Q2 2025 Earnings Summary
- Brepocitinib (BREPO) has the potential for widespread adoption, potentially even in the first-line setting, due to its better efficacy profile compared to HUMIRA and the high unmet need in diseases where TNF inhibitors have limited efficacy.
- The company's anti-FcRn franchise, particularly IMVT-1402, has shown over 75% response rate in patients uncontrolled on ATDs in Graves' disease, positioning it as a potentially best-in-class and first-in-class therapy in an indication with no pharmacologic options.
- Roivant has a strong cash position of $5.4 billion with no debt, and a pipeline stacked with catalysts in the next 18 months, including multiple late-stage data readouts, providing significant opportunities for value creation.
- Competition from HUMIRA biosimilars may limit the market potential of brepocitinib in treating non-infectious uveitis, as patients and physicians might opt for the more established and potentially less expensive biosimilar options. ( , )
- Lack of specific stratification and steroid dosing requirements in the CLARITY Phase III trial design could introduce variability in study outcomes, potentially complicating efficacy assessments of brepocitinib. ( )
- Uncertainty around the pricing strategy for brepocitinib in orphan indications may impact revenue projections, especially if competitive pressures or reimbursement challenges arise in the high-cost therapy market. ( )
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Brepocitinib Pricing Strategy
Q: How should we think about pricing for brepocitinib by indication?
A: While it's early to set firm pricing, we are focused on orphan diseases with high unmet needs, supporting a wide price range. Competitors in dermatomyositis have suggested net pricing in the high $100,000 range, which serves as a benchmark. Recent orphan launches, including both biologics and small molecules, have had similar price points. -
BREPO Positioning Amid HUMIRA Biosimilars
Q: How do you expect brepocitinib to be positioned with the emergence of HUMIRA biosimilars? Will you target anti-TNF refractory patients in CLARITY?
A: We anticipate brepocitinib to be used predominantly in the NIU refractory population. HUMIRA's high failure rate and widespread use, potentially increased by biosimilars, expand the refractory market. If our data shows differentiation, there could be strong demand for first-line use. In the CLARITY trial, we are not specifically stratifying for prior TNF therapy, but we expect to enroll patients who have been on such therapies. -
NIU Phase III Efficacy Expectations
Q: What efficacy do you expect in your Phase III NIU trial?
A: We are very happy with the Phase II efficacy, and anything that approximates it in Phase III would be terrific. Even with some drop-off commonly seen between Phase II and III, our drug could offer a better product profile than HUMIRA, supporting widespread adoption, potentially even in the first-line setting. -
NIU Phase III Placebo Response Assumptions
Q: What placebo response are you assuming in the NIU Phase III trial?
A: We're assuming a placebo rate similar to that seen in HUMIRA's VISUAL I trial. Due to our more stringent tapering (8 weeks vs. HUMIRA's 15 weeks), there's potential for a higher placebo response, but we've conservatively powered the study to detect differences even if the placebo response is higher. -
Brepocitinib in Dermatomyositis (DM) and Lupus Data
Q: Any plans to share the full lupus data, and are there overlaps between lupus and DM? What's the willingness of doctors to prescribe JAKs in DM?
A: We don't see significant read-through from lupus to DM; each rheumatic disease requires focused study design, particularly to manage placebo response. JAK inhibitors are used extensively off-label in DM, with around 600 published case reports, and physicians are comfortable prescribing them. -
BREPO and HS Update
Q: What's the latest on brepocitinib for HS?
A: HS is a great indication with very good Phase II data. It's a competitive field with other mechanisms, and while we are considering various indications, HS remains on our radar. -
CLARITY Trial Design Details
Q: Are you requiring specific steroid doses for the CLARITY trial entry, any stratification strategies, and differences between CLARITY-1 and 2?
A: There's no specific steroid dose requirement; patients may be on up to 40 mg per day or none. No significant stratification strategies. The two sub-studies differ in site assignments; some geographies have sites in both, others in one.
Research analysts covering Roivant Sciences.