Outlook Therapeutics (OTLK) Q3 Earnings call transcript Aug 14, 2024

Outlook Therapeutics, a leading biopharmaceutical company focused on the development and commercialization of novel therapeutics for retina diseases, recently held a corporate third quarter fiscal year 2024 update conference call to discuss its strategic initiatives and financial performance. The call, led by President and CEO, Russell Trenary, and Chief Financial Officer, Lawrence Kenyon, highlighted the company's progress in the European Union (EU) and the United Kingdom (U.K.) and provided updates on the ongoing NORSE EIGHT clinical trial in the United States.

European Successes and Future Plans

Outlook Therapeutics has achieved a significant milestone with the receipt of marketing authorization for its ophthalmic formulation of bevacizumab in both the EU and the U.K. This approval represents a crucial step towards the company's mission to bring this important drug to patients in these key markets, which together represent the second largest market for wet age-related macular degeneration (wet AMD) in the world. Trenary expressed confidence in the team's hard work and the validated data, emphasizing the potential impact on the lives of millions of patients.

Looking ahead, Outlook Therapeutics is focusing on commercialization efforts in Europe, including market access work and inventory planning for Germany and the U.K. The company aims for product availability in the first half of 2025, with discussions ongoing to evaluate potential partners for EU infrastructure. This strategic move underscores the company's commitment to making a difference in the European market and ensuring access to a high-quality ophthalmic bevacizumab.

U.S. Progress and Future Expectations

In the U.S., Outlook Therapeutics' NORSE EIGHT clinical trial is progressing as planned, with 359 of the 400 planned subjects enrolled as of the call. The trial, a 3-month non-inferiority study with an 8-week efficacy endpoint, is expected to complete enrollment before the end of the third quarter of 2024. Top-line results are anticipated in the fourth quarter of this year, providing essential clinical data for the resubmission of the Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) in the first calendar quarter of 2025.

The company has already held Type C and Type D meetings with the FDA, addressing the open CMC items received in the Complete Response Letter (CRL). This proactive engagement with the FDA reflects Outlook Therapeutics' commitment to ensuring the highest regulatory standards and paving the way for a successful BLA resubmission.

Financial Highlights and Future Outlook

Financially, Outlook Therapeutics reported a reduction in adjusted net loss in the third fiscal quarter of 2024, driven by a decrease in R&D expenses following the completion of major NORSE EIGHT initiation activities. The company's cash position of $32 million, combined with the expected $107 million of proceeds from warrant exercises, is expected to support operations through 2025.

Looking ahead, Outlook Therapeutics remains optimistic about its future prospects, with the potential for regulatory approval and commercialization in key markets driving growth. The company's strategic focus on delivering an ophthalmic formulation of bevacizumab, with enhanced quality and efficacy, positions it well to make a meaningful impact on the retina anti-VEGF space.

In conclusion, Outlook Therapeutics' recent achievements and future plans underscore its commitment to advancing ophthalmic care and bringing innovative solutions to patients with wet AMD. With regulatory approvals, clinical trial progress, and a solid financial foundation in place, the company is well-positioned to make a significant impact in the European and U.S. markets.