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Roivant Sciences Ltd. (ROIV)·Q1 2026 Earnings Summary

Executive Summary

  • Q1 2026 was operationally “quiet” with focus on clinical execution and near-term catalysts; GAAP revenue was $2.17M, GAAP diluted EPS from continuing operations was -$0.33, and adjusted loss from continuing operations was $170.1M .
  • Management reiterated imminent Phase 3 dermatomyositis (DM) topline for brepocitinib in 2H 2025 and strong progress across the FcRn (IMVT-1402) franchise (Graves’, Sjögren’s, MG, CIDP), positioning for multiple potential launches over the next 24–36 months .
  • Balance sheet remains robust: $4.5B in consolidated cash, equivalents, restricted cash and marketable securities; completed $1.5B buyback (including $208M in Q1) and authorized an additional $500M repurchase program .
  • Near-term stock catalysts: DM Phase 3 readout (2H 2025), Graves’ remission data from batoclimab (ATA, September), and LNP litigation summary judgment decisions in fall ahead of a U.S. jury trial scheduled for March 2026 .

What Went Well and What Went Wrong

What Went Well

  • Continued clinical execution: brepocitinib DM VALOR reached last patient, last visit in July; NIU Phase 3 and cutaneous sarcoidosis (CS) PoC are enrolling toward 2026–2027 readouts .
  • FcRn portfolio expansion: initiated potentially registrational IMVT-1402 trials in Graves’ and Sjögren’s in June; all six indications remain on track .
  • Capital allocation: completed $1.5B buyback, reduced share count >15% since Mar 31, 2024; board approved new $500M program. “We repurchased just under 150,000,000 shares at an average price of just over $10” .

What Went Wrong

  • GAAP revenue declined to $2.17M and GAAP diluted EPS from continuing operations was -$0.33; loss from continuing operations was $273.9M, reflecting higher R&D and G&A (share-based comp) versus prior year .
  • R&D increased to $152.9M (non-GAAP $141.0M), driven by anti-FcRn and mosliciguat program costs; G&A rose to $134.0M (non-GAAP $62.6M) primarily from higher share-based comp tied to 2024 executive awards .
  • LNP litigation remains an overhang; summary judgment motions filed and case reassigned to a new judge; timeline extends to March 2026 jury trial, adding legal uncertainty into 2026 .

Financial Results

MetricQ3 2025 (Dec 31, 2024)Q4 2025 (Mar 31, 2025)Q1 2026 (Jun 30, 2025)
Revenue ($USD Millions)$9.018 $7.570 $2.170
R&D Expense ($USD Millions)$141.595 $145.238 $152.919
G&A Expense ($USD Millions)$141.545 $147.092 $134.019
Total Operating Expenses ($USD Millions)$283.399 $292.535 $287.092
Loss from Continuing Ops, Net ($USD Millions)$208.945 $252.375 $273.911
Diluted EPS – Continuing Ops ($USD)-$0.22 -$0.29 -$0.33
Adjusted Loss from Continuing Ops (Non-GAAP, $USD Millions)$143.682 $154.399 $170.124

Balance sheet (selected):

MetricQ4 2025 (Mar 31, 2025)Q1 2026 (Jun 30, 2025)
Cash, Cash Equivalents & Restricted Cash ($USD Millions)$2,725.661 $1,248.609
Marketable Securities ($USD Millions)$2,171.480 $3,264.692
Total Assets ($USD Millions)$5,436.940 $5,032.602
Total Shareholders’ Equity ($USD Millions)$5,187.198 $4,815.906

Consensus vs actual (S&P Global)*:

MetricConsensus (Q1 2026)Actual (Q1 2026)
Primary EPS Consensus Mean ($)-$0.261-$0.250
Revenue Consensus Mean ($USD Millions)$6.915$2.170
EBITDA Consensus Mean ($USD Millions)-$305.000-$277.524
*Values retrieved from S&P Global. Note: Company-reported GAAP diluted EPS from continuing operations was -$0.33 .

KPIs:

KPIQ1 2026
Share Repurchases in Quarter ($USD Millions)$208
Basic Weighted Avg Shares Outstanding680,286,922
Consolidated Cash + Marketable Securities ($USD Billions)$4.5

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Brepocitinib DM Phase 3 Topline2H 20252H 20252H 2025Maintained
Brepocitinib NIU Phase 3 Topline1H 20271H 20271H 2027Maintained
Brepocitinib CS PoC Topline2H 20262H 20262H 2026Maintained
Batoclimab Graves’ Remission DataSept 2025 (ATA)Summer/Fall 2025Sept 2025Narrowed/timed
IMVT-1402 Trials (GD, SjD)Initiated June 2025Summer 2025 startInitiated June 2025Executed
Share Repurchase AuthorizationOngoing$1.5B programCompleted; new $500M approvedReset higher
LNP Litigation (Moderna)Summary judgment; trial timingSJ in Q3/Q4 2025; trial Sept 2025SJ fall 2025; U.S. jury trial Mar 2026Updated schedule

Earnings Call Themes & Trends

TopicPrevious Mentions (Q3 2025, Q4 2025)Current Period (Q1 2026)Trend
Brepocitinib DM (VALOR)Fully enrolled; investor event planned; “positive study” bar is stat sig on TIS Last patient/visit complete; steroid taper success; top-line imminent; oral-first positioning Execution to readout; confidence building
FcRn (IMVT-1402) expansion6 INDs; prioritizing first/best-in-class indications (Graves’, DGTRA, SjD, MG, CIDP, CLE) Initiated GD and SjD trials; strong enrollment; deeper IgG strategy emphasized Pipeline advancing across indications
Graves’ remission6-month remission data expected summer/ATA; KOL interest even for modest remission “Any meaningful remission is practice-changing”; drives enrollment and enthusiasm Heightened importance as commercial signal
LNP litigationSummary judgment phase; international cases filed; trial initially targeted 2H 2025 Summary judgment rulings expected fall; U.S. trial set for Mar 2026; new judge assigned Extended timeline; continued legal focus
Capital allocation~$1.3B buybacks as of Mar 31, 2025; cash ~$4.9B Completed $1.5B buybacks; new $500M authorization; cash + securities $4.5B Ongoing returns; opportunistic stance
Pulmovant (mosliciguat)PH-ILD Phase 2 ongoing; platform PK/lung deposition published Japan ODD granted; ERS poster; Phase 2 PHocus ongoing Gradual clinical/regulatory progress

Management Commentary

  • “It is a relatively quiet quarter before [a] very busy fall… three main themes… IVT-1402 and Immunovant; registrational dermatomyositis data from brepcitinib… and… LNP litigation” .
  • “We completed the $1,000,000,000… share repurchase program… repurchased just under 150,000,000 shares at an average price of just over $10… [then] authorized additional $500,000,000” .
  • Financials: “Adjusted… net loss of 170,000,000… $4,500,000,000 of cash as of June 30, no debt, and a significantly reduced share count” .
  • On DM trial bar: “We think… a simple stat sig trial on TIS is the bar for efficacy” .
  • On Graves’ remission: “Any amount of meaningful remission would be practice-changing… good data here would be helpful for… enrollment” .

Q&A Highlights

  • DM steroid taper/rescue: Protocol mandates consistent taper; designed to mitigate TIS variability; 98% achieved taper by week 36; risk of placebo imbalance acknowledged but mitigated .
  • Graves’ dosing and trial design: Lower dose arm included to ensure minimally efficacious dose approvability; trials structured to capture proptosis signals and durability .
  • BD strategy: Balance sheet supports opportunistic late-stage deals; China assets considered given quality/valuation; focus on mechanisms enabling creative development (FcRn, JAK1/TYK2) .
  • IMVT-1402 enrollment/spend: Enrollment “on track” across registrational programs; R&D ramps with multiple Phase 3s; cash runway comfortable to Graves’ data .
  • Competitive positioning in DM: Oral, first-to-market differentiation vs IVIG and injectables; physician familiarity with JAKs supports adoption .

Estimates Context

  • Q1 2026 results vs consensus (S&P Global)*: EPS beat (Primary EPS -$0.25 vs -$0.26), EBITDA beat (-$277.5M vs -$305.0M), but revenue missed ($2.17M vs $6.92M). Primary EPS differs from reported GAAP diluted EPS (-$0.33) due to definition; investors should anchor comparisons accordingly .
    *Values retrieved from S&P Global.

Key Takeaways for Investors

  • Near-term catalysts cluster: brepocitinib DM Phase 3 readout in 2H 2025; Graves’ remission signal at ATA in September; these can reset the commercial narrative and drive the stock into data .
  • FcRn franchise is broadening with multiple registrational tracks; deeper IgG reduction strategy continues to correlate with better outcomes, supporting IMVT-1402 differentiation .
  • Capital returns continue alongside pipeline expansion; $4.5B liquidity enables both opportunistic BD and share repurchases as volatility persists .
  • Legal overhang persists but is scheduled; summary judgments this fall and U.S. jury trial in March 2026 frame potential resolution and optionality .
  • Financials show investment phase: rising R&D tied to registrational activity; monitor non-GAAP loss trajectory and operating expense discipline as trials scale .
  • For trading: anticipate headline volatility around DM topline and ATA Graves’ remission; oral-first position in DM and any remission signal in Graves’ are likely positive skew catalysts .
  • Medium term: stacking indications (DM → NIU → Graves’/MG/CIDP/SjD) could transition Roivant to a multi-asset commercial story over 24–36 months .