What Immunovant (IMVT) Said on Its Q2 Earnings Call

Key Points

• LISRAYA generated $31 million in initial launch revenue, but the figure covered only about five weeks and was boosted by specialty-pharmacy inventory that had not yet been dispensed. Roivant cautioned that the inventory effect could create a modest headwind in the following quarter.
• In a rheumatoid arthritis study, 92.5% of patients taking IMVT-1402 at 600 mg maintained an ACR20 response at week 28, versus about 75% on placebo; the 300 mg dose performed similarly to placebo. The higher dose also showed stronger ACR50 results, with no new safety signals reported.
• Roivant ended the quarter with $4.2 billion in cash and a $153 million net loss from continuing operations, and repurchased about $280 million of stock over six months. FDA discussions on the next IMVT-1402 rheumatoid arthritis trial continue, with an update expected later this year or early next year.

Roivant reported $31 million in net revenue from the initial launch of LISRAYA and highlighted new rheumatoid arthritis data for IMVT-1402 during its fiscal second-quarter earnings call. CEO Matt Gline cautioned that the LISRAYA results covered only about five weeks on the market and included a boost from pharmacy inventory.

The company ended the quarter on September 30, 2026, with $4.2 billion in cash and reported a net loss from continuing operations of $153 million. Roivant also said it repurchased approximately $280 million of its stock during the six months ended September 30.

LISRAYA Launch Shows Early Demand

LISRAYA was approved in August for dermatomyositis, and Gline said hundreds of patients were receiving paid drug at the end of September. That figure had grown to many hundreds by the time of the call, he said, while many hundreds of prescribers had written prescriptions.

Gline attributed the early uptake to demand from patients and physicians, but cautioned against extrapolating from the first quarter. Roivant records revenue when specialty pharmacies purchase the drug, rather than when it is dispensed to patients.

There was a “meaningful amount” of undispensed drug at specialty pharmacies on September 30, all of which had since been dispensed, Gline said. He declined to quantify the inventory contribution, but said it likely provided a tailwind to September-quarter revenue and could create a modest headwind in the December quarter.

Early insurance access has generally been straightforward, according to Gline, although he said coverage policies are beginning to emerge and vary in their restrictions. Patients starting LISRAYA have included people switching from off-label JAK inhibitors, IVIG, steroids and immunosuppressants, as well as some newly diagnosed patients, he said.

IMVT-1402 Data and FDA Discussions

Roivant also presented results from the second period of a rheumatoid arthritis study of IMVT-1402, a drug being developed by Immunovant NASDAQ: IMVT. The trial enrolled patients who had failed conventional therapy and at least two mechanisms of advanced treatment.

In the first period, all patients received the 600-milligram dose. Those who achieved an ACR20 response, a measure of improvement in rheumatoid arthritis symptoms, were then randomized to continue at that dose, move to 300 milligrams or receive placebo. Of the 118 patients re-randomized, 117 were included in the efficacy analysis, Gline said.

At week 28, 92.5% of patients in the 600-milligram group maintained an ACR20 response, compared with approximately 75% on placebo. The study met its primary endpoint for the higher dose, Gline said. The 300-milligram group performed similarly to placebo on that measure.

At the more stringent ACR50 response level, 80% of patients on 600 milligrams had a response at week 28, versus 56% on placebo. Gline said safety findings were consistent with previously reported data, with no new safety signals.

Discussions with the Food and Drug Administration about the next rheumatoid arthritis trial are ongoing. Gline said Roivant expects to provide an update later this year or early next year, but has not settled questions including the endpoint and whether one Phase 3 study would be sufficient for approval. He said a conventional randomized controlled trial was more likely than another randomized-withdrawal design.

Roivant is unlikely to advance IMVT-1402 in Sjögren’s disease, Gline said, citing results and developments involving other companies’ programs. The company plans to complete its Phase 2 study and could reevaluate if the results are surprising.

Other Programs and Financial Outlook

Gline revisited previously reported results for brepocitinib in non-infectious uveitis and mosliciguat in pulmonary hypertension associated with interstitial lung disease, or PH-ILD. Roivant plans to file a supplemental new drug application for brepocitinib in non-infectious uveitis in 2027.

In the PH-ILD study, mosliciguat showed a 56% placebo-adjusted reduction in pulmonary vascular resistance at week 16 and a statistically significant 35-meter improvement in six-minute walk distance, Gline said. A Phase 3 study is screening and enrolling patients. Roivant is also evaluating additional indications for mosliciguat, though Gline did not commit to specific new trials.

For 2027, Roivant expects top-line IMVT-1402 data in Graves’ disease and data in myasthenia gravis. Gline said enrollment in the Graves’ study has been strong and that an update on timing is expected relatively soon.

Roivant’s non-GAAP loss from continuing operations was $133 million for the quarter. Its cash balance reflected in part proceeds from Moderna litigation received over the summer. The company plans to discuss several of its commercial opportunities at an investor day on December 9.

About Immunovant (NASDAQ:IMVT)

Immunovant, Inc is a clinical-stage biopharmaceutical company developing treatments for autoimmune diseases. Its research focuses on inhibiting the neonatal Fc receptor (FcRn), a pathway involved in maintaining levels of disease-causing antibodies.

The company's investigational medicines include batoclimab and IMVT-1402, both designed to reduce circulating antibodies. Immunovant has studied or evaluated these candidates for conditions including myasthenia gravis, Graves' disease and other autoimmune disorders.

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