Immunovant Q1 2027 Earnings Call: Complete Transcript

On Thursday, Immunovant (NASDAQ: IMVT ) discussed first-quarter financial results during its earnings call. The full transcript is provided below. This transcript is brought to you APIs. For real-time access to our entire catalog, please visit for a consultation.

View the webcast at Summary Immunovant reported a quiet first quarter but anticipates a busy second half with several major developments, including the potential launch of brepocitinib for dermatomyositis. The company has initiated a phase 3 study for brepocitinib in cutaneous sarcoidosis and received a significant settlement payment from Moderna, with ongoing litigation against Pfizer and BioNTech. Strategic focus is on a slow and steady commercial approach for brepocitinib, aiming to build a strong foundation for future expansions into other indications such as NIU and CLE.

Financials showed an R&D expense of $200 million and a cash reserve of just under $4 billion, with share repurchases accelerated following the Moderna settlement. Management is optimistic about upcoming data readouts and potential approvals, emphasizing the unique position of their therapies in addressing unmet medical needs. Full Transcript OPERATOR Good day, and thank you for standing by. Welcome to Immunovant's first quarter 2026 earnings conference call.

At this time, all participants are in listen-only mode. After the speakers' presentation, there will be a question-and-answer session. To ask questions during the session, you need to press star, one-and-one on your telephone, please. We advise that today's call is being recorded.

I would now like to hand the conference over to your first speaker today, Stephanie Lee. Thank you. Please go ahead. Stephanie Lee, Investor Relations Good morning, and thanks for joining today's call to review Immunovant's financial results for the first quarter ended June 30, 2026.

I'm Stephanie Lee with Immunovant, presenting. Today we have Matt Glein, CEO of Immunovant. For those dialing in via conference call, you can find the slides being presented today, as well as a press release announcing these updates, on our IR website at 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.

We strongly encourage you to review the information that we have filed with the SEC for more information regarding these forward-looking statements and related risks and uncertainties. And with that, I'll turn it over to Matt. Matt Gline, CEO Thank you, Steph, and good morning, everybody, and thank you for joining. This is a little bit of a calm-before-the-storm moment for us and so a pretty quiet quarter and maybe not the most interesting of our earnings calls in recent memory, but nonetheless a lot of great progress in the business, and certainly we're expecting a jam-packed second half, as I'll get to in a moment.

So I'll be relatively brief in my remarks and then we'll go to Q&A. I'd like to start on slide 4. This is a slide we took from our own prior deck. This is from the investor day that we did in December of last year, and this was a list of our priorities for the year.

And we're sitting here a little bit more than halfway through the year. Just wanted to highlight that it's gone well for us, that we feel really good about the setup. And so on slide 5, you know, looking across the list here, we've got brepocitinib expected to launch by the end of September. Obviously we got priority review and our PDUFA date, as you said, is this quarter.

We had great data from 1402 in the D2RA study that we presented on our last quarterly call. Probably the most notable update for today, the top center of this slide, is that we've now enrolled patients in the phase 3 study in cutaneous sarcoidosis for brepocitinib, which follows on the positive results that we had in our phase 2 data, which I think we announced on our first quarterly call of this year, earlier in the calendar year. We've now received additional payment from Moderna in the settlement, and the second part of that, the ’1498 part of that case, is progressing, and we filed international proceedings against Pfizer and BioNTech in that case.

And finally, earlier this year we added LPP as a fourth pre-specified indication. And as I'll remind people later today, that study is continuing to enroll as well. As I mentioned at the top of the call here on slide 6, I'll just say this is a quiet quarter and this is a quiet day. I don't know exactly how the following statement could be true, but I think it is.

The next 6 to 12 months are in many ways busier than the prior 6 to 12 months for us, and so we just have an enormous amount coming up, starting, as I mentioned, with the upcoming potential brepocitinib launch in DM, which should happen imminently assuming everything goes as we expect it will at FDA. We've got top-line data in brepocitinib from the NIU study, an indication that could easily be as large as dermatomyositis. That data is coming in the second half of this year. We also have top-line data coming shortly in the second half from Moseley, the phase 2 study in PH.

I know that's being closely watched and we're looking forward to getting that data and presenting it. We will provide further updates on the D3 program at Immunovant in the second half of this year, including hopefully a download on a conversation we hope to have with FDA about that program, as well as the results in the second part of the study and a little bit more about our plans going forward. And then finally, probably the smallest of these, we're expecting top-line data from the POC study in CLE also in the second half this year. I'm looking forward to finding out what we've got there when that comes in as well.

So just a jam-packed second half and even more coming in 2027 with the Graves data and beyond. So just a lot, a lot in the— I'll just hit a couple of highlights in terms of the pipeline updates in a little more detail here before going to Q&A, starting on slide 8 with a reminder, because it's been a few months since we talked about it. You know, the initiation of this cutaneous sarcoidosis phase 3 study is a pretty exciting event. It's a little bit ahead of, in terms of, what we're able to do here.

And this is a disease that we're just privileged to be able to work in here. It's a high-morbidity, very difficult disease with a higher urgency to treat. You can see on slide 8 some of the photos we've shared before, but these are patients who are really sick and have very few treatment options. On slide 9, as a reminder of the data that we generated in our phase 2 study, we have set for ourselves a goal of a sort of five-point benefit on this CSAMI scale for clinical meaningfulness.

And in the study in the top left of this chart, we showed a greater than 20-point benefit compared to roughly nothing on placebo. So just a huge benefit to those patients in the phase 2 study and really excited to carry that forward into the pivotal program. You know, as a reminder on slide 10, we think this is a pretty decent-sized indication given the high unmet need—probably about 40,000 patients in the US—and reasonable overlap with some other organ systems, including ocular sarcoidosis, or eye sarcoidosis, where that overlaps with NIU.

That is one of the types of NIU that we're studying, as well as pulmonary sarcoidosis, which is a big potential indication as well, and where we hope to be able to treat some of those patients via either their ocular sarcoidosis or CS. The phase 3 study that we've now begun—the design is laid out on slide 11. I know there were some questions after the phase 2 about what exactly this study would look like. And it is designed to take all of the learnings from the phase 2 study that was successful.

It is a 16-week study with the primary endpoint of CSAMI greater than or equal to 50% response rate, 140-patient study across about 70 sites, 3:2 randomized, with patients either on 45 milligrams of brepocitinib or placebo, and with a mandatory steroid taper going from week two to week eight down to zero, which is roughly consistent with what we did in the phase 2 and generally consistent with what we think is appropriate for patients in this indication. So that study, as I said, has already begun enrolling patients and we expect top-line data in 2028, which just adds to the list of potential registration indications for brepocitinib coming up. I'll reiterate on slide 12.

The other ongoing registration program is the brepocitinib study in lichen planopilaris (LPP) that we announced earlier this year. That study is enrolling, I would say, extremely well. There's a lot of enthusiasm from physicians and patients for that. It speaks to the high unmet need in the indication and speaks to the quality of the work being done by VAN and the prior VAN team.

I'm looking forward to sharing more about that as soon as we've got it. So that's also moving along nicely. Look, finally—and I'm sure there will be questions about this in Q&A and lots of opportunity to talk about it, hopefully with potential approval and beyond—obviously one of the major events in the near term here is the potential launch of brepocitinib in dermatomyositis.

I think we're in a phenomenal position here in terms of what we've got, in terms of what we hope to be able to do, starting with the quality of our clinical data, which, as you know from the multiple times we've talked about it, from the publications, including in the New England Journal and so on, just phenomenal data across all 10 endpoints. Big clinical benefit, a lot of enthusiasm from the doc community. This is a really tough disease, a large addressable population, most of them on sort of polypharmacy, trying a lot of different things and, frankly, most of them still dissatisfied with the available treatments.

So we feel like we have an opportunity to do something big and different for this patient population. Our team has been out spending a lot of time with the physician and patient communities on overall education, and I think the enthusiasm for new therapy is coming out loud and clear, including with all the academic presentations that have been done and so on. Commercial launch—there's not much to say today other than that it's on track; we're ready to launch on time, having received priority review. The sort of commercial and patient support teams are built out, trained, ready to deploy.

We feel really great about the hires we've made there, really great about the organizations we've built there. We think we're doing this in a way that is both capitalizing on all the learnings from successful launches at other companies in recent years and doing it in a relevant, private way. There's nobody in the world I'd be more excited to see oversee this than the team we've got at Priovant with Ben and Daniel and others. And I think we're going to be fully ready.

Everything's on schedule, so we'll have much more to say about that with the potential approval and after. But looking forward to it. I'll say one more thing about the commercial franchise overall. At Priovant, on slide 14, we get a lot of enthusiastic questions from investors around pace of launch.

And we've been pretty consistent that our answer to that question is sort of slow and steady is what we're looking to build there. And I think there's a bunch of reasons for that. Obviously, some of them are: DM is a new indication, and no one's launched novel therapy basically ever—or at least a targeted therapy basically ever—and so it's just hard to know exactly what work will need to be done to get everyone comfortable and excited and on drug, although I think we're fully prepared. But also to me, it's because brepocitinib is a lot more than just dermatomyositis.

And to me, what we're really doing here is not just trying to make that launch as fast as possible. We're trying to lay the groundwork for the overall opportunity, which goes beyond DM into first NIU and then CS and LPP, with the data coming thereafter.

And I think as you think about that layering, to me, it's much less about what week one or month one or quarter one look like, and much more about making sure that the foundation around access, the foundation on patient support, the foundation around the institutional activities, the foundation around our communication with the scientific and physician community, and our communication with patients are all set up to deliver the maximum opportunity for brepocitinib across all of these indications. And so I think, you know, I think slow and steady isn't just about sort of guidance.

Slow and steady is about the approach that we're taking with the program to make sure we have maximum reach across everything that we're doing there, including indications that we're excited about beyond the ones we've already announced. So a lot to come, as I said, on track for that launch. You all hear the same thing we do, which is a ton of enthusiasm from the patient and physician community for new options in all of these indications, and looking forward to sharing more when we know about it. But our guidance is going to continue to be slow and steady because that's what we think we're building.

You know, final business update here is we got the upfront payment in the settlement with Moderna—that $950 million has come in, $770-ish of it to Genevant and the rest to Arbutus. So that's done. There'll be progress in terms of, you know, return of capital, et cetera, of that and so on. The ’1498 ruling— that process is ongoing.

3 billion if we got a favorable outcome there. And then we continue to advance our litigation against Pfizer and BioNTech. We filed three international lawsuits, notably in Canada and the UPC, in July—so just last month—and continue to progress that case as fast as we can. Obviously not all of it in our control, but equally enthusiastic about the potential there in terms of what we could get.

I'll wrap up just with our usual financial update on slide 17. Look, I think overall, most importantly, we are spending in areas that we're excited to be spending. We're excited about all of our R&D programs. About $200 million of R&D expense for the quarter, just under $100 million of non-GAAP adjusted G&A, or $166 of GAAP G&A expense, and cash just under $4 billion.

And that's before the receipt of the $772 million. Notably pretty significant share repurchase activity—about $200 million in the quarter, a bit more than that when you include March. Obviously what we did there was we accelerated our share repurchase program upon the announcement of the Moderna settlement so that we could get those shares in. And the shares that—reminder—the shares that we bought by kind of the first round of this, the billion and a half that we bought back sort of up through mid last year, we bought back at around $10 a share.

I think the average price at which we've been able to buy back stock since we kicked off the second round of this in earnest in March has been in the high 20s. So feeling good overall about retiring those shares and getting that capital back. Shareholders—I'm going to continue doing that according to our authorizations for now. And all of it ahead of, on slide 19, a really rich catalyst calendar ahead with a lot coming.

So looking forward to all of that with just an incredibly busy, incredibly busy stretch ahead. You know, on slide 20—again, a little bit incredulous for the people around Lloyd Grant who are doing all of this work. Incredible around whether or not to do this work. But by the end of calendar 2028, we'll have had hopefully three or more commercial launches, nine full-year pivotal study readouts, four-plus NDA or BLA filings, a number of proof-of-concept studies.

Just a ton, a ton coming up in the near term. So with that, I'm going to wrap up my prepared remarks for the day, and I will hand it back over to the operator for Q&A in just a moment. Thank you again for listening this morning and looking forward to taking your questions. Stephanie Lee, Investor Relations Thank you.

The operator, over to you. OPERATOR Certainly. We will now begin the question and answer session. As a reminder to ask questions, please press star one and one on your telephone.

If you'd like to cancel your request, you can also press star one and one again. P. Morgan. Your line is open.

Please go ahead. P. Morgan Hey guys, good morning. Thanks for taking our questions.

Maybe just thinking through the DM launch pad, can you give us a quick sense of, you know, what metrics we could be receiving right out of the gate to help us better track the initial launch? And then secondly on PH-ILD, as we think about the baseline characteristics here in FOCUS, it seems that more patients are on nintedanib. We're curious if there's any implication in terms of the fibrosis versus emphysema ratio in the population and then further down the line whether there's any implication to what's the bar for success for both extended log and also PVR. Matt Gline, CEO Thank you.

Yeah, perfect. Thanks. I appreciate both questions on the mic. A thing I've gotten fond of saying as I've watched other companies with commercial launches is that you all don't serve our guidance, which isn't quite fair.

But look, I think other than sort of a slow and steady launch and obviously the sort of top-line metrics will be plainly visible in our financials each quarter, I don't know that we're going to provide a ton of detail in the early days. I think it's important for us mostly to spend our time focused on understanding those dynamics ourselves, getting out, talking to patients, talking to physicians, doing the work we need to do.