Roivant Sciences Ltd Q4 2023 Earnings Call Transcript

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

Question: David Risinger - Leerink Partners LLC - Analyst : Yeah. Thanks very much and thank you for all of the updates. So I just wanted to ask a little bit more about batoclimab's readout. So could you please add some more color on what was surprising in the CIDP trial? And I guess, whether your level of confidence for that asset and CIDP is unchanged? And then, also, if you could discuss the slight delay in the MG readout for batoclimab, that would be helpful as well. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. MAY 30, 2024 / 12:00PM, ROIV.OQ - Q4 2023 Roivant Sciences Ltd Earnings Call And then, separately, Matt, you mentioned the very unique modeling capabilities you have for protein-protein interactions. Is that solely for facilitating larger drug companies' drug development via partnerships or would your organization ever design its own drugs with those capabilities and patent drugs to be developed by Roivant? Thanks very much.

Question: David Risinger - Leerink Partners LLC - Analyst : Great. Thank you very much.

Question: Louise Chen - Cantor Fitzgerald & Co. - Analyst : Hi. Congratulations on the progress this quarter, and thanks for taking my questions here. So I wanted to ask you how you think about the peak sales for atopic dermatitis and the pace of the uptake of that potential approval later this year? And then, do you have any updates on your capital allocation strategy? I know in the past, you broke out what you thought about share repurchase, M&A, internal investment. Any thoughts there? Thank you.

Question: Allison Bratzel - Piper Sandler & Co. - Analyst : Hey, good morning. Thanks for the update today, and thanks for taking the questions. So just first following up on the Immunovant strategic update, where you're prioritizing 1402 of batoclimab. Can you just talk more -- help us understand what went into that calculus? A change in competitive landscape or the FDA meeting, something else? And just why you're making that decision now? And just help us understand if there are any scenarios in which batoclimab would be filed for approval in any indications, what would that look like? And then, just separately on brepocitinib, a bigger picture question. I think we hear your excitement on the potential market size in NIU plus BIM, other indications. Just what gives you confidence that the current ownership structure of Priovant is optimal? Any scenarios where you would be open to revisiting that with Pfizer? Or just help us understand your thinking there. Thank you. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. MAY 30, 2024 / 12:00PM, ROIV.OQ - Q4 2023 Roivant Sciences Ltd Earnings Call

Question: Corinne Johnson - Goldman Sachs Group, Inc. - Analyst : Thanks, and good morning, guys. Maybe, a question on the path to profitability comment, I think, for the press release. I guess what are the assumptions that factor into that comment? And is this reliant on VTAMA sales, sales other products, which ones? And then, how do you think about that comment when you're contemplating potential deals? Would you forgo path to profitability in order to acquire something interesting or is that a priority over BD? Thanks.

Question: Corinne Johnson - Goldman Sachs Group, Inc. - Analyst : Yeah. On the deal front, I guess, we had expected maybe some deals earlier this year. Maybe, you could talk a little bit about what you're seeing in terms of those conversations and the difference between sourcing ideas versus executing on a final deal?

Question: Corinne Johnson - Goldman Sachs Group, Inc. - Analyst : Thank you.

Question: Brian Cheng - JPMorgan Chase & Co. - Analyst : Hi, Matt. Thanks for taking our question this morning. Just first, on the back of your FDA meeting, can you give us a sense of how the rollout of your plan of four to five potentially pivotal program will look like over the next 10 years? And what was the key take from the Type B meeting with the FDA? Was the Type B meeting for all four to five programs? And I have a quick follow up. Thank you.

Question: Brian Cheng - JPMorgan Chase & Co. - Analyst : Sorry, the next 10 months, the next 10 months because you'll be teeing up the prototype programs by March, sorry.

Question: Brian Cheng - JPMorgan Chase & Co. - Analyst : Great. And then, a quick follow up is on Biohaven's update on the SAD data yesterday. Just curious what's your view and your stand on their data. Thanks for taking our question.

Question: Brian Cheng - JPMorgan Chase & Co. - Analyst : Great. Thank you, Matt.

Question: Yaron Werber - TD Cowen - Analyst : Great. Thank you. So maybe, I have a couple of questions. The first one just on Graves' disease. Can you give us a sense of how much data are we going to see in the fall? Is it going to be the full data? Is it going to be at a medical presentation? And then, secondly, from that study, do you have enough -- will you have enough sense in dose response to really be able to design a pivotal Phase 3? And maybe just on namilumab, I know this is a drug you really have not talked much about. You're positioning as an upside potential, so to speak, without a lot of downside to the stock. But how strong do you feel about this mechanism, anti-GM-CSF for sarcoidosis? Thank you.

Question: Yatin Suneja - Guggenheim Securities, LLC - Analyst : Hey, guys. Thank you for taking my question. Question on the Immunovant front. So there are indications like myasthenia gravis and TED, where you have a pivotal program ongoing with 1401. Could you talk about what are the key metrics for you to decide if the data are positive, that you will file a BLA or you will advance 1402? Or could you do both of them? Help us understand, because I think the one question that we generally get from investors is that, look, you have two assets. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. MAY 30, 2024 / 12:00PM, ROIV.OQ - Q4 2023 Roivant Sciences Ltd Earnings Call On one hand, you're saying you're going to really advance 1402 across all indications, but you do have to deal with these two pivotal studies ongoing. And then, there are certain investors that care about being on the market first. So help us understand how those decisions will be made. Is there a potential that you will file a BLA for gMG and TED if the data are positive? And then, how should we think about 1402 for those at least two indications? Thank you.

Question: Douglas Tsao - H.C. Wainwright & Co, LLC - Analyst : Hi. Good morning and thanks for taking the questions. Maybe, Matt, just on brepocitinib. Just curious, when you think about the differentiation we saw in your study and you look ahead to Phase 3, I'm just curious, do you have a thought in terms of where you want to lean into in terms of that differentiation? Obviously, you used a shorter steroid tapering period in your study. I'm just curious, would you want to replicate that or would you perhaps just sort of go with the same steroid tapering that they use in the humira studies in which would potentially or should in theory give you even better treatment failure rates? Thank you.

Question: Douglas Tsao - H.C. Wainwright & Co, LLC - Analyst : Okay, great. That's really helpful. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. MAY 30, 2024 / 12:00PM, ROIV.OQ - Q4 2023 Roivant Sciences Ltd Earnings Call

Question: Andy Chen - Wolfe Research, LLC - Analyst : Hey, good morning. Thank you for taking the question. So Matt, the question is on the optionality with batoclimab. So you have four indications on the table. And let's say, hypothetically, we know the data from MG, we know the data from CIDP. The data is that batoclimab is equal or slightly better than (inaudible) on efficacy. I'm just curious if you can rank order the four indications, which ones are you more excited about? Which ones are you less excited about? Because not all of these are the same, right? Because some indications are more competitive. In some indications, the safety is more important. If you can talk about where each indication stands with batoclimab, that would be great. And then, a follow up on VTAMA. So I know you have your NBRx data here on the slide. Can you talk about the drop off? How sticky is this business in psoriasis right now? How much do you lose over time to (inaudible) and biologics? Thank you.

Question: Andy Chen - Wolfe Research, LLC - Analyst : Thank you, Matt. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. MAY 30, 2024 / 12:00PM, ROIV.OQ - Q4 2023 Roivant Sciences Ltd Earnings Call