管理層發言
Good day, and thank you for standing by. Welcome to Roivant First Quarter 2026 Earnings Conference Call. Operator Instructions: Please be advised 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.
Good morning, and thanks for joining today's call to review Roivant's financial results for the first quarter ended June 30, 2026. I'm Stephanie Lee with Roivant. Presenting today, we have Matt Gline, CEO of Roivant. For those dialing in via conference call, you can find the slides being presented today as well as the press release announcing these updates on our IR website at www.investor.roivant.com. 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.
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. It was 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. I'll be relatively brief in my remarks, and then we'll go to Q&A. I want 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. We're sitting here a little bit more than halfway through the year, so I just wanted to highlight that it's gone well for us and that we feel really good about the setup. On Slide 5, 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 we said, is this quarter. We have great data from 1402 in the difficult-to-treat RA study that we presented on our last quarterly call. Probably the most notable update for today in the top center of this slide is that we've now enrolled patients in the Phase III study in cutaneous sarcoidosis for brepocitinib, which follows on the positive results that we had in our Phase II data earlier this calendar year. We've now received the initial payment from Moderna in the settlement and that 1498 part of that case is progressing; we filed international proceedings against Pfizer and BioNTech in that case. Earlier this year, we added lichen planopilaris as a fourth brepocitinib indication, and that study is continuing to enroll really well. As I mentioned at the top of the call on Slide 6, this is a quiet quarter, and this is a quiet day. I think the next 6 to 12 months are, in many ways, busier than the prior 6 to 12 months for us. We have an enormous amount coming up, starting with the upcoming potential brepocitinib launch in dermatomyositis, which should happen imminently assuming everything goes as we hope and expect with FDA. We have top-line data in brepocitinib from the NIU study, an indication that could 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 MOSLI, the Phase II study in PH-ILD. We 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 difficult-to-treat RA 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 of the second part of the study and more about our plans going forward. Finally, we're expecting top-line data from the proof-of-concept study in CLE also in the second half of this year and looking forward to finding out what we've got there when that comes in as well. It's a jam-packed second half and even more coming in 2027 with the Graves data and beyond. I'll hit a couple of highlights in terms of pipeline updates in a little more detail before we go to Q&A. Starting on Slide 8 with a reminder because it's been a few months since we've talked about it: the initiation of the cutaneous sarcoidosis Phase III study is a pretty exciting event. It's a little ahead of schedule in terms of what we've been able to do. This is a disease that we're privileged to work in. It's a high morbidity, very difficult disease with high urgency to treat. On Slide 9, as a reminder of the data we generated in our Phase II study, we had set a goal for a 5-point benefit on the CSAMI scale for clinical meaningfulness. In the study on the top left of this chart, we showed a greater than 20-point benefit compared to roughly nothing on placebo: a huge benefit to those patients in the Phase II study. We're excited to carry that forward into the pivotal program. On Slide 10, we think this is a decent-sized indication, with about 40,000 patients in the U.S. and reasonable overlap with other organ systems, including ocular sarcoidosis or GI sarcoidosis, where that overlaps with NIU that we are studying, as well as pulmonary sarcoidosis, which is a big potential indication where we hope to treat some patients via either their ocular sarcoidosis or cutaneous sarcoidosis. The Phase III study that we've begun is laid out on Slide 11. It is a 16-week study with the primary endpoint of CSAMI greater than or equal to 50% response rate. It's a 140-patient study across about 70 sites, randomized 3 to 2 with patients either on 45 milligrams of brepocitinib or placebo, and with a mandatory steroid taper from week 2 to week 8 down to 0, roughly consistent with what we did in Phase II and generally appropriate for patients in this indication. That study has already begun enrolling patients, and we expect top-line data in 2028, which adds to the list of potentially registrational indications for brepocitinib. I'll reiterate on Slide 12 that another ongoing registrational program is the brepocitinib study in lichen planopilaris that we announced earlier this year. That study is enrolling extremely well. There's a lot of enthusiasm from physicians and patients for that indication, which speaks to the high unmet need and the quality of the work being done by Ben and the Priovant team. Finally, and I expect there will be questions about this, one of the major near-term events is the potential launch of brepocitinib in dermatomyositis. We are in a strong position based on our clinical data, which has been presented in multiple publications, including the New England Journal, showing statistically significant benefit across endpoints and a large clinical benefit. There's a lot of enthusiasm from the physician community. Dermatomyositis is a tough disease and a large addressable population, most on polypharmacy and many dissatisfied with available treatments. We feel we have an opportunity to do something meaningful for this patient population. Our team has been spending time with physician and patient communities on education, and enthusiasm for a new therapy is apparent. Commercially, we're on track: we've received priority review; the commercial and patient support teams are built and trained and ready to deploy. We think we're capitalizing on learnings from recent successful launches while doing it in a Roivant-Priovant way. The Priovant team is excited to oversee this launch, and we expect to be fully ready and on schedule. On Slide 14, regarding the commercial franchise overall at brepocitinib, we get a lot of questions from investors about pace of launch. We've been consistent that our approach is slow and steady. There are reasons for that. Dermatomyositis is a new indication and no one has launched a novel targeted therapy in this space before, so we must be thoughtful about education and adoption. Brepocitinib is more than just dermatomyositis: we're laying groundwork for the overall opportunity beyond DM into first NIU and then CS and LPP with supportive data coming thereafter. We are focused on access, patient support, institutional activities, communications with the scientific and physician communities, and communications with patients to deliver the maximum opportunity for brepocitinib across multiple indications. So slow and steady describes our approach, not just guidance. Final business update: we received the upfront payment in the settlement with Moderna. That $950 million has come in, about $770 million of it to Genevant and the rest to Arbutus. There will be progress in terms of return of capital. The 1498 appellate process is ongoing in the Federal Circuit, which could be another $1.3 billion if we get a favorable outcome, and we continue to advance litigation against Pfizer and BioNTech. We filed three international lawsuits, notably in Canada and the UPC in July, and we're progressing the case. On Slide 17, in terms of financials, we are spending in areas we're excited about: R&D expense was about $200 million for the quarter, non-GAAP adjusted G&A just under $100 million, GAAP G&A $166 million, and cash just under $4 billion before the receipt of the $772 million. We had significant share repurchase activity of about $200 million in the quarter, a bit more including March. We accelerated our repurchase program after the Moderna settlement so we could repurchase shares earlier. The first round of buybacks through mid last year averaged around $10 per share; the average price since March has been in the high $20s. We're continuing repurchases according to our authorizations. On Slide 19, we have a rich catalyst calendar ahead with a lot coming. On Slide 20, by the end of calendar 2028, we hope to have three or more commercial launches, nine or more pivotal study readouts, four-plus NDA or BLA filings, and a number of proof-of-concept studies. With that, I'll wrap up my prepared remarks and hand it back to the operator for Q&A. Thank you again for listening this morning, and I look forward to taking your questions.
分析師問答
Operator Instructions: Our first question comes from the line of Brian Chen of JPMorgan.
Maybe just thinking through the dermatomyositis launch, Matt, can you give us a quick sense of what metrics we could be seeing 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 in PHocus, it seems that more patients are on nintedanib. We are 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 towards the bar for success for both 6-minute walk and also PVR?
Thanks, Brian. On metrics for the launch: having watched other company launches, I think in the early days there's often limited visibility externally. We'll be focused on understanding dynamics ourselves, talking to patients and physicians, and doing the work needed. We'll give more color on what that will look like on a call with potential approvals, and then we'll flesh out the package that we share with each successive quarter. I don't expect a lot to be visible in the early days given how the commercial apparatus is set up, but we'll provide more guidance as we get closer. On PH-ILD: we've been watching, for example, treprostinil data in IPF and trying to understand what's been happening with these PH-ILD patients. One thing to look out for in treatment of PH-ILD with vasodilators is emphysema. The PHocus study was designed carefully around the amount of emphysema allowed to ensure we could serve the patient population broadly but also maximize potential benefit. We are keeping an eye on that. There is a vocal cohort that believes treprostinil has antifibrotic benefit. Our view is if you treat PH-ILD patients well for their pulmonary hypertension, you may deliver a benefit on their lung disease; we believe vasodilation is driving a lot of the activity, though we have some nonclinical evidence of antifibrotic activity as well. Overall on 6-minute walk and PVR: we're hoping to see a clear signal on PVR, and we expect that if the drug is active we will. We don't expect to see a lot of clarity on 6-minute walk because the study is not powered for it. It would be nice to see some separation, but it's not essential for our go/no-go decision. We'll know what we've got once we have a closer look at the full data.
Our next question comes from the line of Dave Risinger from Leerink Partners.
I have three questions, but rather than rattling them all off right now, I'll go one by one. First, on MOSLI, you commented just now on 6-minute walk distance. But if you were to run a large trial, what type of 6-minute walk distance would you be hoping for, i.e., what would be relevant to clinicians and to patients?
Thanks, Dave. We'll have a better answer once we see what we saw in Phase II. PH-ILD patients are really sick and there are not many options. In Group 1 PAH, as more treatment options were introduced, survival and mortality rates improved. It's less about a specific number on 6-minute walk and more about having an approvable therapy that meaningfully helps patients walk and live daily lives. 6-minute walk is noisy and difficult to translate to daily life; if drugs vasodilate effectively and improve lung function and PVR, you'll see meaningful benefit for patients. I don't think we'll articulate a specific numerical bar; successful studies that deliver a clear benefit are what matters.
Next question comes from the line of Samantha Semenkow from Citi.
I have two: one on MOSLI and one on brepocitinib. For MOSLI, can you talk about translatability of PVR reductions in PAH patients to the PH-ILD population enrolled in PHocus? Are there aspects of either disease that could influence the magnitude of PVR change? And then, on brepocitinib and dermatomyositis, in your conversations with physicians about education, how has the reception been given JAK class safety concerns? VALOR safety profile was favorable, but from a class perspective, how are physicians thinking about safety, particularly since DM patients tend to have higher underlying risk for cancer?
Thanks, Samantha. On translatability: that's the fundamental question our study answers. We will have to see what we see. The risk is there's something unexpected in PH-ILD translation; Phase I and PAH data look good on PVR. The lungs of PH-ILD patients are different than PAH patients, so you might expect some pharmacodynamic differences, but when you take an inhaled vasodilator in PH-ILD you deliver drug to healthy lung tissue and it matters. Regarding JAK safety and dermatomyositis: when we in-licensed brepocitinib we considered where JAK safety would be less of a concern. Dermatomyositis fits that profile: physicians are less focused on JAK warnings here because these patients are very sick and already on therapies like high-dose steroids which have their own risks. We expect our label to follow other JAK labels with warnings, and physicians expect that; they are focused on treating a population with high unmet need where alternatives are limited.
Our next questions will come from the line of Prakhar Agrawal from Cantor Fitzgerald.
Congrats on the continued execution. A couple of questions: firstly, on brepocitinib and dermatomyositis, could you remind us what percentage of DM patients are on off-label JAKs based on your latest research? Would you expect rapid switches from these patients to brepocitinib? Secondly, for brepocitinib and the NIU trial, what do you see as the biggest risk for Phase III given Phase II was strong? Is geographic variation a key risk leading to baseline variability?
Thanks, Prakhar. On off-label JAK use in dermatomyositis, physician practice varies. Some use more off-label JAKs, some less. Publicly we've said a low single-digit to mid-single-digit percentage of dermatomyositis patients have experience with off-label JAKs. Some physicians who do use off-label JAKs expect to switch patients to an approved therapy, and we'll work to facilitate those switches where appropriate. On Phase III risk for NIU: variability in placebo response rates is a significant concern in immunology trials and is something we watch closely; that uncertainty about placebo response rates is one of the things that keeps you cautious. Phase II data was compelling and drug activity seems good, so I'm optimistic, but geographic variation can be a source of noise in immunology studies. The team is executing well and we're hopeful for a positive outcome.
Our next question comes from the line of Andy Chen of Wolfe Research.
For the brepocitinib launch, can you talk about a few launch analogs that you're assessing right now, either patient curve or market share curve? What historical products have the most resemblance to brepocitinib and dermatomyositis?
Thanks, Andy. There has never been a launch of a targeted therapy in dermatomyositis before, so there is no direct analog. You can look at various launches in other categories—some were faster, some slower—but none match DM precisely. The cost of being a pioneer in an indication is you can't use a perfect analog. We're focused on the dermatomyositis opportunity itself, the physicians, the patients, and the data. We don't have a specific drug analog to point to.
Our next question comes from Yatin Suneja from Guggenheim.
Just a quick one on difficult-to-treat RA. Could you talk about the strategy there? Would you need one more study, two more studies? How are you thinking about that? What should we expect for the randomized withdrawal phase where we'll get data?
Great question. We'll come back later this year with a full update on the program. We don't yet have the randomized withdrawal period data in hand, so I can't speak to how it will inform strategy. The results of that study may inform whether it can serve as one of our pivotal studies; we've designed it to potentially serve as one of two, but it has to hit for that to work. We're planning for an FDA conversation this fall that will inform the exact design and our approach. The team is working hard, and the data generated so far has been exciting with strong reception from the physician community.
Our next question comes from Yaron Werber from TD Cowen.
Once you release the MOSLI data this year, would you release both the monotherapy and the combination data at the same time? And then for cutaneous sarcoidosis, the trial design is interesting: the primary endpoint is CSAMI greater than a 50% response. Can you translate the Phase II data into that context? Phase II looked at CSAMI over 10 points and change from baseline. What should we expect apples-to-apples?
On MOSLI: we will not release monotherapy and combination data at the same time because the combination study started later and is still enrolling—monotherapy will read out sooner in the second half. The combination study is open-label and was designed to give safety experience and some information on incremental efficacy, but much of the informative data will come from the monotherapy study. On cutaneous sarcoidosis: in Phase II we saw meaningfully higher rates of greater-than-50% CSAMI responses in the treatment arm than in placebo; the delta was wide. In our press materials around the CS study initiation, we noted well north of 50% of patients in the treatment arm of Phase II had a CSAMI response greater than 50%, versus essentially none on placebo. The Phase III is well powered given what we saw in Phase II.
Our next question comes from Thomas Smith from Leerink Partners.
On the 1402 difficult-to-treat RA program, I wanted to clarify how you're approaching disclosure in the second half of the year. Should we expect to see the Part 2 randomized withdrawal data prior to your meeting with FDA? Are you planning to share the data and the regulatory feedback and next steps simultaneously? And then on Graves, what's your view on the competitive landscape? You're first with an advanced therapy and stellar Phase II data, but other approaches are targeting various segments of Graves patients. How are you thinking about potential future studies for 1402 and Graves?
On disclosure for D2T RA: our hope is to come back later this year with everything tied together—the Period 2 data, the FDA conversation, and any additional analyses—so we can provide a fulsome update. That depends on having the Part 2 data in hand. On Graves: competition discussion is somewhat misplaced because there's a large unmet need; the last novel therapy was developed decades ago, so there's room for many mechanisms and products. 1402 will be studied in many patients and is safe and well tolerated; Graves will have room for multiple mechanisms serving different patient subsets. We're likely to be first to market, which gives us influence over treatment paradigms and the chance to provide an option to patients before others are available. We will learn from running studies and engaging the physician community, and those learnings will inform future studies and commercialization.
Our next question comes from Yasmeen Rahimi of Piper Sandler.
Congrats on the quarter. A question about clarity with the forthcoming readouts in the second half of 2026: could you give us what you might be thinking about narrowing guidance if you expect to do that? How are you thinking about the bar for success? And timing post data, would you expect to file an sNDA and what would be the cadence for that?
I doubt we'll provide more specific timing guidance right now than we've already given. We announced the study enrollment and we'll read the study out when it's done and the data are clean. NIU has a lot of unmet need; Humira leaves room on the table and many patients aren't even getting it. The bar for success is a successful study that would support registration. If we get that, we'll have a big opportunity to help many patients. We won't put a numerical bar on success; the more we mirror Phase II, the happier we'll be. On sNDA timing: I won't put Ben on the spot, but the team got DM submitted quickly before and will work quickly if the study is positive to get sNDAs in as fast as possible.
The next question comes from Sam Slutsky from LifeSci Capital.
For the proof-of-concept readout in CLE, there's a few parts to that study. Remind me what we'll be getting in the initial release this year. And for the initial dermatomyositis launch, remind me how many clinics you're targeting and the concentration of patients at those clinics?
On CLE: it's a small proof-of-concept study to understand treatment benefit and how we might stack up in the future landscape. Early dosing data was encouraging. The primary endpoint is at 12 weeks comparing 600 mg to placebo, and in Period 2 all patients collapse to 600 mg at 52 weeks. The initial release this year will report the 12-week 600 mg versus placebo data along with other supportive data. On the initial dermatomyositis launch: I'm not going to share our exact targeting strategy today, but as a reminder there are about 200 myositis referral centers that treat approximately half of the U.S. patient population. Those centers are important but there are other physicians too. Ben and the team have done a great job engaging with the physician community, and the New England Journal publication was an excellent outcome. We're prepared to engage with physicians pending potential approval.
We will now take the last question from Alex Thompson of Stifel.
Two more on 1402. First, going back to placebo responses, how are you thinking about managing placebo response in the Graves studies, particularly with antithyroid drug down-titration and the potential for waxing and waning of disease over longer periods? Second, what's your current thinking on where 1402 could fit within MG and CIDP as that landscape continues to evolve?
On Graves and placebo: if you set the bar high enough on endpoints, these patients are not spontaneously remitting. If you're looking at patients achieving euthyroid status and off antithyroid drugs, placebo should be manageable. Different studies take different approaches to ATD titration; I won't go into the specific operational details here, but it's manageable. On MG and CIDP: FcRn-targeting therapies have been studied many times in MG and 1402 should work in MG. Data we generated in baterovine were encouraging, showing treatment benefit on measures such as MSE and clinical remission where other FcRns have been less compelling. The MG market is large and there is room for multiple classes and multiple FcRns; argenx has done well establishing the space, but there's room for additional options with different dosing and administration. In CIDP, class leadership is less established and there's room for improvement in treatment paradigms; the baterovine results were encouraging and we hope to do something similar with 1402. Overall, we see meaningful opportunities across these indications depending on the clinical data.
That does conclude today's conference call. I will now hand the call back to management for closing remarks.
Okay. Well, thank you, everybody, again. Thank you for the thoughtful questions. I appreciate how much work it is to come up with good questions in a quiet quarter. I promise there'll be lots coming in the coming weeks and months to give you more substrate in the future. In the meantime, we appreciate everyone's attention. I'm super appreciative of everybody who works for Roivant and the Vants who are working very hard on all of these programs to move them forward. I've been very proud of our execution and pleased with the quality progress we've made. I want to thank the physicians, investigators and patients in our studies who trust us with their care. I couldn't be more excited for the 12 months ahead. This is the last—one way or another—this is the last boring quarter we're going to have for a while. I'm looking forward to the more exciting ones ahead and losing sleep over them until we get there. Thank you, everybody. Have a good day.
That does conclude today's conference call. Thank you for your participation. You may now disconnect your lines.