Apogee Therapeutics, Inc. (APGE)·Q3 2024 Earnings Summary

Executive Summary

• Q3 2024 focused on pipeline execution with APG777 Phase 1 data (up to nine months) reinforcing a ~75-day half-life and biomarker inhibition supportive of a potential best-in-class AD profile; cash totaled $753.8M with runway into Q1 2028 .
• Key milestones reiterated/advanced: APG777 Phase 2 Part A 16-week topline in 2H 2025; APG808 interim Phase 1 data in 4Q 2024; APG990 interim Phase 1 in 1H 2025; APG333 Phase 1 initiation targeted for late 2024/early 2025 .
• No product revenue; net loss widened to $49.0M on higher R&D and G&A to advance four programs; interest income partially offset losses .
• Near-term stock catalysts: Dec 2, 2024 R&D Day; APG808 interim Phase 1 (4Q 2024); APG333 Phase 1 start; continued clarity on APG990 and the planned 777+990 AD combination study in 2025 .

What Went Well and What Went Wrong

What Went Well

• APG777 Phase 1 durability and PK continue to support a differentiated dosing profile (half-life ~75 days; sustained pSTAT6/TARC inhibition), strengthening the best-in-class thesis in AD .
• Portfolio momentum across all programs: APG808 interim Phase 1 on track for 4Q 2024; APG990 first participants dosed with interim 1H 2025; APG333 selected and accelerated toward Phase 1 .
• Management tone confident about multi-pronged efficacy strategy: “We continue to execute across our portfolio… positioning our pipeline to achieve potential best-in-class efficacy and dosing” — CEO Michael Henderson, M.D. .

What Went Wrong

• Operating losses expanded with R&D and G&A scaling for multi-program advancement; net loss increased to $49.0M vs $20.8M YoY and vs $33.8M QoQ .
• No revenue; pre-commercial status means results rely on clinical milestones rather than financial beats/misses, limiting traditional earnings levers .
• Estimate comparison unavailable this quarter due to S&P Global request limits; limits ability to benchmark Street expectations on EPS/revenue (see Estimates Context) .

Financial Results

Notes:

• Apogee did not report product revenue; condensed statements of operations list operating expenses and other income only .
• EPS and margin metrics were not disclosed in the press release exhibits; company is pre-revenue, making traditional margin calculations not applicable .

KPIs and Operating Drivers:

Guidance Changes

Earnings Call Themes & Trends

Management Commentary

• “We continue to execute across our portfolio and advance potentially transformative therapies… positioning our pipeline to achieve potential best-in-class efficacy and dosing.” — Michael Henderson, M.D., CEO .
• “The first half of this year has been marked with significant pipeline progress… and we have a strong cash position taking us into 2028.” — Michael Henderson, M.D. (Q2 release) .
• “We… successfully bringing our programs forward ahead of schedule… raised $483 million… providing capital into 2028.” — Michael Henderson, M.D. (Q1 release) .
• On AD strategy and dosing backbone: “APG777… optimized antibody for IL‑13… every 3‑ to 6‑month dosing… 30% to 40% greater exposures compared to lebrikizumab.” — Carl Dambkowski, CMO (Guggenheim chat) .
• On market/payer view: “AD… the largest I&I indication… payers see the value… we would be a first-line biologic equal to DUPIXENT.” — Jeff Hartness, CCO (Guggenheim chat) .

Q&A Highlights

• AD market opportunity and payer positioning: Management expects sizable AD market and payer receptivity, with potential first-line parity with DUPIXENT for 777 given dosing/effectiveness goals .
• IL‑13 backbone and efficacy ambition: 777 targets 30–40% higher exposures vs lebrikizumab and aims for every 3–6 months dosing; efficacy headroom supported by exposure-response analyses and low-weight subgroup data in lebrikizumab .
• OX40L vs OX40 debate: Company prefers OX40L given safer profile and comparable efficacy; plans 777+990 combo to blend deep IL‑13 inhibition with broader upstream control .
• TSLP role in respiratory: 333 is viewed as a combination driver (IL‑13+TSLP) for additive efficacy while maintaining long dosing intervals via co-formulation .
• Co-formulation over bispecifics: Co-formulation offers longer dosing intervals (Q3M+), flexible stoichiometry (e.g., 3:1), and manufacturing/COGS advantages vs bispecifics .

Estimates Context

• Wall Street consensus (S&P Global Capital IQ) EPS and revenue estimates for Q3 2024 were unavailable due to S&P Global request limits, preventing comparison of actuals vs estimates this quarter .
• Apogee is pre-revenue; press releases provide operating expense and net loss detail but do not disclose EPS per share in the exhibits reviewed .

Key Takeaways for Investors

• Pipeline execution remains the core value driver: APG777’s durable PK/PD and Phase 2 design aim to pair differentiated dosing (Q3M–Q6M) with higher induction exposures to potentially lift efficacy vs lebrikizumab .
• Multiple shots on goal in AD: Monotherapy readout (777 Part A, 2H 2025) and a planned 777+990 combination study in 2025 could expand addressable patients and improve efficacy without JAK safety issues .
• Respiratory franchise optionality: IL‑13+TSLP combination strategy (777+333) may produce additive benefits in asthma/COPD while sustaining long dosing intervals via co-formulation .
• Cash runway into Q1 2028 supports clinical execution across programs; cash declined sequentially as R&D ramped, but interest income remains a partial offset .
• Near-term catalysts likely to move the stock: Dec 2 R&D Day (combination strategy, preclinical updates), APG808 interim Phase 1 (4Q 2024), APG333 first-in-human start, APG990 interim (1H 2025) .
• Risk profile: Pre-revenue biotech with widening losses as programs scale; binary clinical outcomes and competitive dynamics (DUPIXENT/lebrikizumab/JAKs) remain key external factors .
• Commercial build underway: Appointment of CCO and early payer research suggest an informed path to first-line positioning in AD if clinical goals are met .