Roivant Sciences Ltd. Common Shares FDA announcement

Please go ahead. Good morning, and thanks for joining today's call to review the FDA approval of LISRAYA.

I am Stephanie Lee with Roivant. Presenting today, we have Matt Gline, CEO of Roivant, and Ben Zimmer, CEO of Priovant. 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 will also be providing the current slide numbers as we present to help you follow along. I would like to remind you that we will 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. With that, I will turn it over to Matt.

Thank you, Steph, and thank you everyone for dialing in this morning. Obviously, an exciting update from us, so we are really happy to be here. I reflected to a few people over the last couple of days a thought that I have had, which is that it is a deeply unsatisfying marathon when the prize for winning is that you get to start running another marathon immediately, and that is the moment that we are at now where we finally, as you all know, have gotten LISRAYA to the point of approval. Now we get to get it out to patients, and there is a ton of work associated with that. So we will talk a little bit today about what this means, about why we are excited about it. Ben is going to talk a little bit about the label and the process from here.

We will do a quick review of the clinical data we have for the drug because we think it is worth remembering, and then we will leave much time at the end for Q&A. So I am going to start just on slide 3 of the deck with the headline, which is that LISRAYA is now approved. It is a huge day. It is the first modern therapy approved for dermatomyositis patients, the first oral-targeted therapy approved for dermatomyositis patients. Just in general, there are so few options that a new option is a great thing here. Then also, there is just a bunch of other firsts associated with what this drug means. We are super excited about the opportunity to get it out to patients. We are super excited to get to deliver this kind of potential benefit to them. So it is a big opportunity.

It'll be available at a list price of $35,000 for a 30-day supply. Ben will talk a lot about this. Access is obviously a huge focus for us, and we're working incredibly hard to make sure that every patient who needs it has access to it at a reasonable out-of-pocket price. I know that was a question on many people's mind. On slide 4, FDA put out a press release on the approval of LISRAYA yesterday. Obviously, we put out one too, but we didn't prompt anything in the FDA press release. Actually, we thought they did a really nice job summing up just how exciting this moment is. I've just included on slide 4 the quote from the director of the Office of Immunology and Inflammation at CDER.

I think it just sums up what we feel too, which is that it's been far too long where patients with dermatomyositis have had a significant unmet need. Today is really the first time that there's something targeted, approved oral, studied specifically in dermatomyositis to help them manage what is a really difficult disease. I hit some of the points on slide 5 earlier, but this is the first ever targeted therapy approved for DM, the first once-daily oral therapy ever approved for DM. It is the first therapy ever approved specifically for a steroid-sparing benefit in DM alongside, obviously, a disease improvement. It's the first therapy ever approved for DM to show statistical significance in a 52-week DM-specific trial.

The first ever TYK2 and JAK1 inhibitor approved for any indication, a novel first-in-class approval for what we think is a unique mechanism that has a lot of potential from here. We've mentioned this, but I'll say it again on slide 6. That's not for lack of trying. There have been a lot of attempts in history to bring some of the greatest drugs in immunology, rituximab, REMICADE, ENBREL, many others, across the finish line in dermatomyositis, and none of those have been successful in DM-specific studies. We've continued to see challenges in getting P values in DM studies until even more recently than that. It's just really exciting that we've been able to deliver this kind of opportunity, and I think the DM patient and physician community have been waiting for a moment like this.

As I said, we'll do a couple things to review the data, et cetera. Before I do that, I just want to hand it over to Ben. By the way, I'll say this at the end as well. One of the things about these approval calls is they're an important moment to thank a ton of people who are involved in bringing these drugs forward. Obviously, among the most important there are the patients and investigators who trusted us in the execution of the clinical trial, who trusted us with their care, and we're forever indebted. This approval is forever indebted to them.

There's also just an enormous number of people at Roivant and at Priovant. I want to give a special note of thanks to Ben and the Priovant team before handing it over to him for the speed, rigor, quality of execution, and patient focus of this program. Although this morning I was doing what I suspect many people do every morning, which is talking to ChatGPT, in this case about the timelines here. The truth is, I looked through the drugs that came to my mind, and with the exception of drugs that have benefited from the new Civil Money Penalty program, vanishingly few drugs have gone as quickly as we were able to go here from the necessary phase III data package to an approval.

We got together to talk about the data for brepocitinib in dermatomyositis less than a year ago in mid-September of 2025, and it's just a huge privilege to be here now with this feed. I think Ben and his team deserve a ton of credit for a lot of things, but one of the things they deserve credit for is that they acted with urgency for a population that needed it. Thank you, Ben, and I'll hand it over to you to take over on slide 7.

Thanks so much. Obviously very exciting and meaningful day for me and all of us at Priovant and many others who have been working on this program for a number of years. It's exciting starting on slide 7, actually, not only because yesterday marks the approval of LISRAYA, but yesterday also marked the commercial launch of LISRAYA about a month ahead of when we had initially planned. Again, speaking to the urgency that Matt spoke about in terms of our enthusiasm to make this drug available to patients and bring it to market for them. Ultimately, that's really what drives us and drives the sense of urgency. DM patients deserve better treatment options. We're excited to finally have one for them, and we want them to be able to access it as quickly as possible. Prescribing is open as of yesterday.

We actually have already received our first prescriptions for LISRAYA. Importantly, we also have our first patients consented into the LISRAYA My Compass Support. This is a critical service that we're offering to patients. Among many other things that will be provided through that is access to insurance assistance and financial assistance programs from Priovant. We believe that many patients on this drug will have actually $0 of out-of-pocket costs. So very excited and committed to ensure that patients are able to get access to this therapy. We're really excited to have the launch underway. As Matt said, we celebrated the completion of the first marathon very quickly, and we've started charging ahead with mile 1 of the next one.

Turning now to slide 8, I want to talk a bit about the label, which generally speaking, we're extremely pleased with how that turned out. I'll just spend a few minutes walking through in a little bit of detail my own personal perspective on it. I think the first thing I would say that in my view, the most important part of the label is the indication statement and restrictions of use. We're really quite pleased with how that turned out. Broad indication statement for adults with dermatomyositis, with no restrictions based on clinical presentation, disease severity, or prior treatment history, and also no restrictions on concomitant use with steroids, conventional DMARDs, or IVIG, which are the therapies that the vast majority of DM patients are on today.