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 Allurean 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, hit the press star then the number one on your telephone keypad. And 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.
Good morning and thank you for joining us. Earlier today, Ellurion Technologies, Inc. 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.ellurion.com. With me on the call today is Shantanu Gore, 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 No. 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 gap results management will also provide a supplementary results on a non-gap basis please refer to the press release issue today in the accompanying supplementary financial data tables for a detailed reconciliation of gap and non-gap 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. And with that, I will turn it over to Shantanu.
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 Illurion 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 the 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 issues. In October, the company underwent a Bio-Research 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 Ellurion 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 Ellurion 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 observed 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 Ellurion. Some customers have indicated that half of their Ellurion 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 Illurion 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, eluding 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 eluding 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 Ovarion 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?
Thank you, Chanteneau. 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 dollars 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 in 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 30th, 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.
Thanks, Tara. We believe the Illurion 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 Allurian 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 Illurion. And finally, as we explore next generation R&D and manufacturing initiatives with our new strategic partner, we have begun to view the Illurion Smart Tapsule 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.
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. And our first question comes from the line of Joshua Jennings with J.D. Cohen. Joshua, please go ahead.
Hi. Good morning. Thanks for taking the questions, Shantanu. Congrats on the progress with the FDA process and 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 it's informing potential U.S. commercial strategy and any updates just on how a Lurion plans to attack the U.S. market once approval is in hand.
One of the clinics still had a churn rate over of their patients, LP1s regaining weight and then coming. We're seeing this, so that's one learning that we're going to apply in the U.S. market, and we've already begun to map out which clinics in the United States fit the bill in our international markets as well. Thanks for that.
And just thinking about the international push and the strategic pivot, the solid third quarter revenue results, can you help us just think about the progression from here just as we're thinking about modeling 4Q in 2026, just how international revenues could shape up over the next 12 to 24 months. churn rate. Appreciate that. And just lastly, you know, you're talking about you're on 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.
Operator
Again, if you would like to ask a question, to the press star followed by the number one on your telephone keypad. There's no further questions at this time. And I will now turn the call back over to Shantanan Gaur for closing remarks.
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- That concludes today's call.
Operator
You may now disconnect.
