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Roivant Sciences Ltd. (ROIV)·Q4 2025 Earnings Summary

Executive Summary

  • Q4 FY2025 delivered minimal revenue ($7.57M) and a larger GAAP continuing EPS loss (-$0.29), while non-GAAP opex stayed comparatively stable; R&D rose on anti-FcRn and mosliciguat program spend, and G&A rose on share-based comp tied to the 2024 program .
  • Versus S&P Global consensus, revenue and EPS were mixed: Q4 revenue missed materially, while Q3 EPS was a modest beat and Q2 EPS was slightly worse than estimates (see Estimates Context). The company emphasized its development-stage profile and pipeline-driven cash utilization *.
  • Cash, cash equivalents, restricted cash, and marketable securities were $4.9B at March 31, 2025, and Roivant had repurchased $1.3B of shares, reducing outstanding shares by 14% YoY—supporting runway “into profitability” and ongoing capital return .
  • Near-term catalysts are predominantly clinical: brepocitinib dermatomyositis Phase 3 topline in H2 2025, TED topline for batoclimab in H2 2025, and multiple IMVT‑1402 programs initiating or enrolling; management hosted/announced investor education and maintained timelines, with litigation milestones (Moderna/Pfizer) progressing .

What Went Well and What Went Wrong

What Went Well

  • “I am incredibly proud of the progress we reported... Continued broad development of brepocitinib, positive data from our myasthenia gravis study, and expansion of IMVT‑1402 into new indications...” (CEO) .
  • Strong capital position and disciplined allocation: “Set up... to capitalize Roivant to profitability... just under $5 billion in cash... already repurchased $1.3 billion... reduced share count by not quite 15%” .
  • Clinical execution and pipeline breadth: five potentially registrational studies for IMVT‑1402, ongoing brepocitinib programs in DM/NIU/CS, and mosliciguat PH-ILD Phase 2 enrolling .

What Went Wrong

  • Higher GAAP opex and deeper loss: R&D +$37.7M YoY to $145.2M; G&A +$39.0M YoY to $147.1M—driven by program costs, personnel, and share-based compensation; Loss from continuing operations widened to $(252.4)M in Q4 .
  • Minimal revenue ($7.57M) amid development-stage portfolio, limiting margin optics and creating headline misses versus consensus revenue in Q4 *.
  • Ongoing litigation timing uncertainty: case narrowing and summary judgment phases continue; court indicated timing updates for Moderna case (trial dates subject to change) .

Financial Results

Core P&L Trends (Quarterly)

MetricQ2 2025Q3 2025Q4 2025
Revenue ($USD Millions)$4.48 $9.02 $7.57
EPS – Continuing Ops, Basic ($USD)$(0.25) $(0.22) $(0.29)
Loss from Operations ($USD Millions)$(341.71) $(274.38) $(284.97)
R&D Expense ($USD Millions)$143.07 $141.60 $145.24
G&A Expense ($USD Millions)$202.88 $141.55 $147.09

Non-GAAP Opex (Quarterly)

MetricQ2 2025Q3 2025Q4 2025
R&D – Non-GAAP ($USD Millions)$132.44 $131.18 $135.14
G&A – Non-GAAP ($USD Millions)$142.34 $71.08 $72.32

Balance Sheet Snapshot

MetricQ2 2025 (9/30/24)Q3 2025 (12/31/24)Q4 2025 (3/31/25)
Cash, Cash Equivalents & Restricted Cash ($USD Millions)$1,969.91 $2,001.67 $2,725.66
Marketable Securities ($USD Millions)$3,428.02 $3,155.83 $2,171.48
Total Assets ($USD Millions)$6,206.03 $5,792.35 $5,436.94
Total Shareholders’ Equity ($USD Millions)$5,580.04 $5,535.97 $5,187.20

Actuals vs S&P Global Consensus

MetricQ2 2025Q3 2025Q4 2025
Revenue – Actual ($USD)$4,475,000 $9,018,000 $7,570,000
Revenue – Consensus ($USD)$55,377,760*$9,200,600*$62,167,220*
Primary EPS – Actual ($USD)$(0.25) $(0.22) $(0.29)
Primary EPS – Consensus ($USD)$(0.24746)*$(0.28495)*$(0.21600)*
EBITDA – Actual ($USD)$(331,298,000)*$(261,538,000)*$(357,001,000)*
EBITDA – Consensus ($USD)$(130,367,410)*$(306,000,000)*$(218,000,000)*

Values retrieved from S&P Global.*

Q4 YoY (Selected)

MetricQ4 2024Q4 2025
Revenue ($USD Millions)$9.02 $7.57
R&D Expense ($USD Millions)$107.56 $145.24
G&A Expense ($USD Millions)$108.10 $147.09
Loss from Continuing Ops, Net ($USD Millions)$(94.96) $(252.38)

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Brepocitinib DM toplineH2 2025“H2 2025” “H2 2025” Maintained
Brepocitinib NIU toplineH1 2027“H1 2027” “H1 2027” Maintained
Brepocitinib CS toplineH2 2026“H2 2026” “H2 2026” Maintained
Batoclimab MG toplineBy 3/31/2025“By 3/31/2025” Positive topline announced Mar 2025 Completed
Batoclimab CIDP Period 1By 3/31/2025“By 3/31/2025” Initial results announced Mar 2025 Completed
Batoclimab TED toplineH2 2025“H2 2025” “H2 2025” Maintained
IMVT‑1402 Sjögren’s trial startSummer 2025“IND cleared; trial expected summer 2025” “Trial expected to initiate in summer 2025” Maintained
IMVT‑1402 second GD trial startSummer 2025First GD trial initiated Second GD trial to start summer 2025 Raised (expanded)
Cash runwayN/ANot explicitly stated prior“Runway into profitability” New
Share repurchasesOngoing$754M cumul. through 9/30/24 $1.3B repurchased by 3/31/25 Increased
Moderna case timeline2025“Summary judgment across Q2–Q3 2025; trial Sep 2025” Court to update timing; first trials in 2026 in certain jurisdictions Timing updated/uncertain

Earnings Call Themes & Trends

TopicPrevious Mentions (Q2 & Q3)Current Period (Q4 2025)Trend
Brepocitinib (DM)Emphasized H2 2025 topline; NIU Phase 3 enrolling; CS program initiation Success criteria: statistically significant TIS separation; June 17 investor education event; placebo arm expectations Execution steady; increased pre-readout education
FcRn/IMVT‑1402INDs cleared; deeper IgG→better outcomes hypothesis introduced “Settling the deeper-is-better debate”; multiple potentially registrational trials; 600mg CIDP dose; device/form factor Confidence strengthened; program expansion
CIDP trial designNoted evolving designs, patient selection focus No washout, direct placebo control aligned with FDA preferences; patient-friendly approach Modernized design; enrollment practicalities
Capital allocation$5.4B cash; buybacks ongoing “Capitalize to profitability,” ~just under $5B cash; $1.3B buybacks Continued discipline; larger buybacks
Litigation (Moderna/Pfizer)Markman hearing (Pfizer) and summary judgment (Moderna) timelines Case narrowing; summary judgment next; court updating timing; international suits filed Progressing; timing adjustments
Pricing strategyLimited prior detailFlexibility across orphan/prevalent indications; benchmark bands consistent with FcRn pricing Strategy articulated

Management Commentary

  • “We are set up… to capitalize Roivant to profitability… with just under $5 billion in cash… [and] repurchased already $1.3 billion… reduced our share count by not quite 15%” .
  • “We really think we have a tiger by the tail in IMVT‑1402… up to ~80% IgG lowering… favorable safety profile… a market‑proven auto‑injector” .
  • “This is really the beginning of a pretty stacked 36 months… multiple launches in potential blockbuster indications… excited for DM as the first domino” .
  • “We remain focused on building value in our late-stage clinical pipeline, and on continued discipline on capital allocation across the portfolio” .

Q&A Highlights

  • DM win criteria and placebo arm: Management reiterated success as statistical separation on TIS; highlighted mandatory steroid taper and protocol adherence to mitigate placebo variability .
  • LNP litigation: Normal pre‑trial narrowing with judge and counterparties; summary judgment forthcoming; timing updates possible; emphasized presenting the cleanest case .
  • CIDP registrational design: No washout; focus on direct placebo control; field’s improved patient selection enables patient‑friendly set‑up; powered around high efficacy goals; 600mg dose chosen to maximize deep IgG suppression .
  • Pricing approach: Flexibility across indications with bands compatible with current FcRn pricing; ultimate decisions depend on launch order and data (e.g., Graves’ remission) .
  • Capital return: ~$200M remaining under current authorization; management will reassess post‑completion in context of market and balance sheet .

Estimates Context

  • Q4 2025: Revenue $7.57M vs $62.17M consensus (miss); Primary EPS $(0.29) vs $(0.216) consensus (miss)* .
  • Q3 2025: Revenue $9.02M vs $9.20M consensus (in line/slight miss); Primary EPS $(0.22) vs $(0.285) consensus (beat)* .
  • Q2 2025: Revenue $4.48M vs $55.38M consensus (miss); Primary EPS $(0.25) vs $(0.247) consensus (slightly worse)* .

Values retrieved from S&P Global.*

Where estimates may adjust: Given clinical milestones upheld and opex drivers called out (share-based comp, program costs), consensus should reflect ongoing development-stage revenue profile and non-GAAP opex cadence (R&D $135.1M non-GAAP; G&A $72.3M non-GAAP in Q4) for forward quarters .

Key Takeaways for Investors

  • Near-term binary readouts (brepocitinib DM H2’25; batoclimab TED H2’25) are the principal stock drivers; management is proactively educating the market ahead of DM .
  • Capital strength and buybacks provide downside support; $4.9B liquidity and $1.3B repurchases reduce share count, enabling opportunistic BD and late‑stage funding .
  • IMVT‑1402 strategy centers on deep IgG suppression with patient‑friendly auto‑injector; expect expanding indication footprint and registrational progression (Graves, CIDP, SjD, RA) .
  • Updated CIDP trial design (no washout, direct placebo) may enhance enrollment quality and patient experience—positioning the program well relative to legacy designs .
  • Monitor litigation milestones (Moderna/Pfizer) for optionality; timing updates introduce uncertainty but potential value realization persists .
  • Expect continued non-GAAP opex discipline (R&D/G&A) as programs advance; share-based comp and program-specific costs remain key drivers .
  • Tactical implication: Trading around DM/TED readouts; medium-term thesis: multi‑asset immunology platform (brepocitinib, IMVT‑1402) with robust capital to fund launches and pipeline growth .