Q4 2021 argenx SE Earnings Call

Good morning, My name is Rob and I'll be your conference operator today at this time I would like to welcome everyone to the <unk> fourth quarter and full year 2021 conference call. All lines have been placed on mute to prevent any background noise.

Operator: Good morning, my name is Rob, and I will be your conference operator today. At this time, I would like to welcome everyone to the Argenx 4th quarter and full year 2021 conference. All lines have been placed on me. TORONTO 2015 PAN AM, PAN AM, TORONTO 2015 VOLUNTEERS, PRESENTED BY CHEVROLET, After the speaker's remarks, there will be a question and answer session. Would you like to ask a question during this time? Press the star followed by the number one on your telephone keypad.

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

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

Beth DelGiacco: If you would like to withdraw your question, again, press... Thank you. Beth DelGiacco, Vice President, Investor Relations and Corporate Communications, you may begin your question. Thank you, operator.

Thank you best Joe Jocko, Vice President Investor Relations and corporate Communications you May begin your conference.

Beth DelGiacco: A press release was issued earlier today with our full year 2021 financial results and a recent business update. This can be found on our website along with the presentation for today's webcast. Before we begin, I'd like to remind you on slide two that forward-looking statements may be presented during this call. These may include statements about our future expectations, clinical developments, regulatory timelines, the potential success of our product candidates, financial projections, and upcoming milestones. Actual results may differ materially from those indicated by these statements. Argenx is not under any obligation to update statements regarding the future or to conform these statements in relation to actual results unless required by law.

Thank you operator, our press release was issued earlier today with our full year 2021 financial results and our recent business update this can be found on our website along with the presentation for today's webcast before we begin I'd like to remind you on slide two that forward.

Looking statements may be presented during this call. These may include statements about our future expectations clinical developments regulatory timelines the potential success of our product candidates financial projections and upcoming milestones and actual results may differ materially from those indicated by these statements.

<unk> is not under any obligation to update statements regarding the future or to conform. These statements in relation to actual results unless required by law.

Tim Van Hauwermeiren: I'm joined on the call today by Tim Van Hauwermeiren, Chief Executive Officer, Carl Gubitz, Chief Financial Officer, and Keith Woods, Chief Operating Officer. I'll now turn the call over to Tim. Good morning, and thank you for joining our call today. We had a truly monumental 2021 and ended the year with the FDA approval of Vyvgart, a first-of-its-kind FCRN blocker for the treatment of generalized myasthenia gravis in adult patients who are acetylcholine receptor antibody positive.

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

Now I'll turn the call over to Tim.

Good morning, and thank you for joining our call today.

We had a truly monumental 2021 and ended the year with the FDA approval of <unk>.

First of its kind F C N N blocker for the treatment of generalized myasthenia gravis in adult patients who are acetyl choline receptor antibody positive.

Tim Van Hauwermeiren: It was a milestone we have been working towards for many years, and we were so gratified to be able to honor our commitment to patients by bringing them a new treatment option. The regulatory momentum continued into 2022, with the subsequent approval of Vyvgart in Japan, just 34 days later. I cannot emphasize enough the work it took for our teams to make this happen seamlessly.

It was a milestone we have been working towards for many years and we were so gratified to be able to honor our commitment to patients by bringing them a new treatment option.

The regulatory momentum continued into 2022.

With a subsequent approval of <unk> in Japan, just 34 days later.

I cannot emphasize enough the work it took for our teams to make this happen seamlessly.

Tim Van Hauwermeiren: I want to start our call today talking about our launch. During these first weeks, we have focused primarily on demand generation through education and awareness efforts. Keith will share some metrics later in the call, but we still have a lot to learn about our lost trajectory in the coming quote. We're doing our best to characterize the state of the launch today. We're doing our best to characterize the state of the launch today.

I want to start our call today talking about our lunch.

During these first weeks, we have focused primarily on demand generation through education and awareness efforts.

We'll share some metrics later in the call but.

But we still have a lot to learn about our launch trajectory in the coming quarters.

We are doing our best to characterize the state of the loans today.

Tim Van Hauwermeiren: Though it's fair to say it's still very early, and these are not necessarily metrics we will share on an ongoing basis, especially as we start to provide revenues during our Q1 earnings call in May. I have had the privilege of being on the road with many members of our field team since the start of the launch. At a high level, we are encouraged by the initial demand in our long. We know that it is still early days and that we face the same challenges that we described at approval. COVID restrictions Because of the lack of a J-code.

So it's fair to say, it's still very early and is not necessarily metrics, we will share it on an ongoing basis.

Especially as we start to provide revenues during our Q1 earnings call in May.

I have had the privilege of being on the road with many members of our field team since the start of the launch at.

At a high level we.

We are encouraged by the initial demand in our launch.

We know that it is still early days and that we have faced the same challenges that we described at approval.

Coverage restrictions the lack of a J code.

Tim Van Hauwermeiren: The need for physician education and better awareness. But eight weeks into the launch, we are cautiously optimistic and trending well against our plans. I have also been encouraged by the feedback I am hearing firsthand from our physicians. All of which is consistent with many of the messages we shared leading up to approval. On slide four, for example, the unmet need faced by GMG patients for new therapies is significant, and we're seeing real demand. The challenge for our sales force has been demonstrating a sense of urgency during a time when patients do not see their doctors regularly.

The need for physician education and federal awareness.

But eight weeks into the launch we have.

Cautiously optimistic and trending well against our plans.

I have also been encouraged by the feedback I'm hearing firsthand from our physicians.

All of which is consistent with many of the messages, we shared leading up to approval.

On slide four for example.

Unmet needs faced by Gmg patients for new therapies is significant and we are seeing real demand.

The challenge for our sales force has been demonstrating it central frozen seats during a time when patients do not see that doctors regularly.

Tim Van Hauwermeiren: We also see physicians rethinking how to treat their patients based on the efficacy and safety profile we demonstrated in ADAPT. And finally, doctors applaud individualized dosing and the Vyvgart label, which allows them the flexibility to dose based on clinical evaluation. In NMG, where every patient is unique and experiences the disease course differently, an individualized approach makes sense to physicians. We believe that the treatment cycle approach will accommodate the majority of

We also see physicians rethinking how to treat their patients based on the efficacy and safety profile, we demonstrated in adapt.

And finally doctors applaud individualized dosing and the Vince got label, which allows them the flexibility to dose based on clinical evaluation.

In Mg.

Every patient is unique and experienced the disease course differently.

Individualized approach makes sense to physicians.

We believe that the treatment cycle approach will accommodate the majority of our patients.

Tim Van Hauwermeiren: We also want to consider the individual needs of patients that may require alternative or more continuous dosing and to have data should we get questions from providers on this topic. Therefore, we started a phase 3b trial called ADAPT-NXT. To evaluate additional dosing schedules that physicians could use to further individualize the Vyvgart treatment approach. As this is a typical phase 3b trial, we will not be providing additional updates on the study outside of an upcoming medical meeting.

We also want to consider the individual needs of patients that may require to alternative or more continuous dosing and.

To have data should we get questions from providers on this topic.

We started a phase <unk> trial called adapt and XT.

To evaluate additional dosing schedules that physicians could use to further individualize the disc ops treatment approach.

As this is a typical phase III trial.

We will not be providing additional updates on this study outside of an upcoming medical meeting.

Tim Van Hauwermeiren: In general, we want to have the most complete offering for patients and physicians, whether on a dosing schedule or around formulation, IV, or subcubes. We continue to believe that having both an IV and subcube option will be important to capture variability in patient and physician preferences. Slide five.

In general we want to have the most complete offering for patients and physicians, whether on a dosing schedule or around formulation or sub Q.

We continue to believe that having both an IV and <unk> option will be important to capture variability in patient and physician preferences.

Slide five.

Tim Van Hauwermeiren: Our Phase 3 ADAPT Sub-Q Non-Inferiority Trial is on track to read out this month, evaluating Sub-Q FGATIGAMOT, which is co-formulated with Halozymes Validated Enhanced Technology. In this trial, we aim to bridge IV to sub-Q based on PD effects, specifically IGG reduction at day 29. We designed our innovative bridging trial based on a few key points. First, we observed in our clinical trials a linear correlation between IgG reduction and clinical benefits in GMG.

Our phase III <unk> non inferiority trial is on track to read out this month evaluating <unk> got to take them out which is co formulated with halo signings validated enhanced technology.

In this trial, we aim to bridge IV to <unk> based on PD effect, specifically ITG reduction at day 29.

We designed our innovative bridging trial based on a few key points.

First.

We observed in our clinical trials.

Linear correlation between ITG reduction and clinical benefit in gmg.

Tim Van Hauwermeiren: We also see a consistent PD effect with Epgartigemab, whether in healthy volunteers or GMG patients. The disease biology of GMG does not affect PD, and actually, we have seen this in all indications we have studied so far.

We also see a consistent PD effect with have got taken up with in healthy volunteers or gmg patients.

The disease biology of Gmg does not affect PD.

And actually we have seen this in all indications we have studied so far.

Tim Van Hauwermeiren: And finally, in our phase one study of sub-Q f-cortigamot, we observed an identical PD effect with a fixed dose of 1,000 milligram sub-Q as with 10 milligram per kilogram IV. Beyond the non-inferiority primary endpoints, a depth subcue will capture additional safety, efficacy, and PKPD data in the secondary end point analysis, which will be important for our commercial team. ADEPT SubQ also serves to satisfy our safety database requirements for SubQ EFGAT-PGMOB. We enrolled more than 50 patients required for the primary endpoint analysis and allowed ADAPT Open Label Extension patients to roll over to the ADAPT SubQ trial.

And finally in our phase one study of <unk> remarks, we observed an identical PD effect with a fixed dose of 1000 milligrams of Q as with 10 milligram per kilogram IV.

Beyond the non inferiority primary endpoint.

<unk> will capture additional safety efficacy and PK PD data in the secondary endpoint analysis, which will be important for our commercial team.

The depths of Q also serves to satisfy our safety database requirements <unk> got taken out.

We enrolled more than 50 patients required for the primary endpoint analysis and allowed a depth open label extension patients to rollover to the adapt subdued trial.

Tim Van Hauwermeiren: We expect to be able to give you an update on the timing of our BLA filing when we report top line results. That sub-Q is the first of our new term data milestones. We also are on track to share results in the second quarter from the advanced trial evaluating IV and I've got tick-a-mots in primary immune tomocytopenia. Slidesick.

We expect to be able to give you an update on timing of our BLA filing when we report top line results.

The depths of Q is the first of our near term data milestones.

We also are on track to share results in the second quarter.

The advance trial.

Evaluating IV <unk> in primary immune thrombocytopenia slide six.

Tim Van Hauwermeiren: We designed our phase 3 advanced trial based on the results from our phase 2 and benchmarking of peer ITP trials. In our phase 2, we ambitiously dosed patients for just 4 weeks while monitoring platelet counts out to 21 weeks. We learned from this trial that more chronic dosing is required in this population. Even with a limited drug exposure, we saw a response to the cross-patient types in a very defective RTP population. These results were published in the American Journal of Hematology.

We designed our phase III advance trial based on the results from our phase II and benchmarking of speed ICP trials.

In our phase two we had ambitiously dose patients for just four weeks, while monitoring platelet counts out to 'twenty one weeks.

We learned from this trial that more chronic dosing is required in this population.

Even with the limited drug exposure with solid sponsors across patient types in a very refractory <unk> population.

These results are published in the American Journal of Hematology.

Tim Van Hauwermeiren: We also saw a high placebo response in our phase two, which in looking at peak trials is very common in ITP, given the fluctuating nature of platelet counts. In phase 3, we are dosing patients weekly for 26 weeks with the potential to push the cadence to bi-weekly dosing based on a stable slated count. We are measuring the primary endpoint between weeks 19 and 24, where a patient has to have a stable platelet count, meaning over 50,000 platelets per microliter, in at least four of those six visits.

We also saw a high placebo response in our phase III.

Which in looking at the <unk> trials is very common in IDP, given the fluctuating nature of platelets.

In our phase III.

We are dosing patients weekly for 26 weeks with the potential to push the cadence to biweekly dosing based on a stable slated counts.

We are measuring the primary endpoints between reached 19 and 24.

The patient has to have a stable platelet counts, meaning over 50000 platelets for micro liters in at least four of those six visits.

Tim Van Hauwermeiren: By managing placebo response with this Traciana endpoint, we are also setting the efficacy bar high for our treated patients. It will be important to focus on the delta between response in the active and placebo groups. The second end points will also be important with the advanced readout, including safety and controllability. [inaudible] CUNY DISPLAYED THAT COUNT, leading events, and quality of life data. This will show a more complete picture of where F-Cartigamot could play a role in ITP. This will show a more complete picture of where F-Cartigamot could play a role in ITP.

By managing placebo response with the stringent endpoints. We are also setting the efficacy bar high for our treated patients.

It will be important to focus on the delta between response in the active and placebo groups.

The secondary endpoints will also be important with the advanced readout <unk>.

Including safety and Tolerability.

Cumulative platelet counts.

Bleeding events and quality of life data.

These will show a more complete picture of where <unk> could play a role in it.

Tim Van Hauwermeiren: We hear from physicians that there remains a high unmet need in ITP and that long-term response rates are not satisfactory. Patients typically cycle through treatment options, including through multiple TPO's in order to maintain a stable planter count. Our hope is that we can break this cycle, and even if an ITP patient fails or relapses on an initial TPO, they will be in a position to try Avgartigemops before the second

We hear from physicians that there remains a high unmet need in IDP and then long term response rates are not satisfactory.

Patients typically cycle through treatment options, including through multiple GPS in order to maintain a stable platelet counts.

Our hope is that we can break this cycle and even IDP patient fails or relapses on an initial GPO, Dave will be in a position to try and take them out before the second or third GPO.

Tim Van Hauwermeiren: You can see that we have a catalyst for the first half of the year, between our launch progress and these two data readouts. It's a busy time, but also a very exciting time to finally have our teams in the field, engaging with physician customers and serving patients. I'm going to turn the call over to Keith, who will provide more details on the Vyvgart launch in the U.S. Thanks, Tim. Good morning.

You can see that we have passed a catalyst, which first half of the year between our launch progress and these two data readouts.

It's a busy time, but also a very exciting time to finally have our teams in the field engaging with physician customers and serving patients.

I am going to turn the call to Keith who will provide more details on the fifth <unk> launch in the U S.

Keith Woods: I'm happy to provide an update on the state of our commercial business. Our sales force has been in the field for eight weeks now, so we are still in the very early stages, but overall, we are seeing encouraging progress and engaging with our key stakeholders. Slide seven, please.

Thanks, Tim Good morning, I'm happy to provide an update on the state of our commercial business.

Our sales force has been in the field for eight weeks now. So we are still in the very early stages, but overall, we are seeing encouraging progress in engaging with our key stakeholders slide.

Slide seven please.

Keith Woods: On our approval call, we talked about our strategic imperatives to empower patients, to provide best-in-class patient support, to ensure rapid adoption from healthcare professionals, and to enable appropriate access. I'm going to share some data on each of these. First, on the patient. We're not going to share patient numbers today, but we are comfortable sharing that we are currently ahead of our own projections. We designed our phase three ADAPT study to enroll a broad patient population. Some patients who were on mestinon alone and very early in their disease, while others were much more severe, relapsed refractory.

On our approval call, we talked about our strategic imperatives to empower patients to provide best in class patient support to ensure rapid adoption from health care professionals and to enable appropriate access.

To share some data from each of these.

First on the patient.

We're not going to share patient numbers today, but we are comfortable sharing that we are currently in front of our own projections.

We designed our phase III adapt study to enroll a broad patient population some patients who were on messaging on alone and very early in their disease, while others were much more severe relapsed refractory.

Keith Woods: With the initial scripts coming in, we see a breadth of patient profiles reflective of the ADAPT population. In the first weeks of launch, we have also seen what we believe is pent-up demand for a new therapy in patients refractory to all other available treatment options. It is too early to know whether or not this is a one-time bolus of patients, but we see these patients contributing to our initial demand. Lighting, please.

With the initial scripts coming in we see a breadth of patient profiles reflective of the adult population.

In the first weeks of launch we are also seeing what we believe is pent up demand for a new therapy in patients refractory to all other available treatment options.

It is too early to know whether or not this is a onetime bolus of patients, but we see these patients contributing to our initial demand.

<unk> please.

Keith Woods: We launched our unbranded DTC campaign in January to create awareness about GMG. The impact of the commercial in empowering patients is clear. The commercial is encouraging patients to learn about new treatment options, including Vyvgart, by speaking with their neurologist or downloading resources from the website. Based on early assessments, approximately 25% of website visits and 50% of phone call inquiries can be tracked back to the DTC campaign. Slide 9, please.

We launched our unbranded DTC campaign in January to create awareness about gmg.

The impact of the commercial and empowering patients is clear the commercial was encouraging patients to learn about new treatment options, including depth guard.

By speaking with their neurologist or downloading resources from the website.

Based on early assessments, approximately 25% of website visits and 50% of phone call inquiries can be tracked back to the DTC campaign.

Keith Woods: Our patient support program has also been serving our patients and health care professionals very well, and approximately 90% of our scripts have come in through my Vivgark pass. We are now seeing scripts translate into infusions, and my Vyvgart path has been crucial to this effort. Our second strategic imperative is with the physician community. Slide 10, please.

Slide nine please our patient support program has also been serving our patients and health care professionals, very well and approximately 90% of our scripts have come in through my Vanguard path. We're.

We are now seeing strips translate into infusions and might be a guard path has been crucial to this effort.

Our second strategic imperative is with the physician community Slide 10. Please.

Keith Woods: Our sales force has done a great job of engaging with neurologists. The goal was to focus on our top group of targets, which includes about 1,000 neurologists. These neurologists are tierred based on the number of GMG patients that they treat, their likelihood to try a new biologic, and their influence amongst other neurologists.

Our sales force has done a great job of engaging with neurologists.

The goal was to focus on our top group of targets, which includes about 1000 neurologists. These neurologists are tiered based on the number of gmg patients that they treat their likelihood to try a new biologic and their influence amongst other neurologists. So far our sales team has reached about 60% of this.

Keith Woods: So far, our sales team has reached about 60% of this top target group. Among physicians, we have also seen impressive breadth and depth among prescribers. Groups are not just coming in from our physician champions, but from a broad group and equally from academic settings, as well as the community. We have also seen depth amongst physician prescribers, with many writing scripts for two or more patients. About 60% of our prescribers have been from the top 1,000 neurologist targets. Our peer-to-peer marketing efforts launched in January, and so far, we have held six national broadcasts and 57 local speaker programs.

Target group.

Among physicians, we have also seen impressive breadth and depth of prescribers.

Grips or not just coming in from our physician champions, but from a broad group and equally from academic settings as well as the community.

We have also seen depth amongst physician prescribers with many writing scripts for two or more patients about 60% of our prescribers have been from the top 1000 neurologists targets.

Our peer to peer marketing efforts launched in January and so far we have held six national broadcast and 57 local speaker programs. We have 74 fully trained physician speakers and these first crucial quarters to launch and raise awareness and increase the education <unk>.

Keith Woods: We have 74 fully trained physician speakers in these first crucial quarters to launch and raise awareness and increase the education of one Vyvgart. Finally, our work with payers. Slide 11, please.

Finally, our work with Payors Slide 11 please.

Keith Woods: We announced at approval that we had reached agreements in principle with several national and regional payers to structure a value-based agreement. As of this week, Vyvgart-specific policies have been published in plans covering approximately 25% of U.S. commercial lives. We're on track to have broad coverage in place by the end of the second quarter. We're on track to have broad coverage in place by the end of the third quarter. So far, almost all the policies are aligned to our label.

We announced and approval that we had reached agreements in principle with several national and regional Payors to structure a value based agreement.

As of this week <unk> specific policies have been published and plans covering approximately 25% of U S. Commercial lives were on track to have broad coverage in place by the end of the second quarter.

So far almost all of the policies are aligned to our label patients can gain access if they have previously been treated effectively with one or more standard of care options, whether it's messaging on steroids for a broad immunosuppressants.

Keith Woods: Patients can gain access if they have previously been treated ineffectively with one or more standard of care options, whether it's mestinon, steroids, or a broad immunosuppressant. We are also seeing encouraging prior authorization language approving for six to 12 months of treatment at a time rather than based on a specific cycle. All in all, we are optimistic after the first eight weeks of launch, but it is still too early for us to understand how this will play out in future quarters. We look forward to updating you again during our first quarter earnings call. Before I turn the call over to Carl, I'd like to quickly discuss our global launch strategies. Slide 12, please.

We are also seeing encouraging prior authorization language approving for six to 12 months of treatment at a time rather than based on a specific cycle.

All in all we are optimistic after the first eight weeks of launch, but it is still too early for us to understand how this will play out into future quarters.

We look forward to updating you again during our first quarter earnings call.

Before I turn the call over to Carl I would like to quickly discuss our global launch strategies Slide 12. Please.

Keith Woods: The upcoming regulatory milestones are covered in our press release. For Japan, we received approval in January, but the official launch will not start until we have a price. This is typically listed in the months following our approval. Our sales team has been active with neurologists talking about Vyvgart and its mechanism of action. They can line up patients before we have a price, but we will not be able to start collecting revenues until after the official launch.

The upcoming regulatory milestones are covered in our press release with Japan, We received approval in January but the official launch will not start until we have a price.

It is typically listed in the months following our approval.

Our sales team has been active with neurologist talking about VM guard and the mechanism of action. They can lineup patients before we have a price, but we will not be able to start booking revenues until after the official launch.

Keith Woods: In Europe, we expect approval in the second half of the year, and, of course, regulatory approval is just the beginning. For most parts, outside of Germany, we will not be able to start our promotional efforts until we have secured reimbursement on a country-by-country basis. With that, I will turn the call over to Karl. Thank you, Keith. Slide 13, please.

In Europe , we expect approval in the second half of the year and of course regulatory approval is just the beginning for the most part outside of Germany, we will not be able to start our promotional efforts until we have secured reimbursement on a country by country basis with that I will turn the call over to Carl.

Carl Gubitz: Our 2021 financial results are detailed in your press release this morning, so I will only highlight some of the key points here. We ended the year with cash, cash equivalence, and current financial assets of $2.3 billion.

Thank you gave slide 15, please our 2021 financial results are detailed in our press release from this morning, So I will only highlight some of the key points here.

We ended the year with cash cash equivalents and current financial assets that you can do $3 billion.

Carl Gubitz: This puts us in a very strong position for our first commercial launch and to execute our plan in 2022. Based on your current plans to fund the business and assuming successful readouts for each of these programs, we expect to utilize up to half of our available cash this year. From a utilization perspective, we think about it in the following way: R&D and our ongoing clinical trial. We will be in 10 FKTG mode indications by the end of the year, and two, argenx 117 indicates. So development continues to be the largest proportion of our spend.

This puts us in a very strong position for our first commercial launch and to execute our plan in 2022.

Based on our current plans to fund the business and assuming successful readouts for each of these programs, we expect to utilize up to half of our available cash this year.

From a utilization perspective, we think about it in the following way.

First R&D and our ongoing clinical trials, we will be in pain <unk> indications by the end of the year.

And do organics 117 indications.

Development continues to be the largest proportion of our spend.

Carl Gubitz: Second, our inventory build and supply chain to support our global launch and global trials. We are building for success to ensure continuity of drug supply to patients. Third, the infrastructure of our global launch, first in the U.S., Vanger Pan, Europe, and Canada. And finally, continued investment in your discovery engine and the expansion of our pipeline through our Immunology Innovation Program. For the full year 2021, we had total revenues of $497.3 million.

Second our inventory both in supply chain to support our global launch and global trials. We are building for success to ensure continuity of supply to patients.

The infrastructure of our global launch first in the U S, When Japan, Europe , and Canada and.

And finally.

Continued investment in our discovery engine and the expansion of our pipeline through our immunology innovation program.

Carl Gubitz: A large majority of this was due to income from collaboration, primarily the one-time recognition of $315.1 million following the termination of a Janssen collaboration agreement and the cost-sharing and milestone payments from Zylab totaling $177.5 million. There were no product revenues in 2021.

For the full year 2021, we had total revenues of $497 3 million.

A large majority of this was due to income from collaborations primarily primarily the onetime recognition of $315 1 million. Following the termination of Aam's and content collaboration agreement and a cost sharing and milestone payments from XI lab totaling.

$77 5 million.

There were no product revenues in 2021.

Carl Gubitz: And it was in 2021. Our operating income was $42.1 million. In 2021, our total R&D expenses will be $580.5 million, and our SG&A expenses will be $307.6 million. As I mentioned at the start, you can find additional details behind these numbers in the press release we issued this morning. I'll now turn the call back to Karl. Before I conclude, I'd like to call out a few personnel updates. You saw in our press release that Yvonne Greenstreet will be leaving our board following her promotion to CEO at Allylum.

However, operating income was $42 1 million.

In 2021, our total R&D expenses was $585 million and SG&A expenses was <unk> $7 6 million.

As I mentioned at the start you can find additional details behind these numbers in the press release, we issued this morning.

I'll now turn the call back to Tim.

Thanks Carl.

Tim Van Hauwermeiren: We are very excited for Yvonne and want to express our gratitude for the contributions she made as a board member. We also announced the appointment of Malini Murthy as General Counsel at ArgenX. This was a planned transition and aligns closely with our evolution to a commercial company. Malini has worked in large commercial organizations for almost two decades and has the perfect experience to help us navigate this new stage of our development. And finally, we are nearing April 1st and our planned CMO transition from Wimpares to Luc Truyen. WIND has transformed our development organization over the past three years.

Before I conclude I would like.

To call out a few personnel updates.

You saw in our press release that Yvonne Greenstreet will be leaving our board following her promotion to CEO at our lineup.

We are very excited for the volume and want to express our gratitude for the contributions teammates as a board member.

We also announced the appointment of millennium, mostly the general counsel at <unk>.

This was a planned transition and.

And aligns closely with our evolution to a commercial company.

Maline has worked in large commercial organizations for almost two decades and has the breadth of his experience to help us navigate this new stage of our development.

And finally, we.

We are nearing April the <unk> and our planned CMO transition from <unk> to look try them.

Lynn has transformed our development organization over the past few years.

Tim Van Hauwermeiren: So we are grateful that he will continue with our genics as an advisor on our board's R&D comedy. Luc joined ArgenX six months ago from J&J and brings significant development experience in the neuromuscular space. We are excited to have him in this leadership role.

So we are grateful that he will continue with our Gen X as in advise us on our boards R&D comedy.

Lynn joined <unk> six months ago from J&J and brings significant development experience in the neuromuscular space.

We are excited to have an industry leadership role.

Tim Van Hauwermeiren: Last year was a remarkable year for the company, and we are off to a great start in 2022. Slide 14.

Last year was a remarkable year for the company and.

And we are off to a great start in 2022 slide 14.

Tim Van Hauwermeiren: We have two new term data readouts, first at sub-Q this month and then advancing ITP in the second quarter. By the end of the first quarter of 2023, we also expect top-line data from our CIDP trial and our second trial in ITP. So we're not short of upcoming catalysts.

We have two near term data Readouts first at <unk>. This month, and then advancing <unk> in the second quarter.

By the end of the first quarter of 2023, we also expect topline data from our <unk> trial, and our second trial in IPP. So.

So we're not short of upcoming catalysts.

Tim Van Hauwermeiren: We announced in our press release this morning that the timing of the top-line data from the Pemphigus trial is currently under review in light of the geopolitical situation in Ukraine. While exposure is limited, given the global nature of the trial, we cannot reiterate our timelines until we have time to assess the situation more closely. Debullet, the trial of Elgatega Modern BP, started late last year, and Alquivia in my zitis will start imminently.

We announced in our press release this morning that the timing of the topline data from the Pemphigus trial is currently under review in light of the geopolitical situation in Ukraine.

While our exposure is limited given the global nature of the trial.

Cannot reiterate our timelines until we have time to assess the situation more closely.

The ballots trial of I've got to take them out and BP started late last year and our caveat in my scientists will start imminently.

Tim Van Hauwermeiren: We also announced four new Elgatega Modern indications that we will start evaluating this year, including sugar and COVID-19 mediated pots through our collaboration with Alquivia and Membrannis Nyafropathy and Lupus Nyfridis through our collaboration with Zai. ArgenX 117 is now in our first patient study in MMN, and we are excited to launch a trial in delayed grasp function later this year.

We also announced four new <unk> indications that we've started evaluating this year, including <unk> and COVID-19 mediated pumps through our collaborations with IQ via and membranous nephropathy and lupus nephritis through our collaborations with XI.

Our journey since 2017 is now in our first patient study in men and we are excited to launch a trial in delayed graft function later this year.

Tim Van Hauwermeiren: You can see how our kidney franchise is taking shape. Overall, we are planning for success and building out commercial franchises that will enable us to have economies of scale as we prepare for future launches. And we would not be Argenx if we did not continue to invest in our science. Slide 15. We will be advancing ArgenX 1.19 into a Phase 1 trial after our CTA is filed later this year. And through our IIP, there are more programs to come. Before we open the call for questions... I really want to applaud our field teams. I have been on the road with them, and I'm very impressed.

Can see how our kidney franchise is taking shape.

Overall, we are planning for success and building out commercial franchises that will enable us to have economies of scale as we prepare for future launches.

And we would not be our Gen X. If you did not continue to invest in our science.

Mid 15.

We will be advancing <unk> hundred 19 into a phase one trial after our Cta filed later this year and through our IAP there are more programs to call.

Before we open the call for questions.

We really want to applaud our field teams.

It has been on the road with them and I'm very impressed.

Tim Van Hauwermeiren: It is thanks to their teamwork and dedication that we have a strong start to our launch. Kids have shared the state of our launch in these early days, and we look forward to sharing more in May. Mostly, I'm excited to finally be reaching patients and bringing them new treatment options. This is honoring a commitment we have long made to the GMG community. Thank you all for your time today.

It is thanks to their teamwork and dedication.

We have a strong start to our launch.

Keats share to state of our launch in these early days and we look forward to sharing more in may.

Mostly.

Im excited to finally be reaching patients and bringing them in new treatment option.

This is honoring a commitment we have long made to the gmg community.

Tim Van Hauwermeiren: We will now take your question. At this time, I would like to remind everyone, in order to ask a question, press star, then the number one on your telephone keypad. E, or the first question, comes from a line Derek Archila from Wells Fargo. Your line is open.

Thank you all for the time today, we will now take your questions.

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

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

Derek Archila: Hey, good morning guys, and congratulations on the progress. We have just two quick questions from us. I guess first, based on what you guys are seeing and hearing on the Vyvgart launch, in my opinion, you should grab this. I guess, are you still pretty comfortable with your consensus estimates right now? And then just a quick follow-up on the ITP study that's expected in the second quarter. You can just kind of frame out for us what your expectations are there in terms of the primary endpoint and where you see the market opportunity for effort coming out in ITP.

Hey, good morning, guys and congrats on the progress just two quick questions from US I guess based on what you guys are seeing and hearing on the <unk> launch in myasthenia gravis.

Feel pretty comfortable we're consistent.

Estimates are right now and then a quick follow up on the ICP study that's expected in the second quarter. Maybe you can just kind of frame out for us what your expectations are there in terms of the primary endpoint and where you see the market opportunity for athletic Ahmad in ITT.

Derek Archila: By Derek, thank you for the question. In terms of revenue projections, we are not going to comment on revenue projections at the moment; we're not providing our own forecast. It really is too early in the launch, and we will provide guidance later. In terms of analyst consensus, as you know, the numbers are 97 million for the full year for US revenues and $6 million. Who can be considered to be successful in a few years?

<unk>. Thank you for the question.

In terms of our revenue projections, we are not going to comment on the revenue projections at the moment, we don't we're not providing.

Providing our own forecast.

<unk> too early in the launch and we will provide guidance later on in terms of.

Analysts' consensus.

As you know by the numbers on 97 million for the full year for use in revenues and $6 million for the quarter.

The analyst consensus and.

Yes, we are.

Tim Van Hauwermeiren: Hopefully, we can work on them in a couple years. And I think you've made it pretty clear. You've got people working on developing the strategy, and people believe it can be done in a while. So I wanted to define those then.

We are increasingly comfortable with those numbers.

So on the second question that Eric and thank you for joining us today.

Remember, what we learned in the phase II clinical trial, but also what we could see in August ITG trials side that is a significant placebo effects going on in ICP patients. So the primary endpoint is a very tough endpoint and some endpoint designed to completely control placebo.

unknown: So the war on tampers is what we've been talking about. It came from when we were working on Internet Explorer. So on the second question, Derek, and thank you for joining us today. Remember what we learned in the phase two clinical trial but also what we could see in other ITP trials, right? There is a significant placebo effect going on in ITP patients. So the primary endpoint is a very tough endpoint.

Tim Van Hauwermeiren: It's an endpoint designed to completely control placebo, you know, having in four out of six consecutive visits, a plate count of 50,000 places per microliters is a very tall bar. So the primary endpoint is really designed to create a statistically significant delta between active and placebo. The full color on the qualities of the molecule in ITP and its potential to have a competitive position there will really come from the secondary endpoints, where we will study things like cumulative plate counts, Plated Council of the Period, bleeding effects, quality of life, and the like.

Having in four out of six consecutive visits a platelet count of 50000 places for micro liters is a very tall bar.

So the primary endpoint is really designed to create a statistically significant delta between <unk> and placebo.

Full color on the qualities of the molecule in ATP and its potential to have a competitive position. This will really come from the secondary endpoints, where we will study things like cumulative platelet counts.

Platelet counts over the periods bleeding affects quality of life and the likes.

Tim Van Hauwermeiren: And that should basically tell us where we could fit in a treatment paradigm. Maybe, Keith, you could come on briefly on how we look at the opportunity. Yeah.

And that should basically tell us where we could fit in the treatment paradigm, maybe Keith you can comment briefly on how we look at the opportunity, yes, so derik as far as the market opportunity I guess I would call out the gpus themselves are doing more than $2 billion in revenue a year globally and.

Keith Woods: So, Derek, as far as the market opportunity is concerned, I guess I would call out that TPOs themselves are doing more than $2 billion in revenue a year globally. And really, where we feel the opportunity is, is we're not going to displace TPOs. We would like to play, as Tim said in the prepared remarks, right after the first TPO.

And really where we feel the opportunity is is we're not going to displace PPL, we would like to play as Tim said in the prepared remarks right. After the first GPO, so about 60% of patients respond to GPO and about 50% of them are going to then relapse, that's where we feel that <unk> can potentially.

Keith Woods: So, you know, about 60% of patients respond to TPO, and about 50% of them are going to then relapse. That's where we feel that efgartigamide can potentially play a role because of its impact on the disease from multiple mechanisms of action. So it's not just about creating more platelets. It's also about managing the clearance and function of the platelets. So it should be a better option than patients rotating through one, two, or three TPOs. Got it.

Play into it because of its impact on the disease from multiple mechanisms of action. So it's not just about it's not just about creating more place I'd say, it's also about managing the clearance the function of the platelets. So it should be a better option than patients rotating through one two or three <unk>.

Got it thanks guys.

Keith Woods: Thanks, guys. Your next question comes from the line of Tazeen Ahmed from Bank of America. Your line is open.

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

Tazeen Ahmad: Hi guys, good morning, thanks for taking my question. Just a clarification question for the upcoming subcue, data set that's due this quarter, assuming that the data shows what you wanted to show, can you just walk us through what the next steps would be in terms of going to FBA and when you think you could file for what I'm assuming would be an FNDA, just to clarify that. Thank you, or an FBA.

Hi, guys. Good morning, Thanks for taking my question just a clarification one for the upcoming sub Q dataset, that's due this quarter.

Assuming that the data shows what you wanted to so can you just walk us through what the next steps would be in terms of going to FDA and when do you think you could file for what I'm, assuming would be an NDA just to clarify that thank you alright BLA.

Tim Van Hauwermeiren: Hi, this is Tim speaking. Thanks for joining us today. And thank you for your questions. So, in the United States specifically, the situation with the FDA is that the sub-cube products, which are a combination with the Halo Simons and Hans technology, are considered to be a separate products. So this is not going to be an S-BLA.

Hi, <unk>. This is Tim speaking, thanks for joining us today.

And thank you for your question so.

Tim Van Hauwermeiren: It will be its own BLA. Therefore, we think it will also have its own distinct product presentation. We will be able to position ourselves in the marketplace. Now, that's great news from a commercial point of view; from a work stream point of view towards submission, we still anticipate that we will be able to reuse big sections of the IV BLA into that dedicated sub-Q BLA. Thanks for that.

In the United States, specifically the situation with the FDA is that the <unk> products, which is a combination with <unk> enhanced technology. This goes to that there'll be a separate products. So this is not going to be in <unk>. It will be its own BLA. Therefore, we think it's also its own distinct product presentation.

We'll be able to position in the marketplace.

That's great news from a commercial point of view from a growth standpoint of view towards submission. We still anticipate that we will be able to re use big sections of the IV BLA into that dedicated sub acute BLA. Thanks for the question.

Tim Van Hauwermeiren: Your next question comes from the line of Akash Tewari from Jeffreys. Your line is open. Hey guys, so, A, the Bullets have responded. What percent of patients have been these ultra-refractory patients? And is there any color you can give us on sizing up that market?

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

Hey, guys.

So.

The bolus of response.

You mentioned.

What percent of early scripts have been these ultra refractory patients and is there any color you can give us on sizing up that market opportunity are we talking about 1000 2000 patients here or something more and then maybe on the Principia PTK, which met its primary and secondary endpoint in pemphigus Sam.

Akash Tewari: Are we talking about 1,000, 2,000 patients here, or something more? And then maybe on the Principi of BDK, which misses the primary and secondary endpoint in Pemphagus, Santa Fe hinted that was due to the high placebo response given the placebo arm also received steroids. Yeah, I'll take the first question.

<unk> hinted that was due to the high placebo response.

The placebo arm also receive steroids.

Yes, I'll take the first question so our caution in regard to what we referenced in the prepared remarks.

Did we lose.

Keith Woods: So Akash, in regard to what we referenced in the prepared remarks, did we lose? Okay, Akash, in response to the severe relapse refractory that we've seen start coming in so far in this first eight weeks, I think it was a little bit of a surprise. These are patients that have experienced really all the other therapies that are available, including and up to C5, and they have not responded, and so they have come on to Vyvgart.

Okay Ah caution response to the severe relapses relapsed refractory that we've seen start.

So far in this first eight weeks I think it was a little bit of a surprise that these are patients that have experienced really all other therapies that are available including in up to five.

And they have not responded and so they have come on to <unk>. So I think that was a little bit of pent up demand that was a surprise to us. The question is is this just going to be in the early days. Because these are the patients that have had no success with any other therapy.

Keith Woods: So I think that there was a little bit of pent-up demand that was a surprise to us. The question is, you know, is this just going to be in the early days, because these are the patients that have had no success with any other therapy? Okay, sorry. Can you guys hear me?

Okay, sorry can you guys hear me.

Yes.

Keith Woods: Yeah. Okay, sorry about that. So look, on the Santa, BGK, Failing, and... That's it.

Okay, sorry about that so look on the on the Santa fee at the BDA failing in pemphigus can you just comment on.

Tim Van Hauwermeiren: Can you just comment on the primary endpoint, patients in the placebo arm got tapered down to minimal steroids; they didn't go completely off the drug. Do you feel like that's a risk for your studies, given it looks like steroids in combination with Vivgart was kind of driving some of the complete responses in your face to data? Thanks. Thank you. Thank you, Akash.

In the primary endpoint patients in the placebo arm got taper down to minimal steroids. They didn't go completely off the drug do you feel like that's a risk for your studies given it looks like steroids in combination with the part was kind of driving some of the complete responses in your phase II data. Thank you.

Tim Van Hauwermeiren: So, difficult for us to comment on, you know, why the FISD trial of Principia failed. Mind you, they failed over the entire line, right? Not just the primary end point but also the second end point. And I think we did our homework well. When we designed our clinical trial, we were talking to typically those KOLs who are deeply involved in pan-ficus trials, including the Principia trial and the Tiximab trial. So we think we have been avoiding some of the classical pitfalls in clinical trial design in pan-ficus. We are in a steroid taping protocol, that is a notoriously difficult protocol, but we don't top of it.

Thank you Luca so difficult for us to comment on.

Why the phase II trial of <unk> failed mind, you they failed over the entire line right, let's just the primary endpoint, but also the secondary endpoints.

I think we did our homework well when we designed our clinical trial, we had been talking to typically dose kols, who are deeply involved in pemphigus trials, including the <unk> trial and Rituximab trial. So we think we have been avoiding some of the classical pitfalls in clinical trial design in pemphigus, we are in a steroid tapering.

Protocol and that is a notoriously difficult protocol, but we'd on top of it. So we carefully monitor the steroid tapering. So that goes according to protocol mind, you that the mode of action between the <unk> inhibitors and have got Gigamon totally a different driver not impacting a b cell repertoire, hoping to see a downstream effects.

Tim Van Hauwermeiren: So we carefully monitor the steroid tapering, so that goes according to protocol, mind you, that the mode of action between the PTK inhibitors and the fatigue amount is totally different, right? I mean, we're not impacting the B-cell repertoire, hoping to see a downstream effect on IGGs and disease states. We're really hitting the disease biology at its heart. So, we have pretty exciting data from the phase two study that if you eliminate these pathogenic IGGs, you can put patients into complete remission, actually a number of them into very durable remissions. Stay tuned. I think, at the upcoming SFID conference later this year, we will continue to show very strong data for our molecule in Pantracus. Thanks for the question. Your next question comes from the line of Yaron Werber from Cowan. Your line is open.

On the <unk> and disease States, we really hitting the disease biology in its hearts.

So we have pretty exciting data from the phase II study that if you eliminate these pathogenic igt's you can put patients into complete remission.

Actually a number of them very durable remissions and stay tuned I think at the upcoming SSID Conference. Later this year, we will continue to show very strong data for our molecule in pemphigus.

Thanks for the question.

Our next question comes from the line of Juran Weber from Cowen Your line is open.

Yaron Werber: Great. Thanks for taking my question. I have an interrelated question on the upcoming data for AdaptSupQ. We're getting a lot of questions about it.

Great. Thanks for taking my question.

And interrelated question on the upcoming data for adapt sub Q, we're getting a lot of questions on it perhaps the first one you've over enrolled thus studies.

Enrollment with 111 patients. So you only needed safety relief to support the BLA filings are all 111 can be included in the primary and the secondary endpoints. That's the first question of the day 29, 90 reduction and then secondly for the secondary endpoint.

Yaron Werber: Perhaps the first one, you've over-enrolled that study. You closed enrollment with 111 patients or so. You only needed 6B, really, to support the BLA filing.

<unk>.

You are looking at a 12 weeks are you going to.

Do you see your statistically powered now was 111 patients show difference. Thank you.

Tim Van Hauwermeiren: Are all 111 going to be included in the primary and the secondary endpoints? That's the first question, day 29, an IDG reduction. And then second, for the secondary endpoints and the NGDL, which you're looking at at 12 weeks, are you going to, do you think you're statistically powered now with 111 patients to show a distance? Thanks. Thanks, Jeroen.

Thanks, Sharon I'm happy we can clarify that so there are two objectives, we need to meet thrived. In this study first is we need to hit the primary endpoint, which is all about demonstrating non inferiority between IV and <unk> and in order to do that.

Tim Van Hauwermeiren: I'm happy we can clarify this. So there are two objectives we need to meet right in this study. First, we need to hit the primary endpoint, which is all about demonstrating non-inferiority between IV and sub-Q.

Tim Van Hauwermeiren: And in order to do that, we believe that with 50 patients, we have sufficient power. Now, the second objective we need to meet is to basically collect the minimum database size, which we require for this separate BLA submission. And in that context, you need to see what you call that over recruitment to 111 patients. These patients, together with the patients we rolled over from the open label extension study from IP to SubQ, together will be a sufficient number of patients to go into that safety database.

We believe that with 50 patients we are sufficiently powered now the second objective we need to meet is to basically.

Collect the minimum database size, which we required for the separate BLA submission and Thats in that context, you need to see what you called it over equivalent to 100 and aerospace 111 patients. These patients together with the patients to be rolled over from the open label extension study from IV to <unk> together will be a <unk>.

Sufficient number of patients.

To go into the safety database. So once we have both data points the primary endpoint and the safety data points, we will be able to go into submission.

Tim Van Hauwermeiren: So, once we have both data points, the primary end point and the safety end points, we will be able to go into submission on the secondary endpoints in the trial. Yes, we are collecting information on ADL and QMG, but this will be more qualitative information because you're right. This study is only powered to hit its primary endpoint.

On the secondary endpoints in the trial, yes.

Yes, we are collecting information on the <unk> and <unk>, but this will be more qualitative information because youre right. The study is only powered to hit its primary endpoint. We are collecting of course further call. It an evidence on both the <unk> score, but its all about you know showing a non into feeders ITG reduction.

Tim Van Hauwermeiren: We are collecting, of course, further color and evidence on both the ADL and the QMG score, but it's all about, you know, showing a non-inferior IgG reduction. Thank you for the question. Your next question comes from the line of Joon Lee from Chua Securities. Your line is open.

Thank you for the question.

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

Joon Lee: All right, thanks for taking our questions and congrats on all the progress. Adrafts Study for... Nonprofit sites, but maybe not impact.

Alright, thanks for taking our questions and congrats on all the progress.

Address steady.

I guess, the only study thats exposed to eastern European sites, including in Ukraine or in other studies, such advance or adhere also in more from Ukrainian sites, but may be not impacted due to the product geographic enrollment and I have a quick follow up thank you.

Tim Van Hauwermeiren: LeProtrachial Graphic Enrollment, and I have a- Now, thank you, Joon. So all of our trials, by definition, are global trials, right? These are all rare indications that spread over the globe. And that turns out to be a strength, you know, when things hit you like COVID, a COVID pandemic, or in this case, you know, a geopolitical issue. So exposure is always going to be relatively limited, whatever study you're talking about. For pentagons, we're in a slightly different position, because the incidence and prevalence are a little bit tied to geography.

Thank you <unk>. So all of our trials by definition are global trials by these are all rare indications that whole spread over the globe and that turns out to be a strength when things hit you like COVID-19 .

Global Pandemics or in this case, a geopolitical issue. So exposure is always going to be relatively limited to whatever study you are talking about for <unk> in a slightly different position because of the incidence and prevalence is a little bit tied to geography, I mean, you'll see different buckets of patients.

Tim Van Hauwermeiren: I mean, you see different pockets of patients. And therefore, you know, we have a slightly higher exposure in Ukraine and Russia. And that's also why we felt compelled to give you a heads up on the data readout for pentagons. In the ITP sub Q and the CITP study, exposure is minimal, and we have time to rebalance without, you know, having to change anything concerning timelines. For pentagons, we're currently going through a risk analysis.

And therefore, we have a slightly higher exposures in Ukraine, and Russia and that's also why we felt compelled to give you a heads up on the data readout for pemphigus. Indeed, it piece of Q <unk> study exposure is minimal and we have time to rebalance without having to change anything concerning timelines.

For <unk>, we are currently going through the risk analysis, and we will be able to give you an update probably in the next quarterly earnings call.

Tim Van Hauwermeiren: And we will be able to give you an update probably in the next quarterly earnings call. Please, your second question. Yes, you know, you have had a lot of trials done. Fected in your arms.

Please to your second question.

Yes.

A lot of trials underway.

This is reflected in your R&D spend.

Joon Lee: And hopefully, many will succeed, but it's unlikely that all will succeed in order to what happens, the muskemg population. So do you have any plans to partner with an AI company to analyze the rich clinical data sets you're generating and to identify certain biological settings? Nguyen, and the last one is a poll by the U.S. government on the future of the United States. The poll was conducted by the U.S. government on the Recess, and we're just asking because we've been talking to a lot of A.I.

And maybe we will succeed but it's unlikely that all with the similar to what happened with the Musk Mg population.

Have any plans to partner with an AI company to analyze the rich clinical data set you are generating and two to identify certain biological signatures to include the odds.

Tim Van Hauwermeiren: Argenix, and Reducing Clinical Risks Using AI, are the focus of many companies. Curious about your thoughts on that, since you have a lot of experience. It's a great question, Joon. And whilst we're not deeply engaged in AI, we're following similar strategies. So, first of all, these are all rare diseases. And there are not too many precedent trials out there or too many data you could mine in an intelligent way. That is the challenge.

Your clinical success and we're just asking because we've been talking to a lot of AI companies with autoimmune focus and and we do some clinical risks using AI since we.

The focus of many companies.

Tim Van Hauwermeiren: So we do talk to experts extensively when we design our clinical trials, trying, you know, to make the studies as de-risked as possible when it comes to inclusion and exclusion criteria. Also, when it comes to our go-to-go decision points, somewhere in these trials, where you have the ability, for example, to further tweak certain aspects of the registrational part of the studies, similar to what we did in CIDP. We're doing that in the BP trial, and we're doing that in the BASCA trial in myositis. So I think we find our ways, you know, to risk mitigate these studies in an intelligent way. Still, I think I will like your comment.

Just your thoughts on that since you have a lot of trials ongoing thank you.

It's a great question unit and whilst we're not deeply engaged in AI. We are following similar strategies. So first of all these are all rare diseases and there are not too many.

Precedent trials out there are too many data you could mine in an intelligent way that as a challenge. So we do talk to experts extensively when we design our clinical trials trying to make the study as you know is derisked as possible when it comes to inclusion exclusion criteria.

So when it comes to our go no go decision points somewhere in these trials, where you have the ability for example to further tweak certain aspects of the Registrational part of the studies similar to what we did in CDP. We are doing that in the BP <unk> trial, we are doing that in the basket trial in myositis.

So I think we find other ways to risk mitigate these studies in an intelligent way.

I think I'd like to comment these are still clinical experiments, which all have their own intrinsic risks associated.

Yeqin Seneja: These are still clinical experiments that all have their own intrinsic risks associated with them. Thanks for the question. Your next question comes from the line of Yeqin Senea from Guggenheim Partners. Your line is open.

Thanks for the question.

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

Keith Woods: Hey guys, thank you for taking my question. We're going to talk about the Chevy... Subcategorize these patients. It is our understanding that, you know, there are different categories within these 17,000, and some might be more or might be easier patients to get early in the launch curve, like, are on chronic IBI. David Seynnaeve, Jeffrey Guptill, Leentje Ceuninck, Simon Bowman, Vyvgart, and Genx NV, Great

Okay, Hey, guys. Thank you for taking my question. So question is on the patient population. So when you talk about the 17000 paid the gmg patients that you are targeting can you maybe help us sub categorize. These patients. It is our understanding that there are different categories within the 17000 and some might be more.

Or might be easier patients to <unk>.

What are the in the in the launch curve like patients who are on chronic IV AIG may be soliris non responder. So if you can just give us a flavor of what exactly you are seeing in these buckets, how big are these buckets and how should we expect.

Some of these okay.

Maybe first to come to your therapy. So Thats first question and the second one I'll ask right now is on the J code can you also talk about what the limitation it might be having if any at this point and how that dynamic could change once you. Once you get it in Q3, so two questions from me.

Keith Woods: Well, thank you for the question, Yatin. First of all, what I'd say is the patient population that we are seeing that is taking Vyvgart in this early period, these first eight weeks, is really aligned with the ADAPT trial. It is really across the treatment spectrum. As I mentioned, we are getting some relapsed refractory patients. We've also had some from IVIG. But typically, when you look at that target population of 17,000, these are patients that have tried mestinon. Many times they've had a steroid added, and many of them have also gone on an off-label broad ISP.

Great well. Thank you for the question Yeah first of all what I'd say is the patient population that we are seeing that is adapting <unk>. In this early period. This first eight weeks is really aligned with the adapt trial. It is really across the treatment spectrum as I mentioned, we are getting some relapsed refractory patients. We've also had some from IV.

But typically when you look at that that target population of 17000. These are patients that have tried <unk>. Many times they've had a steroid added and many of them have also going on and off label broad ISP.

Keith Woods: And we have seen each of those types of patients experience Vyvgart here in the early stages of the launch. As far as your second question on the J code and the limitations, what the J code basically does, it's in the buy and bill situation. And it is putting more work on the office to get reimbursed. It's not that it makes it where it cannot be reimbursed because we are having the product reimbursed in a buy and bill setting. It just may add an extra step of going through an appeals process, and it puts more work on the office staff.

And we have seen each of those types of patients experience.

<unk> here in the early stages of the launch.

As far as your second question on the J code and the limitations with the J code basically does it's in the buy and bill situations and it is putting more work on the office to get reimbursed, it's not that it makes it where it cannot be reimbursed because we are having product reimbursed in a buy and bill setting. It just may add an extra step of going through and <unk>.

<unk> processed and it puts more work on the office staff. You also have a limited number of offices that actually elect not to prescribe a product why they don't have a J code because they don't want to put the extra work on the office I think the last thing that we need to remember.

Unlike an oncology setting.

Your buy and bill market and <unk>.

<unk> is smaller than what you see in <unk> and it's really in that buy and Bill where you see the J code impact.

But we expect to have our own individualized J code in quarter three.

Keith Woods: You also have a limited number of offices that actually elect not to prescribe a product because they don't have a J code because they don't want to put the extra work on the office. I think the last thing that we need to remember is, unlike in an oncology setting, your buy and bill market in neurology is smaller than what you see in HEMOC. And it's really in that buy and bill where you see the J code impact. But, you know, we expect to have our own individualized J code in quarter three. Your next question comes from the line of James Gordon from J.P. Morgan. Your line is open.

Your next question comes from the line of James Gordon from Jpmorgan. Your line is open.

James Gordon: Hello, James Gordon, from JP Morgan. Thanks for taking the questions. The first question was just for Vyvgart and MG, how important do you think the first movers basis and formulation relative to other XJRNs in MG? And I ask because I know UCB are going to present their ROSA XJRN phase three data at AAN, and they talked very confidently about how they're going to present data that shows it's very competitive versus Biffgaard. So do you think the R.A. was where they could actually be competitive, or given the first move advantage formula, other aspects, etc.

Hello, James Gordon Jpmorgan, Thanks for taking the questions.

The first question was just on the vehicle and EMG. How important you think so this will be the state. This is a formulation relative to other <unk> and energy <unk>, because I know UCB going to visit my Rosa Sarah with Phase III data at AAN next month.

Keith Woods: Other areas where there could be a risk, perhaps, how do you feel about that? It's the first question. And I'll ask a follow-up now, which was just on Russian Ukraine destruction. And I did the comment on PV and potential delays there. But the ITP sector, it looks like it's got quite a lot of Russian sites. I think about a third of the sites that look like they're in Russia.

Very constantly about how they are going to present data that serves as a great competitive vessels picked up so do you think the wrong areas, where they can actually be competitive or given will first move advantage formulation and all the other aspects et cetera, or other areas, where there could be a risk. So how are you thinking about that as the first question.

I'll ask a follow up now with the system on Russia, Ukraine disruption.

I'd like to comment on <unk> and potential delays there.

But the OTT subs and trial looks like Coca Cola Watson sites I think about a third at the sites that are either in Russia. So is there a risk that that study is also significantly disrupted and delayed or is it more of an issue that's Ukrainian versus Russia.

James Gordon: So is there a risk that that study is also significantly disrupted and then delayed, or is it more of an issue if it's Ukraine versus Russia? Yeah, let me start with the second question first. And I'm happy to hand over to Keith to talk about our competitive position in the MGM landscape.

Tim Van Hauwermeiren: It's not just about the sites, which you can see on clinicaltrials.gov, but it's about the actual number of patients who have actually been enrolled through these sites. So when we look at the real situation, which is the actual number of patients, we feel that the sub-Q study for Epgar-Tigemod in ITP is perfectly under control. I would say that, indeed, it is. So somewhat more exposure in the pancreas trial. So maybe we will have to overcompensate for that in some of the sites.

Let me start with the second question first and I'm happy to hand over to Keith to talk about our competitive position in the <unk> landscape.

Just about the sites, which you can see on clinical trials start golf, but it's about the extra number of patients, which actually have been enrolled through these slides. So when we look at the real situation, which is actual number of patients we feel that the Q study for <unk>, taking about in IDP is perfectly under control.

I would say that indeed it is.

Tim Van Hauwermeiren: That analysis is ongoing, so I don't think there's any reason to change the guidance on readout timing for the ITP sub-Q study or the CIDP sub-Q study. Maybe Keith, you want to comment on how we look at our competitive position in the MG landscape? Sure.

Somewhat more exposure in the <unk> trial. So maybe we will have to overcompensate that and some other sites that his analysis, which is ongoing.

So I don't think there is any reason to change the guidance on readouts timing for the ITG subdue study or the CIP subdue study, maybe Keith you want to comment on how we look at our competitive position into Mg landscape sure. So James first of all I think it's premature to comment anything on UCB phase III data.

Keith Woods: So James, first of all, I think it's premature to comment on UCD phase three data because we haven't seen any specific data at all. As far as the first mover advantage goes, I think that the opportunity that exists with Vivgard is based on the data itself. Let's start with efficacy. Between the first and second cycle, almost eight out of every 10 patients that take Vivgard are going to have a clinically meaningful response.

Because we haven't seen any specific data at all as far as the first mover advantage I think that the opportunity that exists with did guard is based on the data itself, let's start with efficacy between the first and second cycle almost eight out of every 10 patients that experienced vanguard are going to have a clinically meaningful response we.

Also have a very rapid onset of action with 84% of them responding within the first two weeks and the minimal symptom expression, sending these patients to where they have no symptoms at all right now it's the highest number thats been recorded in a clinical trial.

Keith Woods: We also have a very rapid onset of action, with 84% of them responding within the first two weeks. And the minimal symptom expression, sending these patients to where they have no symptoms at all, right now, is the highest number that's been recorded in a clinical trial. Secondly, take a look at the package insert that we have. It is very clean.

Secondly, take a look at the package insert that we have it is a very clean safety profile. This is one of the things that we're hearing from the physicians that are prescribing theyre impressed about this there is no pre medication theres no black box warning and the safety.

Writing up through all of our studies the last thing I would say is individualized dosing, we're providing convenience to patients when they can take advantage of the individualized dosing.

And so I guess, what I would say is we've set the bar high, but let's wait and see data.

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

Keith Woods: The safety profile, this is one of the things that we're hearing from the physicians that are prescribing it. They're impressed with it. There's no pre-medication.

Great. Good morning, Thanks for taking the questions I guess two for me one I don't know if youre willing, but it would be interesting to hear.

What youre sort of seeing on a month over month basis are you seeing a patient to accelerate or not just just so we can get some sense of how youre thinking about the bolus and then.

Second question, just because I think a lot of us haven't seen.

Japan launch before can you give us some sense of whether or not you think Japan can be a meaningful contributor this year.

And just given the commentary around when you get the price, but the fact that it sounds like you can already start to lineup patients. Thanks very much.

Keith Woods: There's no black box warning, and safety is riding high through all of our studies. The last thing I would say is individualized dosing. We are providing convenience to patients when they can take advantage of individualized dosing. And so I guess what I would say is we've set the bar high, but let's wait and see the data. Your next question comes from Matthew Harrison from Morgan Stanley. Your line is open.

Yes, Matthew Thanks, Thanks, very much for the question so as far as what we're seeing on a month over month basis. We've only had eight weeks. So it's really tough to give you a month over month basis I can tell you that what we're seeing in patient demand, it's been gradual and it's been consistent.

I think that we have prepared well in advance on each of those strategic imperatives and I think the team is out there executing on each of the areas whether it's the patient awareness. The health care professionals are the payers I'm also really pleased with the progress that we have through my view of GARP path because when you have a brand new first in class product with our brand.

New mechanism of action there does take some pull through to turn demand into actual infuse patients. So we can talk a little bit more about patient trends when we actually get to our first quarter earnings call.

As far as your second question about the Japan launch again, I'm going to advise on a very gradual consistent growth because we run into the same issue that exists in the United States and that is education on our first ever mechanism of action and also I would call out to you that the number of clinical trial.

Sites that we had in Japan is smaller than what we even experienced in the U S. So I wouldn't think of you have a bolus of patients that are set to go.

Now one thing that we do have different in Japan, I remind you that in the approval that we received in January the Japan label will include seronegative patients.

Your next question comes from the line of Allison, Brad Zelle from Piper Sandler Your line is open.

Matthew Harrison: Great. Good morning. Thanks for taking the questions. I guess, two questions for me: one, I don't know if you're willing to share what you're sort of seeing on a month over month basis with the patient accelerator or not, just so we can get some sense of how you're thinking about the second question, just because I think a lot of us haven't, Candle, [inaudible] before. Can you give us some sense of whether or not you think Japan, Paul Contributor, this year, and just given the commentary around when you get the price, but the fact that it sounds like you can already start?

Hi, Good morning. Thank you for taking my question. So just one on <unk>.

Sorry.

<unk>.

Okay.

Please now open about.

It seems like there's definitely interest.

Johnson switching from Ipi.

<unk>.

And switching from Sylvia as well so I know, it's early days, but does that match, what you're seeing in the field.

Keith Woods: Yeah, hey, Matthew, thanks. Thanks very much for the question. So as far as what we're seeing on a month over month basis, we've only had eight weeks. So it's really tough to give you a month over month comparison.

And then I guess just to the extent that you are seeing patients having an interest in switching from Soliris to <unk>, what's the primary driver of a reason behind that.

I'm, a patient and neurologist point of view and just how do you expect that dynamic to evolve.

When Altamira, Scott, Jim Daly Mall midyear.

Keith Woods: I can tell you that we are what we're seeing in patient demand. It's been gradual, and it's been consistent. I think that we have prepared well in advance for each of those strategic imperatives.

Yes. So thank you for the question Allison I guess, the first thing that I would say is it's too early to predict a trend because we're talking about individual patients and as you know in rare disease every single patient is different.

And we also know just from the data.

But youre not going to get every single patient to respond to a therapy. You can go back and look at the regain study or the data that was released on altamira. So regardless of what product to patient has gone on that youre going to have a part of that population that is not going to respond and when they have not responded theyre going to look for other options and thats whats happened with <unk>.

Becoming another tool to place in the box.

The health care professionals.

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

Keith Woods: And I think the team is out there executing on each of the areas, whether it's patient awareness, the healthcare professionals, or the payers. I'm also really pleased with the progress that we have made through my Vyvgart path, because when you have a brand new first in class product with a brand new mechanism of action, it does take some pulling through to turn demand into actual infused patients. So we can talk a little bit more about patient trends when we actually get to the first quarter earnings call.

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

Keith Woods: As far as your second question about the Japan launch, again, I'm going to advise on very gradual, consistent growth because we run into the same issue that exists in the United States, and that is education on the first ever mechanism of action.

I'm just curious on the adapt next T trial did.

Did you start that sort of based on any sort of questions from providers to provide clarity in terms of sort of dosing regimens and have you gotten an early sense about how physicians are going to implement.

The individualized dosing that you have in the label. Thank you.

Yes.

Yes, so Douglas we have been working with a group of Kols for better than two years now it's been since the phase II data that we discussed the concept of individualized dosing. It first came from the patients when we shared with them the phase II data and they love the idea of the cycles and they love the idea of having the time.

Off therapy.

We then went and discuss this with the Kols and they've seen the data and they are very pleased with it. The question that they had is what if I require somebody that might.

Need a little bit more consistent dosing and what we always aim to do is to be able to have data based answers and that's basically what this trial has been set up for.

I think the other way to look at deals.

The other way to look at it is look we have a long term commitment to the Mg space and we'll be able to offer mg patients around the globe is the most complete offering and the way you have to understand the most complete offering us maximum flexibility from a dosing point of view. This is a snowflake disease every mg patient is different.

You cannot basically take them to the same standard approach and we also want to have flexibility from a product presentation point of view there are different preferences and meets all of that in the markets for bolt on IV product and a few products. So look at it through this lens.

Keith Woods: And also, I would call out to you that the number of clinical trial sites that we have in Japan is smaller than what we have even experienced in the US. So I wouldn't think that you have a bolus of patients that are set to go. Now one thing that we do have different in Japan; I remind you that in the approval that we received in January, the Japan label will include seronegative patients. Your next question comes from a line from Allison Bratzel on Piper Sandler. Your line is open.

Okay, Great again.

One follow up just in the early days have you any sort of color on how docs are implementing the individualized dosing.

Allison Bratzel: Hi, good morning, thank you for taking the question. So, just one on the source of Vyvgart patients. Having sat through some of the GMG patient webinars about Vyvgart, it seems like there's definite interest not just from IPIP, but surprisingly, from Soliris as well. So I know it's early days, but does that match what you're seeing in the field? And then I guess just to the extent that you are seeing patients having an interest in switching from Soliris to Vyvgart, what's the primary driver or reason behind that from a patient and neurologist point of view? And just how do you expect that dynamic to evolve? when Altamiris gets a DMG label.

Yes, so I mean first of all they like the idea of the individualized dosing they like the idea of only treating a patient when they need therapy. They also like the idea of the data that they've seen what percentage of patients as you know during the launch we shared with you that 58% of patients require five cycles or fewer.

Questions that they've had is how should they start the patient and how do I figure out how to get to the individualized dose that my patient needs and a lot of them have taken a look at how they utilize off label IV to.

Keith Woods: Yeah, so thank you for the question, Allison. I guess the first thing that I would say is, it's too early to predict a trend, because we're talking about individual patients. And as you know, in rare diseases, every single patient is different. And we also know, just from the data, that you're not going to get every single patient to respond to a therapy; you can go back and look at the regain study or the data that was released on ultramurus.

To treat Mg and that is basically let's let's get to our patient into response and get that patient to the maximum response that we can have and then as we have the patient in response based on the label, it's their clinical evaluation and discussion with the patient on how they stretched that interval out and that's what we've seen happen in the open label extension.

And Thats, what we will see happen in the real world.

Keith Woods: So regardless of what product a patient has gone on, you're going to have a part of that population that is not going to respond. And when they have not responded, they're going to look for other options. And that's what happened with Vyvgart becoming another tool to place in the box of healthcare professionals. Your next question comes from a line from Douglas Tsao from H.C. Wainwright. Your line is open.

Your next question comes from the line of Danielle Brill from Raymond James Your line is open.

Hey, guys. Good morning, Congrats on the progress and thanks, so much for the questions I have a couple on ITT.

Douglas Tsao: Good morning, and thanks for taking the questions. I'm just curious about the ADAPT-NEXT T-TRIAL, you start that sort of based on any sort of questions from providers to provide clarity in terms of the sort of dosing regimens, and have you gotten an early sense about how physicians are going to implement the individualized dosing that you have in the label. Thank you.

Keith Woods: Yeah, so Douglas, we have been working with a group of KOLs for better than two years now, and it's been since phase two data that we discussed the concept of individualized dosing. It first came from the patients when we shared with them the phase two data, and they loved the idea of the cycles and they loved the idea of having time off therapy. We then went and discussed this with the KOLs.

Keith Woods: And they've seen the data, and they're very pleased with it. The question that they had is, what if I require somebody that might need a little bit more consistent dosing? And what we always aim to do is to be able to have data-based answers. And that's basically what this trial has been set up for.

And you mentioned placebo responses are common but I believe.

Keith Woods: I think the other way, Matthew, to look at it is, look, we have a long-term commitment to the MG space, and what we want to offer MG patients around the globe is the most complete offering. And the way you have to understand the most complete offering is maximum flexibility from a dosing point of view. This is a snowflake disease; every MG patient is different; you cannot basically take them on the same standard approach.

Keith Woods: And we also want to have, you know, flexibility from a product presentation point of view; there are different preferences and needs out there in the market for both an IV product and subq products. So we look at it through this lens.

Keith Woods: Okay, great. And again, just in the early days, have you any sort of color on how docs are implementing the individualized dose? Yeah, so I mean, first of all, they like the idea of individualized dosing. They like the idea of only treating a patient when they need therapy.

Keith Woods: They also like the idea of the data that they've seen of, you know, what percentage of patients, as you know, during the launch, we shared with you that 58% of patients require five cycles or fewer. The questions that they had were, how should they start the patient? And how do I figure out how to get to the individualized dose that my patient needs?

People respond to it was actually pretty low in <unk> program.

Keith Woods: And a lot of them have taken a look at how they utilize off-label IVIG to treat MG. And that is basically, let's look at our patient in response and get that patient to the maximum response that we can have. And then as we have the patient in response based on the label, it's their clinical evaluation and their discussion with the patient on how they stretch that interval out. And that's what we've seen happen in the open label extension, and that's what will happen in the real world.

Danielle Brill: Your next question comes from a line from Danielle Brill from Raymond James. Your line is o- Good morning, congrats on the progress and thanks so much for the questions. I have a couple on iTunes. Tim, you mentioned placebo responses are common, but I believe the placebo response to it was actually... Low and Rigel's program.

Tim Van Hauwermeiren: Are there specific differences in the population they enrolled versus those in advance that might explain this? And then, in their phase three publication, they showed efficacy was much lower in patients who are antibody negative. I'm just wondering how we should think about the potential risk of including antibody negative patients. Thank you, Danielle.

The specific differences in the population band rolled versus those.

That was an advance that might explain this and then <unk> phase III publication that showed efficacy is much lower on patients who are antibody negative I'm. Just wondering how we should think about potential risks, including antibody Nathan patients.

Thank you.

Tim Van Hauwermeiren: These are two excellent questions. First of all, the reason the placebo response was slow in the RISO trial is because they basically used a similar endpoint as the one we're using. So we have been studying that trial in detail. They also had a durable platelet response requirement.

Thank you Danielle look through excellent questions. So first of all the reason the placebo disposable slowing the ISO trial is because they basically have.

A similar endpoint as the one we had using so we have been studying this trial in detail. They also had an <unk> platelet response requirements. So unlike the GPO registration trials.

After a certain period of treatment it was sufficient to be at 50000 platelets. So hired on a specific day day built into <unk> requirement and you can indeed see how effective that has been in knocking down to placebo I think in lung trial ahead Gino zero percent response, and then in another trial that had you know something like a 1%.

Tim Van Hauwermeiren: So unlike the TPO registration trials, where, you know, after, you know, a certain period of treatment, it was sufficient to be at 50,000 platelets or higher on a specific day, they built in that durability requirement. And you can indeed see how effective that has been in knocking down the placebo. I think in one trial, they had, you know, 0% response.

Bonds and placebo and basically we are trying to achieve similar numbers on placebo by applying a similarly stringent endpoints.

Tim Van Hauwermeiren: And then, in another trial, they had, you know, something like a 1% response to placebo. And basically, we're trying to achieve similar numbers on placebo by applying a similarly stringent endpoint. Now this story on antibody-negative patients, I don't think that exists. I mean, all ITP patients, you know, primary ITP patients, do have auto-antibody styling depleted. The issue is what test you use to analyze the antibody levels and what the sensitivity is, and what the detection limit is for these patients.

Now this story on antibody negative patients I don't think that exists I mean, all ITB patients primary RGB patients do have ultra antibodies styling. The platelets the issue is.

<unk>.

<unk> used to analyze the antibody levels and what the sensitivities for the detection limit is.

For these patients so for example.

Tim Van Hauwermeiren: So, for example, in our 52 trial, we use a more sophisticated method where we basically harvest platelets, we strip the auto antibodies from the platelets, and then we semi-quantify them. 100% of the patients actually are auto antibody positive.

In our phase II trial, we use a more sophisticated methods, where we basically harvest platelets, we stripped the auto antibodies from the placements and then be semi quantified them, 100% of the patients actually is ultra antibody positive. So if you have a true priority ICP patients that patients will have played this.

Associated ultra antibodies.

Thank you for the questions.

Tim Van Hauwermeiren: So if you have a true primary and IPP patient, that patient will have platelets associated auto antibody. [inaudible] Thank you for the question. Your next question comes from the line of Jason Butler from JMP Securities. Your line is open.

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

Jason Butler: Hi, thanks for taking the question. Just one for me on reimbursement. I'm just looking forward to the sub-Q product. Given that that product in Vyvgart will be distinct, will the value-based agreements in place for Vyvgart expand immediately on approval for the sub-Q product? Or do you need to go through another process because they're distinct products?

Hi, Thanks for taking the question just one from me on a reimbursement.

Looking forward to the sub Q product given that that products and <unk> will be distinct with a value based agreements in place for the guard expand.

Lately on approval for the subgroup products or do you need to go through another process because they are distinct products and then same question on essentially for the J code part of the equation will you need to get a separate J code for the sub two products and while you wait for the J code you have in place for Guardant health.

Keith Woods: And then same question essentially for the J-code part of the equation. Will you need to get a separate J-code for the sub-Q product? And while you wait for it, will the J-code you have in place for Vyvgart help in any way? Thanks.

And anyway. Thanks.

Keith Woods: Yeah, Jason, thank you for the questions. So first of all, you know the work that we did with payers in advance by putting them under CDA prior to even having approval for Vyvgart. And that's when we discussed all of the data with them, including what we saw on the distribution of the number of cycles per year.

Yes, Jason Thank you for the questions. So first of all you know the work that we did with payers in advance by putting them under CDA prior to even having approval of Bib guard and Thats. When we discussed all of the data with them, including what we saw on the distribution on the number of cycles per year, we looked at the patient population.

We know that the IV was weight based dosing and so we really discussed with them what would make sense in regard to a value based agreement with them.

Keith Woods: We looked at the patient population. We know that the IV was a weight-based dose, and so we really discussed with them what would make sense in regard to a value-based agreement with them. We have not yet made the decision on exactly how we will handle as we have the approval for subcue, but in a true collaboration goal that we had with our IV launch, we will be out with these same payers in advance of a subcue approval to determine what will be the best method to take considering it will be a separately branded product.

We have not yet made the decision on exactly how we will handle as we have the approval for sub Q, but in a true collaboration.

<unk> that we've had with our IV launch we will be out what these same payers in advance of a sub Q approval to determine what will be the best method to take considering it will be a separately branded product.

Keith Woods: Secondly, you asked the question about the J-code. I think that once you have a sub-Q product that would be available for patients to give themselves a simple, single injection at home, you're going to see by far the majority of that sub-Q product acquired through specialty pharmacy, and so that's not going to come into play with the J-code at the same level that you're seeing with a buy-and-bill infusion. Your next question comes from a line from Joel Beatty Your line is open.

Secondly.

You asked the question about the J code I think that once you have a sub Q product that would be available for patients to give themselves a simple single injection at home you're going to see by far the majority of that sub Q product acquired through specialty pharmacy, and so that's not going to come into play with the with the J code to the same.

A level that youre seeing with a buy and bill infusion IV product.

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

Joel Beatty: Hi, thanks for taking the questions. The first one is, can you describe how the patient experience has been from the time of prescription of Vyvgart to actually starting on therapy, such as what percent of prescriptions are being filled right now and how long it takes to start on the drug? And then the second question is, what is the status of Vyvgart being added to treatment guidelines for GM? Yeah, so first let's talk about the experience from the time that the script was written to the time that the patient is infused, and the reality of it is you have a brand new product that is out and available, and what we're experiencing, what we're seeing is on a patient by patient basis. It completely depends upon who

Alright, thanks for taking the questions first one is could you describe how the patient experience has been from the time a prescription of <unk>, it's actually starting on therapy.

It is what percentage of prescriptions are being filled right now and how long it takes to start on drug.

Second question is what is the status of being added to treatment guidelines for <unk>.

Keith Woods: What we do know is that we don't have a J-code, as you've heard in the prepared remarks, the policies that are being prepared by the payers; we have about 25% that have covered lives that have policies in place right now. So, the process going from demand to actual infusions in some cases is longer. We expect this to shorten over time, but I'm really proud of the team at my Vyvgart Path, our nurse case managers, our case coordinators, and our field reimbursement managers who are working on every single case to make sure that we can shorten the time to the best of their ability. So what was the second question, please?

Yes, so first let's talk about the experience from the time that the script wrote to the time that the patient is infused and the reality of it is you have a brand new product is out and available and what we're hearing and.

What we're seeing is on a patient by patient basis, a completely depends upon who their insurers. What we do know is we don't have a J code as you've heard in the prepared remarks, the policies that are being prepared by the payers. We have about 25% of covered lives that have policies in place right now so the process going from <unk>.

<unk> to actual infusions in some cases as longer we expect this to shorten over time, but I'm really proud of the team.

My view of guard path, our nurse case managers are case coordinators and our field reimbursement managers, who are working on every single case to make sure that we can shorten the time to the best of our ability.

So what was the second question please.

Keith Woods: This card is being incorporated into the treatment guidelines. We're eight weeks into this initial launch, and really, it's too early to say. Right now, the only thing I can say is the treatment guidelines where we are seeing patients that are being prescribed Vyvgart are aligned with ADAPT. So it's not necessarily severe relapse-refractory. In some cases, it's much earlier in the treatment paradigm.

This is Gary.

Being incorporated into treatment guidelines for January .

We're eight weeks into this initial launch and really it's too early to say.

Right now the only thing I can say is that.

The treatment guidelines.

Where we are seeing patients that are being prescribed <unk> gard is aligned with adapt so it's not necessarily severe relapsed refractory in some cases, it's much earlier in the treatment paradigm, but I am sure we will see more treatment guidelines over time as the market matures.

Manos Mastorakis: But I'm sure we will see more treatment guidelines over time as the market matures. Your next question comes from the line of Manos Mastorakis from Deutsche Bank. Your line is open.

Your next question comes from the line of Monovisc, Matthew <unk> from Deutsche Bank. Your line is open.

Tim Van Hauwermeiren: Yes, hello. Thank you for the question. Um, so yeah, you're loaded already very briefly, but I just want to better understand your latest perspective on clinical differentiation against competitors such as Rizunovic Sizumov and Ipocalymov. Hello. Hi. Hi, everybody.

Yes, Hello, Thank you for all the questions.

So yes, you alluded to that already very briefly.

Wanted to better understand your latest perspective on clinical differentiation too.

Competitors, such as <unk> and Nellix citizen mob of nickel Palomar may be coming in the future as well as competitive risk from <unk>.

Our use of <unk> inhibitors in Mg.

Tim Van Hauwermeiren: NMG if Ultimaeris is approved, and a follow-up question, what would your expectations be for the Phase 3 ITP data and the clinical position, the elements we mentioned. So let's start with the biology, right? We're science-based; we follow biology. Myasthenia gravis is truly an IgG-mediated disease.

<unk> is approved.

And a follow up question.

Is what would your expectations be for the phase III.

Data.

And.

Clinical positioning as well.

Okay.

The elements, we mentioned so let's start with the biology right I mean, we'd be science based we followed biology myasthenia gravis is truly an <unk> mediated disease. So the pathogenic <unk> antibodies are very well known we also know what they do at the November .

Tim Van Hauwermeiren: So the pathogenic IgG antibodies are very well known. We also know what they do at the neuromuscular junction. By binding to acetylcholine receptors or other building blocks of the junction, they will basically prevent signaling through the acetylcholine receptors.

Conjunction by binding a statistical intercepted or old older building blocks of the of the junction David basically prevents signaling.

Food also difficulty in this up just they will basically cross link internalize and make the receptor unavailable for signaling and it will also recruit complement so.

Tim Van Hauwermeiren: They will basically cross-link, internalize, and make the receptor unavailable for signaling. And they will also recruit complements. So, definitely complement is one of the several pathogenic modes of action of these old 20 bodies. And by nature of the disease biology, if you clear the old 20 body, you will, of course, eliminate complement recruitment to the junction, but you will also effectively take care of the other pathogenic modes of action of these old 20 bodies.

Tim Van Hauwermeiren: So with upstream of any complement blocker, and I think we have a more complete blockade of the disease biology. I think the clinical data support that I've got taken and what has shown the highest ever clinical efficacy in any clinical trial. Thank you very much.

Definitely complement is one of the several pathogenic modes of action of this ultra antibodies and by by nature of the disease biology issue cleared the auto antibody you will of course eliminate complement recruitment to the junction virtual also effectively take care of the oldest pathogenic modes of action of this <unk> 2000, <unk> so we'd upstream.

And E comm balloon blocker and I think we have a more complete blockade of the disease biology.

The pinnacle of data supports that as <unk> has shown the highest average clinical efficacy in any clinical trial.

Tim Van Hauwermeiren: What about differentiation within the FCRN class? I think it's extremely important you guys remember that not all FCRNs are made equal. I think during our R&D day in the July session last year, we articulated key elements of differentiation. This is not just a high affinity monoclonal antibody targeting a target like SCRN. This is a uniquely designed ligand of FCRN coming with its own unique properties in complex with FCRN.

What about the differentiation of <unk> class I think it's extremely important you guys remember that not all <unk> are made equal I think during our R&D day in the July session last year as we articulated the key elements of differentiation.

This is not to just just to high affinity monoclonal antibody targeting a target like our CRM. This is a uniquely designed a ligand of F. CNN combing that its own unique properties in complex with SDN I think we've demonstrated some pretty fundamental biological differentiation, which is again has the potential.

Tim Van Hauwermeiren: I think we demonstrated some pretty fundamental biological differentiation which again has the potential to translate into best in class efficacy, best in class safety, and convenience. So, as Keith said, let's wait for the data. I think we've set the bar very high, you know, with, you know, close to an 80% response rate over the first two treatment cycles. And by the way, response is a very stringent definition right at four consecutive visits, having a delta of two points or more on the ADL scale.

To translate into best in class efficacy best in class safety and convenience. So as Keith said, let's wait for the data I think we've put the bar very high.

Tim Van Hauwermeiren: I think if you look at the safety profile, we have shown, you know, a unique interaction with FCRM and therefore probably a very clean safety profile, which can be unique and differentiated. And then on the topic of convenience, individualized dosing, that's where we're going into it in this space, also the offering with both IV and SUPQ, I think is giving maximum flexibility to patients. So I think we're well positioned to compete in the FCRM class.

Close to 80% response rate over the first achievement cycles and by debate a sponsor is a very stringent definition rights in four consecutive visits having a delta of two points or more on the ADL scale.

If you look at our safety profile, we have shown a unique interaction with FCA and therefore also probably a very clean safety profile, which can be unique and differentiated and then on the topic of convenience. The individualized dosing, that's where we are going into this space also the offering with both IV and subdue I think is giving.

Maximum flexibility to patients. So I think we are well positioned to compete in.

F series class.

Tim Van Hauwermeiren: With regard to ITP and what to expect, the way we talk about the first of the two registration trials is that the primary endpoint is truly designed to create a statistically meaningful difference between the active arm and the placebo arm. There's not much more to it than that.

With regards to ITT what to expect.

Tim Van Hauwermeiren: But we have gone to great lengths to craft secondary endpoints, which will give the full opportunity for f-cartigma to shine in an ITP indication. We will learn a lot about, you know, cumulative platelet counts in these patients, platelet counts over the entire study period, the resulting bleeding events, and quality of life. Do not forget this is a severe autoimmune disease. It's much worse than just a platelet count and bleeding issue. These patients suffer from debilitating fatigue, depression, and anxiety, and, of course, we want to get some further safety information on f-cartigma in these patients.

The way we talk about the first of the two registration trials as the primary endpoint is truly designed to create a statistically meaningful difference between active arm and placebo arm. There is not much more to it than that but we haven't gone at great lengths to craft secondary endpoints, which will give the full opportunity.

<unk> two <unk> to shine in an ICP indication, we will learn a lot about cumulative platelet counts in these patients platelet counts over the entire stood at periods, the resulting bleeding events quality of life do not forget this is a severe autoimmune disease, it's much worse than just a platelet count them.

Meaning issue these patients suffer from debilitating fatigue depression anxiety and then of course, we want to get some further safety information on <unk> in these patients. So there's a lot of stuff to read out in this trial with the primary endpoint is all about hitting statistically significant differentiation from placebo.

Tim Van Hauwermeiren: So there's a lot of stuff to read out in this trial, but the primary endpoint is all about hitting statistically significant differentiation from placebo. And your final question comes from the line of Charles Pitman from Redburn. Your line is open. Hi, Charles Pitman from Redburn. Thank you very much for taking my questions. Sneaking in at the end here.

And your final question comes from the line of Charles Pitman from Redburn. Your line is open.

Charles Pitman: So first, a clarifying question for Keith. Could you provide a little more detail on your definition of broad coverage for US payers? Can we assume this could mean over 50% of covered lives? And then, secondly, a question for Karl.

Hi, Charles Pitman from Redburn, Thank you very much.

My question's just sneaking me in here.

First just a clarifying question for Keith could you provide a little more detail on your definition of broad coverage for the U S. Payers can we assume this could mean over 50% of covered lives and then just secondly, a question for Carl could.

Could you give us just a little bit more guidance on how youre thinking about that.

Keith Woods: Could you give us just a little bit more guidance on how you're thinking about the COGS for Vyvgart and the split between your operating expense lines for 2022? Or should we expect guidance to be provided in one queue once the launch has progressed? Yeah, Charles, thanks for the question.

So they've got on the split between your operating expense lines for 2022.

Or should we expect guidance to be provided at <unk>. Once the launch has progressed a little more thanks.

Keith Woods: So when we talk about broad coverage, remember, we already work with six national payers, and we were before the launch. But you also have large regional payers that we're working with. And so that's why we said by the end of Q2, because the team is out working with the regional payers on the policies that are being put in place there. So quite frankly, giving the metric this early of 25% of covered lives covered commercial lives at eight weeks in is pretty good.

Yes, Charles Thanks for the question. So when we talk about broad coverage remember, we work already with the fixed national payers than we were before the launch but you also have large regional payers that were working with.

So thats why we said by end of Q2, because the team is out working with the regional payers on the policies that are being put in place there. So quite frankly, giving the metric. This early of 25% of covered lives covered commercial lives at eight weeks and it's pretty good. So when I think of broad coverage I am not prepared to give you a target but.

Keith Woods: So when I think of broad coverage, I'm not prepared to give you a target. But I do feel safe enough to say I'm talking about greater than 50% of commercial lives. Thank you, Joel, for the question. In terms of guidance, we do not plan to give guidance in 2022. So don't expect anything in Q1. In terms of Cox, we're not specific about Cox, but you can expect it to be the same as a typical biologic.

I do feel safe enough to say im talking about greater than 50% of commercial lives.

Carl Gubitz: And in terms of a split on our expenses, again, we're not going to give any more detail. But I would say that we with the R&D will continue to be the bulk of. Thank you very much. Thank you. Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect.

Alright. Thank you John for the question in terms of guidance, we do not plan to give guidance in 2020 to June .

Sure.

Don't expect anything in Q1 in terms of Cogs were not specific on the coax, but you can expect it to be less.

Typical biologic.

And in terms of not only our expenses again, we're not going to give any more detail, but I would but we with the.

R&D will continue to be the bulk of our spend.

Yes.

Industrial <unk> Thanks Charles.

Ladies and gentlemen, this concludes today's conference call. Thank you for your participation you may now disconnect.