Earnings Call Transcript - ARGX Q3 2021

Tim Van Hauwermeiren, CEO

This might explain why patients often switch between treatments. There is a significant market opportunity with around 16,000 to 17,000 addressable patients in the U.S. alone. We continue to enroll patients in the ADVANCE SUBCU, ADHERE, and ADDRESS trials for ITP, CIDP, and Vulgaris, respectively. As we near completion of enrollment, we will be able to provide more detailed insights into these results. We recently published the full results from the Phase 2 Pemphigus study in the British Journal of Dermatology and encourage you to read the manuscript, which supports our understanding of how Efgartigimod may fit into the treatment paradigm for Pemphigus, considering its fast onset of action, good tolerability profile, and the potential for lower initial corticosteroid doses and early tapering. We are finalizing preparations to begin registrational trials for our newest indications. The Bullous Pemphigoid trial is on track to start by the end of this year, and Myositis is expected to start in the first quarter of 2022, following our FDA consultations. We are also collaborating with Zai Lab to launch proof-of-concept trials for additional indications. While we are not ready to share specific plans, Zai is preparing to start enrolling Chinese patients in our ongoing global clinical trials. I will briefly discuss two other important programs in our pipeline, starting with ARGX-117, our first-in-class C2 inhibitor. We presented Phase 1 data for ARGX-117 during our R&D Day, highlighting why we believe C2 is an optimal target within the complement cascade. Notably, it is upstream of C5, minimizes the impact of the alternative pathway to reduce infection risk, and patients with a C2 genetic deficiency exhibit a milder phenotype compared to those with other complement deficiencies. The Phase 1 data indicated a favorable safety profile for both intravenous and subcutaneous formulations, with pharmacokinetics and pharmacodynamics supporting infrequent dosing. We are on track to initiate the Phase 2 trial in MMN by the end of this year and look forward to discussing additional indications for this pipeline in a product opportunity next year. We also introduced ARGX-119 for the first time during our R&D Day, which is a single antibody focused on enhancing the neuromuscular junction. This is the newest product from our Immunology Innovation Program, and we are eager to share more about it next year. Before I hand the call to my colleagues, I want to take a moment to express my gratitude to our team for their hard work as we enter this exciting new phase for argenx. I especially want to acknowledge Wim Parys, who we announced will retire after three years with argenx in March 2022. In this planned transition, he will join the R&D committee on our Board of Directors, and succession plans are ongoing for Luc Truyen to take on the role in April 2022. We are truly thankful for Wim's significant contributions and humble leadership over the past few years. With that, I will turn the call over to Karl for a financial update.

Karl Gubitz, CFO

Thanks, Tim. Slide 15 covers our 2021 financial results for the 9 months ended September 30, 2021. I will summarize them here, but they are covered 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 $315.1 million as a consequence of a termination of a collaboration agreement with Janssen. Additionally, the closing of a strategic collaboration with Zai Lab resulted in the recognition of $151.9 million in collaboration revenue. R&D expenses increased to $413.3 million compared to $276.4 million in 2020. The increase resulted primarily from higher external research and development expenses, mainly for our Efgartigimod programs. SG&A expenses totaled $210.2 million for the first 9 months of 2021 compared to $113.2 million in 2020. The increase resulted primarily from higher personnel expenses. The change in fair value on non-current financial assets totaled $11.2 million so far this year, which is the result of the closing of a Series B financing round of AgomAb Therapeutics in which we have a profit share. Finally, cash, cash equivalents, and current financial assets totaled $2.53 billion as of the end of September compared to $2 billion on December 31, 2020. I'd now like to turn the call over to Keith Woods to provide an update on our commercial launch preparation.

Keith Woods, CMO

Thanks, Karl. Slide 16, please. We are on track with our preparations for the global launch of Efgartigimod in MG. Based on our December '17 PDUFA date in the U.S., we anticipate an effective launch date in January 2022. In Japan, we anticipate an approval in the first quarter of 2022, followed by a commercial launch 3 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. Slide 17, please. We are also excited to announce that as of today, our U.S. and Japan field teams are fully on board. 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, the team also includes the Regional Business Directors, Nurse Case Managers, case coordinators, medical research liaisons, 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, we know that there are certain aspects that are outside of our control. Mainly, the COVID pandemic continues to create uncertainty for our teams 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 a hybrid approach. We also know that it may still be difficult for patients to easily access the 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 scenarios we are facing, there are additional challenges associated with the first launch of a product. 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 the third quarter of 2022. This may slow things down in the first two quarters with prescribers having to go through a reimbursement appeal process. Second, Efgartigimod will be a first-in-class therapy. Targeting FcRn is 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 payers and educate until they are comfortable with this new, innovative class of medicines. Finally, we are limited in the extent of engagement we can have with stakeholders before actual approval. For these reasons, we continue to believe that we are positioned for a launch with gradual, steady growth, and it will take time to reach the full potential of Efgartigimod in MG. With all this in mind, I want to make it clear that our overall outlook on the potential for Efgartigimod in gMG remains unchanged. We know that this community is in need of alternative options and that we have a compelling value proposition based on the strong ADAPT data, the potential for individualized dosing, having both IV and subcutaneous formulations, and our growing safety database. Slide 18, please. In summary, we are excited and prepared for the global launch of Efgartigimod 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 eyelid droop severity. We also learned that 42.4% of participants had depression scores high enough to meet the threshold for this diagnosis, as well as 52.4% for anxiety. In a separate argenx-sponsored patient burden survey, 51% of patients stopped working entirely due to their disease. We have been fortunate enough to spend considerable time with the MG community over the last several years. Hearing about these challenges, we are hopeful that Efgartigimod can be a new treatment option for people living with gMG. I'll conclude there and turn the call back over to Tim for final remarks.

Tim Van Hauwermeiren, CEO

Thank you. I'd first like to echo what Keith said. We are on the precipice of an important moment for argenx, our first opportunity to bring in new medicine to people living with MG, and those suffering from a multitude of other serious autoimmune diseases. This is what motivates us every day. To summarize, we are excited and ready for the global launch of Efgartigimod for the treatment of myasthenia gravis, first in the U.S., then Japan, then Europe. In order to maximize long-term value, we are efficiently developing multiple indications in parallel and working with partners such as Zai and Medicine to accelerate and expand the development and reach of its first and potentially best-in-class assets. As we grow into a fully integrated global immunology organization, we have not lost sight of our strong scientific foundation and commitments to translate immunology breakthroughs into groundbreaking treatments for patients in need. This is why we are simultaneously progressing other assets, such as ARGX-117 and ARGX-119, and fueling our long-term growth by continually adding new assets to our powerful discovery engine, the 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, Operator

Our first question comes from Akash Tewari with Jefferies.

Akash Tewari, Analyst

Have any of your sites from Vetter, Lander, or Cardinal been inspected, either in-person or remotely by the FDA heading into your December PDUFA decision on Efgartigimod? And just if I can take this in, what's the rationale for you initiating trials that are exploring other dosing regimens in gMG? Was that a decision based on doctor feedback or agency feedback?

Tim Van Hauwermeiren, CEO

Thank you, Akash. Thanks for the question. So first question, the manufacturing sites are currently being inspected by the FDA remotely. And remember, these are sites which are very well-known to the FDA. These are sites which have been inspected in the past on numerous occasions, and notable products are being manufactured there, which are FDA approved. So that is ongoing, and we think we're on track. You see on clinicaltrials.gov one of hopefully many Phase 4 studies, we'll continue to Efgartigimod in some of our indications. So I would say there's nothing more or nothing less to say than this is one of the Phase 4 studies we are currently rolling out.

Operator, Operator

Our next question comes from James Gordon with JP Morgan.

James Gordon, Analyst

One question was about Efgartigimod pricing. What is your latest thinking regarding how the product could be priced, assuming U.S. approval? Is it likely to be priced similarly to immunoglobulin at around $100,000, or could it be priced closer to $200,000 per patient per year depending on the number of doses? Also, regarding the ASCO discussion, I noticed the comments about needing a J Code and the time it takes to obtain one, as well as the need to raise awareness of a new mode of action. In light of those comments, I see that Bloomberg consensus has projected revenues of $193 million for next year for the group overall. Could that estimate be a bit higher considering the factors we need to keep in mind for ASCO?

Keith Woods, CMO

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 IVIg and if you look at it with the recent price increases that they've taken over the last couple of years, the average cost of chronic IVIg treatment for an MG patient is about $190,000 per year. And I want to call out, that's the average. Some patients are much more expensive. We believe that we offer a premium value proposition based on our efficacy, our rapid onset of response, and our depth of response over that of IVIg. In 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.

Tim Van Hauwermeiren, CEO

Maybe Karl, you want to comment on the second question, please?

Karl Gubitz, CFO

Thank you, James. I want to address the point you made about consensus being below $193 million. From my perspective, the consensus for product revenues appears to be around $140 million. This is the figure I'm seeing for product sales. Some analysts may still have revenue estimates related to closure included, which has already been recognized this year. I believe this is an aspect analysts will consider as they adjust their models. Thank you.

Operator, Operator

Our next question comes from Danielle Brill with Raymond James.

Danielle Brill, Analyst

Tim, I was wondering if you could provide some color on the topics of focus and maybe the types of questions posed by the agency during your late-cycle review meeting. And then also curious, given the proximity to the PDUFA date as labeling discussions have begun yet?

Tim Van Hauwermeiren, CEO

Thank you for being with us today, Danielle. While we can't share too much about our ongoing discussions with the FDA, I can confirm that the late-cycle review meeting has concluded. It went as we expected, and based on our brief discussion, we feel the company is progressing well with the review. We received confirmation that there is no need for another 5-day panel. We directly asked the FDA if we are on track regarding the review, and they affirmed that. Consequently, we believe we remain on schedule for the PDUFA date of December 17. Thank you for your question.

Operator, Operator

Our next question comes from Yatin Suneja with Guggenheim.

Yatin Suneja, Analyst

Another question about the launch dynamics. I understand that revenue is likely influenced by price and the number of cycles a patient can undergo. Could you elaborate on the expected cycles per patient per year? Additionally, shifting away from revenue, regarding Soliris, they added approximately 750 to 800 patients in their first year after launch. Considering you are targeting a significantly larger total addressable market, I'm trying to determine if Soliris is a reasonable benchmark to use for building a case, with potential for growth as you expand into other regions.

Tim Van Hauwermeiren, CEO

Yatin, thanks for being with us today, and these are 2 great questions. I'm going to give the floor to Keith who's in the best place to address those. Keith?

Keith Woods, CMO

Thank you for the question, Yatin. Regarding cycles per patient per year, the data reveals a distribution curve. Approximately 50% of patients will benefit from significant time off therapy and experience fewer cycles per year, while some patients will need more consistent dosing. Our discussions with payers focus on where they believe an average patient will fall on that curve, understanding that for some patients, costs will be fairly low, whereas others will require ongoing treatment, resulting in higher revenue for us. Relating this to the Soliris launch, it's not a straightforward comparison. While Soliris has a wide label, it is limited to acetylcholine receptor-positive patients. Moreover, many payers restrict it to those with severe relapsed refractory conditions. In contrast, we are aiming for a broader patient population, making it challenging to draw direct parallels.

Yatin Suneja, Analyst

Just one clarification question. The 20,000 addressable patients that you talk about, that's a U.S. number, correct? in gMG?

Keith Woods, CMO

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

Operator, Operator

Our next question comes from Joon Lee with Truist.

Joon Lee, Analyst

Thanks for the update. ICER recently published a report evaluating eculizumab and gave it a B+, while Efgartigimod received a C+. They also concluded that the quality-adjusted life years for Efgartigimod was less than half of that for eculizumab. They based their findings on several assumptions, including a placeholder for price and not considering the differences in dosing frequency and other convenience factors. I would appreciate your insights on their findings and where your views differ regarding the value proposition of Efgartigimod. Thank you.

Tim Van Hauwermeiren, CEO

Joon, thank you for the question. I think that review done by ICER was a great opportunity for us to really take a deep dive into our own data and develop the fullest understanding of our own data, and then we continue to be very excited about this data. And I think if you look at the track record and history of ICER, you can see that typically the conclusions that they report on were never really aligning well for rare disease drugs from a pricing point of view. So it looks like their models are not really in queue with modeling a rare disease drug like Efgartigimod for treatment of MG. We did agree with some of their relative conclusions, however, in terms of positioning vis-à-vis some of the other medications, including eculizumab. And one of the things which really separate us from the data is that if you would look at the subset of patients in the ADAPT study, which would need to regain criteria, you would basically see that the data in the regain light population was in line and as strong as it was in the overall population. And that also gives me the opportunity to relate back to some of the latest data disclosures, which we have given at the EMEM conference, for which we won't give any upcoming reasons during the scientific session of the MGFA. Very excitingly, you see that in the ADAPT study, the effect of Efgartigimod was as potent regardless of the number of lines of background therapy the patient was on. So even in the most refractory patients, we have an equally strong effect, but also across the different muscle domains. So regardless when we talk about ocular, bulbar, respiratory, or limb and growth multifunction, you see that the effect of Efgartigimod is consistent and strong across the different subsets of muscles. So I thought a great further data analysis continuing to underpin the strength of our data. Thanks for the question.

Operator, Operator

The next question comes from Tazeen Ahmad with Bank of America.

Tazeen Ahmad, Analyst

Tim, just a quick question. I'm sorry if it's already been asked. I joined just a tad bit late. But how are discussions with FDA going regarding the application for Efgartigimod and MG and have labeling discussions started yet?

Tim Van Hauwermeiren, CEO

Tazeen, yes, we did cover the FDA topic very briefly based on the status of our reality inspections, the review of the file, and how the late-cycle of each region has been growing. We think that we are on track vis-à-vis the PDUFA date of December 17. And from a labeling discussion point of view, we have to refrain from answering this question. We will talk about labeling discussions hopefully on a later occasion. But so far, we think everything's on track. Ultimately, of course, this remains an FDA decision and only the FDA will decide. Thank you.

Tazeen Ahmad, Analyst

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, but ones that might be coming on for MG in the future. So for example, I think that Regeneron is working on bringing a product into the clinic for MG. Where do you think the biggest point of differentiation will be for Efgartigimod versus anything else that you potentially foresee entering the market? Thank you.

Tim Van Hauwermeiren, CEO

Thank you for your question. To address the query, if we consider areas beyond the FcRn class, such as complement inhibitors, we have gained insights into the biology indicating that the pathogenic autoantibody influences processes upstream of complement. This results in various pathogenic actions at the junction, with complement recruitment being one of them. The ADAPT data highlights the efficacy of eliminating pathogenic autoantibodies, suggesting this benefit extends beyond what complement blockers can offer. Within the FcRn class, we have set a high standard. Our drug's safety profile stands out, supported by the most extensive safety data from healthy volunteers across multiple indications. Efgartigimod's safety profile seems to be becoming a key differentiator. We've also established rigorous benchmarks for efficacy, boasting an 80% response rate in the first two cycles and achieving nearly 60% minimum symptom reduction, coupled with notable durability of effects—these are significant challenges for competitors. Additionally, our exclusive Halozyme license allows for convenient subcutaneous dosing, establishing a new standard for treatment in MG. Overall, in terms of safety, efficacy, and convenience, we are indeed setting a high bar. Thank you again for your question.

Operator, Operator

Our next question comes from Rosie Turner with Barclays.

Rosie Turner, Analyst

I have two quick questions. Regarding the 15 indications and your target timeline of 2025, do those Zai Labs indications count as part of that total or are they additional? Also, I'm curious about the at-home infusion network you mentioned. How is that going to function? Will it be managed by your team or can that responsibility be transferred to the insurers? I'm also interested in how this might affect your margins.

Tim Van Hauwermeiren, CEO

These are 2 great questions. Keith, I will hand over question 2 to you in a minute on the infusion network and how that would work. On the 15 indications, the simple answer is that it does include the strategic alliance with Zai Lab. So this is a totality indication bringing into play, pursuing our own indications but also indications pursued by our partners. Keith?

Keith Woods, CMO

Yes. Thank you. As far as the infusion network goes, we are working with a number of providers across the U.S., and how this is designed is there are certain insurance companies that have preferred home infusion providers, and we will be working with them. 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 environment, is as we launch, we want to be able to meet the patient demand where it needs to be met. And what I mean by that is we will offer through specialty pharmacy, we will offer home infusion, we will offer in-office treatment, we will offer infusion centers where patients can go be treated. So the idea is to make it as convenient as possible.

Operator, Operator

Our next question comes from Jason Butler with JMP Securities. Jason, you might be muted?

Jason Butler, Analyst

Just one on Japan and the reimbursement process there. 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 any relevant reference in Japan? Thanks.

Tim Van Hauwermeiren, CEO

Jason, thanks for being with us today. Keith, this is a question for you, right?

Keith Woods, CMO

Yes. Thanks, Tim, and, Jason, thanks for the question. So as far as the process for reimbursement in Japan is, 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 pricing band across the globe, but we will continue to work with Japan. And after we have regulatory approval in Japan, it is typically 3 months later that you get your NHI price from them. So we will continue through the negotiation of that process with them.

Operator, Operator

The next question comes from Joel Beatty with Citi.

Joel Beatty, Analyst

For the subcutaneous trials underway, such as in MG and ITP, what are your expectations for showing comparable data versus opportunities to show some type of benefit compared to the IV formulation?

Tim Van Hauwermeiren, CEO

Great question. In this situation, we believe that 1,000 milligram for a dose of subcu has an almost identical PD effect as the 70 milligrams IV. So we're actually going from non-inferiorities, and that will be measured in the primary endpoint based on percentage IgG reduction and in the secondary endpoints based on the improvement of clinical symptoms. We've been expecting equivalents at safety and efficacy. Of course, we're aiming for a different product presentation, which could be appealing from a convenience point of view to a subset of patients. Again, for ITP, we've multiple registration trials queued for submission. We've chosen to do one with the IV product and one with the subcu product, but again, we expect that the total data sets will be consistent between both studies. Thank you for the question.

Operator, Operator

The next question comes from Yanan Zhu with Wells Fargo.

Yanan Zhu, Analyst

I have 2 quick ones. Is it reasonable to assume that the antibody-negative patient population might be one of the topics of labeling discussion? And also, more broadly, do you contemplate any head-to-head studies with IVIg in some of the indications that you're pursuing, where IVIg is an approved treatment?

Tim Van Hauwermeiren, CEO

Thank you for the question. Keith, you want to take the seronegative question, please?

Keith Woods, CMO

Yes, happy to do so. If we take a look at the seronegative population, I just want to call out that they were not a part of our Phase 2 study, but we honored our commitment to the MG patient community by including the seronegative in our Phase 3 trial. We did this because of the belief in the impact that Efgartigimod has on specifically IgG-4. We did in the Phase 3 study see in the data that there was a treatment benefit in using Efgartigimod, 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 QMG, we've shared some information on both MG-ADL and QMG as well as those who achieved MSE. So we have provided all of this data to the FDA. But ultimately, this is going to be a decision by the agency.

Tim Van Hauwermeiren, CEO

Thank you, Keith. Regarding the second question, none of the current studies are directly comparing our treatment against IVIg. It's important to note that IVIg is not an approved product for myasthenia gravis. In the case of ITP, our focus is on the chronic setting rather than the acute setting where IVIg is typically used. For CIDP and myositis, the FDA did not require a head-to-head study with IVIg. Additionally, IVIg is not a relevant treatment for Pemphigus vulgaris. Therefore, the current trials do not necessitate any head-to-head comparisons. As for future clinical trials, we cannot provide any comments at this time. Thank you for your question.

Operator, Operator

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

Douglas Tsao, Analyst

I'm curious about how providers are approaching treatment given the high number of patients. Are they administering treatment at a minimal level based on symptom expression? Additionally, in the data, do patients who reach maintenance of stable effectiveness achieve lasting responses in the same way, or when the disease reemerges, do symptoms develop gradually or appear suddenly?

Tim Van Hauwermeiren, CEO

It's a great question. Keith, are you comfortable answering whether we think physicians will dose onto MSE?

Keith Woods, CMO

Sure. We believe that physicians will want to treat their patients to achieve minimal symptom expression, as there is currently no cure for the disease. Having no symptoms and avoiding adverse events from many off-label treatments is very powerful. We recently met with physicians at AANEM, and they expressed a desire to maintain their patients in minimal symptom expression. Payers share this perspective, as patients without symptoms have a significantly lower chance of being hospitalized for the disease, which reduces overall costs. In the ADAPT trial, we did observe minimal symptom expression, but due to the learning process from the trial, we allowed patients to come out of that state before redosing. In real-world scenarios, we expect to see those patients achieve minimal symptom expression and efforts to maintain that status.

Tim Van Hauwermeiren, CEO

Thank you, Keith, and then on durability of the effects. Of course, now we have data from 2 open-label expansions or expansion studies taking patients 2 to 3 years on study drug. And what we said earlier in the call is that the ICER was 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 drug through that data review. The only thing we have publicly said is that in the second treatment cycle, we continue to see an equally strong and not stronger MCE effect in our patients. We will be talking about interim data looks in the open-label expansion studies going forward, but that is data to be expected at conferences, most likely next year, okay?

Operator, Operator

Our next question comes from Charles Pitman with Redburn.

Charles Pitman, Analyst

I just have two, if I may. Firstly, we've seen a number of delayed PDUFA decisions due to COVID-related manufacturing inspection issues due to regulators' inability to visit manufacturing facilities. I was just wondering if you could talk to whether or not this is at risk for the 17 PDUFA date? And then secondly, just on your partnerships, could you give us an indication on the potential approval timelines for Zai Lab in China and Medicine in Israel? And just to clarify, for the Medicine partnership, does this have the potential to extend other indications beyond marginal prowess? Thanks.

Tim Van Hauwermeiren, CEO

Thank you. Keith, I want to give you the second question on likely approval or approval process for Zai and Medicine. And on the first question, what we said publicly is that clinical site inspections have been successfully concluded by the FDA in person. The selected manufacturing sites are being inspected currently remotely. These are facilities which are known to the FDA. They have had numerous FDA inspections before with a good track record. And therefore, there's a good likelihood that the manufacturing site inspection will basically happen completely remotely. So at this moment, I'll just repeat what I said before in this call, we cannot see any risk associated with manufacturing site inspection when it comes to a potential delay of the PDUFA date of December 17. Thank you. Keith?

Keith Woods, CMO

Let's start with Zai. Regarding the timelines, we anticipate making our submission in China after receiving approval in the U.S. Once we submit, we expect the review time to be about one year. Concerning the Medicine agreement, we can initiate the process in Israel once we have U.S. approval. We chose Medicine based on their reputation and proven success. This is part of our business case for partnering in Israel, and we have confidence in their abilities based on their history of success in getting patients started. For context, there are approximately 1,500 diagnosed MG patients in Israel according to available literature. We foresee this being the first of several distribution agreements we will establish globally. It's still too early to determine definitively whether we will operate alone or with a distribution partner, but this is our first example.

Operator, Operator

Next call comes from Emmanuel Papadakis with Deutsche Bank.

Emmanuel Papadakis, Analyst

Essentially, I wanted to ask how important will subcutaneous be in accelerating MG uptake in 2023 once it is approved. And secondly, what are the expectations for ITP data next year relative to the current standard of care and its likely clinical positioning?

Tim Van Hauwermeiren, CEO

Thanks for these 2 excellent questions. Keith, why don't you go ahead and talk about how you look at the importance of the subcutaneous products compared to the IV products for penetrating our engine market, and then I will take the second question, okay?

Keith Woods, CMO

Sure. I'd like to first call out that IV Efgartigimod for MG patients is meeting a substantial unmet medical need. And patients that are experiencing Efgartigimod, 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 steps that I quoted in the prepared statements of 51% of people not being able to go to work, you will gladly go sit down and have an IV if you're going to be able to improve your quality of life and overall, what you're able to do by taking Efgartigimod IV. We do believe that once subcutaneous is 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 on to therapy, while its IV, whereas with subcutaneous, we expect that they are going to be able to self-inject at home. So I think you will see the overall size of the buy grow once we have the subcutaneous available for MG. At the end of the day, it's about optionality for the patients. It's about optionality for the health care professionals. And even when subcutaneous is available, we still expect up to 30% of the patients will remain on IV.