Roivant Sciences Ltd. (ROIV) Earnings Call Transcript & Summary
June 14, 2022
Earnings Call Speaker Segments
Corinne Jenkins
analystThanks for joining us here at the 43rd Annual Goldman Sachs Global Healthcare Conference. This morning, I'm pleased to welcome the team from Roivant Sciences. We've got Richard Pulik, the Chief Financial Officer; and Mayukh Sukhatme, the Chief Investment Officer at Roivant. So thanks guys for joining us.
Corinne Jenkins
analystAnd maybe just to start, can you provide a brief overview of the company, including some of the key subsidiaries and how that all fits together under this Roivant umbrella?
Mayukh Sukhatme
executiveSure. So I'll start and then turn it over to Richard too to add. So we're a company that went public last year. We're roughly a -- I think, these days a $2.5 billion or $2.6 billion market cap company, about $2.1 billion in cash, another $300 million in public banks and another $700 million stake in a private bank called Datavant. And then probably everything else that we'll talk about today is free. We have a number of programs in -- across all stages of development, including a drug that we just got approved a couple of weeks ago called VTAMA for the treatment of psoriasis, and it's also in Phase III for atopic dermatitis.
Corinne Jenkins
analystGreat. And Roivant has a relatively long corporate history for a company that just went public last year. So in the past, I think the model was often to incubate a company and spin it out through the IPO process. Can you tell us a little bit about how the strategy for Roivant today compares to what we might have been familiar with in the past?
Mayukh Sukhatme
executiveSure. Well, I've been with the company since nearly the beginning. And really, the goal of the company is to get -- find attractive and interesting and important medicines, bring them in, get them developed and commercialized. And so that's really what we've been focused on doing. And in our 8-year history now, we've actually gotten 5 drugs approved. The first 4 actually, we did a deal with a Japanese company, Dainippon Sumitomo, where we sold the majority of our rights, the vast majority of our rights for, and then now tapinarof or VTAMA approved. And so really, it's kind of all about execution. I think historically, certainly when we were a private company, we're really trying to figure out kind of a cost of capital. And we also recognize that at certain points, sometimes investors want to make kind of a pure bet on a program. And so that kind of led to us taking several of our companies public. But now that we're public, I think we, I think, are increasingly seeing that our own cost of capital is lower. And actually, we don't really have that same pressure. I think we'll -- we'll consider it. So we don't -- we're not sort of dogmatic about our financing route. If we find that there's a lot of investor appetite for it and sometimes actually it's attractive to our partners to consider a spin-out or going public, but I think that's going to be less the norm going forward.
Richard Pulik
executiveYes. And I would say the idea is really to be an [ intent ] pharmaceutical company. We now have discovery capabilities. We have 8 programs in the clinic, with a few more expected to be added by the end of the year. And now we have a launch product where -- which we think has blockbuster potential. So really, the idea is to be an [ intent ] pharmaceutical company, which is focused not just on sort of the 3 main areas drug development, but also built around a team of engineers that really help solve some of the inefficiencies that we've seen in the pharma model.
Corinne Jenkins
analystAbsolutely. So you've mentioned it, but VTAMA was recently approved. It's a non-steroidal -- non-steroidal topical agent with a novel mechanism of action in psoriasis. So first, can you just highlight some of the key factors in the label that it received? And then also how that label informs some of the decisions the company made around pricing and go-to-market strategy?
Mayukh Sukhatme
executiveYes. So really excited to have the drug approved and now launched. As you said, it's really actually, believe it or not, it's the first novel topical approved in psoriasis in the last 25 years. It's a first-in-class and only in class. We think we got really a fantastic label. Certainly, our commercial team is really, really excited about where we landed on everything. So I'll give you a few of the key attributes, and we got approved on time. In fact, actually, ahead of time, which is no small feat these days with the FDA. In terms of key product attributes, I think, we think about this as regardless of severity of psoriasis, basically, even if you're on a systemic, everyone has a tube of something in their medicine cabinet, and we want to be that tube. And so this -- the label is extremely broad. It goes -- all severities are indicated, mild, moderate and severe psoriasis. There's no limitations on where you can put it on your body, including sensitive areas and difficult-to-treat areas, like the scalp. There's no limits on the duration of use. That's very different certainly than steroids, where you have to use it for only a couple of weeks at a time and then you have to stop due to all the sort of steroid overuse and skin thinning and all those things. And then finally, there's no limitations on the use of concomitant meds, no precautions or warnings or anything like that. So really just a super clean label. The last thing I'll say is that we did, I think it was candidly a bit of an upside surprise for us, managed to get the remittive benefit in the label. And I think that's really, really unique product attribute. I think it's something that really will resonate and has resonated with docs and now in the market with patients. What that means is that actually you can continue to treat on therapy with the cream once a day. But if you stop therapy, you actually don't have the plaque occur. And in the studies, we saw actually a mean or median of about 4 months off therapy for no recurrence. So I think that's something that, again, you don't see with steroids, you don't see with any other mechanism on the market. I can talk about sort of the mechanistic underpinnings why, but really a unique feature of the drug and really kind of the hallmark of it.
Richard Pulik
executiveAnd I think importantly, sort of once patients came off therapy and then they restarted when the plaque came back, so let's say, after a 4-month period, you have the same level of efficacy and quick efficacy that you saw at the beginning. So it's really designed in the real-world setting here where we believe that patients will be -- as they reach clearance, they'll stop using the topical. And then when some of the lesions come back, they will again reuse this. The atopic dermatitis trial is also designed that way so that we can also make sure we have this remittive benefit, which I think is a really key differentiator for us.
Corinne Jenkins
analystGreat. You highlighted it very broadly well. How did that inform the pricing decision that was made and then how you're thinking about go-to-market strategy as you approach this launch here?
Mayukh Sukhatme
executiveYes. So I think it is a really unique product. And so in a certain sense, we're in a bit of uncharted territory in terms of, I think, what the expectations are even looking at, what proxies might be for a lot of different elements of use and pricing and so forth. But we want to price it at a place that I think reflects the premium nature of the product, I think the innovative nature of the product. We also want to sort of, I think, and we did -- there's an enormous amount of work on this. But I think we, on balance, wanted to price it at a place that really was kind of a goldilocks in the modern commercial space. So we wanted to, I think, again, reflect the premium nature of the product, have the ability certainly for PBMs that were rebate sensitive to have some element to rebate. But again, also, I think, fully reflect the value that we're bringing.
Richard Pulik
executiveAnd I would say it's -- the value proposition is very important here, right? Because if you look at some of the systemic drugs, sort of some of the orals, I mean that's kind of in that $50,000 a year range. We ended up pricing at $1,325 per tube. We didn't provide any guidance on how many tubes, but the efficacy that you've seen, the ability to use this for a long time and also knowing that you have 4 million topical prescriptions in psoriasis, 4x as many atopic dermatitis, the value we can bring to the system here versus some of the other available therapies that you can use equally as long is I think pretty incredible and easy discussion to have with payers. Certainly, we did also provide guidance that it would take 12 to 18 months to really sort of work through those payers. But I think we're very excited about where we landed, and I think the data set that we have and the value that we can bring to patients is pretty incredible.
Mayukh Sukhatme
executiveOne other thing, I guess, I would just add is that I think this is -- again, as Richard said, roughly 80% of the prescriptions in psoriasis are for topicals. And ultimately, we wanted to price it at a place where we would not have many barriers to adoption, really kind of get out of the way of docs, docs love to write for topicals, and that's what we want to do.
Corinne Jenkins
analystHelpful. And you mentioned that you were looking for Phase III data in atopic derm in next year in the first half. So could you just provide a brief overview of that trial design and how -- again, you mentioned the remittive [ label ] you got here, how some of the trial design features could inform the label you would get in AD?
Mayukh Sukhatme
executiveYes, sure. So the AD program, it's candidly a very vanilla program in terms of the randomized double-blind portion. It's 2 different studies, 800 patients total, primary endpoint at 8 weeks. It's -- it's a verified IGA 0 or 1, with at least a 2-point change, basically very similar to other AD products, with the primary end point, as I noted, at 8 weeks. And then with respect to the remittive benefit, I think, again, kind of going into the open-label extension, same sort of general strategy as we applied in the psoriasis study, which is that if patients get clear, they can come off drug. We monitor how long they are off drug and then they can go back and get retreated if there are any lesions come back.
Richard Pulik
executiveAnd I think another sort of important dynamic here is this really impacts young patients. And so our trial goes down to the age of 2.
Mayukh Sukhatme
executiveThat's right. We want to go for as broad a patient population as possible. I think I'll just note that that's different than both Opzelura, which is the recently improved JAK inhibitor from Incyte that is currently only approved for what they call adults, but it's age 12 or greater. And then I think topical roflumilast is only studying down to age 6. A lot of that market really is in the very young patients, and we want to capture as many of those in our study as possible.
Richard Pulik
executiveAnd just one more small point, it's for moderate and severe atopic dermatitis.
Corinne Jenkins
analystWonderful. And so together, psoriasis and atopic derm are something like a $40 billion market, but non-steroidal topical agents haven't had the success you might expect in that market. And so how do you think about the size of the opportunity for VTAMA and just given the size of the market and its novel mechanism?
Mayukh Sukhatme
executiveYes. So I think as Richard kind of already gave, I think, the basic facts. So 80% of the volume in these markets is in topicals, the 4 million prescriptions in psoriasis, 16 million or 15 million scripts per year in atopic derm, that's in the U.S. alone. So massive, massive market. I think you alluded to the fact that the non-steroidals haven't done well or generally topicals haven't done well. I think that's really simply a function of those products just weren't very good. Again, we're the first novel topical in psoriasis in the last 25 years. I think -- and there hasn't been much innovation in atopic derm either.
Corinne Jenkins
analystHelpful. So maybe moving on to Immunovant, which is one of the publicly listed companies that you still have ownership of. They recently reopened the development program for batoclimab, which is a FcRn. And obviously, there's potential broad applicability there, but it's relatively crowded as well. So one, how do you think about the potential for differentiation between the different FcRn antibodies? And then two, what's the development strategy that supports kind of finding that differentiation?
Mayukh Sukhatme
executiveYes, sure. So just to recap, so Immunovant, a publicly listed company, we own roughly 2/3 of that company. It's super well-funded, actually. They've got close to $500 million in cash themselves and obviously cash to run Phase III studies across all the different indications that we're going to talk about. I think clearly, the market at this point doesn't ascribe a lot of value to that program, but we feel pretty differently about it. Just to kind of recap, you talked about how it's a crowded market. It actually isn't really that crowded. There are 4 players in the market, and I would say that candidly, UCB is probably -- it will get approved, but I would say it's not really part of the race as it works. I think it's really a 3-horse race. You've got argenx, you've got J&J, which bought Momenta, and you've got the [ Immunovac ] drug. In terms of just competitive differentiation, I think each the companies has taken a slightly different approach. Obviously, argenx is the first to market, really a very good drug, and they've executed extremely well. But we have found that -- I think they're limited. They are capped at roughly a high 60s level of percent IgG reduction from baseline, whereas we can get to in the high 70s to 80%. And I think -- and J&J has a potent molecule, but they've actually elected to go with sort of a go low, go slow approach. So they also are basically getting kind of lower levels of IgG suppression. So we're really the only one that can go to these very high levels of IgG suppression. And so then the question, I think the obvious question is like, well, what's the difference? Is there going to be a difference between mid- to high 60s percent IgG reduction and the high 70s or 80% IgG reduction? And we think that if you look, not just in our own data, but across all the different programs that have reported that data and there's plenty for investors to look at it at this point. We think that, that actually paints a pretty clear picture that actually that difference, that sort of 10-point or 15-point difference in IgG reduction does translate into clinical benefit. I think you see it across multiple programs in myasthenia gravis, whether it's in MG-ADL or deep MG-ADL responders or QMG. And then if you look at an indication like thyroid eye disease, we're going to be the first-in-class and in best-in-class simply because if you look at our own data, you see actually a dose response between -- we did an arm that was roughly the same as what argenx can max out at, and we did a higher dose. And actually, you see a pretty meaningful change in reduction of the relevant autoantibodies and then that translating into a difference in clinical [ proptosis ].
Corinne Jenkins
analystHelpful. Obviously, the trial was paused and recently resumed it was because of an LDL C elevation. So can you talk a little bit about managing that safety and the toxicity profile that you've seen there?
Mayukh Sukhatme
executiveYes. Sure. So yes, as you noted, we had an unexpected finding last year and ourselves decided to put the program on pause. We think that this is actually effectively not unique to us, to be honest. We suspect that other full-length antibodies may have the same effect, including J&J. We think this is an effect seen via mediation and reductions in albumin, which then drive an increase in LDL. In terms of how to manage it, I think there's a few things. I think, first, it's actually not super clear actually, certainly in the minds of treating physicians and also candidly regulators, whether a time -- sort of time limited increase in LDL will actually matter sort of clinically versus, I think, the huge morbidity associated with poorly controlled myasthenia gravis. And so we think that you can actually live with the sort of, again, kind of a time limit increase in LDL. And actually, that's what the regulators were fine with and had no pushback on in our Phase III study. In addition, I think, clinically, just as if you were on any other medication, if you find that your LDL is increased, you can certainly go on cheap generic statins and bring the LDL down, and we've now generated data showing exactly that, that actually, if you put our highest dose of drug plus 40 milligrams of atorva on, you actually get a decrease in LDL. So we think this is a very manageable issue.
Corinne Jenkins
analystOkay. Helpful. Maybe moving on to some other subsidiaries. You announced at the beginning of this year a deal with Eisai and formed Hemavant around that. So can you just help us understand the thinking behind the deal and what we should expect given the data we've seen thus far?
Mayukh Sukhatme
executiveYes, sure. So really excited about this program. It's a clinical stage program. It's a program that is, again, a totally novel mechanism of action. It's an oral spliceosome inhibitor. We're going after lower-risk MDS, which is transfusion dependent. And that's obviously a commercially very well-validated market at this point. You've got luspatercept, a drug that is marketed by Bristol that's, I think, doing roughly $500 million annualized 5 or 6 quarters into its launch, and I think projected to do maybe $3 billion or $4 billion according to their own guidance. And then in addition, you've got Revlimid, which is approved for a tiny subset, roughly 10% to 15% of the population, the so-called 5q-minus population, which also has been a big success for a long time. And so we think that we can actually -- we've got a couple of ways to win here. So one is actually as sort of in the same luspatercept market. So that's the non-5q minus. We think that so far, we've seen efficacy actually in highly refractory patients, so patients that not only failed sort of frontline ESAs, but then went on and failed either lenalidomide or hypomethylating agents, and we saw a 30% response rate in that population. I think it's notable that luspatercept, when studied in a similar population, was only giving a response rate in the low teens and same with Revlimid actually. So we expect that as we move into the sort of post ESA, but pre-hypomethylating agent population, we will see an increase in our own response rate, and that's what we're hoping to see now as we've shifted the study into this earlier line. In addition, we actually saw a really interesting signal, super small [ and concede ] that only 7 patients that had a specific genetic sort of signature called TMEM14C alternative junction splicing. Those patients biologically are ones that you would expect actually, if you correct that, to get proper [indiscernible] and improve their anemia. And so sure enough, and again, our late-line setting, patients with that sort of subtype had a response rate 5 of 7, so roughly 70% response rate in that population. So if we see that in -- as we sort of increase [ our end ] that becomes sort of a path to a very sort of fast path to market, kind of similar to the Revlimid 5q minus story. So we're -- our Phase I/II study is underway. That is a study that will then tee up a pivotal study thereafter. It's an open-label study. So we're just getting rolling, but expect to see data next year. But if we see really compiling signals earlier, we might be in a position to comment on it.
Corinne Jenkins
analystAnd remind me what we should expect to see if the data next year in terms of number of patients, populations?
Mayukh Sukhatme
executiveYes. So the set, I mean, look, again, we're just getting rolling on it. So it's a little bit hard at this point to kind of comment where we're going to be at. It's an open-label study. I think our projected sort of complete enrollment is up to 64 patients. But ultimately, I think this really comes down to when we will feel we've got enough conviction to go to a pivotal study.
Corinne Jenkins
analystOkay. Helpful. Another subsidiary that we could talk about would be Kinevant. So can you provide us an update there and help us understand the development program and rationale for that particular subsidiary?
Mayukh Sukhatme
executiveYes, absolutely. So Kinevant has a program called namilumab, which has just recently kicked off a Phase II study in pulmonary sarcoidosis. This is a highly, highly potent GM-CSF antibody. I think in the field, GM-CSF, candidly has been clinically validated across a number of indications. But in a certain sense, it has lacked that sort of killer indication where it really lets the biology shine. And we think that we found that actually with pulmonary sarcoidosis. In fact, actually, GM-CSF is the sort of core inflammatory cytokine that mediates the action of alveolar macrophages. And in pulmonary sarcoidosis, alveolar macrophages are really the bad actor. They're the cell type that drives the formula -- formation of granulomas, which are the hallmark of the disease. Those granulomas lead to inflammation and fibrosis and then ultimately eventually death.
Corinne Jenkins
analystOkay. Can you just maybe for people who aren't so familiar with sarcoidosis give us an outline of the epidemiology, the market opportunity there and what the current standard of care is?
Mayukh Sukhatme
executiveYes, absolutely. So sarcoidosis, pulmonary sarcoidosis is one of these really, I would say, large [ orphan ] opportunities. It's roughly 180,000 patients in the U.S. alone. There are no approved therapies for pulmonary sarcoidosis. And really the standard of care is steroids, prednisone, and then it sort of goes into the standard kind of non-modern grab bag of other things, things like methotrexate, sulfasalazine, sometimes Rituxan or TNF inhibitors, but those are sort of rarely used off label and not incredibly effective, haven't really been shown to have robust efficacy in clinical studies.
Corinne Jenkins
analystGreat. Okay. Another subsidiary to talk about and touch on would be Aruvant and that's the sickle cell gene therapy program, ARU-1801, and it's currently in Phase I/II. Could you provide a little bit of context around what we've seen thus far with that data, and then maybe we'll jump into what we'll see next.
Mayukh Sukhatme
executiveYes, sure. So as you've said, so 1801 is a lenti program for sickle cell disease. I think I said a bunch of 4 letter words to the investor community right now. But in fairness, I think -- we think that our program is actually quite differentiated. So this program was conceived really from inception to do something that actually no other program in either gene therapy or gene editing can do, which is to be dosed with the reduced intensity regimen. So not using highly, highly myeloablative conditioning regimens, such as busulfan, that we think are both practical and commercial going to be -- end up being difficult in the adoption of programs, like bluebird's or CRISPR's, where because they do require that highly ablative conditioning regimen, you have to be in the hospital for a month or maybe even 2 months to get it. And I think that's a big problem. So our kind of goal, our product profile from the beginning was to see that we could deliver the same kind of cure. And really the name of the game here is clinical cure. So complete reduction of severe VOEs without having to have that highly ablative conditioning regimen. So we use right now a reduced intensity regimen with melphalan. We think that ultimately, we might be in a position to actually dose this as a onetime outpatient treatment. And the reason we're able to do that actually is that we use a proprietary novel construct, which includes actually a modified form of fetal hemoglobin. So again, this is not something that bluebird can do. They've actually tried to go with the reduced intensity route and didn't have the efficacy. And CRISPR is just doing sort of standard HbF and not this modified HbF. And so again, we think ultimately, this is a very differentiated product profile. This is really, I think, what the market needs and what patients want.
Corinne Jenkins
analystGreat. And just remind me, what have we seen with the data thus far, I think, 5 patients? And then what do we expect to see over the first of the next 12 months?
Mayukh Sukhatme
executiveYes. So yes, so we took on this program actually, it was originally out of -- as an academic project out of Cincinnati Children's Medical Center. They had dosed 2 patients, and then we have now dosed 3 additional patients that we reported on publicly. We're continuing to dose, and we'll give additional patient-level updates since then. So since we've taken it on, we've really, I would say, industrialized the process and industrialized manufacturing. I think as the audience well appreciates, manufacturing and gene therapy is sometimes tricky and sometimes I think going from an academic process to sort of a company process does have some fits and starts. I think we've now kindly paid that tuition, so we're ready to go. We've reported on the 5 patients, as I noted, the first 2 actually came out of Cincinnati. One of those did continue to have actually some VOEs. But since we've taken it on, made the manufacturing improvements, actually, none of the patients that we have dosed, the 3 patients, have had any severe VOEs, and we've now got follow-up out a few years actually.
Richard Pulik
executiveAnd I think just in terms of the market population, I mean, there's 100,000 patients in the U.S., who I think really suffer from this disease. As you know, a lot of these patients have stroke risk, organ issues and also very painful crises that ends up in the hospital many times per year, which is very expensive for the system. I think as we sort of think about how the data develops, it will be important to make sure that those VOEs, those patients remain [ VOE-free ] as we think about how we want to take this forward. I mean I think also manufacturing here can be quite tricky and expensive. So I want to make sure that from a capital allocation perspective, we're really thinking long and hard about the right decision as we see that data emerge and that we're going to be competitive given the positioning here.
Corinne Jenkins
analystOkay. Helpful. So you mentioned this at the very beginning. But beyond some of these agents we've talked about today, you are building out some discovery capabilities, particularly focused around targeted protein degradation. So can you just help us understand the efforts, what we should expect to see from those programs and when we should start to see clinical data?
Mayukh Sukhatme
executiveYes, sure. So we're really excited. I mean, I think most of what we have done historically has been obviously, clinical stage candidates, very asset-first kind of approach. But I think as we saw the field, I think we have seen, I think, in a couple of prongs you mentioned one of them in targeted protein degradation. We have another sort of effort in discovery in covalency that I want to highlight in particular. But we've seen, in essence, a new modality that comes along. I think that the ability to take a pill that does this protein degradation is pretty revolutionary. I think like any new modality, it's going to sort of take some time to really bear out. But those kind of revolutions don't happen very often. I think certainly, as I look back in my career, I kind of think putting gene editing, gene therapy aside, really, it's like small molecules, antibodies, and I think this could be kind of the next thing. And we looked at it, we felt that actually we could approach it in sort of a unique, different, I would say, internally, we call it a Roivant-y way, which is really targeted sort of narrow focus on trying to solve a problem where we think we have an edge in this case. We think we have an edge, both in medicinal chemistry because actually, the rules are being rewritten and second, in sort of our computational horsepower. So we've built a real platform in computational drug discovery. And there's no leader in the space, and we're hoping that eventually we will be a leader. So we've got a portfolio that's all still pretty early. We have an IND potentially as early as this year for one of our programs. And then you'll see over the next kind of few years kind of a stream of additional INDs.
Corinne Jenkins
analystAnd remind us what the first IND is going to be?
Mayukh Sukhatme
executiveYes. So the first projected IND is expected to be a degrader for antigen receptor, an AR degrade.
Richard Pulik
executiveAnd I would say, again, there are -- I want to really make sure that we understand sort of the differentiation and the positioning versus the field before we embark on a pretty broad development program. So I think we're looking at that data closely. I think also you probably noticed we had announced deals with Janssen, with Boehringer Ingelheim and also with Blueprint, which really validates sort of the differentiated technology that we have given some of those partners, we said there's potential $1 billion-plus in milestones around those targets. So we're really excited. And it's also been validated externally with some of the partnerships we've recently formed.
Corinne Jenkins
analystWonderful. So we've touched on a bunch of these subsidiaries today. Is there anything that we've missed in our conversation that you would like to highlight in our last couple of minutes here?
Mayukh Sukhatme
executiveSure. I guess I would say I think everything that we do, I think we talked about -- a little bit about sort of our approach, which we think is different. We have this debt model. That's really kind of a means to an end. But ultimately, I think we have had a ton of success. Again, we're an 8-year-old company with 5 approvals. I hesitate to say it for sure. But I think we'll probably have the record for most approvals with the company that's our age. And I think that, that execution hallmark really is something that has continued to kind of help our reputation with pharma and with partners of all types. So stay tuned on new deals. And I think in the current environment, obviously, I think we're in a pretty good position with our cash position. We've got a lot of flexibility. I think, as Richard has mentioned, we have very much an investor mindset, and I come from an investment background. And so anything that we decide to allocate meaningful capital to, we've got an angle or an edge or a differentiated thesis where we think we can actually execute and bring something important to market.
Corinne Jenkins
analystYou mentioned cash, you mentioned deals. Can you just talk a little bit about your philosophy around capital allocation, obviously, $2 billion sitting there right now. So how should we expect to see you guys use that capital over the next [Technical Difficulty]. Should we be worried about that one? It doesn't look like the fire alarm, does it?
Mayukh Sukhatme
executiveAll right. I guess I'll -- Yes. So look, I mean, I think we've got a good capital position, but I think it's a luxury that we need to, I think, appropriately preserve and guard carefully. It's an advantage that we want to kind of continue to retain. In terms of just our approach, I think really, our approach is deploying capital where we think that actually there is sort of the greatest sort of ultimate return for us, where the risk profile is greatest and where there's sort of tangible value creation. And so I think our focus really is on things that will move the needle for our enterprise right now in the coming years. In terms of just kind of macro look, when we started the company 8 years ago, we started really with nothing. And I think right now, we're -- again, we're a $3 billion company, with a big balance sheet, a lot of programs in development. And ultimately, hopefully, that track record really starts to speak for itself.
Richard Pulik
executiveAnd I would say we look very carefully about the internal data we generated, the external environment as we're thinking about, sort of these capital allocation decisions. I think it's very critical here to sort of understand that we're in a position of privilege here to allocate $2.1 billion. And I want to make sure that we're looking long and hard about our internal data and the external data, so we can really bring meaningful drugs to patients.
Corinne Jenkins
analystAbsolutely. Well, maybe in the last minute here, we talked about a lot going on at Roivant today. But like what 1, 2, 3 things do you think people should be most focused on in the next 6 to 12 months because we are pretty short-term minded in this market right now.
Mayukh Sukhatme
executiveSure. Yes. I mean, I guess I would say over the next year, I think you should look at a few things. I would say, watch this space for new additions to our pipeline, which we hope will be -- can be really impactful. Two, I think, monitor our ongoing development, particularly in terms of our launch of tapinarof. That's going to take some time to play out. But obviously, you guys know you can monitor the IMS scripts and our different metrics along the way. We've got Phase III data for atopic derm in the first half of next year. And then we'll get open-label updates for both Aruvant and for our SF3B1 modulator for MDS.
Corinne Jenkins
analystWonderful. Well, that is perfectly timed. So thank you very much, everyone, for joining us, and thanks so much to you both for the interest today.
Mayukh Sukhatme
executiveThanks, Corinne.
Richard Pulik
executiveThank you so much. Bye-bye.
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