Allurion Technologies Q2 2025 Earnings Call Transcript

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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 6 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 speakers' remarks, there will be a question and answer session.

Operator

Thank you. I would now like to turn the conference over to Tara Brady. You may begin. Good morning, and thank

Speaker 1

you for joining us. Earlier today, Allurion Technologies Inc. Issued a press release announcing financial results for the quarter ended 06/30/2025, 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 Gore, Founder and Chief Executive Officer.

Speaker 1

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 ks filed on 03/27/2025. 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 to these forward looking statements.

Speaker 1

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. And 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. But while they have become a popular first line weight loss therapy, challenges with adherence and long term efficacy persist.

Speaker 2

Thirty percent of patients on GLP-1s discontinue their medication within the first month and fifty percent to seventy five percent 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. And importantly, each of these issues is exacerbated when higher doses are needed to achieve clinically meaningful weight loss. 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 and D and clinical pipeline that could shape the future of obesity care. Our new strategy doubled down on metabolically healthy weight loss, losing weight, keeping it off and maintaining muscle mass, with a specific focus on combining the Ellurion program with low dose GLP-one therapy.

Speaker 2

The benefits of combination therapy have become clear, coupling the fast and immediate weight loss from the Ellurion balloon and the Illyrian program's focus on behavior change with a low dose of GLP-one therapy improves all aspects of metabolically healthy weight loss and brings more patients into the funnel. Our new strategy has three key pillars. 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 Eulerion 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.

Speaker 2

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. And 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 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 and 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.

Speaker 2

Distribution and explore the joint development of a novel GLP-one 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-one through an intragastric balloon directly addresses the adherence challenges of GLP-one 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 fifty percent of patients who stop using GLP-1s before achieving any clinical benefit. In addition, we intend to continue to invest in next generation designs for the ELERION 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.

Speaker 2

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 study in Europe designed to study the effects of combination therapy on weight loss, muscle mass and GLP-one 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. 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.

Speaker 2

We believe that the protocol we are testing in this study, where patients will receive the Allurion balloon, start on 0.25 of semaglutide after three months and scale up, if needed, to one point zero 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.

Speaker 2

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 AUDASITY study that meet both of the prespecified co primary endpoints. 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 super superiority margin of 3.14%, exceeding the prespecified 3% super superiority margin in the second co primary endpoint with a p value of 0.0142. At forty weeks, using these same imputation methods, the mean difference in weight loss between the treatment and control groups was 4.9% with a super superiority margin of 3.75%, considerably exceeding the prespecified margin in the second co primary 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. With the PMA now submitted, we are looking forward to working with the FDA toward an approval.

Speaker 2

The results from Audacity, combined with recent publications from outside The United States that clearly demonstrate that long term weight maintenance and muscle mass maintenance are possible with the Eulerion program with or without GLP-one combination therapy, create a compelling setup for The US market where forty percent of adults have obesity, one hundred and seventy million may benefit from obesity therapy, and only eight million people are currently taking injectable obesity therapy. The opportunity quite simply is massive. Shifting now to the second quarter, revenue was $3,400,000 in line with the preannouncement on 08/05/2025, reflecting reduced sales in distributor markets undergoing partner transitions and partially offset by growth in direct markets driven in part by GLP-one combination therapy. In the 2025, clinics where the combination approach was piloted as part of a comprehensive obesity management program grew by 20% compared to the 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 the strategy that we could utilize out of the gate in The U.

Speaker 2

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 1,500,000 in the 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 2025 was $3,400,000 compared to $11,800,000 for the same period in 2024. The year over year decrease in revenue was primarily due to the distributor transitions we initiated in the 2025, lower investments in sales and marketing, as well as the temporary suspension of sales in France. Gross profit for the second quarter was $2,500,000 or 74% of revenue compared to $9,000,000 or 76% of revenue for the same period in 2024. The decrease in gross profit was driven by a decrease in sales.

Speaker 1

Sales and marketing expenses for the second quarter were $2,400,000 compared to $6,700,000 for the same period in 2024. The reduction in expense is primarily driven by increased operating efficiency and the restructuring initiatives implemented during the 2024, which refocus spend on more efficient channels. Research and development expenses for the second quarter were $1,800,000 compared to $4,300,000 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 2024. General and administrative expenses for the second quarter were $5,200,000 compared to $7,300,000 for the same period in 2024.

Speaker 1

The reduction year over year was primarily driven by the restructuring initiatives implemented during the 2024. Loss from operations for the second quarter was $7,000,000 compared to $9,300,000 for the same period in 2024. The reduction was driven by restructuring initiatives implemented during the 2024, leading to a reduction in operating expenses. As of 06/30/2025, we had cash and cash equivalents of $12,700,000 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 Alurion up for long term success. With a renewed focus on our R and 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.

Speaker 2

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. We are looking forward to updating all of you on future calls as we expect these new initiatives to continue unlocking shareholder value.

Speaker 2

With that, operator, please open up the call for questions.

Operator

Your first question comes from the line of Josh Jennings with TD Cowen. You may go ahead.

Speaker 3

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

Speaker 2

Thanks for the question, Josh. And 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 10 times the cost of the same pharmaceuticals available abroad.

Speaker 2

So what we've seen abroad is that by adding a lower dose of GLP-one to the Alerion program, there's actually minimal cost to the patient, which is a big driver of adoption. In The U. S. What we expect is that prices will come down over time, especially with the current administration and some of the initiatives they have launched. And as more GLP-1s enter the market in The U.

Speaker 2

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. And just a follow-up just in terms

Speaker 3

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 sorry. I'm just thinking about

Speaker 3

just any cost effectiveness data that ultimately could be shown with lower dose GLP-1s and the Elerian Blown 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 potentially and especially metabolically sound weight loss?

Speaker 2

Yes, absolutely. With 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. But 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.

Speaker 2

So 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 that allows patients to adhere to the therapy for over a longer period of time. And 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. So that's the thesis that we're operating under.

Speaker 2

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 lowered 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, Dan. I didn't know.

Speaker 3

Just as we're thinking about updating Miles, 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 percentage of total you can share currently and then how you expect new distributor adds 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

Yes. 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. There, that's going to be a process that's going to play out through the second half of this year. So I don't have any data that I can refer you to right now.

Speaker 2

But the process has begun in the second quarter. It will continue in the third quarter and likely into the fourth quarter. And we do expect some disruption along the way. But when you combine the changes that we're making on the sales side, the overall restructuring we just performed, we do expect an impact on top line revenue. And as we go through the process, we'll be able to share more details on that.

Speaker 3

Understood. And then lastly, just thinking of congratulations on the FDA's acceptance of the PMA submission. It's kind of 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 PMA is still be up in 180, but there's clock stops and for questions and responses, etcetera.

Speaker 3

But maybe just help us think through, the potential FDA approval timing from here. Thanks for taking all the questions.

Speaker 2

Thank you, Josh. Yes, in terms of the FDA, we are 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 co primary endpoint in the audacity study. Typically, you're right, after submission of the last module, FDA typically gives feedback within the first hundred and eighty days. Then 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 by FDA.

Speaker 2

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. So 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. But we'll know more, once we receive additional feedback from FDA and begin that dialogue.

Speaker 3

Great. Thanks again.

Operator

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

Speaker 4

Maybe just some guidance on some of the operating expense. You know, stay away from sales and marketing, but in terms of go forward expenses for R and D, let's start there. You just posted 1,800,000,000.0 Is that kind of a good go forward number at least in the near term?

Speaker 2

Yes. Thanks for the question, Kay. 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 reorganization we just performed. But for the second half of this year, I think that's the right way to think about it.

Speaker 4

And then how about, g and a? Again, is there much to do there, you know, to the the 5.2 you you just posted? I know you just talked about some additional restructuring. Does does that number continue to go lower once you get past the one time charge in q three?

Speaker 2

Yes. I I think that's the right way to think about it as well. You know, 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. So, yes, I think you're thinking about that the right way for both R and d and g and a.

Speaker 4

Alright. Thanks.

Operator

Your next question comes from the line of Michael Toomey with Jefferies. You may go ahead.

Speaker 5

Hey, guys. Thanks for taking my question. I'm on for Matt Taylor. Most of my questions have been answered, but could you just remind us of the the cash runway that you have associated with The US launch in mind and any updates on Coach Iris or or uptake there?

Speaker 4

Thanks.

Speaker 2

Yes. Thanks 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. And 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. And 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.

Speaker 2

And so now we're really shifting our attention towards the right type of commercialization strategy in The U. S. Mapping that out, and then assessing based on that strategy what our cash needs are going to be. 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 U. S.

Speaker 2

Market and when that planning starts in earnest. In terms of Coach Iress, we continue to develop Coach Iress, 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 5

Great. Thank you very much.

Operator

Your next question comes from Keane K. With Chardan Capital.

Speaker 4

Yeah. Just thanks for the follow-up. Just want to talk about how the new strategy targeting the combination use is likely to impact your reengagement

Speaker 2

Thanks, Kay. 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. And because the GLP-one 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. And so now many of our bariatric surgeons, and gastroenterologists in France have access to GLP-1s.

Speaker 2

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 Ilureon program. And 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. So 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

At this time, there are no further questions. I would like to turn the call over to Shantanu Gore 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 Allureon's out there and our loyal shareholders. Really, belief in our mission and our and your commitment to our company, is what keeps us going here, at Allureon. So 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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