Roivant Sciences Ltd. Common Shares Citigroup’s Biopharma Back to School Summit 2026

Thank you so much. It is officially, I think, also the first day of school in New York schools, so perfect timing with the conference.

Look, we have had an incredible year so far. As we think about Roivant, look, we are approaching $30 billion market cap here. We have $3.9 billion in cash, which does not include the $700 million plus that we received in July on the Moderna settlement. We have now, I would say, with the mosliciguat data that read out a couple of days ago, really affirmed the third leg of the stool into a place where that can be another big pillar for the company, adding to brepocitinib, which you mentioned just had our first approval for LISRAYA, is the drug name in dermatomyositis, which, look, I think if you look at the label, it is pretty incredible in terms of the indication statement, and no restrictions on concomitant use.

And then also covering the skin and muscle manifestations and breadth of the disease of the study that we had in the phase III data, which was a disease that's been largely ignored and was the largest DM study that's ever run. To kick off and going into this patient population that was ignored for a long time, I think is a very Roivant move, right? As we formed the company and thought about areas where to go, it was really to think about disease areas where there's high unmet need that have been ignored for a long time, that are severe in scope, and also where we had a bit of validation, right? Where certainly there was either data that was driven by investigators or that we had seen from other JAKs that worked here. Look, it's a very exciting time for brepocitinib.

We certainly have three other indications that are late stage there, with NIU reading out this year in a phase III study, and then CS and LPP ongoing. The third leg of the stool is really IMVT-1402, where we also had some exciting data, and I think data that surprised a lot of the investment community, especially in D2T RA. Certainly, nipocalimab paved the way a little bit with an RA, certainly, but in a much earlier population. But we saw that FcRns had activity there. Then we again thought in the Roivant way, where do we go here? Where's the underserved population? That was in patients who are very late line, where JAKs and TNFs have failed, and where we can deliver strong efficacy.

We saw very strong efficacy rates there with ACR70, 50, and 20, and that was period one, and period two is reading out later this year. Then along with we have CLE data, right, which is again another Roivant-type indication where we could potentially be first. Certainly, I think that's a flyer. We're really trying to see if this is an area where we hit a bar that makes sense from a commercial perspective, and I think there's a little bit more competition there. But we had seen a little bit of data in some patients in ulcerative colitis that sort of helped validate this, and we'll see what that looks like. Then we have four other indications with MG and Graves' disease potential approvable data sets next year, and other indications that we can go into, but that's really the third leg of the stool here.

Certainly, we're very active as well on BD, given our cash balance and the breadth of resources we have.

Maybe to back up a little bit. mosliciguat is an sGC activator that we did this deal with Bayer. We paid, I think roughly $15 million or so was the upfront, and then there is milestone payments under $300 million, and then high single-digit royalties. This is an area where sGC activators have been looked at systemically for quite some time in pulmonary hypertension. Then we showed data about a couple of years ago at ERS that showed the highest PVR reductions we have seen in PAH. PAH was a market that had what? Six or seven therapies, I think, at the time when we showed the data. Lots of breadth of available therapies. mosliciguat was a once-a-day inhaled DPI, and then with a differentiated mechanism, with the long half-life, and we delivered in PH.

As we were thinking about where do we want to go, going back to what I said before, to a place that does not have a lot of addressable and really a lot of scientific development. Obviously we have TYVASO, and we saw the great data, and I would say innovation there for PH-ILD patients. We ran the study, and then what happened, and happened a couple of days ago, we saw the highest PVR reductions we have seen in PH-ILD. We surprised people because we did not power for the six-minute walk test, but we delivered with 35, and then this is at week 16, and we saw continued improvement at over 50 placebo-adjusted. If you look at across all of the key measures we had, we saw that they continued to improve.

These are very smooth curves where you actually continue to improve after week 16 and as you are dose escalating. On the safety, we had very good safety data. I would say that the prostanoids obviously have cough as an on-target effect. Again, an easy to use once-a-day molecule that has delivered really the best efficacy markers we have seen so far, and even on six-minute walk, which we were powered for. I think that is really opened up a lot of excitement for these patients. That data was presented at ERS a couple of days ago. On short notice, I think the room, as I was told, was very full. There was a lot of excitement from KOLs, and this is a really severe disease where people really have trouble just walking across the small room.

The morbidity is very high with a lot of people dying within a couple of years and have a terrible quality of life. To deliver this kind of data is very exciting for the field.