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Roivant Sciences Ltd. (ROIV)·Q3 2025 Earnings Summary

Executive Summary

  • Q3 FY2025 (quarter ended Dec 31, 2024) showed minimal revenue ($9.02M) and a GAAP diluted loss per share from continuing operations of $0.22, offset by $327.0M income from discontinued operations tied to the Dermavant sale, yielding positive net income attributable to Roivant of $169.4M .
  • Cash, cash equivalents, restricted cash and marketable securities totaled ~$5.2B at quarter-end; management reiterated a strong cash runway and noted additional inflows in January ($75M VTAMA milestone; $113M Immunovant external capital) not included in the quarter-end figure .
  • Execution milestones: new proof-of-concept brepocitinib trial in cutaneous sarcoidosis (Phase 2 start in Q2 CY2025), imminent batoclimab MG and CIDP readouts by Mar 31, 2025, and continued progress toward brepocitinib DM and NIU readouts; management framed 2025 as a “year of harvest” with stacked clinical catalysts and ongoing LNP litigation timelines .
  • No explicit financial guidance was provided; program timelines and litigation schedules were reaffirmed. Wall Street consensus (S&P Global) for Q3 FY2025 was unavailable due to SPGI access limits; estimate comparisons are therefore not included.

What Went Well and What Went Wrong

What Went Well

  • Management expanded brepocitinib’s scope with a new proof-of-concept program in cutaneous sarcoidosis (30–50k US patients; no approved therapies), aligned to TYK2/JAK1 biology and expected to initiate Q2 CY2025, with topline in H2 CY2026 .
  • Strong balance sheet and capital flexibility: ~$5.2B cash and marketable securities at 12/31/24 (excludes $75M VTAMA milestone and $113M Immunovant capital raised in Jan), and ongoing buyback authorization, supporting pipeline execution and BD .
  • Management emphasized differentiated FcRn positioning and near-term data catalysts; quote: “Deeper is Better has been pretty well established... we’re looking for a nice clear dose response” for upcoming MG data to inform 1402 program design .

What Went Wrong

  • Core operations remain loss-making: GAAP loss from continuing operations of $208.9M in Q3 despite very low revenue ($9.02M), reflecting program and corporate investment; non-GAAP loss from continuing operations was $143.7M .
  • Revenue declined sharply vs Q1 FY2025 as Dermavant contributions ceased (Dermavant is now discontinued ops); net revenue in Q3 was $9.02M vs $55.13M in Q1 .
  • R&D and G&A remained heavy on a GAAP basis (R&D $141.6M; G&A $141.5M in Q3), though adjusted non-GAAP figures were lower (R&D $131.2M; G&A $71.1M), indicating persistent opex intensity despite portfolio transitions .

Financial Results

MetricQ1 2025Q2 2025Q3 2025
Revenue ($USD Millions)$55.132 $4.475 $9.018
Diluted EPS - Continuing Operations ($USD)$0.01 $(0.25) $(0.22)
Net Income Attributable to Roivant ($USD Millions)$95.297 $(230.184) $169.381
Total Operating Expenses ($USD Millions)$285.705 $346.188 $283.399

KPIs and Operating Detail

KPIQ1 2025Q2 2025Q3 2025
Cash, Cash Equivalents & Restricted Cash ($USD Billions)$5.693 $1.970 $2.002
Marketable Securities ($USD Billions)N/A $3.428 $3.156
Non-GAAP R&D ($USD Millions)$121.505 $132.438 $131.182
Non-GAAP G&A/SG&A ($USD Millions)$107.536 (SG&A) $142.344 (G&A) $71.076 (G&A)
Income (Loss) from Discontinued Ops ($USD Millions)$89.093 $(43.083) $327.020

Segment Breakdown: Not applicable; the company reports consolidated results and program-specific costs, with Dermavant reported in discontinued operations following the October 2024 sale .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Batoclimab MG toplineBy Mar 31, 2025By Mar 31, 2025 By Mar 31, 2025 Maintained
Batoclimab CIDP topline (Period 1)By Mar 31, 2025By Mar 31, 2025 By Mar 31, 2025 Maintained
Batoclimab TED toplineH2 CY2025H2 CY2025 H2 CY2025 (with note concurrent sharing of both studies later updated in subsequent quarter) Maintained
IMVT-1402 GD pivotalCY2025 startPivotal initiation expected by YE 2024 Pivotal GD initiated (running) Raised (execution progressed)
IMVT-1402 D2T RA pivotalBy Mar 31, 2025 startIND cleared; initiation by Mar 31, 2025 D2T RA pivotal initiated (running) Raised (execution progressed)
Brepocitinib DM topline (VALOR)H2 CY2025H2 CY2025 H2 CY2025 Maintained
Brepocitinib NIU Phase 3 toplineH1 CY2027H1 CY2027 H1 CY2027 Maintained
Brepocitinib CS Phase 2Start Q2 CY2025; topline H2 CY2026Not previously disclosed New program announced New
LNP litigation (Moderna)Summary judgment Q2–Q3 CY2025; jury trial Sep 2025Summary judgment Q2–Q3 CY2025; trial Sep 2025 Summary judgment Q2–Q3 CY2025; trial Sep 2025 Maintained

No revenue/margin/OpEx/tax/dividend guidance was provided in Q3 FY2025 materials .

Earnings Call Themes & Trends

TopicPrevious Mentions (Q1 & Q2 FY2025)Current Period (Q3 FY2025)Trend
FcRn franchise (batoclimab & IMVT-1402)Q2: Strong GD PoC, INDs cleared, multi-indication plan; “Deeper is Better” thesis reiterated Q3: Emphasis on dose-response in MG, chronic dosing, auto-injector form factor; near-term MG/CIDP readouts; 6 INDs cleared Building momentum; imminent data to shape 1402 program
Brepocitinib (DM, NIU, CS)Q2: NIU 52-week Phase 2 data sustained; DM Phase 3 on track; NIU Phase 3 enrolling Q3: New CS indication announced; DM readout mid-2025; NIU Phase 3 ongoing Program expansion; multiple orphan indications
Cash & Capital AllocationQ1: $5.7B cash; buybacks underway Q3: $5.2B cash & marketable; $75M VTAMA milestone and $113M Immunovant capital in Jan; continued buybacks Robust liquidity; shareholder returns continue
LNP LitigationQ2: Pfizer/BioNTech Markman scheduled; Moderna summary judgment and trial timeline Q3: Summary judgment Q2–Q3 2025; Moderna trial scheduled Sep 2025; DOJ 1498 nuances noted Progressing; key inflection points in 2025
Business DevelopmentQ2: Active BD environment; pipeline additions (mosliciguat) Q3: “Most fruitful BD environment” comment; expectation to add programs Ongoing; opportunistic

Management Commentary

  • CEO on 2025 setup: “We think 2025 is just a pretty incredible year for us… big year with a lot of important milestones” .
  • On FcRn strategy: “Deeper is Better has been pretty well established… we’re looking for a nice clear dose response” in MG to guide 1402 .
  • On brepocitinib CS rationale: “30,000 to 50,000… no approved therapies… dual TYK2 and JAK1 inhibition is particularly well suited” .
  • On cash strength: “We have $5.2 billion in cash and marketable securities… $500 million authorized for additional share buybacks… bought back about $1 billion” .

Q&A Highlights

  • MG/CIDP expectations: Management seeks clear dose-response in MG; emphasized form factor and chronic dosing advantages for commercial viability even without efficacy delta vs competitors .
  • Graves’ disease remission: Hopes for “some reasonable rate” of 6-month off-treatment remission to support disease-modifying potential and payer value narrative .
  • Cutaneous sarcoidosis study design: Proof-of-concept focus with heavy randomization toward drug; low expected placebo response; signal-finding to inform Phase 3 .
  • LNP litigation 1498: DOJ noted only one Moderna contract referenced 1498; court twice declined to remove claims; outcomes could vary across government consent prongs .
  • Competitive positioning: For DM and NIU, form factor (oral for DM; differentiated efficacy for NIU) and high unmet need support adoption even amid biosimilar TNF landscape .

Estimates Context

  • S&P Global consensus estimates for Q3 FY2025 (revenue, EPS) were unavailable due to daily request limit constraints during retrieval. As a result, estimate comparisons and beats/misses cannot be assessed in this recap.
  • Where estimates are required for future iterations, we will anchor on S&P Global consensus.

Key Takeaways for Investors

  • Liquidity and optionality remain strategic strengths (~$5.2B cash/marketable at Q3-end; further January inflows), funding clinical breadth and enabling opportunistic BD and buybacks .
  • Near-term clinical catalysts (MG, CIDP by Mar 31, 2025) could validate FcRn thesis (“Deeper is Better”) and inform IMVT-1402’s registrational design and commercial trajectory; watch for dose-response clarity .
  • Brepocitinib is evolving into an orphan franchise (DM, NIU, CS), with oral form factor and TYK2/JAK1 biology matching high unmet need indications; DM readout is a pivotal mid-2025 event .
  • Earnings optics are dominated by program investment (GAAP loss in continuing ops; low revenue post-Dermavant) and discontinued ops gains; focus should be on catalyst execution vs near-term P&L .
  • LNP litigation is a 2025–2026 event path with potential value unlock/risks; summary judgment mid-2025 and Moderna jury trial scheduled for September 2025; DOJ 1498 commentary suggests nuanced outcomes .
  • No financial guidance; investors should track program timelines: batoclimab MG/CIDP and TED, brepocitinib DM/NIU/CS, and mosliciguat PH-ILD, as primary stock-move catalysts .
  • Immunovant investment signals confidence; management aims for funding through Graves’ data and underscores 1402’s form factor/IP runway, supporting medium-term thesis .