Clearside Biomedical, Inc.
Clearside Biomedical, Inc. Q2 FY2023 earnings call
August 14, 2023 · fiscal period ended 2023-06
EPS · actual vs est
Revenue · actual vs est
Summary
Generated 2023-08-14
Management highlights
• George highlighted Clearside is a leader in delivering agents to the suprachoroidal space with a proprietary SCS microinjector. • XIPERE is the first and only FDA-approved SCS product, with Bausch & Lomb and Arctic Vision advancing its development. • CLS-AX's OASIS Phase I/IIa results showed favorable safety, with 2/3 of participants not needing supplemental treatment for 6+ months. • ODYSSEY Phase IIb trial in wet AMD is underway to evaluate CLS-AX's safety, efficacy, and dosing. • Collaborations with REGENXBIO and Aura Biosciences are making progress, with REGENXBIO reporting on gene therapy and Aura on choroidal melanoma drug candidate.
Segment performance
No specific financial performance details per product segment in terms of absolute revenue and contribution % were provided in the transcript.
Guidance
• As of June 30, 2023, cash and cash equivalents totaled ~$35M. • Expect sufficient resources to fund planned operations into Q3 2024. • Look forward to participating in investor conferences like H.C. Wainright Ophthalmology Conference, Global Healthcare Conference, and Jones Trading Healthcare Summit.
Q&A highlights
Q: Jon Wolleben asked about site enrollment in ODYSSEY and number of dosed patients.
A: George said they're close to 30 sites, feeling good about that, and multiple patients randomized but no update on exact number dosed.
Q: Jon Wolleben asked about modeling for CLS-AX re-dosing.
A: George expects few early rescues, anticipating most patients to go 6 months without supplemental therapy.
Q: Andreas Argyrides asked about ODYSSEY enrollment timeline and powering assumptions.
A: George said it's a Phase IIb trial, not set up for non-inferiority/superiority with powered outcomes, nearly at 30 sites, expecting top line data in Q3 2024.
Q: Shawn Kim asked about retinal vasculitis with Clearside injections and ODYSSEY endpoint.
A: George said no reports of retinal vasculitis, BCVA is key endpoint for dosing interval.
Q: Rohit Bhasin asked about new collaborations and cash balance.
A: George said they're in discussions for new collaborations, Charlie said cash can get them to Q3 2024 and they're looking to extend runway.
Q: Jack Padavano asked about partner economics and catalysts.
A: Charlie said they can't discuss specific milestones or sales, but milestones go to HCR.
Q: Yi Chen asked about REGENXBIO's candidate vs CLS-AX and XIPERE prescription volume.
A: George said REGENXBIO's candidate is complementary, Charlie said they can't discuss XIPERE prescription volume.
Q: Yi Chen asked about Australia approval timeline for XIPERE.
A: George said Australian approval process is similar to US, ~12-month review cycle, expecting news by next year.
Key numbers
Reported versus consensus
Earnings calendar feed
| Metric | Reported | Consensus | Delta | Prior year |
|---|---|---|---|---|
| EPS | $-0.15 | $-0.14 | -7.1% | — |
| Revenue | $1.0M | $120,000 | +748.3% | — |
Transcript
August 14, 2023Full transcript unavailable for redistribution
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