Allurion Technologies Q2 2025 Earnings Call Transcript

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Provided by Quartr
August 13, 2025

Key Takeaways

  • Positive Sentiment: Our new combination therapy strategy pairs the Allurion balloon program with low-dose GLP-1 drugs to drive metabolically healthy weight loss, improve adherence, and broaden patient reach.
  • Positive Sentiment: We signed a term sheet with a strategic partner to co-develop a drug-eluting intragastric balloon, aiming to directly address GLP-1 adherence challenges through an integrated device-drug approach.
  • Positive Sentiment: All four modules of our PMA submission are now filed on schedule, with additional Audacity study analyses exceeding co-primary endpoints and strengthening our FDA approval prospects.
  • Negative Sentiment: Second-quarter revenue fell to $3.4 million from $11.8 million a year ago due to distributor transitions and temporary market suspensions, signaling near-term sales headwinds.
  • Neutral Sentiment: Operating expenses decreased 48% year-over-year, improving operating loss by 26%, although we expect approximately $1.5 million in restructuring charges as we realign cost structure.
AI Generated. May Contain Errors.
Earnings Conference Call
Allurion Technologies Q2 2025
00:00 / 00:00

There are 5 speakers on the call.

Operator

Hello, and thank you for standing by. My name is Lacey, and I will be your conference operator today. At this time, I would like to welcome everyone to the Allurion Second Quarter Earnings Conference 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, followed by the number one on your telephone keypad. If you would like to withdraw your question, press star one again. Thank you. I would now like to turn the conference over to Tara Brady. You may begin.

Speaker 1

Good morning, and thank you for joining us. Earlier today, Allurion Technologies, Inc. issued a press release announcing financial results for the quarter ended June 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 Form 10-K filed on March 27, 2025. Our SEC filings can be found through our company website at investors.allurion.com or the SEC's website.

Speaker 1

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 to forward-looking statements. Please note that this conference call is being recorded and will be available for audio replay on our website under the Events and Presentations section on our Investor Relations page shortly after the conclusion of this call. With that, I will turn it over to Shantanu.

Speaker 2

Good morning, and as always, thank you for joining us today. Before discussing our second quarter results and updating you on the business, I would like to begin today by sharing our vision for the future of obesity care and how we believe the pivot we are making at Allurion sets the company up for long-term success. Due to their ease of use and wide accessibility, GLP-1s have leapfrogged other therapeutic approaches to treat obesity. While they have become a popular first-line weight loss therapy, challenges with adherence and long-term efficacy persist. 30% of patients on GLP-1s discontinue their medication within the first month, and 50% to 75% discontinue during the first year. The adherence obstacle for GLP-1s is caused by three key factors: side effects, muscle mass loss, and high costs. Importantly, each of these issues is exacerbated when higher doses are needed to achieve clinically meaningful weight loss.

Speaker 2

We believe these fundamental issues make GLP-1s ripe for disruption and that our new strategic direction at Allurion systematically addresses these issues and lays the foundation for an exciting R&D and clinical pipeline that could shape the future of obesity care. Our new strategy doubles down on metabolically healthy weight loss: losing weight, keeping it off, and maintaining muscle mass, with a specific focus on combining the Allurion Program with low-dose GLP-1 therapy. The benefits of combination therapy have become clear. Coupling the fast and immediate weight loss from the Allurion Balloon and the Allurion Program's focus on behavior change with a low dose of GLP-1 therapy improves all aspects of metabolically healthy weight loss and brings more patients into the funnel. Our new strategy has three key pillars.

Speaker 2

First, our commercial focus is shifting towards 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 believe this approach will bear fruit outside the United States and be the ideal strategy for a potential U.S. launch. To this end, we launched several initiatives in the second quarter. First, we began transitioning away from distribution partners who did not have access to accounts and clinicians equipped to deliver metabolically healthy weight loss and began either finding new distribution partners or converting those markets to direct operations. While this is disruptive in the short term, we believe it is the right strategy for the long-term success of the business. Second, we resized our sales force to focus on those accounts that can deliver comprehensive obesity care.

Speaker 2

These accounts grew by 20% compared to the first quarter of 2025, and while they are a subset of our existing account base, they deliver superb weight loss results coupled with increasing productivity. Second, our R&D pipeline has been retooled to pursue innovation that enables seamless combination therapy. In the second quarter, we signed a term sheet with a strategic partner to expand manufacturing capabilities and ex-U.S. distribution and explore the joint development of a novel GLP-1 drug-eluting intragastric balloon. This partner has deep experience developing and manufacturing drug-eluting devices and a global footprint in bariatrics with deep conviction in the merits of metabolically healthy weight loss. 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.

Speaker 2

Such an innovation could be the ideal therapy for the nearly 50% of patients who stopped using GLP-1s before achieving any clinical benefit. In addition, we intend to continue to invest in next-generation designs for the Allurion Balloon that reduce its capsule size, increase radio-opacity, and introduce new valve technology that enables longer-residence balloons, which we believe will enhance long-term weight maintenance. Third, our clinical pipeline will focus on the prospective validation of combination therapy leading to metabolically healthy weight loss. We are very pleased with the progress we have made with our prospective multicenter European study, designed to study the effects of combination therapy on weight loss, muscle mass, and GLP-1 adherence. The protocol has now been submitted to institutional review boards, or IRBs, and once approved, we expect to begin enrollment by the end of this year.

Speaker 2

As combination therapy becomes more of a standard of care, we also expect investigator-initiated studies to emerge that test various aspects of metabolically healthy weight loss. We believe that the protocol we are testing in this study, where patients will receive the Allurion Balloon, start on 0.25 milligrams of semaglutide after three months and scale up, if needed, to 1.0 milligrams of semaglutide over the subsequent nine months, directly addresses the issues related to high doses of GLP-1s and provides a compelling future clinical pathway for the U.S. market. With regards to the U.S. market, I am pleased to report that we submitted the fourth and final module of our PMA submission on schedule in the second quarter that included additional supportive analyses from the Audacity study that meet both of the pre-specified coprimary endpoints.

Speaker 2

Additional analyses submitted in the PMA application were conducted to account for the initial results seen in the control group. Using imputation methods that account for the variations observed in the control subjects, the mean difference in weight loss between the treatment and control groups at forty-eight weeks was 4.34%, with a supersuperiority margin of 3.14%, exceeding the pre-specified 3% supersuperiority margin in the second coprimary endpoint, with a p-value of 0.0142. At forty weeks, using the same imputation methods, the mean difference in weight loss between the treatment and control groups was 4.90%, with a supersuperiority margin of 3.75%, considerably exceeding the pre-specified margin in the second coprimary endpoint, with a p-value of 0.0006. We believe that these analyses are more suitable for the trends observed in both groups in the Audacity study and further strengthen our positive top-line data.

Speaker 2

With the PMA now submitted, we are looking forward to working with the FDA toward an approval. The results from Audacity, combined with recent publications from outside the United States, clearly demonstrate that long-term weight maintenance and muscle mass maintenance are possible with the Allurion Program, with or without GLP-1 combination therapy, creating a compelling setup for the U.S. market where 40% of adults have obesity, 170 million may benefit from obesity therapy, and only 8 million people are currently taking injectable obesity therapy. The opportunity, quite simply, is massive. Shifting now to the second quarter, revenue was $3.4 million, in line with the pre-announcement on August 5th, 2025, reflecting reduced sales in distributor markets undergoing partner transitions and partially offset by growth in direct markets driven in part by GLP-1 combination therapy.

Speaker 2

In the second quarter of 2025, clinics where the combination approach was piloted as part of a comprehensive obesity management program grew by 20% compared to the first quarter of 2025, underscoring the potential for the combination approach in the future. While we expect this pivot to continue to be disruptive in the short term, we believe it will lead to long-term growth and refinement of a strategy that we could utilize out of the gate in the U.S. market. Operating expenses in the second quarter decreased by 48% compared to the prior year as the restructuring and reorganization we conducted previously continued to bear fruit. Operating loss improved by 26% compared to prior year, driven by the reduction in operating expenses. Given the near-term disruption we expect from the new strategic direction we are taking, we are reevaluating guidance for 2025.

Speaker 2

In addition, in July, we began implementing a plan designed to align the company's operating expenses with the new strategic direction. We anticipate recording charges of approximately $1.5 million in the third quarter of 2025 related to this plan. I will now turn the call over to Tara Brady, our Interim Chief Financial Officer. Tara?

Speaker 1

Thank you, Shantanu. Our revenue for the second quarter of 2025 was $3.4 million compared to $11.8 million for the same period in 2024. The year-over-year decrease in revenue was primarily due to the distributor transitions we initiated in the second quarter of 2025, lower investments in sales and marketing, as well as the temporary suspension of sales in France. Gross profit for the second quarter was $2.5 million, or 74% of revenue, compared to $9.0 million, or 76% of revenue, for the same period in 2024. The decrease in gross profit was driven by a decrease in sales. Sales and marketing expenses for the second quarter were $2.4 million compared to $6.7 million for the same period in 2024. The reduction in expense is primarily driven by increased operating efficiency in the restructuring initiatives implemented during the fourth quarter of 2024, which refocused spend on more efficient channels.

Speaker 1

Research and development expenses for the second quarter were $1.8 million compared to $4.3 million for the same period in 2024. The reduction was primarily driven by reduced costs related to the Audacity trial and restructuring initiatives implemented during the fourth quarter of 2024. General and administrative expenses for the second quarter were $5.2 million compared to $7.3 million for the same period in 2024. The reduction year-over-year was primarily driven by the restructuring initiatives implemented during the fourth quarter of 2024. Loss from operations for the second quarter was $7.0 million compared to $9.3 million for the same period in 2024. The reduction was driven by restructuring initiatives implemented during the fourth quarter of 2024, leading to a reduction in operating expenses. As of June 30, 2025, we had cash and cash equivalents of $12.7 million. I will now turn the call back over to Shantanu.

Speaker 2

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. With a renewed focus on our R&D and clinical pipelines, high-performing accounts embracing combination therapy, and new strategic distribution partners, we are looking to position Allurion for long-term success in a highly dynamic obesity market with a potential U.S. launch on the horizon. We believe this pivot will establish a new standard of care in obesity, where patients can achieve meaningful weight loss while preserving muscle mass and serve as a model for U.S. market entry.

Speaker 2

We are looking forward to updating all of you on future calls as we expect these new initiatives to continue unlocking shareholder value. With that, operator, please open up the call for questions.

Operator

At this time, I would like to remind everyone, in order to ask a question, please press star then the number one on your telephone keypad. We will pause for just a moment to compile the Q&A roster. Your first question comes from the line of Josh Jennings with TD Cowen. You may go ahead.

Speaker 4

Hi. Good morning. Thanks for taking the questions and appreciate the detailed download. I wanted to just touch on one element of the pivot to the combination therapy, the focus on the combination therapy, and just with more cost sensitivity internationally, how should we be thinking about low-dose GLP-1s plus the Allurion Balloon impacting overall costs for obesity care in the short term and then maybe medium and long terms as well?

Speaker 2

Thanks for the question, Josh. On the combination therapy approach, what we are seeing overseas in particular is that GLP-1s are actually quite inexpensive. It's been in the news recently that in the U.S., certain pharmaceuticals, including GLP-1s, are essentially ten times the cost of the same pharmaceuticals available abroad. What we've seen abroad is that by adding a lower dose of the GLP-1 to the Allurion Program, there's actually minimal cost to the patient, which is a big driver of adoption. In the U.S., we expect that prices will come down over time, especially with the current administration and some of the initiatives they have launched. As more GLP-1s enter the market in the U.S., we do expect pricing to equilibrate and create an opportunity for us to pursue the exact same type of strategy in the U.S. as we're pursuing abroad.

Speaker 4

Excellent. Just a follow-up, in terms of anticipation for potential for cost effectiveness with the combo therapy, I'm sure that the team is optimistic in the medium and long term that the combo approach could deliver. Maybe just add your thoughts if you don't mind.

Speaker 2

On the long term or short term success in the U.S. or abroad, Josh?

Speaker 4

I'm just thinking about any cost effectiveness data that ultimately could be shown with lower dose GLP-1s and the Allurion Balloon, and sustaining weight loss and potentially improving the health and wellness and overall spend on a patient that maintains weight loss for a longer period of time, and especially, you know, metabolically sound weight loss.

Speaker 2

Yeah, absolutely. You know, the data that we have seen so far on the health economics of GLP-1s indicates that they are driving significant health benefits and clinical benefits, but those benefits are, essentially, ineffective from a cost standpoint because of the high prices of GLP-1s. Abroad, where GLP-1s are less expensive, there is a better argument for cost effectiveness. The issue with GLP-1s abroad is that while they are cheaper, they still have issues with adherence because of the side effects and muscle mass issue. When you combine the Allurion Program with a low dose of GLP-1s, you get a combination of the mechanisms of action. The Allurion Program through the Allurion Balloon induces early satiety, whereas the low dose of GLP-1s reduces hunger. You solve the muscle wasting problem, and you also solve the side effect problem because you're operating at lower doses of GLP-1s.

Speaker 2

That allows patients to adhere to the therapy for over a longer period of time. Over that period of time, because it's longer, the patient incurs more health benefits, and therefore, there's a lower cost to the healthcare system. That's the thesis that we're operating under. We've seen some initial data with GLP-1s alone that they are not very effective from a cost effectiveness standpoint. Our belief here is that when we combine the two together and lower the dose of the GLP-1s, that we will get to something that's not only clinically effective but very cost effective as well.

Speaker 4

Great. Thanks for that download in that. Just as we're thinking about updating our models, I know it's too early to issue new guidance, but maybe just some help thinking through the retention of old distributors, if there's any kind of % of total you can share currently, and then how you expect new distributor ads to kind of get you back to the pre-pivot baseline, as we're thinking about OUS revenue contributions in 2026 as well.

Speaker 2

Yeah, it's a good question, Josh. We're making a significant shift in the strategy, with several of our distributors in the Latin America region, the Middle East region. That's going to be a process that's going to play out through the second half of this year. I don't have any data that I can refer you to right now, but the process has begun in the second quarter. It'll continue in the third quarter and likely into the fourth quarter. We do expect some disruption along the way. When you combine the changes that we're making on the sales side and the overall restructuring we just performed, we do expect an impact on top-line revenue. As we go through the process, we'll be able to share more details on that.

Speaker 4

Understood. Lastly, congratulations on the FDA's acceptance of the PMA submission. It's kind of a twelve-month review and potential approval timeline. I know there's not a stake in the ground there, but can you just help us think through what's baked in? I think the PMAs typically have 180 days, but there are clock stops for questions and responses, et cetera. Maybe just help us think through the potential FDA approval timing from here. Thanks for taking all the questions.

Speaker 2

Thank you, Josh. Yeah, in terms of the FDA, we were very pleased with submitting the module number four on time, but also the content of the module. Those additional analyses that we submitted, I believe, really strengthen the overall strength of the clinical trial that we ran, and especially around the second coprimary endpoint in the Audacity study. Typically, you're right, after submission of the last module, FDA typically gives feedback within the first 180 days, and there's dialogue between the company and FDA that, hopefully, results in an approval. In this case, because we did a modular submission, the first three modules have already been submitted to FDA. We've addressed the questions that FDA has asked in all of those modules, and with the addition of these analyses with regards to the Audacity trial, there may be a potential that that timing could be pulled in.

Speaker 2

We had initially said approximately twelve months from the time of submission of module number four. Given the strength of the data, especially around these additional analyses and the fact that this is a modular submission, we may be able to pull that in. We'll know more once we receive additional feedback from FDA and begin that dialogue.

Speaker 4

Great. Thanks again.

Operator

Your next question comes from the line of Keay Nakae with Chardan Capital Markets. You may go ahead.

Speaker 4

Maybe just some guidance on some of the operating expense. You know, stay away from the sales and marketing, but in terms of go-forward expenses for R&D, let's start there. You just posted $1.8 million. Is that a kind of a good go-forward number, at least in the near term?

Speaker 2

Yeah, thanks for the question, Keay. Certainly, for the second half of this year, I think that would be appropriate. Going into 2026, given the restructuring we just performed, we believe that overall operating expenses should decrease by approximately 50%, given the restructuring and reorganization we just performed. For the second half of this year, I think that's the right way to think about it.

Speaker 4

How about G&A? Is there much to do there, you know, relative to the $5.2 million you just posted? I know you just talked about some additional restructuring. Does that number continue to go lower once you get past the one-time charge in Q3?

Speaker 2

Yes. I think that's the right way to think about it as well. The restructuring that we did was really across the entire company so that we are moving in lockstep with this new strategy that we've laid out. Yes, I think you're thinking about that the right way for both R&D and G&A.

Speaker 4

All right, thanks.

Operator

Again, if you would like to ask a question, press star one on your telephone keypad. Your next question comes from the line of Michael Toomey with Jefferies. You may go ahead.

Speaker 3

Hey, guys. Thanks for taking my question along to Matt Taylor. Most of my question has been answered, but could you just remind us of the cash runway that you have, especially with the U.S. launch in mind, and any updates on Coach Iris or UpTaper?

Speaker 2

Thanks. Yeah, thanks for the question, Mike. We performed this restructuring and reorganizations to align to our new strategy, but also to reduce our cash burn, really in 2026. When we look at our cash needs in the future, a lot of that's going to be dependent on the type of commercial strategy we pursue in the United States. Given the submission of module number four and the strength of these additional analyses, as I mentioned, that FDA, potential FDA approval timeline could be pulled in. Now we're really shifting our attention towards the right type of commercialization strategy in the United States, mapping that out, and then assessing based on that strategy what our cash needs are going to be.

Speaker 2

For now, in the short term, we feel good about the cash that we have on the balance sheet, but it will be impacted by the way we think about how to enter the United States market and when that planning starts in earnest. In terms of Coach Iris, we continue to develop Coach Iris from a patient care standpoint. We are looking at multiple different ways that Coach Iris can be proactive rather than reactive. We have not released any new features in the past quarter with Coach Iris, but we continue to work through the pipeline that we had discussed previously.

Speaker 4

Great. Thank you very much.

Operator

Your next question comes from Keay Nakae with Chardan Capital Markets.

Speaker 4

Yeah, thanks for the follow-up. I just want to talk about how the new strategy, targeting the combination use, is likely to impact your reengagement with accounts in France.

Speaker 2

Thanks, Keay. It certainly is going to impact in a positive way our reengagement with our accounts in France. I recently spent almost a full week with our customers in France now that we have officially relaunched. Because the GLP-1 space is moving so fast, while I was there, the use of GLP-1s in channels outside of obesity medicine specialists was expanded by ANSM, the regulatory authority there in France. Now many of our bariatric surgeons and gastroenterologists in France have access to GLP-1s. Many of them are hesitant to use them as monotherapy, but they are very interested in using GLP-1s in combination with our product, mostly because they have a lot of experience with the Allurion Program. They're seeing some pull from their own patients looking at alternative ways that they can use GLP-1s without the side effects and without the muscle wasting.

Speaker 2

I do think that in a territory like France where GLP-1s are relatively inexpensive, their utilization is now expanding into different channels, including bariatrics and GI, that it should be a tailwind for us in the French market as combination therapy becomes more mainstream.

Speaker 4

All right. Thanks.

Operator

This time there are no further questions. I would like to turn the call over to Shantanu Gaur for closing remarks.

Speaker 2

Thank you very much, Lacey. As we close our call today, I'd just like to extend my gratitude and thanks to everyone who joined us today, particularly all my fellow Allurions out there and our loyal shareholders. Really, your belief in our mission and your commitment to our company is what keeps us going here at Allurion. We look forward to updating all of you on our progress in the next quarter. Thank you all again, and have a great day.

Operator

That concludes today's conference call. You may disconnect.

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