Allurion Technologies Inc. Q3 FY2025 earnings call

• FDA Approval Process: Submitted the fourth and final module of PMA submission in June, passed critical milestones including acceptance and filing reviews, pre-approval inspection with 0 findings, BIMO inspection with no observations, and Day-100 meeting with FDA that didn't request additional human clinical data.
• Third Quarter Performance: Revenue $2.7 million despite restructuring and seasonality; customers see GLP-1 discontinuation as a source of new patients.
• Balance Sheet Restructuring: Exchanged outstanding debt for convertible preferred equity and announced private placement financing to be debt-free.
• R&D and Manufacturing: Exploring drug-eluting balloon development with strategic partner, beginning process validation of new R&D and manufacturing line.
• Clinical Pipeline: Completed submissions of combination therapy protocol to IRBs, made necessary changes.

In the third quarter of 2025, revenue was $2.7 million, down from $5.4 million in the same period of 2024. Gross profit for the third quarter was $1.3 million (49% of revenue) compared to $3.1 million (58% of revenue) in the same period of 2024. Sales and marketing expenses for the third quarter were $3.1 million compared to $5.2 million in the same period of 2024. Research and development expenses were $2.0 million compared to $3.2 million in the same period of 2024. General and administrative expenses were $5.8 million compared to $7.0 million in the same period of 2024. Loss from operations was $9.6 million compared to $12.3 million in the same period of 2024.

• Fourth quarter expected to grow sequentially compared to Q3.
• 2026 expected to continue growing top-line revenue as more clinics embrace GLP-1s in combination therapy.
• U.S. market to be boosted by potential price reductions of GLP-1s due to Trump administration initiatives, leading to higher churn rates and more patients seeking alternative therapies.

• Uncertainty regarding FDA approval of the Allurion Smart Capsule.
• Intense market competition in the obesity therapy space.
• Risks associated with the private placement financing and debt restructuring.

Q: How is the learning from the international strategy informing the U.S. commercial strategy and update on U.S. market attack once approval is in hand?

A: Learnings from international markets show GLP-1 discontinuation creates new patients, and in the U.S., mapping clinics that utilize GLP-1s and can deploy Allurion Smart Capsule. Intend to strike new partnerships with distributors in regions embracing combination therapy.

Q: Progression of international revenues over next 12 - 24 months and U.S. market impact?

A: Fourth quarter expected to grow sequentially; 2026 expected to continue growing top line as more clinics embrace GLP-1s. U.S. price reductions of GLP-1s due to Trump admin initiatives will drive uptake and more patients seeking alternatives after GLP-1 discontinuation.

Q: Details on time lines of Smart Capsule development as a platform technology and other pipeline projects?

A: Smart Capsule as a platform has potential for drug elution of various molecules and gut microbiome enhancers. Work on longer-term balloon lasting over 4 months is reinitiated, with opportunities for multiple therapeutics for chronic diseases.