BASEL, Switzerland and LONDON and NEW YORK — November 10, 2025 — Leads & Copy — Roivant (Nasdaq: ROIV) has released its financial results for the second quarter, which ended September 30, 2025, and provided a business update.
Key highlights from the announcement include:
Brepocitinib 30 mg has demonstrated statistically significant improvement compared to placebo on the primary endpoint, as well as all nine key secondary endpoints, in the Phase 3 VALOR study for dermatomyositis (DM). An NDA filing is planned for the first half of calendar year 2026.
The brepocitinib program continues to progress with rapid enrollment in a Phase 3 study focusing on non-infectious uveitis (NIU), as well as a proof-of-concept trial in cutaneous sarcoidosis (CS). Readouts are expected in the first half of calendar year 2027 and the second half of calendar year 2026, respectively.
An Immunovant study involving uncontrolled Graves’ disease (GD) patients, who were treated for 24 weeks, showed a potentially disease-modifying outcome with six-month off-treatment data. Immunovant expects the first of two batoclimab Phase 3 thyroid eye disease (TED) studies to be read out before the end of calendar year 2025. Topline results from both TED studies are anticipated to be shared concurrently in the first half of calendar year 2026.
LNP litigation continues, with the court issuing a favorable Markman ruling in the Pfizer/BioNTech case in September 2025. A jury trial in the U.S. Moderna case is scheduled for March 2026, and international proceedings are ongoing, with the first major hearings expected in the first half of calendar year 2026.
Roivant reported consolidated cash, cash equivalents, restricted cash, and marketable securities of $4.4 billion as of September 30, 2025, which supports cash runway into profitability.
Roivant will host a live conference call and webcast at 8:00 a.m. ET on Monday, November 10, 2025, to report its financial results for the second quarter, which ended September 30, 2025, and provide a business update. Roivant will also host an Investor Day on December 11, 2025.
According to Matt Gline, CEO of Roivant, this quarter signifies a transformation for the company, with the brepocitinib data in DM setting a new trajectory. He also noted that this is supported by Immunovant’s remission data in Graves’ disease, along with execution and progress across the board.
Recent developments include:
Priovant: Brepocitinib 30 mg showed clinically meaningful and statistically significant improvement compared to placebo on the primary endpoint and all nine key secondary endpoints in Phase 3 VALOR study in dermatomyositis (DM); safety profile was consistent with previous clinical trials of brepocitinib and NDA filing is planned for the first half of calendar year 2026. Phase 3 trial for brepocitinib in non-infectious uveitis (NIU) is ongoing and on track for topline readout in the first half of calendar year 2027. Proof-of-concept trial for brepocitinib in cutaneous sarcoidosis (CS) is ongoing and on track for topline readout in the second half of calendar year 2026.
Immunovant: All clinical development timelines remain on track for IMVT-1402 across six announced indications, including potentially registrational trials in Graves’ disease (GD), myasthenia gravis (MG), chronic inflammatory demyelinating polyneuropathy (CIDP), difficult-to-treat rheumatoid arthritis (D2T RA) and Sjögren’s disease (SjD), and a proof-of-concept trial in cutaneous lupus erythematosus (CLE). Immunovant study in uncontrolled GD patients treated for 24 weeks showed first-ever potentially disease-modifying outcome with six-month off-treatment data.
Genevant: In September 2025, the court issued a favorable Markman ruling in the Pfizer/BioNTech case.
Roivant: Roivant reported consolidated cash, cash equivalents, restricted cash and marketable securities of $4.4 billion as of September 30, 2025, supporting cash runway into profitability.
Major Upcoming Milestones:
Priovant plans to file an NDA for brepocitinib in DM in the first half of calendar year 2026. Topline data from the ongoing Phase 3 trial of brepocitinib in NIU and proof-of-concept trial in CS are expected in the first half of calendar year 2027 and second half of calendar year 2026, respectively.
Immunovant expects to report results from the open-label portion of the potentially registrational trial of IMVT-1402 in D2T RA and topline results from the proof-of-concept trial of IMVT-1402 in CLE in calendar year 2026. In calendar year 2027, topline results are expected across three indications from the potentially registrational trials of IMVT-1402 in GD, MG and D2T RA. Immunovant continues to expect the first of the two batoclimab Phase 3 thyroid eye disease (TED) studies to read out before the end of calendar year 2025. However, due to evolving competitive dynamics, Immunovant anticipates sharing topline results from both TED studies concurrently in the first half of calendar year 2026.
Pulmovant plans to report topline data from the ongoing Phase 2 trial of mosliciguat in pulmonary hypertension associated with interstitial lung disease in the second half of calendar year 2026.
Genevant LNP litigation continues to progress, with summary judgment phase ongoing in the U.S. Moderna case and jury trial currently scheduled for March 2026. International proceedings continue as expected with first major hearings expected in the first half of calendar year 2026. Pfizer/BioNTech discovery phase ongoing.
Second Quarter Ended September 30, 2025 Financial Summary:
Cash Position and Marketable Securities: As of September 30, 2025, the Company had consolidated cash, cash equivalents, restricted cash and marketable securities of approximately $4.4 billion.
Research and Development Expenses: Research and development (R&D) expenses increased by $21.5 million to $164.6 million for the three months ended September 30, 2025, compared to $143.1 million for the three months ended September 30, 2024. This increase was primarily driven by an increase in program-specific costs of $13.2 million and personnel-related expenses of $7.1 million.
The increase of $13.2 million in program-specific costs was primarily driven by an increase of $10.2 million related to the anti-FcRn franchise and $4.2 million related to brepocitinib, reflecting the progression of our programs. The majority of share-based compensation and personnel-related expenses, which are unallocated internal costs, were related to the anti-FcRn franchise activities at Immunovant. The increase of $7.1 million in personnel-related expenses was primarily driven by higher headcount to support additional clinical studies for the anti-FcRn franchise. Non-GAAP R&D expenses were $152.9 million for the three months ended September 30, 2025, compared to $132.4 million for the three months ended September 30, 2024.
General and Administrative Expenses: General and administrative (G&A) expenses decreased by $59.8 million to $143.1 million for the three months ended September 30, 2025, compared to $202.9 million for the three months ended September 30, 2024. This decrease was due to a decrease in personnel-related expense of $71.9 million, largely as a result of higher expense during the three months ended September 30, 2024 related to one-time cash retention awards from the 2024 Senior Executive Compensation Program. Non-GAAP G&A expenses were $72.1 million for the three months ended September 30, 2025, compared to $142.3 million for the three months ended September 30, 2024.
Loss from continuing operations, net of tax: Loss from continuing operations, net of tax was $166.0 million for the three months ended September 30, 2025, compared to $236.8 million for the three months ended September 30, 2024. On a basic and diluted per common share basis, loss from continuing operations, net of tax was $0.17 and $0.25, respectively, for the three months ended September 30, 2025 and 2024. Non-GAAP loss from continuing operations, net of tax was $187.8 million for the three months ended September 30, 2025, compared to $218.7 million for the three months ended September 30, 2024.
Investor Conference Call Information Roivant will host a live conference call and webcast at 8:00 a.m. ET on Monday, November 10, 2025, to report its financial results for the second quarter ended September 30, 2025, and provide a corporate update.
To access the conference call by phone, please register online using this registration link. The presentation and webcast details will also be available under “Events & Presentations” in the Investors section of the Roivant website at https://investor.roivant.com/news-events/events. The archived webcast will be available on Roivant’s website after the conference call.
Roivant will also host an investor day on Thursday, December 11, 2025. To attend the event in person or by webcast, please register online using this registration link. The presentation and webcast details will also be available under “Events & Presentations” in the Investors section of the Roivant website at https://investor.roivant.com/news-events/events. The archived webcast will be available on Roivant’s website after the conference call.
Keyur Parekh (keyur.parekh@roivant.com) and Stephanie Lee (stephanie.lee@roivant.com) are the contacts for investors and media, respectively.
Source: Roivant
