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Immunovant, Inc. (IMVT)·Q3 2025 Earnings Summary
Executive Summary
- Fiscal Q2 2026 (calendar Q3 2025) results: net loss of $126.5M ($-0.73 EPS), driven by increased IMVT-1402 clinical spend; cash fell to $521.9M, sustaining runway through Graves’ disease readout expected in 2027 .
- R&D rose versus prior year (to $114.2M vs $97.3M) while G&A fell (to $17.5M vs $18.5M), reflecting clinical execution and administrative streamlining .
- Program update surprise: management will report topline for both Phase 3 TED studies concurrently in H1 2026 (vs prior expectation of first study by YE25), citing evolving competitive dynamics; LPLV imminent .
- Clinical momentum: six‑month off‑treatment GD remission data showed ~80% responders (17/21) and ~50% ATD‑free remission among responders, underpinning IMVT-1402’s registrational path across multiple indications .
What Went Well and What Went Wrong
What Went Well
- GD remission durability: ~80% (17/21) maintained normal thyroid function six months off batoclimab; ~50% (8/17) achieved ATD‑free remission, supporting disease‑modifying potential .
- Strong pipeline execution: potentially registrational trials in GD, MG, CIDP, D2T RA, SjD on track; CLE proof‑of‑concept targeted for 2026 readout .
- Management confidence in FcRn depth: “deeper IgG reductions… drive towards… remission” in GD, positioning 1402 at high dose for competitive differentiation .
What Went Wrong
- Increased quarterly net loss as clinical spend ramped: net loss widened to $126.5M from $109.1M YoY; non‑GAAP net loss to $113.3M from $96.5M .
- TED timing shift: topline reporting postponed to concurrent release of both Phase 3 studies in H1 2026 rather than first study by YE25, reflecting competitive dynamics; introduces timeline uncertainty for batoclimab TED decision .
- Cash drawdown: cash declined to $521.9M from $598.9M in prior quarter as trials scaled, though runway remains adequate to GD 2027 .
Financial Results
Note: IMVT is clinical-stage with no product revenues disclosed; focus is on expenses, loss, cash.
KPIs
Segment breakdown: Not applicable (no commercial segments disclosed).
Guidance Changes
Earnings Call Themes & Trends
Management Commentary
- “We are going to hold off reporting the top-line data from that first [TED] study… and report it when we have it all [both studies]” — highlighting prudent approach amid competition .
- “Remission is about TRAb getting normal for longer… deeper IgG reductions are going to drive towards exactly that outcome” — framing 1402 dose strategy .
- On Graves’ market evolution: “FcRn has been… a pretty undisputed king… first FcRn to launch… has been a tremendous head start… we feel great about our position” .
- “More than a third… [DM] patients were able to get… major TIFS responses and minimal or no steroid burden at week 52” — underscoring batoclimab’s clinical profile in DM context .
Q&A Highlights
- Competitive landscape in GD/TED: Management views deeper IgG suppression as key differentiator; will align TED disclosure to both studies given competitive shifts .
- Litigation watch items: Summary judgment scope in Moderna case contextualized; Pfizer case scheduling seen as near‑term public milestone .
- Sjögren’s opportunity: Potential to be best‑in‑class if deeper IgG yields superior ESSDAI outcomes; considering expedited pathways for BREPO in DM where appropriate .
- DM launch cadence: No direct analogs; cautious launch guidance with large unmet need and oral convenience expected to aid adoption over time .
Estimates Context
- Wall Street consensus (S&P Global) for EPS and revenue was unavailable due to request limits; therefore, we cannot provide a vs‑estimates comparison this quarter.
Key Takeaways for Investors
- TED disclosure strategy change is the main stock narrative this quarter; concurrent topline in H1 2026 reduces piecemeal risk but delays near‑term TED optics; watch for LPLV confirmation and calendar specifics .
- GD remission durability and ATD‑free outcomes materially de‑risk 1402’s registrational path; depth of IgG suppression remains Immunovant’s core competitive thesis .
- Expense ramp reflects accelerated multi‑indication execution; cash runway to 2027 remains intact but expect continued quarterly burn as programs scale .
- Near‑term catalysts: CLE and D2T RA readouts in 2026; GD/MG toplines in 2027; investor day in December should refine commercial narratives and competitive positioning .
- Trading lens: Expect sentiment tied to TED timing shift and competitive GD/TED headlines; durability data in GD supports medium‑term multiple expansion pending 1402 registrational progress .