Roivant at Leerink’s Conference: Strategic Insights and Developments

On Monday, 10 March 2025, Roivant Sciences (NASDAQ: ROIV) presented at Leerink’s Global Healthcare Conference 2025, offering a strategic overview of its operations. CEO Matt Klein discussed the company’s vision, emphasizing management incentives aligned with shareholder value. The presentation highlighted both promising developments and ongoing challenges, such as LNP litigation and upcoming drug data releases.

Key Takeaways

• Roivant’s management incentives are tied to a significant increase in stock price, aligning with long-term shareholder interests.
• Upcoming data readouts for betoklamab in myasthenia gravis and CIDP are crucial for Roivant’s strategic direction.
• Brepacitinib, acquired from Pfizer, shows promise for dermatomyositis, with key data expected later this year.
• LNP litigation with Moderna and Pfizer/BioNTech could impact Roivant’s financial future significantly.
• Roivant aims to be a leading biopharma company through strategic acquisitions and development of promising drug candidates.

Financial Results

• Management Incentives:

- Senior management’s compensation is tied to a 2.5x to 3x increase in stock price, translating to a market cap of $25 billion to $35 billion.

- Executives are required to hold the stock for three years post-goal achievement to ensure long-term alignment.

• LNP Litigation:

- With COVID vaccine sales reaching $150 billion globally, a favorable litigation outcome could be transformative for Roivant.

• Brepacitinib Acquisition:

- Acquired from Pfizer for $14 million, including inventory. Comparatively, AbbVie’s RINVOC is a $7 billion drug, with potential growth to $15 billion.

Operational Updates

• Betoklamab:

- Phase three data for myasthenia gravis and Phase 2b data for CIDP are expected this month.

- TED data release is anticipated later this year.

• 1402:

- Six INDs cleared, with most progressing to pivotal studies for conditions like MG, CIDP, Graves’, and RA.

- RA study data could be available in the next 18-24 months.

• Brepacitinib:

- Registrational data for dermatomyositis expected in the second half of the year.

- Two Phase III studies for NIU are progressing well, with a Phase II study for cutaneous sarcoidosis expected next year.

• LNP Litigation:

- Moderna case jury trial scheduled for September; Pfizer case ruling expected soon.

- International litigations filed in Europe, Canada, and Japan, with trials possible in 12-15 months.

• Moseley Siguat:

- Phase 2b data for PHLD expected in the second half of 2026.

Future Outlook

• Roivant aims to achieve first approvals for 1402 within a few years.
• The company plans to file for NIU approval by 2027, with hopes for approval by 2028.
• LNP litigation outcomes are expected to significantly impact Roivant’s financial trajectory.

Readers are encouraged to refer to the full transcript for more detailed insights into Roivant’s strategic plans and developments.

Full transcript - Leerink’s Global Healthcare Conference 2025:

Dave: Our apologies for the delay in getting started. It is not Matt’s fault. It’s my fault.

Matt Klein, CEO, Royvant: Not his

Dave: fault either. But anyway, it’s very much my pleasure to welcome Matt Klein, the CEO of Royvant. And I guess maybe it would be great to just start off with your vision for the company and how you see it coming to fruition in coming years. I think that many investors are a little bit lost in terms of how to think about the company, yet I think you do have a pretty clear vision on where you want to take it. So if we could start off there, that would be great.

Matt Klein, CEO, Royvant: Yes. Thanks, Dave. Appreciate it. Thanks for having me. And look, part of my vision for the company is we’re going to show up five minutes late to every formal presentation so that everyone thinks we’re really busy.

Look, I do understand why I get this question a lot. But ultimately, our vision for the company, I think, is very straightforward, which is we think we have an opportunity to build a great biopharma company developing medicines that matter and delivering them to patients. And we think today we have a pipeline sufficient to fuel that between the anti FTRN franchise at ImmunoVant, Brepcitinib, Moseley and earlier things behind that. The only thing really that is different about our company versus any other biopharma company is most of our pipeline is assembled through selective in licensing and careful acquisition of programs at the development stage because what we think we are world class at, the thing that we think we are best in the world at is finding those opportunities and developing them in creative ways that matter to patients that maybe their prior owners thought of or maybe they didn’t.

Dave: Excellent, excellent. And management incentives are 100% tied to or virtually 100% tied to shareholders. Could you talk about that?

Matt Klein, CEO, Royvant: Yes, sure. I mean, look, our whole management team are big shareholders in the company and we have been since sorry, I don’t want to to mess with the microphone, since before we went public. And as of last year, which may be part of what you’re referring to, we put in place a package for the senior most team at Roivent that is one of these sort of laddered deals where we don’t get much of it unless the stock is 2.5 to three x what it is now. And I think the reason our board did that is because they agree with what I started with here that we have a pipeline that can carry us to whatever that would imply a $25,000,000,000 30 billion dollars 30 5 billion dollars market cap. And I think we’ve got a pipeline that can carry us there and they wanted us to be batting for the same thing as the shareholders.

Dave: Excellent. And could you talk a little bit about the sort of the durability of those incentives, meaning the actual holding period.

Matt Klein, CEO, Royvant: Sure. Yes, yes.

Dave: Perfect. The incentives are not, let’s say, valiant flash in the pan type of incentives.

Matt Klein, CEO, Royvant: We have about five years to hit those goals, a little bit less now. And once we hit them, we have to hold the stock basically for three years after hitting them. So this is not a this is not like we’re going to hit some goal and then dump a bunch of stock. This is a we have a chance to appreciate a lot of value, but it has to be durable a little bit this way. Every public shareholder will be able to sell any stock at those prices long before we can.

And I think that was the goal, right, is to make us long term aligned with the business.

Dave: Excellent, excellent. So let’s turn to the pending Immunovant news. I think many in the investment community are basically are hesitating or hitting the pause button on purchasing ImmunoVano Royvant stock ahead of the betoklamab readouts ahead. Could you just sort of frame the readouts, and then we’ll go from there?

Matt Klein, CEO, Royvant: That is perhaps the most polite way anyone has described the current sentiment amount of ImmunoVent

Dave: to me. So I appreciate

Matt Klein, CEO, Royvant: that. Yes, look, so mechanically this month, we have two datasets coming. One is our Phase three program in myasthenia gravis, and the other is our Phase 2b program in CIDP, both for betoklamab, the first generation anti FcRNP antibody at Immunovant. My opinion of these datasets is they’re being overanalyzed and overconsidered on the street. And the reason I think that is because there are basically two things that let’s start with the MG data set, two things it could tell us.

One is it could be some kind of referendum on the overall strategy of deeper IgG suppression mattering, which for those who aren’t paying that close attention, our view has always been we in all of our compounds, betoklamab and fourteen oh two suppress IgG more deeply than we think our competition, other FCN antibodies will in practice. And frankly, the biology of this is not that complicated, right? These are diseases caused by pathogenic IgG autoantibodies. In our view, the deeper you reduce the level of those autoantibodies, the more you will treat patients. And my view is that has largely borne out at this point in our own data in Graves’ disease, in our own data in TED, in J and J’s data in Sjogren’s disease, in UCB’s data in ITP.

And it was a benefit of our competitor programs that they advertised up until the point where somebody wound up with deeper IgG expression than they had at the individual patient level in MG studies. So as our pretty clearly held view is that is true and it is largely true in our view irrespective of what this specific data shows. So in that sense, what this data really tells us is how easy is it going to be to show a dose response and generate competitively important data in myasthenia gravis, which is an important question. Myasthenia gravis is a big market. But first of all, we are even with great data, but fourteen oh two was the drug of choice ultimately years behind argenx.

And argenx has done a beautiful, beautiful job making that market. So I think it’s a high hill to climb. And conversely, in every other indication, for example, in Graves’ disease, we will be first in class. And basically every other indication other than MG and CIDP, we can be neck and neck with any competitor because all of these drugs are effectively just starting Phase III studies within the last six or the next six months in these indications. So my view of the MG readout is it is mostly a referendum on how likely we are to develop competitively winning data in MG.

And I think that is a meaningful but not sort of transformative impact to the business. Obviously, the Street has traded it differently.

Dave: And then I want to come back, just to talk about that a little bit more. But just looking ahead to 1402, so could you just talk about expectations for efficacy and safety of fourteen oh two relative to whatever we see in coming weeks for betoklamab?

Matt Klein, CEO, Royvant: Yes, perfect. So what we believe based on the Phase one work we’ve done for fourteen oh two is that it is slightly more potent than betoklamab, which is to say whatever we see from an IgG suppression perspective here, I think we will see that or higher for fourteen oh two and modulo normal variability. And our opinion is that will translate well to efficacy. On safety, BATTLE and fourteen oh two are fundamentally pretty different molecules. The truth is in terms of on target safety, FcRn at least up to a level of sort of 80 ish percent IgG suppression where the field has tested it has been pretty safe.

There have not been a lot of on target sequelae of suppressing IgG. And these are antibodies, so I would not expect a lot of off target tax. The one notable exception to that is some anti FcR antibodies also interfere with the binding of albumin to FcRn, to the receptor. And that results in a lowering of blood albumin levels. And that has had, it turns out, sequelae, most notably in our data, it caused an elevation in LDL as the body goes and produces VLDL in order to increase oncotic pressure once albumin drops.

And our expectation based on the Phase one data is that fourteen oh two does not have that impact. That is, it does not interfere with albumin binding. And so my expectation is that fourteen oh two will show quite comparable efficacy to botoqinib without any LDL or albumin associated safety issues.

Dave: Excellent. And so obviously, the longer term vision is for multibillion dollars in sales from 1402, but it’s years from market. So maybe you could just create a roadmap for 1402 at a high level for us.

Matt Klein, CEO, Royvant: Yes, sure. I mean 1402 now, what we said publicly is that six INDs have been cleared and a significant majority of those INDs are in indications where the path is straight to pivotal. So we are effectively in multiple registrational programs with fourteen oh two now. The ones we’ve effectively confirmed publicly in different forums are MGC IDP, Graves and then a first of two studies in RA for difficult to treat fourth line patients. So that RA study has the potential to show data in the next eighteen to twenty four months.

And if that data looks good, obviously puts us on a really interesting path in terms of access to that market. And then shortly after that, we will start to accumulate data in these various registrational studies that will then lead to first approvals a few years from now. In between now and eighteen months from now, I’d say like the two major events at ImmunoVant, one is to see this MGC IDP and then later this year TED data from betoklamab, which I think should frame up what we think we can do with deep IGG suppression. And there’s some upside outcomes where the data looks good enough that we would consider launching betoklamab in one of those indications. And then also, we’ve been pretty coy so far about our indication roadmap, which is part of the reason I can’t give a very precise answer to the question you’re asking.

And I think that will all be clarified in the relatively near future. And I think once we are through this particular couple of datasets, will put us in an incredibly clean place that is funded as we now are through Graves’ data, if we want to run the business that way with a very sort of catalyst rich period coming only a few years from now that we think could lead to, frankly, one of the largest drugs in I and I.

Dave: Excellent. Excellent. Well, since you you discussed, the betokumab data on recent calls, I won’t go into that again and make you repeat yourself again and again. Everybody else

Matt Klein, CEO, Royvant: at the conference is going to do exactly that also.

Dave: So maybe what we could do is turn to repacitinib. So repacitinib is a very unique asset that you have with its breadth of Phase II data and the validation to date, but not specifically in Yeah. And so if you could paint the picture for brepacitinib, and then I’ll have a follow on.

Matt Klein, CEO, Royvant: Yeah. Look, I think first of all, before getting to brepacitinib, it is a, like, weird and interesting and exciting to me fact of history that Roivint owns brepacitinib. This is one of the best JAK inhibitors ever developed. We know that from many clinical studies run by Pfizer and big indications. We acquired it from them for was $14,000,000 including a whole bunch of inventory in the summer of twenty twenty one when JAK inhibitors were at their nadir, right?

That was right around the time where the EMBL study showing not showing non inferiority on cardiometabolic outcomes had come out around, I forget what jacket was, tofacitinib, And all of the class got slapped with black box labels. And at the time, RINVOC was a $3,000,000,000 drug that I think people expected to flatline, honestly, or even decline. Now we’re sitting here a few years later, RINVOC is a $7,000,000,000 drug going on, I don’t know, $10,000,000,000, 12 billion dollars, 15 billion dollars. And we have one of the best JAK inhibitors in the world. We still to the point that you made about dermatomyositis, we still did not want to walk in front of the AbbVie commercial steamroller.

And so we carved out room for ourselves in orphan rheumatology indication, orphan immunology indications like dermatomyositis. Now one of the unique properties of brepacitinib is it’s a selective inhibitor, but selective inhibitor of two targets JAK1 and TIK2. And we’ve also focused on indications where we think the addition of TIK2 on top of JAK1 is going to be helpful. But bluntly also, we’re just a very, very good inhibitor of JAK1 from a cytokine suppression perspective. And we all know at this point that that JAK1 is one of the most powerful anti inflammatory targets identified by industry.

So all of that is backdrop. This is an incredibly important year for brepacitinib as a drug. We have our first registrational data set coming in the second half of the year in dermatomyositis. Dermatomyositis is a perfect example of the kind of indications I listed earlier. It is I’ll talk about the size in a second, but it is a orphan immunology indication.

It has very high unmet need. These patients are super sick. It causes both muscle wasting and a very bad skin rash and it’s got high mortality within sort of years from diagnosis in many cases, but not very many years. And the only approved kind of novel therapy is IVIG. There’s a Pfizer IVIG called Octogam approved for use there.

But other than that, there’s really nothing. The development pipeline when we started was pretty thin on the ground. There’s a little bit more activity now, but all pretty far behind us. We’ve said we think there’s about 40,000 patients, but one sort of funny fact about the world is we’ve been saying we think dermatomycinet is an interesting commercial market for a few years now, but it wasn’t until argenx progressed into Phase III with their own FcRn and myositis that investors started coming to me and saying, Hey, did you realize DM is a big market? And argenx, I think, has set up maybe up to 70,000 patients in DM.

So tens of thousands of patients in The U. S. At, call it, FcRn price points, now that we know argenx is going to be present in the market, is a really big opportunity. And as with Graves’ for FCRN, we get to define the path for DM here. We get to be the first sort of novel approved therapy other than IVIG, which has a lot of liability that people are familiar with.

And we’re really excited about that possibility in the second half. We don’t have a Phase two study of our own in dermatomyositis, but actually JAK inhibition is relatively well known to doc to treat the disease. There are a good number of case reports. There’s an investigator sponsored study of tofacitinib. And bluntly, I hear all the time that docs at either derm or room KOL panels are asking about Brepo because it’s a brand name drug to me.

I was thinking that many rheumatologists know brepacitinib from its clinical data, and DM is one of these indications where they just don’t feel like they have enough to reach for.

Dave: Excellent. And so you had mentioned, you know, it’s a disease of muscle wasting and skin rash. So obviously, you know, there’s no question about the drug’s ability to treat the skin rash. But could you talk about the drug’s ability to treat muscle wasting?

Matt Klein, CEO, Royvant: Well, it’s a muscle wasting that’s caused by inflammation and it’s understood to be an interferon driven disease. And so scientifically, there’s good reason to believe that that inflammation should be treatable by JAK inhibition. The other thing I’ll say is, if you look at the tofacitinib study and you look at the case reports, the patients are getting better on symptoms of muscle development in those studies in ways that gives us encouragement. Look, the other thing that’s clear is, yes. So I

Dave: think that’s the way to think about it. Yes. Okay. Excellent. Excellent.

And so, and then just taking the next step, how do you see broader potential for brepacitinib speak to NIU and then whether there’s additional indications that you could pursue?

Matt Klein, CEO, Royvant: Yes. So we have two other indications ongoing already. One you mentioned is NIU. In NIU, we are now in two Phase III studies that are enrolling nicely. NIU is an inflammation of the eye.

It is a very large population, it’s about four hundred thousand patients with NIU in America. About seventy thousand of those have sort of posterior back of the eye inflammation that can’t be readily addressed with sort of topical therapies, eye drops. And for those, there’s not a lot of options and it’s a very severe disease. And bluntly, the main line of therapy is high doses of systemic steroids, which is always a tough proposition for patients. Humira is approved and some biologics are used off label.

And in total, there’s probably about forty thousand patients on advanced therapy for NIU, whether it’s Humira or something off label. Our Phase II data was phenomenal. It in HUMIRA’s data, for example, the main clinical endpoint, the primary endpoint for FDA is what’s called time to clinical time to treatment failure. And in HUMIRA studies, they show a little bit less than six months treatment failure. At twelve months when our study stopped, we still had a majority of our patients successfully being treated.

So it’s a transformative data set as far as what it means. And that means even if we wind up, for example, for FDA reasons in a humira or refractory patient population, we have a really, really big opportunity. And then we’re also running a Phase II study now in cutaneous sarcoidosis, which reads out next year. And that’s another orphan indication with very, very few options for patients and with good data from an open label study in tofacitinib that showed actually one hundred percent treatment response rate in that study to JAK inhibition. And so we feel like we’ve got a pretty good case to make there.

Dave: And so when are you hoping to file an NIU?

Matt Klein, CEO, Royvant: I think we’ve said second half of ’twenty seven is sort of the over under for the data. And so I’d hope as soon after we get that data as we can, we’d file and then approval sort of ten months after. So hopefully, we can file kind of within ’twenty seven and get approval in ’28. So maybe a little bit less than two years after the approval in MDM.

Dave: Excellent. Okay. Great. Let me pause for a moment since Matt speaks quickly and efficiently. We’re catching up on time.

So, anybody in the audience have any questions? All righty. In terms of pivoting to LNP litigation, there’s only so much you can say. Obviously, you’re not going to be litigating on stage. But could you just paint the picture quickly for us and what the key cards are that will be turning over over the next six months or so?

Matt Klein, CEO, Royvant: Sure. Yes. Again, I think most people are familiar with the basic backdrop here, but we have a team of scientists that were involved with the earliest invention of lipid nanoparticles, which became which were relevant scientifically all along, became commercially relevant with the approval of the COVID-nineteen vaccines from Moderna and Pfizer. And we believe those vaccines are infringing on inventions from those scientists, patent inventions, which we hold the IP. And so we’ve sued both Pfizer BioNTech and Moderna for infringement.

Obviously, there’s $150,000,000,000 at this point of global COVID vaccine sales. So even a relatively modest royalty would be transformative for us as a business. And so it’s a big deal in that sense. And look, the Moderna case is ahead of the two cases that was done on purpose for a variety of reasons. And in that case, the main event this year is there is a jury trial scheduled for September, in which infringement and damages will be effectively decided by a jury under a relatively short order, probably the soup to nuts three weeks maybe, starting in late September.

Before that, there are some important pretrial motions, what are called summary judgment motions that will go in as early as May and be adjudicated over the summer. And so those will help shape the dimensions of the case, but the truth is we won’t have to wait very long for the ultimate outcome at this point. Now that’s just the outcome of the main jury trial. There are appeals and things like that, but I think we will have a ton more information by October, November.

Dave: Got it. And I had talked to one consultant who had said that juries typically, you know, put meaningful weight on patents, I. E. They respect the U. S.

Patent and Trademark Office. And so they’re more likely to favor, patent holders in the majority of cases. Is that how you see it as well? Or have you heard that, that notion?

Matt Klein, CEO, Royvant: I believe Moderna is infringing on our patents, and I believe a jury will agree with us. Whether that is true, I don’t I’m not a jury consultant, so I can’t speak to the generalities of it, but I believe I believe that to be true.

Dave: Great. And then if you could just talk about the Pfizer, litigation as well.

Matt Klein, CEO, Royvant: Yes. So that one is about a year behind the Moderna case from a time line perspective. And basically, we had what’s called a Markman hearing in that case in December and could get a ruling anytime. It’s up to the judge when he puts it out, and it could be tomorrow or it could be June, but it’s up to the judge. That will then set the stage on claim construction.

We had a similar ruling a similar hearing in the Moderna case about a year ago. The hearing was in February and the decision came at the March, I think. And so I think we’re kind of up expecting a similar set of issues to be decided by the judge. Therefore, we’d hope they go similarly because we were happy with how they went in the Moderna case. That will then kick off discovery and get us a trial date.

And I would expect that to be a year or so after the Moderna trial, but that depends on how all the calendaring goes.

Dave: Yes. Okay. Great.

Matt Klein, CEO, Royvant: And then we just filed last week, as you may have noticed, international litigations in the Moderna case covering another $15,000,000,000 to $20,000,000,000 of sales between Europe and Canada and Japan. And those cases will go to trial a little bit faster, probably within twelve to fifteen months for the first of those cases in overseas jurisdictions.

Dave: So they could potentially start to go to trial that quickly

Matt Klein, CEO, Royvant: in twelve to fifteen months? In some of these other jurisdictions, the path to trial is much faster. These trials are often also separated into phases. There’s an infringement trial and then a separate damages trial, which is not how it works in The U. S, but we could get infringement trials as soon as twelve

Dave: to fifteen months from now. Excellent. Okay. And then maybe we could talk about other pipeline developments to watch. So if you could remind us about your other pipeline assets and what cars will be turning over when?

Matt Klein, CEO, Royvant: Yes. The furthest along of our other pipeline assets is a drug called Moseley Siguat. It is a inhaled once daily SGC activator that we are developing for the treatment of PHILD, Pulmonary Group III Pulmonary Hypertension patients with interstitial lung disease. That as you may remember had really, really strong kind of Phase 1b data showing really the deepest PVR improvements shown across any mechanism of drug in Group one PAH patients and we’re now running a large Phase 2b in PHLD. That is a plan to read out in the second half of next year, and so sort of comes on the heels of 2025 being a very busy year for us.

It’s a major catalyst for 2026.

Dave: Excellent. Well, we are, out of time. Thanks so much for being with us here, Matt. Sorry again to make you late, but No.

Matt Klein, CEO, Royvant: I’m sorry. I appreciate it. Yeah. Thank you. Really appreciate it.

Alright.

Dave: Thanks, Dave. That was good. Thanks again.

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