Business Development Plans
Q: What's the scope of your upcoming BD activities?
A: Roivant plans to pursue multiple late-stage programs over the next year, potentially transformative to their pipeline. These will likely be partnerships or acquisitions of programs entering large late-stage studies, rather than M&A deals. They may involve multiple announcements rather than a single one. " "

Capital Allocation Strategy
Q: When will you update on capital allocation plans?
A: Roivant expects to provide an update on their capital allocation strategy before the next earnings report. This depends on advancing late-stage BD conversations and discussions with shareholders like Sumitomo, who has indicated a desire to exit their position due to their own financial considerations. "

Shareholder Concentration
Q: How will you address your concentrated shareholder base?
A: Roivant is engaging in ongoing discussions with concentrated shareholders to optimize the situation. They plan to be economically thoughtful in using cash to address this, acknowledging that some shareholders believe the stock is meaningfully undervalued and are happy holders. " "

Immunovant's Development Plans
Q: Will Immunovant need partnerships or resources for its plans?
A: Immunovant does not have a financial need for a partner for its aggressive and broad development plan. Roivant and Immunovant together have the resources to execute on multiple potentially registrational programs this year. Roivant is prepared to provide additional resources if needed. " "

VTAMA Commercialization and AD Launch
Q: What's the outlook for VTAMA with the AD approval?
A: VTAMA continues to gain traction in psoriasis, and Roivant is optimistic about its potential in atopic dermatitis (AD), a huge market. They plan to increase their sales force from about 100 to 125 reps for the AD launch, expected towards the end of the year. There's no massive change to the commercial infrastructure planned. "

Litigation with Moderna and Pfizer
Q: Can you update on Moderna and Pfizer litigation?
A: Roivant had their Markman hearing with Moderna and were pleased with their arguments; a decision is expected in about 60 days. The Pfizer case is ongoing, with a remote hearing expected later this year. "

Brepocitinib Development Plans
Q: How are you prioritizing brepocitinib indications after lupus data?
A: Despite the high placebo response in the lupus study, Roivant remains full speed ahead on brepocitinib's original plan, focusing on dermatomyositis (DM) and potentially non-infectious uveitis (NIU). Hidradenitis suppurativa (HS) is also being considered based on upcoming data. "

Pipeline Expansion and Therapeutic Areas
Q: Which therapeutic areas are you targeting for pipeline expansion?
A: Roivant is therapeutic-area agnostic and flexible, focusing on opportunities arising from strategic shifts at partners. They prefer areas where a single program can stand on its own and are less likely to pursue areas requiring multiple drugs in combination, like oncology. "

Adding Value to Acquired Assets
Q: How does Roivant add value to new assets?
A: Roivant adds value through efficient, thoughtful, and creative development strategies, strong execution, and the ability to be aggressive on clinical development. Their capital base allows them to undertake larger studies and be a partner of choice for big pharma seeking to reprioritize portfolios. "

SG&A and R&D Spend Outlook
Q: What is the spend outlook for SG&A and R&D?
A: Roivant anticipates spend to be relatively flat over the next few quarters. There will be an uptick towards the end of the year with the AD approval of VTAMA and as development of RVT-1402 ramps up. "

CIDP Data Expectations
Q: What is the bar for batoclimab in CIDP?
A: Roivant aims to see batoclimab demonstrate efficacy that surpasses current treatments like IVIG, especially at higher doses, offering better outcomes for patients and providers. "

NIU Study Expectations
Q: What's the success bar for the NIU study?
A: In the 24-patient NIU study, Roivant set a bar at a 70% treatment failure rate, but they will evaluate all data comprehensively. The study design includes a more aggressive steroid taper, anticipating a higher placebo failure rate. " "

Net Yield Expectations for VTAMA
Q: How should we think about VTAMA's net yield?
A: Roivant expects a slow and steady increase in VTAMA's net yield over 2024, aiming for a long-term steady-state gross-to-net ratio of 50%, though it will take time and scale to achieve due to volume-based accretion. " "

Retaining Assets Long Term
Q: How many assets will you retain long term?
A: Roivant plans to retain and develop all programs they bring in, unless new information or partner interest prompts a strategic change. They evaluate each program on its merits and are prepared to be flexible based on evolving data and market dynamics. "

Building Scale in New Areas
Q: Will you build scale in new therapeutic areas?
A: While Roivant evaluates each program individually, they acknowledge that certain programs could become nexuses of scale. They are open to building concentration in new areas if it provides strategic advantage and aligns with their development capabilities. "