Roivant Sciences Ltd. (ROIV) Earnings Call Transcript & Summary

Great. Good morning, [Foreign Language], and welcome to Roivant Investor Day 2022. I'm Paul Davis, the Head of Communications at Roivant, and we're so excited you could join us today. We'll be making certain forward-looking statements during today's presentation that reflect our current views and expectations, including those related to our financial performance and the potential attributes of our products and our product candidates. As always, we strongly encourage you to review the risk factors and other information that we have filed with the SEC for more information regarding these forward-looking statements and related risks and uncertainties. We will be collecting questions over the course of the event for a Q&A session at the end. [Operator Instructions] Without further ado, I'll hand things over to our CEO, Matt Gline.

Thank you, Paul, and good morning, everybody. We have an action-packed day with a bunch of interesting announcements. So I'm not going to spend too much time on introductory remarks, but I want to welcome you all and thank you for attending today. And I want to start by laying out some of the key things we're going to talk about at today's Investor Day because we really do have what I think are some significant updates. We're going to focus today on the late-stage clinical and commercial pipeline. So there's a lot of other work going on in the business, including discovery work, work on our computational platform, we'll save that for a future event, but today, we're going to focus on updates on the late-stage pipeline. Starting with probably the biggest announcement for the day. We're unveiling a new program at Immunovant, IMVT-1402, which is a new novel anti-FcRn antibody. So now we have a full franchise of anti-FcRn antibodies at Immunovant. And notably, IMVT-1402 has the same, we believe, best-in-class potential IgG suppression. It is the same simple subcutaneous administration and it has been engineered to have minimal or no impact on albumin and LDL. So a really exciting addition that we think completely transforms that franchise, really puts us in the position of having the leading FcRn franchise with a whole bunch of additional possible indications and ways to sort of work with those 2 products together. The second thing we're going to spend time on today is the VTAMA launch. I know this is important to many of you. It's important to us. We are incredibly pleased with how it's going, and we're going to share some updates and metrics on that progress today. Notably, we have over 30,000 prescribers right now across over 5,000 -- sorry, over 30,000 prescriptions across over 5,200 prescribers. And one of things we're going to share today is a KOL panel with some of those prescribers who will be able to give an update on how that launch is going from their perspective, how that product is resonating with their patients, what they see as the value of attribute. So some interesting insights that come from that discussion as well. And finally, we'll spend less time on it. But just notably, we have a late-stage clinical development pipeline that is really ready-to-bear fruit in the next year for us. And I want to just highlight a couple of key things there, including we'll spend just a minute or 2 this morning on brepocitinib, where I'm proud to announce that the SLE trial there, the potential registrational study that is sort of jointly funded between us and Pfizer is now fully enrolled, 350 patients in. So we know that we're going to get data from that study next year. So we'll talk a little bit again about the rationale and design of that study. And then also, we have data from our Phase III program in atopic dermatitis for VTAMA, coming in the first half of next year, and that takes what's already an exciting launch and puts it into a market that is then 4x larger than psoriasis alone. So really excited for all those updates. I'm not going to spend very much time today sort of in the clouds. I just want to highlight a couple of things about -- to remind people kind of who we are. One is, look, the goal for the company from the beginning has always been to take a [ heme ] at some of the challenges that big pharma faces and to redefine what a big pharma company could be, mostly in 2 ways. One is the Vant model that I think you're all familiar with, where we run the company in a sort of decentralized group of nimble entrepreneurial biotech companies or organizations called Vants. And then the other is that we've planted significant seeds, we've built a lot of computational tools that make us better at drug discovery, we think development and commercialization. And as I said, we'll talk more about those at other events. I think this is really the year the model comes full circle for us, where we launched VTAMA after its approval in May. That's the first wholly-owned commercial product, the first product being launched at a Vant under the Roivant umbrella today. That's actually the sixth FDA approval to come from the Vant family. The other 5 are commercialized by our partner, Sumitomo and are also doing well. And so it's an exciting track record of productivity and obviously, that builds on our clinical success with 8 consecutive positive Phase III trials and obviously, hoping to build on that with those additional pivotal trials that I mentioned earlier. So it's been an incredible year for the business. We've just -- we've accomplished, frankly, a lot. I'm very proud of our team. First of all, the VTAMA launch is obviously a huge thing for us with it being our first sort of in-house commercial product. The Dermavant team, I'd say doing a spectacular job there. The approval came in ahead of the PDUFA date. We were the #1 brand in topical in psoriasis 8 weeks into launch, and all the other metrics and provider feedback, they are supportive of a really, really strong launch. On top of that, we expanded the pipeline. I mentioned brepocitinib, we'll talk a little bit more about it. We announced the in-licensing of brepocitinib and within the last year, we not only fully enrolled that SLE study that I mentioned, we also began our pivotal program in dermatomyositis with a pivotal study that's ongoing there. In addition to that, it's been a tough capital environment. I'm not saying anything anyone here doesn't know. And we've been very focused on making sure that in the context of all these important activities, we've been thoughtful about our burn, we've bee thoughtful about the prioritization of our programs. We made some announcements about that earlier this year. We continue to expand that, we're talking about IMVT-1402 today. But in general, we continue to expand the development efforts at Immunovant with now not only IMVT-1402 getting up and running, but also additional indications in CIDP and Graves' disease with multiple ongoing pivotal trials now running there. We also further expanded the pipeline. We in-licensed RVT-2001 small molecule modulator of SF3B1 for the treatment of transfusion-dependent anemia in lower-risk myelodysplastic syndrome patients. And again, the possibility of important data there next year as well. We -- I know there's a number of people following this. We filed a lawsuit against Moderna. We're out there sort of building on and expanding our IP positioning in the lipid nanoparticle space. Our IP -- our lawsuit there to defend our position, where we feel we played a major role in the invention of the LNPs that went on to be used in the COVID-19 vaccines. So that's something that our investors are watching carefully. And then finally, for this slide, we continue to invest on the discovery side. And not only have we sort of streamlined that effort for maximum efficiency, but also we've done a number of interesting partnerships there with big pharma companies across our computational discovery and targeted protein degradation. So excited about that as well. But really, the focus of today is that late-stage pipeline and on the addition of 1402, and how the VTAMA launch is going. So I'm going to get right into that. And we'll hear more from Pete in just a few minutes on 1402. But I just want to say up front because it's something that we, at Roivant, are really excited about. With the addition of 1402, we feel like we are really building the leading anti-FcRn franchise. We are the only company now with multiple anti-FcRn antibodies soon to be in clinical development. And we feel like that gives us the breadth of ability to go after indications with chronic dosing, broad indications, narrow indications, ton of flexibility. And critically, 1402 just looks to be a great potential product. It's got the same best-in-class potential suppression of IgG. It's got the same simple subcutaneous administration, but also it has minimal or no impact on albumin or LDL in our animal studies, and we believe based on the way it's engineered that will continue. And that is -- it's a phenomenal thing for us to add to the portfolio, and I'm excited to hear Pete talk more about what Immunovant's planning to do with that program and how it builds on that franchise. VTAMA we'll talk much more about later this morning. Suffice to say, we're just -- we're really proud of that launch. We're really proud of the team. We're really proud of the execution. There's many different ways to catch it, to show it. But as we compare our trajectories to other launches, I'll say, for example, that not only are we ahead of basically any branded topical launch in sort of modern history in psoriasis, but we are keeping pace with the launch of OPZELURA in atopic dermatitis. And that's notable because atopic dermatitis is a commercial market with about 4x as many prescriptions as psoriasis. So it really -- it's exciting that we're sort of neck and neck there. So obviously, we'll spend a minute now before we get to the Immunovant, Dermavant content on brepocitinib. Because we've talked a little bit about it on our earnings calls, but this is an important moment because that lupus trial is now fully enrolled. So as a reminder, this is a drug with a novel dual mechanism, it dually inhibits TYK2 and JAK1. We announced the formation of Priovant around it. It was in-licensed from Pfizer. And it's just a really powerful medicine. It consistently delivers clinically meaningful benefits in tough indications. We have 5 positive Phase II studies with the drug, and we'll talk a little bit more about some of that data. Crucially, we're going after specifically diseases that are mediated by a combination of TYK2 and JAK1 signaling, where we think the biological rationale for our work is particularly sort of clear. And that to us has led us to dermatomyositis where we have our ongoing pivotal program and lupus, where as I said, I'm proud to announce, we have a fully enrolled potentially registrational study that we'll read out next year. And that's just the beginning of this franchise. It has IP out to 2039. So given the consistent delivery by the drug, we think there's opportunities to do even more with it in the future. As far as lupus is concerned, again, because this really is a significant clinical catalyst for us in 2023, I would say, there's lots of good biological rationale for JAK1 and TYK2 working based on the signaling, based on understanding of SLE disease biology. But we have also a lot of clinical data to inform what we think this may look like. And as you can see here, in particular, we are a dual inhibitor of JAK1 and TYK2. Well, we've got data from a JAK1 inhibitor. On the left-hand side of this page, you can see data from brepocitinib in SLE. And then we have data from deucravacitinib, the recently approved TYK2 at [ BMS, ] which is a TYK2 in SLE. And you can see both of these drugs demonstrate statistically significant, clinically meaningful benefit in SLE. And we have good reason to believe just simply the combination of JAK1 and TYK2 should provide meaningful benefits. But then on top of that, we're just a big gun. We've been a very potent drug in the studies that we've run. And you can see here, there's a number of indications where we have cross-trial comparison data between brepocitinib and either deucravacitinib, brepocitinib or both. And those indications include psoriatic arthritis, they include plaque psoriasis, they include alopecia, they include ulcerative colitis. And you can see in basically in every situation in which we have a clean comparison across trials, brepocitinib is the bigger gun, brepocitinib has delivered really good efficacy. So these are all cross trials. We're not actually developing brepocitinib today in these indications. But given the efficacy that each of these programs showed in lupus, we feel like there's really good both clinical evidence and biological rationale for brepocitinib's potential to be a best in category treatment for patients with lupus with unmet need. So this is the trial design, as I mentioned, 350 patients fully enrolled. We'll read out next year, and we will be able to sort of see the path there and if successful, we believe this has the potential to be 1 of 2 registrational studies in lupus. So the last thing before we move on for the day is, we're not going to spend a lot of time today on discovery. Obviously, I remain excited about the work that we're doing in discovery, and we've worked hard to make sure that organization is as efficient and focused as it can be. We've done some work to remove some costs from the system and really get the team focused on the problems where we think there's the nearest term chance of delivering valuable evidence. You can see we're currently organized as these 5 Vants and each Vant working on a different specific problem in computationally mediated drug discovery in targeted protein degradation and protein covalency, et cetera. As I said, we will have an event soon either later this year or the very beginning of next year, where we talk more about what's going on in the discovery side and more about our computational platforms more broadly, and I'm looking forward to sharing that when we get there. So the last thing I'll say before we move on, and I'm excited to hear from Pete in just a minute on Immunovant IMVT-1402, is 2023 is definitely without a question, it's Roivant's biggest year yet. The VTAMA launch, which is just at the earliest innings now. We're getting about 3,000 scripts a week, there are 90,000 scripts a week in topical prescriptions for psoriasis alone. We are at the very beginning of what that drug can do in terms of impact for patients. And next year is really the year we're going to see that come to fruition. We're going to see that script volume. And we're going to see the commercially stable P&L. We're going to see the gross to net yields that are sort of supportive of a viable business, and we know that because our early discussions with payers are ongoing right now, and we'll provide you an update on that when I talk a little bit more about Dermavant later today. On top of that, next year is the year that we get our pivotal data in atopic dermatitis. And that massively expands the patient population that could potentially be treatable with VTAMA, if that data are successful and lead to an approval. And so we're really excited about that data and the attributes of the product suggests we could have a really meaningful benefit there. We were also -- we're announcing IMVT-1402 today. Notably, we will get clinical data from IMVT-1402 next year. So that drug will be in a Phase I study more or less immediately very shortly next year, and we'll read out next year. And so we'll understand the profile. And then that drug is set up, the way that program is set up, we will be able to go straight to pivotal trials just after that Phase I study. So with all the biologic rationale that comes from IgG lowering informing our trial decision. So again, more on that from Pete in just a minute. And then finally, and I mentioned this already, we've got a number of important Phase III data readouts, and that includes this potentially registrational study in lupus from brepocitinib, which has the potential to be really interesting and differentiated in that indication. So a huge year ahead. I'm excited to meet many of you, talk to many of you as we get out in the field and talk to people. But really exciting opportunity coming. And with that, we're going to get into meet of today's content and I'm going to hand it over to Pete Salzmann to give a presentation on IMVT-1402, and Pete's calling in from Korea where he is currently traveling. So thank you and take it away, Pete.

Thanks for that introduction, Matt. Today, I'm excited to announce our plans to build a leading anti-FcRn franchise consisting of batoclimab and another asset of ours under development, IMVT-1402. I'll be making some forward-looking statements, and I direct investors to this slide filed with our 8-K today and posted on our website. Everything at Immunovant starts with our vision to enable normal lives for people with autoimmune diseases. We want to bring therapies to market that improve substantially on the standard of care and provide differentiated benefits versus other therapies in development. With that in mind, I'm excited to unveil for the first time today, IMVT-1402. And as I think you'll come to see as we progress through the presentation, 1402 is a truly exciting new product that we believe will dramatically expand Immunovant's clinical and commercial opportunity and together with batoclimab, enable us to deliver a leading FcRn franchise. 1402 is a fully human monoclonal antibody that inhibits FcRn and is the product of a long-standing effort to bring another novel, potentially best-in-class anti-FcRn antibody forward to complement batoclimab. With the addition of 1402, our anti-FcRn franchise has even greater potential to address unmet need for people with autoimmune diseases. To bring everyone up to speed on our progress with 1402, our team has conducted the key development work needed to introduce this next-generation anti-FcRn today. As I'll show in a few minutes, animal studies have demonstrated that 1402 may have deep, potentially best-in-class IgG lowering similar to batoclimab and with minimal impact on albumin and LDL. We believe that 1402 development can be accelerated by leveraging data from across the FcRn class. Data from our ongoing studies with batoclimab also represents an acceleration opportunity as these data provide proprietary insight into patient responses. In addition, we intend to rapidly advance 1402 into the clinic with the goal of initiating a Phase I study early in 2023, assuming FDA clears our IND. Based on this time line, we expect data from this study in mid-2023. Finally, 1402's composition of matter patent, if issued as anticipated, is expected to have a patent term that extends to at least 2042. Before sharing more information about 1402 with you, I want to first take a step back and emphasize the opportunity we see for the anti-FcRn class. This mechanism has broad therapeutic and commercial potential with 19 indications currently being pursued across the class. To date, we have announced development programs for batoclimab in 5 of these indications, which are listed in blue on this slide. As you know, batoclimab, our lead asset has been observed to deliver deep IgG reduction via a simple subcutaneous formulation. With so much opportunity across these indications, we've naturally been focused on continuous innovation. In fact, we've been able to take advantage of our knowledge and capabilities gained while working on batoclimab to develop 1402. I would like to share what makes the anti-FcRn class so attractive for continuous innovation and for a franchise approach. First, IgG is a well-established biomarker with more than 10 late-stage trials showing a correlation between IgG lowering in clinical response. We believe this increases the ability to apply learning across development programs for key decisions like indication, selection and study design. Second, across indications, there's a lot of clinical heterogeneity. This means that different patients likely require different degrees of IgG suppression in order to achieve maximum clinical benefit. This is a central point to our strategy as we believe many patients may require especially deep IgG suppression, potentially as high as 80% to achieve a maximum clinical benefit. In some cases, the need for the steep IgG suppression is for a relatively short period of time, during 12 weeks of induction therapy or during 4 weeks of rescue therapy. In other cases, we believe the need for deep IgG suppression will be longer than 12 weeks. Finally, because IgG reduction is a well-established biomarker for efficacy in autoantibody conditions, we believe we can leverage not only published data from other anti-FcRn programs but also proprietary patient level data from batoclimab's development programs to accelerate the development of 1402, potentially going from Phase I directly into pivotal trials. I'll now share some of our initial insights on 1402. We are developing 1402 with 3 key product attributes in mind. Our first aim is to match the deep IgG reduction what batoclimab can achieve and which we believe may offer an efficacy advantage in multiple indications. We also intend to match batoclimab's simple and convenient route of administration. Our team has completed CMC and formulation work to enable simple subcutaneous delivery that can be administered in seconds. And finally, we aim to deliver a profile with minimal or no changes in albumin and LDL. Animal studies with 1402 predict this potential profile in people. You may be wondering why we decided to introduce 1402 today. We recently received these data from our first 1402 study in monkeys and find them to be promising. With these validated data in hand, 1402 is now an important component of our franchise strategy alongside batoclimab based on studies across the class, cynomolgus monkeys have been observed to be a reliable pharmacodynamic proxy for anti-FcRn mediated impact on IgG and albumin. While this monkey study used intravenous infusions, we have preliminary data from other ongoing studies with 1402 that indicate we have similar pharmacodynamics in cynomolgus monkeys whether it's IV or subcu. And this is also what we observed with batoclimab. Let's look first at the blue line on this slide. The blue line is a positive control and represents batoclimab administered at a very high dose, 50 milligrams per kilogram q. week in the monkey is roughly 5x the 680 milligram q. week dose in humans. So batoclimab is much more than maxed out at this dose. The purple line in this figure is a mid-range dose of 1402. Next, let's look at the gray line. This is 1402 given at the same very high 50 milligram per kilogram dose as batoclimab in blue. We expect the potency of 1402 to be about the same or perhaps slightly higher than batoclimab on a milligram per milligram basis. The gray line shows nearly identical IgG lowering compared to the blue line, suggesting that batoclimab in 1402 are the same or similar at the highest dose with regard to IgG lowering. Remember that we have observed batoclimab is capable of IgG reduction up to 80% in humans. And since we already know how well it behaves in humans, what we're really looking for here was whether 1402 would have a similar effect on IgG lowering. When we studied that question, we found the remarkable overlap between batoclimab and 1402 that you see in this slide. Again, these compounds were studied head-to-head in the same study and at the same dose. So this result really gives us confidence that 1402 can achieve similarly high IgG reductions in humans in our planned Phase I study. Taken together, these data give us confidence that we'll be able to develop 1402 doses that should roughly match the 340 milligram and 680 milligram doses of batoclimab in terms of IgG lowering in people. This slide shows data from the same monkey study. The figures show similar changes in albumin, total cholesterol and LDL for 1402 compared to placebo. I'll walk you through the graphs in more detail, but if you consider the results from the last slide, that 1402 appears to lower IgG to the same extent as batoclimab, and then combine it with what you see here, that 1402 has an effect similar to placebo on albumin, cholesterol and LDL. In this study you can understand why we're so excited to be unveiling 1402 today as part of our franchise strategy. Starting on the left-hand side, this is the most important graph because we believe albumin reductions are the driver of the analyte abnormalities we've observed in LDL in the past. Looking first at the purple line, which is the intermediate dose of 1402, it looks pretty similar to placebo during the dosing period. The gray line shows the supratherapeutic dose of 1402, and it was basically the same as placebo, which is the green line over the dosing period with regard to albumin. Staying with the gray line, if you look at the period of time just after the fourth dose around day 28, the gray line is actually numerically higher than the placebo in green. Remember, 50 milligrams per kilogram is a supratherapeutic dose, around 5x the 680 dose in humans. So even at this very high dose, which we use intentionally to try to surface any issues, you'll see 1402 and placebo looks similar with regard to albumin. This is quite different than the blue line, which is the supratherapeutic dose of batoclimab. Now to the middle and right side. For both cholesterol and LDL, the intermediate dose of 1402 in purple was essentially the same as or sometimes lower than placebo. And the high dose of 1402 in gray was also about the same as placebo throughout the dosing period. Taken together, these data may predict that we'll observe no or minimal albumin or LDL changes in humans with doses of 1402 that are similar to 340 and 680 of batoclimab in terms of IgG lowering. Overall, we believe this is a significant finding. It indicates that 1402 may combine 2 key features not yet found together in other anti-FcRns. This next slide shows a ribbon representation of the X-ray crystallographic structure of batoclimab and 1402 binding to the Fc receptor. This is the result of actual co-crystal structure work that was done and is not just an illustration. Albumin structure and binding to the Fc receptor is also shown. Focusing on 1402 on the right, you can see how 1402 was intentionally selected to not interfere with the albumin binding site. And the binding of 1402 to FcRn looks different than the binding of batoclimab to FcRn. This x-ray crystallographic structure gives us additional confidence in the monkey data that I just presented. Moving now to review our completed and ongoing development work for 1402. This work includes the near-term completion of the 6-week nonclinical study which will support our planned IND filing in early 2023 and the GMP manufacturing run of high concentration drug product earlier this year. Finally and importantly, the expected Phase I development cost for 1402, including CMC costs are included in the cash guidance that we've shared today. So our cash runway remains as previously disclosed, with runway expected to last into calendar year 2025. Given the product profiles and development time lines of both batoclimab and 1402, I'll now share some of our strategic thinking on how we'll pursue this franchise opportunity. As I mentioned, the anti-FcRn class is unique in terms of indication breadth and strength of IgG as a biomarker. Given this, we believe we have a tremendous opportunity for our franchise with the addition of 1402. Batoclimab already comes with a high degree of dosing flexibility and has been observed to deliver among the deepest IgG reductions observed in the anti-FcRn class via a simple subcutaneous injection over a matter of seconds. This dosing flexibility enables 2 attractive dosing strategies, namely induction and maintenance and fixed duration dosing. But given the inherent heterogeneity of many autoimmune diseases, we believe there are other patients that could benefit from sustained maximal IgG reduction, delivered chronically via a simple subcutaneous injection with minimal impact to albumin and LDL. We believe this group represents a large opportunity to expand our reach in autoimmune diseases utilizing 1402. Building on the general dosing strategy on the last slide to get specific, we believe batoclimab is well suited for indications that benefit from tailored dosing. This includes induction and maintenance therapy in myasthenia gravis and CIDP. For these indications, we believe patients need deep IgG reduction early on to gain control of symptoms, and more moderate IgG suppression chronically to manage symptoms. We also believe batoclimab is well suited for fixed duration therapy as in thyroid eye disease, where we anticipate 6 months of therapy will be the norm. Where do we expect deeper IgG reductions to be needed chronically? In many indications in rheumatology and also for indications in hematology. We expect some of these indications will need an induction period longer than 12 weeks. And in other cases, we expect chronic deep IgG reductions to be required for maximum benefit. With this anti-FcRn franchise strategy, we expect to benefit from synergies that result from developing multiple assets within the class. Graves' disease is an example we've been thinking a lot about. The expected development time lines for batoclimab and 1402 in Graves' disease dovetailed nicely. Because we expect to have Phase I data for 1402 in a similar time frame that we plan to have initial Grave's Phase II data for batoclimab, the expected Phase II data with batoclimab will provide us with proprietary insights regarding FcRn development in Graves'. And the planned Phase I study of 1402 should provide data required for dose translation from batoclimab to 1402. This is one concrete example of how applying batoclimab learnings to 1402 development, they enable us to accelerate the development of 1402 from Phase I directly to pivotal studies. This slide shows why we find the potential of our anti-FcRn franchise so compelling in the context of the growing anti-FcRn market. The first column of this table outlines key product candidate and program features for this emerging class. The Xs indicate how this might play out. Recognizing it is early days for 1402, the product candidate features shown in the last column represent our expectation based on animal studies. The first few rows on this table outlined how batoclimab and 1402 may differentiate from efgartigimod on both IgG reduction and route of administration. Importantly, the dashed box highlights how these product differences may potentially translate to differentiated dosing schedules. The deep IgG reduction and subcutaneous dosing in seconds enables multiple dosing strategies that we believe are currently unique to our franchise and enable tailoring to address the heterogeneity inherent in many autoimmune diseases. Should our preclinical results for 1402 be confirmed with our Phase I study planned for 2023, we believe the addition of 1402 may fundamentally shift the competitive landscape in favor of an optimized 2 asset franchise approach to maximize the potential benefits across many indications. To sum up, some broad takeaways. I'll reiterate that batoclimab development continues full speed ahead. We have announced pivotal programs for MG, CIDP and TED. Indications where induction, maintenance or fixed duration dosing leverage batoclimab's unique profile intended to deliver differentiated benefits to patients. As part of this development and with the addition of 1402, we have the potential to benefit from additional synergies. In particular, we believe batoclimab may allow for potentially accelerated development of 1402 by generating data on optimal dose and dose frequency as well as subgroup identification and broader market indications for example, in rheumatology. The combination of batoclimab and 1402 also sets up the opportunity for future commercial benefits. Assuming regulatory approval and success of our brepocitinib program, we believe its earlier launch may enable a range of commercial advantages for the franchise. This slide lays out upcoming expected catalysts. Together, batoclimab and 1402 could deliver both short-term and longer-term value. As seen on this slide, development milestones for 1402 fit in nicely with the rich flow of data expected for batoclimab. Given our confidence in the mechanism, planning for 1402 pivotal trials will be done in parallel with its Phase I so we can move rapidly from top line results to regulatory interactions to start of a pivotal trial. In closing, I want to reiterate the main points from today's call. First, we're excited about batoclimab's potential in MG, CIDP and TED, and those programs are moving ahead as planned. As previously disclosed, we will also continue with our planned Phase II study of batoclimab in Graves' disease, and we expect to engage with the FDA on warm autoimmune hemolytic anemia by the end of 2022. Second, we believe 1402 could bring together a constellation of features not yet seen with any other anti-FcRn. And finally, as I described a few minutes ago, we believe the anti-FcRn market lends itself well to a franchise approach with a strong biomarker that can improve both the efficiency and effectiveness of developing batoclimab and 1402 together. We believe that being in a position to potentially offer 2 distinct FcRn molecules affords us unique development and commercial opportunities and will help Immunovant truly maximize the opportunity ahead of us in this important drug class. Thanks for your time, and I look forward to addressing any questions.

Thank you, Pete. I appreciate that. Obviously, an incredibly exciting development for Immunovant and for Roivant and something that we're excited to watch in the near future. So I'm going to turn now to the next portion of our discussion, which is going to focus on updates on the VTAMA launch and on the KOL panel to comment. I'm going to speak a little bit now about where we are in the launch and some updates and practical status. And then I'm going to turn it over to Phil Brown for Immunovant, who's lined up a panel of some key opinion leaders to talk about their actual experience prescribing VTAMA, on which I think we're going to hear some really interesting things. So first, just to highlight a little bit about what I suspect you know we're really excited about. This launch in short is just -- it's going as well as we could possibly have hoped for. I think we've shown over 30,000 prescriptions since our launch as of September 16, obviously, more every week, across 5,200 prescribers now. And notably, a significant portion of those prescribers have now written the drug multiple times. So it's really -- it's an exciting sort of development from that perspective. This became the #1 prescribed branded topical for psoriasis 8 weeks into launch. And this is just getting started. There's 4 million annual topical prescriptions for psoriasis and 15 million annual topical prescriptions for atopic dermatitis. So even though we've said how the launch is going, really, we're at the very, very earliest part of the very, very earliest innings, in terms of the opportunity space here, and it feels great to be out there with our messaging and out there with the level of good feedback we're getting. We are getting extremely good early feedback from health care providers. You will hear this on the panel. I think one thing that we're hearing a lot about is our onset of action. People are seeing fast results. Frankly, we are seeing significantly lower reported AE rates than we observed in our clinical trials, and so that's also been interesting for us and obviously favorable and helpful from a patient experience perspective. There has been a recent topical launch of a competitor. It has not impacted our launch trajectory. I think we have a clearly differentiated product with our robust remittive effect with no labeled drug-to-drug interactions or contraindications and with a unique mechanism of action. And then we're on track to achieve really high-quality balance reimbursement. I'll talk a little bit about that in just a second. So some key updates here. First of all, we've built and I mentioned this just a second ago, we've built a really strong base of prescribers. We've had 5,200 or more unique writers at this point. And notably, 74% of them have written the product multiple times, which gives us -- many of these prescribers write many, many, many topical scripts a year, seeing literally thousands of psoriasis patients. And so as we build a reputation with these doctors, they see it work in patients, we're really excited for what that means in terms of what we're able to build from here. And then the other thing I'll say, and this is an important update. The quality of our prescriptions has been very high. And what I mean by that among other things is there is a large volume of successful prior authorizations going through the system. So in a significant number of cases, docs are doing the work to get the drug approved and covered by insurance plans. It's obviously good for us economically. It's good for our gross net, it's good for our P&L. But also, those are exactly the kinds of scripts that are needed in order to work with the payers in order for them to understand, and we talked about this a little bit on approval, for them to understand how important this drug is to patients. They need to see it on their P&L and to see those prior auths. So that's been helpful. There is one thing I want to hit head on, we've heard from the buy side, we've heard a little bit from the sell side, something I suspect is coming from one of our competitors in some public and maybe private settings that are -- that somehow our numbers are not apples-to-apples comparable with other launches or that we benefited from some sort of free drug program. And I just want to be very clear, it's just not true. We had no free drug program. Our prescriptions are of high quality, as I just indicated. We are getting the prior auths that we need. We did have a limited time offer program that was a co-pay buy-down program, but I want to be clear that was a very limited program. It ended in August. So obviously, all of our scripts since August are totally unaffected by us, and it's less than 10% of scripts -- 10% of new prescriptions overall. So overall, really, really pleased with the quality of our scripts. I think they are absolutely apples-to-apples comparable with any other topical launch out there and think they're of high quality. I think what comes from that, and I guess one thing I'll say before I get to this, we have not begun any sort of real meaningful broad DTC or broad consumer marketing. We said we probably wouldn't ramp that up until payer contracts were in place. And notably, we haven't. And so there's just a lot of -- again, we're just getting started. There's a huge sort of addressable market that isn't aware of the product that were not out to yet, and that's what comes next after we get this sort of payer phase done. As it goes, the payer discussions are, as you would expect, given these metrics, as you would expect, given the script quality, the payer discussions are encouraging. Contract negotiations are ongoing as you would want them to be. And I'll say, I think the quality of the prescriptions, the quality of the launch allows to -- I think we're pulling in our guidance in terms of how long this is going to take for us. I think we're going to have our first PBM and payer contracts likely in place this year. I think you'll see a corresponding faster rate of transition to a sustainable [ P&L. ] Obviously, this stuff still takes time. Once you get the payer contracts in place, you start to see an improvement, but it's got to filter through the other payers and PBMs and we'll talk more about that in just a second. And then finally, look, the other way in which we're just getting started is we're going to have our Phase III data in atopic dermatitis in the first half of next year. Our Japanese partner, Japan Tobacco produced positive top line data in atopic dermatitis in a much smaller study than ours. So that obviously gives us confidence overall. And we think there's a real opportunity once that approval comes in assuming the data are successful to blow this out into an even larger, 4x larger market. So exciting and stay tuned for that data. Obviously, we'll provide that update when we can. So just a couple of sort of highlights from the launch. We feel really good about our momentum here. We have over 30,000 scripts since launch. Other than Labor Day week, we've been building sort of exactly as we want over time. And it's just -- it's been a really great launch. And you can see our share has been ticking up as well, which is something that we're watching as we would like to become a meaningful portion of that market. As compared to other launches, I'll just say again, we're really pleased. I think you can see, overall, as you look at these other projects, as you look at script volumes, as you look at the field overall, we're sort of rapidly growing in share. We are as of 8 weeks after launch, as I've said before, the #1 branded topical therapy in psoriasis, and we think we've got a huge room to grow from here. And maybe we're outpacing other launches sort of week by week. And I mentioned earlier, we're keeping pace with OPZELURA, which is in a market that's 4x as large. So really exciting from sort of a launch metrics perspective. Now I want to reiterate that we're just getting started point here. And this slide almost looks silly, but just to make a point, we're getting about 3,000 scripts a week. There are -- this was in a recent week. There are over 90,000 scripts for topical patients in psoriasis alone every week. So there is a huge opportunity to grow from here. And given the pace of the launch and the feedback that we're getting from HCPs, this really is what we see as the addressable market. This really is the opportunity for us. And that's just on topicals. There's also many patients on biologic therapy with whom -- for whom this would either be a potentially interesting concomitant therapy or, in some cases, maybe even patients will be happy on VTAMA in a way that they couldn't have been on corticosteroids or other topicals. And so we'll be able to take patient share from some of the biologic in downstream systemic therapies. So it's a really large market. And given our launch velocity and the earlier quality of our scripts, we feel very privileged in terms of where we are. Now the last thing I'll do is I'll just give a brief sort of market access update. And so I'll just remind people, what we said at the beginning, and we talked a little bit about price and we talked a little bit about market access strategy. This is really about balancing all of the different people that are important customers, important sort of stakeholders in the launch. And that obviously includes the 3 major PBMs. Most people sort of negotiate earliest with them, and you can imagine those discussions are ongoing. They cover a significant number of lives. But as you remember, some number of the plans underneath those PBMs follow the PBM formulary determination. So those first contracts that you get with the PBMs flow through to some percentage of lives. But then there are downstream plans from there that are either sensitive to WAC or sort of make their own formulary decisions that are their custom formularies and they may take the contracted rates from the PBM or they may work off the same PBM contracts. But you talk to them separately about getting on plan and getting on formulary. And so as a reminder, as we start to announce contracts coming in, we should see immediate formulary improvements, immediate sort of proper coverage for a portion of covered lives. And then we'll continue to provide updates as we get through the plan universe and as we continue to contract more deeply into this. From a guidance and time line perspective, I'll say this. We are really excited for where we are. And I think we have measurable success at this point that leads us to believe this is going to be an attractive sustainable P&L. I'm now expecting that we will have within the next 3 to 6 months, those first key contracts in place that we will begin to see optimizing formulary position, will begin to see the kind of access that we want during that period. We'll begin to see that transition into a more stable business. It's going take some time to ramp up and then over the 6 to 12 months beyond that, you'll continue to see us optimize our GTN even beyond what we get with those first contracts and it will continue to sort of improve over time as we work to the optimization, we maximize the program value, and we continue to grow both in terms of script volumes, new markets and also in terms of the P&L. So the very last thing I'll say before I turn it over to the Dermavant team to share some of the health care provider feedback. In addition to psoriasis, as you all know, we have this Phase III program ongoing on atopic dermatitis. Our enrollment remains on track. We're going to have data in the first half of next year. There is strong patient and very strong prescriber enthusiasm for the trial, including the long-term extension study, which is similar to what we did on the psoriasis side. We obviously have really good efficacy from our Phase II trial. It's efficacy that we think is competitive and puts us in exactly the right position for these AD patients. You can see some of it on the slide, and you can see the trial design, which we've put out before. Again, first half of next year and then looking forward to what we hope will be a positive study there and then approval thereafter. So with that, I'm going to turn it over to Phil Brown from the Dermavant team to run a panel with some key opinion leaders who have sort of real, from-the-ground feedback on their experience with the product, they're experience prescribing the products for patients. And so I'm going to hand it over to Phil and looking forward to that panel, and then we'll come back together for Q&A after. Thank you very much.

Thank you, Matt, and good morning, everyone. As Matt mentioned, I have the privilege today to speak one-on-one with a group of dermatologists who have had direct experience with VTAMA cream and hear real-life experiences of their patients. I'd like to give a very warm welcome this morning to Dr. Alexandra Golant, Medical Director of the Dermatology Faculty Practice and Program Director of the Dermatology Residency Program at Mount Sinai here in New York. Dr. Ben Lockshin, Director of the Clinical Trial Center at U.S. Dermatology Partners in Silver Spring, Maryland; and Dr. Mona Shahriari, Assistant Clinical Professor of Dermatology at Yale University, Associate Director of Clinical Trials at CCD Research and senior editor for the Journal of Psoriasis and Psoriatic Arthritis. Welcome, and thank you all for joining me today. Now as you know VTAMA cream received early FDA approval in May 23, 2022. And it became the first topical novel chemical entity approved for plaque psoriasis in the U.S. in 25 years. It has an extremely broad label. It was approved for use in both mild, moderate as well as severe adults with plaque psoriasis. And you can see that VTAMA offers some very unique differentiated characteristics where we have the ability to use anywhere on the body for any period of time without concern for these significant safety concerns associated with topical corticosteroids. And then also highlighted on this slide is the remittive effectthis 4 months of therapy where patients can enjoy a period of disease maintenance in the absence of therapy. And this is a completely unique characteristic from not only the existing armamentarium, but even some of the newer entrants that we're seeing come into the space. As you can see by the chart here, the uptake of VTAMA cream has been exceptional. With over 30,000 prescriptions to date, VTAMA cream has become the #1 prescribed topical psoriasis product. This rapid acceptance and robust growth is certainly no surprise to us given the clear clinical differentiation of VTAMA cream. But it's not about what we've accomplished thus far, it's the excitement for what is to come. So let's switch gears at this point and hear from our panelists and knowing that each of you have well over 50 patients at present on VTAMA cream. I'm really excited to hear about your real-world experience and how you've incorporated VTAMA cream into your psoriasis treatment regimen and the results that you've started seeing in your adult patients with psoriasis. And maybe I could just start by focusing in our clinical trial data. Clinical trials are really important for FDA purposes. But obviously, when drugs get into commercial use, it has a very different utility and maybe even a different experience relative to what we observed in clinical studies. So we saw this extremely nice efficacy. We saw a fast onset of action. We saw statistically significant differences at about the 4-week point in terms of a [ PGA ] response, which is clear, or almost clear, and that's associated with 2 grade improvements. So that's a really high threshold to begin with. And that's, of course, the way we think in clinical trials. And then it continued to improve through that 12-week period where we had about a sixfold improvement over vehicle. So I'm just curious, in terms of -- in light of those data, what has been your individual experiences. Maybe Dr. Golant, I can start with you and just hear how you've felt about VTAMA cream and how your patients have responded?

At Mount Sinai, we were really fortunate much like many of my colleagues to be one of the clinical trial sites for the [ Sorin ] trials. And I would say in the real world, it is always a really nice surprise when the drug really exceeds expectations that have been set forth by the trials. And that certainly has been the case for VTAMA. What has really struck me using this post approval in the real world is really the fast onset of action. I am seeing some of my patients come back into the office or message me through the portal telling me they're clearing as early as 1 to 2 weeks into therapy, which has really been a surprise to me. I don't know what my colleagues have been seeing as well, but I guess it might be similar.

Yes, I was granted early access to the medication once it was approved, and I've have had a lot of experience that really mirrors what was seen in the clinical trials. Incorporating patients with both mild, moderate and severe psoriasis really emulates how I'm prescribing this either as monotherapy or in conjunction with other medications, systemic agents. And what I've seen is that the early response mirrors what I'm accustomed to seeing with topical steroids, which for many years, for most of us have been the gold standard. Mona, what do you think?

With the topical cortical steroid, for example, they have to use it for a certain period of time, otherwise, they'll have side effects. And then when they use it, the disease will clear, but as soon as they stop the medication, the disease comes back. But to give them that hope that you're going to use it for a period of time, and then you can stop this cream and not have to worry about your disease is really awesome for patients. There is an inherent bias when you're thinking of a nonsteroidal medication. In dermatology, we've had a track record of medications coming down the pipeline, promising us the world and then not delivering on those promises. So with VTAMA, I think all of us were excited because we were in the trials, we saw what it was going to do, but we didn't know how it was going to perform. But in my personal experience, I have to say, you guys underpromised and overdelivered. The onset of action, the overall efficacy, even in patients who may not have met a primary endpoint by the clinical trial design, we still have clinical success when that patient is happy. And these are all things that make a difference for our patients. Based on my experience in the real world with what we've shared here and what I've seen happen in the eyes of my own patients and the rapidity of the improvement, this has really positioned itself as a first-line monotherapy topical treatment for our patients with plaque psoriasis. And that really is a very significant change in the way we treat this disease.

Has it changed the way that you can interact with your patients in terms of just an introductory conversation and that may be for a patient that's naive to therapy or even a patient with more experience -- has experienced a variety of other therapies.

Absolutely because usually, my conversation with the patient is, I'm going to give you 1 topical for your scalp, 1 topical for your face, 1 for your trunk, you're going to use this for the next 2 weeks. Then when things are a little better, you're going to only use it on the weekends. I'm going to give you this other medicine that you're going to use Monday through Friday. But if the disease comes back, you're going to go back to that first medicine. And I'm sending them home with convoluted regimen that even I can't keep straight and they come back having used the medicine in the wrong location and now they have side effects. But with VTAMA, I'd simplified this whole regimen for them. One cream that they can use for any severity of their psoriasis, anywhere that they have the psoriasis for as long as they want to without having to worry about any sort of side effects.

What I've heard from all 3 of us is, what we did prior to VTAMA, which means that this is really a paradigm shift of how we're managing these patients. I think that the cornerstone of topical therapy for me has radically shifted in a matter of months to using this as a primary treatment and thinking about the other therapies as adjuvant therapies to combine with VTAMA, if necessary.

I guess equally important is how have your patients responded to this. This is new for them as well. So clearly, you've had an opportunity to sort of have a different conversation with them. But how are they -- what's the feedback you're hearing from them in terms of their initial exposure to VTAMA cream?

Well, I'd just say my experience has been fantastic. Patients tell me that the feel of the cream is very elegant. They're not having any tolerability issues. I've been privileged that over the last 3 months of prescribing it, I haven't seen any side effects yet. I did have 1 patient who developed the "folliculitis." She did not want to go off the medication. We kept her on it and it kind of resolved on its own. And 1 patient that really stands out to me with this is a patient I wanted to start on a biologic, who did have that moderate-to-severe disease, primarily on the legs, which is a location that's historically been much more refractory to treatment in general. But she didn't want to go on a biologic. And she asked me is there anything else that we can do. So I gave her VTAMA, and I saw her back in about 4 to 6 weeks to see how she was doing. And she cleared 100% on this medication. She showed me pictures of herself in shorts, and she told me she never thought she could wear shorts again. She got teary-eyed, I got teary-eyed. But that moment just showed me that this drug is not only impacting the disease itself. It's changing people's lives. And I think that's the take-home message.

I think the versatility too in terms of how VTAMA is prescribed and where it fits into the treatment algorithm for psoriasis also makes it very unique. It can -- as we've all talked about, be very safely used as monotherapy, but also as an adjunctive therapy to patients on systemic agents, including orals or injectables before those agents, along with those agents for residual lesions. Similar to hearing your patient story, I also had a similar patient, a gentleman in his mid-20s, who came back to our office was prescribed acitretin a couple of years ago for severe palmoplantar psoriasis. It was the only thing that cleared him when biologics did not. He suffered terrible alopecia from the acitretin, decided to go off, but now psoriasis was really bad. And I said, you know what, if you're up for an experiment, let's do VTAMA cream and let's just see. And he was completely cleared in 3 to 4 weeks into treatment and did not need to go back on his acitretin. That is -- honestly took my breath away. I was extremely, extremely excited about that outcome. And I think we will all have more and more stories like these as time goes on.

And on the other side of the spectrum, I had a woman who came in yesterday, who's been refractory to multiple systemic therapies. And we're always concerned about this patient type. When you fail 2, 3, 4, 5, 6 different biologics, the patients are concerned, and you as a provider are concerned, you're like, okay, what are we going to go to next. And this woman was on a higher than conventional dose for her biologic plus cyclosporin and she still had these large thick plaques on our legs. And I added VTAMA cream on. And what we saw is that when she came back, these spots melted away. And I was a little bit surprised, especially given the fact that previous to the VTAMA cream, we could never get her past the certain point of clearance. And it really does open up that spectrum of disease to really think about using VTAMA in all patient types.

A couple of you brought up -- or all of you have brought up now some experience this with patients that you've achieved complete disease clearance. Obviously, that was a key finding from our studies. And my personal belief is that somewhat unique for topicals to even focus on a PGA 0 or PASI 100 is a complete absence of disease during a clinical trial. We had 79 patients who achieved complete disease clearance in 12 weeks. And ultimately, with continued use, we know the drug continues to work beyond that 12-week period. It's durable on therapy, and it continues to improve. And ultimately, we got about 41% of our full population or over 300 patients through regulatory success. Is that unusual in your experience with a topical to be able to achieve that, whether it's mono therapeutically or in combination with the armamentarium you had at your fingertips prior to VTAMA cream?

I think you should note something that's very important in terms of the patient demographics, is these patients have more body surface area and a higher baseline PASI score than what I would traditionally think of for using a topical medication for. And to see the response rates in these patients really impressed me and makes me think twice about jumping to a systemic agent.

I think either Mona or Ben used the word paradigm shift. And that's what we mean when we talk about a paradigm shift. That is the way it redefines who is a candidate for a topical therapy, who is a candidate that you would give a topical to or offer a topical to, I mean earnest to a patient with psoriasis and hopes that, that alone or in conjunction with the systemic will help provide clearance. That is different than how we treated this disease before and cannot be overstated.

And I know when the medication launched, obviously, I had my experience in clinical trials, but the topical corticosteroids were something I was familiar with. I was reaching for still. But little by little, I kept substituting VTAMA. And those patients were coming back and they were successful, and they were achieving those complete clearance rates. So I remember telling myself that algorithm's changing. I'm reaching for VTAMA now as my first line. And the topical corticosteroids are something that I might think about at a later date. And that's, I think, the beauty of this drug. We can offer safe and effective option. But by far, the most unique thing this medication had, which topicals don't have is that ability for meaningful remission in patients that get to that complete clearance.

Yes, I love hearing that. I was actually going to segue to that, and you beat me to the punch. So the fact that we did achieve PGA 0 in up to 41% of the population. So a very large number of patients, complete disease clearance. That's everywhere on the body, of course. So -- and you're defining that. I wanted to touch on the sensitive area, the intertriginous areas, the genital regions. We know the tolerability was great in the clinical studies and Dr. Lockshin, you just touched on it. But I'm curious, have you all -- either if you all had experience in utilizing the product in more sensitive areas and had a similar result from both what we observed in clinical trials and what was just described?

The key thing, I think, to remember about psoriasis patients is a lot of times, they may have disease where you can see it, but not everybody gets them into a gown. And they may have disease in other areas that you're not aware of. And they may go home with the product you gave them and put it in areas they weren't supposed to put it. With VTAMA as a clinician, I can be assured that if the patient goes home, sees a plaque of psoriasis in an intertriginous area that I may not be aware of, and they decide to slap this medicine on, they are not going to have irritation. They are not going to have stretch marks, telangiectasias, all those things that we would historically worry about a high-potency steroid in those locations.

To be able to give a patient one product that you can say, you can use this head to toe. And I will make a point to say, including face, groin, your underarms, sometimes even the commentary on that prompts them to say, actually, yes, I have a little bit here or there, is it okay? There is sometimes a lot of shame associated, I think, for these patients that have disease in these areas because it is very high impact on their quality of life. So to be able to simplify things for them to be able to give them something they can use without the burning and the stinging and that can get them to an efficacy endpoint they can be happy with, and has been really great as a prescriber.

Excellent. Maybe I can just shift into some photos from the clinical study. This first picture is an individual. Obviously, we're looking just at the forearm, but this patient has extensive disease. So you can see this is a patient with a PGA-3 at baseline, so a moderate level of disease. But the PASI was 17.6. So that would typically be a patient that would be a candidate for systemic therapy. Fairly high burden of disease in terms of quality of life here, the DLQI and a high degree of itch. And then after 4 weeks following randomization, you note that at least the forearm lesion has very much resolved. And you see the PGA has only improved to 2. That's indicating that the patient is moving in the right direction. But we still got an opportunity. We're not at a regulatory endpoint at this point. You'll note that the PASI has decreased to 4 even at that 4 week. And I think this is referencing that very quick onset of action that you all are observing. And then the DLQI and the itch are coming down concordantly with the improvement in the efficacy that's being observed here. And then by week 12, this patient is a complete regulatory success. So that patient has gone from a PGA 3 at baseline to a PGA 0. The PASI is 0 to PASI 100 is a complete absence of disease within that 12-week period. And of course, the DLQI and the itch have come down consistently with the lessening of the burden of the disease. So maybe you could just add some comments of, is this a typical patient for you in your practice, where these erythematous lesions over areas of the body and how you might have approached that type of patient care? And then any sort of experiences that you have since VTAMA has become available?

I would like to speak on this case specifically. Even though this was an individual who was categorized as a PGA 3 moderate disease, by body surface area they are actually considered severe disease, having over 10% body surface area. And to see the robust results as early as 4 weeks is truly remarkable. Traditionally, this would be an individual that I would knee jerk right into a systemic therapy. But this really changes that paradigm in terms of what I'm going to do for these patients.

And is this consistent? I guess, with -- I mean, again, clinical trials can differ from real world experience, but is this similar to what you're experiencing in your use of the product?

I think something that holds true with many of the photos from the clinical trials is how this challenges the treatment algorithm that we've used for so many years because we haven't had a truly new agent or a novel topical agent in so many decades. And what's so powerful in these photos is certainly the regulatory successes, but also looking at the regulatory failures, because to Mona's point, they are thrilled with the level of clearance. They are still much better than where they started that I think it's equally as powerful as looking at the regulatory successes. And I think this is really what we mean when we talk about it being a paradigm shifting in medication in the psoriasis treatment landscape.

I think it's really important to acknowledge the fact that patients don't love being on chronic medications. And when we start patients on biologics, we start them on a lifelong journey. This is not a, oh, when you're clearing you stop, then we're going to restart it. This is, hey, we're going to renormalize what's going on in your body and you're going to stick with this. But for this cream, we can comfortably say, take it until you're clear, stop it, when it comes back, started again. And people love knowing that they can stop and start it and that they don't need to be committed to using a medication all the time.

Yes, I love that. So this next patient is, of course, a different patient. Again, baseline PGA 3 with a PASI of 16. So again, potentially a candidate for a systemic therapy, fairly high significant degree of burden based on quality of life and itch. And this is the lower legs. So this is typically an area that's challenging to treat. But I'm just curious about how you historically might approach a patient like this? And then because VTAMA cream has this very unique pharmacokinetic profile where we don't really generate much in the way of systemic exposure, very, very low levels of systemic exposure can be detected. We don't have to worry about drug-to-drug interactions. And that provides utility for patients who might be on a concomitant therapy or need an additional therapy. So I wonder if you could just comment both in terms of this particular photo and then how you've been able to use VTAMA in your practices. And what the implications of this might be for you?

Label. Especially in this day and age in dermatology, this is a really hot topic. Patients like things that are safe. This makes it easier to counseling your patients in the office when you're not having to walk them through a boxed warning or any serious safety concerns on the label, whether it pertains to the topical or not. You still have to have that discussion. And I think this gives patients extra confidence in something like VTAMA, which has been -- made it extremely user-friendly.

Traditionally, we would switch those patients to a different biologic to get them to that 100% clearance. Because let's face it, in the year 2022, our patients want complete clearance. They don't want kind of sort of clear. But what we can do with VTAMA, which I've done with my patients in particular, is I had a patient who was on a biologic, was doing really well, but had a smallish size plaque on the shin that just wasn't going away no matter what, and he wanted to switch. Historically, I'd either switch to a different biologic or even do an intralesional Kenalog injection for that localized disease but I gave him VTAMA. He came back a couple of weeks later, now he's 100% clear. We're still on the same biologics. My PA team doesn't have to do another round of authorizations. We've saved the health care system money by not starting the process for another biologic. So it's a win-win for all angles.

And just to add on to what Mona was saying, I look at the image of those legs and it reminds me of a patient, a woman who cycled through multiple different biologic agents and is also on cyclosporine as well, still has persistent thick plaques. And I added on VTAMA and her legs look the best I've seen them look in years.

Yes. I think -- and maybe we can switch to a different patient. We'll go to this hand photo next, which is a patient that has obviously a very visible disease. And I can only imagine how debilitating that is, how stigmatizing that is for that particular patient. And while we didn't achieve a regulatory response, a regulatory outcome, very stringent threshold, we see a very nice response that's occurring over the period that they were randomized to study medication. This patient has this 1 grade clinical improvement. And I think that particular patient was probably very happy with that response. So I wonder if you could comment just in terms of any anecdote she may have on a patient who has these very visible lesions. How important a 1 grade improvement might be and whether or not a novel mechanism is contributing to the ability of patients to react to VTAMA cream? Maybe Dr. Golant, I'll start with you.

So when I see photos of " a regulatory failure," knowing that, as you shared, and as the data shows us up to 80% of patients achieved this 1 point or greater improvement, that is closer to what we see in the real world in terms of patient satisfaction. And that really guides so much of what we do, I think, as clinicians. And as again been that really you underpromised and overdelivered, patients come back happy. They come back clear. This is easy to use. They can take a break. It's once a day. I cannot stress that enough. Very, very few patients, at least in my experience, could effectively use a topical twice a day as prescribed. Those things have made huge differences in my practice.

I actually had a patient in particular, who we actually had tried a couple of different agents, and we just decided to go back to basics. She didn't want to be on a biologic anymore and said, I just want to try a more natural approach. But interestingly, she still, when I saw her in follow-up, she had some plaques that were like a PGA of 2 on the legs. The hands were 100% clear, though. And for her, that was a game changer. Because now she didn't have to worry about the pain and discomfort she had every night when those hands opened up and split. She would go to the grocery store, grab an apple and people wouldn't look at her hands thinking that she just puts some contagious disease onto the food that everyone else is going to touch. So it definitely does have more impact in certain areas as well.

Those are great points. And I think just to add to that is this is where there's a true discorrelation between regulatory failure and clinical success. And I think it's represented very nicely in the DLQI scores. This is a happy patient. I go to work and if I've got 1 acne spot on my forehead, my day is kind of ruined. This person no matter what they do, if they're a jeweler, if they're a mechanic, if they're a dermatologist, this is really impacting what they do on a daily basis. So thinking about how the patient feels and how their impact has changed, reflected by that DLQI, is just as important as those numerical changes that we see objectively.

Excellent. Let's move to one last picture. This next patient is an individual. You can see it started out PGA 4, PASI of 19.8. So again, pretty severe, pretty significant target lesion that's highlighted in this particular photo. By the week 12 time point is a regulatory success with the PGA 1 and the PASI is down to 3.8, and you see the DLQI and the itch is completely absent. So we've made a remarkable improvement in terms of how that patient's quality of life, just as you all have been referencing. Now this slide also highlights how that patient responded over the course of the open-label extension study. So while they weren't completely clear at the end of the 12 weeks, this patient obviously entered the open-label extension, continued therapy until they achieve complete disease clearance, that PGA 0, PASI 100, and then they were removed from therapy. So the third photo here highlights the individual who's been off of therapy for a 3-month period of time and still hadn't flared to the requisite PGA 2 required to reinitiate therapy. And the fourth picture here is at week 48. So this patient has been off therapy for a complete 6 months. And you can see this target, this forearm lesion is virtually clear. There may be some lesions beginning to come back on the elbow there. But the patient just at that 6-month time point is beginning to hit that PGA 2 flare requiring a re-initiation of therapy. So again, I wonder if you could comment on the observation of this remittive effect from the clinical trials. And how that might have changed your thinking with regard to approaching patient care and application of VTAMA cream? And Dr. Shahriari, I would start with you on this one.

Yes. So I'd just say in the clinical trial, the remittive effect was by far one of the most amazing features that I saw and I'm sure [ Ally ] saw the same. But it was when the patient went off the drug that they had that meaningful remission. My patient for 5 months, she did not need her cream anymore. And that was very important from a patient care's lifestyle standpoint. They have busy lives. They may not have time to put on a cream even once a day. So to have that opportunity to go off the medication and not be subjected to this chronic medicine for the rest of their life, I think it's very important to the patient.

I think if I can add just to Mona's comments, the ability as a dermatologist to be able to tell your patient that you can use this as a once-a-day treatment, anywhere on the body, you're able to treat until clearance without limitation of that initial period and then stop and potentially have a period of many months after that, that you remain disease-free is something that we didn't have access to from a counseling perspective or from an expectations perspective. And it really makes a huge impact on the lives of these patients with psoriasis to give them time off drug to not make them need to use a topical every day to maintain their clearance. It's incredibly impactful in the real world.

And once again, as we talked about, no one likes putting creams on. No one likes taking pills. They do it because they have to, and knowing that you can potentially have months on end without doing anything and still look pretty darn good, that's pretty impressive.

I think, too, when you look at the baseline photo for this patient, the thickness of this plaque would never be a patient prior to this that I would have thought to treat with a topical, just very frankly. So that is very striking to me. And I think the concept of the remittive effect is not something you're used to talking about in dermatology. It's certainly not something we're used to talking about in the topical space. So the hope that, that provides patients, just the hope that there will be a time they can safely stop this, that they will kind of get this drug-free holiday period where they stay well controlled, is particularly meaningful to them. And as Ben mentioned, the combination of those 2 things, the efficacy, the remittive effect really makes this an unrivaled product in the psoriasis treatment landscape, in my opinion.

I love the way I think Dr. Shahriari, you were describing the freedom or the empowerment patients now have with regard to making decisions about how they're using the therapy. I think it's fairly typical that a patient ends up with a whole drawer full of various topical therapies, and they may get confused about which are to use and when they use it, and now it simplified the regimen, but it's also because they might have this opportunity to enjoy a drug holiday, not for safety reasons, but because their disease is absent. It's really empowering from a patient perspective, I imagine. I wonder if you could -- any of you could comment on that, but maybe I'll start with again with you, Dr. Shahriari because, I thought that was a very poignant statement you made.

Yes, it's definitely empowering because we all have those patients who come and see us with a bag full of meds, half of them are open, half of them are closed, some of the boxes are on them, some of them aren't, they have no idea what's in them. Just to be completely honest, half the time I can't even read the labels because it's been scratched off over the years. For them to be able to throw all that out and just have that VTAMA sitting on their shelf means a lot to them. And this is not me talking about, this is my patient telling me this. I had a patient come in the other day and said that she felt such relief that she could just have a simple regimen that would help her effectively treat her psoriasis because before when I would give her these convoluted regimens, different creams, different times of day, she would go home and have this defeated feeling as if she missed 1 dose in the wrong location, now her disease was going to flare. So that sense of empowerment also leads patient satisfaction.

So in the clinical studies, we also called out AEs of special interest, specifically because we really wanted to understand the profile as a novel chemical entity of VTAMA cream and how patients were responding to it. So these AEs of special interest were called out that we're focused on. And clearly, we see that in our labeling. And I'm just curious, now that you've had the opportunity to participate in real-world use of the product, what you're seeing from a safety perspective? Folliculitis was the most common contact derm. So we do see these localized skin events in our clinical study. So just curious what's being observed in real-world use at this point?

I've been pleasantly surprised in the real world because for the 3 months that I've been prescribing it, I have yet to see any of these adverse events. But if folliculitis is by far the worst thing I'm going to see, I'm a dermatologist, I know how to treat that. So I'm not overly concerned to say the least. What about you guys?

Completely agree. We have many, many patients on VTAMA, both personally and in the practice, and we are not seeing anywhere close to the rates of folliculitis, or the contact dermatitis we -- that were reported from the trials.

Yes. I mean I agree with both of you guys. I mean, in terms of articulating it to our patients, the side effect profile, are they real or perceived, there's very little to talk about. And what I've seen in the real world is actually less than what was reported in the clinical trial data. So I'm very pleasantly surprised. I've had only 1 patient report mild folliculitis. And that's probably because I am prepping them that this may occur. I was like, let me know because I want to know, and I'm just not getting phone calls. And you know what doctors like? Not getting phone calls.

I also think one thing to note on that theme is what's not in the label, right? We're so used to in dermatology, especially in recent years of counseling patients through boxed warnings, through serious language on the label that we have to counsel about. And that does not exist for VTAMA, that provides patients confidence that contributes to the ease of using this medication and I think is also incredibly impactful when considering the safety profile of this drug.

It's nice to know when they go on Google, they're not going to see anything scary.

Thank you so much. Thank you for your support of Dermavant. Thank you for what you do on behalf of patients all day, every day. It's such a great privilege to have such esteemed group of dermatologists come and visit with us today and share their personal experience with VTAMA Cream. Thank you so much. And with that, I would like to hand it back to you, Matt.

Great. Well, I want to thank the Dermavant team for that wonderful panel discussion. And just a reminder, we're now going to the Q&A portion of the event. [Operator Instructions]. So first off, we have Corinne Jenkins from Goldman Sachs. It was a question for Matt. Matt, as you have begun having conversations with payers on reimbursement for VTAMA, what have they learned with respect to their willingness to cover nonsteroidal topical agents at reasonable terms? To the extent there is willingness, what are the features of VTAMA that have shifted payers' view versus prior non-steroidal topical agents in derm markets where reimbursement has been a key headwind to adoption? And then one follow-up for her. Can you describe what you're seeing on refill rates at this point and what -- versus what you expected given where we are in the launch?

Yes, thanks. And thanks, Corinne, for the question. It's a good question. Obviously, top of mind on the sort of payer discussions. As I said in my remarks earlier, which were really good about where the payer discussions are headed. I would say there isn't really like a category -- there's never been a categorical reluctance to cover a topical or give good reimbursement on a typical by payers. I think it's just a question of differentiated products with the kind of demand in the system that payers see and they care about and they want to have the conversation. And so I think the shortest answer is the thing that has got payers excited about this product, having the right conversations with us, willing to cover it, willing to write good formulary, looking for a productive commercial discussion, at some meaningful level, the first thing and the foremost thing is just demand. We're seeing good script demand. We're seeing good quality scripts. We're seeing scripts go through the prior auth process, as I mentioned. And next, the first thing that matters to a payer. I think the attributes of the products that are making that true, you heard a lot of them on the physician panel. I think those same attributes are appealing to payers. And obviously, they do care about the efficacy of the product. I think the remittive benefit is attractive to payers. I think it's really differentiated, the remittive benefit in particular, that helps payers get comfortable with the fact that it's not going to be like a fully continuous treatment. So that's something they care about. I do think, at some level, payers care about the full landscape of therapies in psoriasis, they care about, for example, the approval of deucravacitinib, what that might mean for their P&Ls. But in terms of the sort of tenor of these payer conversations that we're having right now, I'd say, first and foremost, the thing that is really mattering is the high level of commercial demand for the product. The fact that they are seeing their patients and their doctors care about the drug. So that's kind of what I would say about the payer discussions. On the refill rate question, so the NRx and TRx for the product are obviously reported -- we think that reporting is generally pretty good. In terms of versus expectation, look, the launch is going really, really well kind of as well as we could have hoped for. I think the useful sort of factoid or the useful piece of information that we glean from the refill rates isn't like the percentage of refilled script because obviously, the overall number scripts keep growing or whatever, it's good to see a decent number of refills because it means patients like the product, they're using up their tubes. They want to be back on the drug. And that gets us to sort of a little more information on sort of commercial model in terms of tubes per year, but it's really too early to tell because the demand has continued to ramp up through the launch period. But I'd say pleased overall that a decent number of patients are refilling, please both to see that in script data and to hear it from docs and their desire to keep using the drug over and over again with the same patient. And so I'd say overall, all good indicators there.

Great. Next question is for the disembodied voice of Pete Salzmann in Korea. It comes from Dennis Ding at Jefferies. Dennis asks, what will you be measuring in Phase I for IMVT-1402? And what constitutes a successful Phase I result? What gives you the confidence to go straight into pivotal studies and not run a proof-of-concept Phase II?

Thanks, Paul, and thanks, Dennis, for that question. So with regard to Phase I, it's a very straightforward study. We're going to be measuring the same things we looked at in our Phase I trial with batoclimab, which is the impact on IgG across different doses, and we believe we'll be able to predict those doses very efficiently based on the animal studies in both 1402 and batoclimab. And then we'll look at replicating the finding from the animal studies that showed no impact on albumin and LDL. And then finally, there will be a range of adverse event surveying, that's common in Phase I trials. The reason we're able to go directly from Phase I into pivotal trials is normally, the purpose of a Phase II is a lot about defining dose. And in this case, IgG is such a strong biomarker with a really well-established link to clinical efficacy across many, many indications and assets that we don't need to do that dose finding in a Phase II study. But rather we can translate the dose finding from Phase I, combine that with IgG to clinical effect size from other Phase II programs either with batoclimab or other assets and move to our pivotal. So that gives us a real efficiency for our development program for 1402.

Great. Next question is a Dermavant question from Robyn Karnauskas at Truist. When you say 3 to 6 months for formulary contracts, can you clarify the timelines for the 3 major PBMs. Also, it's early, but what is the average duration of therapy at the moment? At what point do patients stop drug? Might be too early to ask.

Yes. Thanks, Robyn. It's a great question. And obviously, again, important stuff for the commercial launch. First of all, I'd say what we said earlier today stands true. We expect the first major contracts to be signed by the end of this year. The PBMs cover showed a different numbers of covered lives. I think as we provide updates when the PBM contracts are signed, you'll get a pretty good sense for the pace of that. But I think it's faster than expected initially. And that 3- to 6-month guidance is kind of -- plus sort of major contracts by the end of this year is kind of the main point there. And then in terms of duration of therapy, I guess, first of all, I think it's too early to tell really because, first of all, at this juncture, if you think about the way the script ramp has gone. So we've seen a decent number of refills. That means those patients have all gotten a script, used it up, fill it again. But then also, there's plenty of patients who have gotten a script, either got it within the last 30 days or got it within the last 60 days and haven't finished their tube yet. And so we don't know whether those patients have discontinued. And I think you heard on the KOL panel. There's also an expectation of pretty flexible use for the product. Get the product, use it for as long as you need to, you stop using it for a little while, you clear up, start using it again. So I think to really get a good read on duration of therapy like numerically, it's just going to take longer, and we're going to have to watch the script, we're going to have to do patient surveys just figure that out. I would say, broadly, the early indicators on duration of use are all positive. I think like probably the easiest to read indicators are what you heard from the KOLs on the panel, it's the -- patients are excited about the product, they keep using it. You get the refill data, which indicates that a decent number of scripts are getting refilled. So I think all of that data is supportive of a good sort of duration of use, good many people want to use the product they want to use it for as long as they need. But I think to put a quantitative number, it's just going to take a little bit more data, frankly, we're too early to know.

Great. So another Dermavant commercial question from Louise Chen at Cantor Fitzgerald. Based on the current VTAMA prescription trajectory in PBM discussions, can you provide more color on gross to net? Should we expect GTN improvement to begin earlier than expected?

Yes. I think the answer to that question is yes. Look, I think at the beginning of the launch, you don't know exactly what the uptake is going to be like. You don't know what the prior auth are going to be like. You don't know how much of the demand is going to wind up on the payer P&Ls. And you don't know what the payer reception is going to be and we've begun to have those conversations. We most importantly have the script data, we have in the prior auths. We know that the drug is being used. We know that docs are going through the effort to get the prior auth. And that will, first of all, directly accrue to GTN that will be directly helpful, every one of those prior auths is a covered script. But then it's also, most importantly, actually indirectly helpful and that it means that the plans care and the plans want to have these discussions. So I think given the quality of the launch, given the trajectory, given the script volume specifically, I think with this volume of scripts and this volume prior auth, you should expect good progress on that.

Great. So getting one more question here. It's an anonymous question. This is for Pete. When you think about development of 1402, how do you weigh POC data from batoclimab versus competitors' anti-FcRns when thinking about their development path in a particular indication?

Yes, that's a great question because they're both important and different. So there's a wealth of data across the class that I think is very transferable. It's within the range of an IgG lowering around 60% or so, which is what most of the other anti-FcRns at the dose is being studied, achieved. So we can use that information to translate what we would expect with maybe a midrange dose of either batoclimab or 1402. The batoclimab data is -- provides us a really unique advantage on 2 levels. First of all, batoclimab achieves deeper IgG reduction, so we can see the relationship between higher degrees of IgG reduction and clinical response in a way that's unique to batoclimab because it's the only one that's achieving that. And then for the indications that we've studied in addition to sort of summary data that we've disclosed. There's also the patient level data that we have in-house and that provides a lot of rich information that can be used to further optimize the development program again of either batoclimab or 1402.

Great. And then another question for you, Pete. Assuming 1402 succeeds in Phase I, should we expect pivotals to start in 2024?

Yes. I think that's a good expectation. 1402 is probably about 18 months behind batoclimab, which is really, really short time window in the scheme of drug development.

I think about, yes -- Pete correct me if I'm wrong here, it's 6 months after the Phase I, basically.

Right. That's what we're targeting.

Okay. Great. Another anonymous question for Dermavant. It says, could you comment on whether the Dermavant team is pitching VTAMA to employers as a potential step therapy ahead of expensive orals and biologics. If so, what are the potential signposts that we should be watching for?

Yes. Thanks. So it's a good question. I assume we're talking about payers here. I think first and foremost, setting aside the sort of mechanics of what payer conversations take place when. I think the basic answer is, absolutely, you have to imagine that a product of this profile, like considerations of systemic therapy are relevant. These are -- the systemic therapies are all expensive. They're all big pieces of payer P&L, the payers care about them. And then you look at something like Sotyktu, deucravacitinib which just approved, I think it was like a $75,000 a year list price or something, it's even more expensive than OTEZLA. There's no question the payers notice that. There's no question they're nervous about it. Sotyktu is a good drug. It has good efficacy. I think like it will be used -- will be in demand from payers and patients as a systemic therapy. Obviously, a different, sort of more severe patients than our main patients, but still it will be in demand. And payers will care. So absolutely, the answer is I would expect payers to want to use every tool available to them to control progression on systemic therapy. And one of the things that we like about VTAMA and one of the things we like about the pricing strategy and the whole access strategy that we set up for VTAMA is that we think we can be a viable off-ramp ahead of systemic therapy in many cases, for many patients. So I think that will matter to payers. I think you will see it in pay your discussions. Look, I think the first conversation with the payer is always about getting the formulary that we want for our main patients, right? It's not about who can or can't get Sotyktu or who can or can't get SKYRIZI, it's about who can or can't get VTAMA. And so the first update, you'll see us providing our -- and you could see in formularies, like making sure that we have good credible access for the broadest possible population of patients. So that we can go after that in psoriasis 4 million topical script market. But I think as you start to see that stabilize, certainly, do I hope and expect that you'll also start to see VTAMA showing up on formulary as step or otherwise or more importantly, like in treatment practice as step or otherwise on the way to a systemic or even sort of avoiding the use of the systemic altogether, I think the attributes of a product are higher, the product is highly supportive of that use case.

Great. We have a few Genevant questions. First up, regarding patent litigation with Moderna, I have 2 questions. So this has been filled by [ Matt ]. First, could you frame the economic opportunity for Roivant shareholders using simple math, if Genevant and Arbutus realize $100 from Moderna, how much would accrue to Roivant? Second, if the court rules in favor of Moderna to assign litigation defense to the U.S. government, could you please explain the timing and potential patent value implications?

Yes, thank you. Look, I think the first answer, the economic question, sort of simplest answer is direct and indirect, it's between $60 and $75 on a basic to fully diluted ownership. So $60 to $75 out of $100 effectively economically accrued to Roivant. On the question of the Moderna sort of motion to dismiss. The first thing I'll say is it's important to note that was a partial motion to dismiss. It was only addressed to claims that could potentially have 1498 applied to them. And so no matter what happens with that motion to dismiss, the main claim will progress according to a time line that we'll share when the court sets it. So we'll know as soon as we sort of hear back on the motion and discuss what that time line looks like. It's just up to the court at this point when they rule on that. And then I'm not going to comment right now on patent value. But I'll just say there's obviously a pretty broad spectrum of possible outcome to that question. In every case, our fundamental position is the same as it is now. That is the question of infringement and the question of what infringement means is not affected by this defense. It's just a question of whether it's a Moderna or U.S. government or both process.

Great. And then one more question. It says besides the IP issues, what has Genevant been doing this past year, are they working with BioNTech still? Any plans to take them public?

Yes. So no immediate plans to take Genevant public. That one's easy. Genevant's had a really busy year. Look, totally aside from mRNA COVID vaccines, the amount of attention on mRNA and on LNP, following the successful level of COVID vaccine has been enormous. There's been a number of new entrants in the field. There's been a number of new ideas, different kinds of oligonucleotides. Genevant is hard at work on partnerships and scientific progress in all of those areas, developing more potent LNPs, developing LNPs that get into specific tissue types, work on the CNS, work on other tissues ongoing. And then continuing to partner with the best out there in the field on all kinds of different oligo payloads, because we think we have the best LNP to bring to bear. Frankly, the overall situation has been good for our sort of partnering in scientific business because it's just made clearer and clearer that we are the -- a, that we have an incredibly important foundational position in the field but b, that we have the cleanest platform from an IP perspective on LNP. And so there's been a lot of really good partnership opportunity. And I think you'll hear updates from us in that direction as they come together. And we're still partnered with BioNTech, for example, and many, many other people at this point.

Okay. Great. And then just one final question. We're at the top of the hour. Douglas Tsao at H.C. Wainwright, and this is for you, Pete. Should we expect 1402 to be developed in MG and other indications that batoclimab is already in Phase III? Or are you going to focus on white space for Immunovant?

Yes. Great question. So batoclimab is really differentiated in myasthenia and in thyroid eye disease and CIDP. These are indications that lend themselves very well to what batoclimab can offer with flexible dosing and induction of maintenance approach or a fixed duration dosing. And then the anti-FcRn class is just so massive. There's so many other indications that provide opportunity. Within indications in both rheumatology and hematology, we think those are particularly well suited to what 1402 can offer because the degree of IgG knockdown required for maximum clinical benefit is likely to be higher, particularly in rheumatology. And then I mentioned Graves' disease. That's a very nice indication to kind of bridge right from a proof-of-concept study with batoclimab into a pivotal trial in 1402.

Great. Well, again, I want to thank everyone for joining us today. Again, if you have any other questions, feel free to reach out to IR team. And I just want to thank everyone for their participation and for everyone who contributed to Dermavant and Immunovant. It's a really exciting year. Any final thoughts, Matt?

Yes. Just to reiterate that. I want to thank everybody involved here, our shareholders and backers, the entire Roivant team, all the Vant teams, Dermavant, Immunovant especially today, but many others as well. It's obviously a huge amount of work that goes into delivering results like these, and we're excited to keep delivering in the year ahead. Obviously, a lot of great catalysts coming up. And I'm glad we were able to end pretty close to on time despite the [indiscernible] outage that we experienced earlier. So thanks, everybody, for bearing with us during that and really looking forward to keeping in touch with all of you virtually and in person in the year to come.

Absolutely. Thanks again.