Roivant Sciences Ltd Q1 2024 Earnings Call Transcript

The following is excerpted from the question-and-answer section of the transcript.

Question: Allison Bratzel - Piper Sandler & Co. - Analyst : Just one for me on Priovant. Now that you've met with FDA on brepo and NIU. Just I guess what is left to be worked out or decided on the Phase 3 design. I think you'd given some high-level guidance looking for 300, 350-ish patients and a protocol basically as close to NEPTUNE as possible. I guess, just high level, is that still the case? And is any of this protocol design dependent on the 52-week readout later this year? And then just, I guess, on that longer-term follow-up, what would you view as an outcome that reinforces your view on the opportunity in uveitis?

Question: Brian Cheng - J.P. Morgan Securities LLC - Analyst : Maybe first is with the recent sell-off in the market, just does it make it easier or harder for you to find a new asset. Does it change the way how you negotiate?

Question: Brian Cheng - J.P. Morgan Securities LLC - Analyst : Maybe just one question on 1402. I guess just overall, I just want to get a better sense of how you're thinking around this asset. As we think through the 10 indications that you're lining up for through the next fiscal year, and you talked about a lot about the range of themes of opportunities that you have laid out in your slide deck today. So how do you pick and choose the different areas? And I think most importantly is how you get credit for it in front of investors, because it seems that investors today are very fixated on MG and CIDP. So in other words, how do you intend to get credit for -- to push 1402 into uncharted indications? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. AUGUST 08, 2024 / 12:00PM, ROIV.OQ - Q1 2024 Roivant Sciences Ltd Earnings Call And then maybe just one last one, more like a housekeeping one. What is the data -- what is the cadence of [calis] flow in the fall because we're going to get Phase 2 asset unveiling in September. Grave's plan also unveiling for Immunovant and psychosis data coming out. So what's the cadence of data flow?

Question: Dave Risinger - Leerink Partners LLC - Analyst : So I have two questions, please. First, could you provide more color on the LNP litigation, including the event path ahead and then second, could you discuss external transaction prospects, including the size potential of deals that you're looking at?

Question: Dennis Ding - Jefferies LLC - Analyst : Two for me. So maybe if we can revisit sarcoidosis briefly. Correct me if I'm wrong, but previously, you may have characterized the Phase 2 is potentially registrational. Can you reiterate that and see and confirm if that's true? Maybe talk a little bit about the path forward if that data is positive. And then number two, around OpEx. I mean, given Immunovant started a bunch of new trials over the next few years, how do you think your OpEx will evolve during that time.

Question: Yaron Werber - TD Cowen (Research) - Analyst : I have a couple. Maybe just the first one, we started getting questions, and I think you highlighted now that you're planning on unveiling your recently in-licensed Phase 2 program in September. Is there anything you can unveil a little bit today. Just indication or how big is the study? Is it a randomized study? Is it just an open-label study? Has there been other studies with this mechanism in whatever indication you're examining? And then maybe just secondly, so it sounds like GMG and CIDP will start Phase 3, let's say, Q1 potentially with 1402. For the other three, is it sort of Grave's, Sjogren's and maybe TED, is that sort of the order?

Question: Louise Chen - Cantor Fitzgerald & Co. - Analyst : I have two for you. The first one I wanted to ask you is if the launch of FcRn is a possibility just for Roivant to do on its own. Is that on the table? And then secondly, just curious on the market opportunity for VTAMA and AD and how you're preparing for the launch of this product coming at the end of this year. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. AUGUST 08, 2024 / 12:00PM, ROIV.OQ - Q1 2024 Roivant Sciences Ltd Earnings Call

Question: Yatin Suneja - Guggenheim Securities, LLC - Analyst : Maybe just one more on VTAMA, specifically on the psoriasis side, I mean if you look at the past, I would say, four, five quarters, you are in that $18 million to $20 million range on a quarterly basis. I mean what does that imply about the overall market opportunity? What can you do to sort of reinflect sales in psoriasis? I understand you talk dermatitis could give a lift, but just in psoriasis, just curious how you view the market, what sort of peak sales you are assuming?

Question: Douglas Tsao - H.C. Wainwright & Co., LLC. - Analyst : Matt, I think from a business development standpoint, you have largely focused on pulling individual assets out, just given the sort of ongoing status in biotech, does it ever change that you become more focused on looking at potentially acquiring companies?

Question: Andy Chen - Wolfe Research, LLC - Analyst : One more question about VTAMA. Can you talk about specifically how you view competitive dynamics between you and your competition, such as [ArQule and Insight], which patients do you think is going to prefer which product? And then on a related note and your pre-approval engagement work with PBMs do you foresee getting hit on gross to net if they prefer your competition?