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 call. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question-and-answer session. If you'd 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. Thank you. I'd like to introduce Beth DelGiacco, Vice President of Corporate Communications and Investor Relations. You may now begin your conference.
Thank you, operator. A press release was issued earlier today with our first half 2022 financial results and second quarter business update. This can be found on our website along with the presentation for today's webcast. 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 those statements in relation to actual results unless required by law. I'm joined on the call today by Tim Van Hauwermeiren, Chief Executive Officer, Karl Gubitz, Chief Financial Officer, and Keith Woods, Chief Operating Officer. I'll now turn the call over to Tim.
Thank you, Beth, and welcome everyone. We are just halfway through 2022, and it has already been a year of incredible execution by our team outlined on slide three. We are delivering on two commercial launches, one in the United States and one in Japan, and are now looking ahead to broaden the global reach of VYVGART. We had two positive phase III data readouts in the first half and are positioned for the series of trial starts and additional data readouts over the next 18 months. We were able to finance our ambitious business plan in a difficult market environment. We live by our reputation for execution, so I want to start by saying thank you to the Argenx colleagues for their thorough preparation and steadfast determination to achieve our goals. To our stakeholders, our shareholders, our physician partners, and of course our patients.
To begin, the second quarter of our VYVGART launch showed significant growth from the first quarter with global net product sales of $75 million. We will expand on our progress across our patients, physician, and payer segments later in the call, but at a high level, I'm really happy with the team's hard work. They were well prepared going into approval with carefully crafted strategies and continued to execute on them. A few highlights to point out on slide number four. Our market access team delivered what they promised and secured broad coverage in the first two quarters of launch. This was crucial in converting physician prescriptions to patients on therapy. We are getting regular feedback from physicians and patients on their experience with VYVGART, which, while anecdotal, aligns with data from the ADAPT trial, including on the fast onset of action and minimal symptom expression.
MSE was an exploratory endpoint in our trial to the metric that is growing in importance among neurologists because of its practical meaning for patients. This feedback is also in line with what we hear from gMG patients and their advocates on the significant unmet need that still exists. We have learned firsthand and through our outcomes research what a devastating and debilitating disease gMG can be. With its novel mechanism of action, VYVGART has the potential to transform the treatment landscape and significantly improve patients' lives. Hearing stories from patients who are already experiencing this benefit has been the most rewarding part of the last six months. I am equally very proud of our ongoing commitment to be leaders in FcRn, not only from the commercial side, but also the scientific.
Our approach starts with solid science and is backed by strong data, and we continue to draw on this to further elucidate FcRn biology and how best to modulate it. We believe our science-based approach will remain a powerful tool as we engage with our key stakeholders. Beyond the good news of our launch, we have had other accomplishments this year across our efgartigimod program. Our ambition is to reach many more patients suffering from autoimmune diseases through our SubQ product launch and label expansions. Slide five. In March, we delivered positive phase III data from our ADAPT SubQ trial. Recall that we had to show non-inferiority of SubQ to IV based on IgG reduction and meet safety database requirements. We have accomplished both, putting us firmly on track to file the BLA by end of the year. Slide six.
In May, we announced positive phase III data from our ADVANCE IV trial. We met a very difficult primary endpoint in a highly refractory ITP patient population. In ITP, efgartigimod showed a consistent response profile as we've seen in other indications. A fast onset of action and patients with sustained responses who were able to switch to every other week dosing. We have gotten feedback from physicians on the data and continue to hear about the importance of the IWG score in how they treat patients. We saw a 51% response rate on the IWG scale, where patients had to show a sustained platelet count over 30,000 and in the absence of any bleeding events for two separate consecutive weekly visits. Safety profile of VYVGART in this chronic dosing setting was also consistent with previous clinical trials. Slide seven.
We promised that we would look at key learnings from ADVANCE and apply them to our ongoing ADVANCE-SC study. We did this and have made a data-based decision to adjust our powering assumptions and expand enrollment in the ADVANCE-SC trial. This pushes the timing of top-line data to the second half of 2023, which we believe is in the best interest of ITP patients. We are set up for a very busy 2023. We expect top-line CIDP data in the first quarter and PV and ITP data in the second half. Before I turn the call over to Karl for our financial results, I want to briefly talk about OncoVerity on slide eight. We announced this morning in our press release that we decided to take the company creation approach to advanced development of cusatuzumab in AML patients.
Here is why we think this is the right decision for us, for the drug, and for patients. We have the unique and exciting opportunity to take the novel translational biology insights from Dr. Clayton Smith at the University of Colorado and combine them with our first-in-class asset, cusatuzumab. Dr. Smith and team have uncovered important insights on the role of the CD70/CD27 pathway in AML, and more specifically, in venetoclax non-responsiveness or resistance, which we think will complement the encouraging data we have already demonstrated in newly diagnosed AML patients unfit for chemotherapy. We believe the data we have shown to date warrant further development of cusatuzumab. Through OncoVerity, this work will happen in an organization that has the expertise and the bandwidth to devote the right time and resources to this opportunity. This is the best decision for AML patients.
OncoVerity is also the fourth company to emerge of our discovery engine, where we have built a company around a promising asset while taking a stake in the development. This strategy requires minimum financial commitment and allows us to maintain significant value creation potential for our shareholders. Between our commercial launch, our progress in R&D, and our commitment to immunology innovation, we are off to a strong start for 2022. Our focus going forward will be about continued execution and sustained growth and expansion. With that, I will turn the call over to Karl.
Thank you, Tim. Our first half and second quarter 2022 results are detailed in our press release from this morning, so I will only highlight the key points here on slide nine. For the second quarter, our global net product revenues from the VYVGART launch were $74.8 million, which includes $1.5 million from Japan and some named patient sales from Israel. Together with the $21 million from the first quarter, this puts our year-to-date global product revenues at $96 million. Inventory in the channel at quarter end was well managed and reflects less than two weeks' worth of sales. Total revenues for the quarter were $85.2 million, which also includes $10 million in collaboration revenue and other operating income. Cost of sales for the quarter were approximately $5 million.
Total R&D and SG&A expenses for the second quarter were approximately $126.9 million and $127.8 million, respectively. These can mainly be attributed to efgartigimod and other pipeline research expenses, as well as marketing and headcount expenses related to our global launch. On our cash, we ended the second quarter with $2.6 billion in cash equivalents, and current financial assets. This includes net proceeds of $761 million from our March financing. We continue to believe that our net cash burn this year will be up to $1 billion, which will specifically support the rollout of our global launch, clinical development of efgartigimod in 10 indications and ARGX-117 in two indications, investment in the global supply chain, and pipeline expansion through our immunology innovation program.
Our business plan is an ambitious one, so we were very happy to be able to bring in the additional capital earlier this year to sustain our ability to drive considerable value for our shareholders. You can find additional details behind these numbers in the press release we issued this morning. I'll now hand the call to Keith for a commercial update.
Thanks, Karl. Slide 10. We are very happy with the continued momentum this quarter with our VYVGART launch, driven by consistent growth in both patient and physician demand. The first six months of a launch are crucial in building the right foundation for the product. I am incredibly proud of the team for their demonstrated commitment to getting us off to a strong start. While we are still in the early days, we are seeing positive signals across each of our stakeholder groups, all of which were key drivers in the $75 million in revenue we generated this quarter. Let's start with patients. Slide 11. We currently have approximately 1,400 patients on therapy globally, which translated to over 1,000 new patient adds in the second quarter. This number includes initial contribution from the first six weeks of the Japan launch.
I was grateful to spend time in Japan with our commercial team and engage with some of our key customers. Overall, we are very pleased with the strong start. We had patients on therapy within the first week, including seronegative patients who benefit from the broader label in Japan. Looking at the types of patients who are going on VYVGART, it remains similar to last quarter. Of the 1,400 patients, about 50% have experience with IVIG, while the other 50% have experience across the treatment paradigm from as early as just Mestinon or steroids, or other biologics. This was a tremendous result from both our field team's engagement with physicians and patients asking about VYVGART by name. It was a true multi-channel approach and also the outcome we had hoped for by empowering patients.
The second quarter was one of extraordinary growth in terms of patient adds, but we expect to see more of a balance between repeat and new patients going forward. The reason being that most patients on VYVGART to date have IVIG or other biologic experience. We are closely watching whether we can gain broad adoption earlier in the treatment paradigm because this will be an important driver of our overall launch trajectory. Before I move on to physicians, I want to share some of the health economics outcomes research we gathered. This reinforces the potential value proposition of VYVGART to gMG patients. First, the majority of patients when entering into the ADAPT study reported issues with mobility, self-care, and completing their usual daily tasks. Often, these challenges were accompanied by pain, discomfort, anxiety, and depression.
From the early data we gathered, gMG patients in ADAPT experienced rapid and substantial improvement in health-related quality of life following VYVGART treatment. At peak response, patients approached the quality of life of the general population. Additionally, we know that hospitalizations can pose a significant burden on gMG patients. In ADAPT, VYVGART-treated patients experienced a 67% lower risk of gMG-related hospitalization than placebo. Overall, it's very rewarding to hear this initial research showcasing another aspect of the value proposition of VYVGART to gMG patients. Moving on to physicians on slide 12. We see that our messages are resonating with physicians. The strength of the ADAPT data in driving robust and deep responses combined with our favorable safety profile. With our launch strategy, we made a commitment to market from the science and stay data-driven.
This is paying off, and physicians are showing increased awareness on the mechanism and action of FcRn and the mechanism of disease of gMG as being antibody-driven. We are seeing breadth in physician prescribers, but also depth from some early adopters. One of the drivers of the breadth we are seeing is that our sales team is focused on and allocated resources to our top priority targets. Our goal is for these early prescribers to share their experience with colleagues and peers. In looking ahead to upcoming quarters, the big unknown with our physicians is going to be driving that adoption curve. At this stage, 78% of our prescribing physicians have written one or two scripts, so shifting these prescribers from initial use to broad adoption is going to be a key indicator in our launch growth trajectory.
Finally, I'd like to cover the excellent work that's being done by our market access team on slide 13. We continue to have constructive conversations with payers, and as we committed last quarter, we have achieved broad coverage. VYVGART-specific policies have been published in Medicare and commercial plans covering almost 85% of covered lives. The majority of these policies are favorable and aligned to the VYVGART label. Patients need to fail only Mestinon or steroids to gain access, and approvals are typically for six to 12 months at a time. Our J-code went into effect on July 1st as expected, which we believe will facilitate a more seamless conversion from enrollment to infusion and give confidence to some prescribers that the process should be straightforward. Moving on to the progress of our global launch on slide 14.
The team in Europe is ready to go after receiving a positive CHMP opinion last month. We expect a decision next month and will first prioritize Germany, where we can book revenues while we go through the AMNOG process and work to obtain reimbursement. We have broad commercial infrastructure in place across Europe, including France, Benelux, Italy, Spain, and also the U.K. We are building infrastructure in Canada to support a filing and potential approval with Health Canada. Our partner, Zai Lab, filed for approval in China, and the filing was accepted earlier this month. We continue to look at distributor arrangements in other geographies beyond those we have in place. In fact, we already saw some named patient sales this quarter in Israel through our partner InMedica. To conclude, on slide 15, I'm really pleased with where we stand after six months of launch.
We see strong signals across all of our initial launch priorities to empower patients, provide best-in-class patient support, drive rapid HCP adoption, and enable appropriate access. It is still early days, though, and the same unknowns we outlined from last quarter are still at play. First, we're in a unique situation where a competitive product launched just five months after us, and we still do not yet know the impact of this. We still have patients primarily on their first and second cycles, so it's too soon to understand dropout rates or how individualized dosing will play out over longer periods. I can say with certainty that our team has built a strong foundation for success, and we are determined to build upon this.
We are not satisfied with the 1,400 patients, but thinking about the total number of gMG patients globally that would benefit from a new therapy. This is what is driving each of us each day to be out there engaging with physicians and working hard on behalf of patients. I'll now turn the call back to Tim to conclude.
Thanks, Keith. Before we open up the call to your questions, I would like to conclude on slide 16 with the following. In the first half of 2022, we have delivered on a number of commercial, regulatory, and clinical achievements. As we look ahead for the next 12 - 18 months, we are focused on achieving the multitude of goals we have set. Continue to reach gMG patients with VYVGART. This is why we come to work every day to be able to improve the lives of patients and deliver solutions to those who need them. Bring more optionality to the gMG community with our Project SubQ product launch. Advance our best-in-class FcRn pipeline with phase III data readouts of efgartigimod in three indications next year.
Expand our next pipeline in a product opportunity with our first-in-class C2 inhibitor, ARGX-117, and further develop our earlier assets that have emerged from our unique discovery engine, including ARGX-119. We have an outstanding team that continues to execute on these plans and a strong balance sheet to support our ambitious goals. It is our hope that by leading with science and building Argenx into the next great immunology company, we can continue to reach patients in need and create long-term value for all stakeholders. With that, we can begin the Q&A. Operator?
At this time, I would like to remind everyone in order to ask a question, press star, then the number one on your telephone keypad. We ask that you please limit yourself to one question and then rejoin the queue for further questions. We'll pause for just a moment to compile the Q&A roster. Your first question comes from the line of Danielle Brill from Raymond James. Your line is open.
Hi, guys. Good morning. Congrats on the strong quarter, and thanks so much for the question. I guess, Keith, you mentioned that you expect more of a balance with repeat and new patients moving forward. Can you elaborate a bit on that? I'm just trying to I know you said that it's too soon to understand dropout rates, but qualitatively, like, can you provide some color on whether you're seeing the patients that began treatment in Q1 returning, and any additional insights on a potential bulge effect here? Thank you.
Danielle, this is Tim speaking. Thank you for joining us on the call. Keith, I think this is a question straight in your camp, right?
Yeah. Danielle, thanks for the question. What I can tell you is that we do have the majority of patients that have had completed one round of therapy. This is to be expected, considering that, you know, 1,000 of the 1,400 patients globally were added in the second quarter. We do have quite a few patients now who have gone on to complete a second round of therapy. Most of these are patients that did start, in fact, in the first quarter. There's a small handful of patients, Danielle, that where physicians have taken a more aggressive approach of four weeks on, four weeks off. We have a handful of patients that have actually gone through three cycles already.
We are seeing a return of patients, and that's what I meant by the statement of a mix of repeat patients and new adds moving forward.
Got it. Thank you so much.
Thanks, Keith.
Your next question comes from the line of Yaron Werber from Cowen. Your line is open.
Great. Thanks for taking my questions and congrats on a very strong launch. Maybe just, as a quick follow-on to Danielle's question, are you expecting that most patients are gonna do an individual treatment approach or sort of the cycles on/off? Secondly, do you expect? I saw you only did $1.5 million in Japan, so the most of the number obviously is in the U.S. Are you expecting some kind of an upfront channel sale as you normally see in Japan? Thank you.
Hey, Yaron. Thanks for joining us this morning and for your great question. Before I hand over the word to Keith, I want to remind everyone of the fact that myasthenia gravis is what we call a snowflake disease. Each and every patient is experiencing his or her disease in their own unique fashion. There is no one-size-fits-all, and maybe Keith, this is a good point for you to continue the answer. Right?
Yeah. Yeah, very. Thank you for the question. First of all, we expect that you're gonna see a variety. Number one, we see patients that are going on cycled therapy, individualized treatment, and as Tim mentioned, every single MG patient is different. We have some patients who have received one cycle and are still maintaining a great response. We have others that I mentioned are being treated a little bit more aggressive. The bottom line is, in the real world, it's not about a two-point drop in MG-ADL like it is in a clinical trial. It's getting patients to minimal symptom expression to where they can walk around and live a normal life like the rest of the general population. When we say individualized dosing, it is truly gonna be that moving forward.
I think you can see some of the comments that patients have made that are enjoying this because they don't wanna go back in for treatment when they're feeling perfectly fine. We expect this trend to be continuing, and as physicians get more comfortable with the drug, I think you'll see a variety of approaches around the cycling of individualized and some that might go to a little bit more chronic.
Thank you, Keith. I would like to hand over to Karl for the Japan-related question.
Thank you for the question. The question was relating to inventory in Japan. Our supply chain in Japan, we recognize revenue when the wholesalers ship to hospitals. The wholesaler doesn't carry any inventory, so there is no wholesaler stocking in Japan. In the U.S., of course, the specialty pharmacies do carry inventory, and that is where we comment it's less than two weeks. It's well managed at quarter end. Thank you.
Your next question comes from the line of Yatin Suneja from Guggenheim Partners. Your line is open.
Hey, guys. Congrats on great performance. A couple questions from me, little quick ones. Can you maybe just help us understand how we should think about the cadence of patients coming onto the drug? Obviously, you added 1,000 patients in Q2. Just trying to get a sense of what's sustainable or what sort of cadence should we expect. Then just overall, in terms of the U.S. market, when the drug was launched, I think you had articulated 17,000 eligible patients. Any revision to that number? Just trying to get a sense of what level of penetration is achievable in the U.S. now that you have more commercial experience. I just wanted to get some updated thoughts on the U.S. opportunity. Thank you.
Thank you, Yatin, and I think, Keith, you're well positioned to talk about our thoughts for the future cadence of patient enrollment, right? Why don't you go ahead with that question first?
Thanks for the question, Yatin. First of all, I would like to say that Q2 1,000 patient adds was an extraordinary quarter. It really was. This is where physicians were beginning to hear from other physicians about VYVGART. Patients were going in and asking for it by name, and the team was really clicking on all cylinders. I don't think that I would set up a model that says 1,000 patients every quarter is going to be the norm. But you know, we will have to wait and see. As far as your 17,000, that is still the plan. That is still the target. That is still the number of patients that we believe that is appropriate for VYVGART therapy here just in the U.S. and patients that could truly benefit from VYVGART. No revision to that as our target number.
Okay.
Your next question comes from the line of Matthew Harrison from Morgan Stanley. Your line is open. Matthew Harrison from Morgan Stanley, your line is open. Your next question comes from the line of Derek Archila from Wells Fargo. Your line is open.
Hey, good morning, and thanks for taking the questions. Congrats on the quarter. Just two quick ones for us. I think they're for Keith. Just following up on your commentary, Keith, about the treatment algorithm. What do you think is really needed to get VYVGART utilization earlier in the treatment algorithm? Just not the IVIG experience, but like C5 refractory. That's just question number one. Just a follow-up clarification. Keith, you said 78% of the prescribers are writing one to two scripts. I guess, what percent of these are for generally like six to 12 months of treatment, or is it just for one treatment cycle? Thanks.
Thank you, Derek. These are two good questions. Keith, can I ask you please to address those?
Yeah, happy to do so. Derek, thank you for the question. The treatment algorithm and how do we get to earlier lines of therapy. I first wanna call out to you that, you know, while 50% experienced IVIG, the other 50%, were aligned with the ADAPT trial. We do have patients that have started VYVGART after only being on Mestinon or only being on Mestinon and a steroid. We also have those that have started VYVGART after Mestinon steroid on their first IST. I think the key to me moving earlier into this treatment algorithm is going to be the experience curve. It actually ties into the second part of your question, which is if 78% of our prescribers have only prescribed for one or two patients, it's getting them to see that patient experience.
One of the things that I've heard from clinicians is how rapid the onset of response is, how their patient is doing so much better after one or two doses. They think about how long some of these oral therapies, particularly ISTs, take to kick in. That combined with favorable payer policy is our plan on how we go earlier into the treatment paradigm. As far as the 78% that have only written one or two scripts, and where do they fall into those policy buckets of a six month or a 12-month, I don't have that data broken down and in front of me at this time, so I can't report to you on that.
Your next question comes from the line of Allison Bratzel from Piper Sandler. Your line is open.
Hi. Good morning. Thanks for taking the question, and congrats on the quarter. A question for you on redosing. I know it's early in launch, but could you comment just on whether redosing has been more patient or physician driven? Any trends you're seeing there in terms of what is driving the initiation of second or third dosing cycles? Maybe talk to the role of nurse case managers from My VYVGART Path in helping drive that. Just on a related note, are you seeing any telehealth prescribing? That is, are docs comfortable prescribing VYVGART over telehealth, particularly for those second or third dosing cycles? Thanks.
Thanks, Allison. These are again two questions for Keith, one with regards to triggering redosing and then the telehealth question. Right, Keith?
Yeah. Thanks for the question, Allison. On redosing, we're really seeing two schools of thought. We're seeing a reactive approach, which that would be patient driven. The patient gets a cycle of VYVGART, they respond, and they're feeling better, and they're given direction that when you begin to lose response, when you begin to feel symptoms, please call, and we'll get you in for your next cycle. That's the patient-driven example. The other one that we're seeing is a physician driven, and that is where a physician gives a cycle of VYVGART and decides when they're gonna bring that patient back for cycle two.
We're seeing some physicians that say, "We're gonna go 4 on, 4 off, and if you have maintained response the whole time before your second cycle, then we'll try to stretch that interval for past four weeks and into five, six, seven, eight weeks." You have others that are gonna start with the cycle and bring them back, similar to what is stated in the package insert, where they'll bring them back, roughly 50 days later for that second cycle. Those are where they're in physician driven. Nurse case managers. As far as driving the need for the second cycle, it's really not the role of the nurse case manager. These are not the treaters of the patients. Nurse case managers are there to assist patients, answer questions, and support them overall on their VYVGART journey.
It is really more of a physician and patient decision on their next treatment cycle. Finally, telehealth. It's too early to say on telehealth whether you're gonna see somebody prescribe a naive patient with telehealth. As far as patients coming back in for second cycle, you know, the majority of our policies, once a patient is prescribed VYVGART, they're approved for six to 12 months. These patients are coming back in and getting their second cycle.
Your next question comes from a line of Akash Tewari from Jefferies. Your line is open.
Hey, thanks so much. First of all, congrats on the quarter. You've shown really robust gMG numbers so far, 1,000 patient adds quarter-over-quarter. That said, we have consensus gone up, and I think we're estimating if you account for the drop-offs, you need about kind of 500-600 starts each quarter in the U.S. to kinda hit numbers in the back half of next year. You know, this question was asked before, but I just kinda wanna double down on it. What's your current view on a reasonable go-forward new patient for new patients going into next year? Then also for starts that you had, just any more color on how many were IVIG-refractory or switches to Soliris-refractory, then naive. Thanks so much.
Thanks, Akash, and I would like to give the floor to Karl to talk about, you know, projections for next year. Before I do so, maybe Keith, you want to comment on that second question, right?
Yeah. Akash Tewari, IVIG experienced patients, it was almost 50%. The percent was almost spot on to what we saw in the first quarter of treatment. As far as the rest of the patient population, they came from across the board. It is some that are moving into earlier treatment. We do continue to get Soliris refractory patients that are added in quarter two. This is not a surprise. You know, I'm happy to share with you that some of our Soliris refractory patients in quarter one are indeed VYVGART responders.
Thank you, Keith. Back to Karl.
Akash, thank you for the question. We aren't gonna give any guidance on patient numbers or revenues at this time. It is just too early in the launch. We want the data to mature, and then we can start thinking about giving guidance on revenues and patients. Thank you.
Your next question comes from a line of Matthew Harrison from Morgan Stanley. Your line is open.
Can you hear me this time?
We can, Matthew. Welcome.
Thanks. I guess I got too excited last time. Just a question for Keith again. Keith, just talk a little bit about J-code and if you expect any inflection off of that or even is there a certain mix of customers that you're not seeing participate very much at this point that you would expect to see participate once you have the J-code?
Yeah. Matthew, thanks for the question.
Keith, is that a J-code question?
Yeah.
Yep. Go ahead, Keith.
Thank you, Tim. Matthew, thanks for the question. You know, we have our J-code. Our J-code is live. It's been running live since July first. Really what the J-code is doing is it is making it easier for physicians and offices to get patients through the process. It's making the conversion process go quicker from time of prescription to time for actual infusion. As far as it opening up additional audiences, you know, really the unmet medical need and the success that patients and physicians are seeing with VYVGART is why we've had pretty substantial demand here in the first couple of quarters. I don't know that you're gonna see an uptick because you have a J-code as much as you're gonna see the ease of getting the patient through the process faster.
Your next question comes from the line of William Olds from Evercore. Your line is open.
Hey, guys. Thanks so much and just a really spectacular quarter. I had a couple questions. The first one is, you know, you guys are at 85% patient-wise covered right now. What's the goal you guys think is realistic by year-end? And then my second question is, what are you guys thinking in terms of COGS long term for efgartigimod?
Hey, William. Two great questions. Let me start by giving the floor to Keith to talk about, you know, how we lives covered. I would like to hand over to Karl to give a brief comment on COGS. Keith, why don't you go first?
Yeah. William, thanks for the question. In regard to coverage, we're really pleased with the progress that we've made through the second quarter. In particular, we're really pleased with the number of the policies. The majority of them are very favorable. They align with the ADAPT inclusion criteria, which means we can have patients as early as second line treatment. As far as the remainder of the population, look, our team is not going to rest. We are going to continue in that minority of policies that are put in place that aren't as favorable as the ADAPT inclusion criteria. We're gonna work with those payers to see that we can get them to a favorable status. And the remaining 15%, we'll continue to work on, but we haven't been public with setting the next number forward.
Thanks, Keith. Karl.
Thank you, Tim. In terms of cost of sales, clearly we're not gonna give detailed guidance here. Safe to say, as we move to larger production facilities, currently the virus is coming out of Slough, a 1000 reactor. We have Singapore, a 2000 reactor, which is also FDA approved. Later on, Portsmouth, an even bigger facility will come online that will drive efficiencies. Also important for you to remember is that once you get SubQ, there's that mid-single-digit royalty on the for Halozyme and so on on the SubQ.
Thanks, Karl.
Your next question comes from the line of Tazeen Ahmad from Bank of America Securities. Your line is open.
Okay. Thank you for taking my question. I apologize if this has already been asked. I did join a little bit late. Can you talk about the reliability of tracking scripts inter-quarter? Because it did seem like Symphony in particular was tracking relatively close to the number you reported this quarter. Is that just by chance, or do you think that there is a reliable component to looking at those trends? And then, second part of the question is, should we expect to see any seasonality in the second half of the year, particularly in 4Q? You know, is it a trend, based on what you know about the gMG space, that patients tend to be less compliant during the holidays, or should we not assume any kind of seasonality? Thank you.
Hi, Tazeen. Thank you for joining us in the call today. I would like to give the first question to my colleague here, Karl. How do we think about the reliability of tracking scripts, please?
Hi, Tazeen, and thank you for the question. I think if we look at Symphony data and IQVIA, it is, it's difficult for us to comment on it. We don't know how their algorithms work. I think it takes time for those algorithms to get more accurate. At the moment, I'll be very careful in using it. If you look forward, the algorithms don't know the discontinue factor, which needs to be built in. The cycling, if we start new patients moving from one cycle to the next cycle, none of those will be built into the algorithms. I think we really need to be careful in using these data points.
Thank you, Karl. Keith, is there anything you want to say with regards to potential seasonality in the treatment of gMG patients?
Yeah. Tazeen, it's a good question. As you know, we haven't been through holiday season yet with VYVGART commercially available. What I will tell you is that when you're treating a patient that has been through other therapies and not had a positive experience, and now they're able to have a quality of life that's similar to someone that doesn't even have the disease, they're gonna wanna stay on therapy.
Sure
One of our patients that happened to walk up to me and said, "I actually didn't realize how bad off I was or how different my life was until I was being treated and realized what I had been missing out on." If I put my mind in that of a patient, I would say, "Hey, I wanna be treated so I can enjoy my holidays even more." Let's wait and see on the seasonality, but I'm not expecting it.
Okay. Thanks, Keith.
Your next question comes from the line of Thomas Smith from SVB Securities. Your line is open.
Hey, guys. Thanks for taking our questions. Let me add my congrats on the really strong launch here. Just wanted to follow up on the new patient start. Can you give us any more granularity on kind of the monthly pace here through the quarter and into July? Maybe just help us better understand the shape of the curve here as you exited the quarter. Then it's obviously off label in the U.S., and I know you aren't promoting to it, but can you comment on whether you're seeing any VYVGART uptake in seronegative patients in the U.S.? You know, appreciate the comments on Japan. Just curious what you're seeing in the U.S., whether you're seeing prescribing for these patients, whether payers are facilitating access here. Thanks.
Thank you, Thomas. Thanks for being with us on the call today. I'd like to give the first question to Karl about new patient starts and monthly visibility. Keith, I'd like to hand over to you for any comment we can give on the question regarding off label. Karl, could you start, please?
Thank you. Thomas, thank you for the question. What we see is a gradual, consistent month-over-month growth. Thank you.
Keith?
Yeah. Thanks for the question, Thomas Smith. As you pointed out, in Japan, where the label is broader, we are seeing utilization in MuSK patients and seronegative patients, also in acetylcholine receptor-positive patients. A real nice across-the-label utilization in the first quarter of launch. As far as in the U.S., we remain consistent with the label. We will not promote off-label. That also means that if it is a patient that is off-label, they're not able to participate in our My VYVGART Path program. If there is, we have far less insight into these off-label patients. Thank you.
Your next question comes from the line of Jason Butler from JMP Securities. Your line is open.
Hi. Thanks for taking the question, and let me add my congrats on the quarter as well. Just had a question about OncoVerity. Have you already established a development strategy for cusatuzumab, either the overall AML population, subpopulations? How are you thinking about, you know, combinations with standard of care? And then, is there a specific funding commitment from Argenx to the new entity? Thanks.
Thanks, Jason. This is a deliberate choice to spin off cusatuzumab in an asset-centric company. It means we can continue to focus and double down on our autoimmune franchise. The co-creation in play here is a unique one because the translational biology insights from Dr. Clayton Smith on the role of the CD70/CD27 pathway in either venetoclax non-responsiveness or refractory patients is a unique complement to what we already have in our hands with our first-in-class asset and pretty strong data in first-line AML patients unfit for transplants. Expect the development path to be a precision shot on goal, fine-tuned with the know-how of University of Colorado in terms of inclusion, exclusion criteria for our AML patients. This is an asset we believe in.
This is a company we will shoulder and therefore, yes, there is a financial commitment both from Argenx and from Colorado. It's a two-step commitment, but first we need to finalize a specific piece of homework, and then actually there's a second bigger tranche of commitment from our company. We're very pleased with the path forward. I think it's a data-based path forward, and we are equipping cusatuzumab with the highest probability of success here. Thank you for the question.
Your next question comes from the line of Alex Thompson from Stifel. Your line is open.
Hey, thanks for taking my question. Congrats on the quarter. I wonder if we can go back to gMG, if you could comment a little bit on net price per patient in the U.S., whether that's tracking with your initial expectations so far, and also if you'd comment on the net price per patient in Japan. Thanks.
Alex, thank you for joining us on the call today. This is a question, I think, for Karl, right?
Yeah. Thank you, Timo. Jason, Alex, thank you for the question. The typical price for a patient three to five, that number which we communicated at the beginning of the year still stands. We don't see any reason for that changing. The gross to net everything adds up to that number. In terms of Japan, the price for a vial in Japan is JPY 421,000. If you do the conversion, you'll see it's between 50%-60% of the U.S. price. Gross to net in Japan is a typical gross to net. It's a very small number there.
Thanks, Karl.
Thank you.
Your next question comes from the line of Joon Lee from Truist Securities. Your line is open
Hi. Thanks for taking our questions. For the ADVANCE-SC, what specific learnings from the IV trial have you incorporated? Other than just the size, I mean, more specific to the increase in the size and powering assumptions, can you comment on the additional number of patients you're enrolling? Thank you.
Thanks, Joon, for the question, and thanks for being with us today. As we said, the benefits of having the two trials running in a slightly staggered fashion is that we can deploy learnings from the first study and see, you know, how they impact the second sister study. Remember, for the first study, we had a very convincing sign of efficacy in the IWG score. Primary endpoint was a clear win, but with a smaller power than we had anticipated. We have been revisiting the initial powering assumptions. We took a blinded look at the patient population for the second study. It looks like broadly speaking, a similar patient population as for the first study, and therefore we can now be more accurate and precise in our powering assumptions.
That means that in order to achieve the power we feel comfortable with, we need to up the number, and that's why actually we are reopening the study to add a number of patients. I would like to hold off until we publish on ClinicalTrials.gov to show you that number. But it's not a dramatic number. It's a reasonable number to give us a significant increase in power. Stay tuned. It will pop up on ClinicalTrials.gov soon. Thanks for the question.
Your next question comes from the line of Colin White from UBS. Your line is open.
Hi, Colin White here, on for Laura Sutcliffe, UBS. My question is about UCB's termination of rozanolixizumab in ITP and if that gives you any pause for thought in terms of the commercial opportunity in this therapy area? Thank you.
Hi, Colin. Thank you for your question. Yeah, we also took note of the UCB news. I think it's good news for us. It means there is less competition out there. I think we're formulating our plans and our strategies based on our own data. I think our conviction level in the potential of efgartigimod in ITP is significant. I think the data we saw in such a refractory patient population are actually quite impressive with a more than 50% IWG response rate. I think the safety profile came out very consistently and very clean, and we have documented very carefully the unmet medical need in ITP. I can also tell you that the initial feedback from the field from treating physicians has been very positive and very consistent, so we're steaming forward with our ITP opportunity. Thanks for the question.
Your next question comes from a line of Douglas Tsao from H.C. Wainwright. Your line is open.
Hi. Good morning, and thanks for taking the questions. Just, I think in the slides you indicated that most script writers. Hello, can you hear me?
We can hear you fine, Doug.
Okay. Yeah, sorry. Just, you know, you indicated most writers have written one to two scripts. I'm just curious, do you have any perspective in terms of the types of patients they're selecting for those initial scripts? Is there a certain profile? Are they waiting for the patients who are perhaps not doing as well on IVIG or their existing therapy, or is it just sort of happenstance just to be the first patient that walks in the door that since the approval?
Thank you, Doug. That's an excellent question. Keith, would you mind taking this one?
Yeah, happy to do so. Doug, we don't actually see an enormous difference in the 78% that have written one or two compared to the remainder that have more patients on therapy. Again, with almost 50% of the patients experiencing IVIG prior to getting VYVGART, it appears that in the early going, we have a higher percent of refractory patients than we expect to have in the future. As I mentioned, we'll continue to try to get earlier in the treatment paradigm, so certainly placed before IVIG, and certainly placed before other infusible therapies. Right now, as a new option on the block, we are getting a high number of refractory patients.
The good news is, I think that, those physicians see that experience and the experience that their patient is having, that's where we have the opportunity, the real opportunity to advance earlier into the treatment paradigm, but also take that 78% and take them from being with one or two patients on therapy to now even more than that.
Your next question comes from the line of Joel Beatty from Baird. Your line is open.
Hi, thanks for taking the question, and congrats on the quarter. Going back to an earlier comment about how 1,000 patient adds was extraordinary and it seems, you know, not to be expected to be repeated. Is that based on feedback that there may have been kind of a pent-up demand effect here?
This is a great question and an opportunity, Keith, to reiterate, you know, the views of the company, you know, on the position we're in. Keith, why don't you go ahead?
Yeah, happy to. Actually, Joel, the point that we're making is that it was a very powerful quarter in patient adds. I mean, 1,000 gMG patients added in a quarter in a rare disease is quite a number for any therapy. The fact that we were able to deliver that is quite impressive. All I was saying is that if I was building out my model, I don't think I would be placing that as all of a sudden the new standard that you can expect to occur quarter-over-quarter.
Your next question comes from the line of Manos Mastorakis from Deutsche Bank. Your line is open.
Yes, hello. My question was asked just earlier, but, in terms of the ITP opportunity, but maybe I could just add if you could say anything else more quantitatively, perhaps about the market opportunity. Thank you.
For ITP, what we learned with the data in hand from the field and from the physician audience we have been interacting with is that there is substantial unmet medical need in primary ITP patients. What basically happens today is that when patients are moved from a steroid to a TPO and they fail a first TPO, they would be typically cycled on a second TPO, and now that there's a third TPO out there on the market, even to a third TPO. It doesn't make a great deal of sense to switch patients between medication using a similar mode of action.
It does make sense to move them after the first TPO failure onto a totally different mode of action, which actually has proven to be a very powerful mode of action, which is the reduction of pathogenic IgGs, which, you know, are responsible for clearing platelets, but also attacking the megakaryocytes. So we think there is a clear positioning here for third line therapy in the ITP market space. What we quantitatively hear from physicians is in line with what some of our analysts have been writing. For example, I have been reading, you know, about a 10% market share based on a third line positioning. The company, based on its data and its market research, would actually feel comfortable with that.
There are no further questions at this time. This concludes today's conference call. Thank you for your participation. You may now disconnect.