Q2 2022 Amicus Therapeutics Inc Earnings Call

Good morning, ladies and gentlemen, and welcome to the advocate Therapeutics second quarter 2022 financial results conference call and webcast.

Good morning, ladies and gentlemen, and welcome to the Amicus Therapeutics second quarter 2022 financial results conference call and webcast.

At this time, all participants are in a listen-only mode.

At this time all participants are in a listen only mode. Later, we will conduct a question and answer session and instructions will follow at that time.

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As a reminder, this call is being recorded.

As a reminder, this call is being recorded I would now.

Like to turn the conference over to your host Mr. Andrew Farthing Executive director of Investor Relations. Please go ahead.

I would now like to turn the conference over to your host, Mr. Andrew Faughnan, Executive Director of Investor Relations.

Please go ahead.

Thank you Paul Good morning, Thank you for joining our conference call to discuss amicus Therapeutics second quarter 2022 financial results and corporate highlights.

Thank you, Cole.

In today's call, we have Bradley Campbell, President and Chief Executive Officer, Cathy <unk>, Chief Financial Officer, Sebastien, Martel, Chief business Officer, and Dr. Jeff Castelli, Chief Development Officer, joining for Q&A, Dr. Mitchell bolt.

Good morning.

As referenced on slide two we may make forward looking statements within the meaning of the private Securities Litigation Reform Act 1995 relating to our business as well as our plans and prospects are forward looking statements should not be regarded as representation by us that any of our plans will be achieved.

All the forward looking statements made on this call may turn out to be wrong and can be affected by inaccurate assumptions, we might make or by known or unknown risks and uncertainties. You are cautioned not to place undue reliance on any forward looking statements, which speak only to the date hereof. All forward looking statements are qualified in their entirety by this cautionary statement and we under takes no obligation.

To revise or update this presentation and conference call.

To reflect events or circumstances. After the date hereof for a full discussion of such forward looking statements and the risks and uncertainties that may impact them. We refer you to the forward looking statements and risk factors section of our annual report on Form 10-K, and on our quarterly report Form 10-Q for the quarter ended June 32022 and installed.

Thank you for joining our conference call to, discuss Amicus Therapeutics second quarter 2022 financial results and corporate highlights.

Later today with the Securities and Exchange Commission at this time. It is my pleasure to turn the call over to Bradley Campbell, President and Chief Executive Officer, Brian .

Leading today's call, we have Bradley Campbell, President and Chief Executive Officer, Daphne Quimi, Chief Financial Officer, Sbastien Martel, Chief Business Officer, and Dr. Jeff Castelli, Chief Development Officer.

Great. Thank you Andrew and welcome everyone to our second quarter 2022 results conference call before we dive into the results of the quarter I'd just like to start with a deep. Thank you to John Crowley as planned after 17, great years, leading amikacin is our founding CEO , Jonathan officially assumed the role of executive chairman of amicus for two years.

Joining for Q&A is Dr. Mitchell Goldman.

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.

Term after which he is expected to continue as the nonexecutive chairman of the board.

It has been an honor working alongside him for 16 of those years and it's been through his leadership and unwavering commitment to all of those living with rare diseases that amicus has been such a great position today.

Now to assume the role of President and CEO and very excited about the opportunities that lie ahead amicus has strong business fundamentals.

And a positive momentum to build on.

We are poised now for the next chapter of our growth as we seek to get our second medicine approved and launched around the world.

Firmly believe that we have the right people and the right assets to deliver on our mission to continue to bring great medicines to people living with rare diseases and create great value for our shareholders.

Building on our commitment to patients leadership at rare diseases and global operating platform I am confident that we can achieve those two objectives.

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

With that let me get started on today's update.

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.

I'm pleased to highlight the successful first half of the year across our business.

For a full discussion of such forward-looking statements and the risks and uncertainties that may impact them, we refer you to the forward-looking statements and risk factors section of our annual report on Form 10-K and on our quarterly report Form 10-Q for the quarter ended June 30, 2022, to be filed later today with the Securities and Exchange Commission.

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

At this time, it is my pleasure to turn the call over to Bradley Campbell, President and Chief Executive Officer.

First <unk> continues its strong performance and remains the cornerstone of our success. We continue to be very pleased with the uptake of <unk> globally. Despite the significant foreign currency headwinds that faced our industry. This year.

Brad?

Great.

Thank you, Andrew, and welcome, everyone, to our second quarter 2022 results conference call.

Before we dive into the results of the quarter, I'd just like to start with a deep thank you to, John Crowley. As planned, after 17 great years leading Amicus as our founding CEO, John has officially assumed the role of Executive Chairman of Amicus for a two-year term, after which, he is expected to continue as the non-executive chairman of the board.

It has been an honor working alongside him for 16 of those years, and it's been through his leadership and unwavering commitment to all of those living with rare diseases that Amicus is in such a great position today.

I'm honored now to assume the role of President and CEO and very excited about the opportunities that lie ahead.

The first half of the year represented 11% reported revenue growth or 18% and an operational revenue growth basis.

In the second quarter operationally our growth in key performance indicators are meeting or exceeding our objectives in all key geographies and we are reiterating our guidance at constant exchange rates Sebastian Martell, Our chief business Officer will provide further detail later in the call.

We're also excited to announce that the <unk> intellectual property estate continues to grow this quarter.

This year alone we have strengthened our IP estate through the issuance of 17 new patents.

There are now 44 Orange book listed issued patents related to <unk> in the United States 28 of which provide protection to 2038 and beyond and importantly includes three newly issued composition of matter patents, bringing the total amount to four we see this patent portfolio along with our orphan drug exclusivity is providing broad.

And long term intellectual property rights well into the late 2030 for this novel precision Medicine, and importantly, we believe we are well positioned to address any potential generic challenges to our patents.

Looking ahead, we expect continued growth for <unk> this year and with a strengthened protection continue to believe it has a long runway well into the next decade.

Second we continue to make progress on our global regulatory filings for <unk>. Our novel next generation therapy for Pompe disease.

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

Clearly all eyes are on the FDA inspection at the Wuxi Biologics facility for ATB 200, the biologic component of a PGA we remain in active dialogue with the agency on how best to support an inspection and we along with our colleagues at Wuxi are fully ready to welcome FAA inspectors to the Wuxi facility in China.

However, as of today, they have not yet conducted their inspection and if the FDA inspection does not take place in the appropriate time, it goes without saying that it could impact the timing of approval that being said the good news is we are in late stage label discussions and are highly confident in <unk> potential approval in the United States.

And at this time, we continue to expect that the two components of ATCA will be approved together by the October 29th action dates.

Importantly in Europe , we're now actively engaged with the EMA on the marketing authorization applications for <unk>. We continue to expect a positive <unk> opinion later this year and commercial launch in early 2023 and.

And as a reminder, the EMA has indicated it does not require an inspection of the Wuxi manufacturing site as a condition of their approval.

I'm also extremely pleased today with the level of interest we're seeing in our expanded access programs globally today.

Today, we announced the first reimbursed access to Atg has been granted in France under their compassionate access program, which was formerly known as the unaudited <unk> program.

Additional access programs are in place in the United States, United Kingdom, Germany, and Japan, with a growing number of patients participating in each.

Across all of our ongoing clinical studies and access programs. There are now more than 175 patients on <unk> today, which we believe represents 5% or more of the total treated pompeii patients around the world.

Our global launch plans continue to move ahead, including prelaunch activities targeted investments in additional personnel to support the launch significant investments in the launch and inventory preparations.

We are now closer to having another potential treatment option for pump for patients living with Pompe disease, both in the United States and Europe .

With further regulatory applications planned in the months ahead.

Amicus has strong business fundamentals and a positive momentum to build on.

Third importantly, amicus has maintained a strong financial position it remains committed to achieving profitability in 2023, as we continued to execute on the global expansion of <unk> and prepare for the global launch of <unk>.

We are rapidly approaching two pivotal inflection points for amicus first the global launch of a second rare disease medicine with Atg AA and second achieving profitability. These are rare feats that we believe will enable amicus to truly enter the upper echelon of rare disease focused biotechnology companies.

We are poised now for the next chapter of our growth as we seek to get our second medicine approved and launched around the world.

I will emphasize that we are sharply focused on three key objectives.

I firmly believe that we have the right people and the right assets to deliver on our mission to continue to bring great medicines to people living with rare diseases and create great value for our shareholders. Building on our commitment to patients, leadership of rare diseases, and global operating platform, I am confident that we can achieve those two objectives.

Continuing to advance <unk> to as many patients in as many geographies the geographies as possible securing approvals for and launching a PGA globally and ensuring the financial strength of amicus.

On slide five we see we're well on our way now towards achieving our key strategic priorities for this year, including continuing to drive <unk> to more people living with fabry with the medical variance in existing and in 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.

With that, let me get started on today's, I'm pleased to highlight the successful first half of the year across our business.

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

We remain steadfast in our commitment to advancing ATCA regulatory filings and initiating the anticipated launch of <unk> in the United States.

Leveraging our season global commercial team an experienced across all areas needed for an effective drug launch we are fully prepared and anticipate a very successful launch for AC GAA.

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

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

With that overview, let me now hand, the call over to Sebastian Martell, Our Chief business Officer, who can further highlights the Gulf will performance.

And as we did in this morning's press release, let me highlight several key accomplishments.

Sure.

First, Galliford continues its strong performance and remains the cornerstone of our success.

Thank you, Brian and good morning to everyone on the call.

We continue to be very pleased with the uptake of Galliford globally, despite the significant foreign currency headwinds that faced our industry this year. The first half of the year represented 11% reported revenue growth, or 18% on an operational revenue growth basis.

Sounds like providing you with more details on <unk> performance for the quarter.

In the second quarter, operationally, our growth and key performance indicators are meeting or exceeding our objectives, in all key geographies, and we are reiterating our guidance at constant exchange rates.

Slide seven as you can see for the second quarter of 2022 total product revenue reached $87 million driven by strong patient accruals, partially offset by foreign currency impact is what is the timing of orders in certain ex U S markets.

Sbastien Martel, our Chief Business Officer, will provide further detail later in the call.

Geographic breakdown.

Revenue during the quarter consisted of $53 million or 66% of revenue generated outside of the U S.

And the remaining $28 million or 34% coming from within the U S. This is roughly in line with the 70 30 that we expect as we continue to grow both parts of the business.

Turning to slide eight.

Our results in the first half of the year like the strength of our global commercial efforts. The business continues to be credit your resilience with patients in all major markets and an operational growth rate of 17% over the first half of 2021 at constant exchange rates.

The negative impact from foreign currencies was six 9% in the first half of the year.

And as a result, Jennifer reported revenue growth was 10, 9% in the first cycle of 2022.

Just to add a bit of color on our geographical performance in the first half of the euro sales in the U S grew 16, 1% a tier one are ex U S sales grew 18, 5% or.

So organic will continues to be the fastest growing product for fabry disease globally.

That's been the greatest contributor to global Fabry market growth over the past 12 months.

I'm pleased to report our monthly net patient trends continued to show positive signals. So for example.

Three months trend is higher than that six months, which is itself higher than the 12 months and.

In the U S. In June we also delivered the highest number of net new patients and Prs.

April of 2021.

And if you look at the growth in net patients who've got a fall on a global basis, which is perhaps the truest measure of art.

Underlying business performance, we see greater than 19% growth in patients who've got a fourth at the end of Q2 this year versus the same period.

Last year.

So all indications are the continued demand for <unk>.

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

And while the global mix remains about 55% switch on 45% naive in.

In many many geographies, we're starting to see stronger uptake in naive populations.

So while we're achieving high market shares in countries, where we have been approved the longest theres still plenty of opportunity to continue to switch patients over to <unk>.

Continue to grow the market as we penetrate into the diagnosed untreated segments and the newly during those segments.

All of that is underpinned by impressive compliance and viewers rates continue to exceed 90% reiterating our belief that these patients who couldnt get a food generally stay on chemicals.

We did experience some impact due to the timing of orders in the second quarter.

And we expect this nonlinear quantity growth to continue.

But certain led to a handful of orders being recognized in the beginning of the third quarter.

Importantly, the value of Canaccord continues to be recognized by payers as we have a very strong track record of successfully negotiating and renegotiating reimbursement outside of the U S.

Our relentless focus remains on ensuring exit to get a hold for any one quarter.

Is it.

Next on slide nine, which we've seen so far this year gasoline uptake continues to track very well and we're seeing growth across all our major markets as well as most of our smaller markets.

I'm trying to achieve full year revenue guidance of 15% to 20% growth at constant exchange rates.

First half growth of 17, 8%.

At CER is right in the middle of that range. So altogether, we view this as a great first half of the year.

Moving to slide 10.

We know that Jennifer.

Essentially to surpass 500 million nominal revenue over the next few years through three key growth drivers first continuing to penetrate into existing markets second expanding into new geographies and thirds broadening the labels.

I'm pleased to share that we're making continued progress on expanding into new markets and just to name a few examples we expect marketing authorization in Turkey. This year.

<unk> in the second quarter in Hong Kong.

And in Chile, we are in pricing and reimbursement discussions.

And the longer term, we continue to see significant growth in the overall fabry market globally. This will be 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.

As well.

And finally, we have orphan exclusivity in the U S and Europe . In addition to our now 44 Orange book listed patents that gives us IP coverage into the late 2013.

We are also excited to announce that the Galliford Intellectual Property Estate continues to grow this quarter. This year alone, we have strengthened our IP estate through the issuance of 17 new patents. There are now 44 Orange Book listed issued patents related to Galliford in the United States, 28 of which provide protection to 2038 and beyond, and importantly include three newly issued Composition of Matter patents, bringing the total now to four. We see this patent portfolio, along with our orphan drug exclusivities, providing broad and long-term intellectual property rights well into the late 2030s for this novel precision medicine. And importantly, we believe we are well-positioned to address any potential generic challenges to our patents.

28 of which for my protection through 2038.

And that includes three new composition of matter patents. So this gives us opportunity to provide access to <unk> globally for a long time to come.

Looking ahead, we expect continued growth for Galliford this year, and with this strengthened IP protection, continue to believe it has a long runway well into the next decade.

Second, we continue to make progress on our global regulatory filings for APGAA, our novel next-generation therapy for Pompe disease. The U.S. and EU regulatory reviews are progressing very well, and we're very pleased with the level of engagement from both regulatory agencies.

Clearly, all eyes are on the FDA inspection at the WUSHI Biologics Facility for APB 200, the biologic component of APGAA. We remain in active dialogue with the agency on how best to support an inspection, and we, along with our colleagues at WUSHI, are fully ready to welcome FDA inspectors to the WUSHI facility in China.

On slide 11.

However, as of today, they have not yet conducted their inspection, and if the FDA inspection does not take place in the appropriate time, it goes without saying that it could impact the timing of approval.

That being said, the good news is we are in late-stage label discussions, and are highly confident in APGAA's potential approval in the United States, and at this time, we continue to expect that the two components of APGAA will be approved together by the October 29th action date.

Shifting gears.

Provide you here with Dave.

Importantly, in Europe, we're now actively engaged with the EMA on the marketing authorization applications for APGAA. We continue to expect a positive CHMP opinion later this year and commercial launch in early 2023, and as a reminder, the EMA has indicated it does not require an inspection of the WUSHI manufacturing site as a condition of their approval.

Launch preparations for <unk>.

We are poised for another successful product launch.

So unlike when we launched <unk>.

And at the time, we were hiring and building the commercial infrastructure from scratch.

I have a presence in over 40 countries around the world, including all the major markets that team will be largely the same.

That will launch a cta with only a handful of new achieve needed for example, take vendors' Pls.

Experienced across all areas that are needed for successful drug launch from regulatory to commercial supply chain experience with payers reimbursement and access.

And in addition, and maybe most importantly with key relationships with physicians.

And our World class commercial organization.

We will leverage their experience and relationships.

And deliver ATCA to people living with Pompe disease around the world.

From the team the medical education with published Phase III data in the highly regarded lancet neurology journals.

<unk> with reimbursement and access around the world and again all of the strategic planning that we're doing together.

And together with our partners at Wuxi Biologics, we believe we're in a very strong position.

Second the successful launch of amicus.

With that let me now hand, the call over to the project capacity, our Chief Development Officer.

Our <unk> program.

Okay.

Yes.

Thank you Sebastian and good morning, everyone.

Moving on to Slide 13, we will start with our <unk> program.

We recognize that pompe disease poses a range of health challenges for people affected by the disease and having therapeutic options as crystal is crucial pump.

Pompei is a severe and fatal neuromuscular disease and one of the most prevalent lysosomal disorders.

Announcing multiple publications and natural history studies highlight the initial benefit of treatment often being followed by continued long term decline on key measures of disease for many individuals.

Slide 14 presents a summary of the primary and key secondary endpoints from our phase III study.

As a reminder.

Brian randomized study addressing and assessing the efficacy and safety of <unk> in adult treatment naive and <unk> experienced participants with late onset Pompe disease R. L. L PD.

Against the approved therapy <unk> Alpha propel.

Propel is the only controlled clinical trial to date that included the CRT experienced patient set which represents one of the greatest groups of patients with unmet needs.

Endpoints across motor function muscle strength pulmonary function and patient reported outcomes and key biomarkers.

Including the two most recognized endpoints in Pompeii six minute walk distance and forced vital capacity.

So in here on the slide favorite Atg over Abu <unk> Alfa in the overall population.

We believe this consistency of effect across the key disease manifestations illustrates the potential impact of <unk> for patients living with Pompe.

Additionally, in the ear to experience population, where 95 participants were on the standard of care for more than seven and a half years on average.

Which is generally associated with the decline phase of disease for most patients. We actually saw an increase in six minute walk distance and stabilization of SEC, which both achieved nominal statistical superiority versus the current treatment and showed a clinically meaningful outcome never before seen in this population.

Moving on to slide 15.

Adding to the overall body of data behind ATCA at the 2022, MDA clinical and scientific conference earlier. This year. The amicus team presented positive long term data from the phase one two study of <unk>.

I've seen here on the side the latest data continue to represent very meaningful and durable improvements in functional outcomes as well as persistent reductions in key biomarkers of muscle damage in disease substrate. After three years.

These results have been shared with the regulatory authorities in the U S and EU as part of their ongoing reviews.

Compared but comparing these results with what is known about the natural history of both untreated and <unk> experienced pumping patients. These durable results give great hope that <unk>. Indeed has the potential to become the new global standard of care for people living with Pompe disease.

On slide 16, we've highlighted key updates on the <unk> program.

First on the regulatory progress last year in the U S. FDA accepted for review of the BLA for cyclical cost today's alpha and the NDA from Nicholas that the two components of <unk>.

It may the agency extended the Paducah action dates to August 29, because the NDA in October 29, 2022 for the BLA.

As Brian mentioned, we expect these filings will be approved together by the October 29th action date.

Dependent again on the ability for <unk> to conduct an inspection at the Wuxi manufacturing facility.

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

<unk> opinion is expected later this year of note. The EMA has indicated in writing that based on the extensive and prior manufacturing inspections of the Wuxi facility.

An inspection is not required for <unk> approval in Europe .

We know third we now have multiple expanded access programs in place, including in the U S U K, Germany, France, Japan and others. This includes the <unk> framework that we announced in which 80 Jay was granted a positive scientific opinion through the early access to medicine scheme by the Uk's NHRA.

I'm also extremely pleased today with the level of interest we are seeing in our expanded access programs globally. Today, we announced the first reimbursed access to APGAA has been granted in France, under their Compassionate Access Program, which was formerly known as the non-ATU program. Additional access programs are in place in the United States, United Kingdom, Germany, and Japan, with a growing number of patients participating in each.

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

And permits eligible adults living with <unk>, who have received <unk> Alfa for at least two years to switch to <unk> granting access prior to marketing authorization in the U K.

As Bradley mentioned, we're seeing significant enthusiasm for <unk> under the <unk> mechanism with multiple physicians now having requested access across all the leading pumping centers in the U K and dozens of patients now receiving this novel two component of treatment.

Since the positive scientific opinion interest and momentum for Atg has grown and we are pleased to be able to provide access to those who are eligible in the U K.

And France is Brad also noted the National agency for medicines and health products safety granted the first reimbursed access to ATCA under their compassionate access program, formerly known as the nominative ATM program.

With this growth in our access programs. We're pleased to report that now more than 175 patients worldwide are being treated with <unk> across our clinical extension studies and our expanded access programs and we expect that to continue to grow.

Across all of our ongoing clinical studies and access programs, there are now more than, 175 patients on ATGA today, which we believe represents 5% or more of the total treated, Pompe patients around the world.

Our global launch plans continue to move ahead, including pre-launch activities, target investments, and additional personnel to support the launch, significant investments in the launch and inventory preparations.

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

For the younger pumping community, we continue to enroll the ongoing open label study in children up to 18 years of age living with low PD and expect to expand in the patients with infantile onset pompe disease or Io PB later this year.

And third, 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 GALFOLD and prepare for the global launch of ATGA.

We are rapidly approaching two pivotal inflection points for Amicus. First, the global launch of a second rare disease medicine with ATGA, and second, achieving, profitability.

These are rare feats that we believe will enable Amicus to truly enter the upper echelon, of rare disease-focused biotechnology companies.

I'll emphasize that we are sharply focused on three key objectives, continuing to advance, GALFOLD to as many patients in as many geographies as possible, securing approvals for and launching, ATGA globally, and ensuring the financial strength of Amicus.

Importantly in response to the many request for treatment that we continue to receive for children living with low PD in IOP D. Our expanded access programs continued to increase.

On slide five, we see we're well on our way now towards achieving our key strategic priorities, for this year, including continuing to drive GALFOLD to more people living with Fabre with amenable variants in existing and in new markets.

On slide 17.

We just announced today an early stage program to explore next generation pharmacological chaperones for Fabry disease.

Academic research collaboration agreement with the University of Seville.

This new collaboration will search for innovative small molecules with optimal activity and pharmacokinetic properties.

Driven by both the science and the needs of people living with Fabry, we will be reviewing fabric compounds based on several attributes, including potency number of addressable amenable mutations and dosing of note. The agreement costs at this point, a very modest and we do not expect our fiscal year operating and will not impact our fiscal year operating expense guidance.

With that I would like to now turn the call over to Dominic <unk>, Our Chief Financial Officer to review, our financial results guidance and outlook Daphne.

We look to achieve double-digit global product revenue growth at 15 to 20 percent, with revenue, of $350 million to $365 million in cost and exchange rates.

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

Thank you, Jeff and good morning, everyone. Our financial overview begins on slide 19, with an overview of our second quarter revenue performance and impact of foreign currency exchange rates for the <unk>.

We remain steadfast in our commitment to advancing ATGA regulatory filings and initiating the, anticipated launch of ATGA in the United States, leveraging our seasoned global commercial team and experience across all areas needed for an effective drug launch.

We are fully prepared and anticipate a very successful launch for ATGA.

We are strategically advancing our best-in-class next-generation genetic medicines and capabilities, and again, we will continue to maintain a strong financial position as we carefully manage our expenses and investments going forward.

With that overview, let me now hand the call over to Sébastien Martel, our Chief Business, Officer, who can further highlight the GALFOLD performance.

Sébastien?

Second quarter, we achieved <unk> revenue of $87 million, which is a four 3% increase over the same period in 2021.

Thank you, Bradley, and good morning to everyone on the call.

I'll start by providing you with more details on our GALFOLD performance for the quarter.

This includes operational revenue growth of 12, 9% offset by a negative currency impact of eight 6%.

On slide 7, as you can see, for the second quarter of 2022, total product revenue reached, $80.7 million, driven by strong patient accruals, partly offset by foreign currency impacts, as well as the timing of orders in certain ex-U.S. markets.

Given the majority of Galliford revenue is generated outside of the U S. We see significant FX exposure to our reported revenue numbers.

The euro British pound and the Japanese yen are the currencies are ex U S. Sales are most exposed to and on a year to date basis. These FX rates have declined by 8%, 10% and 15% respectively.

The geographic breakdown of our revenue during the quarter consisted of $53 million, or 66% of revenue generated outside of the U.S., and the remaining $28 million, or 34%, coming from within the U.S. This is roughly in line with a 70-30 split that we expect as we continue to grow both, parts of the business.

Applying average July 2020 to foreign currency exchange rates.

The impact on 2022 full year Galliford reported sales would be a negative impact of approximately 9% or $26 million.

Slide 20 outlines our income statement for the second quarter ending June 32022.

Cost of goods sold as a percentage of net sales was 10, 2% in the year as compared to 10, 8% for the prior year period.

Total GAAP operating expenses were $133 1 million in the second quarter as compared to $107 9 million in the second quarter of 2021.

The increase included nonrecurring expenses related to the re prioritization of the gene therapy portfolio.

On a non-GAAP basis total operating expenses were $119 2 million in the second quarter as compared to $93 5 million in the second quarter of 2021, we.

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

Consideration and depreciation.

Net loss for the second quarter of 2022 was $62 2 million or <unk> 21 per share as compared to a net loss of $51 2 million or 19 per share for the prior year period.

At June 32022, we had approximately 280 million shares outstanding.

This year, we expect total non-GAAP operating expenses to be at the lower end of our guidance range of 470 million to $485 million driven by continued investment in the global Gaucho lunch and <unk> clinical studies and prelaunch activities.

We highlighted previously this guidance also includes an approximate $70 million related to certain nonrecurring cost for the manufacturer at <unk> to support the global launch as well as commitments for the gene therapy portfolio.

Importantly, in 2023 and beyond we would expect non-GAAP operating expense levels to decline below levels, we saw in 2021.

Turning to slide 8, our results in the first half of the year highlight the strength of, our global commercial efforts.

The business continues to be incredibly resilient, with patients at its all major markets, and, an operational growth rate of 17.8% over the first half of 2021, at constant exchange rates. The negative impact on foreign currencies was 6.9% in the first half of the year, and, as a result, Ganafol reported revenue growth with 10.9% in the first half of 2022. Just to add a bit of color on our geographical performance, in the first half of the year, our sales in the U.S. grew 16.1% at TR, while our ex-U.S. sales grew 18.5% at TR.

Turning now to slide 21, we continue to operate from a position of financial strength and remain on track to achieve non-GAAP profitability in 2023 as defined in our press release we.

So Ganafol continues to be the fastest-growing product for Fabry disease globally, and has, been the greatest contributor to global Fabry market growth over the last 12 months.

I'm pleased to report that our monthly net patient trends continue to show positive signals.

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 counsel.

During approval and launching <unk> globally, as well as driving efficiencies cost savings and careful expense management.

So, for example, the three-month trend is higher than the six-month, which is itself, higher than the 12-month.

A few comments about our cash position in 2022 financial guidance.

Cash cash equivalents and marketable securities were $386 8 million at June 32022, compared to $482 5 million at December 31, 2021.

Our full year, California revenue guidance is $350 million to $365 million at constant foreign currency exchange rates.

In addition to our non-GAAP operating expense guidance at the lower end of $470 million to $485 million.

And with that let me turn the call back over to Bradley for closing remarks.

Great. Thank you Daphne, Jeff Sebastian Andrew and thanks to all of our employees around the world to continue to work tirelessly for people living with rare diseases and with that operator, we can now turn the call over to you to open up for questions.

Thank you ladies and gentlemen, if you have a question. Please press star and then the number one key on your Touchtone phone.

At this time, we ask that you only ask one question. If you have 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 Star then two once again that is star then one to ask your question.

And our first question today will come from.

A new bond Rama with J P. Morgan. Please go ahead.

Hey, guys. Thanks, so much for <unk>.

The question and Brad Congrats on an ascending to the CEO role, we all know what's coming but congrats again man.

I've got I've gotten a couple of inbound on your opening comments that.

In the U.S. in June, we also delivered the highest number of net new patients in PRS, since April of 2021.

And if you look at the growth in net patients on Ganafol on a global basis, which is perhaps, the truest measure of our underlying business performance, we see greater than 19% growth in patients on Ganafol at the end of Q2 this year versus the same period last year. So all indications of the continued demand for Ganafol.

We ended the second quarter with a little under half of the global market share for, treated and medical patients, and while the global mix remains about 55% switch and 45% naive, in many, many geographies, we're starting to see stronger uptake in naive populations.

So while we're achieving high market shares in countries where we've been approved the, longest, there's still plenty of opportunity to continue to switch patients over to Ganafol and to continue to grow the market as we penetrate into the diagnosed and treated segment and the newly diagnosed segment.

All of that is underpinned by impressive compliance and adherence rates that continue to exceed, 90%, reiterating our belief that those patients who go on Ganafol generally stay on Ganafol.

Perhaps you sounded a little bit more cautious or hedged around the wuxi manufacturing.

We did experience some impact due to the timing of orders in the second quarter, and we expect, this nonlinear quarterly growth to continue. This order pattern led to a handful of orders being recognized in the beginning of the third, quarter.

Importantly, the value of Ganafol continues to be recognized by payers, as we have a very, strong track record of successfully negotiating and renegotiating reimbursement outside of the U.S.

Our relentless focus remains on ensuring access to Ganafol for anyone who needs it.

Next, on slide nine, what we've seen so far this year is that Ganafol uptake continues, to track very well, and we're seeing growth across all our major markets, as well as most of our smaller markets.

We're on track to achieve full year revenue guidance of 15 to 20% growth at constant exchange, rate. And our first half growth of 17.8% at CR is right in the middle of that range. So, altogether, we view this as a great first half of the year.

Inspection. So what is your level of confidence here that the inspection is completed in the near term.

Moving to slide 10, we know that Ganafol has the potential to surpass $500 million in annual, revenue over the next few years through three key growth drivers. First, continuing to penetrate into existing markets. Second, expanding into new geographies.

And third, broadening the labels.

I'm pleased to share that we're making continued progress on expanding into new markets.

And we get a timely sort of approval.

And just to name a few examples, we expect marketing authorization in Turkey this year.

Thanks.

We have five in the second quarter in Hong Kong.

And in Chile, we're in pricing reimbursement discussions.

Yeah, Thanks on the Palm and I appreciate the congratulations.

In the longer term, we continue to see significant growth, in the overall fabric market globally.

This will be driven by diagnosing patients, through a variety of measures, including high-risk screening, newborn screening, and other diagnostics initiatives, which we continue to support and invest in as well.

So yes look we just wanted to be very straightforward with where we are with Wuxi, we continue to be extremely prepared.

And finally, we have often exclusivity in the US and Europe.

In addition to our now 44 arranged book-listed patents, that gives us IP coverage into the late 2030s, 28 of which provide protection through 2038. And that includes three new composition-of-matter patents.

So this gives us opportunity to provide access, to Gallup globally for a long time to come.

With our partners at Wuxi to welcome the inspectors in we're working very collaboratively and are in active dialogue with the inspectors I think we still have plenty of time for an inspection to be conducted just wanted to state what I guess, it's fairly obvious that if.

On slide 11, let's shift gears and I'll provide you here, with a date on launch preparations for ATGA as we're poised for another successful product launch.

So unlike when we launched Gallup Fold, and at the time we were hiring and building the commercial infrastructure from scratch, we now have a presence in over 40 countries around the world, including all the major markets.

That team will be largely the same that will launch ATGA, with only a handful of new FTEs needed, for example, cake managers, PELs.

That doesn't happen and ahead of the October <unk> date, and there is an opportunity then for.

For a delay but right now as we said on the call. We remain confident that both products would be approved at the same time and confident that we can hit that October 2019, <unk> date.

We have experience across all areas, that are needed for a successful drug launch, from regulatory to commercial, supply chain, experience with payers, reimbursement and access.

And in addition, and maybe most importantly, the key relationships with physicians.

Thanks, so much for taking our question.

And our next question will come from Ritu <unk> with Cowen. Please go ahead.

We're confident in our world-class commercial organization.

Good morning, Thanks for taking the questions and congrats Brad.

It's been a longtime coming glad to see you in the seat.

Thank you.

Yeah, I wanted to ask about the labeling discussions with FDA and how to appropriately frame expectations.

Or how what you see as the likely label.

We'll help you address the pump market.

You see it.

We will leverage their experience and relationships, and deliver ATGA to people living with pumpkin disease around the world.

Sorry, if I can also ask the flip side to that for Europe . I think you guys have the day 120 questions at this point.

How would you answer that.

What have you.

How EMEA, our CHP is going down the path it helping you addressed the broadest possible market again.

Hey, Brian its label.

From the team, the medical education, the published phase three data in the highly regarded Lancet Neurology Journal, our experience with reimbursement and access around the world, and again, all the strategy planning that we're doing together with, and together with our partners at Wooshy Biologics, we believe we're in a very strong position for a second successful launch of Amicus.

Yeah. Thanks, Ritu. So yes, we are really pleased with where we are with both the agencies and of course the reviews are separate.

Although I think the scenarios you could play out are the same with each well start with the FDA and I think based on where we are we are highly confident on the most important thing is in approval and we're highly confident that we will have a label that will allow us to be successful in our commercialization of <unk>.

I think the most important thing that we're focused on that we've continued to reiterate is that we have what we think is a highly differentiated product in particular based on the very compelling data that that Jeff reviewed around showing nominal statistically significant improvements in six minute walk in the switch population as well as stabilized.

<unk> of course metal capacity those are.

Those data has never been seen before in a well controlled study and we think those are the most important data to have within the label to be successful.

Long as we have those data and as long as we're in line with where we are with the discussions today I think we're very confident that we'll be able to address the.

Commercial needs in the commercial market for ATCA I think it's important to remember that.

There's roughly 3200 patients on atg today, and so that represents the vast majority of the unmet need.

In Pompe disease, and so based on where we are we're very confident we'll have a successful label to support those patients I think in Europe again, it's a separate discussion and I think the same.

Scenarios could play out there I think the same emphasis is there in terms of making sure that we have.

Key data in the label.

We're <unk>.

Confident that the progress there reflects again, a very successful outcome and we're eager to conclude that and looking forward to potential approvals at the end of this year and launch in early next year.

With that, let me now hand the call over, to Dr. Jeff Cassidy, our Chief Development Officer, to highlight our ATGA program pipeline update.

Thanks.

Jeff?

Thank you, Sebastian, and good morning, everyone.

Sorry, let me just will come.

Moving on to slide 13, we'll start with our ATGA program.

We recognize that Pompe disease poses a range, of health challenges for people affected by the disease, and having therapeutic options is crucial.

Go ahead.

I was just going to say, let me just clarify I think I said last time 3200 patients on <unk>, It's 3200 patients on standard of care.

Pompe is a severe and fatal neuromuscular disease, and one of the most prevalent lysosomal disorders.

We've now seen multiple publications, and natural history studies that highlight the initial benefit of treatment, often being followed by continued long-term decline in the risk factors of disease for many individuals.

Slide 14 presents a summary of the primary, and key secondary endpoints from our phase three study. As a reminder, preparing for a randomized study, addressing and assessing the efficacy and safety of ATGA in adult treatment-naive and ERT-experienced participants with late-onset Pompe disease, or LOPD, against the approved therapy, Alglocosidase-alpha.

Propel is the only controlled clinical trial to date that included this ERT-experienced, patient set, which represents one of the greatest groups of patients with unmet needs.

Endpoints across motor function, muscle strength, pulmonary function, patient-reported outcomes, and key biomarkers, including the two most recognized endpoints in Pompeii, six-minute walk distance and four-spinal capacity, shown here on the slide, favored ATGA over aglucosidase alpha in the overall population.

And our next question will come from Joseph Schwartz with Leerink. Please go ahead.

Hi.

Thanks, So much I was wondering if you can talk a little bit more about the expanded access <unk>.

<unk>.

To date for <unk> and are there any unifying characteristics or or or.

We believe this consistency of effect across the key disease manifestations illustrates, the potential impact of ATGA for patients living with Pompeii.

Additionally, in the ERT-experienced population, where 95 participants were on the standard, of care for more than seven and a half years on average, which is generally associated with the decline phase of disease for most patients, we actually saw an increase in six-minute walk distance and stabilization in FEC, which both achieved nominal statistical superiority versus the current treatment and showed a clinically meaningful outcome never before seen in this population.

Moving on to slide 15, adding to the overall body of data behind ATGA, at the 2022 MDA, Clinical and Scientific Conference earlier this year, the Amicus team presented positive long-term data from the Phase I-II study of ATGA. As seen here on the slide, these latest data continue to represent very meaningful and, durable improvements in functional outcomes, as well as persistent reductions in key biomarkers of muscle damage and disease substrate up to three years. These results have been shared with the regulatory authorities in the U.S. and EU as part of, their ongoing reviews.

Our patient segments that.

Our identifiable here in.

Comparing these results with 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 Pompe disease.

And the adoption to date do you think that.

It's likely that any of these patterns might carryover to the marketplace.

If and hopefully when <unk> is approved.

Yes, Thanks, Joe.

On slide 16, we've highlighted key updates on the ATGA program.

So first of all really excited.

The first reimbursed access for <unk> through the compassionate access program in France.

First, on the regulatory progress, last year the U.S. FDA accepted for review the BLA for, ciproglucosidase alpha and the NDA for miglostat, the two components of ATGA. In May, the agency extended the PDUFA action dates to August 29th for the NDA and October, 29th of 2022 for the BLA.

A really important milestone exciting and hopefully a bellwether for for more to come.

And.

I would say there are a few broad buckets of those access programs of course part of it is just our ongoing clinical trial patients who primarily late onset patients.

Who came into our studies in phase II and phase III. The biggest cohort of patients is the <unk>.

Access program in the U K and we think that's really important because it's.

A label that reflects the unmet need in Pompe disease, and it provides an opportunity for patients and for physicians to.

And I think a completely.

Kind of.

On affected way from amicus, where it's not a promotional program allows them to select going onto ATCA and I think that population who are as Jeff mentioned required to be on therapy for two years before being accessed before being eligible for access to a T. J I think that.

Since the vast majority of the market today, and seeing I think a strong preference and strong utilization now more than a dozen patients entering in that program. I think is a great example of what we can see in the future and then we do of course also see a variety of patients who are either.

Infantile onset who are really looking for some opportunity for better outcomes.

As well as pediatric and some later patient onset patients as well in other markets I think that just demonstrates the unmet need that remains out there and the hope that we can provide with a PGA and we're very much looking forward to continuing to be able to serve those markets overtime.

Thank you very much.

As Bradley mentioned, we expect these filings will be approved together by the October 29th, action date, dependent, again, on the ability for FDA to conduct an inspection at the WUSHE manufacturing facility.

And our next question will come from Ellie Merle with UBS. Please go ahead.

Oh, Hey, guys. Thanks for taking the question just a follow up on the you have many fostering a question I guess when typically in the review cycle would you expect the inflection to occur by and I guess, how long had.

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

The CHMP opinion is expected later this year. Of note, the EMA has indicated in writing that based on the extensive and prior manufacturing, inspections of the WUSHE facility, an inspection is not required for ATGA approval in Europe.

We now, third, we now have multiple expanded access programs in place, including in the, U.S., U.K., Germany, France, Japan, and others. This includes the EAMS framework that we announced in which ATGA was granted a positive scientific, opinion through the early access to medicine scheme by the U.K.'s NHRA. This positive opinion recognizes the high unmet medical needs faced by the Pompeii community, and permits eligible adults living with LOPD who have received aglucosidase alpha for at least two years to switch to ATGA, granting access prior to marketing authorization in the UK.

As Bradley mentioned, we're seeing significant enthusiasm for ATGA under the EAMS mechanism, with multiple physicians now having requested access across all the leading Pompeii centers in the UK, and dozens of patients now receiving this novel two-component treatment. Since the positive scientific opinion, interest and momentum for ATGA has grown, and we are, pleased to be able to provide access to those who are eligible in the UK.

In France, as Brad also noted, the National Agency for the Medicines and Health Product, Safety granted the first reimbursed access to ATGA under their Compassionate Access Program, formerly known as the Nominative ATU Program.

With this growth in our access programs, we're pleased to report that now more than 175 patients, worldwide are being treated with ATGA across our clinical extension studies and our expanded access programs, and we expect that to continue to grow.

For the younger Pompeii community, we continue to enroll the ongoing Open Label Study in, children up to 18 years of age living with LOPD, and expect to expand into patients with infantile-onset Pompeii disease, or IOPD, later this year. Importantly, in response to the many requests for treatment that we continue to receive, for children living with both LOPD and IOPD, our expanded access programs continue to increase.

On slide 17, we just announced today an early-stage program to explore next-generation pharmacological, chaperones for Fet-Bray disease through an academic research collaboration agreement with the University of Seville. This new collaboration will search for innovative small molecules with optimal activity and, pharmacokinetic properties.

Driven by both the science and the needs of people living with Fet-Bray, we will be reviewing, Fet-Bray compounds based on several attributes, including potency, number of addressable amenable mutations, and dosing.

Of note, the agreement costs at this point are very modest, and we do not expect our, fiscal year operating – and will not impact our fiscal year operating expense guidance.

The October 29th could you saw what it needed to be schedule of bi.

For you to be confident that it could be completed ahead of the <unk> I guess just in terms of like you know the schedule lag and how long it would take one schedule or just any color you can.

Could give on Mt.

And then just a quick one on <unk>, you mentioned that Angie and you saw the highest number of net new patients in the U S.

Golf ball is that something that you expect just around seasonality or is this a sort of a broader trend that.

Yes.

Hello.

Thanks Ali.

With that, I would like to now turn the call over to Daphne Cleamy, our Chief Financial, Officer, to review our financial results, guidance, and outlook.

Daphne?

Sebastian take the <unk> question and provide additional color there, but starting on the Wuxi inspection.

Thank you, Jeff, and good morning, everyone.

Our financial overview begins on slide 19 with an overview of our second-quarter revenue, performance and impacts of foreign currency exchange rates.

For the second quarter, we achieved gallifold revenue of $80.7 million, which is a 4.3 percent, increase over the same period in 2021. This includes operational revenue growth of 12.9 percent, offset by a negative currency, impact of 8.6 percent. Given a majority of gallifold revenue is generated outside of the U.S., we see significant FX, exposure to our reported revenue numbers. The euro, the British pound, and the Japanese yen are the currencies our ex-U.S. sales are, most exposed to.

Slide 20 outlines our income statement for the second quarter, ending June 30, 2020. Cost of goods sold as a percentage of net sales was 10.2% in the year as compared to 10.8% for the prior year period.

Look I think we've said before there are a variety of.

Options the FDA can utilize to support an inspection there could be paper based there could be hybrid there could be directly inspections from folks from the United States and we're prepared to support any one of those we actually just recently.

She supported a virtual inspection of paper based inspection from a different regulatory authority. We also know they just hosted U S Commerce Department, who inspected on that debt.

Verified list. So we know inspectors are able to get in in seconds or able to be conducted in terms of timing.

Don't want to get too cute there, but I think we just wanted to be fully clear that we're prepared to support an inspection we're confident.

We are poised for approval.

But just acknowledged that does need to happen prior to the Paducah date and order forward for the approval to go forward at that point.

And then Sebastian I'm going to address the <unk> question on the U S Gulf old dynamics, and maybe broadly what we're seeing in golf.

Absolutely. Thanks, Andy for the question I think.

You asked whether there was some degree of seasonality and what we've seen in the U S of late.

My answer would be not really.

This is more related to the level of activity that we've seen clearly our interaction with hcp's has been picking up significantly when we compare.

Of this year versus beginning of last year, we've had we've seen in some countries almost a tenfold increase in face to face interaction that is having an impact rosso second element that we're seeing in the U S. As we continue to see.

Increase in the number of prescribers of gas holds a unique prescribers are going to continue to increase so we have more physicians.

Prescribing that unfolds.

The trend that we've seen over the last few months in the U S.

It seems to continue to.

To play here.

With the July .

So we're in good situation and in the USA.

Oh, great. Thanks.

Yeah.

And our next question will come from Dave.

Uh Huh with Stifel. Please go ahead.

Great. Good morning, Thanks for taking my questions and congrats on all the progress.

<unk> from me is on the 2023 or financial guidance.

Maybe for Daphne can you speak to the sensitivity around your 2023 projections of non-GAAP profitability and how the non-GAAP opex is being lower than 'twenty. One I just saw the footnote on the press release, where it does kind of talk about the variability on predictability. So just wanted to get a little bit color around that sensitive.

Thank you.

Okay.

Yes.

Yes, definitely do want to address that.

Sure.

Yeah Alright.

For the question David So I think the comment is really coming from the fact that.

We do have some are especially in the R&D space, we had some expenses that we had experienced.

Over the past few years, specifically related to <unk> for the manufacturer.

The product once it is approved.

That spending will move over to the balance sheet.

They flow through the income statement and cost of goods sold so there's a large piece of that opex that will no longer be there. So when we look out into the future.

The largest piece.

I would say that that's driving that commentary. There is also some expenses. This year that are nonrecurring in nature as it related to the re prioritization of the gene therapy portfolio. So those are expenses that we had this year that will not occur in the future.

Total GAP operating expenses were $133.1 million in the second quarter as compared to $107.9 million in the second quarter of 2021. The increase included non-recurring expenses related to the reprioritization of the gene therapy portfolio.

On a non-GAP basis, total operating expenses were $119.2 million in the second quarter as compared to $93.5 million in the second quarter of 2021. Net loss for the second quarter of 2022 was $62.2 million or $0.21 per share as compared to a net loss of $51.2 million or $0.19 per share for the prior year period.

At June 30, 2022, we had approximately 280 million shares outstanding.

This year, we expect total non-GAP operating expenses to be at the lower end of our guidance range of $470 million to $485 million, driven by continued investment in the Global GALIFO Launch and ATGAA clinical studies and prelaunch activities. As we highlighted previously, this guidance also includes an approximate $70 million related to certain non-recurring costs for the manufacturer of ATGAA to support the Global Launch, as well as commitments for the gene therapy portfolio.

Importantly, in 2023 and beyond, we would expect non-GAP operating expense levels to decline below levels we saw in 2021.

Turning now to slide 21, we continue to operate from a position of financial strength and remain on track to achieve non-GAP profitability in 2023, as 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 GALIFO, securing approvals and launching ATGAA globally, as well as driving efficiencies, cost savings, and careful expense management.

A few comments about our cash position and 2022 financial guidance. Cash, cash equivalents, and marketable securities were $386.8 million at June 30, 2022, compared to $482.5 million at December 31, 2021.

Our full-year scalable revenue guidance is $350 million to $365 million at constant foreign, currency exchange rates, in addition to our non-GAAP operating expense guidance of the lower end of $470 million to $485 million.

And with that, let me turn the call back over to Bradley for closing remarks.

It's really related to those two items predominantly because of that.

Our comment is coming from.

Okay, great. Thanks, so much for the color.

Thanks Pat.

And our next question will come from <unk>, Richard with Goldman Sachs. Please go ahead.

Great.

Hey, Good morning, this is Matt on for Sterling.

Would you guys. Please just give us.

Leveraging therapy program.

Then also the next generation Chevron's you mentioned thank you.

Thank you, Daphne, Jeff, Sebastian, Andrew, and thanks to all of our employees around, the world who continue to work tirelessly for people living with rare diseases.

Yes, Jeff maybe I'll start and then I'll kick it over to you so.

And with that, operator, we can now turn the call over to you to open up for questions.

As a reminder.

We continue to have we think very differentiated approaches in both fabry and Pompe gene therapy, and those are still important programs for us we continue to move those those technologies forward, but I think in a very measured and targeted way.

Thank you.

Ladies and gentlemen, if you have a question, please press star and then the number one, key on your touchtone phone.

At this time, we ask that you only ask one question.

Given the re prioritization of our program with the idea that I think there are some.

Broader gene therapy questions, we're still looking to answer before we can.

Put those forward into the clinic, but I will say as it relates to the next generation Chaperone I think that's a reflection of amicus as commitments to be continue to be at the forefront of developing new therapies for anything for Fabry Pompe.

And while it's early I think it is an exciting opportunity for us there, but maybe Jeff you could give a little bit more color.

Yeah, Thanks, Brad and nothing really to add on the Fabry gene therapy. In addition to what probably commented on and for that Fabry Chaperone discovery collaboration we're very excited to enter that it.

It is very early stage.

As we have meaningful data, we will present that at conferences, but right now.

It's really trying to see if theres a way to expand the number of amenable mutations that we can benefit more patients with a small molecule chaperone.

And then just related to that and see if we can improve some of what we believe is done already very strong profile for doubtful, but to see if there's additional benefit we can bring to fabry patients through a chaperone.

But we will provide updates as they come.

Okay.

Great. Thank you.

And our next question will come from Christian Christian Costco with Cat Drew Fitzgerald.

If you have additional questions, please enter back into the queue.

If your question has been answered or you wish to remove yourself from queue, please, press star then two.

Go ahead.

Once again, that is star then one to ask a question.

And our first question today will come from Anupam Rama with J.P. Morgan.

Good morning, Brent on for Kristen. Thank you for taking our question what if any effect do you believe the foreign exchange headwinds could have on the 70 30 split you've talked about in ex U S and U S sales as you grow the <unk> business and how are you thinking about this effect as you continue to guide towards.

Please go ahead.

Hey, guys, thanks so much for taking the question, and, Brad, congrats on ascending to the CEO, role.

We all knew it was coming, but congrats again, man.

Expanding into new markets. Thank you.

Thank you.

And I've gotten a couple inbounds on your opening comments that perhaps you sounded, a little bit more cautious or hedged around the WuXi manufacturing inspection.

So what is your level of confidence here that the inspection is completed in the near term, and we get a timely sort of approval of ATTA?

Yes, I think as you saw.

Thanks.

And I'm getting a little echo on the line, but I think as you saw there were.

Yeah, thanks, Anupam, and appreciate the congratulations.

So yeah, look, we just wanted to be very straightforward with where we are with WuXi.

Slightly.

Greater distribution of revenue coming from the U S. This year.

Versus ex U S. So I think it was like 33% versus 67%, which is still near that 70 30, but that just shows that I would say the slight impact on.

On Europe , I think in general going forward, we would expect that 70 30 split on average to your point as new markets come on.

You do see.

Those will typically be outside the United States, but of course, it's all different currencies. So we're not in the business of predicting.

FX around the world globally, but I think the most important thing is the growth rates between the two remained strong we continue to expect significant growth in U S significant growth outside the U S and roughly over time that should balance out to about 70 30.

We continue to be extremely prepared and with our partners at WuXi to welcome the inspectors, in.

We're working very collaboratively and are in active dialogue with the inspectors.

Thanks.

And once again, if you would like to ask a question. Please press Star then one.

I think we still have plenty of time for an inspection to be conducted.

We just wanted to state, you know, what I guess is fairly obvious, that if that doesn't, happen ahead of the October PDUFA date, then there is an opportunity then for delay.

Our next question will come from the King shoe with Baring Berg. Please go ahead.

Hi, good morning, Thanks for taking my questions and congrats on the progress as well.

But right now, as we said on the call, we remain confident that both products would, be approved at the same time and confident that we can hit that October 29th PDUFA date.

Thanks so much for taking our question.

I wanted to ask you about the E. On slide 16, you talked about ongoing support of studies on <unk> and Iot.

And our next question will come from Ritu Baral with Cowen.

Can you talk about the.

The implications there and how does that relate to.

Joe Labor discussion and secondly, just looking at <unk>.

Please go ahead.

In the first half and full year guidance.

Good morning.

Randy.

The negative impacts on sorting exchange it looks like the second half will be pretty flat.

Considering the foreign exchange, maybe provide a bit color on that thank you.

Thanks for taking the questions, and congrats, Brad.

It's been a long time coming.

Glad to see you in the seat.

Maybe I'll take the end of that question first and then Jeff you can come back to the development.

Strategy and how it will impact the label over time, so as it relates to <unk> growth look.

We're not in the business of predicting foreign exchange rates, but I think we just as a point in time, what could the impact be.

On the actual reported revenue for us. The most important thing is the underlying business remained strong remains growing and growing robustly and I think that point that Sebastian made around 19%.

Growth from this time last year in terms of patients that's really the business demand right. So that's really how the business is growing and it's growing really strongly and growing right in line with what we said it would as it relates to the second half of the year.

Usually we see a greater distribution of revenue in the second half of the year versus the first half of the year and so we are very confident that we will see that and from an operational basis. We are reiterating our guidance of $3 50 to 365 again exactly how foreign exchange impacts.

The impact of that is is difficult to predict but but for now we've provided that kind of point estimate for what the impact could be from a reported perspective, but again for us. The importance is that the business is strong and growing and growing in all key markets and we continue to anticipate that going forward, but Jeff you want to talk a little bit about the <unk>.

I wanted to ask about the labeling discussions with FDA and how to appropriately frame expectations, for how what you see as the likely label will help you address the Pompei market as you see it.

Pompeii development strategy in particular, the different populations late onset and pediatric.

Yes, sure. So as a reminder, propel was <unk>.

Included only adult patients so the vast majority of the data in our initial submissions.

We'll be focused on adult pump patients and that would be our expected initial labeling.

Do have an ongoing pediatric allo PD study and we do have agreement with regulatory agencies to do an extrapolation of efficacy from the adult patients down into those pediatric allo PD patients and we are imminently getting ready to start adding io PD patients to that.

Clinical trial as well.

We do need to look at.

Some measures of efficacy and safety in that IOP population.

So we expect initial labels focused on adults, but then as we have data sufficient to add in the pediatric patients we will and as I noted on the call. We continue to treat multiple pediatric patients <unk> through expanded access where there is significant need.

And, you know, if I can also ask the flip side to that for Europe, I think you guys, Yeah, thanks Ritu.

Okay.

Great. Thank you.

Yeah.

And our next question will come from Ritu <unk> with Cowen. Please go ahead.

Hi, guys. Thanks for taking the follow up.

To drill down a little more.

Into the U S dynamics sort of.

Turning to.

Growth of growth Reacceleration.

I guess.

Supply.

New prescribers are still growing.

This long into the launch.

And also I'm wondering how how much mutations play into it you guys have the number of mutations on the European label.

The slides, but how does that compare to the U S label.

Are those still growing the number of mutations in the U S label is that driving the growth is there like a cat youre about to hit which triggered the nexgen program.

So yeah, we're really pleased with where we are with both agencies.

And of course, the reviews are separate.

Yes, thanks for two good questions. So.

Although I think the scenarios you could play out are the same with each.

As it relates to the growth dynamic in the United States I think it really has more to do with what Sebastian described which is increasing opportunity for physicians and our sales and medical team to be together, while we did a great job of maintaining those virtual interactions I think.

Nothing beats face to face and it probably represents also some.

Improved access for patients and physicians and more frequent access for patients and physicians. So that physicians can start patients on therapy. So.

Whether it's a bit of a new normal or whether it's.

Some some adjustment and the ability to know when a candle COVID-19 and in a different way I think thats really whats driving that that kind of a resurgence in demand, but I can say that even in July we're continuing to see great numbers not just the U S, but around the world and again that 93% growth rate in patient coming on to therapy.

And the second quarter versus second quarter last year to me that says the business is growing strong and we continue to expect that.

As it relates to the mutations piece no you are right that remember that the really interesting exciting part about the European labels that we were able to characterize all of the theoretical mutations that could be amenable to the chaperone and the Europeans accepted that that concept is amenability and we were able to expand the label so that even a pay even though we.

Not every mutation had an actual patient.

Diagnosed with that mutation.

If we find one who does have those mutations then they can they can immediately be eligible for therapy in the United States is slightly different while they fully accepted the amenability concept in order to update the label in the United States We are.

We are obligated to find a patient with that mutation and then we can subsequently update the label. So it's just a little bit of a slower process, but eventually presumably we'd find a majority of those medical patients as it relates to prescribers I think honestly, that's just a reflection of the rare disease space, where these patients and physicians.

Our continued we continue to find new patients. We continue to then have new physicians.

And we do continue to see new prescribers come onboard, which I think just again reflects the continuing growth opportunity for California. So all great positive signs for the business for years to come.

How many mutations are I guess left in the U S.

As you see it to be included in that link.

Jeff you want to give the.

What's the European label, Jeff and then what's the U S label.

Yes, so I think it's.

Almost 1400 amenable mutations and European label, and it's around 350 in the U S. So look we continue to add mutations.

Every year as patients and patient families.

Yes.

Barry have a novel mutation. So we do expect that that number will keep coming up overtime I don't think well ever reached.

Truth theoretical rate, but as Brad said, it really doesn't limit access in the U S. It just might cause a slight delay as it might be a mutation thats not in the label we've already tested them. So we don't have to rerun. The assay, we just need to go through the paperwork with FDA to add it to the label.

Thank you.

Thank you Tim.

We'll start with the FDA.

And I think based on where we are, we are highly confident.

And ladies and gentlemen, this will conclude our question and answer session also concluding today's conference call, we'd like to thank you for attending today's presentation and at this time you may now disconnect your lines.

The most important thing is in approval.

And we're highly confident that we will have a label that will allow us to be successful in our commercialization of ATGA.

I think the most important thing that we're focused on that we've continued to reiterate is that we have what we think is a highly differentiated product, in particular, based on the very compelling data that Jeff reviewed around showing nominal statistically significant improvements in six-minute walk in the switch population as well as stabilization of force vital capacity.

Those data have never been seen before in a well-controlled study.

I think it's important to remember that there's roughly 3,200 patients on ATGA today.

And so that represents the vast majority of the unmet need in Pompe disease.

I think the same emphasis is there in terms of making sure that we have those key data in the label.

And so based on where we are, we're very confident we'll have a successful label to support those patients.

We're confident that the progress there reflects, again, a very successful outcome.

I think in Europe, again, it's a separate discussion.

And we're eager to conclude that and looking forward to potential approvals at the end of this year and launching early next year.

And I think the same scenarios could play out there.

Thanks.

And our next question will come...

Go ahead.

Yeah, thanks, Joe.

I was just going to say, let me just clarify.

So, first of all, you know, really excited.

I think I said last time 3,200 patients on ATGA.

Yeah, thanks, Joe.

Thank you all have a great day.

It's 3,200 patients on standard of care.

So, first of all, you know, really excited to have the first reimbursed access for ATGA through the Compassionate Access Program in France.

And our next question will come from Joseph Swartz with SBB Lerig.

And, you know, I would say there are a few broad buckets of those access programs.

Please go ahead.

Yeah, thanks, Joe.

Hi.

So, first of all, you know, really excited to have the first reimbursed access for ATGA through the Compassionate Access Program in France.

Yeah.

Thanks so much.

I think that's just a really important milestone, exciting, and hopefully a bellwether for more to come.

I was wondering if you can talk a little bit more about the expanded access experience to date for ATGA.

And, you know, I would say there are a few broad buckets of those access programs.

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And are there any unifying characteristics or criteria that you're looking at?

Of course, part of it is just our ongoing clinical trial patients who are primarily late onset patients who came into our studies in Phase 2 and Phase 3.

The biggest cohort of patients is the EAMS access program in the U.K.

And we think that's really important because it's...

It's a label that reflects the unmet need in Pompe disease, and it provides an opportunity, for patients and for physicians to, in I think a completely kind of unaffected way from Amicus, it's not a promotional program, allows them to select going on to ATGA.

And I think that population who are, as Jeff mentioned, required to be on therapy for two, years before being eligible for access to ATGA, I think that represents the vast majority of the market today.

And seeing, I think, a strong preference and strong utilization, now more than a dozen patients entering in that program, I think is a great example of what we can see in the future.

And then we do, of course, also see a variety of patients who are either infantile onset who are really looking for some opportunity for better outcomes, as well as pediatric and some later onset patients as well in other markets.

I think that just demonstrates, you know, the unmet need that remains out there and the hope that we can provide with ATGA.

And we're very much looking forward to continuing to be able to serve those markets over time.

Thank you very much.

And our next question will come from Ellie Merle with UVA.

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Yes.

Yes.

Please go ahead.

Hey guys, thanks for taking the question.

Okay.

Just a follow-up on the U.S. manufacturing inspection.

I guess, you know, when typically in the review cycle would you expect the inspection to occur by, and I guess how long ahead of the October 29th to do so would it need to be scheduled by for you to be confident that it could be completed ahead of the PDUFA, I guess just in terms of like, you know, the scheduling and how long it would take, you know, one schedule, just any color that you could give on that.

Sure.

And then just a quick one on Gallifold.

Yes.

You mentioned that in June you saw the highest number of net new patients in the U.S. on Gallifold.

This is Matt on for Salveen.

Yes.

Is this something that you expect just around seasonality or is this sort of a broader trend that you expect to continue?

Could you guys please just give us an update, on the Savory Gene Therapy Program and then also the Next Generation Chaperones you mentioned?

Thanks.

Jeff, maybe I'll start and then I'll kick it over to you.

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Thanks, Ellie.

So as a reminder, we continue to have, we think, very differentiated approaches in both, Fabry and Pompe gene therapy, and those are still important programs for us.

I'll let Sebastian take the Gallifold question and provide additional, color there.

We continue to move those technologies forward, but I think in a very measured and targeted, way, given the reprioritization of our program.

Yes.

But starting in the WUSHI inspection, you know, look, I think we've said before there are a variety of options the FDA can utilize to support an inspection.

With the idea that I think there are some broader gene therapy questions we're still, looking to answer before we can put those forward into the clinic.

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Okay.

There could be paper-based, there could be hybrid, there could be, you know, direct inspections from folks from the United States.

But I will say, you know, as it relates to the next generation chaperone, I think that's, a reflection of Amicus's commitment to be, continue to be at the forefront of developing new therapies for anything for Fabry or Pompe, and, you know, while it's early, I think it's an exciting opportunity for us there, but maybe, Jeff, you can give a little bit more color.

And we're prepared to support any one of those.

Yeah, thanks, Brad, and nothing really to add on the Fabry gene therapy in addition, to what Bradley commented on.

Yes.

We actually know just recently that WUSHI, supported a virtual inspection, a paper-based inspection from a different regulatory authority.

And, you know, for that Fabry chaperone discovery collaboration, you know, we're very excited, to enter that.

Thank you.

We also know they just hosted the U.S. Commerce Department who inspected on that unverified list.

It's very early stage, you know, as we have meaningful data, we will, you know, present, that at conferences, but right now, you know, it's really trying to see if there's a way to expand the number of amenable mutations that we could, you know, benefit more patients with a small molecule chaperone.

Yes.

So we know inspectors are able to get in and inspections are able to be conducted.

And then just, you know, related to that, see if we can improve some of what we believe, is an already very strong profile for Gallifold, but just see if there's additional benefit we can bring to Fabry patients through a chaperone.

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In terms of timing, you know, I don't want to get too cute there, but I think we just wanted to be, you know, fully clear that we're prepared to support an inspection.

But we will, you know, provide updates as they come.

Okay.

We're confident that we're poised for approval, but just acknowledge that that does need to happen prior to the PDUCA date in order for the approval to go forward at that point.

Great, thank you.

And then Sebastian, I want to address Ellie's question on the U.S. Gallifold dynamics and, maybe broadly what we're seeing in Gallifold.

And our next question will come from Kristen Kowalska with Canterbury Fitzgerald.

Yes.

Absolutely.

Please go ahead.

Thanks, Eddie, for the question.

Go ahead.

I think that, you know, you asked whether, there was some degree of seasonality in what we've seen in the U.S. of late, and my answer would be not really. This is more related to the level of activity that we've seen.

Good morning.

Okay.

Clearly, our interaction with HCPs has been picking up significantly. You know, when we, compare, you know, beginning of this year versus beginning of last year, we've had, we've seen in some countries almost a tenfold increase in face-to-face interaction. That's having an impact.

This is Rick on for Kristen.

We're also, you know, a second element that we're seeing in the U.S, is we continue to see an increase in the number of prescribers of Galafold, so unique prescribers of Galafold continue to increase, so we have more physicians prescribing Galafold.

Thank you for taking our question.

Right.

And, you know, the trend that we've seen over the last few months in the U.S., you know, seems to continue to play here with July, so we're in a good situation in the U.S.

What, if any, effect do you believe the foreign exchange headwinds could have on the 70-30, split that you've talked about in ex-U.S. and U.S. sales as you grow the Gallifold business?

Great.

And how are you thinking about this effect as you continue to guide toward expanding, into new markets?

Thanks.

Thank you.

And our next question will come from Dagon Ha with Stifel.

Yeah, I think as you saw, and I'm getting a little echo on the line, but I think as, you saw, there were slightly greater distribution of revenue coming from the U.S. this year versus ex-U.S., so I think it was like 33% versus 67%, which is still near that 70-30, but that just shows, I would say, the slight impact on Europe.

Okay.

Please go ahead.

I think in general, going forward, we would expect that 70-30 split on average.

Okay.

Great.

To your point, as new markets come on, you do see those will typically be outside the, United States, but of course, it's all different currencies, so we're not in the business of predicting effects around the world globally, but I think the most important thing is the growth rates between the two remain strong.

Good morning.

We continue to expect significant growth in the U.S., significant growth outside the, U.S., and roughly over time, that should balance out to about 70-30.

Yes.

Thanks for taking my questions, and congrats on all the progress.

Thanks.

A question from me is on the 2023 financial guidance.

Our next question will come from Ziqiang Xu with Berenberg.

Maybe for Daphne, can you speak to, the sensitivity around your 2023 projections of non-gap profitability and how the non-gap OPEX is being lower than 21?

Please go ahead.

I just saw the footnote on the press release where it does, kind of talk about the variability and predictability.

Hi.

I just wanted to get a little bit of color around that sensitivity.

Good morning.

Thank you.

Thanks for taking my questions and congrats on the progress as well.

Yeah, Daphne, do you want to address that?

I want to ask about the ESY 16, you talked about ongoing support of studies on LOPD and, IOPD.

Sure.

Can you talk about the implications there and how that relates to your label discussion?

Yeah.

And secondly, just looking at Galliford cells in the first half and four-year guidance, considering the negative impacts on foreign exchange, it looks like the second half will be pretty flat considering the foreign exchange, maybe provide a bit of color on that.

Thanks for the question, Dagon.

Thank you.

Alright.

So I think that the comment is really coming, from the fact that we do have some, especially in the R&D space, we have some expenses that we've experienced over the past few years, specifically related to ATGAA for the manufacture of the product.

Maybe I'll take the end of that question first and then, Jeff, you can come back to the development, strategy and how it will impact the label over time.

Once it is approved, that spending will move over to the balance sheet and flow through the income statement and cost of goods sold.

So as it relates to Galliford growth, look, you know, we're not in the business of predicting, foreign exchange rates, but I think we've just said as a point in time, what could the impact be on the actual reported revenue?

Yes.

So there's a large piece of that OPEX that will no longer be there.

For us, the most important thing is the underlying business remains strong, remains growing and, growing robustly.

Sure.

So when we look out into the future, that's the largest piece, I would say, that's driving that commentary.

And I think that point that Sebastian made around the 19% growth from this time last, year in terms of patients, that's really the business demand, right?

Sure.

There is also, or there's some expenses this year that are non-recurring in nature as related to the reprioritization of the gene therapy portfolio. So those are expenses that we have this year that will not occur in the future.

So that's really how the business is growing and it's growing really strongly and growing, right in line with what we said it would.

Okay.

So it's really related to those two items predominantly is where that comment is coming from.

As it relates to the second half of the year, you know, usually we see a greater distribution, of revenue in the second half of the year versus the first half of the year. And so we are very confident that we will see that.

Okay, great.

And from an operational basis, we're reiterating our guidance of 350 to 365.

Sure.

Thanks so much for the call.

Again, exactly how foreign exchange impacts that is difficult to predict.

Thanks, Dagon.

But for now, we've provided that kind of point estimate for what the impact could be from, a reported perspective.

Yes.

And our next question will come from Salveen Richter with Goldman Sachs.

But again, for us, the importance is that the business is strong and growing and growing, in all key markets.

Please go ahead.

And we continue to anticipate that going forward.

Yes.

Hey, good morning.

But Jeff, you want to talk a little bit about the Pompei development strategy in particular, the different populations, late onset and pediatric?

Okay.

Yeah, sure.

Yes.

So as a reminder, Propel was included only adult patients.

Yes.

So you know, the vast majority of the data in our initial submissions will be focused, on adult Pompei patients, and that would be our expected initial labeling.

We do have an ongoing pediatric LOPD study. And we do have agreement with regulatory agencies to do an extrapolation of efficacy, you know, from the adult patients down into those pediatric LOPD patients.

Thank you.

And we are imminently getting ready to start adding IOPD patients to that clinical trial, as well.

We do need to look at some measures of efficacy and safety in that IOPD population.

So we expect, you know, initial labels focused on adults.

But then as we have data sufficient to, you know, add in the pediatric patients, we will.

And as I noted on the call, we continue to treat multiple pediatric patients, IOPD, LOPD, through expanded access, where there's significant...

Okay.

And our next question will come from Ritu Baral with Cowen, please go ahead.

Okay.

Hi guys, thanks for taking the follow-up.

Right.

I just wanted to drill down a little more into the U.S. dynamics and the sort of return, to growth or growth re-acceleration.

I guess I'm surprised that new prescribers are still growing this long into the launch.

And also I'm wondering how much mutations play into it.

You guys have the number of mutations on the European label in the slides, but how does, that compare to the U.S. label?

Okay.

And are those still growing, the number of mutations in the U.S. label?

Sure.

Is that driving the growth?

Or like a calf you're about to hit, which triggered the NextGen program?

Okay.

Yeah, thanks Ritu, good questions.

Sure.

So as it relates to the growth dynamic in the United States, I think it really has more, to do with what Sebastian described, which is increasing opportunity for physicians and our sales and medical team to be together.

Okay.

While we did a great job of maintaining those virtual interactions, I think, you know, kind, of nothing beats face-to-face.

And it probably represents also some improved access for patients and physicians and more, frequent access for patients and physicians so that physicians can start patients on therapy.

Yes.

So, you know, whether it's a bit of a new normal or whether it's, you know, some adjustment, and ability to now kind of handle COVID in a different way, I think that's really what's driving that kind of resurgence in demand.

But I can say that even in July, we're continuing to see great numbers, not just the U.S., but, around the world.

And again, that 90% growth rate in patients coming on to therapy from end of second quarter, versus end of second quarter last year, to me, that says the business is growing strong and we continue to expect that.

Yes.

As it relates to the mutations piece, no, you're right.

Remember, the really interesting and exciting part about the European label is that we were, able to characterize all of the theoretical mutations that could be amenable to the chaperone and the Europeans accepted that concept of amenability and we were able to expand the label so that even though not every mutation had an actual patient diagnosed with that mutation, if we find one who does have those mutations, then they can immediately be eligible for therapy.

In the United States, it's slightly different.

While they fully accept the amenability concept, in order to update the label in the United, States, we are obligated to find a patient with that mutation and then we can subsequently update the label.

So it's just a little bit of a slower process.

But eventually, presumably, we'd find a majority of those amenable patients.

As it relates to prescribers, I think, honestly, that's just a reflection of the rare disease, space where these patients and physicians, we continue to find new patients, we continue to then have new physicians, and we do continue to see new prescribers come on board, which, I think just, again, reflects the continuing growth opportunity for Galliford.

So all great positive signs for the business for years to come.

How many mutations are, I guess, left in the U.S. as you see it to be included in that label?

Okay.

Jeff, you want to give the, what's the European label, Jeff, and then what's the U.S. label?

Yeah, so I think it's, you know, almost 1,400 amenable mutations in the European label, and it's, you know, around 350 in the U.S.

So, look, we continue to add mutations every year as patients and patient families have a novel mutation.

So we do expect that that number will keep coming up over time.

Okay.

You know, I don't think it will ever reach the true theoretical rate, but as Brad said, it really doesn't limit access in the U.S.

Yes.

It just might cause a slight delay as it might be a mutation that's not in the label.

Yes.

We've already tested them, so we don't have to rerun the assay.

Yes.

We just need to go through the paperwork with FDA to add it to the label.

I see.

Thank you.

Okay.

Thanks, you two.

And, ladies and gentlemen, this will conclude our question-and-answer session, also concluding today's conference call.

Yes.

We'd like to thank you for attending today's presentation, and at this time, you may now disconnect your lines.

Yes.

Thank you all.

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Have a great day.

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