Roivant Sciences Q2 Earnings Call Highlights

Key Points

• LISRAYA generated $31 million in initial revenue during roughly five weeks after its August approval, but specialty-pharmacy inventory stocking boosted the quarter and may be a modest headwind in December. Roivant reported a $153 million net loss from continuing operations.
• Roivant’s IMVT-1402 rheumatoid arthritis study met its primary endpoint: 92.5% of patients continuing the 600-milligram dose maintained an ACR20 response at week 28, versus about 75% on placebo. The company is discussing Phase 3 requirements with the FDA.
• Roivant expects to seek approval for brepocitinib in noninfectious uveitis in 2027 and is enrolling patients in a Phase 3 mosliciguat study for pulmonary hypertension associated with interstitial lung disease. It also repurchased about $280 million of stock in the six months ended September 30.

Roivant Sciences NASDAQ: ROIV reported $31 million in net revenue from the initial launch of LISRAYA and said an experimental rheumatoid arthritis treatment met its primary endpoint in a randomized withdrawal study.

Chief Executive Officer Matt Gline said the LISRAYA revenue covered roughly five weeks following the drug’s August approval for dermatomyositis. He cautioned that the result benefited from specialty pharmacies purchasing inventory that had not yet been dispensed to patients by the end of the quarter.

Roivant recorded a net loss from continuing operations of $153 million for the quarter ended September 30, 2026. On a non-GAAP basis, the loss was $133 million.

LISRAYA launch and inventory

Gline said hundreds of patients were receiving paid LISRAYA at the end of September and that the number had grown to “many hundreds” by the time of the call. The company also had many hundreds of prescribers, he said.

Roivant recognizes revenue when specialty pharmacies purchase the drug. A “meaningful amount” remained undispensed at September 30, but all of that inventory had subsequently been dispensed, Gline said. He declined to quantify the inventory or say what share of quarterly revenue it represented.

Gline said the initial stocking likely provided a tailwind to the September quarter and could create a modest headwind in the December quarter. He expected inventory effects to become less relevant next year.

Early payer access had generally been straightforward, although coverage restrictions varied among plans, Gline said. Prescribers were using LISRAYA across a broad range of patients, including some switching from off-label JAK inhibitors, intravenous immunoglobulin, steroids or immunosuppressants, as well as some newly diagnosed patients.

Rheumatoid arthritis study meets primary endpoint

Roivant also reported results from the second period of a study of IMVT-1402 in difficult-to-treat rheumatoid arthritis. Participants had previously failed conventional treatment and at least two mechanisms of advanced therapy.

In the first period, all patients received a 600-milligram dose. Those who achieved an ACR20 response—a measure of improvement in rheumatoid arthritis signs and symptoms—were then randomized to continue that dose, move to 300 milligrams or receive placebo.

At week 28, 92.5% of patients continuing the 600-milligram dose maintained an ACR20 response, compared with approximately 75% on placebo, Gline said. The primary endpoint achieved statistical significance. The 300-milligram group performed similarly to placebo, he said.

For the more stringent ACR50 measure, 80% of patients on the higher dose had a response at week 28, compared with 56% on placebo. Gline said the result achieved a nominal p-value. Safety findings were consistent with prior disclosures, with event rates comparable to placebo and no new safety signals, he said.

Gline said discussions with the Food and Drug Administration about the next trial are ongoing. Roivant does not yet know whether one Phase 3 study would be sufficient for approval or what endpoint regulators would require. He said an update on trial plans could come later this year or early next year.

Other pipeline updates

Roivant is unlikely to advance IMVT-1402 further in Sjögren’s disease, Gline said, citing developments involving competing treatments. The company plans to complete its Phase 2 study and assess the findings. He also reiterated that the company had not succeeded in cutaneous lupus erythematosus.

Gline reviewed previously reported results for brepocitinib in noninfectious uveitis. He said the CLARITY studies met their primary and secondary endpoints, with nearly two-thirds of patients achieving steroid-free quiescence. Roivant expects to file a supplemental new drug application for the indication in 2027.

For mosliciguat in pulmonary hypertension associated with interstitial lung disease, Gline highlighted a previously reported 56% placebo-adjusted reduction in pulmonary vascular resistance and a statistically significant 35-meter improvement in the six-minute walk test at week 16. A Phase 3 study is screening and enrolling patients, he said.

The company is considering additional mosliciguat studies in other indications, but Gline did not commit to specific trials. Roivant also expects 2027 data for IMVT-1402 in Graves’ disease and myasthenia gravis. Enrollment in the Graves’ study has been strong, he said, without providing a more precise readout date.

During the six months ended September 30, Roivant repurchased approximately $280 million of stock, or about 9.4 million shares. The company plans to discuss its commercial opportunities and pipeline further at its December 9 investor day.

About Roivant Sciences (NASDAQ:ROIV)

Roivant Sciences is a biopharmaceutical company that develops medicines through a network of subsidiary companies, which it calls “Vants.” These businesses focus on advancing drug candidates in areas such as immunology, oncology, neuroscience and rare diseases.

Founded in 2014, Roivant has built and supported subsidiaries to develop treatments, manage clinical programs and pursue partnerships. Its portfolio has included both internally developed candidates and medicines licensed from other companies.

Roivant operates internationally, with activities spanning the United States and other markets.

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