Q1 2023 Amicus Therapeutics Inc Earnings Call
Good morning, ladies and gentlemen, and welcome to the Amicus Therapeutics first quarter 2023 financial results conference call and webcast. At this time all participants are in a listen only mode. Later, we will conduct a question and answer session.
She will follow at that time as a reminder, this conference call is being recorded I would now like to turn the conference over to your host Mr. Andrew Faughnan, Vice President of Investor Relations you may begin.
Good morning, Thank you Gigi.
Thank you for joining our conference call to discuss amicus Therapeutics first quarter 2023 financial results and corporate highlights.
Today todays call, we have Bradley Campbell, President and Chief Executive Officer, definitely Queenie, Chief Financial Officer, Sebastien, Martel, Chief business Officer, and Dr. Jeff Castelli, Chief Development Officer, Tony for Q&A, Dr. Mitchell Goldman Chief Medical Officer, and Alan Rosenberg, Chief Legal officer.
As referenced on slide two we might make forward looking statements within the meaning of the private Securities Litigation Reform Act of 1995 relating to our business as long as our plans and prospects are forward looking statements should not be regarded as a representation by us that any of our plans will be achieved any or all of the forward looking statements made on this call may turn out to be wrong.
The affected by inaccurate assumptions, we might make or by known or unknown restaurant uncertainties. You are cautioned not to place undue reliance on any forward looking statements, which speak only to the date hereof. All forward looking statements are qualified in their entirety by this cautionary statement and we undertake no obligation to revise or update this presentation and conference call to reflect event.
Or circumstances after the date hereof for a full discussion of such forward looking statements and the risks and uncertainties that may impact them. We refer you to the forward looking statements and risk factors section of our annual report on Form 10-K for the year ended December 31st 2022, and the quarterly report on Form 10-Q for the quarter ended March 30.
<unk> 2000, 2023 to be filed later today with the Securities and Exchange Commission.
At this time, it's my pleasure to turn the call over to Bradley Campbell, President and Chief Executive Officer Bradley.
Great. Thank you Andrew and welcome everyone to our first quarter 2023 conference call I am pleased to report a successful start to the year across our global business as we did in this morning's press release, let me highlight several key points before I turn it over to the team to provide more detail.
First <unk> continues its strong performance and remains the cornerstone of our success. We continue to be very pleased with the commercial uptake of Dallas hold globally with $86 million in the first quarter revenue, representing 14% growth from the first quarter last year on a constant currency basis.
<unk> trends continue across a number of our key performance indicators, including increasing demand through new patient starts for both switch and naive populations steady growth of in person visits between our field team in Fabry treaters.
Sustained patient compliance and adherence rates of over 90%.
We expect to see continued double digit growth in 2023 fueled by significant demand from patients and physicians and in fact, the Sebastian will highlight in a moment. This was the best first quarter performance for net new patient starts in the past four years.
Second we continue to make great progress on our global regulatory filings and commercial planning for <unk>. Our novel two component therapy for Pompe disease Importantly, I'm very happy to report that the U S. FDA has recently completed the required preapproval inspection of the Wuxi Biologics manufacturing site in China, We're very pleased with the outcome.
Inspection and believe the comments and observations received by Wuxi at the close of the inspection of all addressable. We therefore continue to expect regulatory approval of FPGA in the United States in the third quarter of 2023.
Also I'd like to give a word of thanks to the FDA inspectors, the Wuxi team and the amicus team for the collaborative and professional conduct leading up to and during the course of the inspection.
The regulatory reviews in Europe and U K also remain on track in March the European Commission granted approval probability for the use in combination with Boulder for adults with late onset pompe disease and.
And as we just announced the <unk> also adopted a positive opinion recommending marketing authorization of October . So we continue to anticipate the full approval of possibility plus up for that to occur in the third quarter of this year.
Non approval this will be the first two component therapy available in the European Union for the treatment of adults living with late onset Pompe disease.
And finally, the UK regulatory process for a PGA was initiated in December of last year and it's following a similar timeline as the U S and Europe with expected approval in the third quarter this year as well.
As we've observed throughout 2022, we remain extremely pleased with the level of interest in participation. We're seeing in our expanded access mechanisms for atg globally.
As we get through the first part of 2023 across all of our ongoing clinical studies and expanded access programs. They are now approximately 200 patients on <unk>, which we believe represents more than 5% of the total treated <unk> patients around the world and.
And we have more patients in the queue. So we expect this number to continue to trickle upward as we approach launch.
In anticipation of the regulatory approvals our global launch planning progress continues as we eagerly anticipate the final approvals of <unk>.
We very much look forward to providing a real choice in this therapeutic area both in the United States and in Europe with regulatory applications in additional countries planned in the months ahead.
And third amicus has maintained a strong financial position as we continue to execute on the global expansion of <unk> and prepare for the global launch of <unk> <unk>.
Importantly, based on our latest assumptions on approvals and launch of <unk>. Our current operating plan and continued careful management of expenses, we remain on track to achieve non-GAAP profitability, which we expect in the second half this year.
And on slide four as we laid out at the beginning of the year. We are laser focused on achieving our key strategic priorities for 2023, including number one sustaining that double digit growth revenue of 12% to 17% for Gallup hold at constant exchange rates delivering this important medicine to more people living with fabry disease with amenable variance in existing.
In new markets.
Second securing regulatory approvals of <unk>.
By the FDA EMA NHRA this year as well as continuing to advanced preparations for the anticipated launches.
Number three continuing to judiciously invest in the advancement of our best in class next generation Fabry, and Pompe generic medicine capabilities as well as our next generation chaperone for Fabry disease.
Number four as always maintaining a strong financial position as we carefully manage our expenses and investments on a path to non-GAAP profitability.
With that overview, let me now turn the call over to Sebastian Martell, Our Chief business Officer to further highlight the downhole performance.
Sure.
Thank you Brendan and good morning to everyone on the call I'll start by providing you with more detail on <unk> performance for the quarter.
As you can see on slide six for the first quarter 2023.
<unk> reported revenue reached $86 $1 million, driven primarily by strong patient demand.
The geographic breakdown of revenue during the quarter consisted of $57 million or two thirds of revenue generated outside of the U S and the remaining $29 million or one third coming from within the U S.
That's in line with the Street that we expect as we continue to grow both parts of the business.
As Brendan mentioned, we're pleased to see continued patient growth in countries across our leading markets.
Now turning to slide seven our results for the first quarter highlights the strength of our global commercial efforts the demand for mechanical globally continues to be strong with patients added in all major markets steady bearing operational growth rates of 14% over the same period in 2022.
And exchange rates.
From a year over year perspective, the negative impact from foreign currencies was 4% in the periods.
As a result, <unk> reported revenue growth versus the same period last year with 10% for the first quarter.
Gaslog continues to be the fastest growing treatment for companies globally.
I am pleased to report that our monthly net new patient trends continues to increase and if you look at the growth net patients from Gaslog globally, which is the truest measure of the underlying.
That business, we see a high teen growth rate in patients from Canaccord at the end of Q1 this year versus the same period last year.
So all indications are of the continued and growing demand for chemicals.
When we ended the first quarter, we had more than 55% of the global market share of treated amenable patients.
And within the global mix, we're starting to see stronger taking naive populations.
So while we're achieving high market shares in countries, where we have been approved the longest there's still plenty of opportunity to continue to switch patients over to kind of hold and continue to grow the market as we penetrate into the diagnosed and treated.
Dino segments.
All of that is underpinned by impressive compliance and adherence rates that continue to exceed 90% reiterating our belief that those patients who <unk>.
Predominantly stay on chemicals.
Importantly, the value of what continues to be recognized by payers.
Got it very strong track records of successfully negotiate shaky and renegotiate your reimbursement outside of the U S.
Our relentless commitment remained come ensuring access to kind of hold for anyone who needs. It.
Based on the performance we've seen here in the first quarter of 2023 <unk>.
<unk> continues to track very well and we're seeing those trends continue with growth across all of our major markets as well as most of our smaller markets.
Turning to slide eight.
GAAP growth remained strong with eight to $6 $1 million in revenue in Q1.
As mentioned on past calls due to a variety of factors.
<unk> uneven ordering patterns and FX fluctuations the rate of growth within the year is typically 90 year and we expect that to continue throughout 2023.
The table that you have on the right hand side of the slide we provided a five year historical snapshot of the percent of gasoline sales that ultra each quarter. During a given year, we would expect a similar trend to occur this year.
Now moving on to slide nine we know there is significant demand for kind of fold in that.
Segment of the global Fabry market made of patients with amenable mutations.
The potential surpassed $1 billion annual revenue and around five years.
We anticipate sustained growth throughout 2023 to be driven by several key growth drivers continuing to penetrate into existing market share.
Further uptake into the diagnosed untreated population.
Expanding into new geographies.
And label extensions.
As we just mentioned all of these efforts are supported by Sony compliance and adherence rates and positive reimbursement and access mechanisms around the globe.
I'm pleased to share that we're making continued progress on expanding into new markets and also in extending our label.
To name a few examples we recently received marketing authorization organic will be in Hong Kong.
The extension of used whether it be patients 12 years and above.
Recently been approved in Canada, and we've submitted the marketing authorization application Zeeland.
We've now entered into pricing and reimbursement negotiations for Gaslog in Turkey.
In the longer term, we continue to see significant growth in the property market globally.
Even by diagnosing patients through a variety of measures, including high risk screening newborn screening and other diagnostic initiatives.
We continue to support and invest in as well.
Also important to note here, we have orphan exclusivity in the U S and Europe in.
In addition to our now 14 nine Orange book listed patents, including eight compositions of matter patents and.
33 of our business give us IP coverage into the late 2013, which provides us the opportunity to provide access to <unk> globally for a long time to come.
Now moving onto slide 10.
We're happy today to spend less in the quarter from the commercial launch of stability.
Dale.
On that slide we outline Nox preparations as we are poised for another successful product launch.
As you know because of the presence in over 40 countries around the world today, including all of the major <unk> markets.
That team that will launch mobility and a pull that largely stayed the same with only a few additional ftes were now fully recruited and trained to support the first wave of launch countries.
Please do note that product was being position to support the first group of patients coming onto commercial supply.
We have experienced across all areas that are needed for successful drug launch regulatory commercial supply chain experience with payers reimbursement and access.
In addition, and most importantly, the key relationships with physicians.
Confident that our world class organization that we can leverage their experience and relationships and deliver ATCA to people living with competitors around the world.
Our educational and promotional materials already.
And training in our initial launch countries is now completed.
Mapping is also complete from.
From the team the medical education and publications our ability to market. These products successfully are experienced with reimbursement and access around the world and again August trying to do planning that we've been doing.
Together with building inventory with our partners at Wuxi Biologics, we believe we're in a very strong position in force accounts successful launch of our meters.
With that let me now hand, the call over to Jeff Castelli Chief.
Chief Development officer to highlight our <unk> program and pipeline updates Jeff.
Thank you Sebastian and good morning, everyone on Slide 12, we'll start with our <unk> program.
Pompei is a severe and fatal neuromuscular disease and one of the most prevalent lysosomal disorders and.
In multiple publications and natural history studies have shown that the initial benefits of treatment are often followed by continued long term decline for many individuals.
Recognize that Pompe disease continues to pose a range of health challenges for people affected by the disease and having therapeutic choices is crucial.
Moving on to Slide 13, we remain very excited to be anticipating potential regulatory approvals in three of the largest pump markets in the third quarter of this year as Charlie noted.
On this slide we summarize the status of the anticipated regulatory milestones by market.
First in the EU probability was granted European Commission approval in March and April the <unk> adopted a positive opinion about Florida, and we expect an EC approval to occur in the third quarter of 2023.
In the U S. The FDA recently completed the required pre approval inspection of the Wuxi Biologics manufacturing site in China, and we are very pleased with the outcome and believe that the comments and observations received by Wuxi at the closing inspection are all addressable we continue to expect approval of both components of <unk> together in the third quarter.
This year.
And finally, the regulatory submission process for <unk> in the U K was initiated in December via the recognition procedure based on the <unk> opinion and we're on track for an expected NHRA approval also in the third quarter, so lots of great momentum across the key markets.
Okay.
Moving on to Slide 14, we highlight our ongoing clinical studies and multiple mechanisms of expanded access that support some of the early demand for atg.
For the younger pump a community we continue to enroll the ongoing open label study in children up to 18 years of age living with late onset Pompe disease and have now begun enrolling to open label <unk> study for children living with infantile onset pompe disease.
Importantly in response to the.
Multiple requests for treatment that we continue to receive for children living with <unk> and IOP.
Our expanded access programs continue to enroll those patients.
We have multiple expanded access programs in place, including in the U S U K, Germany, France, Japan and other countries. This includes the early access to medicine scheme or <unk> in the UK, where we continue to see significant enthusiasm for ATCA with physicians, having requested access across all of the leading pompe based centers.
And dozens of patients now on treatment.
Since the positive scientific opinions interest and momentum for <unk> has continued to grow and we are pleased to be able to provide access to those who are eligible.
With this growth and our access programs as Brian noted we are pleased to report that there are approximately 200 patients now worldwide being treated with <unk> across our clinical extension studies and expanded access programs and.
An experienced at ATCA is growing.
Worldwide with approximately 75 centers currently participating in those different programs.
Finally, as highlighted in the pipeline slide in the appendix for our earlier stage pipeline. We continue to focus on novel approaches for Fab brand campaign <unk>.
Including gene therapy to deliver our engineered GLA and GAA transgene.
And our next generation Fabry chaparral.
With that I would like to now turn the call over to Dr. <unk> <unk>, our Chief Financial Officer to review, our financial results guidance and outlook Daphne.
Thank you, Jeff and good morning, everyone. Our financial overview begins on slide 16, with our income statement for the first quarter ending March 31 2023.
The first quarter, we achieved total revenue of $86 3 million, which is a 10% increase over the same period in 2022.
This includes year over year operational revenue growth measured at constant currency exchange rates of 14% impacted by a negative currency up 4%.
Cost of goods sold as a percentage of net sales was 8% in the year as compared to nine 6% for the prior year period.
Total GAAP operating expenses decreased to $117 million for the first quarter of 2023 as compared to $146 5 million in the first quarter of 2022.
On a non-GAAP basis total operating expenses decreased to $80 6 million for the first quarter of 2023 as compared to $109 million for the first quarter of 2022, reflecting decreased program spend.
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 of contingent consideration and depreciation.
Net loss for the first quarter of 2023 was $52 $9 million or <unk> 18 per share as compared to a net loss of $85 3 million or <unk> 30 per share for the prior year period.
Driven by the revenue growth of gallon fold and careful expense management, we continue to make progress towards our path to non-GAAP profitability in the second half of this year.
As of March 31, 2023, we had approximately 283 million shares outstanding.
Turning now to slide 17, we continue to operate from a position of financial strength and our goal remains to achieve non-GAAP profitability in the second half of 2023 as defined in our press release.
Stability is dependent on a number of factors, including the timing of approval and launch of <unk>.
Our full year 2023, non-GAAP operating expense guidance is $340 million to $360 million.
The decrease in operating expense for 2023 as compared to 2022 will be achieved by continuing to drive efficiencies and prudent expense management offset by continued investment in the global growth of <unk> and prelaunch and launch activities for <unk>.
We anticipate operating expenses to be non linear this year due to these prelaunch and launch expenses as well as certain nonrecurring manufacturing costs that we expect will be incurred in the second and third quarters of this year.
We also expect to see a larger portion of our operating expense to be allocated to G&A. This year as we align our resources to support the launch of 80, GAA and the continued growth of doubtful.
A few comments about our cash position in 2023 financial guidance.
Cash cash equivalents and marketable securities were $267 1 million at March 31, 2023, compared to $293 6 million at December 31 2022.
Our full year <unk> revenue guidance is revenue growth of 12% to 17% at constant exchange rates. In addition to our non-GAAP operating expense guidance of $340 million to $360 million.
And with that let me turn the call back over to Bradley for closing remarks.
Great. Thank you Daphne Jeff's adaption for the detail there. So as you can also see we have been relentlessly focused on execution. This year across the business and have laid a strong foundation of what we think will be an important year for amicus as we approach. This next phase of the company. We're confident we can continue to drive sustainable long term value and deliver.
Life changing therapies to people in need.
Operator, we can now open the call to questions.
Thank you ladies and gentlemen, if you have a question. Please press star one to one on your Touchtone telephone at this time, we request that you only ask one question.
Do you have any additional questions. Please enter back into the queue.
Q1.
One moment for our next question.
Our first question comes from the line of our new Palm Rama from J P. Morgan.
Hi, Thanks for taking the question. This is actually Malcolm cuda on per on a pump.
So looking past the third.
Third quarter approval.
Our patients have you learned from Santa fees launch in Pompeii that you can perhaps supply to your own launch and then how should we view your launch curve relative to competition.
Yes, thanks for the question maybe I'll start.
Look so we.
We are laser focused as we said is getting through the approvals and launch and I think for US. The most important thing is providing a new choice that we think is differentiated in particular with its two component mechanism of action.
We have.
Watched and <unk>, both in the United States and other markets around the World and I think you could see depending on when they launched how they've progressed then for US I think it's much more about continuing to demonstrate the value of <unk>.
To physicians and patients I think we look at the expanded access programs and uptake where the product is available.
Through those mechanisms and we take great confidence in the way, we see patients with physicians using the medicine.
From our perspective, the most important thing is looking at what we've demonstrated in the clinic that in particular in the experience population when patients switch from therapy, we see a significant increase in six minute walk distance as well as improvement in forced vital capacity, we think that differentiation the only therapy.
That's shown in a controlled study that we can show those changes, we think that sets us up as a very differentiated therapy. When we launch and we're just really eager to get over the finish line to your second question in terms of.
How we kind of think about the launch uptake.
It will come as no surprise, but of course, the first focus is to convert our existing clinical and expanded access patients over to commercial medicine, and we're prepared to do that as quickly as possible. We will also be focusing of course on.
Patients, who we think we can switch.
Current standard of care over to <unk>.
The goal this year frankly, just given the fact that the approvals happen.
Back half of the year. It takes time from a pricing and reimbursement perspective. The goal really is to maximize the number of patients on therapy by the end of the year and that we think gives us a really strong run rate going into 2024.
Thank you one moment for our next question.
Our next question comes from the line of Ellie Merle from UBS.
Hey, guys. Thanks, so much for taking the question.
Just wondering if you could elaborate a little bit on the comments and observations on risky for me at Berkshire, and maybe just kind of what drives your confidence that all of these are addressable.
Just a question for Steve early on how to think about the timeframe like Robin section to approval I guess just in situations like this with a deferred action how should we think about that the typical timeframe and maybe al Sandrock next steps from here.
In terms of the time lines for addressing that comments and observations.
Yes, thanks, Alex for the questions.
As we said previously leading up to and inspection, we're not going to provide details of the filings, but I will reiterate we're very pleased with the outcome. The color I can provide is that we think the feedback was straightforward and addressable that's shared by Wuxi with all their experience with inspections and that's why we feel very confident here reiterating.
The approval in the third quarter I would say too there was a high level of engagement professionalism between the inspector is wuxi in amicus.
All of this together makes us feel very confident in that timeline that we reiterated today youre right in terms of sort of what happens from here. We are in a little bit of an unusual situation, but typically what happens is as the.
The FDA finalizes the inspection, which has now happened then they finalize the inspection report that takes a period of time and whats. The inspection report is finalized and provided to the review Division, that's where you get that kind of 30 to 60 day timeline to approval and so that gives us a lot of comfort that we're on track there.
Based on the fact that we received the deferred action letter and again will remind folks at least per the regulation that says that those can only be given when no other issues remain in the application otherwise satisfies.
The requirements for approval that gives us great confidence that effectively it's really just getting through the final inspection report and then final memos and the agency and then we're on to approvals and launch.
Thank you one moment for our next question.
Our next question comes from the line of Joseph Schwartz from SBB Securities.
Alright. Thanks, so much I was wondering if you could talk a little bit.
Thanks.
About the market opportunity for mobility and weather.
<unk> has evolved or your strategy for launching it has evolved now that.
The launch has been delayed and a competitor it's been on the market for a while longer than was initially expected.
Yes, maybe Sebastian do you want to talk a little bit about kind of what we're seeing and why we are remaining confident.
That market opportunity to Joe's question.
Yes, so Joe.
Overall market for the last year reached about $1 $2 billion Mark.
That has been growing at high single digit low double digits for a number of years.
Still this is a disease that is under diagnosed.
We expect the overall market growth rate to continue at least at the same.
Right.
As you look at the bias regions and our initial focus in the U S.
In the U K in Europe . These are.
Three largest markets for <unk>, we estimate that there is around 300 patients treated.
We will compete in Europe . Another couple of hundred in the U K and north of 800 patients in the U S.
I think we've seen repeatedly through all the outcome could be done market research assessments that.
Physicians react very well to the product profile of <unk> and in particular to the switch data.
We generated from the propel study.
The CD.
The vast majority of the opportunity lies.
In this switch opportunity the number of.
Newly diagnosed patients.
As a much smaller number on a global basis, maybe 100 to 200 patients per year compared to an overall market actually treated patients somewhere between 3500 for solving so it will be very much focused on.
On ensuring that we have we.
We provide.
Is the access to ATCA and as Bryan alluded to I think that the.
Experience, we're seeing through the early access programs bodes well for for the launch of <unk>.
Thank you one moment for our next question.
Our next question comes from the line of Ritu borrow from T D Cowen.
Hey, guys. This is Athena on for Ritu. Thanks for taking the question just another follow up on the Wuxi inspection has every building as part of the entire supply chain been inspected at this point and you.
Right that any of the inspection findings could be gating for approval.
Thank you.
Yes, thanks for the question Athena.
So.
The important part of this inspection. So wuxi has been inspected that site in China has been inspected multiple times by multiple regulators for multiple products. All successful. So that's a good thing. This particular inspection was focused on the drug substance and drug product manufacturing facilities for our product in particular.
And so I think thats the difference here now that that's been complete there are no other inspections by the United States that we believe are necessary ahead of approval and so we feel very confident at this point that we are on track there.
Based on.
The outcome of the inspection so.
I think at this point were sort of all systems go and looking forward to getting through the Finalization of the review and heading towards approvals module.
Yes.
Thank you one moment for our next question.
Okay.
Our next question comes from the line of Dave Gone Hong from Stifel.
Hey, good morning, guys. Thanks for taking our questions I'll stick to one.
Wanted to get your take on pricing strategy, given the parallel review.
And I understand you guys gave guidance on our <unk> approval for both sides of the Atlantic, but it does seem like you might come sooner.
<unk> the processes remaining for the FDA side. So how are you thinking about that overall.
And how does that compare to your fabry strategy. Thanks, so much.
Yes, Thanks, Dave.
We have taken the strategy that we will price our medicines at parity or modest discount to standard of care and that's really because we value access more than anything else. So our goal is to get as many patients on therapy as quickly as possible.
And we feel like taking price off the table in other words, focusing on the value of the medicine that it brings to patients and physicians versus the cost of the medicine is the best way to ensure that you move through the reimbursement process as quickly as possible.
And what we saw with <unk> to your point is that we actually moved through that reimbursement process successfully.
That we did it in.
Times that were much faster than industry average. So we will look to apply the same strategy here and in some instances.
Actually those discussions are already ongoing and so we look forward to deploying the same strategy and again focusing on the value of the medicine versus versus the cost.
Thank you one moment for our next question.
Our next question comes from the line of Christian <unk> from Cantor Fitzgerald.
Okay.
Hi, everyone. Good morning, Thanks for taking my question wanted to ask what your latest thoughts are on how you might position atg.
Relative to the benefits across our respiratory.
And different measurements, there and I know you're presenting more data at world. This year and in the past you've cited this as a really important end point, considering it's a leading cause.
With mortality for these patients. Thank you.
Yes, Thanks, Chris and Jeff maybe you can talk through.
The data we've seen both in the initial phase of the study and then what we just released that world with the extension data.
Yes, Thanks, Brian and thanks, Kristen for the question so.
As we've seen in our clinical studies with <unk>.
We see on pulmonary function, which is your point. It is one of the basically the leading cause of mortality in Pompeii that.
Patients had had been.
On standard of care <unk> saw quite significant decline in pulmonary function that they remained on treatment, whereas patients switched to a PGA showed good stabilization on that pulmonary function and importantly, as we've now seen data in our extension studies from phase one to four years and from our propel study.
Two years.
That stability seems to be maintained and durable over those additional extended time periods in the trials. So we're very excited about the potential ability to help stabilize that progressive decline in pulmonary function, we see and also importantly, the other key arm of Pompei is on the motor function and muscle strength side of things in there, we're actually really excited to see.
See some improvements even in patients that.
Which are not necessarily expected patients switched to <unk>. So across those two key aspects of disease. We're very excited by both the initial response to treatment has seen a problem. But then the continued durability of response and the extension trials.
Okay.
Thank you one moment for our next question.
Our next question comes from the line of Solvay <unk> Richter from Goldman Sachs.
Hi, This is for nutshell answer Levine.
We have two questions. The first is how soon post approval can we expect the first patients to be treated with APG and rescue patients who are not on the early access programs and the second is could you provide some color on what you can expect in the first few months of the launch thank you.
Yes. Thanks for the question so in terms of.
First patients on therapy. So theres two different situations you have the United States of course, where you get approved.
And then you're typically moving quickly to setting up infusions.
And.
Getting prescriptions.
Fusions to getting patients on therapy, while we've seen in.
Our experience with <unk> is our goal is to convert all of our patients on therapy, who are of course on label to commercial drug within the first 90 days and so thats something we will focus on and we were able to execute that very successfully.
In the Gallup poll launch, we believe we'll be able to do that here.
<unk>.
And then likewise in Europe of course, you get approval in Germany, you've typically have what's kind of colloquially known as that free pricing period. So again, theyre reimbursable will come almost immediately and the goal will be on the back of approval the goal will be to.
Quickly again converted patients on existing therapy I'll note in Europe , or sorry in Germany, We do have an expanded access program ongoing as well and again that's within.
And of that 30 to 90 day period.
And then in the UK, we do we will go through the reimbursement process and again, that's where that focus on access is so important.
So there is a little bit of time to get from from NHRA approval to two nice approval and reimbursement.
We'll also of course, while we're converting our existing patients also be focused on initiating patients who are on existing therapy in the U S and all patients outside the U S as well that are on label.
Thank you one moment for our next question.
Our next question comes from the line of Jeff Hung from Morgan Stanley .
Thanks for taking my question can you talk about the recent feedback you've heard from payers on the ATCA and what kinds of comments do you hear on potential barriers on access restrictions.
Yes. Thanks for the question all of our market research from a payer perspective has been I think very supportive of the approach that we outlined here in terms of our strategy, which is that as long as it on label.
And if we have a parity or amount of discount strategy payers I think will be very supportive of this medicine, they've gotten more sophisticated especially in this disease area. So they do review the data very carefully.
And we expect that process to continue.
And then likewise outside the us where youre going through the BHA assessments again, I think with the data that we have with the.
Market research, we've done leading into this process and now with the ongoing negotiations we started with some of those payers. We think this is going to be a very successful access strategy and we're just eager to get through the process and provide us this medicine to patients.
Thank you.
Thank you one moment for our next question.
Thank you. Our next question comes from the line of Chi Tsang shoe from bearing Berg.
Good morning.
Thanks for taking the question I wanted to ask you're on.
And today announced the expansion of Scott.
The prior manufacturing agreement, which we're seeing.
Ireland facility I guess can you talk about the transition plan from the China facility tiered Ireland facility.
So do you expect the FDA inspection on the island percent intercourse. Thanks.
Thanks very much.
Yeah, Great question. So so yes, we announced in the last couple of weeks, we did enter into a commercial manufacturing agreement with Wuxi that was something that was in.
In the works for quite some time, and we're really thrilled to solidify that that effectively secures.
Capacity longer term capacity and supply from Wuxi from both their China facility as well as the Ireland facility. The strategy really is to eventually transition so that the majority of supply comes from Ireland.
And.
Suggested before is we're on track for that process to conclude that license that facility to be licensed.
And materials start to enter the commercial supply chain in the back half of next year or early 2025 and that process is going well.
In terms of inspection of the facility of course, you'll have to go through the typical.
PDQ.
Asian and comparability.
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As we transition to Ireland all of that it's kind of contained in the timeline that I shared with you.
Will the FDA or other.
Regulatory agencies inspect the facility almost certainly they will at some point whether that will be required.
Pre licensure.
Or whether it will happen some time in due course to be determined but.
We're very confident in that process and we're eager to have of course, a second site of manufacturing come online and one that's geographically diversified as well.
Thank you at this time I would now like to turn the conference back over to Bradley Campbell for closing remarks.
Yes.
Great. Thanks, operator, thanks, everybody for the precision for the participation in the call today all your great questions Hope everybody has a great day take care.
Thank you. This concludes today's conference call. Thank you and have a great day.
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