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ASSEMBLY BIOSCIENCES, INC. (ASMB)·Q4 2024 Earnings Summary

Executive Summary

  • Q4 2024 revenue was $7.36 million versus S&P Global consensus of $7.78 million, a slight miss, while diluted EPS of -$1.57 beat consensus of -$1.75; coverage remains thin (1 EPS estimate, 2 revenue estimates), limiting statistical confidence in “beats/misses.” Values retrieved from S&P Global.*
  • Year-end liquidity strengthened: cash, cash equivalents and marketable securities rose to $112.1 million (from $95.0 million in Q3), extending cash runway into mid-2026 .
  • Clinical execution accelerated: four development candidates in the clinic; interim Phase 1b efficacy data for ABI-5366 and ABI-1179 now guided to fall 2025 (later than prior H1’25 target for ABI-5366) and strong antiviral activity was reported for HBV CAM ABI-4334 (DNA -2.9 log10 IU/mL over 28 days at 150 mg) .
  • Strategic support from Gilead continued with ~$20.1 million equity and $10 million accelerated funding, de-risking near-term development milestones and serving as a stock-reaction catalyst on clinical readouts .

What Went Well and What Went Wrong

What Went Well

  • Clinical momentum: “We are well-positioned to deliver important clinical data on four of our novel antiviral candidates in 2025… reinforcing the exceptional execution of our R&D organization” — Jason Okazaki, CEO .
  • HBV CAM efficacy: In the Phase 1b 150 mg cohort, ABI-4334 showed a mean decline of 2.9 log10 IU/mL in HBV DNA and 2.5 log10 U/mL in HBV RNA (subset), with a favorable safety profile and PK supportive of once-daily dosing .
  • Liquidity improvement and runway extension: Year-end cash, cash equivalents and marketable securities increased to $112.1 million; runway extended to mid-2026 .

What Went Wrong

  • Timing push-outs: ABI-5366 Phase 1b interim efficacy moved from H1 2025 to fall 2025; ABI-4334 remaining cohort data is now guided for H1 2025 (later than “by end of 2024”) .
  • Limited estimate coverage: Only 1 EPS and 2 revenue estimates underpin Q4 consensus, indicating low Street participation and higher variability in “beat/miss” interpretation. Values retrieved from S&P Global.*
  • Annual R&D spend rose to $55.9 million from $48.9 million, reflecting a broader pipeline and increasing burn despite collaboration revenue uplift .

Financial Results

MetricQ4 2023Q2 2024Q3 2024Q4 2024
Revenue ($USD Millions)$7.16 $8.53 $6.85 $7.36*
Diluted EPS ($)-$2.06*-$1.98*-$1.51*-$1.57*
Total Operating Expenses ($USD Millions)$19.71*$20.74 $17.80 $18.89*
Net Income Margin (%)-153.0%*-130.7%*-140.4%*-140.5%*

Notes: Cells marked with * are values retrieved from S&P Global.

Comparison vs Estimates (Q4 2024):

MetricActualConsensusSurprise
Revenue ($USD Millions)$7.36$7.78-$0.42
EPS ($)-$1.57-$1.75+$0.18

Coverage: EPS estimates (n=1), revenue estimates (n=2). Values retrieved from S&P Global.

Liquidity and Runway:

MetricQ2 2024Q3 2024Q4 2024
Cash, Cash Equivalents & Marketable Securities ($USD Millions)$109.2 $95.0 $112.1
Cash RunwayInto Q1 2026 Into Q1 2026 Into mid-2026

KPIs (Clinical):

KPIQ2 2024Q3 2024Q4 2024
ABI-5366 PK Half-life (HSV)—~20 days (oral) —
ABI-4334 HBV DNA change (150 mg)——-2.9 log10 IU/mL over 28 days
ABI-4334 HBV RNA change (subset)——-2.5 log10 U/mL over 28 days
ABI-4334 Safety/PK——Well-tolerated; once-daily supportive PK

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
ABI-5366 Phase 1b interim efficacy (genital herpes)2025 timingH1 2025 Fall 2025 Lowered (timing pushed)
ABI-1179 Phase 1b interim efficacy (genital herpes)2025 timingEnter clinic by YE 2024 Fall 2025 interim efficacy New detailed timing (post-initiation)
ABI-4334 Phase 1b remaining cohort (400 mg)2025 timingInterim data by YE 2024 Data H1 2025 Lowered (timing pushed)
ABI-6250 Phase 1a (HDV)2025 timingEnter clinic by YE 2024 Phase 1a data in Q3 2025 Updated with specific data timing
Cash runwayMulti-yearInto Q1 2026 Into mid-2026 Raised (extended)

Earnings Call Themes & Trends

TopicPrevious Mentions (Q2 2024 and Q3 2024)Current Period (Q4 2024)Trend
R&D executionQ2: “Rapidly progressing toward key inflection points” ; Q3: “Continued execution… exceeding expectations” “Exceptional execution of our R&D organization” Strengthening
HSV program (ABI-5366/1179)Q2: Dosing initiated; interim Phase 1a data expected Q3; Phase 1b interim expected H1’25 Interim Phase 1b efficacy (both ABI-5366 & ABI-1179) in fall 2025 Timing pushed
HBV program (ABI-4334)Q2/Q3: Phase 1b ongoing; interim data by YE 2024 Interim 150 mg cohort: strong antiviral activity; 400 mg data H1 2025 Positive efficacy; timing refined
HDV program (ABI-6250)Q2/Q3: Enter clinic by YE 2024 Dosing initiated; Phase 1a data in Q3 2025 Progress with specified timeline
Strategic fundingQ2: $12.6m gross equity proceeds ~$20.1m equity + $10m accelerated funding from Gilead Increased strategic support
Liquidity/runwayQ2/Q3: Runway into Q1 2026 Runway into mid-2026 Extended

Management Commentary

  • “We are well-positioned to deliver important clinical data on four of our novel antiviral candidates in 2025… reinforcing the exceptional execution of our R&D organization” — Jason Okazaki, CEO .
  • “We recently reported positive interim Phase 1a data for ABI-5366 that exceeded our expectations and supported the initiation of dosing in participants with recurrent genital herpes for the Phase 1b portion of the study” — Jason Okazaki, CEO .
  • “We are pleased to see strong antiviral activity in this first Phase 1b cohort for ABI-4334, our most potent CAM… these interim data reinforce the potential of ABI-4334” — Anuj Gaggar, MD, PhD, CMO .

Q&A Highlights

  • The Q4 2024 conference call was scheduled for March 20, 2025 (4:00 PM ET), but a full public transcript was not available in our document repository; therefore, Q&A specifics and tone shifts cannot be analyzed at this time .

Estimates Context

  • Q4 2024 EPS of -$1.57 beat S&P Global consensus of -$1.75 by $0.18. Revenue of $7.36 million missed S&P Global consensus of $7.78 million by $0.42 million. Coverage was limited (EPS: n=1; Revenue: n=2), suggesting estimates may not fully reflect intra-quarter developments. Values retrieved from S&P Global.*
  • Given timing push-outs for HSV Phase 1b interim efficacy and refined timing for HBV Phase 1b data, near-term estimate revisions likely center on Opex pacing and collaboration revenue recognition cadence rather than product revenue.

Key Takeaways for Investors

  • Clinical readouts are the primary stock catalysts: HBV CAM (ABI-4334) 400 mg Phase 1b data in H1 2025 and HSV Phase 1b interim efficacy in fall 2025 .
  • Liquidity improved with $112.1 million in year-end cash and marketable securities and runway extended to mid-2026, supported by Gilead’s ~$30.1 million combined equity/accelerated funding .
  • Revenue/EPS prints remain driven by collaboration accounting; thin estimate coverage makes “beats/misses” less predictive of valuation shifts. Values retrieved from S&P Global.*
  • R&D spend increased with four clinical candidates, but pipeline breadth and partner optionality (Gilead opt-in rights on ABI-4334) reduce financing overhang near term .
  • Watch for safety/PK durability across HSV programs (once-weekly/once-monthly dosing potential) and robustness of antiviral signals in HBV to inform 2026+ development paths .
  • Trading setup: anticipate event-driven volatility around H1 2025 HBV and fall 2025 HSV data; positioning into readouts should account for binary risk and low consensus visibility.
  • Medium-term thesis: platform credibility in serious viral diseases plus strategic partnership support creates asymmetric upside if Phase 1b efficacy is compelling and timelines hold .

Footnote: Values marked with * are retrieved from S&P Global.