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Clearside Biomedical, Inc. (CLSD)·Q4 2024 Earnings Summary

Executive Summary

  • Q4 2024 revenue was $0.306M, a modest beat vs Wall Street consensus of $0.294M; GAAP net loss was $7.306M with EPS of $-0.10. EPS also came in better than consensus ($-1.55*) with a narrower-than-expected loss; revenue and EPS beats were driven by lower R&D spending post-ODYSSEY completion and stable G&A . Consensus values from S&P Global*.
  • Management completed a successful End-of-Phase 2 FDA meeting, aligning on two pivotal non-inferiority Phase 3 trials in wet AMD for CLS-AX with flexible redosing intervals (12–24 weeks), supported by AI-based OCT biomarkers .
  • Liquidity runway improved: cash and cash equivalents of $20.0M at year-end, with runway extended into Q4 2025 (vs Q3 runway guided in Nov.); financing strategies (including potential partnerships) are being pursued to commence Phase 3 in 2H 2025 .
  • Narrative catalysts: Phase 3 initiation timing and funding clarity, payer receptivity to 3–6 month flexible dosing, and further data releases on ODYSSEY sub-analyses and partner programs (REGENXBIO, Aura, Arctic Vision) .

What Went Well and What Went Wrong

What Went Well

  • Successful FDA End-of-Phase 2 alignment on Phase 3 plans for CLS-AX in wet AMD; design includes two non-inferiority trials with flexible dosing, targeting real-world maintenance therapy needs .
  • Positive ODYSSEY Phase 2b data: stable BCVA and CST through 36 weeks, strong durability (67% intervention-free to 24 weeks) and 84% reduction in treatment burden; favorable safety profile with no ocular/treatment-related SAEs .
  • Validating partner progress (Arctic Vision, REGENXBIO/AbbVie, Aura, BioCryst) and expanded regional approvals/NDAs for ARCATUS/XIPERE, underscoring suprachoroidal platform traction. “We continue to have increasing interest among retinal specialists and leading pharmaceutical companies” — CEO George Lasezkay .

What Went Wrong

  • Revenue mix normalization vs prior-year milestone/licensing: Q4 2024 license & other revenue fell to $0.306M from $6.345M YoY, driving a higher YoY net loss and underscoring dependence on partner payments timing .
  • Financing uncertainty: Management reiterated Phase 3 readiness but noted trial funding is not yet secured; timeline contingent on financing with options under evaluation (including partnerships) .
  • Operating leverage still limited near-term: while R&D decreased post-ODYSSEY, total OpEx remained significant (Q4 R&D $4.244M; G&A $3.062M), keeping GAAP losses elevated in a low-revenue quarter .

Financial Results

P&L vs Prior Quarters (units: $USD Thousands)

MetricQ2 2024Q3 2024Q4 2024
License and other revenue$90 $1,038 $306
Net loss$(7,594) $(7,688) $(7,306)
Net loss per share (basic & diluted)$(0.10) $(0.10) $(0.10)
Research & development$4,603 $4,128 $4,244
General & administrative$3,077 $2,844 $3,062
Total operating expenses$7,680 $6,972 $7,455

YoY comparison (units: $USD Thousands)

MetricQ4 2023Q4 2024
License and other revenue$6,345 $306
Net loss$(4,832) $(7,306)
Net loss per share$(0.08) $(0.10)

Liquidity KPIs

MetricQ2 2024Q3 2024Q4 2024
Cash and cash equivalents$18,238 $13,888 $20,020
Short-term investments$11,122 $9,703 —

Estimates vs Actuals (Q4 2024)

MetricConsensus (S&P Global)Actual
Revenue ($USD)$294,430*$306,000
EPS ($USD)$(1.55)*$(0.10)

Notes: Values retrieved from S&P Global*.

Highlights:

  • Revenue: $0.306M vs $0.294M consensus — bold beat on a small base.
  • EPS: $(0.10) vs $(1.55)* consensus — bold beat with narrower loss; consensus may reflect different reporting basis.

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Liquidity runwayOperating funding horizon“Into Q3 2025” as of Q3 release “Into Q4 2025” as of Q4 release Raised
Phase 3 initiation (CLS-AX, wet AMD)2025 timingTarget start in 2H 2025 (Q3 call) “Ready to start in 2H 2025; contingent on funding” (Q4 call) Maintained timeline; added funding contingency
Trial design clarityPhase 3 programPlanned EoP2 early 2025 (Q3) EoP2 meeting completed; alignment on design Formalized/advanced

No revenue, margin, tax rate, or OpEx numerical guidance was provided .

Earnings Call Themes & Trends

TopicPrevious Mentions (Q2 2024)Previous Mentions (Q3 2024)Current Period (Q4 2024)Trend
CLS-AX Phase 3 strategyODYSSEY on track; safety review clean; planning Phase 3; flexible maintenance dosing focus Phase 3 likely two non-inferiority trials vs aflibercept; flexible dosing; EoP2 early 2025 EoP2 meeting successful; aligned on two non-inferiority trials, PTI-based flexible redosing (12–24 weeks), AI OCT biomarkers Advancing from planning to aligned design
Durability and redosingAnticipated value of redosing data from ODYSSEY 84% injection reduction; up to 6 months intervention-free; multi-dose data unique among TKIs Reiterated durability; minimal/no anti-VEGF rescue expected in Phase 3 due to tighter redosing criteria Reinforced as differentiator
Financing for Phase 3Not discussedNot quantified; costs TBD Funding not yet secured; options include partnerships; studies comparable peers ~$55–$60M each cited (others’ programs) Active pursuit; cost framework referenced
Payer and pricingNot discussedKOL preference for flexibility; adoption considerations Payer research supports reimbursement for 3–6 month label; low COGS may allow competitive pricing Positive payer stance
Pipeline expansion (GA)Evaluating small molecules; consensus SCS delivery guidelines published Two approaches: choroidal perfusion and inflammatory modulation Continued GA preclinical work towards candidate/IND; rationale for choroidal-first targeting Steady progress
Partner programsXIPERE/ARCATUS progress; REGENXBIO updates REGENXBIO pivotal DR in 1H25; Aura Phase 3 enrollment RGX-314 Phase 3 planning; Arctic Vision NDA accepted in China; regional approvals Broad validation increasing

Management Commentary

  • “We are redefining the delivery of therapeutics to the retina through the suprachoroidal space... designed the CLS-AX Phase 3 program to maximize commercial potential in wet AMD” — George Lasezkay, CEO .
  • “We are aligned on a pivotal Phase 3 program... positioned for success and maximizes the commercial potential for CLS-AX in wet AMD” — CEO prepared remarks .
  • “By targeting treatment-naive patients in a Phase 3 trial, there may be an even greater percentage of patients reaching 6 months without the need for any intervention” — Victor Chong, CMO .
  • “We need to fund the clinical part of the study... pursuing all our options, including potentially partnering with one or more third parties” — Charlie Deignan, CFO .

Q&A Highlights

  • Enrollment timeline and design: Phase 3 enrollment expected ~12 months; FDA will assess safety/efficacy on overall arm rather than by interval subgroup, consistent with EYLEA HD/VABYSMO precedents .
  • Program costs and feasibility: Management referenced peer Phase 3 costs ~$55–$60M per study; global CRO will be used; team has prior Phase 3 execution experience (RVO) .
  • Trial design choice: Two non-inferiority studies preferred (proven regulatory path) vs superiority, consistent with recent retinal approvals .
  • Masking and sham procedures: Monthly assessment and procedure at each visit (injection/sham/aflibercept) to ensure blinding per FDA discussions .
  • Redosing vs rescue criteria: Redosing guided by AI-derived OCT biomarkers (intraretinal vs subretinal fluid); rescue reserved for combined vision loss and worsening anatomy; expectation of minimal/no rescue in Phase 3 .

Estimates Context

  • Q4 2024 results vs consensus: Revenue $0.306M vs $0.294M consensus — beat; EPS $(0.10) vs $(1.55)* consensus — beat with narrower loss . Consensus values from S&P Global*.
  • Implications: Given small absolute revenue, estimate revisions likely modest; key revisions may center on Phase 3 start probability/timing and cash runway extension rather than near-term P&L.

Key Takeaways for Investors

  • Phase 3-ready asset with FDA-aligned design; CLS-AX aims to be a flexible, durable maintenance therapy (12–24 week intervals) in a >$12B wet AMD market — a clear strategic positioning vs fixed 6-month TKI competitors .
  • Liquidity improved to fund operations into Q4 2025; near-term stock drivers are funding clarity and Phase 3 initiation milestones (2H 2025 target) .
  • Durable ODYSSEY data and positive safety profile support the redosing strategy; minimal rescue expectation reduces regulatory risk and enhances commercial narrative .
  • Payer research indicates receptivity to a 3–6 month flexible label; lower COGS potential could enable competitive pricing and facilitate uptake .
  • Partner programs (REGENXBIO/AbbVie, Aura, Arctic Vision) strengthen platform validation and possible non-dilutive catalysts via milestones/royalties .
  • Revenue is currently lumpy and driven by licensing/services; investment thesis hinges on clinical execution and financing rather than near-term top-line growth .
  • Short-term trading: Watch funding announcements, Phase 3 site activation updates, and additional ODYSSEY sub-analyses; Medium-term: monitor Phase 3 enrollment cadence, payer dialogues, and GA pipeline progress .

Notes: Values retrieved from S&P Global* where marked.