Roivant Sciences (ROIV) investor relations material

Key clinical data and product positioning

• Recent brepocitinib (brepo) data mark a major advance for dermatomyositis (DM), offering the first successful novel targeted therapy in a field with limited options.

• Brepo demonstrated meaningful clinical benefit, enabling steroid reduction and providing a once-daily oral alternative to cumbersome IVIG regimens.

• Adoption is expected across both IVIG and high-dose steroid patient segments, with broad eligibility among the 35,000–40,000 treated DM patients.

• Both dermatologists and rheumatologists are familiar with JAK inhibitors and are eager for new options, with safety data showing favorable comparisons to background therapies.

• The concentrated prescriber base (about 200 referral centers) allows for a capital-efficient launch focused on physician and patient engagement.

Pipeline and future development

• Brepo is being studied in non-infectious uveitis (NIU, registrational study) and cutaneous sarcoidosis (phase II), with NIU data expected in the first half of 2027.

• The drug has a strong IP runway through 2039 and prior positive data in multiple inflammatory indications under previous ownership.

• The company is positioned as a unique JAK1/TYK2 dual inhibitor in rare/orphan diseases, with limited late-stage competition.

• NIU market opportunity is comparable in size to DM, with 40,000 eligible patients and a preference for aggressive therapies.

Graves’ disease and FcRn portfolio

• In Graves’, the primary endpoint is ATD-free euthyroid status, expected to drive a paradigm shift away from prolonged methimazole use.

• A large prevalent pool of uncontrolled patients (330,000) is managed mainly by endocrinologists, who are receptive to new options.

• The company is monitoring thyroid eye disease (TED) outcomes and may pursue label claims or additional studies if data are strong.

• FcRn portfolio includes high-risk, high-reward indications like RA, with lower-risk opportunities in MG and CIDP, where deeper IgG suppression may offer differentiation.