Q1 2022 argenx SE Earnings Call

Unknown Executive: Thank you very much. Good morning, everyone.

Unknown Executive: And thank you for joining today's call, slightly. I'm thrilled to discuss our strong first-quarter results. In particular, we have shared two sets of exciting news this morning. First, we exceeded expectations for the first quarter of our U.S. fifth outlaw, generating $21.2 million in net product revenue.

I'm thrilled to discuss our strong first quarter results in particular, we have shared two sets of exciting news this morning.

First we have exceeded expectations for the first quarter of our U S kicked out launch generating $21 2 million in net product revenues.

Unknown Executive: Keith is going to provide more context on our commercial progress later in the call, but at a high level, this demonstrates both the clear unmet need for new treatments in the GMT community and the tremendous execution of our team to translate that need into real demand from patients and physicians. Our carefully crafted strategies with regard to patients, physicians, and patients are paying off today, and I'm more confident than ever that we have the right team in place to bring Vyvgart to the GMG community. We're also on track to launch in Japan this month, so we are advancing well on our global launch strategy.

Keith is going to provide more context on our commercial progress later in the call, but at a high level.

This demonstrates both the clear unmet need for new treatments in the GMT community.

The tremendous execution of our team to translate that needs into real demands from patients and physicians.

Our carefully crafted strategies.

With us to face physicians and patients are paying off today.

Im more confident than ever that we have the right team in place to bring <unk> to the GNC community.

We are also on track to launch in Japan. This month, so we are advancing well.

Our global launch strategy.

Second.

Unknown Executive: Sakon, We announce positive results from the advanced trial, the first of our two registration IPP trials. We met a very high bar in achieving this positive result with a difficult primary endpoint and a refractory, very heavily pre-treated patient group. We also have a robust set of data from a secondary endpoint that provided additional context on basic conductivity throughout the study.

We announced positive results from the advance trial.

First of our two Registrational trials.

We met a very high bar in achieving this positive results with a difficult primary endpoints and creative factory very heavily pre treated patient group.

We also have a robust set of data from the secondary endpoints that provide additional context on sales headcount activity throughout the study.

Unknown Executive: These data points align closely with how physicians treat ITP patients and will be critical as we look to bring a new treatment option to the ITP community. ITP is now the second serious autoimmune disease in which we've shown a statistically significant treatment benefit. We are starting to see the reality of Advertising Ops as a pipeline in the product. I want to spend most of the call on these topics, so I'm going to be brief in talking through the rest of our first quarter program.

These data points align closely with how physicians treat ICT patients and will be critical.

As we look to bring a new treatment option to the ICP community.

ITT is now the second serious autoimmune disease in which we've shown a statistically significant treatment benefit risk.

Starting to see the reality of Piedmont as a pipeline in a product.

I want to spend most of the call on these topics.

Going to be brief and talking through the rest of our first quarter progress.

Unknown Executive: We reported positive results from the Phase 3 Adepts Sub-Q trial and are on track to file by the end of the year. We've been building the positive momentum of our IG long by bringing additional optionality to patients who may prefer a subcutaneous option. You're executing well across all programs, and expect by the end of the year to be in clinical development with 10 acceptable indications and 2 ArgenX 117 indications and also to start the Phase 1 trial with ArgenX 119.

We reported positive results from the phase III that subdued trial.

And are on track to file by the end of the year.

We will build on the positive momentum of our IV launch by bringing additional optionality to patients who may prefer a delivery option.

We are executing well across all programs and expect by the end of the year to be in the clinical development with timing of captive demand indications and two <unk> 2017 indications and also to start the phase one trial with <unk> hundred 19.

Unknown Executive: We saw in our test release that we are expanding enrollment in the ADDRESS trial for time figures and therefore pushing back the timeline for top-line results to the second half of 2023. We decided to take a conservative view on our exposure in Ukraine and Russia because we believe it sets us up for the best chance of success with the trial.

You saw in our press release. This we are expanding enrollment in your test trial for benefits and therefore perspective timeline for top line results to the second half of 2023.

We decided to take a conservative view on our exposure in Ukraine and Russia.

We believe this sets us up for the best chance of success with the trial.

Unknown Executive: Ultimately, we want to reach patients as quickly as we can, of course. We will update you with any changes as we make progress on enrollment. Moving on to the advanced trial results in ITP, who will walk through the data in detail. But I'd like to first spend a few minutes on why we selected ITP as our second indication and what these positive results could mean for ITP patients. ITP, like all our indications, clearly aligned with our multi-faceted indication selection strategy.

Ultimately move onto these patients as quickly as we can.

Of course, we will update you with any changes as we make progress on enrollment.

Moving onto the advance trial results in ITT.

Rich will walk through the data in detail.

But I'd like to first spend a few minutes on why we selected <unk> as our second indication and what is the positive results could mean for <unk> patients.

ITT like all our indications clearly aligns with our multi faceted indication selection strategy.

Unknown Executive: First and foremost, the biology of rationale is evidence. Primary ITP is truly an ITT-mediated serious autoimmune disease in which pathogenic autoantibodies work through four modes of action, as depicted on slide 4. We believe that Africa fills them up with its novel mechanism of action, which could be a differentiated approach by targeting all four modes of action simultaneously.

First and foremost the biology rationale is evident.

Timely ITT is truly an ITT mediated serious autoimmune disease in which pathogenic auto antibodies work through foremost of action as depicted on slide four.

We believe it has got to come up with its novel mechanism of action could be a differentiated approach by targeting all four months of action simultaneously.

Unknown Executive: This means that we can right-size the balance between enhanced creative production and reduced creative clearance by targeting the autoantibodies driving both modes of action. We pursue rare disease and orphan mutations because there is a significant unmet need for new treatment options, and ITP is no different. ITP affects more than 70,000 adults in the United States. This is a disease that affects not only the patient's stated count but is also associated with bruising, bleeding, fatigue, anxiety, and depression, all of which significantly impact the individual's quality of life.

This means that we can right size the balance between enhanced base of production and reduced basis premiums by targeting the auto antibodies driving both modes of action.

Second.

We pursue rare disease, an orphan indications because there is a significant unmet need for new treatment options and ATP is no different.

IPP affects more than 70000 adults in the United States.

This is a disease that affects not only the patients that account.

It is also associated with bruising bleeding fatigue, and science and depression.

All of which significantly impact the individuals quality of life.

Unknown Executive: The challenge in treating like a key patient is that no defined treatment paradigm exists, and physicians have adopted the trial and error approach in which they cycle patients on and off different therapies as one or the other. As part of KLLT's treatment goals for an IPP patient, they shared consistent feedback around the need for more options. We are aiming to drive platelets to a safe and sustained platelet level, whether it's 20,000 or 30,000 platelets, while managing bleeding events, and to do this without adding known toxicity to the treatment approach.

The challenge in treating <unk> patients.

No defined treatment paradigm exists and physicians have adopted a trial and error approach in which case size of patients on and off different therapies.

One of the other loses effect.

We asked our kols about the treatment goals for ITT patients and this shift consistent feedback around the need for more options.

We're aiming to drive <unk> to a safe and sustained platelet level, whether its 20000 30000 placements, while managing bleeding events and to do this without adding known toxicity to the treatment approach.

Unknown Executive: We kept these goals in mind with a selection of secondary endpoints that we evaluated in. We will need to wait for the outcome of the advanced sub-Q trial before we file our DMA, but we believe we have a strong data set from the first trial across our primary and secondary endpoints. This puts us on track to deliver a new treatment option to people living with a serious disease. This is a commitment we make to the ITP community. With that, I will hand the call over to him to walk through the data in detail. Thank you, Tim, and good morning, everyone.

We kept these goals in mind with a selection of secondly importance typically evaluated in advance.

Do they need to wait for the outcome of the advance of acute trial.

Before we file our BLA for.

But believe we have a strong data set from the first trial across our primary and secondary endpoints.

This puts us on track to deliver a new treatment option to people living with this serious disease.

This is a commitment we made to the ITT community.

With that I will hand, the call to Luke.

To walk through the data in detail.

Thank you, Tim and good morning, everyone.

Unknown Executive: I'm very excited that we have positive data readout for my first conference call as chief medical officer of ArgenX, a role which I assumed on April 1st. Let's start with the trial design on slide 6. We included patients both on concomitant therapy or a watch and wait approach to therapy. 131 patients were randomized 2 to 1, treatment versus placebo, and for two weeks during the screening period. All patients received a fixed weekly infusion for the first four weeks.

I'm very excited as we are a positive data readouts for my first conference call as Chief Medical Officer of our Jennings.

Well rich I assumes on April one.

Let's start with the trial design on slide six.

We included patients both on concomitant therapy, or a watch and wait approach of therapy.

131 patients were randomized two to one treatment versus placebo after two weeks screening period.

All patients receive a fixed weekly infusions for the first four weeks.

Unknown Executive: Between weeks 5 and 16, if patients have platelet counts of 100,000 or more for three out of four visits, they could transition to every other week. The primary endpoints were measured starting at week 19, and Patients were reclassified as Sustained Responders if they achieved a platelet count of 50,000 in four out of the last six visits. His primary endpoint was selected to fulfill regulatory requirements, but we also looked at metrics throughout the study that align with real-world treatment objectives. One of these is the International Working Group assessment.

Between weeks five in 16, if baseline platelet counts over 100000 or more for three out of four visits.

They could transition to every other week dosing.

The primary endpoint was measured starting in 2019 and patients reclassified a sustained responders. They achieved a place accounts of 50000 in four out of the last six visits.

Primary endpoint was selected to fulfill regulatory requirement.

But we also look at metrics throughout the study that the language real world treatment objectives.

One of these is the international working group assessment.

Yeah.

Unknown Executive: Patients who completed ADVANCE could roll over into ADVANCE Plus. The Open Label Extension We had 101 patients total all over, which is 95% of those who completed the trial. On slide seven are the patient baseline characteristics. We enrolled primarily chronic ITP patients into the advanced phase, but also had a small number of persistent patients in each arm. We stratified for a history of synectomy and concomitant therapy. Approximately half of the patients had Platelet counts below 15,000 at baseline.

Patients, who completed advanced goodwill over advance plus.

The open label extension.

We had 101 patients total rollover, which is 95% of those who completed the trial.

On slide seven are the patient baseline characteristics.

Enrolled primarily chronic ITT patients into advance, but also had a small number of persistent patients in each arm.

We stratified for Easter of Splenectomy, and a concomitant therapy.

Fortunately the half of the baseline platelet counts below 15000 at baseline.

Unknown Executive: The mean time since diagnosis was approximately 10 years, and over 50% of patients had received three or more prior ITP therapies. This could be classified as refractory, heavily pre-treated patient blood. Turning to slide eight.

The meantime, since diagnosis was approximately 10 years and over 50% of patients that's received three or more prior ITB therapies.

This could be classified as a refractory heavily pretreated patient group.

Turning to slide eight.

Unknown Executive: On the left is the clear correlation of discard infusions and platelet count improvement. The separation of the treat and do from placebo is evidenced throughout the trial period. On the right is a primary endpoint analysis. In the treated arm, we had a response rate of 21.8% or 17 out of 78 compared to 5% in the control group. This was encouraging in such a heavily pre-treated population, and even with a tough primary endpoint measure, we've met a high regulatory hurdle.

On the left is a clear correlation of this card infusions and platelet count improvement.

The separation of the treatment group from placebo as evidenced throughout the trial period.

On the right is the primary endpoint analysis.

In the treated arm, where the response rate of 21, 8% or $17 78 compared to 5% in placebo.

This was encouraging and such a heavily pretreated population and even with the tough primary endpoint measure we've met the high regulatory hurdles.

Unknown Executive: On slide 9, we can see that we also looked at the responders based on criteria from the International Working Group for ITP. These endpoints were developed by leading ITP physicians as a way to incorporate real-world treatment implications into clinical trial assessment. We include this as a secondary endpoint because this is incorporated in the EMA guidelines for drug development of novel IgP drugs, and we also wanted to capture our response rate along the same axis as how physicians think about treatment. A response on an IWG scale is defined as platelet counts of at least 30,000 and a twofold increase from baseline in the absence of bleeding events for at least two separate consecutive visits.

On slide nine we can see that we also looked at the responders based on criteria from the international working group for ITT.

These endpoints were developed by leading ITB physicians as a way to incorporate real world treatment implications into clinical trial assessments.

We include this as a secondary endpoint.

These are incorporated in the EMA guidelines for drug development of novel IV drugs and.

We also wanted to capture a response rate along the same axis is how physicians think about treatment goals.

Our response on <unk> scale is defined as having platelet counts of at least 30000 in a twofold increase from baseline in the absence of bleeding events for at least two separate consecutive visits.

Unknown Executive: A complete response has a higher threshold for platelet counts and is defined as having at least 100,000 platelet counts and absence of bleeding for at least two separate consecutive analysis visits. You can see how this alliance with the treatment goals of physicians gets platelets to a safe level in the absence of bleeding events. 51.2% of treated patients achieved an IWG response, and 27.9% achieved a complete response, compared to placebo, where 20% of the chiefs and IWG responded, and 4.4% the complete list. On slide 10, we highlight additional context around the platelet response in Vyvgart-treated patients throughout the trial. The first answer to the question is obvious.

A complete response is a higher threshold for platelet counts and is defined as having at least 100000 platelet counts and absence of bleeding for at least two separate consecutive analysis visits.

You can see how it is alliance through the treatment goal to physicians platelets to a safe level and the absence of bleeding events.

51, 2% of treated patients achieved an <unk> response and.

And 27, 9% a complete response.

<unk> to placebo, where 20% achieved an <unk> response.

Four 4% of the complete response.

On slide 10, we have.

Highlights additional context around the platelet response and please call treated patients throughout the trial.

The fast onset of action as evidenced and you can see a clear separation between the <unk> and placebo arms as early as week one.

Unknown Executive: And you can see a clear separation between the Vyvgart and placebo arms as early as week one. Durable platelet count increase is observed over the duration of the study with a clear separation between Vyvgart and placebo arms at each week. We have 10 Vyvgart patients switched to every other week doses. Patients are eligible to make this switch. They surpassed 100,000 platelet counts at three out of four consecutive visits. Importantly, 9 of the 10 patients who switched remained responsive. Only one placebo patient was able to switch to every other week dosing, and this patient was not a result. Moving to slide 11.

The durable platelet count increases observed over the duration of the study with a clear separation between <unk> and placebo arms at each week.

We have 10 bps guard patients switched to every other week dosing.

Based on eligible to make the switch.

We surpassed 100000 platelet counts at three out of four consecutive visits.

Importantly, 90.

Over the 10 patients who switched remains responders.

Only one placebo patients was able to switch the every other week dosing and this patient was not a responder.

Moving to slide 11.

Unknown Executive: We look at sustained latent cancer response across many different subtypes, and as you can see on the slide, regardless of the category, there's a high response rate in Vyvgart-treated patients. We observed responders in each patient type regardless of age, disease severity, time since diagnosis, prior ITP treatment, use of background medication, or history of sputnik. Next slide, please. You can see on the chart here that we show statistical significance in our key platelet-derived secondary endpoints, including the cumulative number of weeks where platelet counts were at least 50,000 in the chronic ITT population and sustained platelet response in the overall population, including both chronic and persistent ITP patients.

We looked at a sustained platelet count response across many different subtypes and as you can see on the slide that regardless of the category, there's a higher sponsorship in <unk> treated patients.

We observe responders in each patient type regardless of age disease severity time since diagnosis prior ITB treatment use of background medication or history of splenectomy.

Next slide please.

You can see on the chart here that we showed statistical significance in our key platelet derived secondary endpoints, including.

Cumulative number of weeks, where platelet counts for at least 60000 in the chronic ITT population.

And sustained platelet response in the overall population, including both chronic and persistent ITD patients.

Unknown Executive: The response rate in the overall population was slightly higher than the chronic population alone, which indicates that a small number of persistent patients performed well in the trial. However, we did not show statistical significance in the number of WHO-classified breeding events.

The response rate than the overall population was slightly higher than the chronic population alone which indicates that the small number of persistent patients performed well in the trial.

We did not show a statistical significance in the number of <unk> classified bleeding events.

Unknown Executive: This was not surprising because bleeding events below the baseline made a delta difficult to achieve. However, we did see numerically fewer bleeding events categorized as adverse events in treated patients compared to placebo, and we also saw fewer platelet transfusions as a rescue therapy in treated patients compared to placebo.

This was not surprising because bleeding events, the lower baseline, making available a difficult to achieve.

We did see numerically fewer bleeding events <unk> adverse events in <unk> treated patients compared to placebo.

And we also saw fewer platelet transfusions, as a rescue therapy and treated patients compared to placebo.

Unknown Executive: This would indicate that placebo patients require more immediate rescue therapy than Vyvgart patients. And finally, with the last key secondary endpoint, we show a significant difference between Vyvgart and placebo-based Endurable Sustained Platelet Count Response. However, due to hierarchical testing, we could not classify it as having met the end point.

This would indicate.

The placebo patients required more immediate rescue therapy than safeguard patients.

And finally, we felt last key secondary endpoint.

We showed a significant difference between <unk> and placebo patients and durable sustained platelet count response.

Unknown Executive: This is an important data point, though, because the response rate holds up when you look at the four of the last six visits, 6 of the last 8 visits, or even 8 of the last 12. This means if you're a responder, you're a de facto leader of a voice. On slide 13, we cover safety and tolerance. ADVANCE is our first registrational trial with chronic administration. We are very pleased to confirm the safety and tolerability profile of Vyvgart as we move from a cyclical treatment schedule and adjust your chronic 24-week schedule in advance. There were no new meaningful safety fines.

Due to our article testing, we could not classify it as having met the endpoints. This is an important data point, though because the response rate holds up whether you look at the four of the last six visits six over the last eight visits or even eight over the last 12 months.

It means if you're a responder you would've durable responder.

On slide 13 recover safety and Tolerability.

Advantages, our first Registrational trial with chronic administration.

We were very pleased to confirm the safety and Tolerability profile of this card as we move from a cyclical treatment scheduling of adapt.

Chronic 24 week schedule in advance that we're in.

No new meaningful safety findings.

Unknown Executive: To conclude, we are very excited with the totality of the data we're showing today. First, we met the primary endpoint, which was a high bar, especially for a difficult-to-treat patient group. We also gathered important data for physicians that aligns with how they make treatment decisions. For example, we showed a fast onset of action and a durable platelet count with clear separation from placebo throughout the trial. We saw a significant proportion of respondents switch to every other week dosing and maintain their response.

To conclude we are very excited with the totality of the data that we're showing today.

We met the primary endpoint, which was a high bar, especially for a difficult to treat patient group we are.

Also got us important data for physicians that aligns with how they make treatment decisions.

We showed a fast onset of action and a durable platelet counts with clear separation from placebo throughout the trial.

We saw a significant proportion of respond to switch to every other week dosing and maintain their response and we are.

Unknown Executive: We are particularly pleased with the safety profile as we move from cyclical to chronic dosing. With that, I will turn the call over to Karl for a financial update.

I'm, particularly pleased with the safety profile as they move from cyclical to chronic dosing with that I will turn the call over to Carl for a financial update call.

Karl Gubitz: Thank you, Luke. Slide 15. Our first quarter 2022 results are detailed in our press release this morning, so I will only highlight the key points. First on cash, we ended the first quarter with cash, cash equivalents, and current financial assets circling $2.9 billion, which includes 761 million of net proceeds from a successful financing round in March. Based on current plans, it expects to utilize approximately 1 billion of available cash in 2022.

Thank you Luke.

Slide 15.

Our first quarter 2022 results are detailed in our press release from this morning.

I will only highlight the key points here.

Based on the cash balance we ended the first quarter with cash cash equivalents and current financial assets totaling $2 9 billion, which includes $761 million of net proceeds from a successful financing announced in March based on current plans again.

Karl Gubitz: The spend will support the global discount launches Clinical development of S. corticomote in 10 indications and argenx 117 in 2 indications, investment in the global supply chain, and continued focus on pipeline expansion through our immunology innovation program. We will not be providing any revenue guidance on today's call or any guidance on the expected ramp of product revenue.

Expect to utilize approximately $1 billion of our available cash in 2022.

<unk> will support our global best quarter launches.

The clinical development of <unk>, multi and indications and <unk>.

Indications invest.

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

We will not be providing any enabling new guidance on today's call or any guidance on the expected ramp of product revenue.

Karl Gubitz: We expect to be able to provide guidance once we have a few quarters underway and can have a better perspective on the ramp of a launch, competitive market dynamics, and how individualized dosing translates to real world use. Now on financial aid for the first quarter of 2022. Net product revenue from the Vyvgart launch in the US was $21.2 million. Inventory in the channel at Kortend was well managed and reflects less than two weeks worth of... Total revenues of the quarter were $31.5 million, which also included $2.2 million in collaboration revenue and $8.2 million in other operating income. Cost of sales for a quarter were $1.4 million.

We expect to be able to provide guidance. Once we have a few quarters anyway and you can have a better perspective on the ramp of our launch competitive market dynamics, and how individualized dosing translates to real world use.

Now on financial results.

While our first quarter 2022.

Net product revenue from our first quarter launch in the U S with $21 2 million.

Inventory in the channel at quarter end was well managed its next less than two weeks worth of volumes.

<unk> revenues for the quarter were $31 5 million, which also included $2 2 million in collaboration revenue and $8 2 million.

Income.

Cost of sales for the quarter were $1 4 million.

Keith: Our total R&D and SG&A expenses for the first quarter were approximately $152 million and $100.9 million, respectively. These can be mainly attributed to both research expenses related to FCAR-TGMOT and other programs, as well as planned marketing and headcount expenses related to the global commercialization of FCAR. You can find additional details behind these numbers in the press release we issued this morning. I'll now hand the call to Keith for a commercial update. Thanks, Karl.

Our total R&D and SG&A expenses for the first quarter were approximately $152 million.

$190 million respectively.

These can be mainly attributed to both the research expenses related to export to give more than other programs.

As well as planned marketing and head count and expenses related to the global commercialization of <unk>.

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

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

Keith: Next slide, please. To echo Tim's earlier comments, we are excited about the strong start we had in the first quarter with regard to our commercial efforts. Our progress reflects both the benefit of our strategic preparation and the hard work and dedication of our experienced team. We outlined our launch priorities in our December 2021 approval call around empowering patients to demand better, providing best-in-class patient support, encouraging rapid Vyvgart adoption by healthcare professionals, and enabling appropriate access. We have been systematically executing on all of these to deliver results today that exceed our expectations. First, we continue to make progress on our work with payers. Next slide, please.

Thanks Carl.

Slide place capital Tim's earlier comments, we are excited about the strong start we've had in the first quarter with regard to our commercial efforts. Our progress reflects both the benefit of our strategic preparation and the hard work and dedication of our experienced team.

We outlined our launch priorities in our December 2021 approval call around empowering patients to demand better providing best in class patient support.

Encouraging rapid <unk> adoption by health care professionals, and enabling appropriate access.

We have been systematically executing on all fronts to deliver results today that exceeded our expectations.

Keith: On our quarter-four call, we announced that Vyvgart specific policies had been published in plans covering approximately 25% of US commercial lives. We're pleased to share today that that number has increased to over 60% of covered lives, and we remain on track to have broad coverage in place by the end of the second quarter. We are encouraged that policies continue to align to the Vyvgart label, both in terms of step-through and prior authorization requirements. We are seeing many favorable policies where patients need to fail Mestinon or steroids only to gain access to Vyvgart, and approvals are typically for 6 to 12 months of therapy with retreatment at the physician's discretion.

First we continue to make progress on our work with Payors next slide please.

On our quarter four call, we announced the giftcard specific policies had been published in plans covering a box approximately 25% of U S commercial lives.

We are pleased to share today, but that number has increased to over 60% of covered lives and we remain on track to have broad coverage in place by the end of the second quarter.

We are encouraged that policies continue to align to the V Gard label.

In terms of step through and prior authorization requirements.

We are seeing many favorable policies, where patients need to failed <unk> or steroids only to gain access to <unk> and approvals are typically for six to 12 months of therapy with re treatment at the physician's discretion.

Keith: We also received confirmation that the J code has been approved and will go into effect on July 1st, 2022. Second, we've made great strides in our efforts to engage with the physician community. Next slide, please.

We also received confirmation that the J code has been approved and will go into effect on July one 2022.

Second we've made great strides in our efforts to engage with the physician community next slide please.

Keith: With a brand new mechanism of action, we knew it would take time to encourage adoption, and we are pleased with the initial excitement from the community. At the end of the first quarter, we continue to see both breadth and depth of prescribers. We're still in the early stages of our plans for educational programs and peer-to-peer engagement, but we're pleased to report that we've had 129 speaker programs held since launch with over 600 health care providers attending. Key Opinion Leader Physician Feedback also continues to be positive.

With a brand new mechanism of action, we knew it would take time to encourage adoption and we are pleased with the initial excitement from the community as.

At the end of the first quarter, we continue to see both breadth and depth of prescribers. We're still in the early stages of our plans for educational programs and peer to peer engagement, but we're pleased to report that we had 102009 speaker programs that have been held since launch with over 600 healthcare providers attending.

Key opinion leader physician feedback also continues to be positive.

Keith: Most KOLs report that they plan to utilize the individual treatment cycles for Vyvgart and are comfortable initiating subsequent cycles based on their evaluation. They also report that the safety profile of Vyvgart is a positive differentiator. We're pleased to see that the prescriptions being written reach a wide breadth of individuals and closely reflect the population we observed in the Phase 3 ADAPT trial. Half of the patients on Vyvgart have previous experience with IVIG, and the other half have experienced other available therapies across the treatment paradigm, some with only steroids or ISTs and some with other biologics. Moving on to the next slide.

Most kols report that they plan to utilize the individual treatment cycles forbid guard and are comfortable initiating subsequent cycles based on their evaluation.

They also report that the safety profile of <unk> is a positive differentiator.

We are pleased to see that the prescriptions being written reach a wide breadth of individuals and closely reflect the population we observed in the phase III adapt trial.

As of the patient's own good guard had previous experience with IV AIG and the other half have experienced other available therapies across the treatment paradigm somewhat only steroids are isps and some with other biologics.

Moving on to the next slide.

Keith: Third and most importantly, we are thrilled to finally be reaching patients in need. And as of the end of the first quarter, we have approximately 380 patients on Vyvgart. We're sharing this metric today because we think it's important to show the strong early demand. We will continue to share patient numbers as we are able, but it is possible that patients on therapy will be harder to track going forward with staggered start times for subsequent treatment cycles. We expect to rely mostly on revenue numbers to show growth on a quarter over quarter basis.

Third and most importantly, we are thrilled to finally be reaching patients and meet and as of the end of the first quarter. We have approximately 380 patients on <unk>.

We are sharing this metric today, because we think it's important to show the strong early demand.

We will continue to share patient numbers as we were able but it is possible that patients on therapy will be harder to track going forward with staggered start times for subsequent treatment cycles, we expect to rely mostly on revenue numbers to show growth on a quarter over quarter basis.

Keith: We shared at the time of approval that empowering patients would be a core component of our launch. Next slide, please. We are inspired by the feedback we have received so far, which is depicted on this slide, and know that we have the right team in place with MyVyvgartPath to help them through each step of their treatment journey.

We shared at the time of approval that empowering patients would be a core component of our launch next slide. Please we are inspired by the feedback we have received so far which is depicted on this slide and know that we have the right team in place with <unk> path to help them through each step of their treatment journey.

Next slide please.

Keith: We're still in the very early days of this launch, and market dynamics are changing already. This successful first quarter has opened our eyes to the real unmet need for patients, but we know that we will need to continue to execute and engage with our key stakeholders to maintain this strong momentum.

We're still in the very early days of this launch and market dynamics are changing already.

The successful first quarter has opened our eyes to the real unmet need for patients, but we know that we will need to continue to execute and engage with our key stakeholders to maintain the strong momentum. There are still many unknowns ahead with competition the contribution of more refractory patients and the reality of.

Keith: There are still many unknowns ahead with competition, the contribution of more refractory patients, and the reality of how individualized dosing will play out cycle over cycle. We're very proud of the effort that our teams have put forward for this quarter, but we also know that we need to see results from the next few quarters before we can understand our real launch trajectory. Before I turn the call back to Tim for his concluding remarks, I'll wrap up with a brief update on our global launch strategy. Next slide.

How individualized dosing will play out cycle over cycle, we're very proud of the effort that our teams have put forward for this quarter, but we also know that we need to see results from the next few quarters before we can understand our real launch trajectory.

Before I turn the call back to Tim for concluding remarks, I'll wrap up with a brief update on our global launch strategy next slide.

Keith: In Japan, we plan to officially launch next. Our field teams have been engaging with health care providers and can start to book sales now that we have aligned on price. The approval decision from the European Medicines Agency is also on track for the second half of 2022. We plan to proceed with a gated approach to building out our commercial organization in Europe on a country by country basis.

In Japan, we will plan to officially launch next week, our field teams have been engaging with health care providers and can start to book sales now that we have aligned on price.

The approval decision from the European Medicines Agency is also on track for the second half of 2022.

We plan to proceed with a gated approach to building out our commercial organization in Europe on a country by country basis.

Keith: ArgenX Canada was established in the first quarter, and we are in the process of engaging with regulatory bodies on a path forward there. With that, I'll turn the call back to Tim. Thank you, Keith. Before we open the call to your questions, I would like to conclude with the following on slide 21, has got to come up against from the procession to be not only the first in class at CNN Blockers but also the best in class.

<unk>, Canada was established in the first quarter and we are in the process of engaging with regulatory bodies on a path forward there.

With that I'll turn the call back to Tim.

Thank you Keith.

Before we open the call to your questions I would like to conclude with a summary on slide 21.

That's gone, particularly amongst remains firmly positions to be not only the first in class of Shannon blockers, but also the best in class.

Timothy Hauwermeiren: We hope to continue to extend our leadership in the FCRM space with upcoming publications and presentations, and investment in our health economics outcomes research in order to demonstrate the broad potential and differentiation of a pathogen. We are also realizing the potential of Elkartigamot to be a true pipeline in the product opportunity with the potential to address a multitude of serious IGG-mediated autoimmune diseases. You've strung out of the gates on our first commercial launch, with a second expected next year with so few I've got picking up in GMG.

We hope to continue to extend our leadership in the <unk> space.

Upcoming publications and presentations and investment in our health economics outcomes research.

Order to demonstrate the broad potential and differentiation of our best digital apps.

We're also realizing the potential of taking them up to be a true pipeline in a product opportunity with the potential to address in most acute leukemias IGT mediated autoimmune diseases.

With strong out of the gates on our first commercial launch with a second expected mix shift with so few of them taking them up into energy.

Timothy Hauwermeiren: We have reported positive phase 2 data for two indications and proof-of-concept data for four indications, and we remain committed to our ambition to be active in 15 indications by 2025. And perhaps most importantly, Kigemont is just the first of what we hope will be several pipelines in the product opportunity. Vincent, Richard, with the support of our strong balance, Strategic Partners, and Experience Global Team, we are set up to deliver sustainable growth and long-term With that, we can begin the Q&A session at this rate. Thank you. As a reminder, if you'd like to ask a question today, that's a star followed by one on your telephone keypad. If you'd like to withdraw your question, that's a star followed by two.

We have reported positive phase II data in.

Two indications and proof of concept data in full indications and we remain committed to our ambition to be active in 15 indications by 2020.

And perhaps most importantly heska.

<unk> is just the first of what we hope will be several pipeline in a product opportunities.

In sum.

With the support of them.

Our strong balance sheets strategic partners and experienced global team.

We are set up to deliver sustainable growth and long term shareholder value as a fully integrated immunology organization in 2022 and beyond.

With that we can begin the Q&A session.

Operator.

Thank you.

If you'd like to ask a question today that star followed by one on your telephone keypad, if you'd like to withdraw your question Phillip like too.

Operator: Our first question today comes from Yatin Sineshwar from Guggenheim Partners. Yatin, your line is open; please go ahead. Hey guys, congrats on a good quarter and positive results. A couple questions for me. Can you just clarify or quantify what the inventory bill was, then what type of patients you are getting, and what the cadence was throughout the quarter, any pent-up or bolus demand dynamics that we should be thinking about? And then, on the ITP side, could you comment on the bleeding rate in the study? I think in phase two there was a slight imbalance. I just want to get a sense of how it was balanced between the drug and placebo.

First question today comes from Jeff <unk> from Guggenheim Partners. Your line is open. Please go ahead.

Hey, guys congrats on a good quarter.

And positive results a couple of questions for me can you just.

Clarify or quantify what the inventory build was.

And then what type of patients, you're getting and what the cadence Ross.

Out of the quarter any pent up our bullish demand dynamic that we should be thinking about and then finally on the IPP side could you comment on the bleeding rate in the study I think in phase two there was a spike in Merrill Lynch I, just wanted to get a sense.

It was balanced between drug and placebo arm. Thank you.

Unknown Executive: Thank you. Thank you, Jochen. Thank you for being with us today. On the bleeding side, I can be brief. There was a perfect balance between both study arms.

Thank you, Jeff and thank you for being with US today on the breeding side I can be brief.

Unknown Executive: The truth is, in this study, that there was very little bleeding going on at baseline. About 50% of the patients had no bleeding, so it's very difficult to create a real meaningful delta on a crude scale like a WHO scale. There is a lot more data to be unpacked, however, so more sophisticated tests will lead to bleeding, and we will be reporting on these data at a future clinical conference. Now for the inventory, type of patients, and bonus question, I'm going to hand over to Keith. Hi, it's Karl here.

That was a perfect balance between both study arms.

<unk> in this study that there was very little breathing going on at baseline of about 50% of the patients have no bleeding.

It's very difficult to create a real meaningful delta on accrued scaled like W. We chose scale.

There is many more data to be impacted however, so.

As Takeda tests will deeply to bleeding and we will be reporting on these data at a future clinical conference now for the inventory.

Patients and bonus question I'm going to hand over to Keith.

Karl Gubitz: I will quickly take the inventory question. So we're not going to be specific about the number of vials or the dollar amount associated with that in the channel. But inventory is really well managed at quarter end; it's less than two weeks' worth of inventory.

Hi, Anthony its colony I'll quickly take the inventory question. So we're not going to be specific on the number of bottles or the dollar amount associated but OLED in the channel, but inventories really well and manage at quarter end its less than two weeks worth of inventory.

And those inventory are antero specialty pharmacies.

Okay.

Keith: And those inventories are at a special Thank you, Keith. Hi, Yad, and thank you for the question. In regard to patient types, what we saw is almost half of the patients that are now on Vyvgart had a previous experience with IVIG. That's really not a surprise, as we thought at the beginning with the new biologic. Physicians would turn to patients that were very much in need having failed several lines.

Thank you for the question in regard to the patient types.

What we saw is almost half of the patients that are now on VM Gartner had a previous experience with IV <unk>.

Really not a surprise as we thought at the beginning with a new biologic physicians would turn to patients that were very much in need having failed several lines, what we believe and what we're seeing.

<unk> that get experienced with good guard then see the benefit that <unk> can provide a wider range of patients and so the other half of the population that hadn't experienced IV AIG come from across the spectrum. Some have just experienced <unk> and steroids others have had.

Keith: What we believe and what we are seeing is that physicians that get experience with Vyvgart then see the benefit that this can provide a wider range of patients. The other half of the population that hadn't experienced IVIG come from across the spectrum. Some have just experienced mestinon and steroids, others have been on broad ISTs, and then we have some that have come from relapsed refractory biologics. As far as pent-up demand is concerned, we're one quarter in. It's really too early to say.

Then on broad Isps and then we have some that have come from relapsed refractory biologics so as far as pent up demand, where one quarter and it's really too early to say I think just overall the launch reflects the unmet medical need that exists in Mg.

Okay.

As a reminder, the scholar one to ask a question on start to to withdraw participants osteogenic yourselves to one question per person. So we can get through the queue in good time.

Keith: I think, just overall, the launch reflects the unmet medical need that exists in MG. As a reminder, that's star one to ask a question and star two to withdraw. Participants are asked to limit themselves to one question per person so we can get through the queue in good time. The next question is from Matthew Harrison from Morgan Stanley. Matthew, please go ahead, your line is open. Great. Good morning.

Next question is from Matthew Harrison from Morgan Stanley Matthew. Please go ahead. Your line is open.

Keith: Thanks for taking the question. I was just wondering if you could comment a little bit more on insurance and prior authorizations. I know you gave some commentary on this in your prepared remarks, but just broadly what you're seeing, what you're expecting, or how many more plans you need to see to codify what they may be doing on prior auths or reauthorizations and the frequency there. Any more details would be super helpful.

Great. Good morning, Thanks for taking the question.

I was just wondering if you could comment a little bit more on insurance and prior authorizations. I know you gave some commentary in your prepared remarks, but just broadly what youre seeing if youre expecting or how many more plans to you need to see to codify what they may be doing on prior offs or re authorizations and the frequency there.

Any more details would be super helpful. Thank you.

Keith: Thank you. Hey Matthew, thank you for the question. So as you heard, even one month into it, we alluded to the fact that we had 25% of covered lives. I credit that to the fact that our market access team was already working with payers prior to the PDUFA date. And in fact, looking at contracts in principle that were value-based agreements, we've moved forward with signing those value-based agreements, and now, at the end of quarter two, we have greater than 60% of covered lives. We expect that number to go up here in quarter two.

Hey, Matthew Thank you for the question.

As you heard even one month into it.

To the fact that we had 25% of covered lives I credit that to the fact that our our market access team, we're already working with payers prior to the <unk> date and in fact looking at contracts in principle that we're value based agreements we'd move forward with signing those value based agreements and now at the end of quarter two we have <unk>.

Later than 60% of covered lives, we expect that number to go up here in quarter two.

Keith: So continued success in market access. For the most part, these plans have been very favorable, many requiring only the utilization of one previous oral therapy, whether that be mestinon, steroid, or an IST. Also, we're seeing approval for six to 12 months right off the bat; this is not being approved on a cycle by cycle basis. It's six to 12 months. As far as reapplying, we haven't got to the six to 12 months yet. So we'll cross that bridge when we get there.

So continued success.

And market access for the most part these plans have been very favorable many requiring only the utilization of one previous oral therapy, whether that be messaging on steroids or an ISP.

Also we're seeing approval for six to 12 months right off the bat. This is not being approved on a cycle by cycle basis at six to 12 months as far as reapplying, we haven't got to the six to 12 months, yet So we'll cross that bridge when we get there, but overall very pleased with the work that the team has done with payers.

The last thing you heard in the prepared remarks.

We will clear the hurdle on July one and will have a J code in place that specific for FTR ticking them off.

Keith: But overall, very pleased with the work that the team has done with payers. Last thing you heard in the prepared remark, that we will clear the hurdle on July 1 and we'll have a J code in place that's specific to EFGAR Ticket. The next question is from Tazine Amat from Bank of America. Tazine, your line is open, please go ahead.

The next question is from <unk> <unk> from Bank of America to seeing your line is open. Please go ahead.

Unknown Executive: Hi, okay, on the sub-queue, can you just remind us what remains to be done for the application to be submitted? And would you expect an accelerated pass because the original filing for the original approval did get a standard review? And then quickly on the J code. I know you're not providing sales guidance. But once you do get that, do you expect that that should meaningfully increase your uptake for the rest of the year? Thanks. [inaudible] Thank you for joining us today. I'm going to give the J-Code question to Keith in a minute. But the path to registration in ITP remains as we said.

Alright, okay.

Thank you.

Language, but it remains to be done for the application.

Ed.

And would you expect an accelerated path because the original filings had EBIT.

Our profile the kind of standard breakdown and then quickly on the J code I know youre not providing guidance, but once you get that do you expect that that said meaningfully increase your uptick for the rest of the year.

Okay.

Yesterday, I am going to give the J code question to Keith in a minutes DFAST two registration ICP remains as we said so the second Registrational trial is required before we can submit that is identically the same steady, but with the <unk> project execution.

Unknown Executive: So the second registration trial is required before we can submit. That is the identically the same study, but with a sub-Q product execution of Apgrap Digimod. We are on track to read our top line data in Q1 next year, and then I think you can expect further guidance on what we think is a realistic timeline for submission and approval. But you're right, you will require two studies to submit. And that's going to be a regular review timeline. V, Jacob, Yeah, just first a quick clarification, Tim, Tazine, were you inquiring about the sub-q to MG? And what are the hurdles needed?

<unk>.

We are on track to read out top line data in Q1 next year and then I think you can expect further guidance on what we think is a realistic timeline to submission.

And approval.

Youre right you will require two studies to submit and is going to be a regulatory review timeline.

The J code.

Yes, just first a quick clarification, Tim Brasil, where you inquiring on the sub Q2, Mg and what are the hurdles needed or.

Unknown Executive: Yeah, okay. Yeah, yes.

Okay, Yes.

Keith: So quickly, we've already shown the top line results, and we're really pleased with the non-inferior effect that sub-q FGAR-TIGAMOD has compared to RD 10 milligram per kilogram. It's really the safety database that we've agreed upon with the FDA that is the time-limiting factor, and we've said we'll file a BLA before the end of the year. As far as accelerated review is concerned, I would say that that is probably doubtful because there is already a product available in the US to treat MG, in particular Vyvgart IV.

Yes, so quickly.

We've already shown the topline results and we're really pleased with the non inferior affected sub Q <unk> has compared to RMB 10 milligram per kilogram.

Really the safety database that we've agreed upon with the FDA that is the time limiting factor and we've said, we'll file a BLA before the end of the year as far as the accelerated review I would say that that is probably doubtful because there is already product available in the U S to treat Mg in particular.

<unk> IV, but remember we do have a priority review voucher and we will share with you. If we plan to use that for sub Q Mg at the time of filing.

Keith: But remember, we do have a priority review voucher, and we will share with you if we plan to use that for sub-q MG at the time of filing. Lastly, the J code. The J code is going to make things go through smoothlyer, faster, and easier for offices with less work and less time with rejections and appeals. But I don't necessarily think that you're all of a sudden going to see a quarter three bolus because you have a J code in place.

Lastly, the J code. The J code is going to make things go through smoother faster and easier for offices with less work and less time with rejections and appeal I don't necessarily think that youre all of a sudden you're going to see a quarter three bolus because you have a J code in place and I say this because we our team with <unk>.

Keith: And I say this because my team and I are on my Vyvgart path, and our field reimbursement managers are working with offices and with the specialty pharmacies to help patients that want to be on Vyvgart today be able to get on it. So we're working through the issues. It's just taking a little longer, and the J code will make it easier. The next question comes from Akash Tewari from Jeffreys. Akash, please go ahead.

Good guard path and our field reimbursement managers are working with the offices and with the specialty pharmacies to help patients that want to be on <unk> today be able to get on it and so we're working through the issues. It's just taking a little longer in the J code will make it easier.

Okay.

The next question comes from a cash tomorrow from Jefferies. Please go ahead.

Unknown Executive: Hey, so congrats on the really strong Vyvgart launch. Any idea why it's been just so much stronger than Solaris was out of the gate? I think Solaris had 43 patients; you have 380. Do we know what percent of patients have actually switched from IVIG regimens? And specifically, which patients within those 380 were refractory to Solaris and now went on to Vyvgart? And then maybe on IDP as well? You know, the data was positive in a pretreated population, but the response rate looks optically similar to what Rigel had.

Hey.

Congrats on the really strong beat start launch.

Any color why it's been just so much stronger than Soliris was out of the gate I think Soliris had 43 patient you have 380.

Do we know what percent of patients have actually switch from IV regiments, and specifically what patients within those 380 were refractory to Soliris amount went after they've got.

And then maybe on <unk> as well.

Data was positive in a pretreated population, but the response rate looks optically similar to what Rigel had.

Unknown Executive: Given that consensus peak sales for IDP are now approaching a billion, and Rigel's products have had a modest launch out of the gate doing about 120 million in sales, if they had Vyvgart's price, do you feel like the consensus numbers for Vyvgart and IDP may have gotten a bit ahead of themselves? Thanks so much.

Given consensus peak sales for IPP are now approaching $1 billion in regular products have had a modest launch out of the gate doing about $120 million sales. If they had <unk> price do you feel like consensus numbers for <unk> and <unk> may have gotten a bit ahead of themselves. Thanks. So much.

Unknown Executive: Thank you, Akash, for the two questions. Let me start with the ITP question, and then I will pass it over again to Keith. I think, Akash, it's very difficult to compare trials and molecules in an ITP space. It's very tempting to try and do that.

Thank you our cash for the two questions. Let me start with the NDP question, and then I'll pass it over again to Keith.

It's very difficult to compare between trials and molecules and an ICP space is very tempting to try and do that but you are looking at different trial designs different patient populations different endpoints and in an ITT space the benefit risk profile, which we put forward I think is very strong the.

Keith: But you are looking at different trial designs, different patient populations, different endpoints. And in an ITP space, the benefit risk profile, which we put forward, I think is very strong. The primary endpoint has met a very stringent bar to satisfy the regulatory requirements, But then I feel we've put forward very exciting clinical data, relevant clinical data, with an exciting novel mode of action, which is supporting the positioning which we have in mind, which is to break that cycle, you know, where people are cycled from one TPO to the other one, when the first one doesn't work, they just take you to the second one, when the second one no longer works, they take you to the third one.

The primary endpoint is met a very stringent bar to satisfy the regulatory requirements.

Keith: It does make sense now to switch to another mode of action, which has proven to be fast, durable, and working across all lines of therapy. The safety profile of the molecule, as Luke called out, is exciting. So I feel that with the IWG endpoint, where we have about one in two of these refractory patients responding in a clinically meaningful way, with such a clean safety profile, that's a very compelling proposition.

So then I feel we've put forward a very exciting clinical data relevant clinical data with an exciting novel mode of action.

Which is supporting the positioning which we have in mind, which is to break that cycle, where people of cycle from lumpy or to the other one when the first one doesn't work that just take into the second one then the second one no longer works I think is a third one.

Just makes sense now to switch to an automotive action, which has proven to be fast durable and working across all lines of therapy.

The safety profile of the molecule as Luke called out is exciting.

So I feel that with the <unk> endpoint, what we have about one and two of these refractory patients responding in a clinically meaningful way with such a clean safety profile, that's a very compelling proposition.

Keith: I'm handing over to you for the comment on the strong start. Yeah, Akash, thank you for the question. I guess first of all, I want to put into context that I think a comparison of the EFGAR-TIGIMOD, the Vyvgart launch to that of Soliris is really not an accurate comparison because we're looking at two different audiences.

I'm handing over to you for the comment on the strong stance.

Keith: Soliris really studied a severe relapsed refractory population, and therefore, they were targeting a smaller percentage of MG patients. So comparing the numbers is really kind of apples to oranges. What I will say is that we had a team that was built well in advance and was well prepared.

Yes, Josh. Thank you for the question I guess first of all I want to put into context that I think the comparison of the <unk> launch to that of Soliris is really not an accurate comparison, because we're looking at two different audiences.

Soliris really studied as severe relapsed refractory population and therefore, they were targeting a smaller percentage of Mg patients. So comparing the numbers is really kind of apples to oranges. What I will say is we had a team that was built well in advance and we're well prepared we've hired people from across the <unk>.

Keith: We've hired people from across the industry that have MG experience and have experience in neurology, whether that's coming from previous IVIG companies or coming from other companies that have therapies in neurology, so they have existing relationships with healthcare professionals. You know the work that we did with the payers in advance. I think that that put us in a position to be able to work through some of the payer issues earlier in the treatment paradigm.

History that have Mg experience and have experience in neurology, whether thats coming from previous IV AG companies are coming from other companies that have therapies in neurology. So they had existing relationships with health care professionals. You know the work that we did with the payers in advance.

Think that that put us in a position to be able to work through some of the payer issues earlier.

Keith: But really, one of the big things is that physicians have clearly told us that there is an unmet medical need for MG, and they love having this new mechanism of action and a new tool in their toolbox. Lastly, I really am pleased with the effort that our team has done in being a patient-focused organization because we have communicated directly to people that are suffering from M.G. and have come in and asked for a different opportunity or a different treatment for their disease. The next question comes from Yaron Werber from Cohen. Yaron, your line is open.

Ross the treatment paradigm.

But really one of the big things is this is clearly told us from the physicians that there is an unmet medical need in Mg and they love, having this new mechanism of action and a new tool in their toolbox.

Lastly, I really am pleased with the effort that our team has done in being a patient focused organization.

We have communicated directly to people that are suffering with Mg and they have come in and ask for a different opportunity or a different treatment for their disease.

The next question comes from Yaron <unk> from Cowen.

Line is open.

Keith: Great, and congrats on the launch. I thought maybe just a couple of really quick questions. The first one, can you give us a little bit of a sense of how fast launches typically happen given that it's a fairly concentrated GMG market in Japan? And then secondly, on PV, are you able to use any of the data from the Ukraine or Russia or those 14 sites, and all that data is totally out, so you need to essentially accrue 14 new sites? Is that what you mean by expanding the study? Thank you. Let me maybe start with the benefit of this question and then hand it over to Keith for Japan.

Great and congrats on the launch I thought maybe just a couple of really quick questions. The first one can you give us a little bit of a sense in Japan now that you are underway, how fast food launches typically happened given that it's a fairly concentrated J&J market and then secondly on PV are you able to use any of the data from the <unk>.

Crane, or Russia, or those 14 sites and all of that data are totally out. So you need to essentially crew 14, new sites is that what you mean by expanding the study. Thank you.

Let me maybe started to benefit US question, and then hand over to Keith for Japan. So, we'll just see on the clinical trials of cough is indeed, a number of clinical sites that doesn't mean that this is an equivalent number of patients. So what happens in reality with these patients is some of them, we were able to move them to other clinical sites.

Unknown Executive: So what you see on clinicaltrials.gov is indeed a number of clinical sites, but that doesn't mean this is an equivalent number of patients. So what happens in reality with these patients is some of them, we were able to move them to other clinical sites, you know, across the border where they could continue the clinical trial. But the bulk of these patients are actually, from a conservative risk management point of view, considered by the team to be lost for data collection, data review, and inspection afterwards.

Across the board or were they could continue to clinical trial, but the bulk of these patients actually are from a conservative risk management point of view considered by the team to be lost for data collection data review and inspection. Afterwards, so yes, we would be taking a conservative approach showroom and we are seeking to replace.

Unknown Executive: So, yeah, we've been taking a conservative approach, Jeroen, and we're seeking to replace that number of patients inside, you know, in a more secure place on the globe. Back to you Keith on expectations for the launch in Japan. Yeah, thank you for the question. I'm really excited to hop on a plane Saturday morning to head to Japan as we launch next Monday in the country.

That number of patients inside channel in a more secure place of the globe.

But you keep on expectations for the launch in Japan.

Keith: And then I'll be able to give you a lot more color on next quarter's earnings call. The good news about the launch in Japan is that, with approval and reimbursement established, you have 100% of the people that are insured for MG. So it's going to take that issue off the table. Now, the challenge is why you don't see this just all of a sudden take off is that in Japan, most infusions, almost all infusions are given in a hospital setting. And just like we have in the US, you have to go through the formulary process.

Yes. Thank you for the question.

Excited to hop on a plane Saturday morning to head to Japan as we launch next Monday in the country and then I'll be able to give you a lot more color on next quarter's earnings call.

The good news.

About the launch in Japan is with the approval and with reimbursement established you have 100% of the people that are insured.

MG so it's going to take that issue off the table now the challenges why you don't see this just all of a sudden take off is in Japan. Most infusions almost all infusions are given in a hospital setting and just like we have in the U S. You have to go through the formulary process. So we will be going through the formulary process.

Keith: So we will be going through the formulary process. The last thing is, the number one thing that I've been saying to you all for about a year that was going to be required is education on this brand new mechanism of action. We have very few physicians in Japan that have experience actually infusing a patient with Vyvgart.

The last thing is the number one thing that I've been saying to you all for about a year that was going to be required as education on this brand new mechanism of action. We have very few number of physicians in Japan that have experience actually infusing a patient with <unk>. So it's going to take time for that.

Spirit to occur that comfort to exist and then we will be able to up over time.

Keith: So it's going to take time for that experience to occur, for that comfort to exist. And then we will build up over time. The next question is from James Gordon from J.P. Morgan. James, your line is open, please go ahead. Hello, James Gordon, JP Morgan.

The next question is from James Gordon from Jpmorgan. Your line is open. Please go ahead.

Unknown Executive: Thanks for taking the question and following up. The first question was on the ITP data. So it was just subject to regulatory approval based on the data we saw this morning. Where exactly do you see Vivcart used? So do you think it's going to be mostly used by people who have had multiple TPO failures or earlier? And any other ways that we should segment the market if we're trying to build our models?

Hello, James Gordon Jpmorgan, Thanks for taking the question a follow up.

First question was on the ICP data. So it was just subject to regulatory approval based on the data with you. This morning.

<unk> got you. So do you think it's going to be largely people who are in multiple GPO sightings aurilia.

The other ways that we segment the market if we're trying to build our models.

Unknown Executive: And could you just remind us, if it was TPO failures, how many TPO failure patients do you think there are in the US that we should be using for model purposes? And then the follow-up was Vivcart and MG, so it looks like a really good first quarter. Can you just talk a bit? Was the build fairly linear through the quarter in terms of the number of patients? Have you seen that same trajectory being maintained for April?

Could you just remind us if it was TSA is how many patients you think there are in the U S that we should be using for model purposes.

And then the follow up was a.

<unk> said, it's a really good first quarter can you just talk what's the what's the build fairly linear through the quarter in terms of number of patients that have you seen that same trajectory. They maintains April or did you accelerate through the quarter at April I think patients even more quickly.

Keith: Or did you accelerate through the quarter and April's add patients even more quickly? Thank you, James. So let me maybe start with the ITP questions and then hand over back to Keith. So I think the beauty of this study is that we see activity of advertigamot across the board. So wherever you are in the treatment paradigm, you have the right to respond to this therapy, you know, splenectomized, refractory to steroids, ISPs, TPO receptor agonists, even a fair share of prediction map experienced people in the trial, which is, you know, a pretty refractory patient population. So that basically allows us to play across the board.

Thank you Jim So let me maybe start with the NTP questions and then hand over back to Keith So.

I think the beauty of this study is that.

We see activity of GAAP figure marks across the board. So wherever you are at in the treatment paradigm you have the right to respond to this setup splenectomy.

Refractory to steroids Isps.

If you were to separate agonist, even a fair share of prediction of experienced people in the trial.

Which is a particularly refractory patient population so that basically allows us to play across the board. How we think about positioning is <unk> receptor antagonist agonist. So they are very well entrenched in this market and because there is a shortage in different most of action.

Unknown Executive: How we think about positioning is that, you know, TPO receptor agonists are very well entrenched in this market, and because there is a shortage of different modes of action, patients who are failing a first TPO are typically put on a second one. And now with the approval of Avatrombopag, that even puts it on a third TPO. So it does make sense with this new mechanism of action, this fast onset of action, and activity across the board to basically try and position it on the heels of a first TPO receptor agonist.

Patients who are failing first people are typically put on a second one and the approval of a combo box that even put them a third TBO.

So it just makes sense with this new mechanism of action. This fast onset of action and activity across the board to basically try and position on the heels of our first GPO receptor agonist excitingly.

Unknown Executive: Excitingly, a fair amount of patients, you know, who respond to our drug are actually people who stopped responding to the TPO receptor agonist. So the data are supportive of the positioning, and that is a pretty exciting opportunity in the market.

A fair amount of patients general, which visible on our drug.

Our actually people, who stopped responding on a <unk> receptor agonist. So the data are supportive of our positioning and that is a pretty exciting opportunity in the markets. The way to think about success of the different agents, which are currently approved James is that.

Keith: The way to think about success of the different agents which are currently approved is that almost, you know, one third of the patients regardless of the type of therapy show a long-term response, and other people just relapse and need a different type of agent. So whoever you put on a TPO receptor agonist, roughly speaking, only one third of these patients will give you a long-term response. And the two-thirds of other patients will need a different therapeutic agent. So I think that that should help you from a modeling point of view.

Almost one third of the patients regardless of the type of therapy show long term response and other people just relapse I need a different type of agents. So whoever you put on a CPU or a separate agonist roughly speaking only one third of these patients will give you a long term response ended June <unk>.

All the patients who need a difference.

Therapeutic agents. So I think that should help you from a modeling point of view, maybe Keith you want to comment on the Mg.

<unk> question.

Keith: Maybe Keith, you want to comment on the NG question? Sure, Tim, happy to do so. So James, basically, what we've seen in patients being prescribed Vyvgart has been consistent and gradual growth over the first quarter. Really, the answer is the pull-through time, the conversion from when you're prescribed to when you actually become a Vyvgart patient or are treated. I can tell you that that time has been reducing month over month as we get more policies in place with payers. But really, we're one quarter into it, and it's really too early to provide any direction on how this is headed.

Sure Tim happy to do so.

So James basically what we've seen in patients being prescribed <unk> has been consistent and gradual growth over the first quarter really the answer is the pull through time the conversion from when you are prescribed to when you actually become a big guard patients are being treated I can tell you that that time has been reducing in a month over.

One month basis, as we get more policies in place with payers, but really we're one quarter into it and it's really too early to provide any direction.

On how this is headed.

Keith: Thank you. The next question is from Derek Archila from Wells Fargo. Derek, your line is open.

The next question is from Derek ocular from Wells Fargo, Eric Your line is open.

Unknown Executive: Hey, thanks, and thanks for taking the questions. Good morning, and congrats on the progress here. Just two quick ones from us. I guess, maybe you could talk about how you expect the gross margin to progress over time? Just want to understand how a normalized out-year gross margin might look.

Hey, Thanks, and thanks for taking the questions. Good morning, and congrats on the progress here just two quick ones from US I guess, maybe can you talk about how you expect the gross margin to progress overtime, just want to understand how a normalized out your gross margin might look like and then just a follow up I think to <unk> question in terms of how long is it really taking.

Karl Gubitz: And then just to follow up, I think, to James's question in terms of, you know, how long is it really taking to get MG patients on therapy? And then how do you think this could, you know, maybe shorten, you know, once the J code is in force? Thanks. It's Kali. I'll take the question on the gross margin. So Derek, we have a gross margin of cost of sales of 1.4 and a gross margin of around 6%.

To get Mg patients on therapy, and then how do you think this could.

Maybe shorten.

The J code is in force. Thanks.

I mean, it's call it I'll take the question on the gross margin and <unk>.

<unk>.

Gross margin of course, the sales was $1 four gross margin of around 6%. We don't expect that number to change materially in the short term, but we're not going to keep any more guidance at this stage.

Keith: We don't expect that number to change materially in the short term, but we're not going to give any more guidance. Hey, Derek, it's Keith. Thank you for the question. As far as how long does it take for a patient that's prescribed Vyvgart to get on therapy? It varies. It just absolutely depends upon what insurance that they have.

Hey, Derek it's Keith Thank you for the question as far as how long does it take from a patient that is prescribed they've got to get on therapy. It varies it just absolutely depends upon what insurance that they have we have had some that have been able to be infused within a week. After the time that they were prescribed we've had others, where we've had to work on their case.

Keith: We've had some that were able to be infused within a week after the time that they were prescribed. We've had others where we've had to work on their case for better than four weeks. We've had to go through appeal processes and denials. You have some insurance companies that are going to deny your first claim right off the get go.

For better than four weeks, we've had to go through appeal processes and deny you have some insurance companies that are going to design. Your first claim right off the get go. So there is no answer what I can tell you is when I look at the entire group of patients that timeline is coming down in a month over month basis, and really by the time, we get to quarter three.

Keith: So there is no answer. What I can tell you is when I look at the entire group of patients, that timeline is coming down on a month over month basis. And really, by the time we get to quarter three, we should be in a better spot where we have more policies in place, more covered lives, and we'll have a specified J code, which should really shrink that time down to what you see typical for the industry for infusion.

Right, we should be in a better spot, where we have more policies in place more covered lives and we will have a specified J code, which should really shrink that time down to what you see typical for the industry for infusions.

Keith: The next question is from Danielle Brill from Raymond James. Danielle, your line is open, please go ahead. Good morning, congrats on all the progress and thanks so much for the questions. Two quick ones. First, on ITP, what was the antibody status of the enrolled population, and did you see any differences in response rates based on the presence of identifiable antibodies? And then on the MG launch, Keith, you have a really solid base.

The next question is from Tanya <unk> from Raymond James Your line is open. Please go ahead.

Hi, guys. Good morning, Congrats at.

All the progress and thanks, so much for the question two quick one on.

<unk>.

Well. This is the antibody status of the enrolled population and did you see any differences in response rates based on identifiable antibodies.

Then on the Mg launch Keith.

Really solid base can you just remind us what you're anticipating in terms of re treatment on a quarterly basis and how we should be thinking about modeling revenues any patients moving forward. Thank you.

Unknown Executive: Can you just remind us what you're anticipating in terms of retreatment on a quarterly basis and how we should be thinking about modeling revenues for these patients moving forward? Thank you, Danielle. Thank you for these two excellent questions. So we did not use antibody status as an enrollment criteria; we believe that true primary ITP is 100% antibody mediated. And there's a bunch of scientific literature supporting that the presence of the autoantibody is basically detectable if your assay is sufficiently sensitive, especially when you go and look at platelet-associated antibody.

Thank you Danielle and thank you for these two excellent questions. So.

Did not use antibodies status as an enrollment criteria. We believe the true primary ICP is 100% antibody mediated and Theres a bunch of scientific literature supporting that that the presence of the auto antibody.

Is basically detectable if you'd etsy is sufficiently sensitive, especially when you go and look at platelets associated antibodies. So we believe that all through primary <unk> patients or antibody mediated we did collect the data however, and we will be able to report on that in a post hoc analysis. So it's too early to comment on your question.

Keith: So we believe that all two primary ITP patients are antibody-mediated. We did collect the data, however, and we will be able to report on that in a post-hoc analysis. So it's too early to comment on your question. Keith, can I refer you to you on the retreatment dynamic? Sure, Danielle, thank you for the question. You know, the data from the ADAPT study shows that 58% of patients are going to require five cycles per year or less. And right now, that's the only data that we have to go on. We're just one quarter into this.

Sure.

Keith can I referred to you on the lead treatment dynamics.

Keith: And so we need to really have a close look at individualized dosing in the real world and what that actually means. Almost all patients that started on Vyvgart were only completed one cycle or were in their first cycle by the end of quarter one. So we're going to have to come back to you later on with retreatment, but for the time being, I go with the ADAPT data of 58% for five cycles or fewer. The next question is from Charles Pitman from Redburn. Charles, please go ahead.

Sure Danielle Thank you for the question.

The data from the adapt study shows that 58% of patients are going to require five cycles per year or less and.

And right now that's the only data that we have to go on with <unk>.

One quarter into this and so we need to really have a close look on individualized dosing in the real world and what that actually means.

Almost all patients that started on <unk> were only completed one cycle or in their first cycle by the end of quarter. One. So we're going to have to come back to you later on re treatment, but for the time being I would go with the adapt data of 58% five cycles or fewer.

The next question is from Charles Pitman from Redburn Charles Please go ahead.

Unknown Executive: Hi, thank you, and congratulations on the positive results today. I've just got one question on the PV trial. You mentioned the 12-month delay is more conservative.

Hi, Thank you and congratulations on the posted results today.

I've just got one question one question on the PV trial, you mentioned the <unk> is more conservative.

I was just wondering if you could give us an update on the enrollment for those other areas you've got to enroll now.

Youre dropping the Ukraine, Russia clinical sites on kind of what's left to complete until you have a more firm expected readout date and how this is this delay has changed your commercial expectations for PV.

Unknown Executive: I was just wondering if you could give us an update on the enrollment for those other areas you've got to enrol. Now you're dropping the Ukraine and Russia clinical sites, and kind of what's left to complete until you have a more firm expected readout date and how this delay has changed your commercial expectations for PV. Thanks. Thanks, Charles, for the question. So let's not forget that in the background, there is something else still playing, which is called COVID.

Thanks, Charles for the question, so, let's not forget it in the background that is something else still playing which is called cohorts. So.

We still see an impact of <unk> on the dynamics of our global clinical trials, but that's no different from what we used to report them in the past quarter size. So I think we did a good job spreading these global registrational trials geographically, thereby accommodating in OAS of Covid.

We should still occurring so I think we feel good about our ability to enroll pemphigus patients within a reasonable period of time based on reopening of existing sites, whether it be no.

Unknown Executive: So we still see an impact of COVID on the dynamics of our global clinical trials, but that's no different from what we used to report on in the past quarter. So I think we did a good job spreading these global registrational trials geographically, thereby accommodating waves of COVID which are still occurring. So I think we feel good about our ability to enroll pancreas patients within a reasonable period of time, based on the reopening of existing sites, you know, where we know the enrollment dynamics, but also adding a couple of other sites, which simply didn't make it in time for the original enrollment Commercial expectations, I think what we put forward in our Phase II study of panfugus is very exciting data in panfugus. I think we show a fast onset of action.

Enrollment dynamics, but also adding a couple of other sites, which simply didn't make it in time to the original enrollments.

Commercial expectations.

I think will be put forward in our phase II study, a very exciting data in pemphigus.

I think we show a fast onset of action, we show an ability to push patients into Seattle minimum background therapy.

Unknown Executive: We show an ability to push patients into CR on minimum background therapy in a pretty spectacular fashion. And then, unexpectedly, we see the nice durability of the effects, where some of our responders go into long-term remission. And we will be talking about the biology understanding behind the dynamics, because I think it's very exciting. So stay tuned for further scientific explanation on that topic. But I feel we have a very strong and unique proposition in the panfugus space, and that's not changing fundamentally because of a few quarters of delay.

They're pretty spectacular fashion, and then unexpected BBC demise, Jude ability of the effects with some of our respondents go into long term remission and we will be talking about the biology and the spending behind the dynamic because I think it's very exciting so stay tuned on further scientific explanation on that topic, but I feel we have a very strong and unique.

Proposition independent space, and Thats, not changing fundamentally because of a few quarters of delay.

Thank you for the question.

Okay.

Unknown Executive: Thank you for the question. The next question comes from Joon Lee of True Securities. Joon, please go ahead.

The next question comes from Joon Lee of <unk> Securities. Please go ahead.

Unknown Executive: Hey, thanks for taking our questions and congrats on the quarter. Regarding ITP, you mentioned a reduced need for platelet transfusions in the drug arm. Can you help us quantify that? And, you know, if you stratify patients on the magnitude of platelet improvement with FGARD, do you see a better response in bleeding? And also related to that, what can you tell us about the PQPD of FGARD and ITP? In other words, what's the magnitude of autoantibody reduction that you're able to achieve with FGARD and ITP?

Hey, Thanks for taking our questions and congrats on the quarter regarding ATP, you mentioned reduced need for platelet transfusions in the drug arm can you help us quantify that and.

And also if you stratify patients on the magnitude of improvement thus far do you see a better response in bleeding and also related to that what can you tell us about the PK PD of eschar ATP in other words, what's the magnitude of auto antibody reduction that you are able to achieve that as part of it. Thank you.

Unknown Executive: Thank you. Thank you, Joon. Thank you for the question. So before I hand over to Luke, on the question regarding the ITP platelets, what I would like to say is that there are no PK PD data available to the company at this point in time; these are only top line data. But based on everything we have seen across healthy volunteers and the different disease indications, we feel comfortable predicting that the PK PD profile in ITP patients is going to be very comparable to all other indications and healthy volunteers.

Thank you. Thank you for the question so before I hand over to Luke.

On the question.

Regarding the <unk>.

ICP platelets.

What I would like to say.

Is that a no PK PD data available to the company at this point in time is of top line data, but based on everything we have seen across healthy volunteers and a different disease indications, we feel comfortable predicting that the PK PD profile and ATP patients is going to be very comparable to.

All of the indications in the healthy volunteers and maybe Luke you want to comment on the new medical difference in the use of platelet transfusions rescue therapy, and the potential impact of platelet counts at baseline.

Unknown Executive: And maybe Luc you want to comment on the numerical difference in the use of platelet transfusion as rescue therapy and the potential impact of platelet count at baseline on ability to respond. Yeah, and thanks for the question. I'll start with the last one first.

To response.

Yes, and thanks for the question I'll start with the last one first so.

Unknown Executive: So, the platelet counted baseline is something that was used, of course, in the change from baseline analysis of the primary endpoint. So any differences there were already taken into account in the analysis. And then if you look at it in a categorical way, like below and above 15, you see that the response is the same in the subgroup.

Yes.

The platelet counts at baseline.

It's something that was used of course in the change from baseline analysis of the primary endpoints. So any differences there were already taken into account in.

Unknown Executive: So on those two counts, I don't think this had a material impact. The numerical advantage of need for transfusions and IVIG, for that matter, between placebo and active is, for us, in a general picture where we also see, on adverse events, a numerical imbalance between placebo and active. And we will be looking at that in more detail and rolling that into future data presentations. But it's fair to say, look, if I can complete for just a moment, we see a clear trend in the AE table for less bleeding events in apartheid compared to placebo and the need for less acute rescue. So Joon, thank you for these questions and stay tuned.

In the analysis and then if you look at it at a categorical below and above 15.

Youll see that the response is the same in the subgroup. So on those both counts I don't think this has a material impact.

The numerical advantage.

Of <unk>.

Need for transfusions, and <unk> for that matter.

Between placebo.

And active.

It's for us in a general picture, where we also see on the adverse events than a numerical.

Imbalanced between.

Placebo.

Active.

And then we will be looking at adding more detail and roll that in future data presentations.

But it's fair to say look if I can complete we're just we see a clear trend in the AE table for less bleeding events in the aircraft, taking about arm compared to placebo and the need for less acute rescue. So thank you for discretions and stay tuned and many more.

Data to be unpacked from this interesting trial. Thank you.

Unknown Executive: Many more data to be unpacked from this interesting trial. Thank you. Next question is from Allison Bratzel from Piper Sandler. Allison, your line is open. Hi, good morning.

The next question is from Alex <unk> from Piper Sandler Your line is open.

Keith: Thanks for taking the question. So at the Vyvgart launch, I think you talked about having good prescriber breadth. Could you maybe talk about the prescriber mix between academic and community physicians and how you expect that to evolve over time once Sub-Q comes to market? And also, just on the site of Vyvgart infusions, could you talk about what you're seeing in the split between in-office infusion centers and at-home administration volume at this point in launch and how you expect that to evolve, you know, as the launch gets further underway and as the COVI Thanks. Yeah Allison, thank you for the question. Go ahead, Tim. Heath, go ahead man. I was going to hand it over to you. Sorry. Sorry.

Hi, good morning, Thanks for taking the question so just.

We've got launch I think you talked about having good prescriber breadth could you may be talk to the prescriber mix between academic and community physicians and how you expect that to evolve over time once that comes to market and also just on the side of the garden patients could you talk about what youre seeing on the split between an office.

Infusion centers and at home administration volume.

At this point in launch and how you expect that to evolve.

As the launch gets further underway and as the Covid situation continues to develop.

Unknown Executive: Thank you. So, Allison, thank you for the question. As far as the split between academic and community, we haven't given the specific numbers publicly. We did say that we expected there to be more experience in the academic community with Vyvgart from the clinical trial. But if we look at the last launch in this segment, the community had the majority of the business.

Yes, Alex for the question.

Go ahead Tim.

Please go ahead, Matt I was going to hand over to you.

Keith: It's only one quarter in, so it's too early to make projections based on just where we've seen the initial patients come on therapy. As far as the site of infusion, this is heavily determined by the type of insurance that the patient has. I can tell you that we have patients that are being treated in the office in a buy and bill situation, and we have them being treated in home infusion. We have them being treated in infusion centers and in outpatient hospitals.

Oh, sorry, sorry. Thank you Allison. Thank you for the question as far as the split between academic and community. We havent given the specific numbers publicly we did say that we expected there was more experience and the academic community with <unk> from the clinical trial, but if we look at the last launch in this segment the <unk>.

Community had the majority of the business, it's only one quarter and so it's too early to make projections off just where we've seen the initial patients come on therapy as far as the site of infusion. This is heavily determined by the type of insurance that the patient has I can tell you that we have patients that are being treated in office in a buy and bill.

The situation, we have them being treated in home infusion, we have them being treated and infusion centers and an outpatient hospital. So we're seeing site of care.

Ross The board again too early to make predictions or trends off just one quarter worth of data.

Keith: So we're seeing sites of care across the board. Again, too early to make predictions or trends off just one quarter worth of data. The next question comes from Laura Sutcliffe from UBS. Laura, your line is open. Hello, thank you. I hear what you say about your J-Code smoothing things for you, but from an inventory perspective, would you expect any extra channel stocking when you get that permanent J-Code in the middle of the year? And then, secondly, maybe you could just talk briefly about some of the characteristics of your repeat prescribers. I realize there probably aren't many, but some color there would be helpful.

The next question comes from <unk> <unk> from UBS Lawrie Your line is open.

Hello, Thank you.

I hear what you say on your J code.

<unk> full year.

<unk> Chief of factor would you expect any extra channel stuffing when you get a permanent J Kate in the middle of the year.

And then secondly, maybe you could just talk briefly about <unk>.

Some of the characteristics of your repeat prescribers I realize that probably many some color that would be helpful. Thank you.

Yeah.

Karl Gubitz: Thank you. Thank you, Laura, and thank you again, Elizabeth. Yeah, go ahead, Karl.

Thank you Laura and installed.

Yes go ahead, Carl my apology.

Karl Gubitz: My apologies. Thank you. I will take the question on inventory channel stocking. So we monitor the inventory at our specialty pharmacies, where the bulk of our inventory is. And constructually, we have to keep it within certain limits.

And frankly I'll take the I'll take the question on the inventory channel channel stocking so we.

We monitor the inventory at our specialty pharmacies, we have a bulk inventories.

But actually we have to keep the griffing certain limits. So we do know.

I mean numerically the amount of volumes will increase of course, but it will be within.

Two weeks of sales.

Karl Gubitz: So we do not, numerically, the amount of vials will increase, of course, but it will be within two weeks of sales. Thank you. Yeah, thanks, Karl.

Thank you Keith.

Thanks, Karl as far as repeat prescribers.

We do have physicians that have more than one patient on therapy.

Keith: As far as repeat prescribers go, we do have physicians that have more than one patient on therapy. I said before the launch that I thought the most difficult patient to get on therapy was going to be the first one for each physician. We feel confident in the data that almost eight out of every ten patients that are prescribed Vyvgart have a clinically meaningful response, and we believe that when physicians see this, they're going to want to use the product more. So I can give you examples, but they're going to be small and anecdotal.

I said before the launch that I thought the most difficult patient to get on therapy was going to be the first one for each physician, we feel confident in the data that almost eight out of every 10 patients that are prescribed <unk> have a clinically meaningful response, and we believe that when when physicians see this theyre going to want to use the product more.

So I can give you examples, but theyre going to be small and anecdotal. This is where we see the example of physicians that first used <unk> on maybe somebody that was exposed to IV AIG are more relapsed refractory type patient and had a positive experience and said I'm going to move this earlier into the treatment paradigm.

Keith: This is where we see the example of physicians that first used Vyvgart on maybe somebody that was exposed to IVIG, a more relapsed refractory type patient, and had a positive experience and said, I'm going to move this earlier into the treatment paradigm. And that's why we've seen patients treated all the way across the ADAPT population. The next question comes from Joel Beatty of Baird. Joel, please go ahead; your line is open.

And that's why we've seen patients treated all the way across the adult population.

Okay.

Sure.

The next question question comes from Joe <unk> of that Joe. Please go ahead. Your line is open.

Unknown Executive: Hi, congrats on the progress. Now that you've seen today's trial results from the first phase three ITP trial, what's your confidence in the powering of the second trial? And do you see any potential to make trial design changes to help increase powering? Today's results are clearly statistically significant, but with a p value of 0.03, that's perhaps somewhat close to 0.05. Thanks, Jordan.

Hi, Congrats on the progress now that you've seen today's trial results from the first phase III ICP trial, what's your confidence in the powering of the second trial and do you see any potential to make trial design changes to help increase powering today's results are clearly sadistically significant but with a P value of <unk> III.

Thats, perhaps somewhat close to <unk> five.

Unknown Executive: Excellent question. Because both studies are running staggered, you're spot on. We're trying to identify lessons learned from this trial and see what it makes sense to basically still tweak the second study. Now, from a powering point of view, we feel pretty confident. The primary endpoint was a very tall bar.

Thanks, Joe that's an excellent question.

Both studies are running stagger.

Spot on we are trying to identify lessons learned from this trial and see when it makes sense to basically still tweak. The second study now from a quality point of view, we feel pretty confident the primary endpoint was the very tall bar I think we achieved our objective in terms of trying to nail placebo as good as we can.

So.

Placebo is as close to zero as we can realistically get so overall when it comes to the construction of the trial and the design of the endpoint, we feel sufficiently comfortable with leaving additional further work in <unk>.

Unknown Executive: I think we achieved our objective in terms of trying to nail placebo as well as we could. So, placebo is as close to zero as you can realistically get. So, overall, when it comes to the construction of the trial and the design of the endpoint, we feel sufficiently comfortable. But we will do some further work and see where it makes sense to still tweak and tune some of the other details. Thank you for the suggestion.

Makes sense to tweak and tune snowmobile the details. Thank you for the suggestion.

Unknown Executive: The next question is from Douglas Tsao from HV Wainwright. Douglas, please go ahead. Hi, good morning.

The next question is from Douglas Tsao from H C. Wainwright Douglas. Please go ahead.

Unknown Executive: Thanks for taking the questions. Just maybe, to start, just curious in terms of the people who are writing prescriptions, I'm just curious, what percentage were writers or writers were investigators in the ADAPT trial? Or, as well as, you know, and how much penetration are you getting outside of sites that weren't in ADAPT?

Hi, good morning, Thanks for taking my questions just maybe to start just curious in terms of the people who are writing prescriptions I'm just curious what percentage were writers.

Writers for investigators in the adapt trial.

As well as in how much penetration you're getting outside of site at warrant and adapt and then I'm just curious in terms of the customized dosing I'm just curious how.

Physicians are implementing that are they.

We should've, having patient SKU ADL does on a regular basis are they really sort of starting and I know it's early days.

Unknown Executive: And then I'm just curious, in terms of the customized dosing, how physicians are implementing that? Are they, you know, sort of having patients do ADL on a regular basis? Are they really sort of starting, and I know it's early days, you know, sort of starting with a more regular four week on, on, off schedule? Or are they sort of starting to push things out on a customized basis based on individual responses?

Starting with more regular four week on off schedule or are they sort of starting to push things out on a customized basis based on individual responses. Thank you.

Unknown Executive: Thank you. Thanks, Douglas. Again, two excellent questions. So maybe each of you would want to comment on the number of death prescribers and, then, how, in reality, people are picking up on individualized dosing, you know, which mechanism they use to do that. Please. Yeah, happy to do so, Tim.

Thanks, Douglas again, two excellent questions. So maybe Keith you want to comment on the number of in depth prescribers and then having a reality people are picking up on individualized dosing, which mechanism they use to do that please.

Unknown Executive: So Douglas, first of all, we haven't given information on the number of individual prescribers here in the US. But when you look at the total number of study sites that existed in the US, which I think is public, from ClemTrials.gov, you'll note that the number of 380 patients comes from a much broader set than those that participated in the ADAPT Phase 3 study. So we are starting to see good breadth in prescribers outside of just those that participated in the study.

Yes happy to do so Tim So Douglas I think first of all we haven't given information on the number of individual prescribers here in the U S. But when you look at the total number of study sites that existed in the U S, which I think is public.

From the <unk> trials Dot Gov.

Youll note that the number of 380 patients comes from a much broader set than those that participated in the adapt phase III study. So we are starting to see good breadth and prescribers outside of just those that participated in the study as.

Unknown Executive: As far as customized dosing, the majority of patients are being started on individualized dosing. Right now, the question about ADLs varies from physician to physician. Some are using the ADL for insurance purposes, and some are using it to track their patients' progress on a regular basis. But that's not 100%.

As far as the customized dosing the majority of patients are being started on the individualized dosing.

Now the question on Adl's it varies from physician to physician.

Or using the ADL for insurance purposes, some are using it to track their patients progress on a regular basis, but thats not 100%. Many will tell you adl's is only something that I've used in a clinical trial. So it varies on a physician by physician basis last thing dosing cadence.

Unknown Executive: Many will tell you ADLs are only something that I've used in a clinical trial. So it varies on a physician by physician basis. Last thing, dosing cadence.

We have we have a few different things that are taking place. We have some folks that are giving the four weeks that one cycle of infusion and then they are monitoring their patient on a regular basis and asking their patient as soon as you feel returned to sometimes you need to notify us and we will we will retreat. That's one example of what's taking place we have others that are going with.

The four week treatment, and then theyre waiting and asking the patient to come back in four weeks later for an appointment and then they will begin to stretch their dosing interval out. So you see variability and how this is taking place.

Unknown Executive: We have a few different things that are taking place. We have some folks that are giving the four weeks, the one cycle of infusion, and then they're monitoring their patient on a regular basis and asking their patient, as soon as you feel returned to symptoms, you need to notify us, and we will retreat. That's one example of what's taking place. We have others that are going with the four-week treatment, and then they wait and ask the patient to come back in four weeks later for an appointment, and then they will begin to stretch their dosing interval out.

Unknown Executive: So you see variability in how this is taking place. But overall, what I can say is once we get patients to their consistent dose, so those that have been on the ADAPT and the ADAPTO-LE that rolled into commercial product, they're on a very consistent regimen. This concludes today's call, and thank you very much for joining us. You may now disconnect your line. Thanks for watching!

Overall, what I can say is once we get patients to their consistent dose. So those that have been on the adapt and the adapt OLED that rolled into commercial product. They are on a very consistent regimen.

This concludes today's call. Thank you very much for joining you may now disconnect your lines.

Yeah.