Allurion signals sequential revenue growth into 2026 as FDA review nears completion

Earnings Call Insights: Allurion Technologies Inc. (ALUR) Q3 2025

MANAGEMENT VIEW

* Shantanu Gaur, Co-Founder, CEO, President, Principal Financial & Accounting Officer and Director, highlighted recent progress with the FDA, remarking on several major milestones for the Allurion Smart Capsule PMA submission: "In July, FDA completed its acceptance and filing reviews, and we entered the substantive review phase. In August, we successfully passed our pre-approval inspection with 0 findings." He further stated, "In October, we held our Day-100 meeting with FDA, and we were quite pleased with the outcome. After reviewing our PMA submission, FDA did not request any additional human clinical data."
* Gaur announced restructuring efforts in Q3 focused on targeting accounts and distributors offering metabolically healthy weight loss and combination use of the Allurion program with low-dose GLP-1s. He noted, "Revenue was $2.7 million, reflecting the restructuring we conducted in the third quarter."
* The CEO pointed to a new transaction to exchange all outstanding debt for convertible preferred equity and a concurrent private placement financing: "We have entered into a transaction to exchange all outstanding debt for convertible preferred equity and concurrently announced a private placement financing that strengthens our financial position."
* Gaur revealed that Allurion is developing a drug-eluting balloon in collaboration with a strategic partner and pursuing process validation for a new R&D and manufacturing line.
* Tara Brady, Interim Chief Financial Officer, stated, "Our revenue for the third quarter of 2025 was $2.7 million compared to $5.4 million for the same period in 2024. Gross profit for the third quarter was $1.3 million or 49% of revenue compared to $3.1 million or 58% of revenue for the same period in 2024."

OUTLOOK

* Management expects the new strategy to continue yielding results in Q4, with onboarding of new distributors meeting the company’s criteria and internal launch preparations advancing in anticipation of a potential U.S. FDA approval.
* Gaur stated, "We expect our new strategy to continue to bear fruit in the fourth quarter as we onboard new distributors who meet our criteria, and we have been encouraged by the results we have already seen in quarter so far."
* In the Q&A, Gaur indicated, "I would expect in the fourth quarter sequentially to grow compared to Q3. And then moving into 2026, I do expect that sequentially we should be able to continue to grow the top line revenue for the business as more and more of these clinics start to embrace GLP-1s in combination therapy."

FINANCIAL RESULTS

* Revenue for Q3 2025 was $2.7 million, reflecting the impact of restructuring and seasonality. Gross profit was $1.3 million or 49% of revenue, including $0.1 million in restructuring costs.
* Sales and marketing expenses were $3.1 million, research and development expenses were $2.0 million, and general and administrative expenses were $5.8 million, all reflecting cost reductions from previous periods due to restructuring.
* Operating loss for the quarter was $9.6 million, with adjusted operating loss at $6.9 million, excluding $2.7 million in one-time restructuring costs. Cash and cash equivalents as of September 30, 2025, were $6.1 million, not including the $5 million from the private placement financing.

Q&A

* Joshua Jennings, TD Cowen, Research Division, asked about learnings from the international strategy and how it informs U.S. commercialization. Gaur responded, "What we're seeing in our direct accounts is that as accounts embrace and utilize GLP-1s more and more, they are creating new patients as those GLP-1 patients discontinue and then look for alternative therapies."
* Jennings sought clarity on international revenue progression. Gaur replied, "What we're seeing right now in the fourth quarter is continued growth in the direct markets where we are seeing an embrace of combination therapy and GLP-1s...I would expect in the fourth quarter sequentially to grow compared to Q3."
* Jennings asked about development timelines for the Smart Capsule as a platform technology. Gaur explained, "We're also reinitiating the work that we had started a year ago or so on a longer-term balloon that's intended to last in the stomach well beyond 4 months...that is a longer-term project, and we are really thrilled to be initiating it right now."

SENTIMENT ANALYSIS

* Analysts focused on the strategic pivot, international growth, and U.S. market entry, showing a neutral to slightly positive tone, with questions centered on operational execution and strategic milestones.
* Management maintained a confident and optimistic tone in both prepared remarks and responses, using phrases such as "we are confident," "we believe," and "we are thrilled with the progress."
* The tone remained consistent with the previous quarter, with management continuing to show conviction in the revised strategy and analysts probing for details on execution and future revenue progression.

QUARTER-OVER-QUARTER COMPARISON

* The company’s focus on accounts offering combination therapy and metabolically healthy weight loss remained unchanged, but Q3 saw concrete restructuring actions and deeper commentary on FDA milestones and internal U.S. launch preparations.
* Guidance language shifted to anticipate sequential revenue growth in Q4 and into 2026, compared to prior caution about disruption due to restructuring.
* Key metrics reflected lower revenue and gross margin, but operating losses narrowed and cost controls intensified relative to Q2.
* Analysts continued to focus on combination therapy, international uptake, and U.S. market prospects, with a similar tone of cautious inquiry.
* Management’s confidence in the new strategy and operational efficiency gains strengthened, supported by recent FDA feedback and financial restructuring.

RISKS AND CONCERNS

* Management cited ongoing risks tied to FDA approval timing and market launch preparations.
* The company acknowledged revenue decrease as a result of restructuring and seasonality.
* The company referenced the need for new distributor onboarding and the importance of successful execution of the strategic pivot.
* No additional specific analyst concerns were raised in the Q&A.

FINAL TAKEAWAY

Allurion Technologies underscored major regulatory and operational milestones this quarter, highlighting the positive outcome of FDA reviews, a continued pivot toward combination therapy with GLP-1s, and aggressive cost control measures. Management signaled confidence in sequential revenue growth into the fourth quarter and 2026, supported by new distributor relationships and a strengthened balance sheet. The company’s strategic initiatives and readiness for a potential U.S. launch position it for long-term growth, with ongoing innovation in drug delivery platforms and manufacturing capabilities set to drive future value.

Read the full Earnings Call Transcript [https://seekingalpha.com/symbol/alur/earnings/transcripts]

MORE ON ALLURION TECHNOLOGIES

* Allurion Technologies Inc. (ALUR) Q3 2025 Earnings Call Transcript [https://seekingalpha.com/article/4842474-allurion-technologies-inc-alur-q3-2025-earnings-call-transcript]
* Seeking Alpha’s Quant Rating on Allurion Technologies [https://seekingalpha.com/symbol/ALUR/ratings/quant-ratings]
* Historical earnings data for Allurion Technologies [https://seekingalpha.com/symbol/ALUR/earnings]
* Financial information for Allurion Technologies [https://seekingalpha.com/symbol/ALUR/income-statement]