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EYPT

EyePoint, Inc.

EyePoint, Inc. Q4 FY2023 earnings call

March 7, 2024 · fiscal period ended 2023-12

EPS · actual vs est

$-0.33 / $-0.60Beat +45.0%

Revenue · actual vs est

$14.0M / $9.0MBeat +56.2%
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Summary

Generated 2024-03-07

Management highlights

• Transformed into a clinical-stage biopharmaceutical by licensing YUTIQ franchise for $82.5M plus royalties. • Advanced EYP-1901 in wet AMD, NPDR, and DME. Phase 2 DAVIO 2 in wet AMD achieved primary and secondary endpoints. • Planned Phase 3 LUGANO and Lucia trials for wet AMD, Phase 2 PAVIA for NPDR, and Phase 2 VERONA for DME. • Ended 2023 with $331 million in cash and investments, no debt. • Introduced new Chief Medical Officer Dr. Ramiro Ribeiro.

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Segment performance

For the quarter ended December 31, 2023, total net revenue was $14 million compared to $10.5 million in the prior year. Net product revenue for the 2023 quarter was $0.7 million vs. $9.9 million in 2022. Royalty and collaboration revenue for the 2023 quarter was $13.3 million vs. $0.6 million in 2022. For the full year ended December 31, 2023, total net revenue was $46 million vs. $41.4 million in 2022. Net product revenue for the full year was $14.2 million vs. $39.9 million in 2022. Royalty and collaboration revenue for the full year was $31.8 million vs. $1.5 million in 2022.

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Guidance

• Anticipate top-line data from Phase 2 PAVIA trial in 2Q 2024. • End of Phase 2 meeting with FDA in April. • Initiation of Phase 3 LUGANO trial in wet AMD in 2H 2024. • Enrollment completion of Phase 2 VERONA trial and top-line data in 1Q 2025. • Pipeline programs advancing towards clinical development.

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Risks

• Forward-looking statements subject to actual results differing due to factors like those in the Risk Factors section of Form 10-K. • Clinical trial risks, including potential failure to meet endpoints or regulatory hurdles.

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Q&A highlights

Q: As you think about the potential opportunity for EYP-1901, can you provide further context around segmenting the NPDR population and identifying low-hanging fruit?

A: Jay Duker and Ramiro Ribeiro discussed NPDR population segmentation, with most severe NPDR patients being initial targets to prevent site-threatening complications.

Q: For the planned end of Phase 2 meeting with the FDA, can you elaborate on key discussion topics?

A: Jay Duker mentioned general agreement on non-inferiority trial design with a -4.5% margin, and discussion around inclusion/exclusion criteria and safety cohort.

Q: On NPDR study, why a 30% response rate floor and focus on BCVA?

A: Jay Duker explained the 30% floor is a lower limit, and BCVA isn't a primary endpoint for NPDR as most patients retain good vision.

Q: On NPDR and DME studies, what's the readthrough and market dynamics?

A: Jay Duker stated key readthrough is showing benefit in diabetic population, with DME being an extension of NPDR, and modeling $1B+ opportunity in DR and DME.

Q: In light of wet AMD data, any new market research on clinician/payer reactions?

A: Jay Duker mentioned ongoing market research, with positive initial feedback from practitioners and payers.

Q: On wet AMD Phase 3 design, role of low dose arm?

A: Jay Duker said low dose arm is for masking, and 2mg and 3mg doses worked equivalently in DAVIO 2.

Q: For DME, what's the paradigm difference and modeling?

A: Jay Duker explained DME is a VEGF-mediated disease where sustained release could reduce treatment burden, with modeling based on showing biological improvement in NPDR.

Q: View on gene therapy as competitor for wet AMD?

A: Jay Duker noted gene therapy is exciting but faces challenges in cost-effectiveness and narrow therapeutic window compared to current therapies.

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Key numbers

Reported versus consensus

Earnings calendar feed

MetricReportedConsensusDeltaPrior year
EPS$-0.33$-0.60+45.0%$-0.61
Revenue$14.0M$9.0M+56.2%$10.5M

Transcript

March 7, 2024

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