Q4 2022 argenx SE Earnings Call
Speaker 2: After the speaker's remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press star followed by the number 1 on your telephone keypad. If you would like to withdraw your question, again press the star 1. Thank you. I'd like to introduce Beth DelGiaco.
Speaker 2: Vice President of Corporate Communications and Investor Relations. You may now begin your conference.
Speaker 3: Thank you, operator. A press release was issued earlier today with our full year 2022 financial results and the recent business updates. 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 the webcast.
Speaker 3: indicated by these statements. Our gen X 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 Haramaren, Chief Executive Officer, Carl Zubit, Chief Financial Officer, and Keith Woods, Chief Operating Officer.
Speaker 4: I will now turn the call over to Tim. Thank you, Beth and welcome everyone. Next slide. Reflecting on 2022, it was a year of many achievements for our genics, as we evolved from an R&D organization into a fully integrated R&D and commercial organization. We launched our first in-class FCRN blocker VIVGARC into US.
Speaker 4: Japan and Germany and exceeded our own expectations generating $401 million US dollars in global net products revenue.
Speaker 4: I am very proud of the team for the strategy they built and executed, solidifying our reputation with our key stakeholders. With this significant momentum, we start 2023 in a position of strength.
Speaker 4: We also have our marching orders in hand for multi-dimensional expansion to reach more patients with VIVCARC, who anticipated the regulatory approval and launches in New Region and by driving usage earlier in the GMG Deepen paradigm. Next slide. This year we also generated a significant amount of data on our first in class as CERN blocker to clinical trial readout.
Speaker 4: Translational research and peer-reviewed publications.
Speaker 4: We reported 50 data from our sub-cube bridging study in GMG, which demonstrated non-inferiority to the IV based on IGG lowering, as well as consistency across secondary efficacy endpoints and safety. We have now filed for approval with the FDA, EMA and PMDA, and have a Purdue Faktarget Action Date in the US of June 20, 23. We received a communication from the FDA in January , notifying as of a 3-month-clock extension.
Speaker 4: Since that time, the FDSV view continues and we are engaging regularly with the agency being responsive to inquiries as we advance through an anticipated approval. We reported this 3-ITP data from our first registration trial last May and presented these data during a plenary session at Ash in December .
Speaker 4: which triggered significant interest from the hematology community. We are preparing to submit an MAA in Japan in the middle of this year for approval based on the first advanced trial and will await the data readout of Advanced Subq in the second half of this year to support filing in the US and Europe . across all our aggresiven up studies
Speaker 4: We also generated significant data in 22 to broaden the scope of our safety database.
Speaker 4: which now includes more than 3000 commercial patients globally, more than 1300 clinical subjects, up to 19 cycles of intermittent cyclic dosing, and more than 2 years of weekly chronic dosing, all with the cumulative exposure of more than 1000 patient years.
Speaker 4: Lastly, before we look at H220-23, I want to call out a strong sign that continues to serve as the cornerstone of our genics, solidifying our leadership in S-D-R-N as both a first in class and likely best in class therapy. Our teams are committed to building a deep repertoire of preclinical and translational data.
Speaker 4: which can serve as an important basis for indication selection or to underscore the clinical of commercial data we are generating. We had several key publications in 22, including on one. The long-term remissions we observed in Pemphagus and the underlying reduction of all of the reactive Buju P ???.
Speaker 4: 2. The differentiation of our FC fragment and its intercellular state keeping FCN in its recycling path without interfering with albuming homeostasis. 3. Review of the humoral immune response to vaccines during and critical treatment and 4. Multiple publications and presentations on the health economic outcomes front.
Speaker 4: highlighting the value that this God can bring to Gen G patient from a quality of life perspective. Next slide. We are going our way to achieving the Argenics 2025 vision which we laid out a couple of years ago.
Speaker 4: Specifically, we are now reaching patients with regard globally, evaluating and taking them up in 13 severe autoimmune indications, preparing for the first clinical efficacy data from Argenics 117, our next pipeline in the product candidate, and we are investing in our ecosystem of innovation.
Speaker 4: We have an impressive track record for molecules that have emerged from our immunology innovation program, both within our own pipeline and those with our partners. Beyond I've got taken up an Argenics 117, some of these include Argenics 119, an agonist to muzzle specific kindings.
Speaker 4: We dosed the first subject last month, so our third pipeline candidate is now clinical stage. Here's a Tuesday map targeting CD70. We formed oncovarity with the University of Colorado last year based on the translational work of Dr. Clayton Smith on the CD27-CD70 pathway, which when combined with our clinical studies is a pretty robust data set. Argenix 1-12 targeting IL-22 receptor in development by Leo Farmer and moving forward in development.
Speaker 4: and our Genics from 15, Thriving Garb and Developing by AdV, which is also advancing. Next slide. We have a very busy year ahead, that the progress is even further on our path as an integrated immunology company. We continue to expect top-line data from the AdVee file of Agafigemab in CLDP in the second quarter of 2023. There remains a significant amount need for CRDP patients for a safe, effective therapy with the manageable dosing schedule and delivery.
Speaker 4: With adhered, we hope to address these needs and demonstrate the potential for agafigem op to provide patients with a differentiated therapeutic profile across efficacy, safety and convenience measures. In addition to the advanced QVDOT, in the second half of this year, we also expect pivotal data from the address trial for PENFIGERS.
Speaker 4: With the dress, we hope to see efficacy data which build on the exciting results from Phase 2, a fast onset of action driving patients into disease control and ultimately complete remission with the ability to taper to a minimal dose of steroids. We will have our first group of constant data in post-COVID-POP.
Speaker 4: In the fourth quarter of 2023, this was an indication that was brought to us, particularly with the growing incidents in the wake of COVID. Physicians report that IVRG and Plex work well in these patients, and we know that anti-adrenergic and anti-nuclear antibodies are involved in disease pathophysiology.
Speaker 4: All of this is from rationale for evaluating efficacy in what could be a very sizable indication. Finally, we're also planning for the first clinical efficacy data from Argenics on 17 in patients with multi-focal motor neuropathy. I.V.A.G. the only treatment option for M&M and its comprises a significant proportion of that market. With our internal analysis in the middle of this year, we will have data from the first cohort of nine patients.
Speaker 4: this is from rationale for evaluating efficacy amount in what could be a very sizable indication. Finally, we're also planning for the first clinical efficacy data from Argenics on 17 in patients with multi-focal motor neuropathy. IVIG is the only treatment option for NNM, and its comprises is significant proportion of that market. With our internal analysis in the middle of this year, we will have data from the first cohort of nine patients. Our COVID is data snapshot.
Speaker 4: is to determine whether to advance to its second larger cohort and at which dose. We continue to produce translational data supporting the pathological role of RGM auto antibodies in M&N and the rationale for its C2 inhibitors as in new treatment modality. Before I turn the call to Carl, I want to spend a few minutes on the leadership transition we announced today with Cleats Planned Retirement. We are very excited to welcome Karen Massey to the team
Speaker 4: She is joining us from Genentech Roche, there for the last three years she led a global clinical operations team of over 2000 people. She has a broad commercial experience, including specific experience within the neuroinflammation space, having launched first in-class medicine, which disrupted the treatment paradigm. I was very impressed to hear about her role with the Okrevus launch, taking an already successful launch and accelerating it in a crowded market. Beyond this remarkable achievement, the quality that most caught my attention is her focus on building teams, creating a company culture and community, and designing nimble, global, innovative organizations, all of which will benefit our genics. I would also like to share with you my gratitude to Keith for his partnership and friendship. He is a visionary leader, who has always kept both science and the patience at the center of everything we do. We are so fortunate for the role he's played in our growth over the last five plus years of his distinguished career in biofarm.
Speaker 4: He joined Arjenix after the release of these two MJ data when he convinced me that Arjenix could launch a Gravitichimov. He saw a vision for Arjenix commercially, not only in the US but also Japan, Europe and Canada. I could never imagine at that time the impact we could have on patients even in the first year of launch.
Speaker 4: He joined Arjenix after the release of these two MJ data when he convinced me that Arjenix could launch a Graftecumov. He saw a vision for Arjenix commercially, not only in the US but also Japan, Europe and I could never imagine at that time the impact we could have on patients even in the first year of launch. He tells committed throughout our research process.
Speaker 4: to find the right person to fill his role. I knew I could count on him to stay until we all agreed we had the right successors and we are both very confident we have that in Karen. We are also fortunate he will be staying with the company not only during the transition period through the SC and Gartikamot launch but also after he detires. He will transition to serve as a bold advisor on our commercial comedy where he will continue to make a significant impact on our commercial strategy and for our patients.
Speaker 4: role. I knew I could count on him to stay until we all agreed we had the right successors and we have both very confidence we have that in Karen. We're also fortunate he will be staying with the company not only during the transition period to the SCF-Gartikamot launch but also after he detires he will transition to serve as a bold advisor on our commercial comedy where he will continue to make its significant impact on our commercial strategy and for our patients and with that
Speaker 4: I will turn the call to call. Thank you, Tim. Our full year 2022 results are detailed in our press release from this morning. So I will keep this section over call short. On the next slide, you will find global net wave card revenues for the fourth quarter and the full year 2022. We generated 411 million in global net product revenues in 2022 and $173 million in the fourth quarter, specifically which was comprised of 159.1 million from the US, 8.3 million from Japan and 6 million from Europe and our distributed markets. Next slide. Total revenues for the full year 2022 were $445.3 million, which also includes 10 million in collaboration revenues.
Speaker 4: and 34.5 million in average operating income. Cost of sales for the year were 29.4 million dollars. Our total R&D and SGNA expenses for the full year 2022 were approximately $663 million and $472 million respectively and can mainly be attributed to FCA TIGIMOT and have a pipeline research expenses as well as marketing and headcount expenses related to our global launch.
Speaker 4: The research and development expenses includes the recognition of a priority review voucher submitted with a BLA filing for SEF Cartigamote.
Speaker 4: We ended the year with 2.2 billion in cash, cash equivalents and current financial assets. Based on your current operating plans and a projected 2023 cash burn of approximately $500 million, we expect our existing cash, cash equivalents and current financial assets.
Speaker 4: together with anticipated future product revenues to fund the company to profitability. You can find additional details behind these numbers in the press release we issued this morning. Before I turn the call over to Keith.
Speaker 4: I would also like to share my gratitude and that his leadership we were ready to launch with court and it has been a very successful first year both with our performance but also seeing the team of leaders that Keith has built across the commercial organisation. I am confident that Karen is the right person to build on this momentum and lead us to the next stage of our growth as a global company. Keith? Thank you Carl and thank you both for the kind words. I am very much looking forward to this next phase.
Speaker 5: spending more time with my family and transitioning to an advisory role for our Genics, it was still a difficult decision to make. The last five plus years have been the most rewarding of my career. Being able to build a commercial team and launch a truly transformative first-in-class medicine for patients.
Speaker 5: I am proud of the success we had in the first year and know that this is just the beginning for our genics and for patients, especially with Karen at the helm and the team of impressive leaders behind her. We closed out the first year of our VivGuard launch in a very strong position. We were able to reach more than 3,000 patients in 2022 with our transformative therapy well beyond the expectations we set for ourselves at the beginning of the year.
Speaker 5: Our commercial and medical teams have done an outstanding job, working hard every day on our path to redefine how autoimmune diseases are treated and the work has just begun. First on patients, we continue to see a steady demand from new VivGuard patients, both in new scripts and patients on therapy. We also see positive trends in moving earlier into the treatment paradigm. We still see approximately half the patients coming from IVIG as their most advanced therapy, but the dynamic is shifting in the other half. With more coming from earlier lines and refractory, we still continue to learn about our launch.
Speaker 5: and the trends, but we are going in the direction that we want. We are seeing a similar positive trend with physicians. Increasing numbers of repeat prescribers and the growth in the number of physicians have written greater than five or even greater than 10 prescriptions. Our field teams have reached more than 90% of their key targets and almost 8,000 healthcare professionals overall across targets and non-targets. Our medical affairs teams have had a significant presence at all major neurology conferences broadly reaching the prescribing community. They also worked on more target engagement through scientific road shows.
Speaker 5: to reach the typically difficult to access institutions. The field teams were nimble throughout the year, leaning in on tactics that work well, which led to an overall successful year of physician engagement. Pay or interactions also continued to be an area of strength for this launch. We ended the year with approximately 90% of commercial logs covered and almost 80% of these policies are favorable. The team is still successfully working to switch unfavorable policies to favorable, removing IVIG as a step through just as an example. The recertification dynamic does appear to exist as we are switching to a new year, but this is something we are watching closely.
Speaker 5: And for the most part, re-approvals have been smooth and occurring every six to 12 months, which allows the physicians to re-dose as they see fit. We presented data last month on the time distribution between cycles one and two from over 400 VivGuard patients. As we saw in a DAP and a DAP Plus, it is a true distribution with 32% of patients receiving a second cycle less than six weeks after the conclusion of the first, but on the other side, we also had 32% of patients receiving a second cycle greater than nine weeks after their last dose of the first cycle. The rest fall in the middle. Based on the data we see and the feedback we hear.
Speaker 5: individualized dose is doing what it's supposed to do. Patients ask for this when we were designing our trial and we're pleased to see that a substantial number of patients are benefiting from that decision. Next slide. We're now looking ahead to the expected FDA approval of subcutaneous F.G.T. TIGAMOD in June . The team is using the extra three months to refine our strategies and expand our opportunity to reach patients both with IV infusion and subcutaneous administration. We're taking a similar early engagement approach with payers as we did with the IV launch, but we still expect several months where we won't have a published policy in place post-approval.
Speaker 5: Beyond subcutaneous approval, we also expect to drive VivGuard expansion geographically this year with anticipated regulatory approvals in China, Canada, and additional launches in Europe as we work through price negotiations. For I turned the call to Tim, I went to end with one VivGuard patient story from my trip to Japan earlier this year. I heard from a young mother who was really struggling when she learned that she had a chronic disease because she was feeling very socially isolated. She was not being able to participate in family activities, play with her children, or pick them up and give them a hug.
Speaker 5: She had lost her job because she could not use the equipment for perform small manual tasks. Viv Garry worked quickly for her and within a week or two she had restored more movement than she had in several years. Her gratitude was so rewarding. We shared her story more broadly with our teams to remind them of the impact that we can have. This is the motivation we are taking forward as we build on our momentum from 2022 and apply it to our successful strategies for the year ahead.
Speaker 4: Thanks, Keith. Next slide. 2022 was a historic year for us. Our first year as a commercial company. And we are very happy with the outcome. We build momentum across our teeth, take holders, with physician and patient demand, and a smooth payer process.
Speaker 4: We know from precedence that the initial six months of the launch often defines its trajectory and now we have our trajectory. We are looking forward to the rest of 2023 focusing on multidarmential expansion into new geographies. We have dissipated the launch of FC Agatigama and moving into early-line GMG patients.
Speaker 4: We also see the opportunity to transform the treatment paradigm in many over-opening locations. As we look ahead to our upcoming data readouts in CIDP, ITP and PV and the first effective to look at our Gen X1 17 and M&M. Thank you for your time today. I would now like to open the call to your questions.
Speaker 2: 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 you please limit yourself to one question and then rejoin the queue for further questions. And your first question today comes from the line of Tuzinamak from Bank of America. Your line is open. Hi guys, good morning. Thanks for taking my questions. Keith, I want to wish you really well. It's been great to get to know you and you've been an amazing head of commercial and all companies deserve to have. Someone is good at you. Maybe my question will be on MMM for the interim read in mid 2023. What level of data should we be expecting to see at the top line? And what would you consider to be clinically meaningful? Thank you. Thank you Tuzina. Thank you for joining us in today's call.
Speaker 4: document their IVIG cycle and then we switch either to placebo or Argenics on 17 and see whether we can keep the patient stabilized compared to possible so we think this first dose cohort should give us a very clear idea of you know whether the drug works
Speaker 2: and more importantly, what level of C2 in the BIS should we need going forward. Okay, thank you Tim. Thanks for the question. Your next question comes from a line of Rajan Sharma from Goldman Sachs. Your line is open. Hi, thanks for the question. So I was just wondering if you could get your thoughts on kind of, we've got Project actually this year and whether kind of the slight delay to the pedo for the subcutaneous formulation has changed your it.
Speaker 5: we haven't given guidance at this time. And so all I can say is that we believe that the trend that we're currently on will continue to allow for growth. And we believe that sub-Q will expand the total potential market for patients that would receive VivGurth. Thank you.
Speaker 2: Your next question comes from a line of Thomas Smith from SVP Securities. Your line is open. Hey guys, good morning. Thanks for taking the questions and let me add my will wishes to Keith on his transition and retirement. Just the, I guess, one quick one on the sub-cute producer. It sounds like the dialogue here is pretty dynamic regarding the application. Can you comment on whether there's been, I guess, any area of particular focus for the FDA in the review?
Speaker 4: could do for that.
Speaker 6: Okay, great. Thanks. And if I could just squeeze in one follow-up just on the commercial, just on the commercial trajectory. If you could just comment on expectations, I guess, for Q1 relative to Q4 and how to think about combination of seasonality and kind of a better reset there would be very helpful. Thanks.
Keith, would you like to take this question please?
So it's calling. So I think for Q1, I mean we launch adding new patients, consistent growth, two things to call out in Q1, we do see the impact of seasonality. If we lose the selling day because of an holiday or a winter storm, bad cells do not move to the next day, we basically lose those cells.
And also we do see the verification of benefits, which typically happens in Q1. Understand, thank you guys. Thank you. Your next question comes from a line of yarnwerber from Calon. Your line is open.
Hi guys, this is Brendan Anferioran, thanks for taking the question. First, quickly on CIDB, can you maybe just tell us how many patients you have randomized into stage B as of today? That's something you're able to share with us. And then just looking back at the ice in past studies, it looks like there may be some slight difference in the rate of relapse and treatment naive versus IVIG experience patients. So are you able to-
said earlier that we have exceeded the number you would normally need to successfully come to the 88 events.
So that all continues to progress well. In terms of representation of patients with the different backgrounds being newly diagnosed on naive, being on steroids or being on IVIG, I believe the last disclosure we did is a disclosure to go for. I think that was about 40 patients in the process. So.
We think there may be an relative in increasing IVIG patients who is the second half of the trial because we had more U.S. sites getting online and involved, but that's my speculation. From a biology point of view, looking at the mode of action of a gut digimop, I cannot think of a reason why an IVIG patient or a steroid patient would react differently to VIVGAR's mode of action. So let's wait for the data and see that we can create our C&D correlations.
between for example baseline characteristics of prior therapy and your ability to respond Thanks for the question. Thanks for the question. Thanks guys.
Your next question comes from the line of the Ateen Suéa from Guggenheim Partners. Your line is open. Good morning everyone. Pete, it's been great working with you. Good luck with the future, and so just following up on a question on the CIDP, could you provide some detail on the baseline in Capscore that you should or you might be? Thank you.
expecting in stage B and the reason I ask is because for the first 40 patients in that year the baseline was around five which seems to be a little bit higher than previous study and there seemed to be this inverse correlation between a higher ticket score and probability of revapsing so just trying to get a sense of you know how the placebo might perform is there a particular ticket score that you are looking for and then the second part is like what about the maxione number of patients that can be enrolled in stage B. Thanks.
file, there is probably a difference in placebo response. But it's premature first to comment on that.
So let's wait until we unblind the data. Is there a limit to how many patients we can enroll in stage B? No, there is no real limit above and beyond the numbers which we highlighted for enrollment on clinical trials.gov. And then you can see that we basically stop screening for the study. We feel that we have ample of patients which now made it into the funnel.
data is that a limit to how many patients we can roll in stage B. No, there's no real limits above and beyond the numbers which we highlighted for enrollment on clinical trials.gov. And then you can see that we basically stop screening for the study. We feel that we have both patients which now made it into the funnel.
Let's see, let's wait. This is a Q2 event as far as we can see today. And let's look at the unblinded data together soon. Thank you. All right, thank you. Your next question comes from a line of miles, mentor from William Blair. Your line is open. Thanks for taking a minute.
question. Just on you mentioned you stopped screening the study for it here. Is your screen out rate when you do the independent investigator sort of confirmation of the NCAT scores? Is that remained consistent with what you presented at AEM? I think it was about a 50% screen out rate. Has that remained consistent with the patients that you've been enrolling beyond the 120 to 130 range? Thanks.
Thank you. Niamath, thanks for the question. My information is that that screening failure rate continues to be consistent. So it is around the 50%. It is also perfectly in line with earlier published studies looking at the accuracy of the CRDP diagnosis. So we feel that's in sync with VWOL and we think it is a constant throughout the study.
Neymar, thanks for the question. My information is that that screening failure rate continues to be consistent. So it is around the 50%, it is also perfectly in line with earlier published studies looking at the accuracy of the CRDP diagnosis. So we feel that's in sync with the world and we think that it is a constant throughout the study. Thank you for the question.
Thanks. Your next question comes from a line of Manoast Master Acres from Georgia Bank. Your line is open. Yes, so thanks for taking my question. So wanted to ask first of all, in terms of the prior to review voucher, in the unwanted scenario of an FDA rejection, what happens to the prior to voucher? Did you get it back?
and maybe a quick follow up on whether you have any data on duration of the second cycle that is patients going from second to third dose. Thank you. Keith, would you mind starting with the second to third dose? Relative distribution we see in the real world and then I will take on the question on the PRV. Thank you. Yeah, so the data that I quoted in the prepared remarks are the first to second.
world on between second and third, but as you might recall from the past, we've referenced that from the Adapt OLE study, you can typically see that when a patient gets in their individualized cadence. So if they become a nine-week interval between the last dose of one cycle and the first dose of the next one, that cadence typically holds.
standard and once they get dialed in, it just becomes the regularly scheduled dosing. So although we haven't been public with something between second and third, right now I'm not expecting a major change except for maybe some of those patients that went with shorter interval to see if there isn't an opportunity to stretch a little further. Thank you, Keith. Thank you.
And then on the PRV, we continue to understand our options, but technically speaking guys, we still in a priority review. And we decided to take a forward-looking approach with the FDA and try to collaborate as swiftly and expedite it as possibly towards the Purdue for date.
Thank you for the question. Your next question comes from a line of Danielle Brill from Raymond James. Your line is open. Hey guys, this is Alex from for Danielle. Just another one on CIDP. We had a few questions come our way. Just when did you decide to increase the
to increase enrollment. We decided to just not stop enrollment and continue to enroll. And the reason is that it would be pity for those patients who all have an opportunity to come on drugs, not to do that, because you know, not all of them, of course, are going to make it to the end of stage B. But all of these patients would then have the opportunity to roll over to the open-able extension.
and also contribute to the safety database, remembering the backgrounds, not only do we need to build efficacy data, but also strong files, strong evidence of safety. So it was a decision not to stop rather than to enlarge the study. If you see what I mean, thank you. Great, thanks. Your next question comes from Alina, of Allyson Breadsell from Piper Sandler. Your line is open. Hi, good morning. Thanks for taking my question. Just another one on Adhere.
related, will you have actual relapse rate data in time for the top line readout? Just given that a bunch of patients may not have made it to the end of stage B by the time the ADA event has occurred. Thanks. Thank you, Alison. Maybe better, you take on, you know, what would be expected in terms of, you know, top level data disclosure?
And then I can take the question on the competitors and the path file. Thank you. So the primary endpoint, as you said in stage B, is time to relax. And I think during our communication, we're committed to showing the primary endpoint of part A, the response rate, the primary endpoint of part B.
Of course, you're a view of safety, but beyond that, we're not ready to provide too much information on what that top line will look like. I think what you can expect is exactly what you've seen with ADAPT and ADAPT that we are transparent in our communication, and we will make sure that we give a complete picture of what we're seeing with those data to make sure that you understand them well.
Thank you, Beth. You're absolutely correct, Alison. The primary endpoint for stage B is time to relapse. It would be a proper way, for example, to look at these data. We're still thinking about how we're going to present the top line data. But you should be able to draw a fair comparison with the path trial. In the way we present the data, for example, if you're number to take a specific time point. So we're still embellying it over. But in terms of separation between active and possible path continues to be, I think, the proper benchmark.
to match or to beat. Thank you. Your next question comes from a line of Matthew Harrison from Morgan Stanley . Your line is open. Great. Thanks for taking the question. I've asked the flavor of this question before, but I wanted to ask it again in a different way, which is, you know, we're expecting to get some case two studies from from Jane J. this year, especially some of the larger indication.
class venture into other indications than the Argentinex indications because so far we saw mainly imitation and not too much creativity so good to see new indications coming on deck where we feel there's a different proposition from a biology rationale point of view and we're actually very happy to see all the people de-vis these indications. So we have our own list of preferred indications at you.
you know how we select them based on biology rationale, technical feasibility and then then let's not let medical aid and commercial opportunity, we're not going to deviate from our own list which starts from the signs and the biology and it of course keenly looking at other indications which are turning data cards. Overall I believe they will just show that the F7 opportunity is a really big opportunity, what I think you know multiple players active in the space.
Thank you for your question. Your next question comes from a line of Alex Thompson from Steeple. Your line is open. Hey great. Thanks for taking my question. So I guess keep maybe on your commentaries relates to real world observations of cycles on DITGAR. How should we think about net price per patient in 2023? To expect that to stay pretty constant as to what you've been guiding in 2022 or how is that going to look moving forward?
at least for the IV version. Thanks. It's callier, so maybe I'll take that question. So we got it in the beginning of last year, a typical net price of 225. And if we look at all the data points, average weight per patient, the number of cycles, the growth to net per value based agreements, taking all of those things in account, we think that the $225,000 per patient for both of patients
Those stands for 2020. Thanks. Thank you for your question. Your next question comes from a line of, will old from Evercore, like your line is open. Hey guys, congrats on the great work. I'm really curious about the head of the issue. What is the thought of the decision? And what's the key to about the actually registration trial design? I could not understand the question. Did anyone else understand it?
It's about thyroid eye disease and the positioning and the potential trial design. Okay, so what the only thing we have disclosed at the GP Morgan conference is the choice for this indication. This is for once an indication where we're not leading. I mean, we will not be first to market in this indication. So I think we have been speaking mainly about the biology rationale, but we reserve the right to answer your question until we will disclose the trial design and then we can expand on competitive positioning. But it's a bit premature for us to comment on it right now. So there with us that will come later in the year. Thank you. Your next question comes from a line of Joel Beady from Beard. Your line is open.
Great, thanks for taking the questions. For the current FDA review of sub-QF-pertission mod, is there potential to add zero negative patients to both sub-Q and IV labels? Now, thank you for this question. In the bridging study, remember this was a head-to-head comparison in the inferiority trial between the IV version of Vivgard and the sub-Q product presentation of Vivgard. We basically included, again, both pseudo-positive patients and zero negative patients. And again, Vivgard has shown that it works equally well across the board in a non-inferior manner between sub-Q and IV.
together with some other data, which we collected from the real world and the role over from the adapt trial in the OLE. We have been bringing all these data together and we resubmitted them to the FDA, making a case for the civil negatives. But again, this is a review issue. This is not in our hands only. We submitted the data and we look forward to the interaction with the FDA on this topic.
of data, which we collected from the real world and the role over from the adapt trial in the OLE. We have been bringing all these data together and we resubmitted them to the FDA, making a case for the civil negatives. But again, this is a review issue. This is not in our hands only. We submitted the data and we look forward to the interaction with the FDA on this topic. Thanks for the question.
Your next question comes to the line of Douglas Hale from HC Wainwright. Your line is open. Hi, good morning. Thanks for taking the questions and first seminal guards to keep and congratulations. It's been great. I need to know him. Maybe the first question, two keys. You mentioned sort of insurance resets and just curious how that might be, how that's playing out in the real world just given timing of cycles and redosing and just assuring sort of continuity of treatment. Yeah, no, first of all, thanks for the comments Douglas and also the question, but the bottom line is as we go through the insurance re-verification, almost all of our policies, we said 90% covered lives, which 80% of those being favorable.
Most of those policies almost all are approved for anywhere from six to 12 months. So we just go through the re-verification process. I can tell you that as Carl said about our net that we projected even prior to launch, still stands true and goes into 2023. I think it puts us in a very credible position with payers because what we talked about before launch is actually coming to fruition. And so as we go through the re-certification, we're not seeing challenges. We're just seeing a little bit more time consuming.
Thanks for the 117 question. Look, 117 is its own program and its own plan behind it. We do believe it's a pipeline in the product if you look at the biology which is so universal across multiple indications. We are already public on MMM.
also in the late graph function and also on dermatomyitis and there are more indications to come. You know whether 117 ever will become as big as a fatigue amount is a different question, but we believe that you know that is a significant pipeline of indications where the biology of 117 gene is really in play and what is similar to a fatigue amount is that we invest a lot in the translational biology and showing the right to succeed with the C2 blocker in these indications.
For example, the work we presented on multiple occasions for MMM, but now also at the GP Morgan conference, that's a transfer model. Think of that type of quality translation biology work, which is taking place in all indications we're addressing. So that is definitely a similarity between 117 and a Grapecchima.
Thank you for the question. Hey, just for the quick. Yeah, please. When should we get more indications beyond this first? Do you have a sense of that? But leave that to the future. So there are definitely more indications. The guys will continue at this space soon. We will already be in 20 indications. It also needs to be executionable. So let's continue to roll out indications in a thoughtful, a fashion, an in a fashion that we can execute. Okay. Okay, great. Thank you so much.
Should we get more indications beyond this first? But leave that to the future. So there are definitely more indications. The guys will continue at this space. Soon we will already be in 20 indications. It also needs to be executionable. So let's continue to roll out indications in a thoughtful, a fashion, an illustration that we can execute. Okay. Okay. Great. Thank you so much. Thank you.
Your next question comes from a line of James Gordon from JP Morgan. Your line is open. Hello, James Gordon from JP Morgan, the next question. Question about the CRDP. I guess the question was, is good data bleeds showing what ice troster and stage A and parts are chosen stage B? And if you do that, is that enough? Do you think to be a blockbuster indication that Vivgar and CRDP and the other part just also in CRDP in terms of what a CRDP launch could look like? If you do show similar data to what IG is showing in CRDP, do you think the Vivgar IV MG launch is a good proxy for CRDPs in a launch like in 2024? How are you thinking? Would that one of the considerations please? Thanks James and it's a bit premature to talk about how our launch would look like in absence of data, but I believe it will feed in a minute through share some conceptual thinking on how a launch could be different between CRDP and the MG. I just see people I said before.
Also during our analyst breakfast at the JP Morgan conference, we believe that we are well equipped to compete if we come up with a roughly speaking similar response in stage ASI and similar effect size to path in stage B. We feel we will be equipped to effectively compete in such a position. The launch of course in such a well entrenched market could look quite different. Yeah, I mean certainly James, I think the first thing we need to do is to see the data to see how we stack up and you know not only efficacy but you know.
market where physicians and patients are satisfied with IVIG. So I would not use the MG as a proxy to the CIDP launch. But let's wait and see the list data. Your next question comes from a line of June Lee from Truist. Your line is open. Hey, thanks for taking our questions.
The keys have done a phenomenal job of Viv Garc launch and conventionalism is that if they don't grow you don't fix it but they totally understand Keith has personal reasons. Could you elaborate a bit more on what Ms. Karen Matty brings to the table and what aspects of her expertise you think is particularly well suited to further drive Viv Garc uptake? I'm sure you had many qualifiers I can just to choose. Thank you. Thank you.
Thank you for joining us on the call. As you correctly call out, this was a planned transition right. So Keith is retiring. His aspiration is to spend more time with family and serving on boards, including continuing to be an advisor to our board as a participant in our commercial committee. I think with Karen, we have the right person at the right time for our genics. Thank you.
She brings global operation experience. She has successfully led launches in the new information space, specifically I referred to the Okreverse launch, where she accelerated an already successful launch. And then I think she has a proven tactic of building innovative global nimble teams, exactly the type of teams which we need if you want to continue to be successful.
on the commercial side. We also believe that Karen is gonna be a great cultural fit. And I think the culture of the company is strong. And although it did be higher, a great leader from a technical master point of view, we also think we have an excellent cultural fit. So you're right, I mean, there was choice. And we've actually been excited about Karen joining us on March 13th.
two questions if I may. So the question one is, can you discuss the IP position for Vanguard beyond the March 2036 composition pattern expiry, particularly on the subcutaneous formulation? And the question two is...
Can you give us an update on the European rollout of Vanguard in which countries do expect to begin selling in 2020? Thank you. Please repeat question one on patterned list. Please. I couldn't hear it. Yeah, go ahead and take a look. Yeah. So the question one is can you discuss the IP position for Vanguard beyond March 2046, a composition pattern expiry, particularly on the Southcutaneous formulation?
Oh, okay, I got it. A key that will hand over the question to you on, you know, what do we expect in the context of your penal out for that guy this year from an protection point of view. What I would like to leave you with conceptually is that of course there are multiple layers of IP protection, protecting with guards. Of course we have the specific mutations which we used and analyzed actually from UT Southwestern. Then indeed we have the composition of meta claims which run roughly.
Yeah, happy to do so, Tim. So as you know, we are currently in the Amnod process in Germany and VivGart is available in Germany and we're off to a successful launch there. But we will continue to go through that reimbursement process to have final and official approval in quarter three, late quarter three of this year.
Also in France, we're in an AP-2 program, which makes the gut available to patients. It's not quite as broad as the label at this point, but it does give access to patients that need it while we continue to go through the reimbursement process in France. We've submitted dossiers in numerous countries across Europe , including that of Italy. We've been working with the UK and Spain. I want to call out that we have a broad pre-approval access program so that we can begin to serve patients, but basically this is all going to be based on the timeline.
of gaining approved reimbursement on a country by country basis. And your next question comes from a line of Charles Pittman from Berkley's. Your line is open. Hi, thank you very much for taking my question in the following days. If these are any repeats, but just on the first one, on OPEX, could you give us an idea of how this is going to progress over 20-23? R&D obviously came in a bit light at 4Q. I'm just thinking in terms of you got a number of pivotal trials set to read out ahead of the earlier stage trial starting in 4 Q2 3.
just at the high level conceptually we can talk about the OPEX numbers for 2023. If you look at Q4 you will see that your R&D spend is roughly $150 million. It is lighter than Q3 but Q3 of course included 100 million for the PRB. Going forward I would expect that.
the Q4 number to increase or to be flat or to increase by inflation for the rest of the year by quarter. For SGNA, if you look at the Q4 number of around 140 million dollars a little bit below that, if you think about what's going to happen in 23, we're going to have the second launch in the US for sub-Q, but we will not be material account increases over that, but there will be marketing spent for the second campaign. And of course, Steve mentioned about the European launches.
and both investments in those countries are stage skate. We don't put commercial colleagues in the market and those have time but we do have pricing and reimbursement in place. So the point is that the SGNA number will increase quarter by quarter for the year 2020. Thank you Carl and I'm very happy with the Tenshiga's question. Tenshiga is a significant medical needs. There is hardly any option, pre-eminent option out there for these patients and the trial actually has been going very well. This is a global fee field registration problem.
minimum corticosteroid dose is the primary endpoint. In the second, in the second reason, we will be looking at CR off therapy. We will be looking at quality of life and safety and the cumulative use of corticosteroids. These are the key secondary end points. So this is a data point to be expected.
for the second half of this year. Thank you for the question. And there are no further questions at this time. This does conclude today's conference call. Thank you for your participation. You may now disconnect.