Q2 2022 argenx SE Earnings Call

Good morning.

Good morning, My name is Rob and I'll be your conference operator today at this time I'd like to welcome everyone to the call.

My name is Rob, and I will be your conference operator today.

At this time, I'd like to welcome everyone to the call.

All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question and answer session.

Do you like to ask a question. During this time simply press star followed by the number one on your telephone keypad. If you would like to withdraw your question again press Star one.

All lines have been placed on mute to, prevent any background noise.

I'd like to introduce Beth <unk>, Vice President of corporate Communications and Investor Relations you May now begin your conference.

After the speaker's remarks, there will be a question and answer session.

Thank you operator, our press release was issued earlier today with our first half 2022 financial results and second quarter business update this can be found on our website along with the presentation for today's webcast.

Before we begin I'd like to remind you on slide two that forward looking statements may be presented during this call.

They include statements about our future expectations clinical developments regulatory timelines the potential success of our product candidates financial projections and upcoming milestones actual results may differ materially from those indicated by these statements are generics is not under any obligation to update statements regarding the future or just inform those.

Statements in relation to actual results unless required by law.

I'm joined on the call today by Tim been Harrow Marin Chief Executive Officer, Carl <unk>, Chief Financial Officer, and Keith Woods, Chief operating Officer.

I'll now turn the call over to Tim.

If you'd like to ask a question during this time, simply press star followed by the number one on your telephone keypad.

Thank you Beth and welcome everyone.

We're just halfway through 2022.

And it has already been a year of incredible execution by our team outlined on slide number three.

We are delivering on two commercial launches.

In the United States and one in Japan.

And then now looking ahead to broaden the global reach of its Scott.

We had two positive phase III data readouts in the first half.

And are positioned for a series of trials faster and additional data readouts over the next 18 months.

And we were able to finance our ambitious business plan in a difficult market environment.

We live by our reputation for execution.

I want to start by saying, Thank you to the <unk> colleagues for their thorough preparation and steadfast determination to achieve our goals.

And to our stakeholders, our shareholders, our physician partners and of course our patients.

If you would like to withdraw your question, again, press

To begin with.

star one.

The second quarter of our fifth card launch showed significant growth from the first quarter with global net product sales of $75 million. This will expand on our progress across our patient physician and payer segments later in the call, but at a high level and really help.

Thank you.

With the teams hard work.

Our prepared going into approval with carefully crafted strategies and continued to execute on them.

A few highlights to point out on slide number four.

Our market access team delivered what I promised and secured broad coverage in the first two quarters of launch.

I'd like to introduce Beth DelGioco, Vice President of Corporate

This was crucial in converting physician prescriptions to patients on therapy.

Communications and Investor Relations.

We are getting regular feedback from physicians and patients on their experience with <unk>, which while anecdotal airlines.

You may now begin your conference.

Airlines with data from the adapt trial, including on the fast onset of action and to minimum symptom expression.

MFC was an exploratory endpoint in our trial.

The metric that is growing in importance amongst neurologists because of its practical meaning for patients.

This feedback is also in line with what we hear from Gmg patients and advocates on the significant unmet need that still exists.

We have learned firsthand and through our outcomes research for the devastating and debilitating disease gmg can be with its novel mechanism of action.

Thank you, operator.

<unk> has the potential to transform the treatment landscape and significantly improve patients' lives.

Hearing stories from patients who are already experiencing this benefit has been the most rewarding park over the last six months.

I am equally very proud of our ongoing commitment to be leaders in F. <unk>.

Not only from the commercial side, but also the scientific.

Our approach starts with solid signs and is backed by strong data.

And we continue to draw on this to further elucidate <unk> biology, and how best to modulate it.

We believe our science based approach will remain a powerful tool as we engage with our key stakeholders.

Beyond the good news of our launch we have had other accomplishments this year across our aircraft taking about program.

Our ambition is to reach many more patients suffering from autoimmune diseases through our <unk> product launch and label expansions.

Slide five in March we delivered positive phase II data from our subcutaneous <unk> recall that we had to show non inferiority of <unk> Q2, IV based on ITG reduction.

And meet safety database requirements.

We have accomplished both.

Putting us firmly on track to file the BLA by the end of the year.

Slide six.

In May we announced positive phase III data from our advance IV trial.

We met a fairly difficult primary end points in a highly refractory patient population.

In IDP.

I've got taken months showed a consistent response profile as we've seen in other indications the fast onset of action and patients with sustained responses.

Able to switch to every other week dosing.

We have gotten feedback from physicians on the data and continue to hear about the importance of the <unk> score in how they treat patients.

We saw a 51% response rates on the <unk> scale.

Where patients had to show a sustained platelet counts over 30000.

And in the absence of any bleeding events for two separate fields.

<unk> weekly visits.

Safety profile of <unk> gotten this chronic dosing setting was also consistent with previous clinical trials.

Slide seven.

We promised that we would look at key learnings from advance and apply them to our ongoing advanced <unk> study.

With this and have made a database decision to adjust our powering assumptions and expanded enrollment in the S. C trial.

This pushes the timing of top line data to the second half of 2023, which we believe is in the best interest of ITG patients.

We are set up for a very busy 2023.

We expect top line <unk> data in the first quarter MTV and <unk> data in the second half.

Before I turn the call over to Carl for our financial results I want to briefly talk about on Coverity on slide eight.

We announced this morning in our press release that we decided to take the company creation approach to advance development of <unk> in the AML patients.

That is why we think this is the right decision.

For us.

For the drug.

And for patients.

We have the unique and exciting opportunity.

Take the novel Translational biology insights from Dr. Clayton Smith at University of Colorado.

And combine them with our first in class assets gives us <unk>.

Dr. Smith and team have uncovered important insights on the role of the CD 70, CD 27 pathway in ammo.

And more specifically in Valletta collection on responsiveness or resistance, which we think will complement the encouraging data we have already demonstrated in newly diagnosed AML patients unfit for chemotherapy.

We believe the data we have shown to date warrant further development of Joseph Tucci map.

And through on Coverity.

This work will happen in an organization that has the expertise and the bandwidth to default the right time and resources to this opportunity.

This is the best decision for AML patients.

Coverity is also the fourth company to emerge of our discovery engine.

Where we have built the company around the promising assets, while taking a stake in the development.

This strategy requires minimal financial commitments and allows us to maintain significant value creation potential for our shareholders.

Between our commercial launch.

Our progress in R&D.

And our commitment to immunology innovation we.

We are off to a strong start for 2022.

Our focus going forward will be about continued execution and sustained growth and expansion.

With that I will turn the call over to Carl.

Thank you Tim.

A press release was issued earlier today with our first half, 2022 financial results and second quarter business update. This can be found on our website along with the presentation for today's webcast.

First half and second quarter 2022 results are detailed in our financial release from this morning.

Before we begin, I'd like to remind you on slide two that forward-looking statements may be presented during this call. These may include statements about our future expectations, clinical developments, regulatory timelines, the potential success of our product candidates, financial projections, and upcoming milestones.

Only highlight the key points here on slide nine.

For the second quarter Global net product revenues from the webcast launch was $74 $8 million, which includes $1 5 million from Japan, and some named patient sales from Israel to Kevin we have a $21 million Shlomo first quarter.

Actual results may differ materially from those indicated by these statements.

ArgenX is not under any obligation to update statements regarding the future or to conform, those statements in relation to actual results unless required by law.

I'm joined on the call

today by Tim Van Houwermaeren, Chief Executive Officer, Carl Gubitz, Chief Financial Officer, and Keith Woods, Chief Operating Officer.

This puts our year to date global product hated news of $96 million.

I'll now turn the call over to Tim.

Entertainment channel quarter, eight while swallowed managed clinics.

Two weeks whitlow bottles.

Total revenues for the quarter.

$85 2 million, which also includes $10 million in collaboration revenue.

<unk>.

Cost of sales for the quarter were approximately $5 million total R&D.

G&A expenses for the second quarter with approximately $26 9 million.

$127 8 million respectively.

These can mainly be attributed to aircraft taking mode than ever pipeline, what would you say its expenses.

As well as marketing and head count expenses unrelated to walgreen for launch.

On our cash.

We ended the second quarter were two $6 billion in cash cash equivalents and current financial assets.

This includes net proceeds of $761 million from our March financing.

We continue to believe that our net cash burn this year will be up to $1 billion.

Which will specifically support the rollout of our global launch.

<unk> development of <unk> in 10 indications and <unk> savings in two indications.

Investment in the global supply chain and pipeline expansion through our immunology innovation program.

Our business plan is an ambitious one.

So we were very happy to be able to bring in additional capital earlier this year to sustain our ability to drive considerable value for our shareholders.

And find additional details behind these numbers in the press release, we issued this morning.

Thank you, Beth, and welcome everyone.

I'll now hand, the call to Keith for a commercial update.

Thanks, Carl Slide 10.

We are just halfway through 2022, and it has already, been a year of incredible execution by our team outlined on slide number three. We are delivering on two commercial launches, one in the United States and one in Japan, and are now looking ahead to broaden the global reach of VivGuard.

We are very happy with the continued momentum this quarter with our <unk> launch driven by consistent growth in both patient and physician demand.

We had two positive phase three data readouts in the first half and are positioned for a series of trial starts and additional data readouts over the next 18 months. And we were able to finance our ambitious business plan in a difficult market environment.

First six months of our launch are crucial and building the right foundation for the product.

We live by our reputation for execution, so I want to start by saying thank you to the ArgenX colleagues for their thorough preparation and steadfast determination to achieve our goals, and to our stakeholders, our shareholders, our physician partners, and of course, our patients.

Im incredibly proud of the team for their demonstrated commitment to getting us off to a strong start.

To begin, the second quarter of our VivGuard launch showed significant growth from the first quarter with global net product sales of 75 million U.S. dollars.

While we are still in the early days, we are seeing positive signals across each of our stakeholder groups all of which were key drivers in the $75 million in revenue we generated this quarter.

This will expand on our progress across our patient, physician, and payer segments later in the call, but at a high level, I'm really happy with the team's hard work. They were well prepared going into approval with carefully crafted strategies and continue to execute on them.

A few highlights to point out on slide number four.

Let's start with patients.

Our market access team delivered what they promised and secured broad coverage in the, first two quarters of launch. This was crucial in converting physician prescriptions to patients on therapy.

We are getting regular feedback from physicians and patients on their experience with Vyvgart, which, while anecdotal, aligns with data from the ADAPT trial, including on the fast onset of action and minimum symptom expression.

<unk> 11, we currently have approximately 4500 patients on therapy globally, which translated to over 1000, new patient adds in the second quarter.

This number includes initial contribution from the first six weeks of the Japan launch I was grateful to spend time in Japan with our commercial team and engaged with some of our key customers and overall, we are very pleased with the strong start.

MSC was an exploratory endpoint in our trial, but a metric that is growing in importance amongst neurologists because of its practical meaning for patients.

We had patients on therapy within the first week, including seronegative patients who benefit from the broader label in Japan.

Looking at the types of patients who are going onto <unk> guard. It remains similar to last quarter of the <unk> hundred patients about 50% have experienced with IV AIG, while the other 50% have experienced across the treatment paradigm from as early as just <unk> or steroids.

Our other biologics. This was a tremendous result from both our field team's engagement with physicians and patients asking about VM guard by name. It was a true multichannel approach and also the outcome we had hoped for by empowering patients.

Second quarter was one of extraordinary growth in terms of patient adds but we expect to see more of a balance between repeat and new patients going forward. The reason being that most patients only <unk> to date have IV AIG or other biologic experience. We are closely watching whether we can.

<unk> gained broad adoption earlier in the treatment paradigm, because this will be an important driver of our overall launch trajectory.

Before I move on to physicians I want to share some of the health economics outcomes research. We gathered this reinforces the potential value proposition of bid guard to gmg patients.

This feedback is also in line with what we hear from GMG patients and their advocates, on the significant unmet need that still exists.

We have learned firsthand and through our outcomes research, what a devastating and debilitating disease GMG can be.

With its novel mechanism of action, Vyvgart has the potential to transform the treatment landscape, and significantly improve patients' lives.

First the majority of patients when entering into the adapt study reported issues with mobility self care and completing their usual daily tasks.

Often these challenges were accompanied by pain discomfort anxiety and depression.

From the early data, we gathered gmg patients and a depth experienced rapid and substantial improvement in health related quality of life. Following <unk> treatment at peak response patients approach the quality of life of the general population.

Additionally, we know that hospitalizations can pose a significant burden on gmg patients and adapt <unk> treated patients experienced a 67% lower risk of Mg related hospitalization than placebo overall.

Hearing stories from patients who are already experiencing this benefit, has been the most rewarding part of the last six months.

I am equally very proud of our ongoing commitment to be leaders in FCRN, not only from the commercial side, but also the scientific.

Overall, it's very rewarding to hear this initial research showcasing another aspect of the value proposition of Bib guard to gmg patients.

Moving on to physicians on slide 12, we see that our messages are resonating with physicians the strength of the adapt data and driving robust and deep responses combined with our favorable safety profile.

Our approach starts with solid science and is backed by strong data, and we continue to draw on this to further elucidate FCRN biology and how best to modulate it.

We believe our science-based approach will remain a powerful tool, as we engage with our key stakeholders.

With our launch strategy, we made a commitment to market from the science and stay data driven.

Beyond the goodness of our launch, we have had other accomplishments this year, across our FCRN program.

Our ambition is to reach many more patients suffering from autoimmune diseases, through our SubQ product launch and label expansions.

This is paying off and physicians are showing increased awareness on the mechanism and action of FC RM and the mechanism of disease of gmg as being antibody driven.

Slide 5.

In March, we delivered positive phase 3 data from our ADAPT SubQ trial. Recall that we had to show non-inferiority of SubQ to IV based on IgG reduction, and meet safety database requirements. We have accomplished both, putting us firmly on track to file the BLA by end of the year.

We are seeing breadth and physician prescribers, but also depth from some early adopters.

Slide 6.

One of the drivers of the breadth. We are seeing is that our sales team is focused on an allocated resources to our top priority targets. Our goal is for these early prescribers to share their experience with colleagues and peers.

In May, we announced positive phase 3 data from our ADVANCE IV trial. We met a very difficult primary endpoint in a highly refractory ITP patient population. In ITP, AVGAR-TIGAMOD showed a consistent response profile, as we've seen in other indications. A fast onset of action and patients with sustained responses, who were able to switch to every other week dosing.

We have gotten feedback from physicians on the data, and continue to hear about the importance of the IWG score in how they treat patients. We saw a 51% response rate on the IWG scale, where patients had to show a sustained platelet count over 30,000 and in the absence of any bleeding events for two separate consecutive weekly visits.

Safety profile of IVCAR-T in this chronic dosing setting, was also consistent with previous clinical trials.

Slide 7.

We promised that we would look at key learnings from advance and apply them to our ongoing, advanced sub-Q study. We did this and have made a database decision to adjust our powering assumptions and expand enrollment in the SC trial.

This pushes the timing of top-line data to the second half of 2023, which we believe is in the best interest of ITP patients.

And looking ahead to upcoming quarters, the big unknown with our physicians is going to be driving that adoption curve at this stage, 78% of our prescribing physicians have written one or two scripts. So shifting these prescribers from initial use to broad adoption is going to be a key indicate.

We are set up for a very busy 2023.

We expect top-line CIDP data in the first quarter and PV

and ITP data in the second half.

Before I turn the call over to Karl for our financial results, I want to briefly talk about OncoVerity on slide 8. We announced this morning in our press release, that we decided to take the company creation approach to advanced development of Q-SATUS MAP in EML patients. Here is why we think this is the right decision for us, for the drug, and for patients.

We have the unique and exciting opportunity to take the novel translational biology insights from Dr. Clayton Smith at the University of Colorado and combine them with our first-in-class assets, Q-SATUS MAP. Dr. Smith and team have uncovered important insights on the role of the CD70-CD27 pathway in EML, and more specifically in venetoclax non-responsiveness or resistance, which we think will complement the encouraging data we have already demonstrated in newly diagnosed EML patients unfit for chemotherapy.

We believe the data we have shown to date warrant further development of Q-SATUS MAP, and through OncoVerity, this work will happen in an organization that has the expertise and the bandwidth to devote the right time and resources to this opportunity.

<unk> and our launch growth trajectory.

This is the best decision for EML patients.

OncoVerity is also the fourth company to emerge of our discovery engine, where we have built a company around the promising assets while taking a stake in the development. This strategy requires minimal financial commitment and allows us to maintain significant value creation potential for our shareholders.

Finally, I'd like to cover the excellent work, that's being done by our market access team on slide 13, we continue to have constructive conversations with payers and as we committed last quarter. We have achieved broad coverage <unk> specific policies have been published in Medicare and commercial plans covering <unk>.

Between our commercial launch, our progress in R&D, and our commitment to immunology innovation, we are off to a strong start for 2022.

Our focus going forward will be about continued execution and sustained growth

and expansion.

With that, I will turn the call over to Karl.

Thank you, Tim.

Almost 85% of covered lives the <unk>.

Our first half and second quarter 2022 results are detailed in our press release from this morning, so I will only highlight the key points here on slide 9.

Majority of these policies are favorable and aligned to the <unk> Gard label patients need to fail only <unk> or steroids to gain access and approvals are typically for six to 12 months at a time.

R. J code went into effect on July 1st as expected, which we believe will facilitate a more seamless conversion from enrollment to infusion and give confidence to some prescribers that the process should be straightforward.

For the second quarter, our global net product revenues from the VivCard launch were $74.8 million, which includes $1.5 million from Japan and some named patient sales from Israel, together with $21 million from the first quarter. This puts our year-to-date global product revenues at $96 million.

Inventory in the channel at quarter end was well managed and reflects less than two weeks worth of vials.

Moving on to the progress of our global launch on Slide 14. The team in Europe is ready to go after receiving a positive <unk> opinion last month, we expect a decision next month and we will first prioritize Germany, where we can book revenues, while we go through the <unk> process and work to obtain.

Total revenues for the quarter were $85.2 million which also includes $10 million in collaboration revenue and other operating income. Cost of sales for the quarter were approximately $5 million.

Total R&D and SG&A expenses for the second quarter were approximately $126.9 million and $127.8 million respectively. These can mainly be attributed to FCAR-TIGIMOT and other pipeline research expenses as well as marketing and headcount expenses related to our global launch.

On our cash, we ended the second quarter with $2.6 billion in cash, cash equivalents and current financial assets. This includes net proceeds of $761 million from our March financing.

Reimbursement.

We have broad commercial infrastructure in place across Europe , including France, Benelux, Italy, Spain, and also the U K.

We are building infrastructure in Canada to support a filing and potential approval with health Canada.

Our partners XI lab filed for approval in China, and the filing was accepted earlier this month.

We continue to believe that our net cash burn this year will be up to $1 billion which will specifically support the rollout of our global launch, clinical development of FCAR-TIGIMOT in 10 indications and ArgenX 117 in two indications, investment in the global supply chain and pipeline expansion through our immunology innovation program.

And finally, we continue to look at distributor arrangements and other geographies beyond those we have in place in fact, we already saw some named patient sales this quarter in Israel through our partner and medicine.

Our business plan is an ambitious one.

To conclude on slide 15, I'm really pleased with where we stand after six months of launch we see strong signals across all of our initial launch priorities to empower patients provide best in class patient support drive rapid HCP adoption and enable appropriate access.

It is still early days, though and the same unknowns, we outlined from last quarter are still at play.

First we are in a unique situation where competitive product launched just five months after us and we still do not yet know the impact of this.

And we still have patients primarily on their first and second cycles. So it's too soon to understand dropout rates or how individualized dosing will play out over longer periods.

Can say with certainty that our team has built a strong foundation for success and we are determined to build upon this we are not satisfied with the <unk> hundred patients, but thinking about the total number of gmg patients globally that would benefit from a new therapy. This is what is driving each of us each day to be.

Out there engaging with physicians and working hard on behalf of patients I'll now turn the call back to Tim to conclude.

Thanks Keith.

Before we open up the call for your questions I would like to conclude on slide 16 with the following.

So we were very happy to be able to bring in the additional capital earlier this year to sustain our ability to drive considerable value for our shareholders.

In the first half of 2022, we have delivered on a number of commercial regulatory and clinical achievements as.

You can find additional details behind these numbers in the press release we issued this morning.

As we look ahead for the next 12 to 18 months, we are focused on achieving the multitude of goals we have set.

Continued to reach gmg patients with <unk>.

This is Ravi come to work every day to be able to improve the lives of patients and deliver solutions to those who need them.

Bring more optionality to the Gmg community with our project <unk> product launch.

Advance our best in class of Sharon pipeline with Phase III data Readouts of <unk> in key indications next year.

Expand our next pipeline in a product opportunity with our first in class <unk> inhibitors or <unk> from 2017.

And further develop our earlier assets that have emerged from our unique discovery engine, including our <unk> thousand 19.

We have an outstanding team that continues to execute on these plans and a strong balance sheet to support our ambitious goals.

It is our hope.

By leading with science and building our journey into the next great Immunology company.

Can continue to reach patients in need and create long term value for all stakeholders.

With that.

We can begin the Q&A.

Operator.

At this time I would like to remind everyone in order to ask a question Press Star then the number one on your telephone keypad.

We ask that you. Please limit yourself to one question and then rejoin the queue for further questions. We'll pause for just a moment to compile the Q&A roster.

And your first question comes from the line of Danielle Brill.

James Your line is now open.

Hi, guys. Good morning, Congrats on autonomous John Carter and thanks, so much for the question.

Keith you mentioned that you expect more more of a balance of three P. Indian patients moving forward can you elaborate a bit on that I'm, just China. I know you said, it's too soon to understand dropout rates, but qualitatively can you provide some color on whether you are seeing the patients that began team and <unk> returning.

And any additional insights on our potential bullets setbacks here. Thank you.

Danielle This is Tim speaking, thank you for joining us on the call.

Keith I think this is a question is treated indoor Cam Bryant.

Yes, Danielle thanks for the question what I can tell you is that we do have the majority of patients that have had completed one round of therapy and this is to be expected considering that 1000 <unk> hundred patients globally were added in second quarter we.

We do have quite a few patients who have gone on to complete a second round of therapy. Most of these are patients that did start in fact in the first quarter and there is a small handful of patients Danielle that where physicians have taken a more aggressive approach of four weeks on four weeks off so we have a handful of patients that have actually.

Gone through three cycles already so we are seeing a return of patients and that's what I meant by the statement of a mix of repeat patients and new adds moving forward.

Okay.

Got it thanks, Thanks Keith.

Your next question comes from the line of year ever from Cowen. Your line is open.

Great. Thanks for taking my questions and congrats on a very strong launch.

Maybe just as a quick follow on to <unk> question are you expecting that most patients are going to do an individual treatment approach or sort of the cycle on and off and then secondly, do you expect I saw you only did $1 5 million in Japan.

Most of the number obviously is in the U S are you expecting some kind of an upfront channel sale as you normally see in Japan. Thank you.

Hey, everyone. Thanks for joining us this morning and for your Great question before I hand over to work to Keith I want to remind everyone of the fact that myasthenia gravis is what we call a snowflake disease, each and every patient is experiencing his or her disease in their own unique fashion. So there is no.

I'll now hand the call to Keith for a commercial update.

Thanks, Carl.

Slide 10.

We are very happy with the continued momentum this quarter with our VivGuard launch, driven by consistent growth in both patient and physician demand. The first six months of a launch are crucial in building the right foundation for the product. So I am incredibly proud of the team for their demonstrated commitment to getting us off to a strong start.

While we are still in the early days, we are seeing positive signals across each of our stakeholder groups, all of which were key drivers in the $75 million in revenue we generated this quarter.

One size fits all and maybe Keith this is a good points for you to continue the answer right.

Yes.

Thank you for the question.

First of all we expect that youre going to see a variety number one we see patients that are going on cycled therapy individualized treatment and as Tim mentioned every single Mg patient is different. So we have some patients who have received one cycle and are still maintaining a great response, we have others that I mentioned are being treated a little bit more.

Let's start with patients.

Slide 11.

We currently have approximately 1,400 patients on therapy globally, which translated to over 1,000 new patient ads in the second quarter. This number includes initial contribution from the first six weeks of the Japan launch.

<unk> the bottom line is in the real world, It's not about a two point drop in Mg ADL like it is in a clinical trial. It is getting patients to minimal symptom expression to where they can walk around and deliver normal life like the rest of the general population. So when we say individualized dosing it is truly going to be that moving forward.

I think you can see some of the comments that patients have made that are enjoying this because they don't want to go back in for treatment. When they are feeling perfectly fine. We expect this trend to be continuing and as physicians get more comfortable with the drug I think youll see a variety of approaches around the cycling of individualized and some that might go to a little bit more chronic.

I was grateful to spend time in Japan with our commercial team and engage with some of our key customers.

Thank you Keith I would like to hand over to Carl for the Japan related question.

And overall, we are very pleased with the strong start. We had patients on therapy within the first week, including seronegative patients who benefit from the broader label in Japan.

Looking at the types of patients who are going on VivGuard, it remains similar to last quarter.

For the question. The question was relating to inventory in Japan, So our supply chain in Japan, we recognize revenue when the wholesalers ship towards portals for alternatives as we've got at any inventory. So based no wholesaler stocking in Japan in the U S of course with specialty pharmacies do.

<unk> inventory and that is where we'd comment it's less than two weeks its well managed at quarter end. Thank you.

Your next question comes from the line of <unk> <unk> from Guggenheim Partners. Your line is open.

Hey, guys. Congrats on great performance a couple of questions for me in a quick ones can you can you maybe just help us understand how we should think about the cadence of patients coming on to the drug obviously.

<unk> added 1000 patients in Q2, just trying to get a sense of what's sustainable or what sort of cadence should we expect and then just overall in terms of the U S market. When the drug was launched I think you have articulated 17000 eligible patients any revision to that number just trying to get.

A sense of what level of penetration is achievable in the U S. Now that you have more commercial experience I just wanted to get some updated thoughts on the on the U S opportunity. Thank you.

Thank you yet.

I think Keith you're well positioned to talk about our thoughts for the future cadence of patient enrollment right. Why don't you go ahead with that question first.

Yes, thanks for that.

Question here, Tim first of all I would like to say that quarter to 1000 patient adds was an extraordinary quarter.

It really was this is where decisions were beginning to hear from other physicians about bib guard patients, we're going in and asking for it by name and the team was really clicking on all cylinders. So I don't think that I would set up a model that says a thousand patients every quarter is going to be the norm.

<unk>.

But we will have to wait and see as far as your 17000 that is still the plan that is still the target that is still the number of patients that we believe that is appropriate for <unk> therapy here just in the U S and patients that could truly benefit from Bip guard. So no revision to that is our target number.

Okay.

Your next question comes from the line of Matthew Harrison from Morgan Stanley . Your line is open.

Matthew Harrison from Morgan Stanley Your line is open.

Okay.

Your next question comes from the line of Derek <unk> from Wells Fargo. Your line is open.

Hey, good morning, and thanks for taking my questions. Congrats on the quarter. So just two quick ones for US I think they are for Keith but just following up on your commentary Keith about the treatment algorithm. So what do you think is really needed to get we've got utilization earlier in the treatment algorithm. So just not the IV experience been like C. Five refractory.

So that's question number one and then just a follow up clarification. So Keith you said, 78% of the prescribers are writing one or two scripts I guess what percent of these are for generally like six to 12 months of treatment or is it just for one treatment cycle. Thanks.

Thank you that is these are two good questions Keith would like can I ask you please to address dose.

Yes happy to do so derik. Thank you for the question. So the treatment algorithm and how do we get to earlier lines of therapy I first want to call out to you that while 50% experienced IV AIG. The other 50% we are aligned with the adapt trial. So we do have patients that have started <unk>.

Of the 1,400 patients, about 50% have experience with IVIG, while the other 50% have experience across the treatment paradigm, from as early as just mestinon or steroids or other biologics.

This was a tremendous result from both our field teams engagement with physicians and, patients asking about Vyvgart by name.

It was a true multi-channel approach and also the outcome we had hoped for by empowering, patients.

The second quarter was one of extraordinary growth in terms of patient ads, but we expect, to see more of a balance between repeat and new patients going forward. The reason being that most patients on Vyvgart to date have IVIG or other biologic experience.

We are closely watching whether we can gain broad adoption earlier in the treatment paradigm, because this will be an important driver of our overall launch trajectory.

Before I move on to physicians, I want to share some of the health economics outcomes, research we gathered. This reinforces the potential value proposition of Vyvgart to GMG patients. First, the majority of patients when entering into the ADAPT study reported issues with, mobility, self-care, and completing their usual daily tasks. Often these challenges were accompanied by pain, discomfort, anxiety, and depression. From the early data we gathered, GMG patients in ADAPT experienced rapid and substantial, improvement in health-related quality of life following Vyvgart treatment. At peak response, patients approached the quality of life of the general population.

Guard after only being on <unk> are only being on <unk> and a steroid and we also have those that have started bib guard after matched and non steroid on their first IFC I think the key to moving earlier into this treatment algorithm is going to be the experience curve. So it actually ties into the second part of your question.

Additionally, we know that hospitalizations can pose a significant burden on GMG patients. In ADAPT, Vyvgart-treated patients experienced a 67% lower risk of MG-related hospitalization, than placebo.

Overall, it is very rewarding to hear this initial research showcasing another aspect, of the value proposition of Vyvgart to GMG patients.

Moving on to physicians on slide 12, we see that our messages are resonating with physicians. The strength of the ADAPT data in driving robust and deep responses combined with our, favorable safety profile.

With our launch strategy, we made a commitment to market from the science and stay data-driven. This is paying off, and physicians are showing increased awareness on the mechanism and action, of FCRN and the mechanism of disease of GMG as being antibody-driven.

We are seeing breadth in physician prescribers, but also depth from some early adopters. One of the drivers of the breadth we are seeing is that our sales team is focused on and allocated, resources to our top priority targets.

Our goal is for these early prescribers to share their experience with colleagues and, peers.

Which is a 78% of our prescribers have only prescribed for one or two patients it's getting them to see that patient experience one of the things that I've heard from clinicians is how how rapid onset of responses how their patient is doing so much better after one or two doses and they think about how long.

Long some of these oral therapies, particularly <unk> take to kick in.

That combined with favorable payer policy is our plan on how we go earlier into the treatment paradigm.

In looking ahead to upcoming quarters, the big unknown with our physicians is going to, be driving that adoption curve. At this stage, 78% of our prescribing physicians have written one or two scripts, so shifting, these prescribers from initial use to broad adoption is going to be a key indicator in our launch growth trajectory.

As far as the 78% that have only written one or two scripts and where do they fall into those policy buckets of a six month or 12 month I don't have that data broken down in front of me at this time, So I can't report to you on that.

Your next question comes from the line of Allison <unk> from Piper Sandler Your line is open.

Finally, I would like to cover the excellent work that is being done by our market access, team on slide 13.

Hi, good morning, Thanks for taking the question.

Grafts on the quarter. So a question for you on re dosing I know it's early in launch, but could you comment just on whether re dosing has been more patient or physician driven and any trends youre seeing there in terms of what is driving the indices of secondary third dosing cycles, and maybe talk to the rollout of <unk>.

We continue to have constructive conversations with payers, and as we committed last quarter, we have achieved broad coverage. Vivgard-specific policies have been published in Medicare and commercial plans covering, almost 85% of covered lives. The majority of these policies are favorable and aligned to the Vyvgart label.

Patients, need to fail only mestinon or steroids to gain access and approvals are typically for six to twelve months at a time.

Nurse case managers from our past.

And helping drive that and then just unrelated note are you seeing any telehealth prescribing that is our docs comfortable prescribing depth guard over telehealth, particularly for the second or third dosing cycles. Thanks.

Thanks Allison.

Two questions for Keith one with regards to triggering re dosing and then the telehealth question right Keith.

Our J-code went into effect on July 1st as expected, which we believe will facilitate a more seamless conversion from enrollment to infusion and give confidence to some prescribers that the process should be straightforward.

Yes. Thanks for the question Allison So on re dosing, we're really seeing two schools of thought were seeing a reactive approach, which that would be patient driven so the patient gets the cycle of bib guard they respond and they are feeling better and they're given direction that when you begin to lose response when you begin.

Moving on to the progress of our global launch on slide 14.

The team in Europe is ready to go after receiving a positive CHMP opinion last month.

We expect a decision next month and will first prioritize Germany, where we can book revenues while we go through the AMNOG process and work to obtain reimbursement.

We have broad commercial infrastructure in place across Europe, including France, Benelux, Italy, Spain, and also the UK.

We are building infrastructure in Canada to support a filing and potential approval with Health Canada.

Our partner Zylab filed for approval in China and the filing was accepted earlier this month.

And finally, we continue to look at distributor arrangements in other geographies beyond those, we have in place.

In fact, we already saw some named patient sales this quarter in Israel through our partner in medicine.

It is still early days, though, and the same unknowns we outlined from last quarter are still at play. First, we are in a unique situation where a competitive product launched just five months after us and we still do not yet know the impact of this. And we still have patients primarily on their first and second cycles, so it's too soon to understand dropout rates or how individualized dosing will play out over longer periods.

To conclude, on slide 15, I'm really pleased with where we stand after six months of launch.

I can say with certainty that our team has built a strong foundation for success and we are determined to build upon this.

We see strong signals across all of our initial launch priorities to empower patients, provide best-in-class patient support, drive rapid HCP adoption, and enable appropriate access.

To feel symptoms please call and we'll get you in for your next cycle. So that's the patient driven example, the other one that we're seeing as a physician driven and that is where a physician gives us cycle a bit guard and decides when theyre going to bring that patient back for cycle too. We're seeing some physicians that say, we're going to go for on for off and if.

You have maintained response the whole time before your second cycle, then we'll try to stretch that interval for past four weeks in the 5678 weeks.

Have others that are going to start with the cycle and bring them back.

Similar to what is stated in the package insert with them bring them back roughly 50 days later for that second cycle. So those are where they are.

Physician driven.

<unk> case managers as far as driving the need for the second cycle, it's really not the role of the nurse case manager. These are not the treaters of the patients nurse case managers are there to assist patients answered questions and support.

Overall on their <unk> journey. So it is really more of a physician and patient decision on their next treatment cycle. Finally, telehealth, it's too early to say on telehealth.

Whether youre going to see somebody prescribed naive patient with telehealth as far as patients coming back in for a second cycle you know that many of the majority of our policies. Once a patient is prescribed bid guard they're approved for six months to 12 months. So these patients are coming back in and getting their second cycle.

Your next question comes from the line of of cash Tomorrow from Jefferies. Your line is open.

We are not satisfied with the 1,400 patients, but thinking about the total number of GMG patients globally that would benefit from a new therapy.

Hey, thanks, so much.

First of all congrats on the quarter, you've shown really robust J&J numbers. So far 1000 patient adds quarter over quarter that said, we consensus has gone up and I think we're estimating if you account for the Dropbox you need about kind of 500 600 starts each quarter in the U S.

Hit numbers in the back half of next year.

A question was asked before but I, just kind of want to double down on it. What's your current view on a reasonable go forward new patient.

Going into next year.

And then wholesale for starts that you had just any more color on how many of our IV <unk>.

<unk> or switches Solaris refractory then naive.

Thanks, so much.

Thanks for question I would like to give the floor to Carl to talk about to no projections for next year, but before I do so maybe Keith you want to comment on that second question right.

Yes.

<unk> experienced patients it was almost 50%.

The first sample is almost spot on to what we saw in the first quarter of treatment as far as the rest of the patient population they came from across the board.

So it is some that are moving into earlier treatment, but we do continue to get soliris in refractory patients that are added in quarter two.

This is what is driving each of us each day to be out there engaging with physicians and working hard on behalf of patients.

I'll now turn the call back to

This is not a not a surprise.

And I'm happy to share with you that some of our soliris refractory patients in quarter, one R&D <unk> Gard responders.

Tim to conclude.

Thanks, Keith.

Before we open up the call to your questions, I would like to conclude on slide 16 with the following. In the first half of 2022, we have delivered on a number of commercial, regulatory, and clinical achievements.

As we look ahead for the next 12 to 18 months, we are focused on achieving the multitude, of goals we have set.

Continue to reach GMG patients with VIVGARD.

Thank you Keith back to Carl.

This is why we come to work every day to be able to improve the lives of patients and deliver solutions to those who need them.

Bring more optionality to the GMG community with our project SubQ product launch.

Josh Thank you for the question.

We're not going to give any guidance on patient numbers or avenues at this time, but there is just too early in the launch we want the data to mature and then we can start thinking about giving guidance on the revenues and patients. Thank you.

Watch.

Your next question comes from the line of Matthew Harrison from Morgan Stanley . Your line is open.

Advance our best-in-class FCLN pipeline with phase 3 data readouts of FGaP Digimod, in three indications next year.

Expand our next pipeline in a product opportunity with our first-in-class C2 inhibitors, argenx-117, and further develop our earlier assets that have emerged from our unique discovery engine, including argenx-119.

Can you hear me this time.

We can let you welcome.

Thanks, I guess I got too excited last time so.

Can you just talk a little bit about J code and if you expect any inflection off of that or even is there a certain mix of customers that youre not seeing participate very much at this point that you would expect to see participate once you. Once you have the J code.

We have an outstanding team that continues to execute on these plans and a strong balance sheet to support our ambitious goals.

It is our hope that by leading with science and building argenx into the next great immunology company, we can continue to reach patients in need and create long-term value for all stakeholders.

Yes, so Matthew thanks for the question.

Yes.

Go ahead Keith.

With that, we can begin the Q&A.

Thank you Tim.

Matthew Thanks for the question.

We have our J code, our J code five it's been running live since July one.

Operator?

Really what the J code is doing is it is making it easier for physicians and offices to get patients through the process, it's making the conversion process go quicker from time of prescription to time for actual infusion.

So as far as it opening up additional audiences.

Really the unmet medical need and the success that patients and physicians are seeing with <unk> is why we've had pretty substantial demand here in this in the first couple of quarters. So I don't know that youre going to see an uptick because you have a J code as much as youre going to see the ease of getting the pace.

Through through the process faster.

At this time, I would like to remind everyone, in order to ask a question, press star, then the number one on your telephone keypad.

Your next question comes from the line of William <unk> from Evercore. Your line is open.

We ask that you please limit yourself to one question and then rejoin the queue for further questions.

Hey, guys. Thanks, so much and just a really spectacular quarter I had a couple.

Question. So the first one is.

You guys are at 85% patient lives covered right now whats. The goal you guys are thinking realistic by year end and then my second question is.

What are you guys thinking in terms of Cogs long term for <unk>.

We'll pause for just a moment to

Hey, Brian two great questions, let me start by giving the floor to Keith to talk about how we.

compile the Q&A roster.

Lives covered and then I would like to hand over to Carl to give a brief comment on Cogs. So Keith why don't you go first.

And your first question comes from the line of Danielle Brill from Marine James.

Your line is open.

Yes, William Thanks for the question and regarding coverage, we're really pleased with the progress that we've made through the second quarter. In particular, we're really pleased with a number of the policy is the majority of them are very favorable they align with the adapt inclusion criteria, which means we can have patients.

Early as second line treatment as far as the remainder of the population look our team is not going to rest.

We're going to continue in that minority of policies that are put in place that arent as favorable as the adapt inclusion criteria, we're going to work to work with those payers to see that we can get them to a favorable status and the remaining 15% will continue to work on but we haven't been public with setting the next number forward.

Hi, guys.

Thanks Carl.

Get them in terms of cost of sales.

Not going to give detail.

Guidance here, but safe to say as we move to large larger production facilities.

Currently the losses coming out of slow or one caveat that maybe we have Singapore that Duke Eddie active which is also FDA approved and later on Fort Smith, and even bigger facility will come online that will drive efficiencies also important for you to remember is that once we get sub Q.

Mid single digit royalty on.

Good morning.

Pull banners arm enzyme on the sub Q. Thanks.

Thanks Carlo.

Your next question comes from the line of <unk> Ahmad from Bank of America Securities. Your line is open.

Congrats on the strong, quarter and thanks so much for the question.

Okay. Thank you for taking my question I apologize. If this has already been asked I did join a little bit late but.

Can you talk about the reliability of tracking script intra quarter, because it does seem like symphony in particular, that's tracking relatively close to the number you reported this quarter is that just by chance.

Think that there is.

A reliable component and looking at those trends and then second part of the question is should we expect to see any seasonality.

And the second half of the year, particularly in <unk> is it a trend.

Based on what you know about the G&P space that.

Patients tend to be less compliance during the holidays or should we not assume any kind of seasonality. Thank you.

I guess, Keith, you mentioned that you expect

Anthony and thank you for joining us in the call today I would like to give the first question to my colleague Carl how do we think about the reliability of.

more of a balance with repeat and new patients moving forward.

<unk> scripts please.

Alright. Thank.

Thank you for the question I.

Fingers to liquid symphony data in <unk>.

It's difficult for us to comment on it we don't know how the algorithms work I think it takes times.

Time for those algorithms to get more accurate it at the moment that will be very careful in using it and also if you look forward with all of them has done over discontinue it.

This continued effect that which needs to be both in the cycling as we started patients moving from Julin cycled through the next cycle. None of those will be built in <unk> I think we really need to be careful in using these data points. Thank you Carl Keith is there anything you want to say with regards to potential seasonality in the treatment of <unk> patients.

Can you elaborate a bit on that?

I'm just trying to – I know you said it's too soon to understand dropout rates, but qualitatively, like, can you provide some color on whether you're seeing the patients that began treatment in 1Q returning and any additional insights on a potential bullet

<unk>.

Yes, <unk>. It's a good question as you know we haven't been through the holiday season, yet with <unk> Gard commercially available, but what I will tell you is that when you are treating a patient.

setback here?

Thank you.

That has been through other therapies and not had a positive experience and now theyre able to have a quality of life data similar to someone that doesn't even have the disease, they're going to want to stay on therapy.

Hi, Danielle.

I haven't.

One of our patients.

Happened to walk up to me and said I actually didn't realize how bad off I was or how different my life was until I was being treated and realized what had been missing out on.

I'd actually yes.

I put my mind and that of a patient I would say hey, I want to be treated so I can enjoy my holidays, even more so let's wait and see on the seasonality, but I'm not expecting it.

This is Tim speaking.

Okay. Thanks Keith.

Your next question comes from the line of Thomas Smith from SVP Securities. Your line is open.

Hey, guys. Thanks for taking our questions and let me add my congrats on a really strong launch here just wanted to follow up on the new patient starts can you give us any more granularity on kind of the monthly pace here through the quarter and into July and maybe just help us better understand the shape of the curve here as we exited the quarter.

And then it's obviously off label in the U S and I know you are promoting to it but can you comment on whether youre seeing any uptake in seronegative patients in the U S. I appreciate the comments on Japan, just curious what youre seeing in the U S. Whether youre seeing prescribing for these patients whether payers are facilitating access here. Thanks.

Thank you Thomas Thanks for being with US on the call today I'd like to give the first question to Carl about new patient starts and monthly visibility and then Keith I'd like to hand over to you for any comment we can give on the question regarding off label, but Carl could you start. Please thank you and Thomas Thank you for the question what we see.

Thank you for joining us on the call.

Keith, I think this is a question straight in your camp, right?

Yeah, Danielle, thanks for the question.

What I can tell you is that we do have the majority of patients that have had completed one round of therapy.

And this is to be expected considering that, you know, 1,000 of the 1,400 patients globally were added in second quarter.

We do have quite a few patients who have gone on to complete a second round of therapy.

Is it gradual consistent month over month growth. Thank you.

Most of these are patients that did start, in fact, in the first quarter.

And there's a small handful of patients, Danielle, that where physicians have taken a more aggressive approach of four weeks on, four weeks off. So we have a handful of patients that have actually gone through three cycles already.

Yes.

Yes. Thanks for the question Thomas So as you pointed out in Japan, where the label is broader we are seeing utilization in musk patients in seronegative patients also acetyl choline receptor positive patients so a real nice.

So we are seeing a return of patients, and that's what I meant by the statement of a mix

of repeat patients and new ads moving forward.

Across the label utilization in the first quarter of launch as far as in the U S.

We remain consistent with the label we will not promote off label that also means that if it is a patient that is off label, they're not able to participate in our in our <unk> Gard path program. So if there is we have far less insight into these off label patients. Thank you.

Your next question comes from the line of Jason Butler from JMP Securities. Your line is open.

Got it.

Alright, Thanks for taking my question and let me add my congrats on the quarter as well.

Thank you so much.

I had a question about <unk> have you already established.

Your next question

Development strategy for Canada.

Either the overall AML population subpopulations, how youre thinking about combinations with standard of care and then is there a specific funding commitment from our Gen X to the new entity.

Thanks, Jason. So this is a deliberate choice to spin off <unk> in in acetic acid Sunday care company. It means we can continue to focus and double down on our autoimmune franchise now the co creation in play here is a unique one because the translational biology insights from Dr. <unk>.

<unk> Smith.

On the role of the CD 70, CD 27 pathway.

<unk>, new definitive plex, non responsiveness or refractory patients is a unique complements to what we already have in our hands with our first in class assets and pretty strong data in first line AML patients unfit for intensive.

Transplants.

So expect to development pads to be.

Precision shot on goal.

Fine tuned with the know how of Colorado University in terms of inclusion exclusion criteria for our AML patients. This is an asset we believe and this is a company we will shoulder and therefore, yes. There is a financial commitments both from our genetics and from Colorado.

Two step commitment, but first we need to finalize specific piece of homework and then actually there is a second biggest plans of commitment.

From our company. So we are very pleased with the path forward.

It's a database of path forward, and we had equipment <unk> them up with the highest probability of success for us. So thank you for the question.

comes from the line of Yara Ever from Cowan.

Your next question comes from the line of Alex Thomson from Stifel. Your line is open.

Your line is open.

Hey, Thanks for taking my question and congrats on the quarter I Wonder if you could go back to <unk>. If you could comment a little bit on net price per patient in the U S. Whether that's tracking with your initial expectations. So far and also if you'd comment on net price per patient in Japan. Thanks.

Great.

Alex Thank you for joining us on the call today and this is a question I think for Carl right. Yes. Thank you Tim.

Thanks for taking my questions and congrats on that.

Jason Alex Thank you for the question the typical.

A very strong launch.

Brian .

225, a number which we communicated at the beginning of the year as those then we don't see any reason for that.

Maybe just as a quick follow on to

But.

Changing the gross to net everything adds up to that number.

Danielle's question, are you expecting that most patients are going to do an individual

In terms of Japan.

<unk> for <unk> in Japan. This fall and then from 'twenty, one Japanese yen. If you do the conversion you will see $2 50 and 60%.

Off of.

The U S price grows to Nathan Japan is a typical gross to net its a very small number.

Thanks Carl.

Thank you.

Your next question comes from the line of Joon Lee from <unk> Securities. Your line is open.

treatment approach or sort of the cycles on off?

Alright, thanks for taking our questions for the advance SC what specific learnings from DIY trial have you incorporated and other than just the size I mean, it's more specific to.

Increasing the size and powering assumptions can you comment on the number of patients you. Additionally, the additional number of patients enrollment.

And secondly, do you expect, I saw you only did one and a half million in Japan, so most of the number obviously is in the U.S. Are you expecting some kind of an upfront channel fill as you normally see in Japan?

Enrollment thank you.

Thanks, Jim for the question and thanks for being with US today. So as we said the benefits of having the two trials running in a slightly staggered fashion is that we can deploy learnings from the first study and see how.

Thank you.

Thank you.

How they impact and the second study and remember for the first study we had a very convincing.

Hey Yaron, thanks for joining us this morning and for your great question.

Before I hand over the work to Keith, I want to remind everyone of the fact that Myasthenia, Gravis is what we call a snowflake disease.

Each and every patient is experiencing his or her disease in their own unique fashion. So there is no one size fits all.

Efficacy in the hydro <unk> core primary endpoints was a clear win but with a smaller power than we had anticipated. So we have been revisiting. The initial powering assumptions, we took a blinded look at the patient population for the second study it looks like broadly speaking a similar patient population is for the first study.

And therefore, we cannot be more accurate and precise in our powering assumptions that means that in order to achieve the power we feel comfortable with we need to up the number and that's why I'd actually be reopening to study to ads.

Number of patients.

I would like to hold off until we are public on the clinical trials World Golf to show you that number but it's not a dramatic number it's I think a reasonable numbers to give us.

A significant increase in power so stay tuned it will pop up on clinical trials for the Gulf soon thanks for the question.

And maybe Keith, this is a good point for you to continue to answer it.

Your next question comes from the line of Colin White from UBS. Your line is open.

Yeah.

Hi, Collyn right here on for Laura Sutcliffe of UBS.

Thank you for the question.

My question is.

Ucp's termination of Rosa and ATP.

That gives you any pause for thought in terms of the commercial opportunity in this therapy area. Thank you.

So first of all, we expect that you're going to see a variety.

Hi, Collyn. Thank you for your question. So we also took note of the UCB News I think is good news for us it means that there's less competition out there.

We are formulating our plans and our strategies based on our own data. So I think our conviction level in the potential of <unk> modern ICP.

Number one, we see patients that are going on cycled therapy, individualized treatment.

And as Tim mentioned, every single MG patient is different. So we have some patients who have received one cycle and are still maintaining a great, response.

We have others that I mentioned are being treated a little bit more aggressive.

Is significant I think the data we saw in such a refractory patient population or actually quite impressive with a more than 50% <unk>.

G response rates.

I think the safety profile came out very consistently and very clean and we have a document them very carefully the unmet medical need in ICP I can also tell you that the initial feedback from the field from treating physicians has been very positive and very consistent so we see moving forward with our ATP.

The bottom line is in the real world, it's not about a two point drop in MGADL like it, is in a clinical trial.

The opportunity.

Thanks for the question.

Your next question comes from the line of Douglas Tsao from H C. Wainwright. Your line is open.

It's getting patients to minimal symptom expression to where they can walk around and live a normal, life like the rest of the general population.

So when we say individualized dosing, it is truly going to be that moving forward.

I think you can see some of the comments that patients have made that are enjoying this, because they don't want to go back in for treatment when they're feeling perfectly fine.

Hi, good morning, and thanks for taking my questions.

We expect this trend to be continuing.

And as physicians get more comfortable with the drug, I think you'll see a variety of, approaches around the cycling of individualized and some that might go to a little bit more chronic.

I think in the slides you indicated that most script writers.

Can you hear me.

We can hear you fine okay.

Just you indicated most.

Writers have written in one to two scripts I'm. Just curious do you have any perspective in terms of the types of patients. They are selecting for those initial scripts is there a certain profile are they waiting for the patients who are perhaps not doing as well in IV AG are there existing therapy or is it just sort of happenstance just to be the first patient that walks in the door that since that since the approval.

<unk>.

Thank you Doug that's an excellent question and Keith will jump would you mind, taking this one.

Thank you, Keith.

Yes happy to do so so Doug we don't actually see an enormous difference in the 78% that have written one or two compared to the remainder that have more patients on therapy again with almost 50% of the patients experiencing IV AIG prior to getting Vim guard it appears that in the.

Early going we have a higher percent of refractory patients then we expect to have in the future as I mentioned, we'll continue to try to get earlier in the treatment paradigm. So certainly placed before IV AIG and certainly placed before other infusible therapies, but right now as a new option.

On the block we are getting.

A high number of refractory patients. The good news is I think that most physicians see that experience and the experience that their patient is having that's where we have the opportunity the real opportunity to advance earlier into the treatment paradigm, but also take that 78% and take them from being with one or two patients on therapy.

<unk> to now even more than that.

I would like to hand over to Carl for the Japan related question.

Okay.

Next question comes from the line of Joel Beatty from Baird. Your line is open.

So thank you for the question.

Okay.

Alright, Thanks for taking my question and congrats on the quarter.

The question was a lot relating to inventory in Japan.

So our supply chain in Japan, we recognize revenue when the wholesalers ship to hospitals.

Going back to an earlier comment about a thousand patient adds was extraordinary.

<unk>.

Not to be expected to be repeated.

Is that based on feedback that there may have been kind of a pent up demand effects here.

This is a great question and an opportunity to keep to reiterate you know the views of the company.

The wholesaler doesn't carry any inventory.

So there is no wholesaler stocking in Japan.

In the U.S., of course, the specialty pharmacies do carry inventory, and that is where we comment, it's less than two weeks.

Position, we are in Keith why don't you go ahead.

It's well-managed at court end.

Thank you.

Yes, happy to actually Joel the point that we're making is that it was a very powerful quarter in patient adds I mean, 1000 gmg patients added in a quarter and a rare disease is quite a number for any therapy.

And so the fact that we were able to deliver that is quite impressive.

All I was saying is that.

Building out my model I don't think I would be placing that has all of a sudden the new standard that you can expect to occur quarter over quarter.

Your next question comes from the line of Jatin Sinha from Guggenheim Partners.

Your next question comes from the line of Mannose Mastorakis from Deutsche Bank. Your line is open.

Your line is open.

Hey, guys.

Congrats on a great performance.

Yes, Hello, My question was asked earlier, but.

A couple of questions for me, a little quick one.

In terms of the ICP opportunity, but maybe I could just add if you could say anything else more quantitatively perhaps.

Can you maybe just help us understand how we should think about the cadence of patients, coming on to the drug?

So for IPP would be learned with the data in hand from the field and from the physician audience. We have been interacting with is that there is substantial unmet medical needs.

Obviously, you added 1,000 patients in Q2.

Just trying to get a sense of what's sustainable or what sort of cadence should we expect.

And then just overall, in terms of the U.S. market, when the drug was launched, I think, you had articulated 17,000 eligible patients.

Any revision to that number, just trying to get a sense of what level of penetration is, achievable in the U.S. now that you have more commercial experience.

I just wanted to get some updated thoughts on the U.S. opportunity.

Thank you.

Thank you, Jatin.

Yeah.

I think Keith, you're well-positioned to talk about our thoughts for the future cadence, of patient enrollment.

Thanks for the question, Jatin.

Why don't you go ahead with that question first?

First of all, I would like to say that Q2 1,000 patient ads was an extraordinary quarter.

It really was.

<unk> primary NTP patients what basically happens today is that base.

Patients are moved from a steroid to a GPO and they feel a first GPO they would be typically cyclical in a second GPO and noted that as of 30 <unk> are there other markets even to a third PPL. So it doesn't make a great deal of sense to switch patients between litigation using a similar mode of action it doesn't make sense.

We move them.

After the first GPU a failure on two totally different mode of action, which actually has proven to be a very powerful motive action, which is the reduction of pathogenic <unk>, which are responsible for cleaning plate, but also attacking the mega carrier sites.

So we think that is a clear positioning here for third line therapy in the ATP market space would.

This is where physicians were beginning to hear from other physicians about Vivgard.

Patients were going in and asking for it by name.

And the team was really clicking on all cylinders.

So I don't think that I would set up a model that says 1,000 patients every quarter is, going to be the norm.

But we will have to wait and see.

It would be quantitatively here from physicians is in line with what some of our analysts have been riding.

As far as your 17,000, that is still the plan.

That is still the target. That is still the number of patients that we believe that is appropriate for Vivgard, therapy here just in the U.S. and patients that could truly benefit from Vivgard.

Your

So no revision to that as our target number.

line is open.

Your next question comes from the line of Matthew Harrison from Morgan Stanley.

Matthew Harrison from Morgan Stanley, your line is open.

Your next question

comes from the line of Derek Akila from Wells Fargo.

Your line is open.

I would like to give the first question to my colleague here, Karl.

For example, I have been reading about a 10% market share based on a third line positioning the company based on its data and its market research would actually feel comfortable with that.

Hey, good morning and thanks for taking the questions.

How do we think about the reliability of tracking scripts, please?

Congrats on the quarter.

Hi Tahseen, thank you for the question.

So just two quick ones for us.

I think if we look at Symfony data and IQVR, it is difficult for us to comment on it.

I think they're for Keith, but just following up on your commentary, Keith, about the treatment algorithm.

We don't know how the algorithms work. I think it takes time for those algorithms to get more accurate.

So what do you think is really needed to get Vyvgart utilization earlier in a treatment, algorithm?

At the moment, I'll be very careful in using it.

So just not the IVIG experience and like C5 refractory.

And also, if you look forward, the algorithms don't know the discontinue factor which needs to be built in, the cycling, if we start patients moving from one cycle to the next cycle, none of those will be built into the algorithms.

So that's just question number one.

I think we really need to be careful in using these data points.

And then just to follow up clarification.

Thank you, Karl.

So Keith, you said 78% of the prescribers are writing one to two scripts.

Keith, is there anything you want to say with regards to potential seasonality in the treatment of GMG patients?

I guess what percent of these are for generally like six to 12 months of treatment or is it just for one treatment cycle?

Yeah, Tahseen, it's a good question.

Thanks.

As you know, we haven't been through the holiday, season yet with Vivgard commercially available.

Maybe just help us better understand the shape of the curve here as he exited the quarter.

Thank you, Derek.

But what I will tell you is that when you're treating a patient that has been through other therapies and not had a positive experience, and now they're able to have a quality of life that's similar to someone that doesn't even have the disease, they're going to want to stay on therapy. I have one of our patients that happened to walk up to me and said, I actually didn't realize how bad off I was or how different my life was until I was being treated and realized what I had been missing out on.

And there are no further questions at this time. This concludes today's conference call. Thank you for your participation you may now disconnect.

And then it's obviously off-label in the U.S. and I know you aren't promoting to it, but can you comment on whether you're seeing any Vyvgart uptake in seronegative patients in the U.S.?

These are two good questions.

If I put my mind in that of a patient, I would say, hey, I want to be treated so I can enjoy my holidays even more.

You know, appreciate the comments on Japan, just curious what you're seeing in the U.S., whether you're seeing prescribing for these patients, whether payers are facilitating access here.

Keith, can I ask you please to address those?

So let's wait and see on the seasonality, but I'm not expecting it.

Thanks.

Yeah, I'm happy to do so.

Your next question comes to the line of Thomas Smith from SVP Securities.

Thank you, Thomas.

Derek, thank you for the question.

Your line is open.

Thank you for your participation.

Thanks for being with us in the call today.

So the treatment algorithm and how, do we get to earlier lines of therapy?

Hey guys, thanks for taking our questions and let me add my congrats on the really strong launch here.

You may now disconnect.

I'd like to give the first question to Karl about new patient starts and monthly visibility.

I first want to call out to you that while 50% experienced IVIG, the other 50% were aligned with the ADAPT trial.

Just wanted to follow up on the new patient start.

And then, Keith, I'd like to hand over to you for any comments we can give on the question regarding off-label.

So we do have patients that have started, Vyvgart after only being on mestinon or only being on mestinon and a steroid.

Can you give us any more granularity on kind of the monthly pace here through the quarter and into July?

But, Karl, could you start, please?

We also have those that have started Vyvgart after mestinon steroid and their first ISD.

Thank you.

I think the key to moving earlier into this treatment algorithm is going to be the experience curve.

Okay.

And, Thomas, thank you for the question.

So it actually ties into the second part of your question, which is if 78% of our prescribers have only prescribed for one or two patients, it's getting them to see that patient experience.

What we see is a gradual consistent month-over-month growth.

One of the things that I've heard from clinicians is how rapid the onset of responses, how their patient is doing so much better after one or two doses, and they think about how long some of these oral therapies, particularly ISTs, take to kick in.

Thank you.

That combined with favorable payer policy is our plan on how we go earlier into the treatment paradigm.

Keith?

As far as the 78% that have only written one or two scripts and where do they fall into those policy buckets of a six-month or a 12-month, I don't have that data broken down and in front of me at this time.

Yeah, thanks for the question, Thomas.

So I can't report to you on that.

So, as you pointed out, in Japan where, the label is broader, we are seeing utilization in musk patients, in seronegative patients, also in acetylcholine receptor positive patients.

Your next question comes from a line of Allison Brazel from Piper Sandler.

So, a real nice across the label utilization in the first quarter of launch.

Your line is open.

As far as in the U.S., we remain consistent with the label.

Hi, good morning.

We will not promote off-label.

Thanks for taking the question and congrats on the quarter.

That also means that if it is a patient that is off-label, they're not able to participate in our MyVivGuardPath program.

So a question for you, on redosing.

So, if there is, we have far less insight into these off-label patients.

I know it's early in launch, but could you comment just on whether redosing has been more patient or physician-driven and any trends you're seeing there in terms of what is driving the initiation of second or third dosing cycles?

Thank you.

And maybe talk to the role of nurse case managers from my VivGuard path in helping drive that.

Your next question comes from a line of

And then just on a related note, are you seeing any telehealth prescribing?

Jason Butler from JMP Securities.

That is, are docs comfortable prescribing VivGuard over telehealth, particularly for those second or third?

Your line is open.

are dosing cycles.

Hi.

Thanks.

Thanks for taking the question, and let me add my congrats on the quarter as well.

Thanks, Allison.

Just had a question about OncoVerity.

And these are again, two questions for Keith's one with regards to triggering re-dosing and then the Taylor Health question, right, Keith?

Have you already established a development strategy for KUSA, either the overall AML, population, subpopulations, how you're thinking about combinations with standard of care?

Yeah, thanks for the question, Allison.

And then, is there a specific funding commitment from Argenix to the new entity?

So on re-dosing, we're really seeing two schools of, thought.

Thanks.

We're seeing a reactive approach, which that would be patient driven.

Thanks, Jason.

So the patient gets the cycle of Vyvgart.

So, this is a deliberate choice to spin off KUSA Tuzimap in an, acid-centric company.

They respond and they're feeling better. And they're given direction that when you begin to lose response, when you begin to feel symptoms, please call and we'll get you in for your next cycle.

It means we can continue to focus and double down on our autoimmune franchise.

So that's the patient driven example.

Now, the co-creation in play here is a unique one because the translational biology insights, from Dr. Clayton Smith on the role of the CD70, CD27 pathway in either venetoclax non-responsiveness or refractory patients is a unique complement to what we already have in our hands with our first-in-class assets and pretty strong data in first-line AML patients unfit for transplant.

The other one that we're seeing is a physician driven.

So, expect the development path to be a precision shot on goal, fine-tuned with the know-how of, Colorado University in terms of inclusion-exclusion criteria for our AML patients.

And that is where a physician gives a cycle of Vyvgart and decides when they're going to bring that patient back for cycle two.

This is an asset we believe in.

We're seeing some physicians that say we're going to go four on four off.

This is a company we will shoulder, and therefore, yes, there is a financial commitment both from Argenix and from Colorado.

And if you have maintained response the whole time before your second cycle, then we'll try to stretch that interval for past four weeks and into five, six, seven, eight weeks.

It's a two-step commitment where first we need to finalize a specific piece of homework, and then actually there's a second bigger tranche of commitment from our company.

You have others that are going to start with the cycle and bring them back similar to what is stated in the package insert where they'll bring them back roughly 50 days later for that second cycle.

So, we're very pleased with the path forward.

So those are where they're physician driven.

I think it's a data-based path forward, and we're equipping KUSA Tuzimap with the highest probability of success here.

Nurse case managers, as far as driving the need for the second cycle, it's really not the role of the nurse case manager.

So, thank you for the question.

These are not the treaters of the patients.

Your next question comes from the line of Alex Thompson from Stiefel.

Nurse case managers are there to assist patients, answer questions, and support them overall on their Vyvgart journey.

Your line is open.

So it is really more of a physician and patient decision on their next treatment cycle.

Hey, thanks for taking my question.

Finally, telehealth.

Congrats on the quarter.

It's too early to say on telehealth whether you're going to see somebody prescribe a naive patient with telehealth.

I wonder if we go back to GMG, if you could comment a little bit on net price per patient in the US, whether that's tracking with your initial expectations so far, and also if you'd comment on the net price of per patient in Japan.

As far as patients coming back in for second cycle, you know that the majority of our policies, once a patient is prescribed Vyvgart, they're approved for six to 12 months. So these patients are coming back in and getting their second cycle.

Thanks.

Your next question comes from a line of Akash Tiwari from Jeffries.

Alex, thank you for joining us in the call today.

Your line is open.

And this is a question, I think, for Karl, right?

Hey, thanks so much.

Yeah, thank you, Tim.

So first of all, congrats on the quarter.

Alex, thank you for the question.

You've shown really robust GMG numbers so far, 1,000 patient ads quarter over quarter.

The typical price, for a patient, 2 to 5, that number which we communicated at the beginning of the year still stands.

That said, we have consensus gone up, and I think we're estimating if you account for the drop-ups, you need about kind of 500 and 600 starts each quarter in the U.S. to kind of hit numbers in the back half of next year.

We don't see any reason for that changing.

You know, this question was asked before, but I just kind of want to double down on it.

The gross net, everything adds up to that number.

What's your current view on a reasonable go-forward for new patients going into next year?

In terms of Japan, the price for a vial in Japan is 421,000 Japanese yen.

And then also for the start that you had, just any more color on how many were IBIG, refractory or switches, hilarious refractory patients and then naive patients?

If you do a conversion, you'll see it's between 50 and 60% of the US price.

Thanks so much.

Gross to net in Japan is a typical gross to net.

Thanks, Akash.

It's a very small number there.

And I would like to give the floor to Carl to talk about, you know, projections for next year.

Thanks, Karl.

But before I do so, maybe Keith, you want to comment on that second question, right?

Thank you.

Yeah.

Your next question comes from

Akash, IVIG experienced patients, it was almost 50%.

the line of June Lee from Truist Securities.

The percent was almost spot-on to, what we saw in the first quarter of treatment.

Your line is open.

As far as the rest of the patient population, they came from across the board.

Hi, thanks for taking our questions.

So it is some that are moving into earlier treatment, but we do continue to get cilirus refractory patients that are added in quarter two.

For the advanced SC, what specific learnings from the IV trial have you incorporated?

This is not a surprise.

And other than, just the size, I mean, more specific to the increase in the size and powering assumptions, can you comment on the number of patients, the additional number of patients you're enrolling?

And, you know, I'm happy to share with you that, some of our cilirus refractory patients in quarter one are indeed Vivgart responders.

Thank you.

Thank you Keith.

Thanks, June, for the question.

Back to Karl.

And thanks for being with us today.

Akash, thank you for the question.

So as we said, the benefits of having the two trials running in a slightly staggered fashion is that we can deploy learnings from the first study and see how they impact the second sister study.

We're not going to give

Okay.

And remember, for the first study, we had a very convincing sign of efficacy in the IWG score.

any guidance on patient numbers or revenues at this time.

<unk>.

Primary endpoints was a clear win, but with a smaller power than we had anticipated. So we have been revisiting the initial powering assumptions.

It is just too early in the launch.

We took a blinded look at the patient population for the second study. It looks like, broadly speaking, a similar patient population as for the first study. And therefore, we can now be more accurate and precise in our powering assumptions. That means that in order to achieve the power we feel comfortable with, we need to up the number. And that's why actually we are reopening the study to add a number of patients.

We want the data to mature and then we can start thinking about giving guidance on revenues and patients.

I would like to hold off until we are public on clinicaltrials.gov to show you that number, but it's not a dramatic number.

Thank you.

It's, I think, a reasonable number to give us a significant increase in power.

Your next question comes from the line of Matthew Harrison from Morgan Stanley.

So stay tuned.

Your line is open.

It will pop up on clinicaltrials.gov soon.

Can you hear me this time?

Thanks for the question.

We can, Matthew.

Your next question comes from a line of Colin White from UBS.

Welcome.

Your line is open.

Thanks.

Hi, Colin White here on for Laura Sutcliffe at UBS.

I guess I got too excited last time.

My question is about UCB's termination of ROSA and ITP, and if that gives you any pause for thought in terms of the commercial opportunity in the therapy area.

Just a question for Keith again.

Thank you.

Can you just, talk a little bit about J code and if you expect any inflection off of that or even is there a certain mix of customers that you're not seeing participate very much at this point that you would expect to see participate once you have the J code?

Hi, Colin.

Yes.

Thank you for your question.

So Matthew, thanks for the question.

Yes, so we also took note of the UCB news.

Go ahead, Keith.

I think it's good news for us.

Thank you, Tim.

It means there is less competition out there.

Matthew, thanks for the question.

I think we're formulating our plans and our strategies based on our own data.

And we have our J code.

So I think our conviction level in the potential of agliptic hematoma in ITP is significant.

Our J code is live.

I think the data we saw in such a refractory patient population are actually, quite impressive with a more than 50% IWG response rate.

It's been running live since July 1st.

I think the safety profile came out very consistently and very clean, and we have documented very carefully the unmet medical need in ITP.

Really what the J code is doing is it is making it, easier for physicians and offices to get patients through the process. It's making the conversion process go quicker from time of prescription to time for actual infusion.

I can also tell you that the initial feedback from the field from treating physicians has been, very positive and very consistent.

So as far as it opening up additional audiences, you know, really the unmet medical need and, the success that patients and physicians are seeing with Vivgard is why we've had pretty substantial demand here in the in the first couple of quarters.

So we're steaming forward with our ITP opportunity.

So I don't know that you're going to see an uptick because you have a J code as much as you're going to see the ease of getting the patient through through the process faster.

NV.

Your next question comes from a line of William Old from Evercore.

Thanks for the question.

Your line is open.

Your next question comes from a line of Douglas, Tsao from H.C. Wainwright.

Hey, guys.

Your line is open.

Thanks so much.

Hi, good morning.

And just a really spectacular quarter.

Thanks for taking the questions.

I had a couple questions.

I think in the slides you indicated that most script writers... Hello, can you hear me?

So the first one is, you know, you guys are at 85 percent patient lives covered right, now.

We can hear you fine, Doug.

What's the goal you guys are thinking is realistic by year end?

Okay.

And then my second question is, what are you guys thinking in terms of COGS long term for extractive GMAT?

Yeah, sorry.

Hey, William.

You indicated most writers have written one, to two scripts.

Two great questions.

I'm just curious, do you have any perspective in terms of the types of patients they're selecting for those initial scripts?

Let me start by giving the floor to Keith to talk, about, you know, how we.

Is there a certain profile?

Life's covered.

Are they waiting for the patients who are perhaps not doing as well on IVIG or their existing therapy or is it just sort of happenstance just to be the first patient that walks in the door that sends the approval?

And then I would like to hand over to Carl to give a brief comment on COGS.

Thank you, Doug.

So, Keith, why don't you go first?

That's an excellent question.

Yeah, William, thanks for the question.

Keith, would you mind taking this one?

In regard to coverage, we're really pleased with, the progress that we've made through the second quarter. In particular, we're really pleased with a number of the policies.

Yeah, happy to do so.

The majority of them are very favorable.

So, Doug, we don't actually, see an enormous difference in the 78% that have written one or two compared to the remainder that have more patients on therapy.

They align with the ADAPT inclusion criteria, which means we can have patients as early as second line treatment.

Again, with almost 50% of the patients experiencing IVIG prior to getting Vyvgart, it appears that in the early going, we have a higher percent of refractory patients than we expect to have in the future.

As far as the remainder of the population, look, our team is not going to rest.

As I mentioned, we'll continue to try to get earlier in the treatment paradigm, so certainly placed before IVIG and certainly placed before other infusible therapies.

We are going to continue in that minority of policies that are put in place that aren't as favorable as the ADAPT inclusion criteria.

But right now, as a new option on the block, we are getting a high number of refractory patients.

We're going to work to work with those players to see that we can get them to a favorable status and the remaining 15 percent we'll continue to work on.

The good news is I think that those physicians see that experience and the experience that their patient is having, that's where we have the opportunity, the real opportunity to advance earlier into the treatment paradigm, but also take that 78% and take them from being with one or two patients on therapy to now even more than that.

But we haven't been public with setting the next number forward.

Your next question comes from a line of Joel Beattie from Baird.

Thanks Keith.

Your line is open.

Karl?

All right.

Thank you Tim.

Thanks for taking the question and congrats on that quarter.

So in terms of cost of sales, clearly we're not going to give detailed guidance here, but safe to say, as we move to larger production facilities, currently Viles is coming out of Slough, a 1K reactor, then we have Singapore, a 2K reactor, which is also FDA approved, and later on Portsmouth, an even bigger facility will come online, that will drive efficiencies.

Going back to an earlier comment about how 1,000 patient ads was extraordinary and, it seems not to be expected to be repeated, is that based on feedback that there may have been kind of a pent-up demand effect here?

Also important for you to remember is that once we get sub-Q, there's that mid-single-digit royalty for, Viles enzyme on the sub-Q.

I think this is a great question and an opportunity to reiterate the views of the, company on the position we're in.

Thanks Karl.

Keith, why don't you go ahead?

Your next question comes from the line of

Happy to.

Tahseen Ahmad from Bank of America Securities.

Actually, Joel, the point that we're making is that it was a very powerful quarter, in patient ads. I mean 1,000 GMG patients in a quarter in a rare disease is quite a number for any therapy. And so the fact that we were able to deliver that is quite impressive.

Your line is open.

All I was saying is that if I was building out my model, I don't think I would be placing that, as all of a sudden the new standard that you can expect to occur quarter over quarter.

Okay, thank you for taking my question.

Your next question comes from a line of Manos Mastarakas from Deutsche Bank.

I apologize if this has already been asked, I did join a little bit late, but can you talk about the reliability of tracking scripts intra-quarter, because it did seem like Symfony in particular was tracking relatively close to the number you reported this quarter.

Your line is open.

Is that just by chance, or do you think that there is a reliable component to looking at those trends?

Yes, hello.

And then the second part of the question is, should we expect to see any seasonality in the second half of the year, particularly in 4Q?

My question was asked just earlier in terms of the ITP opportunity, but maybe I could just add if you could say anything else more quantitatively perhaps, about the market opportunity.

Is it a trend, based on what you know about the GMG space, that patients tend to be less compliant during the holidays, or should we not assume any kind of seasonality?

Thank you.

Thank you.

So for ITP, what we learned with the data in hand from the field and from the physician, audience we have been interacting with is that there is substantial medical need in primary ITP patients.

Hi Tahseen, thank you for joining us in the call today.

What basically happens today is that when patients are moved from a steroid, to a TPO and they fail a first TPO, they would be typically cycled on a second TPO and now that there's a third TPO out there on the market even to a third TPO.

So it doesn't make a great deal of sense to switch patients between medication using a similar mode of action.

It does make sense to move them after a first TPO failure onto a totally different mode of action which actually has proven to be a very powerful mode of action which is the reduction of pathogenic IGGs which are responsible for clearing platelets but also attacking the megakaryocytes.

So we think there is a clear positioning here for third line therapy in the ITP market space.

What we quantitatively hear from physicians is in line with what some of our analysts have been writing. For example, I have been reading about a 10% market share based on a third line positioning.

The company based on its data and its market research would actually feel comfortable with that.

And there are no further questions at this time.

This concludes today's conference call.