Release Date: August 14, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Outlook Therapeutics Inc (OTLK, Financial) received marketing authorization for its ophthalmic formulation of bevacizumab in both the European Union and the United Kingdom.
- The company is making significant progress in the United States with its ongoing NORSE EIGHT clinical trial, which is expected to serve as the basis for resubmitting their BLA with the FDA in the first calendar quarter of 2025.
- Outlook Therapeutics Inc (OTLK) has reduced its outstanding convertible notes balance to approximately $30.3 million, with further conversions continuing.
- The company's cash position of $32 million, combined with expected proceeds from warrant exercises, is projected to support operations through calendar 2025.
- The company has completed Type C and Type D meetings with the FDA, addressing all open CMC items received in the CRL, indicating positive progress in regulatory discussions.
Negative Points
- The timing for the BLA resubmission has been pushed to the first calendar quarter of 2025, indicating a delay from the initial expectations.
- Enrollment for the NORSE EIGHT trial is progressing slower than the aggressive initial goal, which has impacted the timeline for BLA resubmission.
- G&A expenses increased in fiscal Q3 compared to fiscal Q2 due to prelaunch expenses for Europe, indicating higher operational costs.
- The company still faces uncertainties in the UK process with NICE, with a tech assessment expected by December, which could impact market access and pricing.
- There are market-specific challenges in Europe regarding off-label use of bevacizumab, which could affect the commercial launch and market penetration.
Q & A Highlights
Highlights from Outlook Therapeutics Inc (OTLK) Q3 2024 Earnings Call
Q: Can you provide more details on the enrollment progress for NORSE EIGHT?
A: We currently have 359 of the planned 400 subjects enrolled and expect to complete enrollment before the end of the third quarter. We have dozens of people in screening, which should take us to 380 patients soon. (C. Russell Trenary, President and CEO)
Q: Will completing enrollment in NORSE EIGHT make it easier to guide the BLA resubmission timeline?
A: Yes, once enrollment is complete, we can better predict the timeline for the last patient visit and database lock, making it easier to provide precise guidance for BLA resubmission. (C. Russell Trenary, President and CEO)
Q: Any updates on the UK process with NICE?
A: We have submitted a well-informed dossier to NICE, and they have accepted our application. We will know more about pricing and other details later in the year. (C. Russell Trenary, President and CEO)
Q: What came out of the Type C and D meetings with the FDA?
A: The timing of the BLA filing is based on enrollment completion, not the FDA meetings. Our discussions with the FDA have been positive, and we have addressed all CMC questions. (C. Russell Trenary, President and CEO)
Q: What led to the shift in BLA filing guidance to Q1 2025?
A: We needed to finish enrollment by the end of July to meet the end-of-year filing goal. Our current enrollment pace is faster than the industry average, but we will complete enrollment by the end of Q3, pushing the BLA submission to early next year. (C. Russell Trenary, President and CEO)
Q: What investments are being made for the European launch, and will this inventory be used for the US as well?
A: We have inventory ready from last year, which will be available for both Europe and the US. We are extending the shelf life of this product, expecting 30-36 months of dating by year-end. (C. Russell Trenary, President and CEO)
Q: How does off-label use dynamics change in the EU and UK post-approval?
A: Off-label use varies by market. Some markets have close to zero off-label use due to legal restrictions. We believe our approved product will compete well based on quality, clinical data, and GMP standards. (C. Russell Trenary, President and CEO)
Q: What are the checklist items for the commercial launch in Europe in the first half of 2025?
A: We are focusing on market access, engaging with health technology assessment groups, attending trade shows, and conducting symposia with doctors. The final step will be deciding on a sales force and medical scientific liaisons. (C. Russell Trenary, President and CEO)
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
