Roivant Sciences at Guggenheim Conference: Strategic Pipeline Focus

On Tuesday, November 11, 2025, Roivant Sciences (NASDAQ:ROIV) presented its strategic outlook at the Guggenheim Securities 2nd Annual Healthcare Innovation Conference. The company showcased its promising pipeline and financial strategy, highlighting strengths like a robust cash position and potential product launches. However, ongoing litigation and market challenges remain areas to watch.

Key Takeaways

• Roivant is optimistic about brepocitinib, with plans to file for approval next year and a potential launch in 2027.
• The company is advancing its 1402 asset in TED and Graves' disease, with multiple trials and data readouts expected by 2027.
• Roivant maintains a strong cash balance of $4.4 billion, with plans to allocate equally among R&D, business development, and share buybacks.
• The ongoing LNP litigation with Moderna could have significant financial implications, with a damages ask of $5 billion.
• Roivant has reduced its share count by over 14% and continues to focus on strategic buybacks.

Financial Results

• Cash balance: $4.4 billion as of yesterday
• Share count reduction: Over 14%, with shares priced around $10 each
• Remaining share buyback authorization: $500 million
• Damages ask in the Moderna trial: $5 billion, excluding willful infringement
• Planned capital allocation from the Telavant deal: $2 billion each for business development, buybacks, and internal pipeline

Operational Updates

• Brepocitinib: NDA filing expected in the first half of next year; potential launch in 2027
• Immunovant 1402: Two Phase 3 studies in TED, with data expected at the end of this year and first half of 2026
• Graves' Disease: Phase 3 data expected in 2027
• Cutaneous Lupus Erythematosus (CLE): POC data readout next year
• Rheumatoid Arthritis (RA): Period one data from a potentially registrational study reading out next year
• Mosley (PH-ILD): Phase 2 data readout next year
• Non-Infectious Uveitis (NIU): Phase 3 data reading out in 2027
• LNP Litigation: U.S. Moderna trial going to jury trial in March; OUS Moderna trials expected to start next year

Future Outlook

• Brepocitinib: Focused launch strategy targeting niche centers and a concentrated prescriber base
• Immunovant: Prioritizing 1402 for Graves' disease and TED, exploring potential combination therapies
• Business Development: Actively seeking strategic deals with upfronts in the $1-4 billion range
• Cash Deployment: Committed to allocating capital equally between internal R&D, business development, and share buybacks
• LNP Litigation: Awaiting jury decision in Moderna trial, with potential for significant cash infusion
• Clinical Trials: Expecting multiple data readouts in 2026 and 2027 across various indications

Q&A Highlights

• TED Strategy: Data disclosure planned for the first half of next year
• Graves' Disease Enrollment: Data has supported enrollment in ongoing Phase 3 study
• Brepocitinib in Dermatomyositis: Infrastructure needed for a concentrated launch in niche centers
• NIU Market: Confidence due to better clinical data than Humira
• LNP Litigation: Strong case in the Moderna trial
• Cash Deployment: Adhering to a one-third allocation strategy for R&D, business development, and buybacks

Readers are encouraged to refer to the full transcript for a detailed understanding of Roivant Sciences' strategic plans and financial outlook.

Full transcript - Guggenheim Securities 2nd Annual Healthcare Innovation Conference:

Yatin Suneja, Biotech Analyst, Guggenheim: Good morning, everyone. Welcome to Guggenheim Healthcare Innovation Conference. My name is Yatin Suneja, one of the biotech analysts here at Guggenheim. It is my pleasure to welcome Roivant Sciences here with me. From the company, we have the Chief Financial Officer, Richard Pulik. Richard, why don't you make some opening comments? You did the earnings call yesterday. There were some incremental updates. Why don't you just make some comments, and then we'll go into the Q&A?

Richard Pulik, Chief Financial Officer, Roivant Sciences: Great. First of all, it's great to see everybody here. Especially surprised to see people in the audience, given some of the travel issues. Nice to see that there's actually some bodies here. Look, we've had incredible momentum since we read out the brepocitinib dermatomyositis data and also the Graves' data. I think people are finally starting to see brepocitinib as an asset that will be a large commercial asset that we plan to file next year and launch in 2027. I think there's been a lot of excitement around that from the KOL community, from patients. I think the data speaks to itself that this is an incredibly devastating disease that impacts both skin and muscle. We have data now with an oral solution that showed very strong efficacy across 10 endpoints that were statistically significant.

It's probably, in my 25-year career in healthcare, one of the cleanest trials I've seen. I think that's brought a lot of excitement into the BREPO story, or JAK1/TYK2 inhibitor. Of course, we have some POCs reading out next year around CS, CLE. We're going to see the difficult-to-treat RA data. We have also the TED data readout. Lots of very interesting POCs to go in 2026. Of course, getting ready for the BREPO launch. Of course, Mosley. That's also reading out in 2026. There we had some very exciting data in PAH, and we're developing that for PH-ILD, where there's a large unmet need and very little competition right now.

Yatin Suneja, Biotech Analyst, Guggenheim: Very good. I think there was some incredible momentum, both for Roivant and Immunovant perspective this year. I think next year is going to be even more catalyst-rich. I want to spend some time on the Immunovant story first. I think yesterday you sort of provided a little bit of an incremental update on the TED strategy in terms of when you'll disclose the data. Can you just talk about what is the strategy now? Will you disclose the data? How much of a disclosure would you do? Is there a particular bar in TED that you are looking for if you were to sort of move ahead as a standalone indication for 1401?

Richard Pulik, Chief Financial Officer, Roivant Sciences: Maybe just to step back a little bit, we had data with batoclimab in TED, where we saw roughly doubling of response rates, proper dose response rates, between the high dose and the low dose. The high dose ends up lowering IgG at the sort of 80% mark. We're pretty much alone in the field to be able to do that. This is before we actually had our second asset, 1402. Then we quickly moved into a phase three study with TED, two phase three studies. The first study will be reading out sometime at the end of this year, and then the second study in the first half of 2026. Look, when we talked about that study and the data, a competitor quickly sort of followed up a year later to move into a pivotal there.

That same competitor moved to announce a pivotal in Graves, where we also had pretty incredible data where we showed disease-modifying benefit. Frankly, I found it a little bit of a head-scratcher, given that we're the only ones who can get IgG at 80%. If you look at the cutoffs of the data points across even 70% and greater, there's very meaningful efficacy deltas. I think that's going to be just a hard space for competitors to compete in, given the much better efficacy data we've seen. I think we learned our lesson there a little bit to keep some of the stuff closer to the chest. We'll talk about it when we see the data in the first half of next year.

Yatin Suneja, Biotech Analyst, Guggenheim: Got it. Yeah, I think it makes sense. Is there a path forward for batoclimab in TED, in the sense that I understand you are all prioritizing 1402, which I think is a superior molecule? If the data in TED meets the internal bar, could you go ahead and file and get that asset commercialized?

Richard Pulik, Chief Financial Officer, Roivant Sciences: Look, it's hard to say without seeing the data. But I think, look, if I just think about it holistically, we're very focused on what makes most sense for the patient. 1402, we have a clean molecule that didn't have any impact on albumin or LDL. We are obviously bringing that forward with two Graves studies. If I think about Graves, there's roughly 40% of patients who have TED in the Graves population. We know that when we looked at the batoclimab data, we saw an impact on proptosis reduction by looking at the batoclimab data in our Graves study. We're actually measuring proptosis also in the two phase three studies. I think we're approaching this pretty holistically to look at the disease, sort of to look at this earlier in the disease across a much larger patient pool.

I think, look, as we see the phase three TED data, then I think that'll be insightful in terms of how we approach the entire treatment paradigm much earlier. Certainly, we'll make a call there based on the risk-benefit that we see.

Yatin Suneja, Biotech Analyst, Guggenheim: Got it. Got it. I think you have put more data, more Graves data out in public. How has that helped from an enrollment perspective in the ongoing phase three study? When exactly are we going to see the data? It is maybe probably a little bit early to set the expectation. In general, what are you looking for in that data set?

Richard Pulik, Chief Financial Officer, Roivant Sciences: Look, we showed data that essentially had a, we kept patients on a 680 dose of batoclimab for 12 weeks. Then we reduced them to the lower dose, the 340 dose, for another 12 weeks. Then we took patients off drug, and then we followed them. When you look at it, many of these patients are on high ATDs. We had complete disease control on very low ATDs, so 2.5 milligrams or lower. Some patients were entirely off ATDs, which is pretty unheard of. I mean, when you think about the population that we went after, these were patients that were not controlled on ATDs. That is roughly a prevalent population of 330,000 patients. If I think about the incident population, that is roughly 30,000. These are usually working-age women who are motivated to a large commercial segment.

There really has been no innovation for these patients for the past 20 years. I think that was really eye-opening to many KOLs and patients to finally provide a treatment option. Look, this is a disease that causes very increased risk factors across basically thyroid cancer and other diseases that have high mortality benefits. Trying to control these patients on ATDs causes weight gain, weight loss, then mood swings. It is a really difficult disease. I think it was eye-opening to see the disease-modifying data we saw really without ATD support. It's been very exciting as we go to KOLs and enroll the study. We didn't update anything. We said we're going to see that in 2027.

Yatin Suneja, Biotech Analyst, Guggenheim: 2027. OK. All right. From the POC standpoint, what are some indications that could be unlocked with FcRn next year from the studies that you're running?

Richard Pulik, Chief Financial Officer, Roivant Sciences: We had done a sort of quietly in the background, saw a couple of patients in CLE that had good responses with NTFCRN. I think that data reads out next year. That could be another area where we'll be first. Look, if you looked at the skin resolution there, it looked very good. I think some of the investigators were excited. We're essentially running a small POC study that reads out next year. I think another one that sort of, look, people were not crazily excited about the J&J RA data. Obviously, they killed their combo study. I would look, we still think it's a very interesting place to go because you actually saw direct correlation between IgG reduction and efficacy. We decided to go and explore this in a much later population, so first-line population, where there's really not much for these patients.

We have the period one of that data, which is a potentially registrational study reading out next year. That will be another interesting place to go, where really nobody is going right now. Nobody can follow, given the IgG suppression we have. The following year in 2027, you are going to have the MG, Graves, and CIDP potential registrational studies. You have Sjogren's the following year. I think a lot of readouts. We have six different trials ongoing in 1402.

Yatin Suneja, Biotech Analyst, Guggenheim: Got it. Got it. Let's move to BREPO. Obviously, the data are now out in the public. What has been the physician's feedback on the data? What is needed, or what are the gating factors to the NDA filing?

Richard Pulik, Chief Financial Officer, Roivant Sciences: On the filing, it's easy just pulling it together and writing, which obviously takes a little bit of time. That is underway. We should have that ready for the first half of next year. If you think about the population here, and you just look at the SCRIPT data, there's roughly 40,000 patients. Most of them are being treated with high-dose steroids. This is, again, largely commercial-age patients who end up exhibiting a full-body rash or muscle weakness, usually in the periphery, sort of around the shoulders and legs. Pretty severe and scary symptoms. Usually they'll get treated with high-dose steroids. Small, maybe 10%-12% get treated with IVIG. When we were thinking about the patient population and the study design, being on high-dose steroids for a long time is very difficult.

We wanted to make sure that we saw a significant benefit here with meaningful steroid reduction. We had, by the end of the study, very low steroid dose with, I think, 40% of patients completely off steroids. Still, we had some of the best data we've seen across muscle, skin, quality of life endpoints. I think we have a really exciting package to bring to physicians here. The primary is sort of this composite endpoint. We wanted to make sure that as we were designing the study and delivering this solution for patients, we had an arsenal of data points to show the benefit of this once-a-day oral drug. Also, on the safety side, look, when we got this drug from Pfizer, we had it in 1,500 patients. They were exploring this in much more prevalent diseases.

We feel very good about the data set we have from a safety perspective and also the safety that we saw in the study.

Yatin Suneja, Biotech Analyst, Guggenheim: What would be the infrastructure needed to launch this, given that it's more of a niche indication?

Richard Pulik, Chief Financial Officer, Roivant Sciences: Perfect question. Look, we didn't provide exact guidance yet in terms of the dollar amount or the numbers of sales reps. But again, very concentrated launch where the prescriber base is concentrated. And these patients are treated in fairly niche centers.

Yatin Suneja, Biotech Analyst, Guggenheim: Yeah. And then you have a follow-up indication, right, NIU, where you had generated phase two data first. The pivotals are going to read out relatively soon. How are you thinking about the NIU non-infectious uveitis market? I think the feedback that we are getting is a little bit mixed, much more positive on the DM side. I would love to hear from you the opportunity there. I think from a price point, both indications are a little bit different. How are you thinking about the price in DM and NIU?

Richard Pulik, Chief Financial Officer, Roivant Sciences: Personally, I thought the DM study was scarier because we were relying on investigator studies for hypothesis. When we did the NIU study, I was actually, look, there is one drug right now that is used and approved in NIU, which is Humira. We showed essentially it was a placebo-controlled study. If you just look on a cross-taught comparison basis, you see data that is really not comparable there. I mean, you have no edema. You have edema resolving. This is actually a disease that is one of the causes of blindness in the U.S. We know that the eye leads. Again, uveitis is treated in specialty centers. You usually have to do a one-year fellowship after you are off the residency to treat these patients. It is very specialized.

We showed essentially data that was twice as good in terms of treatment-free remission, actually more than twice as good than Humira. All of the important ophthalmic endpoints were also incredibly positive. That was one where I felt very comfortable to move that quickly to phase three. That is reading out in 2027. We have had very strong KOL feedback and excitement around that, given this devastating disease that causes potentially blindness in quite a lot of patients. If you think about the dose in that study, it is 45 milligram versus 30 in the DM. Certainly, I think there is some flexibility to think about from a commercial perspective. These are sort of similarly sized rare disease patient segments. Obviously, we will be priced appropriately.

Yatin Suneja, Biotech Analyst, Guggenheim: Got it. Other areas that you are considering with BREPO? I think there is a cutaneous sarcoidosis study happening or going on. Expectations there?

Richard Pulik, Chief Financial Officer, Roivant Sciences: Yeah. So we kind of thought about that very much like the NIU study, where we essentially did a small POC study. That is reading out next year. Look, I think there is a lot of rationale there, given the data we have seen and impact on skin and inflammation now with DM and six other positive studies that we received from Pfizer. So seven positive studies now with this JAK1, TYK2. I think, look, let's see what that looks like. I think it would be another interesting indication. Of course, we have a pretty high bar in terms of what we bring forward. If that makes sense from a commercial perspective, we will flip that into a phase three.

Yatin Suneja, Biotech Analyst, Guggenheim: Got it. Very good. So then we'll quickly touch on Mosley PH-ILD. What are the expectations there? I think you have a readout coming up next year in PH-ILD.

Richard Pulik, Chief Financial Officer, Roivant Sciences: Look, we had seen data here in a phase one study in PAH, where we had PVR reductions of 38%. This is a once-daily DPI. That proved out to us that, look, when we were doing the deal with Bayer, we had seen that this mechanism had a very long half-life. The data we saw was in the group one setting versus PAH-ILD, which is in group three. There is certainly a little bit of risk in terms of having that data read out positive in the group three setting. Because we saw such high PVRs, we were still confident to do a phase two here. It is over 100 patients. That is reading out next year. There is obviously one competitor, United Therapeutics. I think this is, again, a disease where people have a lot of trouble.

Even just walking from here to across the room, it's pretty devastating. There's not a lot of options. That'll be, given the data we saw in PAH, I think it'll be interesting to see how this develops in PH-ILD. There's, again, a very large unmet need. We're excited to see that data for potentially third leg of a commercial franchise.

Yatin Suneja, Biotech Analyst, Guggenheim: Got it. Very good. Yesterday on the call, I think you provided some incremental color on the LNP litigation that is ongoing with Moderna and Pfizer. Could you maybe review for us what are some of the key milestones there? What happens in March? Anything before March? Yeah.

Richard Pulik, Chief Financial Officer, Roivant Sciences: Yeah. I want to be a little bit careful to comment on ongoing litigation. If you just look at what's on the docket, the U.S. portion of the Moderna trial is going to a jury trial in March. Pretty soon, we'll see there will be a jury decision. We'll see how that plays out. I think, look, if you look at some of the documents, we have a very strong case. We're excited to see the outcome there. I think, look, our damages ask in that was $5 billion. That's excluding willful infringement. It could potentially be an event that means our cash balance increases even more than we have, which we're at $4.4 billion as of yesterday. The Pfizer trial is roughly a year behind. We just had the Markman decision there, which was very favorable.

Obviously, that drug did a little COVID drug did a little bit better in terms of sales. That is even a bigger pie. If you just sort of think about Genevant, I mean, we have spent about 20 years developing IP around LNP and how to, I think if you step back and think about the challenge here was how do you get these large mRNAs into the body without them, just to put it simply, falling apart and getting to the target. There was a lot of science that went behind the thinking there and encompassing that mRNA. From that, you can see we have multiple partnerships from the mid-single digit to low teens royalties. Those were with no clinical data.

I think there's a lot of precedent here across many different partnerships and with people who used and needed our technology to actually make mRNA functional in the body and be of therapeutic.

Yatin Suneja, Biotech Analyst, Guggenheim: Got it. Got it. What about the OUS piece from a litigation standpoint?

Richard Pulik, Chief Financial Officer, Roivant Sciences: The OUS Moderna trials are expected to start next year. Again, I think if you think about the OUS sales, they're more than 50%. I think we'll see some progress there. Obviously, Pfizer is, we don't have a timeline yet on the jury trial or the court dates yet.

Yatin Suneja, Biotech Analyst, Guggenheim: Got it. Then final questions on the deployment of cash that you have, $4.5 billion close to. I think in the past, maybe a couple of years ago, you used to put in three buckets: internal R&D, BD, and sort of buyback. Where are we on that? How are you thinking about BD and deploying some of the cash that you have on the balance sheet?

Richard Pulik, Chief Financial Officer, Roivant Sciences: When we did the Telavant deal, we had roughly $6 billion. We said a third, a third, a third. So $2 billion for BD, $2 billion for buybacks, and $2 billion for internal pipeline. We're funded through profitability. We have a lot of cash. Look, if you look at our 10-year history, the upfronts that we usually did were $1-4 billion. You can do a lot of deals there because you usually do a fairly modest upfront. Then you're really just paying for the phase two study to validate the hypothesis, just like we had done in NIU, just like we are doing with CS, CLE. That just gives us lots of capacity to do additional deals. Look, given the readouts we expect in the POCs, I have plenty of cash to fund those additional development areas.

We're proud of reducing our share count by over 14% and $10, roughly $10 a share. I have another $500 million share buyback authorization remaining.

Yatin Suneja, Biotech Analyst, Guggenheim: Got it. Very good, Richard. Thank you so much.

Richard Pulik, Chief Financial Officer, Roivant Sciences: Thank you.

Yatin Suneja, Biotech Analyst, Guggenheim: Thank you.

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