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Clearside Biomedical, Inc. (CLSD)·Q2 2024 Earnings Summary

Executive Summary

  • Q2 2024 was operationally steady with minimal revenue ($0.09M) and a narrower net loss ($7.6M; $0.10 EPS) versus Q2 2023, driven by lower R&D and G&A and a $1.9M non-cash “other income” item from warrant revaluation; cash and short-term investments were $29.4M, with runway into Q3 2025 .
  • ODYSSEY Phase 2b (CLS-AX in wet AMD) remained on track as of the Q2 release, with no drug-related SAEs observed and topline data expected in late Q3 2024; safety committee recommended trial continuation with re-dosing per protocol, positioning CLS-AX for potential Phase 3 planning .
  • Ex-U.S. XIPERE momentum strengthened: Arctic Vision reported positive Phase 3 China results and NDA acceptances in Australia and Singapore; U.S. real-world data showed durable effect (87.7% of eyes free from injected/implanted corticosteroid retreatment for 6 months after a single XIPERE dose) .
  • Company skipped a Q2 earnings call, hosting a July 24 KOL webinar instead; earnings calls expected to resume with Q3 2024 results. Next major stock catalyst: ODYSSEY topline (later updated to “week of Oct 7, 2024”) .

What Went Well and What Went Wrong

What Went Well

  • ODYSSEY safety reaffirmed with no drug-related SAEs (no endophthalmitis or retinal vasculitis) and continuation without protocol changes; re-dosing underway—key to evaluating durability and informing Phase 3 design. “Both arms…completed six months of treatment…Re-dosing with CLS-AX is an important and differentiating feature…” — CEO George Lasezkay .
  • XIPERE/ARCATUS momentum: Arctic Vision Phase 3 met primary and secondary endpoints in China, with significant BCVA and CST benefits; NDAs accepted in Australia and Singapore, validating global opportunity .
  • Published consensus guidelines for suprachoroidal administration (RETINA®) and OASIS safety paper in Ophthalmology Science bolstered physician confidence and platform credibility .

What Went Wrong

  • Revenue downtick YoY as milestone/licensing contributions lapped prior-year items: license and other revenue fell to $0.09M from $1.02M in Q2 2023; operating model remains dependent on partnering and milestone timing .
  • Non-cash royalty-financing drag persisted: $2.34M non-cash interest expense on the royalty liability; core P&L remains loss-making pending pipeline inflections .
  • Estimates comparison not available: S&P Global consensus data could not be retrieved (temporary access limit), limiting external benchmark of quarterly results vs. Street expectations (see Estimates Context) [GetEstimates error].

Financial Results

MetricQ2 2023Q1 2024Q2 2024
License and other revenue ($M)$1.018 $0.230 $0.090
Research & development ($M)$4.948 $5.615 $4.603
General & administrative ($M)$3.127 $2.824 $3.077
Total operating expenses ($M)$8.288 $8.439 $7.680
Loss from operations ($M)$(7.270) $(8.209) $(7.590)
Interest income ($M)$0.458 $0.348 $0.419
Other income (expense), net ($M)$0.000 $(1.499) $1.917
Non-cash interest expense on royalty liability ($M)$(2.294) $(2.403) $(2.340)
Net loss ($M)$(9.106) $(11.763) $(7.594)
Diluted EPS ($)$(0.15) $(0.17) $(0.10)
Weighted avg shares (M)61.655 69.853 74.731

Notes:

  • Cash and cash equivalents were $18.238M and short-term investments $11.122M at 6/30/24 (total $29.4M); company guides runway into Q3 2025 .

No segments are reported; KPIs center on clinical progress and cash runway .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
ODYSSEY topline timing2024“Topline data expected in late Q3 2024” (Q2 release) “Topline data expected during the week of Oct 7, 2024” (Aug 27 update) Slight delay from late Q3 to early Q4
Quarterly earnings call cadence2024Normal cadence (held in Q1 2024) No Q2 call; KOL webinar July 24; earnings calls to resume with Q3 2024 results Temporarily suspended in Q2
Cash runwayThrough 2025“Into Q3 2025” (Q1) “Into Q3 2025” (Q2) Maintained
ARCATUS (XIPERE) ex-APAC regulatory2024Positive Phase 3 expected; filings planned China Phase 3 positive; NDAs accepted in Australia & Singapore Progressed as expected

Earnings Call Themes & Trends

TopicPrevious Mentions (Q4 2023 and Q1 2024)Current Period (Q2 2024)Trend
CLS-AX/ODYSSEY progress, design, durabilityFocus on ODYSSEY Phase 2b timing (Q3 2024 topline), design to inform Phase 3; emphasize long-acting maintenance potential and re-dosing; strong physician interest Safety committee: no drug-related SAEs; re-dosing under protocol; topline expected late Q3 2024 Continued execution; later timing update to week of Oct 7
Suprachoroidal platform acceptancePermanent Category 1 CPT code; partners showing progress (REGENXBIO, Aura) RETINA® consensus guidelines; OASIS safety publication; KOL webinar highlighting real-world utility Physician education and validation increasing
Partner programsREGENXBIO DR/AMD updates; Aura Phase 3 SPA; BioCryst license (DME) Arctic Vision Phase 3 positive; NDAs accepted in AU/SG for ARCATUS Portfolio of external programs advancing
XIPERE real-world performance>75% of eyes with 6-month durability in U.S. real-world analysis 87.7% of eyes free of injected/implanted corticosteroid retreatment at 6 months after one dose (new data) Strengthening durability signal
Capital runwayInto Q3 2025 (post financing) Into Q3 2025 reiterated Stable

Management Commentary

  • “Our Phase 2b ODYSSEY clinical trial…continues to advance on track and on time with topline data expected in late Q3 2024…[no] drug-related Serious Adverse Events…both arms…completed six months of treatment…Re-dosing with CLS-AX is an important and differentiating feature…” — George Lasezkay, CEO (Q2 release) .
  • “Data…on the real-world use of XIPERE…showed…excellent durability as 87.7% of eyes did not require an injected or implanted corticosteroid for 6 months after a single dose…” — George Lasezkay (Q2 release) .
  • “Our target profile for CLS-AX is to maintain visual acuity without the need for retreatment for potentially up to 6 months…ODYSSEY…allows re-treatment…[and] will provide valuable data…as we begin planning our Phase 3…” — Victor Chong, CMO (Q1 call) .
  • “As of June 30, 2024, cash, cash equivalents and short-term investments totaled $29.4 million. The Company believes it will have sufficient resources to fund its planned operations into the third quarter of 2025.” — Company statement (Q2 release) .

Q&A Highlights

  • Durability/endpoints and Phase 3 design: Management emphasized focusing Phase 3 on visual acuity and retreatment dynamics, leveraging multi-dosing data from ODYSSEY’s 36-week design and mandated 6-month re-dosing in CLS-AX arm .
  • Positioning of TKIs: Viewed as complementary maintenance therapies with anti-VEGF, aiming to extend dosing intervals; potential class role emerging despite heterogeneous mid-stage designs across companies .
  • FDA guidance: Draft guidance for wet AMD remains unfinalized; company expects direct engagement with FDA ahead of Phase 3 design decisions .
  • Safety of suprachoroidal injection: Management reiterated strong safety profile comparable to intravitreal procedures and favorable OASIS safety outcomes (no inflammation or DLTs in Phase 1/2a) .

Note: There was no Q2 2024 earnings call; comments above reflect Q1 2024 Q&A and Q2 press communications .

Estimates Context

  • We attempted to retrieve S&P Global (Capital IQ) consensus for Q2 2024 revenue and EPS; data was unavailable due to a temporary access limit. As a result, we cannot declare a beat/miss versus Street for this quarter (S&P Global consensus unavailable at time of analysis) [GetEstimates error].

Where estimates may need to adjust:

  • Given minimal reported revenue and primarily non-cash P&L drivers (warrant revaluation, royalty financing imputed interest), Street models likely remain focused on cash runway and ODYSSEY timing; the subsequent timing update to the week of Oct 7, 2024 may slightly shift event-driven timelines in models .
  • Positive external validation for XIPERE/ARCATUS and continued partner progress could support longer-term royalty/milestone scenarios in out-years .

Key Takeaways for Investors

  • Binary-ish near-term catalyst remains ODYSSEY topline (now guided to week of Oct 7, 2024); safety and re-dosing datasets are central to Phase 3 design and durability narrative .
  • Operating discipline showed in Q2 with lower R&D and G&A YoY and a narrower net loss; however, the core model remains pre-commercial for CLS-AX and sensitive to non-cash items (warrants, royalty financing) .
  • Cash runway into Q3 2025 provides sufficient time to read out ODYSSEY and prepare for Phase 3, reducing near-term financing overhang, assuming timelines hold .
  • Suprachoroidal platform acceptance is building (CPT code, published guidelines, OASIS safety paper), a potential strategic moat supporting both internal assets and partner economics .
  • Real-world and ex-U.S. clinical data for XIPERE/ARCATUS reinforce platform durability and global potential; partner regulatory progress can unlock future milestone/royalty streams .
  • Trading setup is event-driven around ODYSSEY; in the absence of estimate benchmarks this quarter, stock movement likely keys off trial timing updates and any pre-readout sentiment shifts .
  • Medium-term thesis depends on CLS-AX demonstrating meaningful durability with maintained vision and acceptable safety; positive Phase 2b readout could catalyze partnership or financing on improved terms ahead of Phase 3 .

Citations

  • Q2 2024 8-K and Exhibit 99.1 press release and financial tables:
  • Q2 2024 press release duplicate (GlobeNewswire) and financial tables:
  • KOL webinar announcement (June 27, 2024):
  • Clinical presentations and platform update (June 12, 2024):
  • Arctic Vision Phase 3 and NDAs (July 29, 2024):
  • ODYSSEY final visit and topline timing update (Aug 27, 2024):
  • Q1 2024 8-K and call transcript (for prior-quarter comps and Q&A themes):
  • Q4 2023 8-K and call transcript (for trend context):
  • Estimates retrieval attempt: S&P Global consensus unavailable due to access limit [GetEstimates error].