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Apogee Therapeutics, Inc. (APGE)·Q4 2024 Earnings Summary

Executive Summary

  • Q4 2024 marked continued rapid execution: APG777 Phase 2 Part A was over-enrolled and Part B initiated ahead of schedule, with 16‑week Part A data expected mid‑2025; APG990 interim Phase 1 data showed ~60‑day half‑life supporting a first-in-class coformulated combo (APG279) dosed every 3–6 months .
  • Cash, cash equivalents and marketable securities were $731.1M at year‑end, with runway into Q1 2028, supporting multiple catalysts (APG777 Part A, APG279 head‑to‑head vs DUPIXENT) .
  • OpEx stepped up on program advancement: FY R&D $167.9M (+145% y/y) and G&A $49.0M (+99% y/y), reflecting clinical trial progression and personnel costs; FY net loss widened to $182.1M, partly offset by higher interest income .
  • Wall Street EPS and revenue consensus for Q4 2024 via S&P Global were unavailable; the company reports no product revenues in its releases (financial statements present operating expenses and other income only) .

What Went Well and What Went Wrong

What Went Well

  • APG777 execution ahead of plan: “over‑enrolling Part A and dosing the first patient in the Part B portion of our Phase 2 APEX clinical trial for APG777 in AD, well ahead of schedule,” with 16‑week readout in mid‑2025 .
  • APG990 interim Phase 1 exceeded objectives: ~60‑day half‑life, favorable tolerability up to 1,200mg, enabling APG279 quarterly/semi‑annual maintenance dosing as a single 2mL injection .
  • Strong balance sheet and runway: $731.1M cash/cash equivalents/marketable securities; runway into Q1 2028, enabling rapid progression of multiple trials .

What Went Wrong

  • Higher OpEx and net loss: FY R&D rose to $167.9M (from $68.4M) and G&A to $49.0M (from $24.6M), widening FY net loss to $182.1M (from $84.0M), driven by clinical advancement and headcount/equity comp .
  • Lack of product revenue persists; statements present only operating expenses and other income (pre‑revenue stage), limiting traditional revenue/EPS beat/miss analysis .
  • Estimates comparison unavailable: S&P Global quarterly EPS and revenue consensus could not be retrieved; thus, beats/misses vs Street cannot be assessed this quarter (see Estimates Context) .

Financial Results

Quarterly Operating Metrics (Q2 → Q4 2024)

Metric ($USD Millions)Q2 2024Q3 2024Q4 2024
Total Operating Expenses$44.1 $58.7 $75.9 (FY $216.9 − 9M $141.0)
R&D Expenses$33.2 $45.7 $60.2 (FY $167.9 − 9M $107.6)
G&A Expenses$10.9 $13.0 $15.7 (FY $49.0 − 9M $33.4)
Interest Income$10.3 $9.7 $8.7 (FY $34.7 − 9M $26.1)
Net Loss$(33.8) $(49.0) $(67.2) (FY $(182.1) − 9M $(114.9))
Cash, Cash Equivalents & Marketable Securities (Period-end)$789.6 $753.8 $731.1

Note: Q4 figures are computed from FY and nine‑month totals reported by the company; the releases do not present standalone Q4 statements .

Full-Year Comparison

Metric ($USD Millions)FY 2023FY 2024y/y Change
R&D Expenses$68.4 $167.9 +145%
G&A Expenses$24.6 $49.0 +99%
Net Loss$(84.0) $(182.1) +117% (more negative)
Interest Income$9.0 $34.7 +285%
Cash, Cash Equivalents & Marketable Securities (Period-end)$395.5 $731.1 +85%

KPIs (Program PK/PD)

KPIAPG777APG990APG808
Half-life (days)~75–77 (Phase 1; updated to 12 months follow-up) ~60 (Phase 1 interim) ~55 (Phase 1 interim HV)
pSTAT6 inhibition durationNear complete up to 9–12 months after single dose ——
TARC inhibition durationDeep and sustained up to 9–12 months after single dose ——
Tolerability summaryWell-tolerated up to single 1,200mg; no serious AEs reported in Phase 1 Well-tolerated up to 1,200mg; common TEAE headache; no severe AEs Well-tolerated in Phase 1; interim suggests 2–3 month dosing potential

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash RunwayThrough 2028“Runway into 2028” (Q2/Q3 2024) “Runway into Q1 2028” (FY 2024) Maintained (timing refined)
APG777 Phase 2 Part A readout (AD)Mid‑20252H 2025 (earlier communications) Mid‑2025 confirmed Pulled forward
APG777 Phase 2 Part B initiation2025Not previously specifiedInitiated ahead of schedule (first patient dosed) New milestone achieved
APG279 (APG777+APG990) Phase 1b vs DUPIXENTInitiate 2025; data 2H 2026Plan to initiate in 2025 Initiation 2025; interim readout 2H 2026 Maintained with readout timing added
APG333 Phase 1 (TSLP)2025; data 2H 2025Initiate late 2024/early 2025 HV trial underway; data 2H 2025 Maintained (clarified timing)
APG808 Phase 1b (asthma)1H 2025Interim HV data 4Q 2024 Phase 1b asthma data 1H 2025 Maintained

Earnings Call Themes & Trends

TopicPrevious Mentions (Q2 & Q3 2024)Current Period (Q4 2024)Trend
R&D execution speedMultiple programs advancing; APG777 Phase 2 initiated; APG990 Phase 1 accelerated APG777 Part A over‑enrolled; Part B dosed; APG990 interim met/exceeded goals Positive acceleration
Combination strategy (AD)Planned APG777+APG990 combo in 2025 APG279 head‑to‑head vs DUPIXENT in 2025; readout 2H 2026 Formalized path and timeline
PK/PD differentiationAPG777 ~75‑day half‑life; durable pSTAT6/TARC APG990 ~60‑day half‑life; supports quarterly/semi‑annual combo dosing Strengthened
Cash runway~$790M Q2; ~$754M Q3 with runway to 2028 $731.1M; runway into Q1 2028 Strong, modest decline QoQ
Regulatory/IND plansAPG990 Phase 1 cleared; APG333 candidate nomination and Phase 1 plan IND/foreign equivalent planned for APG279; multiple trials to start in 2025 Advancing towards combinations

Management Commentary

  • “We kicked off 2025 by over‑enrolling Part A and dosing the first patient in the Part B portion of our Phase 2 APEX clinical trial for APG777 in AD, well ahead of schedule… we are on track for our critical 16‑week readout for APG777 in mid‑2025.” — Michael Henderson, CEO .
  • “APG990… demonstrated an approximately 60‑day half‑life… supporting the potential for every three‑ and six‑month maintenance dosing… with a single 2 mL coformulated injection.” — Company statement .
  • “APG279… has the potential to approach JAK‑like efficacy… with readout expected in the second half of 2026.” — Management webcast remarks .

Q&A Highlights

  • Timeline/operational pacing: Management emphasized strong site enthusiasm; while cautious on accelerating APG279 timelines, they highlighted three efficacy readouts across APG777 Parts A/B and APG279 in 2025–2026 .
  • Placebo mitigation in APG777 Phase 2: Rigorous site/region selection, stricter IE criteria (e.g., EASI ≥16 at screening and baseline), and intense site oversight to ensure reliable outcomes .
  • Head‑to‑head goals vs DUPIXENT: A “numerical win” threshold of ~10 percentage points improvement on key endpoints (EASI‑75 or IGA0/1) viewed as clinically meaningful and payer‑relevant .
  • Path to approval for combo: Contribution‑of‑components design contemplated; leverage optimized APG777 monotherapy dose to underpin APG279 regulatory path; coformulation precedent cited .

Estimates Context

  • S&P Global consensus EPS and revenue estimates for Q4 2024 were unavailable due to data access limits; the company did not report product revenue in its earnings materials (financial statements focus on operating expenses and other income). As a result, beat/miss vs Street cannot be assessed this quarter .
  • Where investors typically anchor on revenue/EPS, for pre‑revenue biotech we recommend focusing on OpEx trajectory, cash runway, and clinical milestone timing to frame risk‑adjusted valuation drivers .

Key Takeaways for Investors

  • Execution outperformance: Over‑enrolled APG777 Part A and early Part B dosing signal operational strength; mid‑2025 APG777 PoC is the next major stock catalyst .
  • Differentiated dosing profile: APG777 (~75–77 day half‑life) and APG990 (~60 day half‑life) enable a quarterly/semi‑annual maintenance paradigm; patient adherence and market share could benefit vs bi‑weekly competitors if efficacy is at least comparable .
  • Combo ambition: APG279 aims for “JAK‑like” efficacy without JAK safety liabilities; head‑to‑head vs DUPIXENT planned in 2025 with readout in 2H 2026 — a pivotal efficacy narrative for the stock .
  • Balance sheet supports rapid development: $731.1M cash/securities and runway into Q1 2028 de‑risks funding for multiple Phase 2/1b programs and readouts over the next 24 months .
  • OpEx ramp is intentional: Higher R&D/G&A reflect pipeline progression and team build‑out; interest income offsets some burn; monitor quarterly OpEx vs enrollment pace .
  • Near‑term: Trading set‑ups likely around APG777 Part A mid‑2025; medium‑term: APG279 head‑to‑head trajectory and APG333/APG808 respiratory data will inform combo breadth .
Document cross-references:
- Q4/FY 2024 8-K press release and exhibits: **[1974640_0001104659-25-019467_tm258007d1_8k.htm:1]** **[1974640_0001104659-25-019467_tm258007d1_ex99-1.htm:0]** **[1974640_0001104659-25-019467_tm258007d1_ex99-1.htm:1]** **[1974640_0001104659-25-019467_tm258007d1_ex99-1.htm:2]** **[1974640_0001104659-25-019467_tm258007d1_ex99-1.htm:3]** **[1974640_0001104659-25-019467_tm258007d1_ex99-1.htm:4]** **[1974640_0001104659-25-019467_tm258007d1_ex99-2.htm:0]** **[1974640_0001104659-25-019467_tm258007d1_ex99-2.htm:1]** **[1974640_0001104659-25-019467_tm258007d1_ex99-2.htm:2]** **[1974640_0001104659-25-019467_tm258007d1_ex99-2.htm:3]**
- Q3 2024 8-K press release: **[1974640_0000950170-24-124542_apge-ex99_1.htm:0]** **[1974640_0000950170-24-124542_apge-ex99_1.htm:1]** **[1974640_0000950170-24-124542_apge-ex99_1.htm:3]** **[1974640_0000950170-24-124542_apge-ex99_1.htm:5]**
- Q2 2024 8-K press release: **[1974640_0001104659-24-088029_tm2421302d1_ex99-1.htm:0]** **[1974640_0001104659-24-088029_tm2421302d1_ex99-1.htm:1]** **[1974640_0001104659-24-088029_tm2421302d1_ex99-1.htm:2]** **[1974640_0001104659-24-088029_tm2421302d1_ex99-1.htm:4]**
- APG777 Phase 1 9-month update (Q4 2024): **[1974640_0001104659-24-111027_tm2426705d1_ex99-1.htm:0]** **[1974640_0001104659-24-111027_tm2426705d1_ex99-1.htm:1]**
- APG990 interim webcast transcript: **[1974640_APGE_3419070_0]** **[1974640_APGE_3419070_1]** **[1974640_APGE_3419070_2]** **[1974640_APGE_3419070_3]** **[1974640_APGE_3419070_4]** **[1974640_APGE_3419070_5]** **[1974640_APGE_3419070_6]** **[1974640_APGE_3419070_7]** **[1974640_APGE_3419070_8]** **[1974640_APGE_3419070_9]** **[1974640_APGE_3419070_10]** **[1974640_APGE_3419070_11]** **[1974640_APGE_3419070_13]** **[1974640_APGE_3419070_14]**