Roivant Books First LISRAYA Product Sales After Launch

The Tip Desk · November 9, 2026 · 4 min read

Net product revenue was $31.0 million in the three months ended September 30, 2026, as brepocitinib sold in its first five U.S. weeks after August FDA approval.

Roivant Sciences Ltd. (ROIV), a commercial-stage biopharmaceutical company, generated $31.0 million of net product revenue from LISRAYA (brepocitinib) in the three months ended September 30, 2026, its first five weeks of U.S. sales after FDA approval in August 2026. The company had no product revenue in the year-ago quarter.

Total net revenues were $35.1 million, including $4.2 million of license, milestone and other revenue.

Chief executive Matt Gline said the quarter marked a major transition, with LISRAYA commercially available and early demand from patients and prescribers.

Clinical readouts that had been expected later in the year arrived. Brepocitinib 45 mg once daily met the primary and all key secondary endpoints in both Phase 3 CLARITY trials in non-infectious uveitis. Median time to treatment failure was greater than 48 weeks versus about 12 weeks on placebo in each study. Pooled, 62% of patients on brepocitinib achieved steroid-free quiescence at Week 48 versus 20% on placebo. Priovant intends to file a supplemental New Drug Application for NIU in the first half of calendar 2027.

Immunovant’s IMVT-1402 600 mg met the Period 2 primary endpoint of ACR20 response at Week 28 in difficult-to-treat rheumatoid arthritis, 92.5% versus 75.6% on placebo (p=0.0139), after 170 participants were enrolled in a 16-week open-label lead-in and 117 were included in the randomized withdrawal. The 300 mg dose did not differ from placebo. FDA discussions are planned later this year on the registrational path.

The company said it is unlikely to advance IMVT-1402 further in Sjögren’s disease beyond the ongoing, fully enrolled Phase 2 trial, citing the evolving disease landscape and recent field data. Graves’ disease, myasthenia gravis and CIDP timelines remain on track, with topline data expected in calendar 2027 for GD and MG and in 2028 for CIDP.

Pulmovant’s mosliciguat met the Phase 2 PHocus primary endpoint in pulmonary hypertension associated with interstitial lung disease, with a -56.3% placebo-adjusted reduction in pulmonary vascular resistance at Week 16 and a +35.2-meter improvement in six-minute walk distance. The Phase 3 PHrontier study has been initiated.

Research and development expenses were $145.7 million, down $18.8 million from $164.6 million a year earlier. The company said the decline was primarily driven by $7.4 million less personnel-related expense, $6.4 million less program-specific cost and $3.0 million less share-based compensation. Program-specific costs fell $6.4 million overall, primarily driven by an $18.3 million decrease related to the anti-FcRn franchise, reflecting lower costs after the IMVT-1402 cutaneous lupus erythematosus study was discontinued in September 2026, the wind-down of batoclimab trials and the timing of contract manufacturing costs, partly offset by higher Graves’ disease trial costs and an $11.6 million increase in mosliciguat costs. Adjusted R&D was $137.4 million.

Selling, general and administrative expenses rose $11.0 million to $154.1 million from $143.1 million, primarily from the LISRAYA launch, partly offset by $11.2 million less one-time cash retention awards recognized a year earlier. Adjusted SG&A was $82.5 million.

Loss from continuing operations, net of tax, was $153.0 million, or $0.29 a share, versus $166.0 million, or $0.17 a share, a year earlier. Adjusted loss from continuing operations, net of tax, was $133.4 million.

Net loss attributable to Roivant was $191.6 million, or $0.27 a share, versus $113.5 million, or $0.17 a share. The period included $95.9 million of Genevant dividend-equivalent distributions on Moderna settlement proceeds, which increased basic and diluted loss per share by $0.13.

In July 2026, Genevant and Arbutus received $950 million from Moderna as the initial payment under a $2.25 billion patent-infringement settlement. An additional $1.3 billion remains contingent on a favorable resolution of Moderna’s Section 1498 appeal; oral arguments took place on November 5, 2026.

Consolidated cash, cash equivalents and marketable securities were $4.2 billion as of September 30, 2026, including the July Moderna payment. The company said the balance supports cash runway into profitability. Roivant repurchased 2.1 million common shares for about $72.5 million in the quarter.

An investor day is scheduled for December 9, 2026.