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Immunovant, Inc. (IMVT)·Q2 2026 Earnings Summary

Executive Summary

  • Q2 FY2026 was execution-heavy: R&D spend rose on IMVT-1402 registrational programs; net loss widened modestly YoY, while cash remains sufficient to fund announced indications through the Graves’ disease (GD) readout expected in 2027 .
  • Clinical timing pivot in TED: while the first of two batoclimab Phase 3 TED studies remains on track to conclude in 2025, management now plans to disclose topline from both studies together in H1 2026 given the evolving competitive landscape—an important narrative shift for the stock .
  • GD durability data: six-month off-treatment remission data in uncontrolled GD (batoclimab) showed ~80% (17/21) maintained normal T3/T4 at Week 48 and ~50% (8/17) were ATD-free—supporting potential disease-modification and strengthening the case for IMVT-1402 in GD .
  • Upcoming catalysts: Dec 11 investor day, 2026 readouts in D2T RA (open-label) and CLE (PoC), and 2027 registrational readouts in GD/MG/D2T RA; these events anchor the medium-term setup .

What Went Well and What Went Wrong

What Went Well

  • Disease-modifying signal in GD: six-month off-treatment remission data from batoclimab showed ~80% maintained normal thyroid function; ~50% achieved ATD‑free remission, reinforcing FcRn’s potential and 1402’s positioning in GD .
  • Pipeline breadth and execution: 1402 in six indications (potentially registrational in GD, MG, CIDP, D2T RA, SjD; PoC in CLE) remained on track; management reiterated multiple 2026/2027 data milestones .
  • Management tone/confidence: “A tremendous moment of transformation for the business,” with excitement to detail the future at investor day; the team emphasized the strength and depth of the late-stage pipeline .

Selected quotes:

  • “Valor succeeded with really highly significant, robust, and consistent data across the primary and all key secondary endpoints…” .
  • “This is a very large patient population with a significant unmet need… we showed real disease-modifying benefit” (GD) .

What Went Wrong

  • TED disclosure timing shifted: topline for the first Phase 3 TED study will be held to report concurrently with the second study in H1 2026 due to competitive dynamics; this defers a potential 2025 data catalyst .
  • Operating intensity rose: R&D expenses increased to $114.2M vs $97.3M YoY on 1402 clinical/CMC and personnel costs, driving a higher quarterly net loss ($126.5M) .
  • Competitive overhang: Management acknowledged intensifying competition in GD and TED (e.g., FcRn entrants and other mechanisms), reinforcing the need to demonstrate best-in-class depth/durability and safety .

Financial Results

Quarterly comparison (oldest → newest):

MetricQ4 FY2025Q1 FY2026Q2 FY2026
Revenue ($USD Millions)$0.0 $0.0 $0.0
R&D Expense ($USD Millions)$93.7 $101.2 $114.2
G&A Expense ($USD Millions)$20.2 $26.0 $17.5
Total Operating Expenses ($USD Millions)$113.8 $127.2 $131.8
Net Loss ($USD Millions)$106.4 $120.6 $126.5
Diluted EPS ($)$(0.64) $(0.71) $(0.73)
Cash & Equivalents (period-end, $USD Millions)$714.0 $598.9 $521.9
Shares Outstanding (period-end)170,111,593 171,069,176 174,532,710

Non-GAAP (where disclosed):

MetricQ4 FY2025Q1 FY2026Q2 FY2026
Adjusted R&D ($USD Millions)N/A$93.3 $106.5
Adjusted G&A ($USD Millions)N/A$15.4 $11.9
Adjusted Net Loss ($USD Millions)N/A$102.1 $113.3

Notes:

  • YoY (Q2): R&D up ~17% ($114.2M vs $97.3M); G&A down ~5% ($17.5M vs $18.5M); Net loss widened ($126.5M vs $109.1M), reflecting increased pipeline investment .

Guidance Changes

Metric/ItemPeriodPrevious GuidanceCurrent GuidanceChange
Batoclimab TED Phase 3 topline disclosureCY2025–H1 CY2026First of two Phase 3 studies to read out before end of CY2025 Plan to share topline from both TED studies concurrently in H1 CY2026 Deferred/modified (timing consolidated)
IMVT-1402 D2T RA (open-label portion)CY2026CY2026 readout expected CY2026 readout expected Maintained
IMVT-1402 CLE PoC toplineCY2026CY2026 readout expected CY2026 readout expected Maintained
IMVT-1402 GD/MG/D2T RA registrational toplineCY2027CY2027 readouts expected CY2027 readouts expected Maintained
Cash runwayThrough GD readout (2027)Runway through GD readout expected in 2027 Runway through GD readout expected in 2027 Maintained

Earnings Call Themes & Trends

TopicPrevious Mentions (Q4 FY2025, Q1 FY2026)Current Period (Q2 FY2026)Trend
GD strategy & dataPlanned initiation of second GD study; remission data to be shared in summer/ATA Sept 2025 Six-month off-treatment remission data showed ~80% maintained normal T3/T4; ~50% ATD-free Positive momentum; durability strengthens 1402 thesis
TED program timingExpected Phase 3 data in H2 2025 Will disclose both Phase 3 studies together in H1 2026 due to competitive dynamics More cautious; timing consolidated
1402 execution across six indicationsTrials “on track,” focus on execution Registrational programs ongoing (GD, MG, CIDP, D2T RA, SjD) + CLE PoC; 2026/2027 readouts reiterated Execution consistent
Competitive landscape (GD/TED)Limited explicit commentaryMgmt acknowledges intensifying competition; emphasizes depth of IgG suppression and FcRn safety profile Competitive intensity rising
Cash runway & funding~$714M (Mar 31); runway through 2027 $521.9M (Sept 30); runway through 2027 reiterated Runway intact; cash trending down with spend

Management Commentary

  • “A tremendous moment of transformation for the business… a late-stage pipeline that we are really excited about…” .
  • On DM (brepocitinib) data: “Textbook… statistically significant at the high dose starting at the earliest time point. Nice clear separation, nice clear dose response” .
  • On GD durability: “After being off drug for six months, 17 out of the 21… remained responders… a pretty remarkable disease-modifying benefit” .
  • On TED timing: “We are going to hold off reporting the top-line data from that first study… report it when we have [both]” .
  • On competition: “FcRn… a pretty undisputed king so far [in MG]… we think we’ve built something similar in Graves’ disease” .

Q&A Highlights

  • Competitive dynamics in GD/TED: Management views FcRn depth of IgG suppression and safety/tolerability as key differentiators; sees broad opportunity despite more entrants .
  • TED disclosure strategy: Consolidated readout in H1 2026 to provide a fuller competitive picture and inform next steps with partner .
  • Sjögren’s: Belief in best‑in‑class potential if deeper IgG suppression translates; aim to be close to first-in-class on launch timing .
  • Launch cadence (DM analogs discussion): No direct analogs; company will guide conservatively on early cadence, emphasizing large unmet need and long‑term penetration potential .

Estimates Context

  • S&P Global consensus EPS and revenue estimates for IMVT were unavailable at the time of query; therefore, we cannot assess beats/misses versus consensus. Values retrieved from S&P Global.*

Key Takeaways for Investors

  • GD durability data de-risks the FcRn approach and bolsters 1402’s potential in a large, underserved market; look for additional granularity at the Dec 11 investor day .
  • The TED pivot (bundled disclosure in H1 2026) removes a late-2025 binary but concentrates attention on a single, higher‑information event—expect sentiment to hinge on TED competitiveness and safety .
  • Spending is elevated but purposeful; R&D growth reflects registrational execution across multiple large indications, with runway reiterated through 2027 .
  • 2026 readouts in D2T RA (open‑label) and CLE PoC, plus multiple 2027 registrational readouts (GD/MG/D2T RA), create a dense catalyst path supporting medium‑term thesis formation .
  • Competitive intensity in GD/TED is rising; IMVT’s edge likely hinges on demonstrating deeper IgG suppression, durable remission, and favorable tolerability vs. peers .
  • Near-term trading setup: investor day messaging and clarity on TED timing/positioning; medium-term, value accrues from clean readouts across 2026–2027 and evidence of best‑in‑class efficacy/tolerability .

References:

  • Q2 FY2026 8-K press release and financials
  • Q2 FY2026 earnings call transcript - (see specific citations above)
  • Sep 3, 2025 GD remission press release
  • Q1 FY2026 press release and financials (quarter ended June 30, 2025)
  • FY Q4 FY2025 press release and financials (quarter ended March 31, 2025)