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Roivant Sciences Ltd. (ROIV)·Q2 2026 Earnings Summary

Executive Summary

  • Q2 FY2026 delivered a pivotal clinical and strategic quarter: brepocitinib’s Phase 3 VALOR trial in dermatomyositis hit the primary and all nine ranked secondary endpoints, with an NDA planned in 1H 2026 . Immunovant unveiled six‑month off‑treatment remission data in uncontrolled Graves’ disease, showing 17/21 responders at week 48 and 8/17 off all ATDs, underscoring potential disease modification .
  • Financially, revenue was $1.571M and diluted EPS from continuing operations was $(0.17); the company ended the quarter with $4.4B in cash, restricted cash, and marketable securities, supporting runway into profitability .
  • Versus Wall Street: EPS beat consensus by ~$0.06 (actual $(0.2758) vs $(0.3342)) and revenue missed materially ($1.571M vs $6.303M), reflecting limited near‑term revenue given Roivant’s late‑stage pipeline focus [*].
  • Management highlighted upcoming catalysts: NDA filing for brepocitinib (DM) in 1H 2026, TED data now planned to be released concurrently for both Phase 3 trials in 1H 2026, and an Investor Day on Dec 11, 2025 .

What Went Well and What Went Wrong

What Went Well

  • Brepocitinib VALOR success: 30 mg achieved mean TIS 46.5 vs 31.2 for placebo (p=0.0006), with significant steroid‑sparing; >2/3 achieved TIS≥40 and nearly half achieved TIS≥60 .
  • Graves’ disease remission durability: 17/21 off‑drug responders at six months, with ~50% ATD‑free remission; TRAb reductions persisted off treatment, supporting potential disease modification .
  • Capital position and execution: $4.4B consolidated liquidity and continued R&D progress across IMVT‑1402 and mosliciguat; management emphasized a strong runway to profitability .

“Not at all a quiet quarter for us… the brepocitinib data in DM putting us on a new and exciting trajectory… further supported by Immunovant's remission data in Graves’ disease” — Matt Gline, CEO .

What Went Wrong

  • Revenue under consensus and sequential decline: $1.571M vs $2.170M prior quarter; material miss vs consensus ($6.303M*), consistent with pre‑commercial profile [*].
  • Ongoing litigation introduces uncertainty: Moderna/Pfizer LNP litigation timelines remain subject to judicial scheduling; management avoided detailed timing commentary .
  • TED communication timing adjusted: initial plan to share first TED topline in 2H 2025 shifted to concurrent release of both TED trial toplines in 1H 2026 due to evolving competitive dynamics (a delay) .

Financial Results

Sequential P&L Trend (oldest → newest)

MetricQ4 FY2025Q1 FY2026Q2 FY2026
Revenue ($USD Thousands)$7,570 $2,170 $1,571
Diluted EPS from Continuing Ops ($USD)$(0.29) $(0.33) $(0.17)
Loss from Continuing Ops, Net ($USD Thousands)$(252,375) $(273,911) $(166,039)

YoY Comparison

MetricQ2 FY2025Q2 FY2026
Revenue ($USD Thousands)$4,475 $1,571
Diluted EPS from Continuing Ops ($USD)$(0.25) $(0.17)
GAAP G&A ($USD Thousands)$202,881 $143,125
GAAP R&D ($USD Thousands)$143,073 $164,568

Actual vs Wall Street Consensus (Q2 FY2026)

MetricActualConsensus
Revenue ($USD Thousands)$1,571 $6,303*
Primary EPS (GAAP) ($USD)$(0.2758)*$(0.3342)*

Values marked with * retrieved from S&P Global.

Operating Expense Detail

Metric ($USD Thousands)Q4 FY2025Q1 FY2026Q2 FY2026
GAAP R&D$145,238 $152,919 $164,568
Non‑GAAP R&D$135,140 $141,034 $152,896
GAAP G&A$147,092 $134,019 $143,125
Non‑GAAP G&A$72,320 $62,628 $72,054

KPIs / Balance Sheet

KPI ($USD Thousands)Q4 FY2025Q1 FY2026Q2 FY2026
Cash, Cash Equivalents & Restricted Cash$2,725,661 $1,248,609 $1,247,160
Marketable Securities$2,171,480 $3,264,692 $3,148,825
Total Assets$5,436,940 $5,032,602 $5,062,598
Total Shareholders’ Equity$5,187,198 $4,815,906 $4,805,458

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Brepocitinib (DM) NDA filing1H 2026File in 1H 2026 File in 1H 2026 Maintained
Brepocitinib (NIU) Phase 3 topline1H 20271H 2027 1H 2027 Maintained
Brepocitinib (CS) POC topline2H 20262H 2026 2H 2026 Maintained
Batoclimab TED toplines2H 2025Report first study in 2H 2025 Report both studies concurrently in 1H 2026 Lowered/Delayed
Cash runwayN/A“Into profitability” “Into profitability” Maintained
Share repurchase authorizationN/ANew $500M approved (June 2025) $500M authorized remains in place Maintained

Earnings Call Themes & Trends

TopicQ-2 (Q4 FY2025)Q-1 (Q1 FY2026)Current (Q2 FY2026)Trend
Brepocitinib DMFully enrolled; DM readout expected 2H 2025 Last patient last visit completed; readout 2H 2025 VALOR positive across endpoints; NDA 1H 2026 Strongly positive, moving to filing
FcRn programs (Graves’, MG, CIDP, SjD)Broad expansion plans; positive batoclimab MG/CIDP data IMVT‑1402 registrational starts in GD/SjD Off‑drug remission in GD; registrational trials ongoing; heightened competitive focus Momentum with validation, competitive intensity rising
LNP litigation (Moderna, Pfizer)Expanded international suits; trials expected 2026 Summary judgment ongoing; March 2026 US trial Favorable Markman in Pfizer; scheduling next steps; March 2026 Moderna trial Progressing toward trials
Capital allocation$1.3B buybacks; strong liquidity Completed $1.5B; new $500M authorization $4.4B liquidity; buybacks noted Consistent discipline
Pulmovant (mosliciguat)N/APhase 2 PH‑ILD ongoing Japan ODD; Phase 2 PHocus underway Building optionality

Management Commentary

  • “Valor succeeded with really highly significant, robust, and consistent data… sets us up for 30 milligrams to be the optimal dose here.” — Matt Gline, CEO .
  • “We are going to hold off reporting the top‑line data from [first TED study]… until we see the top‑line data for the second study in the first half of next year.” .
  • “Our capital position remains very strong with $4.4 billion… expected to carry us through profitability.” .
  • “Argenx… validating of our strategy that they're following in our footsteps… deeper IgG reductions… competitive profile.” .

Q&A Highlights

  • Litigation timelines: Watch for Pfizer case scheduling and trial date; Moderna US trial currently set for March 2026; management framed 1498 scope as a fraction of total damages at issue .
  • Competitive landscape in Graves’/TED: FcRn mechanism highlighted as well‑suited with safety/tolerability; intent to present both TED toplines together amid evolving competition .
  • Pulmovant translation risk: Cautiously optimistic PVR translation from PAH to PH‑ILD; inhaled format aims to mitigate V/Q mismatch concerns .
  • DM launch cadence: No specific analogs; focus on cautious guidance and building long‑term penetration in a high unmet‑need market .

Estimates Context

  • Q2 FY2026 EPS: Beat consensus (actual $(0.2758) vs $(0.3342)) [].
  • Q2 FY2026 Revenue: Miss consensus ($1.571M vs $6.303M*) [*].
  • Implication: Consensus models likely need to reflect ongoing pre‑commercial revenue profile and emphasize milestone timing (DM NDA and 2026/2027 readouts) .

Values marked with * retrieved from S&P Global.

Key Takeaways for Investors

  • Brepocitinib’s best‑in‑class data in DM and steroid‑sparing profile position it for a compelling first oral launch; NDA in 1H 2026 is a key stock catalyst .
  • Graves’ remission durability off drug and ATD‑free outcomes de‑risk IMVT‑1402’s registrational program and underpin a potentially large market opportunity; watch 2027 toplines .
  • Near‑term revenue remains minimal; investment case hinges on clinical/regulatory execution and the December Investor Day narrative setting commercial expectations .
  • TED topline communication shift to 1H 2026 reduces near‑term headline risk, but aligns with competitive positioning; monitor class dynamics and safety profiles .
  • Strong $4.4B liquidity and ongoing buyback authorization support capital flexibility through profitability, mitigating financing risk .
  • Litigation outcomes are non‑core but potentially value‑enhancing; key dates into 2026 can drive optionality; avoid over‑weighting binary outcomes .
  • Pulmovant ODD in Japan and PH‑ILD Phase 2 progress broaden pipeline optionality beyond autoimmunity; PHocus data in 2H 2026 is another potential swing factor .

Notes:

  • Segment breakdown: Not applicable; Roivant reports consolidated results and program updates rather than revenue segments .
  • Non‑GAAP adjustments materially affect OpEx comparability; we anchored on GAAP and reconciled non‑GAAP as disclosed .