Roivant Sciences Ltd. Q3 FY2022 Earnings Call

Good day, and thank you for joining us. Welcome to the Roivant Third Quarter 2022 Earnings Call. Please note that today's conference is being recorded.

Thank you. Good morning, and thank you for joining today's call to discuss Roivant's financial results for the quarter ended December 31, 2022. Presenting today, we have Matt Gline, our Chief Executive Officer. For those dialing in via conference call, you can find the slides being presented today as well as the press release announcing these results on our IR website at www.investor.roivant.com. We'll also be providing the current slide numbers as we present to help you follow along. I'd like to remind you that 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 product candidates. We strongly encourage you to review the information that we filed with the SEC, including the earnings release and the Form 10-Q filed this morning for more information regarding these forward-looking statements and related risks and uncertainties. We will begin with Matt Gline, who will review key business updates and provide a financial update. We will end the call with a Q&A session. And with that, I'll turn it over to Matt.

Thank you, Stephanie, and thank you, everyone, for joining us this morning. I am pleased to share our financial results for the third fiscal quarter, which ended on December 31, 2022. It's great to be here today, and I am enthusiastic about our meeting, although this will be a shorter update due to our busy quarter. Since our last quarterly update, we have in-licensed and published data for RVT-3101. We also provided a pre-announcement of certain fiscal results during a financing round a couple of weeks ago. I appreciate everyone being here, and I'm looking forward to sharing updates, particularly regarding the commercial launch of VTAMA. Starting with Slide 5, I want to remind everyone that it's still early in 2023, and we are quite excited about the year ahead. We kicked off strongly with the announcement of RVT-3101 data from our ongoing Phase IIb study. We anticipate several critical updates from across the business, particularly regarding payor coverage for VTAMA, which we believe will eventually improve our gross net yields and prescriptions. Both the ADORING 1 and ADORING 2 studies for atopic dermatitis are now fully enrolled, and we plan to share top-line data from these studies in March and May of 2023, respectively. This data is crucial as it opens up a much larger market than we currently serve in psoriasis. We expect critical data in the first half of this year from RVT-3101, particularly from the 52-week chronic dosing period, which we believe will set a precedent in the field. By mid-year, we will also have human data on our next-generation anti-FcRn antibody, IMVT-1402, which has the potential to be a leading treatment in the category due to its efficacy and safety profile. In the fourth quarter, we expect to have pivotal data from brepocitinib in SLE, our dual-inhibitor targeting TYK2 and JAK1, which looks promising. I'm particularly eager to share that data when it's ready. Now, let's move on to the commercial launch of VTAMA, which is an area of great enthusiasm for us. On Slide 7, I'll briefly review our financial results. As I mentioned previously, we disclosed a near doubling of revenue for the quarter, with revenues now at $9.2 million in our second quarter post-launch. I'm excited to report that we've already seen an improvement in our gross-to-net yield, increasing from 12% in our first quarter to 18% in the most recent quarter. We anticipate that continued payor updates will help this figure improve further. The demand from patients and physicians for the product has been strong, and the positive feedback we've received has had a favorable impact on our payor conversations. We're thrilled with how the launch is progressing and will continue to provide updates throughout the year. On Slide 8, we continue to lead as the number one branded topical since our eighth week at launch, following some fluctuations during the holidays. We are optimistic about the growth trajectory moving forward. As for the script volumes, they indicate strong enthusiasm from doctors and payors. Slide 9 illustrates that we are just beginning. In the latest IMS report, we recorded about 3,800 scripts, which is impressive for the early stage of our launch. It’s important to note that there are 90,000 topical prescriptions weekly for psoriasis alone, largely for topical steroids. Once we gain access to the atopic dermatitis market, with 300,000 weekly prescriptions, there lies a significant opportunity ahead. Our data demonstrates that we are not only more effective than topical corticosteroids but also safer and better tolerated. We're eager to present our findings for atopic dermatitis and are committed to leveraging these advancements to expand into these substantial markets. It's been a productive quarter for the Dermavant team, with both atopic dermatitis trials now fully enrolled. We expect the results from ADORING 2 in March 2023 and ADORING 1 in May, bringing important clinical data soon. On Slide 11, I’m pleased to report that we now have 57% of commercial lives covered for VTAMA, equating to nearly 95 million lives, aided by a growing number of health plans recognizing the value of VTAMA. We are making solid progress in securing formulary access, driven by patient and physician demand, as well as the positive evaluations from medical teams at these payors. I would like to note several examples showcasing the quality of our coverage as seen on Slide 12. Various factors, including demand and assessment from payors, have driven this progress. For instance, one major PBM removed the new-to-market block, allowing us easier access, while others have added VTAMA into their formulary with minimal restrictions. We maintain a competitive edge in coverage compared to our topical competitors, supporting our pricing strategy and leading to robust market access. While some competitors have made strides in similar indications, we anticipate achieving comparable results as our coverage and demand strengthen over time. The early part of the year can be challenging due to deductible resets, but we expect more progress in the following quarters, positioning us well to achieve a favorable commercial P&L. Now, shifting to our inflammation and immunology franchise on Slide 14, we are thrilled about the scope of our projects and the multiple new approvals on the horizon. Our pipeline boasts over ten Phase II and III readouts anticipated each year until 2025, with the prospect of expanding our I&I franchise to peak revenues exceeding $15 billion. This encompasses our efforts with FcRn, TL1A, TYK2/JAK1, and VTAMA. You can see the details of our late-stage pipeline on Slide 15. I will highlight that our forthcoming updates will be significant, as we’ve seized an unprecedented opportunity to gather high-quality clinical data soon. Before wrapping up the clinical and business updates, I want to review the RVT-3101 or anti-TL1A antibody data briefly. Launched just over a month ago, this antibody is a Phase III-ready candidate being developed for ulcerative colitis and Crohn’s disease, with exciting data demonstrating compelling efficacy across all tested doses. We believe this may be a first-in-class agent in validated markets, supported by an excellent safety profile. As noted, we anticipate Phase IIb data shortly for RVT-3101, marking a critical milestone. TL1A operates as a signal amplifier affecting multiple inflammatory and fibrotic cytokines, reinforcing our confidence in the quality of clinical data and safety profile. Data depicted on Slides 18 and 19 reveals compelling activity for our agent, presenting some of the highest efficacy in its class. Notably, we can maintain efficacy in patients with previous biologic experience—an often challenging demographic—opening doors for RVT-3101 to be a second-line option. In summary, our safety profile remains strong, with adverse events being comparatively mild. I look forward to discussing these topics further and answering questions during the upcoming Q&A. Lastly, I will provide a financial update before we adjourn to Q&A. We reported adjusted R&D expenses of $117 million and SG&A expenses of $116 million, the latter primarily related to the launch of VTAMA. Our cash position remains robust, with balances around $1.5 billion and expectations from recent financing and asset sales giving us a runway into the second half of 2025. We’re on track to generate significant clinical data during this period, advancing our goals for RVT-3101 and other projects. I am proud of the Roivant team's accomplishments over the last quarter and look forward to your questions. Thank you for joining us this morning. I will now turn it over to the operator for the Q&A session.

Our first question comes from Brian Cheng with JPMorgan.

As we look into you're going to read out next month, what should we expect there in terms of efficacy at top line? And what do you think that we'll need to see to be commercially viable?

Thanks, Brian. I appreciate the question. I appreciate your listening this morning. So thank you. What should we expect to see at top line? That's always a good question. We have not yet seen the data. Our Phase IIb data was really compelling. As you may know, we showed 49% gross efficacy on an IGA responder rate at our 8-week endpoint. I'd say there's a pretty wide range of what could look good in that study. What I would say if we're in the 40s from a gross efficacy perspective, that's a grand slam for us. And if we're in the mid- to high 30s, I'd say it's a solid home run. And I'd say, anything in the 30s up would be commercially viable for products given the quality of our data, the quality of our competitors' data, the quality of our safety data, et cetera. So I'd say stay tuned for what the actual data looks like. But feeling excited about the opportunity and for a broad range of data that could be commercially promising.

Great. And maybe just one on VTAMA. I think we talked previously about the potential for our DTC campaign. I'm just curious what's your latest thought on the timing or the need to launch a DTC campaign here based on the trajectory that you see? And how important is it based on where you stand in terms of uptick? And are there any pockets of opportunities that you haven't fully tapped in yet for the VTAMA launch?

Yes. Thanks. It's a great question. And I'll give an answer and then over to Frank to see if there is anything to add. Look, I think, first of all, we have some DTC efforts ongoing already. They are highly targeted in specific markets. They're using social media. We are excited about what we've been able to show there, but it's really the earliest days in terms of DTC strategy, and we haven't pulled out anywhere near to the level of stops that we could to sort of make this a thing. For us, we've been relatively conservative here because, in our view, it makes sense to drive DTC volume only as payer coverage really ramps up. So the patients who are sort of finding out about the drug are eligible for coverage when they go to their doctors. So we're still planning for that. Obviously, our patient model is different than some of the systemic therapies that advertise very aggressively. But I think you'll continue to see us being thoughtful and use targeted DTC to drive volume. And I think we have a lot of opportunities from here to make an impact. But Frank, anything you would add to that?

I think that's a nice summary, Matt.

Our next question comes from Yaron Werber with Cowen.

This is Joyce speaking on behalf of Yaron. Our understanding is that formularies are usually negotiated during the latter half of the year, specifically in the fall and winter, for the upcoming calendar year. So my first question is whether you feel prepared with your formulary additions for 2023 or if you anticipate more additions. My second question is regarding the Crohn's disease indication for 3101. I noted that the original start date listed on clinicaltrials.gov was around mid-2023. Is that when you plan to begin the study? Have you determined the dosage yet, and are you possibly waiting for the chronic maintenance data from the UC study to finalize the dosage?

I will answer those questions in reverse order. So on the 3101 question on Crohn's, there was a trial on clinicaltrials.gov that Pfizer had put up. That was a specific trial design that is not the study that we intend to run. And Pfizer basically decided not to run that study around the time they got a serious discussion with us in order to allow us to design a study of our choosing. We are preparing to share information about our Crohn's plan shortly, and we'll share it when we're ready. And we'll continue to share updates on our clinical plans overall for 3101 over the course of this year, including partially after the maintenance data has read out, and we've spoken to the FDA about our Phase III plans in usage. So that's on that one. I'll hand it over to Frank to answer the formulary question, other than to say, we are not done for the year, and we have some other major formulary additions that we expect to make imminently that would have a meaningful impact on that number. But Frank, I'll hand it over to you.

Thanks, Matt. What you mentioned is generally accurate regarding industry structure, but what we've observed with VTAMA and the outstanding work by our team at Dermavant is that the significant demand from patients and physicians for the product has altered those cycles, modified the negotiation timelines, and generally resulted in a much higher level of engagement overall, with typical timelines no longer being a key factor in our access discussions. We find this very encouraging because it highlights the essential value the product is delivering to patients and the dermatology community.

And just to reiterate, I expect our covered lives to increase significantly between now and the next update we provide. Thank you very much for the question.

Our next question comes from Louise Chen with Cantor.

Congratulations on a productive quarter. So I had a few questions for you. First, what I wanted to ask you is that I know we're expecting some updates in the anti-FcRn space from some of your competitors, second quarter for CIDP from J&J, rheumatoid arthritis later in the year. How do you think those read-throughs will impact your thinking on your clinical development program?

Yes. Thanks, Louise. It's a great question. Maybe I'll hand over to Mayukh if he's got a bunch after I say a couple of words. Look, I think the really nice thing about FcRn as a target is that IgG has been a phenomenal biomarker for clinical efficacy. And so I think we will get a lot of information from any competitor readout that shows a relationship between IgG and clinically meaningful data. I think we'll learn more about how Nipocalimab's RA study was conducted and a little more about that when J&J choose to share it. Obviously, the world is watching the organic study very closely. One of the things, I think, would be interesting for us in that study, and the reason we're running a study of our own is because that study is not going to inform us on what the impact of a higher IgG suppression would be simply because Efgartigimod can't suppress IgG at the same level as our agents can. So we're excited to learn more about dose ranging from our own CIDP study. But obviously, there's a lot of interesting questions around the way FcRn works for that patient population, that we will learn from that study. So, at a high level, I think that data will be informative, and there's probably other data coming, too. There was data from a competitor and a small indication just a couple of weeks ago that was probably sort of new to the field and informative on yet another place which FcRn appears to work. So that's sort of at a high level. Mayukh, anything you would add there?

Not really, Matt. I mean, I think as you said it, really the home run scenario for our program and our franchise overall is to see that there is sort of validation and efficacy from these other programs, but an efficacy picture that leaves room on the table for greater efficacy from our greater IgG suppression.

Okay. And then can I ask you about Brepocitinib also on SLE? I know you have some data coming up. And just curious how it's performed versus some of its competitors such as baricitinib and Deucravacitinib. And what are you expecting would be considered a positive outcome for your studies?

Yes. Thanks, Louise. It's a great question. Look, obviously, we're excited to generate the data from Brepo and SLE. Obviously, SLE has been a challenging indication. And so we're approaching it with a healthy amount of respect for that challenge understanding that Pfizer did a lot of the preliminary work and a lot of the execution on that study. That said, I think there's a lot of reason to be very optimistic here. For starters, you mentioned a couple of competitors, basically Brepo, as you know, is a dual inhibitor, TYK2 and JAK1. We have data about JAK1, you mentioned baricitinib in SLE, which was, I think, pretty good in Phase II and okay in Phase III from a top-line perspective. And then we have data from Deucravacitinib, which is a little bit variable but also fairly impressive relative to the field in SLE. And then what we know is in cross-shop comparisons across other indications, and we have cross-trial data with either bari or Deucra in each of psoriasis, psoriatic arthritis, ulcerative colitis, and alopecia. And in each of those indications, Brepo has produced sort of numerically superior data across our comparison than either or both of the sort of stand-alone JAK1 or TYK2. This is kind of in line with how we think of Brepo, which is it's just a really big gun. It's a powerful drug that appears to produce sort of top-end efficacy. And we think SLE is the kind of population where that could make a big difference. Mayukh, anything you'd add there?

No, not really. I mean, I think, look, BENLYSTA was approved in efficacy, but with an SRI-4 delta between 9% and 14% across all of its different studies. And in spite of that, it is a blockbuster drug, I think, just showing kind of the unmet need that is still remaining there, and we're looking forward to the results by this year.

As a reminder, that's a 22-week study fully enrolled as of August.

Okay. And then just one last really quick question. When do you expect to reach steady state for your gross to net for VTAMA?

We haven't provided specific guidance on that yet, as it depends on some final discussions with payers. Similar to our competitors, it typically takes over six months for gross to net effects to come through from the contracting process. I anticipate significant improvements throughout this year, particularly in the middle and later parts. The final movements may slow as we approach steady state, potentially taking additional time. Payer contracting will cover about 80% to 90% of the process, while the remaining adjustments, like distribution costs, are often based on volume and may take longer to materialize.

Our next question comes from Neena Bitritto-Garg with Citi.

So on the anti-TL1A, I appreciate you providing some additional color on kind of next steps and additional indications. But maybe can you just talk a little bit more about the breadth of indications that you see applicable for an anti-TL1A agent? And when we could see some updates on that front? And then just a follow-up to the last question on the gross to net. I guess any updated thoughts on what we should expect in terms of the long-term gross to net for VTAMA?

So I'll take the second question first and then I'll start on the first one and probably hand it over to Mayukh for his thoughts as well. On the GTN question, we haven't given specific numerical guidance. That's been sort of a principal stance of ours because we are actively negotiating as you can see, with probably literally dozens of payers and regional plans and some PBMs and those discussions are all sort of active negotiations. That said, I will say, it seems like the field was sort of settled on a standard answer to the question of what a biotech company steady-state GTN looks like. And it seems like our various topical competitors as well as even things like Nurtec at Biohaven or whatever, all have sort of settled on a similar answer. And so I would expect us to be kind of the same as everybody else of steady state is the honest answer to that question. So TL1A in terms of breadth of indications, I think you can probably hear it from me, there's a lot of enthusiasm for where to go beyond UC and Crohn's. I think in terms of timing, look, we will share thoughts on our clinical plan when we're ready. And because of the competitive nature of that space, we're probably going to be a little bit careful about disclosing exactly when and what we're doing from an indication perspective. But, Mayukh, if you want to talk a little bit about the potential breadth there and how broad it could really go.

Yes, we're excited about the wide range of indications where TL1A is implicated, particularly in both anti-inflammatory and anti-fibrotic areas. As with some of our other programs, we plan to balance clinically validated indications with first-in-class and novel ones.

The only thing I'd add to that is just remember, we ultimately expect to have a franchise in anti-TL1A antibodies. We have an option on next-generation compounds that Pfizer has now disclosed as a bispecific antibody to TL1A and P40, which we think will have super interesting biology and potential applicability in different indications and in different settings. And so we're watching that closely. A little bit of ways out, we're going to get Phase I data in 2025 there. But excited for the full breadth of what we should be able to do with that franchise.

Our next question comes from Robyn Karnauskas with Truist.

I have a couple of questions. First, regarding the new to brand segment, it appears to be stabilizing. Could you provide some insight on the trends you’re observing with patients? Are there new patients joining? Is this related to coverage, or are these more general trends among patients? What do you anticipate for the future? Additionally, I have a question about 1402 and Immunovant. There’s a significant data set on the way for 1402 along with upcoming RA data from nipocalimab. We’re receiving numerous inquiries about how much this opportunity could expand. Would more trials be necessary once the data for rheumatoid arthritis and 1402 is available? How do you collaborate with Immunovant in determining how broadly you can expand the market for 1402? I also want to address the topic of M&A. If a company showed interest in acquiring Immunovant, how would you approach the decision-making process regarding that potential acquisition?

Thank you, Robyn, for your great questions. I appreciate it, and it's good to hear from you. First, I want to clarify that we do not believe scripts are stabilizing. There has been some fluctuation recently, partly due to the holidays and winter sales meetings, which took one-third of our sales force out of the field for three consecutive weeks. However, when we examine trends at the doctor level, we remain optimistic about continued growth in important areas. We anticipate script growth moving forward. The AV data could significantly enhance this by attracting doctor attention to the drug's broader potential. Regardless, you should expect to see real growth in those numbers. The recent progress in payer contracting is beneficial, and we believe enthusiasm will help build script volumes. Although it may appear a bit uneven recently, we expect improvement over time. Regarding 1402, we see significant opportunity here. Our partnership with Immunovant is strong, and we closely collaborate on indication strategy. Their team is experienced, and we aim to contribute our best ideas for consideration. We have numerous concepts for where this could lead, both internally and externally, and we gather valuable insights from the field. As for M&A, it is exciting to be part of a category with such therapeutic relevance, especially as opportunities arise frequently with our competitors and the new data we present. We acknowledge the considerable interest surrounding FcRn as a target for many large pharmaceutical companies. While we would participate in any discussions regarding Immunovant, we intend to act thoughtfully and rationally as we receive information.

And just a follow-up there, and this is really a typical question, but like can you stop it, for example, to say if someone approaches and they have an offer for Immunovant that are interested? And I just ask because I get this question a ton of times, but how does the relationship between Roivant and Immunovant work if that situation were to unfold? Sorry to follow up like that.

No, it's good. And I appreciate there's a lot of questions about the stuff. Look, the simple answer is that we are a majority shareholder, like any other majority shareholder. And so we have mechanical voting control. But as I said, we're an economically rational actor. And so I don't think the question of whether we could stop M&A winds up being a particularly relevant question to the way that we expect any situation to develop.

Great. And one last one. So you really have done a good job of talking about all your programs ongoing, a lot of catalyst driven. When we go back to the original format of Roivant of having an engine that produces drugs, like what are your thoughts on how we should view the cadence of new vants coming out of the company this year when you have so much data coming out and there's so many big opportunities with the current vant you have on the market? How do we think about the rest of the company as a whole?

It's a great question. Look, the first thing I'll say is, we've been very mindful of the capital environment over the last, call it, 18 months. And obviously, that affects the bar for new programs and it affects the way that we think about opportunity. That said, look, I think there's approximately nobody out there who regrets the fact that we brought in our anti-TL1A antibody that was something that was not on anybody's radar as a part of Roivant as recently as about 3.5 months ago. So this is the thing we often do best. And what I think is, the bar is high, but if we see more opportunities of the same quality as TL1A, you've got to imagine we're going to take them. And the same thing is true for external opportunities and for things that develop internally, whether it's clinical data or something sort of bring to a new phase of life. If the data are compelling, we will figure out a way to progress it.

Our next question comes from Corinne Jenkins with Goldman Sachs.

With additional time since the VTAMA launch, can you share what you are observing regarding patient behavior, particularly in relation to refills? What is the refill rate you are experiencing?

Yes, thank you, Corinne. That's a great question. The most significant takeaway since the launch is the enthusiasm from both patients and doctors for the product. We have a good number of refills, which is reflected in the IMS script data comparing new prescriptions to total prescriptions. We expect many patients will continue to use multiple tubes in a year. However, determining the exact number of tubes per year is still somewhat uncertain. Generally, steroids are seen as one to two tube products per year, and our primary goal is to replace steroid prescriptions with VTAMA prescriptions. There is potential for more scripts and possibly more tubes used each year, which presents a substantial opportunity in the near term. While it's premature to quantify the usage per year, we are noticing a healthy amount of refill activity, indicating strong patient interest.

Helpful. And then maybe on 3101, just as you think about additional indication selection through the year, can you help us understand which criteria you're using to assess which indications you're interested in pursuing?

I'll hand it over to Mayukh for that question.

Sorry, I missed the question.

It's criteria to select new indications.

Yes, I think we view this very holistically. It's a combination of the strength of the biological basis and the mechanistic evidence that supports it. To some extent, it's also about the design and structure of a clinical trial. We are looking for ways to identify signals or answers without necessarily conducting a large study as the next step. Additionally, we are focused on commercial opportunities, particularly the size and significance of those opportunities. Given the quality of the clinical data we've observed in ulcerative colitis, there is substantial potential for this class of treatments, and we want to ensure we are taking full advantage of it. Furthermore, this area allows us to build a franchise with various approaches to TL1A, including our lead program and the TL1A P40 bi-specific. This enables us to consider a comprehensive strategy for indications over time. Currently, we are concentrating on the largest and quickest opportunities for TL1A to make an impact in inflammatory bowel disease, and we will expand from there.

Our next question comes from Dennis Ding with Jefferies.

I have three questions on TL1A, so #1, if you look at the industry maintenance data for UC, this looked a little bit noisy with some drugs showing remission going up, some showing it coming down. And for Roivant will be the first time maintenance data will be reported for anti-TL1A antibody. And obviously, you've looked at some of the initial data already, and you said that the data has held up. So are you confident that when we get the chronic data in the first half, that remission wouldn't come down from the induction period?

And then #2, I don't see anywhere on your slides about your Phase III plants in UC. And given TL1A is obviously a very competitive space, what additional things do you need to do before Phase III starts? And are you confident that Phase III would start this year?

And then lastly, can you remind us and perhaps reiterate your confidence around the subcutaneous reformulation that you'll be taking into Phase III?

Thank you, Dennis. Those are all excellent questions. Regarding the first one, while I'm not superstitious, I find it challenging to express confidence in clinical outcomes, though we still have real data to gather. There are patients for whom we haven't obtained data yet, and others who are still under evaluation. I agree that we see a wide range of responses from drugs, from degradation to enhancement in efficacy. I believe we have a strong starting point; our induction data was very solid, and even maintaining flat results could yield some of the best 52-week data available. Thus, this question feels somewhat less pertinent for us compared to other classes where the induction data may be underwhelming but gets uplifted through maintenance data. For us, maintaining flat or experiencing slight degradation should still be commercially acceptable. Of course, there's the potential for better outcomes with the anti-fibrotic effects, but we'll ascertain that when we receive the data. Overall, we're optimistic about our current position and the interim results we've seen, but we’ll have a clearer picture once the data is available, and we'll share it when we can. Regarding Crohn's, I acknowledge that it's a competitive landscape. We are being cautious about communicating our study start timelines for both Crohn's and UC due to this competitive environment. We possess an extensive Phase IIb data set with full dose-ranging results; our Phase IIb study was conducted subcutaneously. You inquired about subcutaneous administration in Phase III, and we are currently the only TL1A antibody with actual patient data from any subcutaneous formulation in clinical trials. This wealth of information will significantly inform our Phase III design, allowing us to execute a streamlined, expedited Phase III program. Consequently, we are holding much of our design information strategically until we're ready for it, considering it an advantage when we pursue product approval. Concerning the subcutaneous opportunity, I want to emphasize that we are the sole anti-TL1A antibody studied in patients via subcutaneous administration. Our data instills a high level of confidence in our ability to treat patients subcutaneously and achieve the efficacy we've observed. We are prepared to move a more concentrated formulation than our Phase IIb one into Phase III. While we won't discuss the specifics at this moment, we are very confident in that formulation, which was essentially finalized before we brought the program to Pfizer. Therefore, we don't foresee any difficulties with the subcutaneous formulation, and we are assured of our capability to progress the drug subcutaneously into Phase III based on the data from our Phase II. Our formulation issues are nonexistent.

Our next question comes from Douglas Tsao with HCW.

Congrats on the progress, Matt. So maybe just touching on your emerging I&I franchise. Just curious, Matt, because as a company, Roivant has had a history of monetizing assets. Obviously, to Robyn's question, there's questions around strategic value of Immunovant as well as other individual assets. So just curious how essential do you think each of these are individually towards building an I&I franchise or do you think given the strength of the assets that some individual ones can be potentially separated out and still have the franchise stand on its own?

Look, it's a great question. I think the short answer is, we are fiercely economic actors in every way. And so on the one hand, we're very proud of the franchise that we've built and the opportunity for each of these things. And on the other hand, we've got the track record that you've observed. The last thing I'll say is, there is a lot of interest in individual I&I programs and targets out there, obviously. But also as a whole, there are many businesses that may need to expand by multiple opportunities at the same time. And so the franchise, in aggregate, could also present some unique opportunities. And actually, at least one of our past monetizations that you referred to involved a franchise with multiple programs, and I'd say nothing is off the table.

Matt, at what point do you think that having multiple assets is necessary to be effective in the I&I market, especially considering the size of that category and the structure of leading players? Or do you believe that isn't a correct interpretation, and that the strength of each of your assets allows them to thrive independently?

As a practical matter, I think most of the things in our portfolio could mechanically stand on their own, just given the quality of the individual things that we've got. Right? Certainly, one of our competitors in FcRn has shown that a single FcRn antibody can succeed on its own. I think our competitor in TL1A, it's such a unique target, talks about the fact that it could mechanically stand on its own. That's it. There's purely also a synergistic opportunity in these things sort of coexisting and being next to each other. And certainly, if any of these things were to wind up in big pharma hands, there would be benefits to sort of being co-resident with other I&I programs. So look, I think these things can definitely stand alone, but I think there's also some value to having them together.

I am showing no further questions at this time. I would now like to turn the conference back to Matt Gline for closing remarks.

Thank you, operator. Thank you, everybody, for listening this morning. We appreciate it. It's been an exciting quarter. We've had a lot of opportunity to talk about some updates, looking forward to sharing more in the very near future and look forward to getting back together when we file our 10-K later this year as well. So we'll talk multiple times before then, and we'll speak again on a call like this closer to the middle of the year. Thank you, everybody, and have a great day.

This concludes today's conference call. Thank you for participating. You may now disconnect.