that we expect as we continue to grow both parts of the business. Now turning to slide eight. Q1 results highlight the strength of a global commercial effort. This business continues to be incredibly resilient, with patients added in all major markets and an operational growth rate of 23.5% over the same quarter last year at Constance Exchange, As you can see in the two graphs depicted on this slide, Q1 results follow the revenue pattern we've continued to observe, where due to a variety of factors, including timing of orders, as well as pay reauthorizations in the United States, the rate of growth is typically nonlinear, and a smaller percentage of annual revenue falls into Q1.

Now turning to slide eight.

Q1 results highlight the strength of our global commercial efforts.

This business continues to be incredibly resilient with patients added in all major markets and an operational growth rate of 23, 5% over the same quarter last year at constant exchange rates.

As you can see in the two graphs depicted on this slide Q1 results follow the revenue pattern, we've continued to observe where due to a variety of factors, including timing of orders as well as payer reauthorization in the United States. The rate of growth is typically non linear and a smaller percentage of annual revenue falls into Q1.

Bradley Campbell: Here we've also called out several of the drivers and metrics which will lay the foundation for growth this year and beyond. We ended the first quarter with a little under half of the global market share of treated amenable patients.

Here, we've also called out several of the drivers and metrics, which will lay the foundation for growth this year and beyond.

We ended the first quarter with a little under half of the global market share of treated amenable patients.

Bradley Campbell: And while the global mix remains about 55% switch patients and 45% naive patients, in many geographies, we're starting to see stronger uptake in naive populations, which is in line with our strategy from Washington. So, we're achieving high market shares in countries where we've been approved the longest, but there's still plenty of opportunity to continue to switch patients over to Gallifold and to continue to grow the market as we penetrate the diagnosed, untreated, and newly diagnosed segments as well. Within our core business, the EU, the US, the UK, and Japan, we continue to see growth in these markets.

And while the global mix remain remains about 55% switch patients and 45% in naive patients in many geographies, we're starting to see stronger uptake in naive populations, which is in line with our strategy from launch.

So we're achieving high market shares in countries, where we've been approved the longest but theres still plenty of opportunity to continue to switch patients over to California and to continue to grow the market as we penetrate into the diagnosed untreated and newly diagnosed segments as well.

Within our core business, the EU U S U K and Japan, we continue to see growth coming out of these markets.

Bradley Campbell: And in fact, in Europe, where we've been on the market the longest, we're now at about an 80 to 90 percent market share of switch patients. The growth there is now being driven by bringing on diagnosed, untreated patients and newly diagnosed patients. Whereas in Japan and the United States, the overall patient mix is still about 50-50, switch versus naive. However, there, we're evolving more towards naive patients as well. On the other hand, if you look at the newer markets coming in, Latin American countries like Brazil, Chile, Argentina, and Colombia, the Asia-Pacific countries outside of Japan, the Gulf States, as well as countries in the Middle East and North Africa, including Turkey, where we're hoping to get approval later this year.

And in fact in Europe , where we've been on the market. The longest we're now at about an 80% to 90% market share of switch patients growth. There is now being driven by bringing on diagnosed untreated patients newly diagnosed patients, whereas in Japan, and the United States. The overall patient mix is still about 50 50 switch versus naive although there.

There were evolving more towards naive patients as well.

On the other hand, if you look at the newer markets coming in Latin American countries, like Brazil, Chile, Argentina, and Colombia, The Asia Pacific countries outside of Japan, The Gulf States as well as countries in the Middle East and North Africa, including Turkey, where we're hoping to get approval. Later this year, we see the majority of net new patients are switch patients.

Bradley Campbell: We see the majority of net new patients are switch patients, and we expect that to continue throughout the next several weeks. All of that is underpinned, again, by impressive compliance and adherence rates that continue to exceed 90%, reiterating our belief that those patients who go on Gallifold generally stand by it. And importantly, the value of Galliford continues to be recognized by payers, with the vast majority of insurance reauthorizations granted in 2022 by U.S. payers within the first quarter, and a very strong track record of successfully negotiating and renegotiating reimbursement outside the United States.

And we expect that to continue throughout the next several years.

All of that is underpinned again by impressive compliance and adherence rates that continue to exceed 90%.

Reiterating our belief that those patients who go on Gallup polled generally stand golf old.

And importantly, the value of golf hold continues to be recognized by payers with the vast majority of insurance reauthorization is granted in 2022 by U S payers within the first quarter.

And a very strong track record of successfully negotiating and renegotiating reimbursement outside the United States.

Bradley Campbell: A relentless focus remains on ensuring access to GALFOLD for anyone who needs it. In the table on the right side of the slide, we've provided a three-year historical snapshot of the average proportion of Gallup hold sales that occur each quarter during a given year, and we expect a similar trend to occur this year.

Our relentless focus remains on ensuring access to gal, a hold for anyone who needs it.

Within the table on the right side of the slide we.

Provided a three year historical snapshot of the average portion of <unk> sales that occur each quarter during a given year and we expect a similar trend to occur this year.

Bradley Campbell: Now moving to slide nine, what we've seen so far this year is that Galliford's uptake continues to go very well, and we're seeing growth in demand across all of our major markets, as well as most of our smaller markets as well. We're on track to achieve our full-year revenue guidance of $350 million to $365 million at constant exchange rates, and Daphne will provide a little bit more color on FX later in the call.

Now moving to slide nine what we've seen so far this year is the <unk> uptake continues to track very well and we're seeing growth in demand across all of our major markets as well as most of our smaller markets as well.

On track to achieve our full year revenue guidance of 350 million to $365 million at constant exchange rates and Daphne will provide a little bit more color on FX later in the call.

Bradley Campbell: Encouragingly, we continue to see signs of improvement in terms of patient access in the COVID environment. We recently conducted a survey of a number of Fabry physicians around the world, and only about 40 to 50 percent of Fabry physicians still feel that COVID is impacting the diagnosis of new patients and initiation of treatment.

Encouragingly, we continue to see signs of improvement in terms of patient access in the Covid environment.

We recently conducted a survey of a number of fabry physicians around the world and only about 40% to 50% of Fabry physicians still feel that COVID-19 is impacting the diagnosis of new patients and initiation of treatment but.

Bradley Campbell: But the majority said they're starting to prioritize Fabrite care again. And we've actually seen an almost tenfold increase in the number of in-person physician interactions with our field sales and medical team, from 150 face-to-face interactions in January and February of 2021 to over 1,000 in the same period, January and February 2022. We think that's a great sign for things to continue to improve.

But the majority said theyre starting to prioritize fabry care again, and we've actually seen in almost 10 fold increase in the number of in person physician interactions with our field sales and medical team from a 150.

Face to face interactions in January February of 2021 to over 1000 in the same period January February 2022, we think that's a great sign for things to continue to unlock.

Bradley Campbell: And all together, we view this as a very strong start. Moving to slide 10, looking ahead a little bit, we know that Gallup has the potential to surpass $500 million in annual revenue over the next few years through three primary growth drivers that we continue to talk about, continuing to penetrate existing markets, continuing to expand into new geographies, and broadening the labels for Gallup Holdings. In the longer term, we remain confident in that billion-dollar peak revenue opportunity as we continue to see significant growth in the Fabre market globally, driven by diagnosing patients through a variety of measures, including high-risk screening, newborn screening, and other diagnostic initiatives, which we continue to support and invest in as well.

And altogether, we view this as a very strong start to the year.

Moving to slide 10, looking forward a little bit we know that <unk> has the potential to surpass $500 million in annual revenue over the next few years through three primary growth drivers that we continue to talk about.

Continuing to penetrate existing markets continued to expand into new geographies and broadening the label for golf ball.

In the longer term, we remain confident in that $1 billion peak revenue opportunity as we continue to see significant growth in the fabry market globally, driven by diagnosing patients through a variety of measures, including high risk screening newborn screening and other diagnostic initiatives, which we continue to support and invest in as well.

Bradley Campbell: And finally... As John touched on, we have orphan exclusivity in the U.S. and Europe, in addition to our now 35 Orange Book-listed patents that give us IT coverage into the late 2030s, 19 of which provide protection through 2038, including the latest Composition of Matter patents, all of which give us opportunity to provide access to Gallup Hold globally for many years, With that, let me turn the call now over to Dr. Jeff Castelli, our Chief Development Officer, to highlight our ongoing Galliford initiatives across our clinical, regulatory, and medical teams, as well as our APGA program. Jeff.

And finally.

As John touched on we have orphan exclusivity in the U S and Europe . In addition to our now 35 Orange book listed patents that give us IP coverage into the late 2000, <unk> 19 of which provide protection through 2038, including the latest composition of matter patents, all of which give us opportunity to provide access to Gulf world globally for many years to come.

With that let me turn the call now over to Dr. Jeff Castelli, Our Chief development officer to highlight our ongoing golf with initiatives across our clinical regulatory medical teams as well as our Atg AA program Jeff.

Jeff Castelli: Thanks, Bradley, and good morning, everyone. Starting here on slide 11, we'll highlight the ongoing work we're doing to build the body of evidence around Galliford. First, we continue to look to broaden the global label within the adolescent and pediatric populations, as well as add additional variants or mutations to the label. Second, our medical team continues to work diligently on our publications and medical conference schedule. Long-term data were published last year in the Molecular Genetics and Metabolism Reports, as well as presented at the 2022 World Symposium in February. These long-term data highlighted stable renal function during treatment up to eight and a half years on Galifold, irrespective of treatment status, gender, or phenotype, and inclusive of classic males.

Thanks, Bradley and good morning, everyone.

Starting here on slide 11.

We highlight the ongoing work, we're doing to build the body of evidence around California.

We continue to look to broaden the global labels within the hour I sent in pediatric populations as well as adding additional variants or mutations to the label.

Second our medical team continues to work diligently on our publications and medical conference schedule.

Long term data was published last year in the molecular genetics and metabolism reports.

Well as presented at the 2022 World Symposium in February .

These long term data highlighted stable renal function during treatment up to eight and a half years on California irrespective of treatment status gender or phenotype and inclusive of classic males.

Jeff Castelli: We have also presented at conferences and recently submitted a publication looking at fibroid outcomes measured by rates of kidney, cardiac, and CNS events, which we believe compare favorably to similar studies in the medical literature. Third, Amicus has over 500 patients in a large global registry as part of our post-marketing commitments and is exploring ways to leverage this wealth of long-term data to add to the growing body of evidence for Gallup polls through publications as well as towards providing confirmatory evidence to support our remaining post-marketing requirements.

We have also presented at conferences recently submitted a publication looking at fabry outcomes measured by rates of kidney cardiac and CNS events, which we believe compare favorably to similar studies in the medical literature.

Third anika over 500 patients in a large global registry as part of our post marketing commitments.

It is exploring ways to leverage this wealth of long term data.

To add to the growing body of evidence for golf ball through publications as well as towards providing confirmatory evidence to support our remaining post marketing requirements.

Jeff Castelli: Additionally, we have multiple other ongoing and planned Phase IV studies that we continue to move forward with. And last, as Bradley mentioned, we continue to add to our IP coverage and now have 35 Orange Book-listed patents. We see all of this continued work on evidence generation for Gallifold as an important driver of long-term success. Moving on to slide 13 in our ATGA program. It's important to recognize that Pompe disease continues to pose a range of health challenges for people affected by the disease, and having therapeutic choices is crucial. Pompe disease is a severe and fatal neuromuscular disease and one of the most prevalent lysosomal disorders.

Additionally, we have multiple other ongoing and planned phase four studies, we continue to move forward.

Alaska as Bradley mentioned, we continue to add to our IP coverage and now have 35 Orange book listed patents.

We see all of this continued work on evidence generation for golf vote is an important driver of the long term success.

Moving on to slide 13, and our a T V program. It's important to recognize that Pompeii disease continues to pose a range of health challenges for people affected by the disease.

Having therapeutic choices is crucial.

On days of severe and fatal neuromuscular disease, and one of the most prevalent lysosomal disorders.

Jeff Castelli: Multiple publications in natural history studies continue to highlight the initial benefit of treatment being followed by continued long-term decline on key measures of disease for many patients. Here, on slide 14, we present a summary of the primary and key secondary endpoints from our phase 3 study. As a reminder, PROPEL was a double-blind, randomized study assessing the efficacy and safety of ATGA in both treatment-naive and ERT-experienced patients against the approved therapy, aglucosidase alpha.

Multiple publications and natural history studies continue to highlight the initial benefit of treatment being followed by continued long term decline on key measures of disease for many patients.

Here on slide 14, we present, a summary of the primary and key secondary endpoints from our phase III study.

As a reminder, propel was a double blind randomized study assessing the efficacy and safety of Atg E and both treatment naive and <unk> experienced patients against the approved therapy Aglukkaq today's alpha.

Jeff Castelli: Propel is the only controlled trial, to date, that's included ERT-experienced patients, which represent one of the greatest sets of patients with unmet needs. Endpoints across motor function, muscle strength, pulmonary function, patient-reported outcomes, and biomarkers, including the two most recognized endpoints in Pompeii, six-minute walk distance in FDC, shown here on the slide, favored ATGA over aglucosi We believe this consistency of effect across the key disease manifestations of POMPEI illustrates the potential impact of ATGA for patients.

Propel is the only controlled trial to date, that's included experienced patients, which represent one of the greatest set of patients with unmet needs.

Endpoints across motor function muscle strength pulmonary function patient reported outcomes and biomarkers, including the two most recognized endpoints in Pompeii six minute walk distance and FTC shown here on the slide favored a T J a overhead with companies alpha in the overall population.

We believe this consistency of effect across the key disease manifestations of Pompeii illustrates the potential impact of atg for patients.

Jeff Castelli: On slide 15, we call out the ERT experience population, which are 95 participants who have been in the standard of care for more than seven and a half years on average. Generally, this is associated with a decline phase of disease for most patients, and we actually saw an increase in the six-minute walk in these patients and stabilization in their FEC, which achieved nominal statistical superiority on both endpoints versus aglokosmides alpha and showed a clinically meaningful outcome never before seen in this population.

On slide 15, we call out the ear T experienced population.

We're 95 participants were on the standard of care for more than seven and a half years on average.

Generally this is associated with the decline phase of disease for most patients and we actually saw an increase in six minute walk in these patients and stabilization in their I P C.

To achieve nominal statistical superiority on both endpoints versus Iowa properties Alpha and showed a clinically meaningful outcome never before seen in this population.

Jeff Castelli: Moving on to slide 16, adding to the overall body of data behind ATGA, recently at the 2022 NDA Clinical and Scientific Conference a few months ago, the Amicus team presented positive long-term data from the Phase I-II study of ATGA. As seen on slide 16, these latest data continue to represent very meaningful and importantly durable improvement in functional outcomes, as well as persistent reductions in key biomarkers of muscle damage and disease substrates out to three years.

Moving on to slide 16, adding to the overall body of data behind a T. J a recently at the 2022 NDA clinical and scientific conference a few months ago. The amicus team presented positive long term data from the phase one two study of a T. A C.

As seen on slide 16. These latest data continue to represent very meaningful and importantly, durable improvement in functional outcomes.

As well as persistent reductions in key biomarkers of muscle damage in disease substrate out to three years.

Jeff Castelli: The results have been shared with global regulatory authorities in the U.S. and EU as part of their ongoing reviews, and compared to what is known about the natural history of both untreated and ERT-experienced Pompe patients, these durable results give great hope that ATGA indeed has the potential to become the new global standard of care for people living with Palm Day.

The results have been shared with global regulatory authorities in the U S and EU as part of their ongoing reviews and compared to what is known about the natural history of both untreated and NRT experienced Pompeii patients. These durable results get great hope that atg A&D and has the potential to become the new global standard of care for.

For people living with Pompe <unk>.

Jeff Castelli: Moving on to slide 17, we have highlighted the key updates on the ATGA program. First, as John mentioned, regulatory progress. Last year, the U.S. FDA accepted for review the BLA for ciproglucosidase alpha and the NDA for miglisat, the two components of ATGA. And the agency set a PDUFA action date of May 29, 2022 for the NDA and July 29, 2022 for the BLA.

Moving on to Slide 17, we've highlighted that we had highlighted the key updates on the Atg a program.

First as John mentioned on our regulatory progress last year. The U S. FDA accepted for review the BLA for <unk> Alfa and the Anda from English that the two components of Atg E and the agencies that a <unk> action date of May 29, 2022 for the NDA and July 29, 2022 for the BLA.

Jeff Castelli: We expect these filings will be approved together by the July 29th action date, again dependent on the ability of FDA to conduct an inspection at the WuXi manufacturing facility. And again, we're working with the FDA to consider alternatives to a full on-site inspection. We've also shared that the MEA has been submitted to the European Medicines Agency and is under review. The CHMP opinion is expected later this year. Of note, as John also mentioned, the EMA has indicated in writing that, based on prior manufacturing inspections of this facility, an inspection is not required for ATGA at WUSHI to support the MAA.

We expect these filings will be approved together by the July 29th action date again dependent on the ability for FDA to conduct an inspection that the wuxi manufacturing facility and again, we're working with the FDA to consider alternatives to a full onsite inspection.

We've also shared that the MAA has been submitted to the European Medicines Agency and is under review.

To see HMP opinion is expected later this year of note as John also mentioned the EMA has indicated in writing.

On prior manufacturing inspections of this facility and inspection is not required for ATCA I Wuxi to support the MAA.

Jeff Castelli: We are now very excited to also have multiple expanded access programs in place globally, including in the UK, Germany, Japan, and other countries. This includes the EAMS framework that we announced in June, where ATGA was granted a positive scientific opinion through the Early Access to Medicine Scheme by the UK's MHRA. This positive opinion recognizes the high unmet medical need faced by the Pompeii community and permits eligible adults living with late-onset Pompeii disease who have received aglutinase alpha for at least two years to switch to ATGA, granting access prior to marketing in the UK.

We are now very excited to also have multiple expanded access programs in place globally, including in the U K, Germany, Japan and other countries.

This includes the EMS framework that we announced in June in which a T D. A.

A positive scientific opinion through the early access to medicines gained by the U K is an H R E.

This positive opinion recognizes the high unmet medical need faced by the pump a community.

And permits eligible adults living with late onset Pompe disease, who have received <unk> Alfa for at least two years to switch to a T D. A.

<unk> access prior to marketing in the U K.

Jeff Castelli: We're seeing significant enthusiasm for ATJ under the EAMS mechanism, with multiple physicians having requested access across all the leading pump-based centers in the U.K., and multiple patients now receiving this novel two-component treatment. Since the positive scientific opinion, interest and momentum for ATJ have grown, and we are pleased to be able to provide access to those who are eligible. And we continue to report that well more than 150 patients worldwide continue to be treated with ATJ across all our clinical extension studies and expanded access programs.

We're seeing significant enthusiasm for a T J under the EMS mechanism with multiple physicians, having requested access across all of the leading pompe based centers in the U K and multiple patients now receiving this novel two component treatment.

Since the positive scientific opinion interest and momentum for a T. J has grown and we are pleased to be able to provide access to those who are eligible.

And we continue to report that well more than 150 patients worldwide and continuing to be treated with a T. J across all our clinical extension studies and expanded access programs.

Jeff Castelli: And for the younger Pompeii community, we continue to enroll the ongoing open-label study in children with late-onset Pompeii disease up to 18 years of age and look to expand it to patients with infantile-onset Pompeii as soon as possible.

And for the younger pump a community we continue to enroll the ongoing open label study in children with late onset Pompe disease up to 18 years of age and look to expand into patients with infantile onset pompe a as soon as possible and finally in response to the many requests for expanded access that we received for children living with I O P D.

Jeff Castelli: And finally, in response to the many requests for expanded access that we received for children living with IOPD, our expanded access programs for both those living with infantile and late-onset Pompeii continue to add patients for multiple individuals as appropriate. And with that, let me hand the call back over to Bradley to further discuss our launch preparations for ATJ. Brad?

Our expanded access programs for both those living with infantile and late onset pompe they continue to add.

AD patients for multiple individuals as appropriate.

And with that let me hand, the call back over to Bradley to further discuss our launch preparations for <unk> Brad.

Bradley Campbell: Sorry about that. Thanks, Jeff. Just on slide 18, as Jeff mentioned, as we talk through our launch preparations for ATGA, we are poised for another successful product launch building on the success of our Galliford franchise. Although unlike when we launched Galliford... When we are hiring a commercial organization in support of infrastructure from scratch, we now have a presence in over 40 countries around the world, including all the major markets. And that team will be largely the same that will launch ATGAA, with only a small handful of new FTEs needed.

Sorry about that.

Thanks, Jeff just on slide 18, as Jeff mentioned as we talk through our launch preparations for Atg. We are poised for another successful product launch building on the success of our <unk> franchise, although unlike when we launch scalpel.

When we are hiring the commercial organization in support of infrastructure from scratch, we now have a presence in over 40 countries around the world.

Putting all of the major markets and that team will be largely the same that launch atg.

And with only a small handful of new ftes needed.

Bradley Campbell: We have experience across all areas that are needed for a successful drug launch, regulatory, commercial, supply chain, experience with payers, reimbursement, and access, in addition, and most importantly, key relationships with physicians and the medical community around the world. We're very confident in our world-class commercial organization, which we can leverage with their experience and relationships and deliver ATGA to people living with Pompe disease around the world. From the team, the medical education, the now published phase three data, and the highly regarded Lancet Neurology.

We have experienced across all areas that are needed for successful drug launch regulatory commercial supply chain experience with payers reimbursement and access in addition, and most importantly, the key relationships with physicians and medical community around the world.

We're very confident in our world class commercial organization that we can leverage with their experience and relationships and deliver atg to people living with pompe disease around the world.

From the team the medical education than our published phase III data in the highly regarded lancet neurology.

Bradley Campbell: Our experience and focus on reimbursement and access, and again, all the strategic planning that we're doing together with Building Inventory, with our partners at WuXi Biologics, we believe we're in a very strong position for a second rapid and successful launch. And with that, I'll turn the call now over to Daphne Queeney, our Chief Financial Officer, to review our financial results, guidance, and outlook.

<unk> and focus on reimbursement and access and again all the strategic planning that we're doing together with building inventory with our partners at Wuxi Biologics. We believe we're in very strong position for a second rapid and successful launch for amicus.

And with that let me turn the call now over to Daphne Queenie, our Chief Financial Officer to review, our financial results guidance and outlook.

Hey.

Daphne Quimi: Thank you, Bradley, and good morning, everyone. Our financial overview begins on slide 20 with an overview of our Q1 revenue performance and FX impact. For the first quarter, we achieved Galliford revenue of 78.7 million, which is a 19% increase over the same period in 2021. This includes year-over-year operational growth of 24% and a negative currency impact of 5%.

Thank you Bradley and good morning, everyone. Our financial overview begins on slide 20, with an overview of our Q1 revenue performance and FX impact.

Daphne Quimi: As Bradley highlighted, given 69% of Galliford revenue is generated outside the U.S., we see significant FX exposure to our reported revenue numbers. Applying average April 2022 exchange rates, the FX impact on 2022 full-year Galliford reported sales would be a negative impact of approximately 6% on our reported numbers for the whole year. Slide 21 outlines our income statement for the first quarter ending March 31, 2023. Cost of goods sold as a percentage of net sales was 10.4% in the year as compared to 10.2% for the prior year period.

For the first quarter, we achieved <unk> revenue of $78 7 million, which is a 19% increase over the same period in 2021.

This includes a year over year operational growth of 24% and a negative currency impact of 5%.

As Bradley highlighted given 69% of gallon sold revenue is generated outside the U S. We see significant FX exposure to our reported revenue numbers.

Applying average April 2022 exchange rate.

FX impact on 2022 full year Galliford reported sales would be a negative impact of approximately 6% to our reported numbers for the whole year.

Daphne Quimi: Total GAAP operating expenses were $146.5 million in the first quarter as compared to $112.9 million in the first quarter of 2021. The increase reflected expenses related to the reprioritization of the gene therapy portfolio, manufacturing and marketing costs to support the global launch of ATGAA, and increased stock compensation expenses. On a non-GAAP basis, total operating expenses were $109 million in the first quarter as compared to $90.5 million in the first quarter of 2021.

Slide 21 outlines our income statement for the first quarter ending March 31 2022.

Cost of goods sold as a percentage of net sales was 10, 4% in the year as compared to 10, 2% for the prior year period.

Total GAAP operating expenses were $146 5 million in the first quarter as compared to $112 9 million in the first quarter of 2021.

The increase reflected expenses related to the re prioritization of the gene therapy portfolio manufacturing and marketing costs to support the global launch of Atg, AA and increased stock compensation expense.

On a non-GAAP basis total operating expenses were $109 million in the first quarter as compared to $90 5 million in the first quarter of 2021.

Daphne Quimi: We define non-GAAP operating expenses as research and development and SG&A expenses, excluding share-based compensation expense, loss on impairment of assets, changes in fair value of contingent consideration, and depreciation. The net loss for the first quarter of 2022 was $85.3 million, or $0.30 per share, as compared to a net loss of $25.7 million, or $0.25 per share for the prior year period.

We define non-GAAP operating expense as research and development and SG&A expenses, excluding share based compensation expense loss on impairment of assets.

<unk> in fair value of contingent consideration and depreciation.

Net loss for the first quarter of 2022, with $85 3 million or <unk> 30 per share as compared to a net loss of $65 7 million or 25 cents per share for the prior year period as.

Daphne Quimi: As of March 31, 2022, we had approximately 280 million shares outstanding. This year, we expect total non-GAAP operating expense to be within the range of $470 million to $485 million, driven by continued investment in the Global Gallup Hold launch and ATGAA clinical studies and pre-launch activities. As we highlighted previously, this guidance also includes an approximate $70 million related to certain non-recurring costs for the manufacturing of ATGAA to support the global launch, as well as committed obligations, for the Gene Therapy Portfolio. Importantly, in 2023 and beyond, we would expect non-GAAP operating expense levels to decline to a similar level as in 2021.

As of March 31, 2022, we had approximately 280 million shares outstanding.

This year, we expect total non-GAAP operating expense to be within the range of 470 million to $485 million driven by continued investment in the global <unk> launch and a T J, a clinical studies and prelaunch activities.

As we highlighted previously this guidance also includes an approximate $70 million related to certain nonrecurring costs for the manufacturing at a T. G. A a to support the global launch as well as committed obligation.

For the gene therapy portfolio.

Importantly, in 2023 and beyond we would expect non-GAAP operating expense levels to decline to a similar level as in 2021.

Daphne Quimi: Turning now to slide 22, we continue to operate from a position of financial strength and remain on track to be self-sustainable without the need for any future dilutive financing and expect to achieve profitability in 2023, as defined in our presentation. We will focus the majority of our investments on our core value-driving franchises in Fabry disease and Pompe disease by continuing to deliver on the global growth of Gallup. Securing approval and launching ATGAA globally as well as driving efficiencies, cost savings, and careful Expense Management. Any comments about our cash position and 2022 financial guidance? Cash, Cash Equivalents, and Marketable Securities were $411.2 million at March 31, 2022, as compared to $482.5 million at December 31, 2020.

Turning now to slide 22, we continue to operate from a position of financial strength and remain on track to be self sustainable without the need for any future dilutive financing and expect to achieve profitability in 2023, as we defined in our press release.

We will focus the majority of our investments on our core value driving franchises in fabry disease, and pompe disease by continuing to deliver on the global growth of California's secure.

Securing approval and launching atg eight globally as well as driving efficiencies cost savings and careful expense management.

A few comments about our cash position in 2022 financial guidance cash cash equivalence and marketable securities were $411 2 million at March 31 2022.

As compared to $482 5 million at December 31, 2021.

Daphne Quimi: Our full year Galliford revenue guidance is $350 million to $365 million before any currency impact, in addition to our non-GAAP operating expense guidance of $470 million to $485 million. And with that, I will turn the call back over to John for closing remarks. Great, thank you Daphne and Jeff and Bradley as well. So, as you can see, we have been relentlessly focused on performance across the business, driven by our team of global entrepreneurs, passionate people who have led and will continue to lead us on our patient-focused mission. And with that operator, we're happy to take questions. Thank you. Ladies and gentlemen, if you have questions, please press star and then the number one key on your touchtone telephone.

Our full year Galiform revenue guidance is 350 million to 365 million before any currency impact. In addition to our non-GAAP operating expense guidance of 470 million to $485 million.

And with that let me turn the call back over to John for closing remark.

Great. Thank you Daphne and Jeff Bradley as well so as you can see we have been relentlessly focused on performance across the business driven by our team of global entrepreneurs passionate people, who have led and will continue to lead us on our patient focused mission and with that operator, we're happy to take questions.

Thank you.

Ladies and gentlemen, if you have questions. Please press star and then the number one key on your Touchtone telephone at this time, we ask that you only ask one question. If you have any additional questions. Please enter back into the queue.

Operator: At this time, we ask that you only ask one question. If you have any additional questions, please enter back into the queue. If your question has been answered or you wish to remove yourself from the queue, please press the pound key.

If your question has been answered or you wish to remove yourself from the queue. Please press the pound key thank you.

Operator: Thank you. Your first question comes from Ritu Baral from Cowen. Your line is now open.

Your first question comes from Marie <unk> from Cowen. Your line is now open.

Ritu Baral: Good morning, everyone. Thanks for taking the time to answer the question. John, since you mentioned that labeling discussions for ATGAA have already started, can you talk about the tenor of those discussions around the breadth of the label? And then, you know, as you're having those discussions overall, including on manufacturing, I guess. What's negotiable on that WUSHI inspection? Has there been prior inspection? So there are only elements, I guess, to focus on.

Good morning, everyone. Thanks for taking the question.

John since you mentioned that labeling discussions for <unk> have already started can you talk to the tenor the tenure.

Discussions around.

The breadth of the label and then as you.

We're having those discussions.

They're all <unk>.

On manufacturing I guess.

What what what is negotiable.

Wuxi inspection has had been prior inspections. So there's all the elements I guess.

John Crowley: Can you give us a little more clarity on that? Thanks. Sure, Ritu, good morning. Thank you. So I'll take both parts of those.

<unk> can you give us a little more clarity around that thanks.

Sure Ritu. Good morning. Thank you so I'll take both parts of those.

John Crowley: With respect to the label negotiations, obviously, we take it as a very good sign that we're moving through negotiations on the label and discussions with the FDA. I'm not going to talk about exactly what we're discussing with the FDA. But obviously, the things that we care about, so, for instance, making sure that we highlight the important data in the switch population and other matters.

With respect to the labeling negotiations obviously, we take it as a very good sign that we're moving through negotiations on the label and discussions with the FDA I'm not going to talk about.

Exactly what we're discussing with the FDA, obviously, the things that we care about.

So for instance, making sure that we highlight the important data in the switch population and other matters, we feel really good about the tone and tenor of those negotiations and we continue to believe that the label will support a launch that will provide access to people living with pompe disease that would be in.

John Crowley: We feel really good about the tone and tenor of those negotiations, and we continue to believe that the label will support a launch that will provide access to people living with Pompe disease that would be in patients' interests and also commercially very viable. But again, we think it's very good and have continued with the practice that we've had with the FDA of spirited discussions. And again, we're very confident in the approvability of ATGAA with the label that will support extraordinary success for patients and for the product commercially.

Patients' interest and also commercially very viable.

But again, we think it's a very.

Very good and continued with the practice that we've had with the FDA of the spirited discussions and again, we were very confident in the approved the ability of atg, a a with a label that will support extraordinary success for patients and for the product commercially with respect to manufacturing. The FDA has indicated all along.

John Crowley: With respect to manufacturing, the FDA has indicated all along that they're going to have to do an on-site inspection of the WuXi Biologics facility in WuXi City, China. We've completed with WuXi all of the preparatory work necessary to facilitate that inspection. We completed, for instance, in March, a mock inspection with our auditors internally that went very well.

Long that theyre going to have to do an onsite inspection of the Wuxi biologics facility in Wuxi City in China, We've completed with Wuxi all of the preparatory work necessary to facilitate that inspection. We've completed for instance in March a mock inspection with our auditors internally.

Very well, we continue to look at all options with the FDA around other ways in which they may conduct the inspection.

John Crowley: We continue to look at all options with the FDA around other ways in which they may conduct the inspection. And right now, we continue to expect that the FDUFA action date of July 29th would be something that would be able to be achieved in this timeframe. Great, thanks. Sure, Ritu

And right now we continue to.

Expect that piece to do for action date of July 29th would be something that would be able to be achieved in this timeframe.

Great. Thanks.

Sure Ritu. Thank you.

Operator: Thank you. Your next question comes from Anupam Rama of J.P. Morgan. You may now state your question. Hey guys, thanks so much for taking the time to answer my question. Maybe following up on Ritu's question here about the FDA review of the Wuxi facility in China, could you expand a little bit on the strategies that you're kind of exploring? You've previously talked about maybe FDA employees in the region helping to conduct the review, what other strategies are being employed here.

Your next question comes from Amit <unk> of J P. Morgan you May now state your question.

Hey, guys. Thanks, so much for taking the question.

Maybe following up on Rich's question here about the FDA review of the Wuxi facility in China could you expand a little bit on the strategies that you are kind of.

Exploring.

Previously talked about maybe FDA employees in the region, helping conduct.

The review what what other strategies are being employed here. Thanks, so much.

Operator: Sure, thanks. I won't comment on any ongoing discussions with the FDA. You're correct, Anupam, that the FDA does have FDA-designated employees in China. The Wuxi City facility is not currently under lockdown. A lot of the complexity here has to do with Shanghai itself. Again, to remind everybody, Wuxi is about three or four hours north of Shanghai.

Sure. Thanks, I won't comment on any ongoing discussions with the FDA, yeah, you're correct on a pump that the FDA does have FDA designated employees in China.

Bouchey City facility is not currently under locked down a lot of the complexity here has to deal with Shanghai itself again to remind everybody Wuxi is about three or four hours north.

Of Shanghai.

Anupam Rama: So we continue to expect that we will need a full on-site inspection by the FDA. That's what they've indicated to us. And we expect that that could be completed by the July 29th PDUFA deadline. In parallel, we are also evaluating all other options, remote interactive options, and other ways in which the inspection could be conducted, ways in which they've done it with other sponsors as well. So we're fully prepared for all potential contingencies. And, of course, Anupam, thank you. Our next question comes from Ellie Merle from UBS. Your line is open.

So we continue to expect that we will need a full onsite inspection by the FDA, that's what they've indicated to us and we expect that that could be completed by the July 29th to do for action date in parallel we are also evaluating all other options remote interactive.

Options in other ways in which the inspection could be conducted ways in which they have done it with other sponsors as well.

So we're fully prepared for all potential contingencies.

Thanks, so much for taking the question.

Now of course on upon thank you.

Our next question comes from Ellie Merle from UBS. Your line is open.

Operator: Hey guys, thanks for taking the question. Maybe just on sort of Pompeii launch preparation, maybe first, if you could give, you know, the latest color in terms of how the EAP is going in the UK and maybe any color in terms of uptake and physician feedback there. And then just thinking towards the U.S., maybe just if you could give some color on your expectations for uptake in patients that have already maybe started on Neo-GAA and how you're thinking about sort of uptake in the ERT switch patients as well as potentially, you know, switches from Neo-GAA and any initial thoughts there. Thanks. Sure. Thank you, Ellie. Good morning.

Hey, guys. Thanks for taking my question, maybe just on sort of Pompeii launch preparation, maybe first if you could give.

As color in terms of how the EAP.

Going in the U K and maybe any color in terms of uptake and physician feedback there and then just thinking towards the U S. Maybe just if you could give color on your expectations for uptake in patients that have already maybe started IV neo GAA and how youre thinking about sort of uptake in the ERP switch.

Patients as well as potentially you know.

Switches from Neo GAA and any initial thoughts there. Thanks.

Ellie Merle: Bradley, do you want to handle both of those on the EAMS and EAP as well as our launch expectations in the United States? Sure, John. Thanks, Ellie, for the questions. So first, expanded access, yeah, we've continued to provide expanded access through a number of mechanisms. Probably the most visible one or the most important one is EAMS at this point, which is the Early Access Medicine Scheme in the UK.

Sure. Thank you Ali Good morning, Bradley do you want to handle both of those on the yields in EAP as well as our launch expectations in the United States.

Sure. Thanks, John Thanks, Alex for the questions. So first fruit for expanded access yes, we've continued to.

Bradley Campbell: And that's important because both ATGA and NeoGA are available through that scheme, and what we've heard is very positive feedback about ATGA. We know that all of the key centers that prescribe Pompe medication have asked for and are now receiving EAMS, sorry, access to ATGA through the EAMS program. So that's, I think, really important to see how much support and excitement there is for ATGA through that program. We would expect that number to continue to climb.

Provide expanded access through a number of mechanisms probably the most.

Visible one of the most important one is aimed at this point, which is the early access medicine medicine scheme in the U K and that's important because both.

Atg and Doj are available through that scheme and what we've heard is very positive feedback towards towards atg, a we know that all of the key centers.

Prescribed pump medication have.

As for and are now receiving.

<unk>, sorry access to atg through the <unk> program.

I think really important to see how much support and excitement there is four atg through that program, we would expect that number to continue to climb.

Bradley Campbell: And it's the UK is actually a pretty significant Pompei market, and so we think that's a great opportunity for patients to get access to ATGA while the UK is reviewing the application, and obviously gives us a great view into how the community sees ATGA as a potential treatment for Pompei. And again, we have other mechanisms in other countries around the world as well where we see strong uptake, in the United States, to your point around, opportunities for uptake.

And it's the U K is actually a pretty significant pompeii market and so we think that's a great opportunity for patients to get access to atg.

While the UK is reviewing the application and obviously gives us a great view into how the community sees atg as a potential treatment for Pompeii and again, we have other mechanisms in other countries around the world as well, where we see strong uptake.

In the United States.

To your point around.

Bradley Campbell: For sure, we think the switch population, as we've noted all along, is the clearest unmet medical need. We are, as John alluded to, you know, continuing to negotiate what the indication would be for ATGA. But if you just focus on the two segments you talked about, experienced patients who are on my enzyme, and experienced patients who perhaps have gone to Neo GA. From our perspective, I think, you know, any Pompe patient who falls within the label would be indicated for APGA.

Opportunities for uptake for sure we think the switch population as we've noted all along is the clear unmet medical need.

We are as John alluded to continuing.

Continuing to negotiate what the indication would be for for Atg, but if you just focus on the two segments you talked about.

Experienced patients with who are on my assignment experienced patients, who perhaps have gone to Doj.

From our perspective I think.

Pompeii patient, who falls within the label would be indicated for <unk>. We believe that the data show that our product has significant improvements in particular in switch patients and would encourage folks to re familiarize themselves with the longer term data from the studies on EOG.

Bradley Campbell: We believe that the data show that our product has significant improvements, in particular in switch patients, and would encourage folks to re-familiarize themselves with the longer-term data from the studies on the OGA in the Phase I, II, and then the publicly available data in the Phase III to see how those... Patients perform over time, but we're very confident that ATJ can have utility in both of those populations, and we think the data are our friend there, and you'll see over time that we have the chance to be, we think, standard of care in all Pompe patients. Great, thanks. Your next question comes from Joe Schwartz from SVB Securities. Your line is now open. Hi everyone. This is Beth Feinscott on for Joe.

In the phase one two and then the publicly available data in the phase III to see how those.

Patients perform over time, but we're very confident that atg could have utility in both of those populations and we think the data are from there.

Youll see over time that we have the chance to be we think standard of care at all pompe patients.

Great. Thanks.

Your next question comes from Joe Schwartz from SBB Securities. Your line is now open.

Operator: I was just wondering if you could share any physician feedback you received on the 36-month data you presented at the MDA conference this year. And also, building on that, I believe you said you plan to have open-label extension data from the PROPEL trial later this year. We were just wondering if you'll be able to share that open-label extension data from PROPEL with regulators ahead of the approval decision. Thanks. Great. Thanks, Beth, and good morning.

Hi, everyone. This is best friend Scott on for Joe I was just wondering if you could share any physician feedback you've received on the 36 months data you presented at the MBA Conference. This year and also building off that I believe you said you plan to have open label extension data from that propel trial later this year.

We're just wondering if youll be able to share that open label extension data from that's helped propel with regulators ahead of.

The approval decision. Thanks.

Great. Thanks, Beth and good morning, Jeff do you want to take both of those on the physician feedback on the 36 month data that we shared at world as well as any color on the open label of propel study extension data.

Operator: Jeff, do you want to take both of those on the physician feedback on the 36-month data that we shared at World, as well as any color on the Open Label or Propel Study extension data? Sure, yeah, you know, one of the biggest unmet needs in Pompeii is really durability of treatment effect. I think that's something we see now in every study that's involved for a longer term, just for whatever reason, these patients show some potential initial mixed benefit, but then they generally tend to decrease longer term.

Sure. Yeah, you know one of the biggest unmet needs in Pompei is really durability of treatment effect I think that's something we've seen now in every study that's a bulk longer term just for whatever reason these patients show some potential initial mixed benefit but then they generally tend to decrease longer term and I think we've seen that now with multiple treatment.

Beth Feinscott: And I think we've seen that now with multiple treatments that the long-term data seems to show some weaning of effect. And I think what was really exciting about that phase one, two data that we just presented was, you know, after three years, those improvements we saw in those phase one, two patients have been maintained. And again, that was in switch patients and IU patients.

Is that the long term data seems to show some waning of effect and I think what was really exciting about that phase one two data that we just presented was after three years those improvements we saw in this phase one two patients has been maintained.

And again that was in switch patients naive patients.

Jeff Castelli: So we were excited by that data. You know, we got very good reception for that data as well. And then, yeah, this year we will continue to, you know, we have patients we've been following now in that phase one, two that are now on five plus years of treatment. So we'll have later data cuts even in that phase one, two population.

So we were excited by that data.

We've got very good reception to that data as well and then this year. We will continue to you know we have patients who have been following now in that phase. One two that are now after five plus years of treatment. So we will have later data cut even though of that phase one two population and in addition, we'll have a data cut from our ongoing propel extent.

Jeff Castelli: And in addition, we'll have data cuts from our ongoing Propel extension. You know, the patients after one year continuing on ITGA or that lumizyme arm that switched to ATGA, we'll have at least one year of data analysis. We don't have specific, you know, dates and conferences we can announce yet, but we do plan to have that data disclosed here this year. But we don't necessarily have obligations to include that data in the submissions in the U.S. or the EU.

And the patients after one year continuing on IQ G E. R. Loomis arm that switch the atg will have at least one year.

Those patients.

We don't have specific dates and conferences, we can announce yet, but we do plan to have that data disclosed here. This year, but we don't have necessarily obligations to include that data in the submissions in the U S or the EU at some point, we may add that longer term data, but for the initial review and approval, we don't need to add additional data.

Jeff Castelli: You know, at some point, we may add that longer-term data, but for the initial review and approval, we don't need to add additional data. Great. Thanks, Jeff. Thank you, Beth. Your next question comes from Kristen Kluska from Cantor Fitzgerald. Your line is now open. Hi. Good morning, everybody.

Yeah.

Great. Thanks, Jeff Thank you Beth.

Okay.

Your next question comes from Kristen <unk> from Cantor Fitzgerald. Your line is now open.

Operator: Thanks for taking my question. I wanted to ask, outside of all the additional findings that you've presented and published on ATGAA since the Propel readout, what else gives you confidence heading into this decision, but then also in the role that ATGAA could play in the market? So, for example, thoughts around the agency commentary on the unmet need for the EAMS, Next Viaduct Labels, and then also publications around the different endpoints. So, for example, I know in the past you really emphasized some of the newer work on FDC and the understanding around mortality risk.

Hi, good morning, everybody. Thanks for taking my question.

Ask outside of all of the additional findings that you presented and published on <unk> since the propel readout what else gives you confidence heading into this decision. But then also in the role that Atg eight had placed in the market. So for example around the agency commentary on the unmet need the aim <unk>.

The label and then also publications around the different endpoints. So for example, I know in the past you really emphasized some of the newer work on the FCC and the understanding around mortality risk.

Operator: Great. Thank you, Kristen. Good morning. And you actually made our job easier by highlighting a number of the different elements that we think will go into making this a differentiated medicine for people. Again, I'll just highlight that the Propel study was the largest study ever conducted in any lysosomal storage disease, and nearly 80% of the patients in that study had switched from the standard of care from myozyme to lumizyme.

Great. Thank you Christy and good morning, and actually made our job easier by highlighting a number of the different elements that we think will go into making this a differentiated.

A medicine for people.

Again I'll just highlight that this was the propel study was the largest study ever conducted in any license almost storage disease and nearly 80% of the patients in that study had switched from the standard of care from Myles I'm Lumens I'm, it's switched to atg AA and again, the vast majority of people who we see.

Operator: They switched to ATGAA, and again, the vast majority of people who we see taking ATGAA for the first number of years are going to be people who are currently on enzyme replacement therapy, whether that be myozyme or lumizyme or any of those who may already be switching to the Neo product, and we would expect and hope for a label to support that.

Taking a T G. A a for the first number of years there are going to be people, who are currently on enzyme replacement therapy, whether that'd be my assignment lunar zyme or any of those who may already be switching to the neo product and we would expect and hope for a label to support that so again the data that we have in that very large study.

Kristen Kluska: So again, the data that we have in that very large study, particularly in that switch patient population, again showing nominal statistical significance on the six-minute walk, on forced vital capacity, and virtually all secondary endpoints, you know, this is a very sophisticated patient community and physician scientist community, and they will be data-driven. So the look at the data from that study, and again, the look at the data that Jeff just talked about, the long-term durability data that we see from our phase 1, 2, and in the months ahead, the data that we'll show, we hope, with the long-term durability of patients in the PROPEL study.

Particularly in that switch patient population again, showing the nominal statistical significance on six minute walk and forced vital capacity in virtually all secondary endpoint.

This is a very sophisticated patient community and physician scientist community.

And they will be data driven to the look at the data from that study and again to look at the data that Jeff just talked to the long term durability data that we see from our phase one two and in the months ahead. The data that will show, we hope with the long term durability.

Kristen Kluska: So we think all of the data from all the clinical studies, together with the real-world experience of physicians, now with multiple uses in patients ranging from infants all the way through adults in the EAM study, we would expect, again, to Bradley's point, significant numbers of patients in the United Kingdom to switch from existing standard-of-care enzyme, from the approved myozyme, to ATGAA over the coming months and into 2023, as we then look to the full approval.

Patients in the propel study so we think all of the data from all the clinical studies together with the real world experience of physicians now with multiple uses in pace.

Patients ranging from infants all the way through adults in the emerge study, we would expect again to Bradley point significant numbers of patients in the United Kingdom to switch from existing standard of care enzyme from the approved <unk> two eight T. G. A a over the coming months and into 2023 as well.

John Crowley: So I think all of that builds the totality that's overwhelmingly, we think, positive for ATGAA and presents a very, very strong risk-benefit profile for physicians. We know doctors, and as we're engaged appropriately with physicians, the patient community is extremely excited for the potential option of ATGAA. So Jeff, I don't know if you've got any other comments to add. No, I think, John, you covered it well. It's really just that consistency of effect across parameters that we measured in patients that we treated, you know, all the different endpoints, across the key manifestations, either nominally significantly or numerically favored ATG over aglutosidase alpha.

And then look to the full approval. So I think all of that build that totality. That's overwhelmingly we think positive for atg, a a and presents a very very strong risk benefit profile for physicians, we know doctors and as were engaged appropriately with physicians patient community are extremely excited for that.

Potential option of Atg I E.

I don't know if you've got any other comments to add.

No I think John you covered it well, it's really just that consistency of effect across parameters that we measure it in patients that we treated all the different endpoints.

Across the key manifestations, either nominally significantly or numerically favored you know atg ever roundwood costs. It is often then cross naive patients experienced patients nonambulatory patients from phase one to patients with higher or lower baseline severities.

John Crowley: And then across naive patients, experienced patients, non-ambulatory patients from phase 1 to patients with higher or lower baseline severities, we've just seen a really consistent effect. And I think that that's really the key, that that consistency, you know, adds to the weight and the meaningfulness of this.

We're just seeing a really consistent in fact, and I think that that's really the key that that consistency.

Then to the weight and the meaningfulness of the treatment.

Jeff Castelli: Now it's an important point, Jeff, too, and again, Kristen. I'd probably summarize it by saying that when you look across all the data that we've had now more than six years of clinical research, to look at the magnitude, the consistency, and the durability of that data, we think it is particularly impressive and will bode very well. And again, this is a market where you had enzyme replacement sales last year, global revenue of over a billion dollars, and with increased diagnosis rates and the ability to affect and positively affect the lives of many people living with Pompeii and find many more new patients broadly for us and for others in the market.

No. It's an important point, Jeff too I'd and again, Christine I'd, probably summarize it that when you look across all the data that we've had and now more than six years of clinical research to look at the magnitude the consistency and the durability of that data. We think are particularly impressive and will bode very well and again. This is a market where you are.

You had enzyme replacement sale last year global revenue with one product.

Of over a $1 billion and with increased diagnosis rates and the ability to affect positively affect we hope the lives of many people living with pompe paying finding many more new patients broadly for us and for others in the market.

Jeff Castelli: We think this is a market with the potential for more than $2 billion in global revenue, and we think we have the potential for at least half of that by the end of this decade. So when you step back then and look at Amicus with Gallifold as the cornerstone of our success, where we are today and where we'll take it with the length of that intellectual property protection well into the 2030s, with a billion-dollar revenue potential for Gallifold, and with what we believe will be an approved product in Pompeii disease that we think has the potential to become the standard of care, or at least split the market with the existing entre That, combined with the financial strength of the Company, we think is pretty distinguished, particularly in this volatile market.

We think this is a market with the potential for more than $2 billion in global revenue and we think we have the potential for at least half of that by the end of this decade. So when you step back then and look at amicus with Gallo hold as the cornerstone of our success.

Where we are today and where we'll take it with the length of that intellectual property protection well into the 2000, <unk> with $1 billion revenue potential for <unk>.

With what we believe will be an approved product in pompe disease that we think has the potential to become the standard of care.

Or at least split the market with the existing entrenched at other competitor in the field. That's another potential billion dollar revenue product also with significant intellectual property protection, including composition of matter on Atg AA extending well into the 2030 is that combined with the financial strength of <unk>.

The company, we think is pretty distinguished, particularly in this volatile market.

Operator: Thank you, John. Thank you, Kristen. Our next question comes from Tse Gon Ha of CIFL.

Thank you. Thank you Kristen.

Our next question comes from I'd say Gon Ha of Stifel. You May now state your question.

Tse Gon Ha: You may now state your question. Hey, good morning, guys. Thanks for taking our question. On the labeling discussion, I was kind of curious, you know, in terms of differentiating ATGAA from NeoGAA, wondering if you could comment on whether FDA has asked for any additional data cuts. We've seen some of that happen recently, and perhaps that could accentuate some of the profiles that you were just alluding to.

Hey, good morning, guys. Thanks for taking our question on the labeling discussions I'm kind of curious.

In terms of differentiating our atg a from Neogaf wondering if you can comment on whether FDA has asked for any additional data cuts we've seen some of that happened recently.

Perhaps I could accentuate some of the profiles that you were just alluding to thank you very much.

John Crowley: Thank you very much. Yeah, thanks Degan. They've not asked for any additional data cuts. We have supplied them with all the data. So, for instance, they've seen the 36-month data from the Phase 1-2 study, but they haven't asked, for instance, in the PROPEL study for any additional data cuts.

Yeah. Thanks, they've got they've not asked for any additional data cuts we have supplied them with all the data and so for instance, they've seen the 36 month data.

From the phase one two study, but they've not asked for instance for the propel study for any additional data cuts.

Operator: Thank you. Your next question comes from Salveen Richter of Goldman Sachs. Your line is now open. Hey guys, thanks for taking the question. This is Elizabeth on behalf of Salveen.

Thank you.

Thank you.

Your next question comes from <unk> Richter of Goldman Goldman Sachs. Your line is now open.

Hey, guys. Thanks for taking the question. This is Elizabeth <unk> for Zalviso maybe.

Elizabeth: Maybe going back to some of the initial questions. You know, how do you expect to message around the WUJI inspection, and should we expect you guys to communicate when that takes place on the street? And then maybe you could just remind us of what we should expect to learn from the first FDA review date. Thank you. Sure, let me take that first part again to be perfectly clear, and we've had this discussion with the agency. We expect no action on May 29th from the agency, and we expect both the NDA and the BLA.

Maybe going back to some of the initial questions.

How how do you expect to message around the Wuxi inspection and should we expect you guys to communicate when that takes place to the street and then maybe you could just remind us of what we should expect to learn from that the first.

FCA review date, thank you.

Sure let me take that first part again to be perfectly clear and we've had this discussion with the agency. We expect no action on May 29th from the agency and we expect both the NDA and the BLA. We expect action by July 29th which of course, we hope to be approval with respect to look theres a lot of.

John Crowley: We expect action by July 29th, which, of course, we hope will be approval. With respect to, look, there's a lot of activities going on right now with labeling discussions, all of our internal launch preparations, but in addition, of course, the important final CMC parts. Important to note that this has, we've had tremendous manufacturing history here with WUSHI, and we think that bodes quite well, and we've been very successful in all of our discussions, and much of the focus in the BLA review has been on the CMC section, which we fully expected, you know, dozens and dozens of information requests from the agency going all the way back to September into the early part of this year. We believe we've satisfied Again, in a lot of different ways, we think that could be satisfied.

Activities going on right now with labeling discussion all of our internal launch preparations.

But in addition of course the important final CMC parts important to note that this as well.

We've had tremendous manufacturing history here with Wuxi, and we think that bodes quite well and we've been very successful in all of our discussions and much of the focus in the at the BLA review has been on the CMC section, which we fully expect it.

Dozens and dozens of information requests from the agency going all the way back to September into the early part of this year. We believe we have satisfied the fda's questions.

With respect to the CMC section and we do have this.

Important Wuxi inspection again, a lot of different ways, we think that could be satisfied we're to the point now were not going to be providing the street with.

John Crowley: We're to the point now that we're not going to be providing the street with, you know, I mean, literally daily or week to week, we have our exchanges with the agency. We're not going to provide the blow by blow, including updates on manufacturing inspections. You know, when did that take place?

I mean literally daily or week to week, we're having our exchanges with the agency, we're not going to provide the blow by blow including updates on manufacturing inspections. When did it take place when is it scheduled how did it go what did they ask we're not going to provide that color. We're now into the final stretches coming up to the July 29th Paducah date, So continue to.

John Crowley: When is it scheduled? How did it go? What did they ask? We're not going to provide that color.

Operator: We're now into the final stretches, coming up to the July 29th PDUFA date. So continue to expect the medicine to be approved by that date, and obviously, if there are any changes to that, we would provide that update to the street. But again, we remain very, very confident in the approvability of ATGAA and are fully prepared for the launch in the United States, and again, we're in active discussions with the EMA on the MAA and expect the CHMP opinion before the end of the year, with launch in Europe in 2023. Great, thanks for the color.

Spec the medicine to be approved by the Paducah date, and obviously if there are any changes to that we would provide that update to the street, but again, we remain very very competent and you prove ability of atg I Eh and are fully prepared for the for the launch in the United States and again, we're in active discussions with the EMA on the MAA and expect.

C H M P opinion.

For the end of the year with launch in Europe in 2023.

Great. Thanks for the color.

Great. Thank you Elizabeth.

Yun Zong: Great. Thank you, Elizabeth. Your next question comes from Yun Zong of BTIG. Your line is now open. Hi, good morning. Thanks very much for taking the questions. Can you remind us the size of the sales force that you have in the U.S. and in Europe?

Your next question comes from UN Zhong of BPH. Your line is now open.

Hi, good morning, Thanks, very much for taking the questions.

Can you remind us the size of the sales force that you have in the U S and Europe did.

John Crowley: Did you or do you plan to increase the size in preparation for the ATGA launch? And also, given that it's still an IV infusion, not like the oral for Gallifo, do you expect that you still have to face some type of COVID-related challenges when you launch ATGA? Yeah, sure. Bradley, I'll go ahead and take that over to you, particularly to highlight the operating leverage that we have at Amicus. Yeah, thanks

Did you or do you plan to increase the size in preparation for the Atg launch and also given that it's still an IV infusion not like the world for California.

Do you expect that you have to have to face some type of a co.

Covid related challenges when you launch atg.

Yeah sure Bradley I'll go ahead and take that over to you, particularly to highlight the operating leverage that we have at amicus.

John Crowley: So just as a reminder, what we've characterized is we have about 100, and Mara Roth, Chief Tools Officer, perhaps less than a dozen SBEs globally to support the launch, primarily in direct marketing, direct medical, and then in the United States, some market access folks in particular in support of our patient assistance hub. So, highly leverageable organization to be able to support the launch of ATGA. In terms of your second question, as relates to COVID impacting the uptake of ATGA, at this point, based on what we know from the Gallup poll, and based on where we see the global markets evolving, we don't expect any significant impact on ATGA uptake.

Yes, Thanks John .

So just as a reminder, what we characterize as we have about 100.

50 global field personnel between sales medical market access et cetera that.

That organization is.

Secondly, the organization will use to launch Atg Ace, we get significant leverage out of the Gulf old commercial organization commercial and medical organization I should say, what we've said is we would intend to add.

Perhaps less than a dozen fte's globally to support the launch primarily in direct marketing direct medical and then in the United States. Some market market access folks in particular in support of our patient assistance hub.

So highly Levered Leverages Bowl.

Organizationally to be able to support the launch of Atg.

In terms of your second question as it relates to Covid impacting the uptake of a P. J at this point based on what we know from Gallup poll based on where we see the global market's evolving we don't expect any significant impact on.

Atg uptake of course, we'll continue to monitor that but I think the trends. We're seeing now gives us good confidence that we're moving into a place where we're patient care is largely.

John Crowley: Of course, we'll continue to monitor that, but I think the trends we're seeing now give us good confidence that we're moving into a place where patient care is largely able to move forward, perhaps in a slightly evolved way, perhaps more hybrid interactions between our field force and physicians. But at this point, we don't see any significant impact by COVID on our ATGA launch.

To move forward, perhaps in a slightly evolved way, perhaps more hybrid interactions between our field force and positions, but at this point, we don't see significant impact by Covid.

On our ATCA launch.

Great. Thank you.

Operator: Great, thank you. At this time, I would now like to turn the conference back to Mr. John Crawley, Chairman and CEO, for closing remarks. Great, thank you, operator. Thank you, everybody, for listening and for the great questions. As you can see, we're sharply focused on all of these strategic priorities for Gallup-OLD, ATGAA, our pipeline, and the financial strength of the company.

At this time I would now to turn the conference back to Mr. John <unk>, Chairman and CEO for closing remarks.

Great. Thank you operator, thank you everybody for listening for the great questions. As you can see we're sharply focused on all of these strategic priorities for Gallup old Atg AA.

Our pipeline and the financial strength of the company. So we will continue to press on onward. Thank you and have a great day.

John Crowley: So we will continue to press on, onward. Thank you. Have a great day. This concludes today's conference call. Thank you, and have a great day! [music]

This concludes today's conference call. Thank you and have a great day.

Okay.

Okay.

Okay.

Yes.

[music].

Okay.

Thanks.

Sure.

Uh huh.

Yes.

[music].