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Sep 30
Allurion Q3 2025 Earnings Report
Allurion reported its financial results for the third quarter of 2025, highlighting significant milestones towards FDA approval and strategic financial strengthening.
Key Takeaways
Allurion Technologies, Inc. announced its third-quarter 2025 financial results, reporting a revenue of $2.7 million and a net loss of $11.9 million. The company successfully passed FDA inspections with zero observations and completed its Day-100 meeting, indicating progress towards FDA approval. Additionally, Allurion strengthened its balance sheet by exchanging outstanding debt for convertible preferred equity and securing $5 million in private placement financing.
Successfully passed U.S. FDA Pre-Approval Inspection and Bioresearch Monitoring (BIMO) audit with zero observations.
Completed Premarket Approval (PMA) Acceptance and Filing Reviews, entering Substantive Review for the Allurion Smart Capsule.
Exchanged all outstanding debt for convertible preferred equity and secured $5 million in private placement financing.
Operating expenses reduced by 29% and operating loss by 22% compared to the previous year.
Allurion
Allurion
Forward Guidance
Allurion is optimistic about its future, particularly regarding FDA approval for the Allurion Smart Capsule and its potential as a platform technology for drug delivery beyond obesity management.
Positive Outlook
- Anticipates entering the final stages of FDA approval for the Allurion Smart Capsule.
- Strengthened balance sheet positions the company to deliver on key catalysts, including FDA approval.
- Executing a strategy to focus on accounts offering comprehensive obesity care and distributors with network access.
- Exploring next-generation R&D and manufacturing initiatives with a new strategic partner.
- Believes the Allurion Smart Capsule could become a platform technology for delivering various drugs, addressing adherence issues in pharmacotherapy.
Challenges Ahead
- General economic, political, and business conditions could impact performance.
- Ability to obtain and maintain regulatory approval for the Allurion Program is crucial.
- Timing and results of clinical studies and trials, especially for GLP-1 combinations, are uncertain.
- Evolution of competitive markets, including the impact of GLP-1 drugs, poses a risk.
- Maintaining listing on the New York Stock Exchange and navigating a changing regulatory landscape are ongoing challenges.