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Disc Medicine, Inc. (IRON)·Q4 2024 Earnings Summary

Executive Summary

  • IRON reported Q4 2024 via an 8‑K press release, emphasizing pipeline progress and a well-funded balance sheet; cash, cash equivalents and marketable securities were $489.9M at year-end 2024, with January 2025 equity offering proceeds expected to fund operations into 2028 .
  • Management is targeting an NDA submission for bitopertin in EPP in H2 2025 and is on track to initiate the APOLLO confirmatory trial by mid-2025, following positive end‑of‑Phase 2 FDA guidance on accelerated approval using PPIX reduction as a surrogate endpoint .
  • Q4 OpEx and net loss increased versus Q3, consistent with portfolio advancement; by derivation from reported full-year and nine-month figures, Q4 OpEx was ~$34.6M and Q4 net loss was ~$29.5M, while Q3 OpEx and net loss were $32.9M and $26.6M, respectively .
  • Q4 earnings call transcript was not available in the document catalog; however, management commentary was provided through the press release and recent FDA and ASH-related calls/slides in Q4/Q1 .

What Went Well and What Went Wrong

What Went Well

  • Positive FDA end-of-Phase 2 feedback for bitopertin: alignment on APOLLO confirmatory study design and potential accelerated approval with PPIX reduction as surrogate endpoint; CEO: “we’re particularly excited by the potential to file under the Accelerated Approval Program” .
  • Portfolio momentum: DISC‑0974 Phase 2 in MF anemia initiated in Dec 2024; CKD Phase 1b multiple-dose data expected H2 2025; DISC‑3405 Phase 2 in PV expected to initiate H1 2025 .
  • Strengthened capital position: $259M gross equity raised in Jan 2025 and $200M Hercules debt facility (initial $30M drawn) to support catalysts; runway expected into 2028 .

What Went Wrong

  • Operating expenses and net loss grew YoY with R&D/SG&A scaling to support bitopertin and broader pipeline; FY 2024 R&D $96.7M vs $69.3M in 2023; SG&A $33.0M vs $21.9M; FY net loss $109.4M vs $76.4M .
  • Quarterly OpEx and net loss stepped up sequentially in Q4 vs Q3 (derived): OpEx ~$34.6M vs $32.9M; net loss ~$29.5M vs $26.6M, reflecting intensified development and manufacturing activities .
  • No consensus estimates comparison available (S&P Global data unavailable), limiting beat/miss assessment for traders [GetEstimates error].

Financial Results

Quarterly P&L and Balance Metrics

Note: Q4 2024 and Q4 2023 values are derived from reported full-year and nine‑month figures. All amounts are USD Millions unless stated.

MetricQ2 2024Q3 2024Q4 2024
Total Operating Expenses$30.85 $32.86 $34.55 (derived from $129.72 FY 2024 − $95.17 9M 2024)
Net Loss$26.35 $26.60 $29.46 (derived from $109.36 FY 2024 − $79.90 9M 2024)
Net Loss per Share$(1.03) $(0.89) n/a (not disclosed quarterly)
Cash, Cash Equivalents & Marketable Securities$500.95 $487.36 $489.88
R&D Expense$23.49 $24.69 $24.80 (derived from $96.67 FY 2024 − $71.87 9M 2024)
SG&A/G&A Expense$7.37 $8.17 $9.75 (derived from $33.05 FY 2024 − $23.30 9M 2024)

Derivation notes: Q4 figures computed by subtracting nine‑month amounts reported at Q3 from full‑year amounts reported at Q4 press release .

Year-over-Year (Q4 2024 vs Q4 2023)

MetricQ4 2023Q4 2024YoY Change
Total Operating Expenses$29.71 (derived from $91.13 FY 2023 − $61.41 9M 2023) $34.55 +16.3% (derived)
Net Loss$23.58 (derived from $76.43 FY 2023 − $52.85 9M 2023) $29.46 +24.9% (derived)
Cash, Cash Equivalents & Marketable Securities$360.38 (12/31/2023) $489.88 (12/31/2024) +35.9% (derived)

Estimates vs Actuals

MetricConsensus (Q4 2024)Actual (Q4 2024)Result
RevenueUnavailable (S&P Global data not accessible)n/a (no revenue reported) n/a
EPSUnavailable (S&P Global data not accessible)n/a (not disclosed quarterly)n/a

S&P Global consensus data were unavailable due to access limits; therefore beat/miss analysis cannot be provided for Q4 2024.

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash RunwayMulti‑year“Well into 2027” (Q3) “Into 2028” (post Jan 2025 raise) Raised
Bitopertin APOLLO Confirmatory TrialMid‑2025Plan to initiate by mid‑2025; FDA alignment imminent On track to initiate by mid‑2025 Maintained
Bitopertin NDA TimingH2 2025Q1 2025 to update NDA pathway/timing Targeting NDA submission in H2 2025 Clarified (timing set)
DISC‑0974 MF Anemia Phase 2Start by end‑2024Expected to initiate by end‑2024 Initiated Dec 2024 Achieved
DISC‑3405 PV Phase 22025Plans to initiate in 2025 Expected to initiate in H1 2025 Clarified earlier half

Earnings Call Themes & Trends

Note: No Q4 earnings call transcript found; themes reflect Q4 press release and related Q4 FDA/ASH communications.

TopicPrevious Mentions (Q2 2024)Previous Mentions (Q3 2024)Current Period (Q4 2024)Trend
Regulatory path (bitopertin)Preparing for EOP2 & registrational endpoints Positive EOP2; potential accelerated approval; APOLLO design alignment Targeting H2 2025 NDA; APOLLO to start mid‑2025; PPIX surrogate accepted Strengthening, clarity increased
R&D execution (DISC‑0974)MF/NDD‑CKD data encouraging; planning Phase 2 MF SAD CKD data; MF Phase 2 to start by year‑end MF Phase 2 initiated; CKD multiple‑dose data expected H2 2025 Advancing per plan
R&D execution (DISC‑3405)SAD/MAD in HV; proof of mechanism; more data H2 ASH MAD HV data; preclinical SCD data; PV Phase 2 in 2025 PV Phase 2 expected H1 2025 Advancing; timeline specified
Financing & runway$178M equity; runway well into 2027 $200M debt facility; $487M cash at Q3 $490M year‑end cash; $259M Jan 2025 equity; runway into 2028 Strengthened
Commercial readiness (bitopertin)NAAnnounced ASH presentations; patient survey work Ongoing payer/HEOR/manufacturing prep; concentrated EPP center network Building

Management Commentary

  • CEO (Q4 press release): “2024 was a transformative year for Disc… opening the door to a potential accelerated approval for bitopertin… We expect to initiate the APOLLO trial in mid‑2025 followed by an NDA submission in the second half of this year” .
  • CEO (Q3 press release): “We now have clarity on the path forward for bitopertin in EPP, with the potential for accelerated approval, and added to the data set supporting the potential of DISC‑0974” .
  • CEO (FDA EOP2 press release): “We’re particularly excited by the potential to file under the Accelerated Approval Program… and use of PPIX reduction as a surrogate endpoint” .

Q&A Highlights

  • No Q4 earnings call transcript available; however, during the Nov 4, 2024 EOP2 call, management reviewed FDA alignment on APOLLO parameters (primary endpoint: pain‑free time in sunlight, 60 mg dose, 6‑month duration) and reiterated accelerated approval potential with PPIX reduction as surrogate .

Estimates Context

  • Wall Street consensus (S&P Global) for Q4 2024 EPS and revenue was unavailable due to data access limits; as a pre‑revenue clinical-stage biotech, IRON did not report product revenue in Q4, and quarterly EPS was not disclosed in the press release . S&P Global consensus data were unavailable, so beat/miss determinations cannot be provided (S&P Global data unavailable).

Key Takeaways for Investors

  • Regulatory clarity and timeline: Bitopertin’s accelerated approval path and APOLLO design alignment with FDA de‑risk near‑term regulatory steps; NDA targeted for H2 2025 .
  • Pipeline breadth: Multiple programs (DISC‑0974 in MF/CKD; DISC‑3405 in PV) with 2025 data and initiation milestones, providing several catalysts over the next 12–18 months .
  • Capital strength: Year‑end 2024 cash ~$490M plus Jan 2025 offering supports operations into 2028, limiting near‑term financing risk through key readouts .
  • Operating spend scaling: Higher R&D and SG&A reflect manufacturing, trial execution, and commercialization prep; expect spending to remain elevated as programs advance .
  • Bitopertin commercial groundwork: Focused EPP treatment centers and ongoing payer/HEOR/manufacturing readiness position IRON for potential launch upon approval .
  • MF anemia opportunity: DISC‑0974 Phase 2 initiation and prior Phase 1b signals across patient segments (including transfusion reduction) support potential differentiation; initial Phase 2 data expected H2 2025 .
  • Near-term stock narrative likely tied to regulatory updates (APOLLO initiation), financing resilience, and cadence of clinical data disclosures across programs .

Appendix: Additional Q4 Press Releases and Events

  • ASN CKD SAD cohorts (DISC‑0974) showing dose‑dependent hepcidin suppression and hemoglobin increases .
  • Hercules Capital $200M debt financing details; initial $30M draw; interest-only period minimum 48 months .
  • ASH 2024 management call slides summarizing bitopertin, DISC‑0974, DISC‑3405 updates and commercial readiness .