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Roivant (ROIV) Q4 FY26 earnings call: guidance and Q&A

Earnings call· Mar 2026 (Q4 FY26)· May 20, 2026

Source: earnings call transcript

Executive summary

Roivant Q4 FY26 — Strong Clinical Data & Financial Position

Roivant delivered a quarter of significant clinical and financial milestones, highlighted by unexpectedly strong open-label data for IMVT-1402 in refractory rheumatoid arthritis and the substantial Moderna settlement. The company is advancing its pipeline with brepocitinib's imminent launch and mosliciguat's Phase II data readout, while navigating the complexities of trial design and regulatory discussions for its diverse portfolio.

Highlights

5

  • IMVT-1402 showed clinically meaningful responses in DTRA study with 73% ACR20, over 50% ACR50, and over 33% ACR70 responses in heavily refractory RA patients.

  • Brepocitinib received Breakthrough Therapy Designation for cutaneous sarcoidosis and is on track for launch in dermatomyositis by end of September.

  • Moderna settlement of $2.25 billion, with $950 million upfront payment expected in July, strengthening the cash position to $4.3 billion.

  • Mosliciguat (mosli) Phase I data showed mean PVR reduction of 38% in PH patients, positioning it as a potential first-in-class inhaled sGC activator.

  • Full enrollment achieved for IMVT-1402 CLE study and mosliciguat PH-ILD study (135 patients).

Concerns

3

  • Bitokamab studies in TED failed, though hyperthyroid patients showed normalization.

  • IMVT-1402 DTRA study's Period 2 (randomized withdrawal) primary endpoint (ACR20 loss) may be less meaningful due to deep ACR50/70 responses, making separation harder.

  • Mosliciguat Phase II study is not powered for 6-minute walk p-value, focusing on PVR, safety, and dosing affirmation.

Guidance & targets

CategoryTargetConfidence
Brepocitinib launch
Launch by end of September
high materiality
High
Brepocitinib Phase III study initiation
Begin this year
medium materiality
High
Brepocitinib NIU Phase III top line data
Back half of this year
medium materiality
High
Mosliciguat Phase IIb top line data
Second half of 2026
high materiality
High
IMVT-1402 DTRA data, analysis, and FDA discussions
Share all of that in the second half of this year
high materiality
High
IMVT-1402 CLE POC top line data
Second half
medium materiality
High
IMVT-1402 Graves' and MG data
Next year
high materiality
High
Moderna settlement upfront payment
$950 million
high materiality
High

Deals & partnerships

Moderna Settlement of patent litigation $2.25 billion

Settlement related to patent litigation, with a total value of $2.25 billion.

Risks & headwinds

Bitokamab studies in TED failed Earlier in this quarter

failure

Mitigation:Hyperthyroid patients showed normalization, supporting ongoing Graves' studies.

IMVT-1402 DTRA Period 2 primary endpoint (ACR20 loss) may be less meaningful Ongoing

paradoxically, I think we still have a good shot of success there. But in some ways, Period 2 was less meaningful than it might otherwise have been.

Mitigation:Focus on patient-level analysis and FDA discussions for path forward.

Mosliciguat Phase II FOCUS study not powered for 6-minute walk p-value H2 2026 data readout

This study is not powered to achieve a p-value on 6-minute walk.

Mitigation:Looking for affirmation of dosing, safety, and PVR, and interesting trends in 6-minute walk data.

Competitive landscape for brepocitinib in dermatomyositis Ongoing, post-launch

will become a more competitive field

Mitigation:Head-down execution on commercial prep, payer engagement, physician community work, specialty pharmacy partnerships, strong commercial team, unbranded patient engagement.

What to watch in Q1 FY27

Brepocitinib launch in dermatomyositis

by end of September
Current Commercial prep underway
Target Launch

Why it matters

Successful launch is crucial for revenue generation and market penetration for a key pipeline asset.

Obviously, one of the most important things we're going on, we will hopefully be launching brepocitinib [indiscernible] by the end of September.

Find out whether ROIV delivers this. Inve re-checks your case every morning.

Q&A highlights

How do 16-week ACR responses compare to typical later-stage reporting, and how might they trend with more time on therapy, impacting the randomized withdrawal phase?

Management stated it's unknown how responses will trend beyond 16 weeks as it's the first time this patient population has been studied this way. They noted that sicker patients generally need more time to improve and that there was nothing in the data to suggest responses were complete at week 16.

“I don't think there was anything specific about the data leading into week 16 that suggested we were done. And I think there's certainly a possibility for continued improvement with therapy over time.”

asked by Corinne Johnson · answered by Matthew Gline

2 min read 6 chapters

Detailed narrative

IMVT-1402 DTRA Study Highlights

The preliminary open-label data from the IMVT-1402 DTRA study in heavily refractory rheumatoid arthritis patients showed unexpectedly strong responses. Patients had failed at least two advanced lines of therapy, including TNF and JAK inhibitors, and had strict autoantibody positivity criteria. The study design included a 16-week open-label active treatment period followed by a 12-week randomized withdrawal.

IMVT-1402 Efficacy and Safety

In the DTRA study, 73% of patients achieved ACR20 responses, over 50% achieved ACR50, and over 33% achieved ACR70. These deep responses are considered clinically meaningful, especially given the lack of significant placebo response at ACR50/70 levels. The efficacy was preserved in the JAK-experienced subset (65% of patients). IMVT-1402 was safe and well-tolerated, with no new safety signals identified across hundreds of patients dosed, including no impact on LDL.

Mosliciguat (mosli) for PH-ILD

Mosli is an inhaled sGC activator delivered directly to the lungs, aiming to address both pulmonary vascular and lung parenchymal diseases in PH-ILD. Phase I data showed a mean PVR reduction of 38% and a mean peak PVR reduction of approximately 38% with a single dose, placing it among the highest reductions seen in the PH treatment space. It was well-tolerated with limited systemic side effects and no significant cough.

Mosliciguat Phase II FOCUS Study Design

The Phase II FOCUS study is a blinded, placebo-controlled, randomized trial targeting 120-135 patients with PH-ILD, carefully selected based on Seventh World Symposium guidelines. The primary endpoint is change from baseline PVR at 16 weeks. The study is not powered for a p-value on 6-minute walk, but will look for trends. Enrollment was completed quickly, with 135 patients, and over 95% reached the maximum 4mg dose.

Brepocitinib Program Updates

Brepocitinib received Breakthrough Therapy Designation for cutaneous sarcoidosis, with a Phase III study expected to begin this year. The LPP study is actively enrolling. Commercial preparations for the dermatomyositis launch by the end of September are underway, including payer engagement, physician community work, and specialty pharmacy partnerships. The Phase III data for dermatomyositis was published in NEJM.

Financial Strength and Capital Allocation

Roivant maintains a strong financial position with $4.3 billion in cash and cash equivalents as of March 31, 2026, prior to the $2.25 billion Moderna settlement ($950 million upfront in July). The company continues to execute share repurchases and has no debt. R&D spend has increased with program scope.

Summary of the company's earnings call; see how call summaries are prepared. Not investment advice.