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    ROIV
    Earnings call· Mar 2026(Q4 FY26)

    Roivant Sciences Q4 FY26 earnings call ROIV

    May 20, 2026 Source

    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

    8
    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

    Operational metrics

    27
    Cash and cash equivalents
    $4.3Bbefore Moderna settlement
    Q4 FY26

    Cash and cash equivalents balance prior to the Moderna settlement.

    Moderna settlement
    $2.25B
    FY26

    Total value of the settlement with Moderna.

    Moderna settlement upfront payment
    $950M
    Q1 FY27

    Upfront payment expected from the Moderna settlement.

    DTRA study evaluable patients
    165
    Q4 FY26

    Number of evaluable patients in the IMVT-1402 DTRA study.

    DTRA study JAK inhibitor experienced patients
    65%
    Q4 FY26

    65% of these patients roughly have failed specifically JAK inhibitors. And notably... basically every single one of the patients who fail the JAK inhibitor also failed the TNF.

    IMVT-1402 ACR20 response rate
    73%
    Week 16

    We saw 73% of patients roughly with ACR20 responses

    IMVT-1402 ACR50 response rate
    over half
    Week 16

    we saw quite deep responses. We saw over half of patients with the ACR50

    IMVT-1402 ACR70 response rate
    over 1/3
    Week 16

    and over 1/3 of patients with an ACR70.

    IMVT-1402 ACR20 response rate in JAK-experienced subset
    basically fully preserved
    Week 16

    one of the things that I think is maybe most exciting about this data is it's basically fully preserved in that subset.

    DTRA patient population size
    85,000 or higherrevised from 70,000
    Future

    Immunovant has now done that looks like that number could be 85,000 or higher.

    Mosliciguat PVR reduction
    38%mean peak
    Phase I

    mean peak PVR reduction of approximately 38%.

    Mosliciguat PVR reduction
    greater than 30%mean
    Phase I

    mean PVR reduction of greater than 30%

    Mosliciguat mPAP reduction
    up to 20%mean
    Phase I

    mean reduction in NPAT of up to 20%

    Mosliciguat cardiac output increase
    up to 25%mean
    Phase I

    mean increase in cardiac output of up to 25%.

    Mosliciguat FOCUS study enrollment
    135targeting 120 patients
    Q4 FY26

    We ended enrollment with 135 patients.

    Mosliciguat FOCUS study max dose achievement
    over 95%
    Q4 FY26

    the vast majority, over 95% of our patients achieving that 4-milligram dose

    Mosliciguat FOCUS study baseline mean PVR
    7.1
    Baseline

    Our mean TVR came in at 7.1 Wood units

    Mosliciguat FOCUS study baseline mean pulmonary arterial pressures
    39.3%
    Baseline

    Mean pulmonary arterial pressures of 39.3%

    PH-ILD patient population
    approximately 200,000
    Current

    up to approximately 200,000 patients in the U.S. and Europe

    PH-ILD median survival
    less than 5 years
    Current

    less than a 5-year median survival

    PAH market aggregate sales
    $100B
    Current

    revenue in the PAH market has really reached a stellar level at $100 billion in aggregate sales

    PAH market annual sales
    $7B
    Current

    and a robust $7 billion per year

    PAH patients initiating dual therapy
    over 40%
    Current

    over 40% of patients with PAH initiate their treatment with dual therapy

    PAH patients adding third therapy
    15%
    Annual

    and 15% of these patients will add a third therapy by the end of the year.

    Dermatomyositis addressable patients
    close to 300,000
    Current

    possibly close to 300,000 patients addressable by the existing indications

    Dermatomyositis patients on steroids
    75%
    Current

    75% of these patients are on principally steroids

    LPP patient population
    probably 100,000
    Current

    There's probably 100,000 or so such patients in the U.S.

    Industry KPIs

    4
    MetricValueDetails
    Pipeline read out calendarMultiple readouts and initiations
    Regulatory approvals filingsBrepocitinib Breakthrough Therapy Designation
    Clinical trial efficacy safety dataIMVT-1402 DTRA study: 73% ACR20, >50% ACR50, >33% ACR70%
    Collaboration milestone royalty revenue$2.25 billionUSD

    Deals & partnerships

    1
    ModernaSettlement of patent litigation$2.25 billion

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

    Risks & headwinds

    4
    Bitokamab studies in TED failedEarlier 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 meaningfulOngoing

    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-valueH2 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 dermatomyositisOngoing, 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

    5

    Brepocitinib launch in dermatomyositis

    by end of September
    CurrentCommercial prep underway
    TargetLaunch

    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.

    Q&A highlights

    6

    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 read6 chapters

    Detailed Narrative

    01

    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.

    02

    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.

    03

    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.

    04

    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.

    05

    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.

    06

    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.

    AI-generated summary of the company’s earnings call. Not investment advice.