Q2 2025 Ocular Therapeutix Inc Earnings Call Transcript

Aug 5, 2025 / 12:00 PM GMT

Release Date Price: €9.74 (-2.29%)

Transcript 10-Q8-K

Key Points

Positve

Ocular Therapeutix Inc (OCUL) has made significant progress in its registrational trials for expaxley, with both SoLL1 and SoLLA trials advancing expeditiously and maintaining exceptional retention rates.
The company has secured a Special Protocol Assessment (SPA) agreement with the FDA for its SoLL1 trial, which is designed as a superiority study, potentially positioning expaxley as the first product for Wet AMD with a superiority claim.
Ocular Therapeutix Inc (OCUL) has over $390 million in cash and cash equivalents, providing financial flexibility and expected runway into 2028, supporting both near-term execution and long-term strategic investments.
The company is preparing to expand its reach into diabetic eye diseases, following positive FDA feedback on its proposed trial design for diabetic retinopathy, which could offer a long-acting solution with just 1 or 2 treatments per year.
Ocular Therapeutix Inc (OCUL) plans to leverage the 505(b)(2) NDA review pathway for expaxley, potentially shortening the review timeline by 2 months compared to the traditional review pathway for new molecular entities.

Negative

Despite recent advances, the burden of frequent injections for Wet AMD remains unmanageable for many patients, with nearly 40% of patients in the US discontinuing treatment within the first year.
The company faces the challenge of translating the success of the SoLL1 trial to the SoLLA trial, as the patient populations are deliberately different, which may impact the confidence in the translation of results.
The change in rescue criteria for the Solar trial, although strategically advantageous, was not required by the FDA, and there is no guarantee that it will not impact the primary endpoint readout.
Ocular Therapeutix Inc (OCUL) is still in the planning phases for potential clinical trial activities for expaxley in NPDR and the long-term extension study in Wet AMD, which could impact future cash guidance.
The company acknowledges that the market for Wet AMD treatments is crowded with 'me-too' drugs, and achieving a superiority label is crucial for distinguishing expaxley from competitors.

Refinitiv StreetEvents Event Transcript
E D I T E D V E R S I O N

OCUL.OQ - Ocular Therapeutix Inc
Q2 2025 Ocular Therapeutix Inc Earnings Call
Aug 05, 2025 / 12:00PM GMT

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Presentation
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Unidentified_1 [1]
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Good morning and welcome to the Ocular Therapeutics 2nd quarter 2025 earnings conference call. At this time, all participants are in listen-only mode. After the prepared remarks, we will conduct a question and answer session. To ask a question, please press 1. As a reminder, this conference call is being recorded and will be available for replay on the investor relations section of the Ocular Therapeutics website.

I would now like to return the call over to Ocaur's Vice President of Investor Relations, Bill Slattery Junior. Please go ahead, Mr. Slattery.

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Unidentified_2 [2]
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