Roivant Sciences Ltd.: Q3 FY2025 earnings call
What management said about Q3 FY2025, from the documents filed with the SEC on 6 February 2026: press release. Guidance figures: 2 new, 5 kept. The quarter’s numbers.
Key takeaways
- Loss from continuing operations widened: Loss from continuing operations, net of tax, was $313.7 million, against $208.9 million a year earlier and $166.0 million in the second quarter. Diluted loss per share was $0.38. Source
- Sarcoidosis Phase 2 reached primary endpoint: The 45 mg arm showed a 22.3-point mean CSAMI-A improvement at Week 16, against 0.7 points for placebo. The company described it as the first positive placebo-controlled trial for any therapy in this disease. Source
- Dermatomyositis filing now submitted: The NDA for brepocitinib in dermatomyositis has been submitted to the FDA. The prior release had planned that filing for the first half of calendar year 2026. Source
- Sarcoidosis moves to pivotal study: Priovant plans a pivotal Phase 3 study in cutaneous sarcoidosis following FDA engagement. It would be the third indication with a pivotal program for brepocitinib. Source
- R&D expense rose $23.8 million: GAAP R&D expense was $165.4 million, up from $141.6 million a year earlier. Program costs rose $11.3 million and share-based compensation rose $8.4 million. Source
- Cash and securities total $4.5 billion: Consolidated cash, cash equivalents, restricted cash and marketable securities were about $4.5 billion at December 31, 2025, up from $4.4 billion at September 30, 2025. Source
- Immunovant raised about $550 million: A financing led by Roivant, with key institutional investors, brought gross proceeds to Immunovant of approximately $550 million. Source
- Favorable Moderna summary judgment ruling: A summary judgment decision in the U.S. Moderna case affirmed Genevant’s view on section 1498, placing most liability in the current case against Moderna. Source
“2025 was a transformative year for Roivant, driven by the quality of our clinical execution and its resulting data.”
Matt Gline, CEO of Roivant
Guidance
| Area | Period | Figure | Against last quarter |
|---|---|---|---|
| Cutaneous sarcoidosis (brepocitinib) program Source | calendar year 2026 | Phase 3 study starting in calendar year 2026 | New |
| Non-infectious uveitis (brepocitinib) Phase 3 topline Source | second half of calendar year 2026 | second half of calendar year 2026 | |
| IMVT-1402 difficult-to-treat rheumatoid arthritis topline Source | second half of calendar year 2026 | second half of calendar year 2026 | |
| IMVT-1402 cutaneous lupus erythematosus proof-of-concept topline Source | second half of calendar year 2026 | second half of calendar year 2026 | |
| Mosliciguat Phase 2 topline (PH-ILD) Source | second half of calendar year 2026 | second half of calendar year 2026 | Kept |
| Batoclimab thyroid eye disease Phase 3 topline Source | first half of calendar year 2026 | first half of calendar year 2026 | Kept |
| IMVT-1402 Graves’ disease and myasthenia gravis topline Source | calendar year 2027 | calendar year 2027 | Kept |
| Genevant LNP litigation, U.S. Moderna case Source | March 2026 | March 2026 | Kept |
| Genevant LNP litigation, international proceedings Source | first half of calendar year 2026 | first half of calendar year 2026 | Kept |
| Immunovant cash runway Source | through launch of IMVT-1402 in Graves’ disease | runway to the launch of IMVT-1402 in Graves’ disease | New |
What changed from last quarter
- New: Brepocitinib NDA for dermatomyositis was submitted to the FDA. The prior release had planned filing in the first half of calendar year 2026. Source
- New: Priovant reported positive Phase 2 results for brepocitinib in cutaneous sarcoidosis in February 2026. The prior release had a proof-of-concept readout expected in the second half of calendar year 2026. Source
- New: Cutaneous sarcoidosis moves to a pivotal program with a Phase 3 study planned to start in calendar year 2026. Source
- New: Roivant-led financing at Immunovant raised gross proceeds to Immunovant of approximately $550 million. Source
- New: The company recorded a $17.1 million impairment loss tied to relocating the U.S. corporate headquarters of Roivant Sciences, Inc. Source
Quarter results and losses
- Loss from continuing operations widened: Loss from continuing operations, net of tax, was $313.7 million, against $208.9 million a year earlier and $166.0 million in the second quarter. Diluted loss per share was $0.38. Source
- Non-GAAP loss narrowed from second quarter: Non-GAAP loss from continuing operations was $167.0 million, compared with $143.7 million a year earlier and $187.8 million in the second quarter. Source
- Revenue remained minimal: Revenue was $1,999 thousand for the quarter, against $9,018 thousand a year earlier and $1,571 thousand in the second quarter. Source
- Diluted loss per share reported: Basic and diluted loss from continuing operations was $0.38 per common share, compared with $0.22 a year earlier and $0.17 in the second quarter. Source
Brepocitinib cutaneous sarcoidosis data
- Sarcoidosis Phase 2 reached primary endpoint: The 45 mg arm showed a 22.3-point mean CSAMI-A improvement at Week 16, against 0.7 points for placebo. The company described it as the first positive placebo-controlled trial for any therapy in this disease. Source
- Response rates higher than placebo: All 45 mg patients reached a 10-point CSAMI-A improvement, against 14% of placebo. Functional remission was 62% against 0%, and 69% reached clear or almost clear on IGA. Source
- Small trial of 31 patients: The BEACON study enrolled 31 patients at 15 U.S. sites, randomized 3:2:2 to 45 mg, 15 mg or placebo over 16 weeks. The 15 mg arm also improved against placebo. Source
- No serious adverse events reported: No serious adverse events occurred during the treatment period, and all adverse events were mild or moderate. More than 1,500 patients and subjects have been evaluated. Source
“I’m proud of our continued execution elsewhere in our pipeline, including with today's announcement of the NDA filing for brepocitinib in dermatomyositis”
Matt Gline, CEO of Roivant
Brepocitinib filings and pipeline
- Dermatomyositis filing now submitted: The NDA for brepocitinib in dermatomyositis has been submitted to the FDA. The prior release had planned that filing for the first half of calendar year 2026. Source
- Sarcoidosis moves to pivotal study: Priovant plans a pivotal Phase 3 study in cutaneous sarcoidosis following FDA engagement. It would be the third indication with a pivotal program for brepocitinib. Source
- Other brepocitinib indications still explored: The company said it continues to look at other indications for brepocitinib beyond the programs it has named. Source
Immunovant anti-FcRn programs
- Lupus and rheumatoid arthritis readouts later in 2026: The difficult-to-treat rheumatoid arthritis trial is fully enrolled, and the lupus proof-of-concept readout is also expected in the second half of 2026. Source
- Thyroid eye disease readouts in early 2026: Immunovant anticipates topline data from both batoclimab Phase 3 thyroid eye disease studies in the first half of calendar year 2026. Source
- Graves’ disease and myasthenia gravis in 2027: Topline data from the potentially registrational trials of IMVT-1402 in Graves’ disease and myasthenia gravis are expected in calendar year 2027. Source
“We are entering 2026 with early momentum across our late stage pipeline with ambitions of another groundbreaking year.”
Matt Gline, CEO of Roivant
Research and development spending
- R&D expense rose $23.8 million: GAAP R&D expense was $165.4 million, up from $141.6 million a year earlier. Program costs rose $11.3 million and share-based compensation rose $8.4 million. Source
- Mosliciguat and brepocitinib drove program costs: Program-specific costs rose $5.7 million for mosliciguat and $5.3 million for brepocitinib, which the company tied to program progression. Source
- Non-GAAP R&D below second quarter: Non-GAAP R&D expense was $146.7 million, against $131.2 million a year earlier and $152.9 million in the second quarter. Source
General and administrative costs
- G&A rose to $175.1 million: GAAP G&A expense was $175.1 million, up from $141.5 million a year earlier. Non-GAAP G&A was $71.0 million, against $71.1 million a year earlier. Source
- Headquarters relocation impairment: The G&A increase was primarily due to a $17.1 million impairment loss tied to the relocation of the U.S. corporate headquarters. Source
- Share-based pay rose from exchange offer: Share-based compensation in G&A rose $17.5 million, which the company primarily attributed to the Priovant Exchange Offer. Source
- Retention award expense ended: Personnel-related expense fell $5.3 million, mainly because one-time cash retention awards under the Cash Bonus Program concluded. Source
Cash, investments and financing
- Cash and securities total $4.5 billion: Consolidated cash, cash equivalents, restricted cash and marketable securities were about $4.5 billion at December 31, 2025, up from $4.4 billion at September 30, 2025. Source
- Marketable securities rose, cash fell: Cash and restricted cash were $1.49 billion and marketable securities were $3.05 billion at December 31, 2025, against $2.73 billion and $2.17 billion at March 31, 2025. Source
- Immunovant raised about $550 million: A financing led by Roivant, with key institutional investors, brought gross proceeds to Immunovant of approximately $550 million. Source
Genevant LNP litigation
- Favorable Moderna summary judgment ruling: A summary judgment decision in the U.S. Moderna case affirmed Genevant’s view on section 1498, placing most liability in the current case against Moderna. Source
- Pfizer/BioNTech discovery and hearings: International hearings are expected in the first half of 2026, and the Pfizer/BioNTech case remains in discovery. Source
Strategy and leadership view
- CEO calls 2025 transformative: The CEO described 2025 as a transformative year, driven by clinical execution and its resulting data. Source
- Pipeline built through separate subsidiaries: The company advances its pipeline through subsidiaries it calls Vants, which develop and commercialize its medicines and technologies. It also incubates discovery-stage and health technology companies. Source
- 2026 expected to bring further readouts: The CEO said the company enters 2026 with early momentum across its late-stage pipeline and expects another year of progress. Source
Coming up, as management said on 6 February 2026
- Jury trial in U.S. Moderna case: The jury trial in the U.S. Moderna LNP case is scheduled for March 2026. Source
- International LNP hearings: First major hearings in international LNP proceedings are expected in the first half of calendar year 2026. Source
- Batoclimab thyroid eye disease topline: Topline data from both batoclimab Phase 3 thyroid eye disease studies are expected in the first half of calendar year 2026. Source
- Sarcoidosis Phase 3 study start: Priovant plans a Phase 3 study in cutaneous sarcoidosis starting in calendar year 2026, following FDA engagement. Source
Figures management reported
| Figure | Reported |
|---|---|
| R&D expenses (GAAP), quarter Source | $165.4 million |
| Non-GAAP R&D expenses, quarter Source | $146.7 million |
| Trial readout: brepocitinib Phase 2, cutaneous sarcoidosis Source | Positive; 22.3-point mean CSAMI-A improvement at Week 16 for 45 mg versus 0.7 for placebo |
| Regulatory submission: brepocitinib NDA, dermatomyositis Source | Submitted |
| Trial enrollment: IMVT-1402 difficult-to-treat rheumatoid arthritis, potentially registrational trial Source | Fully enrolled |
Risks management discussed
- Regulatory: The planned sarcoidosis Phase 3 study depends on engagement with the FDA before it starts in calendar year 2026. Source
- External: The U.S. Moderna jury trial is scheduled for March 2026, and international LNP proceedings are at an early stage, so the litigation outcome remains open. Source
- Operational: The company recorded an impairment tied to relocating its U.S. corporate headquarters during the quarter. Source
- Financial: Loss from continuing operations was $313.7 million for the quarter, compared with $208.9 million a year earlier. Source
Earlier plans management reported on
- On track: Management said all other IMVT-1402 timelines across announced indications remain on track. Source
- Not stated: The prior release planned this filing for the first half of 2026. The current release says the NDA was submitted.
- Not stated: The prior release said topline results from both TED studies would be shared together in the first half of 2026. The current release repeats that timing.
Other quarters
Summarised with AI from the documents the company filed with the SEC. Every point is checked against the filing before it is shown: management’s own words word for word, figures against the line or table row they come from. A point that fails the check is left out. Source opens the filing at that line.