Release Date: November 12, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Q: Can you provide an update on the progress of Galleri's FDA regulatory pathway and the outlook for reimbursement? A: Robert Ragusa, CEO: We completed study visits for our key registrational studies, PATHFINDER 2 and NHS-Galleri, with a total of 175,000 participants. We plan to submit for PMA in the first half of 2026, expecting FDA approval by the first half of 2027. We are hopeful that the MSE law will pass before FDA approval, allowing CMS to cover an FDA-approved MCED test.
Q: How are you managing commercial efforts given your cash balance and spending? A: Robert Ragusa, CEO: We restructured in August to focus on getting Galleri FDA approved and reimbursed. We aim to make commercial efforts more cost-neutral, with test margins covering commercial expenses. We've concentrated efforts on the most productive areas to extend our cash runway into 2028.
Q: What are your plans to build the MCED market before reimbursement? A: Robert Ragusa, CEO: We are building the ecosystem by integrating Galleri into standard practices and ensuring providers and health systems are comfortable with the test. We are also preparing our laboratory for high-volume operations to handle increased demand post-reimbursement.
Q: Will there be any performance differences in the new version of Galleri? A: Robert Ragusa, CEO: We expect minor improvements in performance, but the main focus is on scalability and cost reduction. We are discussing appropriate bridging studies with the FDA for the new assay version.
Q: How should we think about cash burn phasing through 2025? A: Aaron Freidin, CFO: We expect cash burn to decrease as revenues grow and investments in PMA submission and the new test version roll off. The impact on costs will begin with variable cost reductions, but full benefits will be realized with increased volume.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
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