Q3 2021 argenx SE Earnings Call

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This might explain why patients consistently switch between treatments.

Finally, there is a considerable market opportunity with approximately 16 to 17000 addressable patients.

This alone.

We are continuing to enroll patients in the advance to achieve and address trials for ITT see IDP and <unk> respectively.

As shown on slide seven eight and nine.

As we approach enrollment completion.

We'll be able to provide more granular standing for these results.

We recently shared the full results from the Phase II study in the British Journal of Dermatology.

We would encourage you to read its managed care.

Data to support our latest understanding of how else can pick them up good fits into the treatment paradigm in pemphigus.

Given the observed fast onset of action.

Favorable tolerability profile and potential to use smell with initial doses of corticosteroids and start early steroid tapering.

With our newest indications we are in the final preparation stages to initiate the registrational trials.

Keith will expand <unk> trial is on track to start by the end of the sheet and my scientists is expected to start during the first quarter of 2022 now that we have ramped up our SBA consultations and these are depicted on slides 10 and 11.

Through our collaboration with silence.

We are also planning to launch proof of concept trials in additional indications.

I am ready to be public on the plan yet but in the meantime.

This preparing to start enrollment of Chinese patients into our ongoing global clinical trials.

I'm going to quickly talk about two other important programs in our pipeline.

Starting with <unk>, our first in class <unk> two inhibitors.

We shared phase one data from our Phoenix 117 during our R&D day.

When we explained the reasons why we believe that Q2 is the ideal point of intervention within the complement cascade.

To name a few.

Cmos five.

The alternative pathway impact to reduce infection risks.

And patients with genetic deficiency of ship to have a more benign phenotype.

The complement deficiencies.

The phase one data showed a favorable safety profile with both the IC and sub Q formulation.

And PK PD profiles since you bought infrequent dosing.

We remain on track to begin the phase II trial, and then by the end of this year.

And look forward to talking about additional indications for this pipeline in a product opportunity next year.

Slide 14.

We also talked about <unk> 19 for the first time during our R&D day, which is a simple antibody aimed at boosting the neuromuscular junction.

This is the latest pipeline products that has emerged from our immunology innovation program.

We are excited to share more on this program to execute.

Before I turn the call to my colleagues I would like to take a moment to thank our team for their collective efforts as we approach this exciting new stage for <unk>.

In particular, I would like to acknowledge when price.

We announced to date had been moving tires after three years with our genetics in March of 2022.

This planned transition he will become a member of the RMB Committee of our board of directors and succession plans are underway for lipid trying to assume the role in April 2022.

We are so grateful to him for his invaluable contributions.

The transformation of our R&D organization.

And for US Unbeliever ship these past few years.

With that I will turn the call over to Carl to provide a financial update.

Carl.

Thanks, Tim Slide 15 cabinets, our 2021 financial results over nine months ended September 32021.

We will summarize them here.

Highlights in more detail in today's press release.

Total operating income increased to $494 6 million compared to $47 7 million during the same period in 2020.

The significant increase was primarily due to the recognition of end of <unk>.

$15 1 million.

The consequences of a termination of our collaboration agreement with BMS.

Additionally.

Leveraging other strategical collaboration will reside that resulting in recognition of 151 9 million.

Collaboration revenue.

R&D expenses increased to $418 3 million compared to two ended some $76 4 million trees.

The increase resulted primarily from higher external research and development expenses.

Finally for our <unk> Division.

Programs.

SG&A expenses totaled $210 2 million for the first nine months for 2021.

Page $218 2 million E <unk>.

The increase resulted primarily from higher <unk> expenses.

The change in fair value on non current financial assets totaled 11 2 million. So far this year, which is a result of it.

Of our series B financing round of.

<unk> therapeutics, and which we have a profit share finally cash cash equivalents and current financial assets totaled 253 billion as of the end of September compared to 2 billion on December 31st 2020, I'd now like to turn.

The goal with <unk> to provide an update on our commercial launch preparation.

<unk>.

Thanks, Carl 516 please.

We are on track with our preparations for the global launch of Escarcega Mod and MG based on our December 17th <unk> date in the U S. We anticipate an effective launch date in January 2022, and Japan, We anticipate an approval in the first quarter of 2022, followed by a commercial launch three.

Months later once we have price set in Europe, we expect to have an approval in the second half of 2022, and then we will negotiate price and reimbursement on a country by country basis and this is a process that can take anywhere from 12 to 36 months.

2017 please.

We are also excited to announce that as of today, our U S and Japan field teams are fully onboard.

We are currently conducting training and account profiling to ensure that we are prepared to reach patients providers payers and other stakeholders upon approval.

We have 70 territory business managers in the U S and 24 in Japan, but our full field force in the U S will be a team of 146 people. In addition to the territory business managers that team also includes our regional business Directors nurse case managers case coordinators medical research liaisons.

<unk> thought leader liaisons field reimbursement managers regional account managers and national account directors.

We continue to be impressed with the level of talent experience and enthusiasm the new team members bring and we see their shared commitment towards the patient.

We know that the investments we are making in our team and our other infrastructure now will benefit us for the long term because we will recognize economies of scale as we expand to each commercial franchise across new indications and with new assets.

While we feel we have assembled a best in class team that is equipped to handle the challenges associated with this potential launch.

No there are certain aspects that are outside of our control, namely the COVID-19 pandemic continues to create uncertainty for our team and the communities we hope to serve.

We are building a launch plan that incorporates both virtual and in person components based on feedback from physicians on how to optimize our interactions with our hybrid approach.

We also know that it may still be difficult for patients to easily access a facility for treatment. So in addition to building a network of infusion centers. We have also built a home infusion network.

In addition to the unique COVID-19 scenarios, we are facing there are additional challenges associated with the first launch of a product as.

As we've said many times, we will not have a J code at launch we will apply for one shortly after approval in the first quarter and expect to have a dedicated J code in place by quarter. Three of 2022. This may slow things down in the first two quarters with prescribers, having to go through a reimbursement appeal process.

Second <unk> will be a first in class therapy targeting FC RM has a novel mechanism of action that many physicians are not familiar with and do not have hands on experience. It will take time to get to the physicians patients and payors and educate until they are comfortable with this new.

Innovative class of medicines.

Finally, we are limited and the extent of engagement, we can have with stakeholders before an actual approval for these reasons. We continue to believe that we are positioned for a launch with a gradual steady growth and it will take time to reach the full potential of <unk> in Mg with.

All of this in mind I want to make it clear that our overall outlook on the potential for <unk> in Gmg remains unchanged. We know that this community is in need of alternative options and then we have a compelling value proposition based on the strong adapt data the potential for individualized dosing, having both IV.

In sub Q formulation, and our growing safety database.

Slide 18 please.

In summary, we are excited and prepared for the global launch of <unk> and see the significant unmet need that people living with Mg still face we learned from our real world evidence study that people living with this disease are negatively impacted on multiple levels physically mentally socially.

And emotionally.

In fact, 92% of survey responders agree that there is a significant need for new treatments and 96% of responders were hopeful for options with fewer side effects.

Participants in the study were most likely to experience problems with double vision breathing and island Droops severity. We also learned that 42, 4% of participants had depression score high enough to meet the threshold for this diagnosis as well as 52, 4% for anxiety and a separate argentic sponsored patient.

Burden survey, 51% of patients stop working entirely due to their disease.

We have been fortunate enough to spend considerable time with EMG community over the last several years hearing about these challenges we are hopeful that <unk> can be a new treatment option for people living with gmg.

Included there and turn the call back over to Tim for final remarks, Tim. Thank.

Thank you I'd first like to Echo what Keith said.

We are on the precipice of an important moment for our journey.

Our first opportunity to bring in new medicines to people living with Mg and those suffering from in multitude of oversee this autoimmune disease.

This is what motivates us every day.

To summarize we are excited.

And ready for the global launch of adapting them up for the treatment of masking the greatest.

First in the U S then Japan than Europe.

In order to maximize long term value, we auto efficiency developing multiple indications in parallel.

And working with partners, such as <unk> and medicine to accelerate and expand the development and bleach hope its first and potentially best in class assets.

As we grow into a fully integrated global Hematology organization, we have not lost sight of our strong scientific foundation and commitments to 10 states immunology breakthroughs into groundbreaking treatments for patients in need.

This is why we are simultaneously progressing other assets such as our genius <unk> 17, and <unk> hundred 19.

Fueling our long term growth by continually adding new assets to our powerful discovery engine.

Immunology innovation program.

We believe this will provide long term sustainable growth for all stakeholders.

With that I will open up the call now to your questions.

Operator.

Yes.

We will now begin the question and answer session to ask a question you May Press Star then one if youre using a speakerphone. Please pick up your headset before person keeps if at any time. Your question has been addressed and you would like to withdraw your question. Please press Star then two.

In the interest of answering as many questions as possible each person in the queue is limited to one question only at this time, we will pause momentarily to assemble roster.

Continuing to test cartridge amongst some of our indications. So I would say there is nothing more than enough to say that this is one of the sport's study, which is currently rolling out. Thank you.

Our next question comes from James Gordon of Jpmorgan. Please go ahead.

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

One question.

On export pricing.

What is your latest thinking assuming U S approval about how the product could be price is it product, we should think of as being priced similar price to what it would cost to give sort of a unit totaling so not much more than $100000 or could it be more like a $200000 per patient per year product, depending upon how many doses a patient but to get antibodies squeeze in a follow up question just.

Heska ramp and I think some of the comments about needing to J code all.

On the time taken to Ajay I would also like to build awareness of and you might've action that will makes total sense.

In today's comments I think Bloomberg consensus has revenues of 193 million for next year, particularly if I could.

A little bit high given just some of the things we need to bear in mind today is correct.

Would you mind, taking the first question on pricing please.

Thank you.

Happy to do so Tim So James we've been doing homework for quite a while on pricing.

And we've also been looking at IAG.

And if you look at it with the recent price increases that they've taken over the last couple of years the crop the cost of the average cost of chronic IV G treatment for an Mg patient is about $190000 per year and I want to call. That's the average.

Some patients are much more expensive.

We believe that we offer our premium value proposition based on our efficacy our rapid onset of response and our depth of response over that of IV <unk> in <unk>.

Addition, we think we provide greater convenience and overall safety and Tolerability with our individualized dosing schedule. So that's kind of where we are on this with our pricing thoughts and this should be the last earnings call before we can actually disclose price.

Any color you want to comment on the second question. Please.

Thank you James So I'm just going to comment on you said that consensus is under the 93.

I looked at the consensus.

For product revenues et cetera.

$114 million. So that's what I see for consensus for product sales and Im seeing some analysts still have revenue assumptions in the fall.

<unk>, which of course.

Now all being recognized in this year, so I think thats something which in addition, we'll look at as they as they reassign the models okay.

Our next question comes from Danielle Brill with Raymond James. Please go ahead.

Good morning, and thanks, so much for your questions. Ken I was wondering if you could provide some color on the topics that focus and maybe the types of questions posed by the agency dying I think Craig I'll Review meeting and then also curious on.

Given the proximity nature.

Ethylene buying discussions have begun yet thank you.

Neil Thanks for being with us today.

So there's nothing really too much of course, we can still receive is just above the ongoing dialogue.

But we can confirm that the late cycle review meeting was behind us.

I would say it was leaving in London.

Patients and we believe that based on the short discussion.

Companies on fresh with a review of the file.

We got confirmation again.

The leach pad.

<unk> panel.

We did a specific answer questions with the FDA.

Our on site from the fall within the meaning of the funnel, which is something that has been confirmed and therefore based on the description. We believe feels like sort of dilutes updating of December 17.

Thank you for the question.

Our next question comes from <unk> Zhang.

Guggenheim. Please go ahead.

Hey, guys. Thank you for taking my question.

Another question on the on the launch dynamics, So I understand I think the answer to that one meal.

Is likely a function of price and how many cycle a patient can receive so can you just talk about.

Harmony and how should we think about cycles per patient per year and then.

Retail is moving away from <unk>, a few local soliris, let burton.

They added about $7 50 to 800 patients in the first year of launch and obviously you are growing off of a much bigger Tam. So just trying to get a sense that is solely as a good com.

So the reasonable base to build the case, and then sort of more upside.

You expand in other geographies.

Thanks for being with US today and these are two great questions I'm going to do the sort of key three best places to address those.

Yes. Thank you for the question. So when it comes to cycles per patient per year, what we're seeing from the data is the distribution curve. So youre going to have about 50% of patients that are going to be able to take advantages of a substantial period of time off therapy and experience few cycles per year, where we also have part of the popular.

<unk> that it's going to require closer to chronic dosing so I think what the.

How we are discussing this with the payers is they're taking a look at where on that distribution curve do they feel a typical patient will fall realizing that with some of their patient it's going to be relatively low expense for them and with others. It will be more of a chronic dosing and therefore, it would be a higher revenue patient.

For us as far as the read through from.

From the Soliris launch, it's really hard to give a read through because it's not a pure apples to apples comparison.

They do have a broad label, but they are restricted to ask Joe choline receptor positive patients, but the real thing is a lot of the payers have limited them to the severe relapsed refractory and as you know we are targeting a broader audience. So it's difficult to use that as a direct read through.

Just one clarification question on the 20000 addressable patients that you talk about that's a U S number correct.

That's correct that's correct that is the U S.

Yes.

Our next question comes from Joon Lee with <unk>. Please go ahead.

Hi, Thanks for the updates on taking our questions.

<unk> recently published a report, giving <unk> and Cartesian amount of people, but.

Also they concluded that the quality adjusted life years was less about us less than half of that is acquisition that obviously, they made several assumptions, including placeholder for price and not accounting for differences in frequency of dosing or are there other convenience factors, but would love to hear your comments on their findings.

And where you differ from them on the value prop or at customer. Thank you.

Thank you for the question.

I think that we view.

We don't buy.

Those are great opportunities for us to really take a deep dive into our own data and develop the sewage the understanding of.

Our own data and we continue to be very excited about these data.

I think if you look at that.

Frankly, I have been Lithia Sciences, you can see that's typically the conclusions they report on or metal really aligning low for rare disease drugs that consumer pricing.

It looks like their mobiles are leading in Q <unk>.

In our modeling a rare disease, where clients entertainment model sort of seasoned OMG.

As indicated some of the relatives are conclusions about that but in terms of positioning.

Please proceed with some of the other medications.

Including the provisions.

Of these amounts.

One of the things, which really surface from the data is that these.

And as you would look at the subset of patients in the study, which would need to be regained criteria.

Maybe you can keep at the data in the regain lines the population was <unk>.

In line and as strong as it was.

Overall population.

And that also gives us the opportunity to relate back to some of the latest data disclosures, which can have given at the <unk> conference, which was included in the upcoming meetings during the scientific sessions of the Mgsv very excitingly, we see that in the event study.

The effect of mosquito muscles as Portland.

Regardless the number of lines of therapy, given based on gross AUM. So even in the most effective patients we have an equally strong.

But also of course, a different muscle domains.

Regardless, when we talk about <unk> <unk> or.

Lehman gross multifunction, you'll see that and we think that's a particular instance system and strong across the different services of muscles. So.

Great excellent data analysis continue to underpin the strength of our data.

Thanks for the question.

Thank you.

The next question comes from <unk> Ahmed with Bank of America. Please go ahead.

Hi, guys good morning, or good afternoon to you.

And just a quick question I'm sorry, if it's already been asked I joined US just to tap gently, but how our discussions with FDA.

Regarding the application.

Dana Martin empty and half labeling discussion.

Started yet.

Stephen and thanks for joining us.

Colombia, resulting percentage loosely based on the.

The state of affairs, we already inspections.

We hope to file and how the latest cyber leasing leasing has been growing and we think that we are on strike since visibility neutral date of December 17th.

From <unk> point of view, we have to refrain from answering that question.

We will talk about labeling discussions hopefully formulate location, but so far we think the system.

Looking forward. This remains an FDA decision in <unk> NDA will be science. Thank you.

Okay, and then just a follow up on how you think of the market opportunity just not including the products that are on the market now.

Ones that might be coming on at <unk> and in the future for example, I think that.

Regeneron is working on.

Bringing our products into the clinic for <unk>, where do you think the biggest point of differentiation with <unk> for FY <unk> versus anything else that you potentially foresee entering the market. Thank you.

Both of them.

To start the answer to the question, which is a great question. If you look we only have seven class. Two for example complement inhibitors I think we now have an understanding of the biology is such that we do know that the pathogenic autoantibody is exiting upstream of components. So it's actually having multiple pathogenic modes of action on the junction.

Complement recruitment is one of them and I think it is fair to see that our to say that you know the best data show the strength of you know for the power of removing the pathogenic autoantibodies.

Hollywood Chipotle goes above and beyond what we have.

And what we can do.

Now we didn't sit in class I think is the deposit costs and if you look at the safety profile of albacore whereby fog.

And the largest safety data set of all of course healthy volunteers and multiple indications, it's fair to say that some of the safety profile of <unk>.

Emerging as a potential differentiators.

I think they've also put the bar very high when it comes to the efficacy, having an 80% response rates.

The first two cycles.

Cheating almost a 60% Midland symptom expression and then the durability of the effect that that is a very tall bar for other people to come and even tried too much and then on the convenience angle. We do continue to believe that the exclusive sales on license and this is a very.

Convenient <unk> that enables that need again, setting a whole new standards.

Space <unk> municipality.

Efficacy convenience I think be revisiting at Toshiba.

Thanks for the question.

Alright, Thank you Tim.

Our next question comes from Brandon <unk> with Barclays. Please go ahead.

Hi, good afternoon, thanks, very much taking my questions.

Okay clean Frank quick one for me.

In terms of successful <unk> and <unk>.

Targeting banyan.

25 and in fact.

Todays finance, indicating fee in addition to that.

<unk> finance indication and then just thinking about <unk>.

Training teams and network nation, just wondering kind of how that will work.

In fact in foreign buyer, south ore coming into popcorn reinsurance and thinking about what that will have an impact on margin. Thank you.

These are two great questions Keith I will handle the question queue to you in a minute on the infusion network and how that would work.

The <unk> indications the simple answer is that this includes the strategic alliance with <unk> services. The fulfillment of indications, we're going to play in pursuing a range of indications, but also indications pursued by our quality Keith.

Yes, thank you as far as the infusion network goes we're working with a number of providers across the U S and how this is designed as there are certain insurance companies that have preferred.

<unk> infusion providers, and we will be working with them and we also have targeted.

The home infusion centers that currently treat a great deal of neurology patients at home. So it is a broad network because our overall concept here, especially in a COVID-19 environment is as we launch we want to be able to meet.

Patient demand, where it needs to be met and what I mean by that is we will offer through specialty pharmacy, we were offer home infusion, we will offer an office treatment.

We will offer infusion centers, where patients can go be treated so the idea is to make it as convenient as possible.

Yeah.

Great. Thank you very much.

Our next question comes from Jason Butler with JMP Securities. Please go ahead.

Jason you might be music.

Alright, thanks for taking the question.

Just one on Japan.

Reimbursement process can you just talk to us at a high level, how you think about price dynamics versus the U S and also.

The reimbursement process.

Relative to 'twenty reference.

<unk> referenced in Japan. Thanks.

Thank you Jason contributed up to date.

So this is a question for you, though yes, thanks, Kevin and Jason Thanks for the question so as far as the process for reimbursement in Japan in the first thing that we need to do is negotiate price with Japan. That's an ongoing process that takes some time ideally our pricing strategy is to have as close of a tight.

<unk> band.

<unk> the globe, but we will continue to work with Japan and after we have regulatory approval in Japan. It is typically three months later that you get your NHI price.

Them.

So we will we will continue through and the negotiation of.

Of that process with them.

Great. Thanks for taking the question.

The next question comes from Joel <unk> with Citi. Please go ahead.

Hello, Thanks for taking the question further subcutaneous trials underway so Jason.

<unk> and <unk>.

What are your expectations for showing comparable data versus opportunities to show some type of benefit compared to the LNG formulation.

Great question.

Angie situations, we believe that the thousands milligrams flat dose of the Q hasnt almost identical PD effects as do some of the <unk>. So it would actually bring some non inferiority.

This will be measured in the primary endpoint based on percentage as you see the direction and in the secondary endpoints based on improvement of chemical synthesis and expecting equivalents.

The safety and efficacy of course, retaining all the different public presentation, which could be appealing from a convenience point of view to a subset of patients.

Again for ITT CBD queue registration trials for submission we have chosen to do one with the IV product and when we see some key products would again identical to vehicles.

We expect that the total data sets will be consistent between both cities.

Thank you for the question.

Thank you.

The next question comes from Ian <unk> with Wells Fargo. Please go ahead.

Hi, Thanks for taking my questions.

I have two quick ones.

Is it reasonable to assume that the antibody negative patient population that might be one of the topics for labeling discussion and also.

More broadly are you.

To you.

Contemplate any head to head studies with <unk> in.

Some of the.

Indications that you're pursuing.

Ivy.

Proved.

Treatment. Thanks.

Thank you for the question.

Keeping market.

Similar negative questions.

Yes happy to do so if we take a look at the seronegative population I just wanted to call out there.

They were not a part of our phase III study.

But we honored our commitment to the Mg patient community by including the zero negatives in our phase III trial. We did this because of the belief of the impacted <unk> chicken market has on specifically ITG for.

We did in the phase III study and the data that there was a treatment benefit in using <unk>, but I want to call out that the response to placebo was nearly equivalent so the data we saw are not statistically significant.

We continue to look at this group even further.

By not just looking at ADL, but also QM G. We've shared some information on both Mg ADL and <unk> as well as those who achieved MSE. So we've provided all of this data to the FDA, but ultimately this is going to be a decision by the agency.

We're going to keep and then on the second question the level for the current studies. None of these studies are doing head to heads of course against by the AG operating line that in myasthenia gravis <unk> is not approved products in ICT needed in the chronic setting and look for the acute setting.

The <unk> team is in place.

<unk> loans automotive requirement by the FDA to do associated head to head study. These are the <unk> and then in terms of example expensive board idea additional media players.

For the current announced trials, there's no head to head comparison.

While we are warranted.

Grocery set of common yet on future clinical trials, but thank you for the question.

Got it very helpful. Thank you.

Our next question comes from Douglas Tsao with H C. Wainwright. Please go ahead.

Hi, Good morning, Thanks for taking my question I'm, just curious if you have a sense.

Form providers are they going to be treated and just that you have some indications you do achieve sort of minimally.

Simply the expression.

Are they going to be dosing to that level and then just I'm curious do you see in the data patients through chief MSC debate at the same level of durability of response or is when they start to the disease starts to manifest again is it sort of slow progression or participants come on fairly quickly.

It's a great question keeping this as possible to ask Bob to answer the question what are we seeing physicians through Nielsen to MFC.

Sure ultimately, we believe not only physicians are going to want to treat their patients to achieve MSC because im sure. There is a cure, there's really nothing more powerful than being able to walk around with no symptoms and not having to deal with adverse events that are associated with many of the current off label treatments for.

For AMG, we've also met with physicians most recently at <unk>, where we got to meet with them live and ideally they want to put their patient and to MSC and be able to maintain them there.

By the way payers feel the same way because of patient that is not experiencing symptoms.

Standard substantially lower opportunity for wind up being hospitalized for Mg and therefore incurring higher costs. So.

Ultimately the adapt trial you did see MSC, but as you know in the dosing cycles because of how we needed to learn from the trial. We did allow patients to lift back up out of MFC before re dosing I think real world Youre going to see them those patients achieve MSC and then attempt to be maintained there.

We think you're keeping an eye on durability of the effects of course now we have data from two open label extension of our extension studies, taking patients through continued on study.

And what we said earlier in the call was that the ice will be viewed as an opportunity for us to really take a deep dive into the totality of our data and we continue to be excited about the strength of the drugs.

To the data <unk> the only thing we have suddenly consists.

Is that in the second treatment cycle, we've continued to see an equally strong if not stronger than the CV affect patients.

We'll be talking about.

<unk> data loops Lindsay OLED extension studies going forward.

Data to be expected at conferences, most likely next chief Okay.

Okay.

Great. Thank you.

Thank you.

Our next question comes from Charles Pitman with Redburn. Please go ahead.

Hi, Good morning. Good afternoon. Thank you very much for taking my questions I just have two if I may.

Firstly, we've seen a number of delayed decisions due to COVID-19 related manufacturing inspection issues due to regulators and the ability to visit manufacturing facilities.

I'm wondering if you could talk to whether or not this is a risk for the SMB.

And then secondly, just on your partnerships could you give us an indication on the potential approval timelines design lab in China in medicine in Israel, and just to clarify for the Medicine partnership is does this have potential to extend to other indications beyond myasthenia gravis.

Thank you Keith.

I want to give you. The second question on license approval or approval process design and medicine than on the first question will be said publicly is that.

Clinical site inspections have been successfully concluded by the FDA in person.

Net solicit manufacturing side.

Slides are being inspected and currently the Molson.

These earnings.

<unk> switch of a loan to the SBA business has numerous FDA inspections before with a good sector.

And therefore, there is a lot of good likelihood that the manufacturing site inspection, where we basically communicated Morgan. So at this moment I'll just repeat what I said before in this call we cannot see any risks associated with manufacturing site inspections. When it comes to a potential delay of listed.

Recently the December 17.

Thank you.

Keith.

So let's take <unk> first so in regard to XI and the timelines.

We expect that we will make a submission in China that will occur. After we have approval here in the U S and after we've made that submission we expect the review timeline to be approximately one year.

As per the Madison agreement the process and Israel can actually start once we have approval in the U S.

We've done this medicine has been selected on the basis of the reputation and their track record.

As part of our business case on whether to partner Israel.

And we just believed in their capabilities, we've seen their track record of success, there and being able to get patients started just so to give you some reference in Israel from the literature that we can see there is about 500 diagnosed mg patients.

There. So this is.

We expect this to be the first of several distribution agreements that we will be.

<unk> throughout the world.

It's too early to give definitive regions on whether we will be <unk> by ourselves or with a distributor partnership but this is just the first example of one.

Brilliant thank you very much.

Your next call comes from minutes Master Atkins with Deutsche Bank. Please go ahead.

Yes, thanks for taking my question.

Essentially I wanted to ask how important will surpass the and accelerating.

And the uptake.

In 2010.

Okay.

Once it is approved and secondly.

What are the expectations.

Or <unk> deep data next year.

Those are the sub acute products relatively compared to the IV products.

For penetrating other ends in the market.

And then I will take the second question.

That are experiencing <unk> taken them up that I've had the opportunity to meet with are extremely happy with their experience. So I think that because if you think of.

Some of the stats that I quoted in our prepared statements.

51% of people not being able to go to work.

You will gladly go sit down and have an IV, if youre going to be able to improve your quality of life and overall.

You are able to do by taking <unk> IV, we do believe that one sub qs available that there will be.

Where the market will get slightly bigger and.

That is because you do have some patients that just from a convenience point of view or how far they are from a possible infusion site might not go onto therapy, while it's IV, whereas with <unk>. We expect that they are going to be able to self injected home. So I think you will see the overall size of the pie grow once we have the.

Sub Q available for Mg.

At the end of the day, it's about Optionality for the patient to that Optionality for the health care professionals and even like sub Q is available we still expect up to 30% of the patients will remain on IV.

Thank you Keith and then with regards to the ICT question I would like to reset to the phase two results. When we study the phase two.

File, which we published and you can see the sea has quite effective patient populations at home study. So it expected to splenectomy Coca Cola steroids PPL is one of one or more.

And we hear the responses.

46%, so our expectations for the readout of the phase II trials when it comes to the patient population, we will be able to enroll and the likelihood of sponsors as you can see our expectations of comparable activities.

From a product positioning point of view, we are thinking about repositioning right assets. During the first GPO in settlement cycle, the patient to the Mexican the NXT deal, which will be equally successful and it is not not enlightened within central line <unk> and <unk>.

<unk> efficacy competitive climate affected patient population, you're expecting in the phase III.

Thanks for the questions.

This concludes the question answer session. The conference has now concluded. Thank you for attending today's presentation you may now disconnect.

Yeah.