Roivant Sciences (ROIV) TD Cowen 46th Annual Health Care Conference summary

Regulatory and clinical milestones

• Priority review granted by FDA for a key therapy, with PDUFA date in Q3 and planned launch by end of September, accelerating patient access compared to standard review timelines.

• Label discussions aim for broad indication in dermatomyositis, with inclusion of steroid tapering data based on secondary endpoint success.

• Phase III studies for non-infectious uveitis (NIU) and cutaneous sarcoidosis are designed to closely mirror successful phase II trials, with ongoing FDA discussions on study design and dosing.

• FORWARD-1 and FORWARD-2 studies for Graves’ disease are ongoing, with data expected next year; endpoints include time off therapy and avoidance of ablative treatments.

• Moderna litigation trial is set to begin soon, with expectations for a short trial and possible lengthy appeals process.

Market landscape and physician sentiment

• Physician surveys indicate strong excitement and expectation of 30% market share for the new dermatomyositis therapy, with high interest in reducing steroid burden.

• Treatment landscape for dermatomyositis and myasthenia gravis remains dominated by older therapies, with significant unmet need for alternatives to steroids and IVIG.

• JAK inhibitors, including the discussed therapy, are expected to see use across both skin and muscle manifestations, with rapid onset of action noted in clinical data.

• In pulmonary hypertension associated with interstitial lung disease (PH-ILD), new therapies are positioned for first-line or add-on use, with administration convenience and tolerability as key differentiators.

• In Graves’ disease, there is a large population inadequately managed by current therapies, with strong demand for novel, non-ablative options.

Forward-looking statements and development plans

• Launch of the new dermatomyositis therapy is targeted for end of September, pending FDA approval.

• Phase IIb PHocus study in PH-ILD will read out in the second half of the year, with focus on PVR reduction and six-minute walk trends to inform phase III readiness.

• Phase III cutaneous sarcoidosis trial will closely follow phase II design, with ongoing FDA discussions to finalize details.

• FORWARD-1 and FORWARD-2 Graves’ disease studies are expected to complete enrollment and deliver data next year, with potential for significant clinical impact.

• Ongoing litigation with Moderna is entering trial phase, with outcomes potentially subject to appeal.