Allurion Technologies Q3 2025 Earnings Call - FDA Milestones Signal U.S. Launch Readiness Amid Strategic Pivot

Mark, Conference Operator: Hello, and thank you for standing by. My name is Mark, and I will be your conference operator today. At this time, I would like to welcome everyone to the Allurion Third Quarter Earnings Call. All lines have been placed on mute to prevent any background noise. After the speaker’s remarks, there will be a question-and-answer session. If you would like to ask a question during this time, simply press star then the number one on your telephone keypad. To withdraw your question, press star one again. Thank you. Now, I would like to turn the call over to Tara Brady. Please go ahead.

Tara Brady, Interim Chief Financial Officer, Allurion Technologies: Good morning, and thank you for joining us. Earlier today, Allurion Technologies issued a press release announcing financial results for the quarter ended September 30, 2025, and provided a business update. You can access a copy of the announcement on the company’s website at investors.allurion.com. With me on the call today is Shantanu Gaur, Founder and Chief Executive Officer. Before we begin, I would like to inform you that comments mentioned on today’s call contain forward-looking statements within the meaning of federal securities laws. Actual results may differ materially from those expressed or implied as a result of certain risks and uncertainties. These risks and uncertainties are described in detail in our Securities and Exchange Commission filings, including our annual report on our Form 10-K filed on March 27, 2025, as amended by Amendment Number 1, thereto filed on August 19, 2025.

Our SEC filings can be found through our company website at investors.allurion.com or the SEC’s website. Investors are cautioned not to place undue reliance on such forward-looking statements, and Allurion undertakes no obligation to publicly update or release any revisions on these forward-looking statements. In addition to the company’s GAAP results, management will also provide supplementary results on a non-GAAP basis. Please refer to the press release issued today and the accompanying supplementary financial data tables for a detailed reconciliation of GAAP and non-GAAP results, which can be accessed from the investor relations section of the company’s website. Please note that this conference call is being recorded and will be available for audio replay on our website under the events and presentation section on our investor relations page shortly after the conclusion of this call. I will turn it over to Shantanu.

Shantanu Gaur, Founder and Chief Executive Officer, Allurion Technologies: Good morning, and as always, thank you for joining us today. Before discussing our third-quarter results, I would like to begin by sharing what we believe are several exciting updates regarding the FDA approval process for the Allurion Smart Capsule. As you may recall, in June, we submitted the fourth and final module of our PMA submission to the FDA. Since June, we have passed several critical milestones on our way to a potential FDA approval. 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 zero findings. The pre-approval inspection is designed to assess a company’s systems, methods, and procedures to ensure that the quality management system is effectively established. The inspection covered compliance with regulatory requirements, process quality, and documentation standards. There were no observations raised and no Form 483 issued.

In October, the company underwent a bioresearch monitoring, or BIMO, inspection. The BIMO inspection is designed to assess a company’s clinical trial systems, methods, and procedures to ensure data integrity. Again, there were no observations raised and no Form 483 was issued. 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. We believe this is a very positive sign that we are entering the final stages of the review process. We believe passing these inspections with no observations and completing the Day 100 meeting in this manner are major milestones for Allurion on our path toward FDA approval, are testaments to our commitment to upholding the highest quality standards, and are indicative of our readiness to serve the U.S. market.

In light of these developments, we have begun to advance our own launch preparations internally and intend to share further updates on upcoming calls. Shifting now to the third quarter, revenue was $2.7 million, reflecting the restructuring we conducted in the third quarter to refocus our efforts on accounts and distributors who promote metabolically healthy weight loss as part of a comprehensive obesity management strategy that includes combination use of the Allurion program with low-dose GLP-1s. We were pleased with our performance in the third quarter despite the restructuring that we conducted in August and the seasonality we often observe due to the summer months. In my recent conversations with our customers, it is becoming clear that GLP-1 discontinuation can be a rich source of new patients for Allurion.

Some customers have indicated that half of their Allurion patients have previously tried a GLP-1, validating our hypothesis that by focusing on accounts that offer multiple modalities of care, we can have access to a steady supply of patients. Even among clinics that offer exceptional follow-up to their patients who are taking GLP-1s, over half of these patients churn after one year. As a result, we continue to believe that the pivot we executed last quarter will lead to long-term growth and refinement of the strategy that we could utilize out of the gate in the U.S. market, especially if GLP-1 prices continue to drop in the future. Operating expenses were $10.9 million, a decrease in expense of 29% compared to the prior year. Operating loss was $9.6 million and narrowed by 22% compared to prior year.

Adjusted operating expenses were $8.4 million, a decrease in expense of 42% compared to the prior year. Adjusted net operating loss was $6.9 million and narrowed by 39% compared to the prior year. These improvements reflect the improved efficiencies we have been able to gain from the restructurings we have conducted over the past year. 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. As we announced previously, we also plan to restructure our balance sheet and are on a path to being debt-free. 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. As we pursue FDA approval and plan a U.S.

Launch of the Allurion Smart Capsule, we wanted to have a clear path to being debt-free, and this transaction provides that path. The private placement further strengthens our balance sheet, helping to position us to achieve future catalysts, and we were very pleased to have participation from key existing stockholders and our strategic partner who has deep expertise in obesity. With this stronger balance sheet, I believe Allurion is better positioned to increase value for shareholders in the short and long term. I would like to now turn to the other two aspects of our strategy that we discussed on our last call, namely retooling our R&D pipeline and manufacturing capabilities in collaboration with our strategic partner and bolstering our clinical pipeline with additional data on combination therapy. We are pleased to report that we are exploring the development of a drug-eluting balloon in collaboration with our strategic partner.

While this is a long-term project, the potential could be massive. First, eluting GLP-1 medications in a controlled-release manner could be a game-changer for obesity therapy. Delivering GLP-1s through an intragastric balloon directly addresses the adherence challenges of GLP-1 use, which we believe will become even more apparent with once-daily pills, while directly combining two independent mechanisms of action into a single therapy. Such an innovation could be the ideal therapy for the nearly 50% of patients who stop using GLP-1s before achieving any clinical benefit. Second, and perhaps more importantly, the drug-eluting balloon could become a platform to deliver a wide array of medications, supplements, and microbiome enhancers that are important for gut health and the treatment of chronic gastrointestinal diseases. We believe this project also dovetails nicely with our intention to create a longer-lasting device that remains in the stomach beyond four months.

We have also now begun process validation of a new R&D and manufacturing line in collaboration with our strategic partner. This line has the potential to expand our current capacity, reduce costs, and accelerate the implementation of design changes in the future. Regarding our clinical pipeline, we have completed submissions of the combination therapy protocol to the institutional review boards, or IRBs, for approval, fielded questions from the IRBs, and made the necessary changes to the protocol. We believe that the protocol we are testing in this study, where patients will receive the Allurion Smart Capsule, start on 0.25 milligrams of semaglutide at the end of balloon therapy and scale up, if needed, to 1.0 milligrams of semaglutide over the subsequent eight months, directly addresses the issues related to high doses of GLP-1s and provides a compelling future clinical pathway for the U.S. market.

I will now turn the call over to Tara Brady, our Interim Chief Financial Officer. Tara?

Tara Brady, Interim Chief Financial Officer, Allurion Technologies: Thank you, Shantanu. Our revenue for the third quarter of 2025 was $2.7 million compared to $5.4 million for the same period in 2024. The year-over-year decrease in revenue was primarily due to the restructuring that took place in the third quarter. 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, and included $0.1 million in restructuring costs. Gross profit for the third quarter was negatively impacted by the reduction in revenue in the period and lower production volumes, which resulted in less manufacturing labor and overhead being absorbed into inventory costs. Sales and marketing expenses for the third quarter were $3.1 million compared to $5.2 million for the same period in 2024 and included $1.1 million in restructuring costs.

The reduction in expense was primarily driven by increased operating efficiency and the restructuring initiatives implemented previously. Research and development expenses for the third quarter were $2.0 million compared to $3.2 million for the same period in 2024 and included $0.5 million in restructuring costs. The reduction was primarily driven by reduced costs related to the Audacity trial and restructuring initiatives implemented previously. General and administrative expenses for the third quarter were $5.8 million and included $0.9 million in restructuring costs compared to $7.0 million for the same period in 2024. Adjusted general and administrative expenses for the third quarter of 2025 were $4.9 million compared to $6.1 million for the third quarter of 2024. The reduction year-over-year was primarily driven by previous restructuring initiatives. Loss from operations for the third quarter was $9.6 million compared to $12.3 million for the same period in 2024.

Adjusted loss from operations for the third quarter of 2025 was $6.9 million, excluding one-time restructuring costs of $2.7 million. Adjusted loss from operations for the third quarter of 2024 was $11.4 million, excluding one-time financing costs of $0.9 million. The reduction was driven by restructuring initiatives implemented previously. As of September 30, 2025, cash and cash equivalents were $6.1 million, not including the private placement financing of $5 million. I will now turn the call back over to Shantanu.

Shantanu Gaur, Founder and Chief Executive Officer, Allurion Technologies: Thanks, Tara. We believe the Allurion program is the only solution for obesity management that has consistently demonstrated significant and immediate weight loss while maintaining or increasing muscle mass. In combination with low-dose GLP-1s, we believe the clinical benefit increases even more with higher levels of adherence to GLP-1s, and we are confident that by pivoting to this approach, we will capitalize on the success of GLP-1s and set Allurion up for long-term success. We are thrilled with the progress we have made in a short period of time with the FDA and remain bullish on the overall U.S. market opportunity. As we onboard new partners outside the U.S., we believe we can unlock synergies with GLP-1s. In my own travels and conversations with physicians on the front lines of obesity care, even those with outstanding wraparound support have rates of discontinuation of GLP-1s above 50%.

We believe this population of patients represents a substantial opportunity for Allurion. Finally, as we explore next-generation R&D and manufacturing initiatives with our new strategic partner, we have begun to view the Allurion Smart Capsule as more of a platform technology that could deliver drugs of all kinds, not just GLP-1s, to address adherence issues that are inherent to pharmacotherapy. We believe that with this approach, we could build a new standard of care in not only obesity management but also across several other disease areas, and we are looking forward to proving this out in the future. With that, Operator, please open up the call for questions.

Mark, Conference Operator: We will now begin the question and answer session. If you would like to ask a question at this time, just press star, then the number one on your telephone keypad. Our first question comes from the line of Joshua Jennings with D.D. Cohen. Joshua, please go ahead.

Joshua Jennings, Analyst, D.D. Cohen: Hi. Good morning. Thanks for taking the questions. Shantanu, congrats on the progress with the FDA process. Just thinking about that progress, I wanted to start with just how you’re taking the learnings from the international strategy to focus on accounts that offer comprehensive obesity care and how that’s informing potential U.S. commercial strategy and any updates just on how Allurion plans to attack the U.S. market once approval’s in hand.

Shantanu Gaur, Founder and Chief Executive Officer, Allurion Technologies: Thanks for the question, Josh. Certainly, we’re learning a lot from what we are doing internationally, especially after we made this most recent pivot in our strategy. 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. I was in Ireland a few weeks ago discussing this concept with one of the best GLP-1 clinics in the entire country of Ireland. Even with exceptional care, with multidisciplinary support across nutrition, physical activity, exercise, even psychological support, this particular clinic still had a churn rate over 50% at one year. Half of their patients were churning off of GLP-1s, regaining weight, and then coming back looking for another therapy.

We are seeing this across the board in all of the international markets that we operate in. That is one learning that we are going to apply in the U.S. market, and we have already begun to map out which clinics in the United States fit the bill in terms of utilizing GLP-1s and also being equipped to potentially deploy the Allurion Smart Capsule. In our international markets as well, we are seeing the same uptake in distributor markets where the distributors have access to accounts that are providing comprehensive obesity care. We intend, over the next couple of months, to strike some new partnerships with distributors in certain regions that clearly have embraced GLP-1s and combination therapy and are seeing in their own businesses how those patients filter through the funnel and get other therapies down the line.

Joshua Jennings, Analyst, D.D. Cohen: Thanks for that. Just thinking about the international push and the strategic pivot, the solid third-quarter revenue results, help us just think about the progression from here just as we’re thinking about modeling 4Q and 2026, just how international revenues could shape up over the next 12 to 24 months.

Shantanu Gaur, Founder and Chief Executive Officer, Allurion Technologies: Yeah, great question. 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. Similarly, in our distributor markets, where we have either launched a new distribution partner or refocused our existing distributors on our new strategy, we’re seeing some nice momentum there as well. I would expect in the fourth quarter sequentially to grow compared to Q3. 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 and combination therapy.

The other thing that we’re starting to see is that as new GLP-1 agents come to market or as prices drop, we see that there’s more utilization of GLP-1s, and ironically, there is actually more discontinuation because many of these new agents or less expensive agents are being delivered without the appropriate care. I actually expect that this trend that we are seeing now in 2025 should continue into 2026. Coming back to your point on the U.S. market as well, Josh, with some of the new initiatives from the Trump administration that are resulting in a reduction in price in GLP-1s in the U.S., that should drive more uptake in the U.S., which in turn should drive a higher churn rate and even more patients who are looking for alternative therapies after they stop their GLP-1 and regain the weight.

These are some of the tailwinds that I see now finally behind our backs as we head into 2026.

Joshua Jennings, Analyst, D.D. Cohen: Appreciate that. Just lastly, you’re talking about the Allurion Smart Capsule as potentially transforming into a platform technology with drug delivery. Any other details to share just in terms of timelines of the development program and then any other elements of the pipeline that you want to highlight in terms of development projects for the platform? Thank you.

Shantanu Gaur, Founder and Chief Executive Officer, Allurion Technologies: Thank you. When we think about the Smart Capsule as more of a platform, there’s actually a whole universe of molecules and even gut microbiome enhancers that could be eluted off of our balloon in a controlled-release manner. What we’re finding, especially as GLP-1s proliferate and some of these other pharmaceuticals that are delivered through DTC services where the follow-up is pretty limited, adherence has become the number one issue for pharmaceuticals. With a capsule like ours that turns into a balloon that lasts inside the stomach for four months, we can solve that adherence issue for patients over a four-month period. 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 four months.

The vision there potentially as a platform could be you swallow, a patient swallows a Smart Capsule of ours, it remains in the stomach for, say, 12 months. Over that 12-month period, drug, therapeutic, or a gut microbiome enhancer is eluted over time. In that scenario, you could imagine a patient being able to swallow a capsule once a year and really not have to worry about taking their medications or managing their obesity since they have an intragastric balloon inside their stomachs. That is a longer-term project, and we’re really thrilled to be initiating it right now. When you combine that drug-elution approach with a longer-term intragastric balloon, the opportunities actually become sort of endless in terms of how many different therapeutics or small molecules we could potentially elute in patients with various different chronic diseases.

Mark, Conference Operator: Again, if you would like to ask a question, simply press star followed by the number one on your telephone keypad. There are no further questions at this time, and I will now turn the call back over to Shantanu Gaur for closing remarks. Shantanu?

Shantanu Gaur, Founder and Chief Executive Officer, Allurion Technologies: Thank you, Operator. As we close our call today, I’d just like to extend my thanks to everyone who joined us today, particularly all of my fellow Allurions who are building this next generation of Allurion. Of course, our loyal shareholders, the collective belief that all of you have in our mission and commitment to our company has really been unwavering. I believe through that commitment, we have set ourselves up for long-term success. We really look forward to updating all of you on our progress in the next quarter. Thank you all. Have a great day.

Mark, Conference Operator: That concludes today’s call. You may now disconnect.