Allurion at Jefferies Conference: Strategic US Market Entry

On Wednesday, 04 June 2025, Allurion Technologies Inc. (NYSE:ALUR) presented at the Jefferies Global Healthcare Conference 2025, unveiling strategic plans for its metabolically healthy weight loss program. The company highlighted its financial strides and operational goals, aiming for a significant entry into the US market. Despite challenges, Allurion is optimistic about reducing cash burn and achieving positive EBITDA outside the US by 2026.

Key Takeaways

• Allurion is preparing to enter the US market with a non-surgical weight loss device.
• The company has reduced operating expenses and losses by nearly 50% in Q1.
• Allurion plans to submit the final PMA module to the FDA this month.
• Integration of AI through Coach Iris is set to enhance patient data analysis.
• The company expects to significantly cut cash burn in 2025.

Financial Results

Revenue and Growth:

• Allurion operates in a $50 billion obesity market, demonstrating program traction while maintaining financial discipline.

Operating Expenses and Losses:

• Operating expenses and losses reduced by nearly 50% in Q1, signaling a move towards sustainable outcomes.

Gross Margins:

• Improved gross margins due to restructuring and focus on direct sales in higher ASP markets.
• The US market is expected to have the most favorable pricing.

Cash Flow and Burn Rate:

• Allurion aims to reduce cash burn by half in 2025, compared to $34 million in 2024.
• Closed Q1 with $20 million in cash following early 2025 financings.

Profitability:

• Targeting positive EBITDA for its ex-US business by 2026.

Operational Updates

Market Expansion:

• Re-entered the French market with initial shipments and patient treatments starting this month.

US Market Entry:

• Progressing with modular PMA submission for US entry, with a strong safety profile for its intragastric balloon.
• Over 50% of AUDASITY trial patients lost more than 5% of body weight, meeting FDA criteria.

Coach Iris and AI Integration:

• Coach Iris launched in the US, managing GLP-1 and non-Allurion balloon patients.
• Plans to evolve Coach Iris into an AI agent for enhanced patient data analysis.

Future Outlook

US Market Potential:

• The US is a key market due to high obesity rates, with Allurion poised to offer the first non-surgical device.

US Launch Strategy:

• Preparing for a strategic launch with selected clinics and physicians, leveraging the synergy between its balloon and GLP-1 therapies.

Q&A Highlights

Synergy with GLP-1s:

• The combination of Allurion’s program and GLP-1s helps patients lose over 20% of total body weight while maintaining muscle mass.

Monetization of Coach Iris:

• Commercialized alongside the balloon with premium tiers, with potential as a standalone SaaS model.

Real-World Data:

• Patients typically lose 10-15% of total body weight in about four months, maintaining muscle mass with the Allurion program.

In summary, Allurion Technologies is strategically positioning itself for a robust US market entry while enhancing its financial and operational framework. For further details, refer to the full transcript below.

Full transcript - Jefferies Global Healthcare Conference 2025:

Michael Toomey, US Med Tech Analyst, Jefferies: Alright. We can, we can make a start here. I’m Michael Toomey covering for for Matt Taylor, US med tech analyst at Jefferies. Pleased to be joined by Shantanu Gore, founder and CEO of Allurion. So thank you for joining us today.

So maybe we can just level set to start for people not as familiar with the story. Obviously, you founded the company and just run us through maybe a history of Allurion and where we are today.

Shantanu Gore, Founder and CEO, Allurion: Thank you for having us here, Mike. And to all the ALUR shareholders out there and my fellow Allureons, thank you for tuning in. We’re pioneering something at Allureon called metabolically healthy weight loss, where we’re focused on helping people lose weight, keep it off, and also maintain muscle in the process. And when we founded this company in 02/2009, we were really focused on developing device solutions that were truly noninvasive and really easy and frictionless for patients and providers to use. And what we ended up developing was the program where at the heart of it is the Allurion balloon, which is a swallowable weight loss device that can be deployed in a fifteen minute office visit, spends four months inside the stomach, and then automatically opens up and passes out of the body.

And as you can imagine, with that type of device, patients feel full, they have early satiety, and they lose weight. But what we’ve also done at Allurion is pair that balloon with a behavior change program and a virtual care suite that provides remote monitoring, AI powered coaching, and guidance to help our patients not just lose weight, but keep it off through more permanent changes to their lifestyle. And when we put all that together, we’ve really charted out a pretty unique position for Allurion in this obesity space where we’re not just focused on short term weight loss. It’s really about helping people change their habits and lifestyle over a long period of time. Our balloons have now been used in over 150,000 patients.

We have over 60 patents on the technology. And very recently we’ve started to present and collect some very interesting data on how our program can actually intersect with GLP-one therapy, in fact lower doses of GLP-one therapy.

Michael Toomey, US Med Tech Analyst, Jefferies: Yeah. Maybe we can start there and compare some of the results you see with the Ilurean program versus, GLP use. Yeah. Maybe some of the differences in maybe the muscle, retention and the fat loss and comparing those those figures.

Shantanu Gore, Founder and CEO, Allurion: One of the things that we pride ourselves on with the Ilureon program is not only is it something that patients and providers find easy to use, but it really does deliver best in class clinical results and outcomes. When, you study our balloon and the program in patients who aren’t getting any, combination therapy with GLP-1s, typically our patients will lose on average fifteen percent of their total body weight. One year later, they will have maintained 95% of that weight loss. And typically, they will actually gain muscle mass as a percentage of, total body weight, over the four to twelve month period, of the Illyrian program. So even with the Illyrian program by itself without any combination therapy, patients achieve best in class outcomes.

And when we look at diabetes for instance, hypertension, cardiovascular disease, high cholesterol, patients also see a significant reduction in those comorbidities. We’ve also seen really interesting effects with the weight loss that we achieve with the Allurion program and effects on PCOS and infertility which are quite meaningful to a lot of our patients. When we combine the Elerion program with a low dose of GLP-1s, and here we’re talking about one milligram of semaglutide weekly, which is, half of what you would normally take, What we see is that our patients lose more weight over a longer period of time because the balloon and the GLP-one act synergistically. The balloon typically works by inducing satiety. The GLP-one works by reducing hunger.

And our patients on average instead of losing 15% will lose close to 20% or over 20% of their total body weight. They will remain on their GLP-1s for much longer and instead of losing 40% of their weight in muscle they will actually gain muscle mass as a percentage of total body weight, over the period where they’re taking the balloon and the GLP-one. So what we do by combining those two modalities is, one, we get the best of the GLP-1s at the low dose. We get some of the hunger suppression. We don’t get the side effects.

We don’t get the muscle wasting. And we combine that with the fast weight loss that we achieve with the balloon and the behavior change that we deliver through our digital program to create a much more sustainable and long term solution for patients.

Michael Toomey, US Med Tech Analyst, Jefferies: That’s great. And maybe we can touch on the most recent quarter and how the market’s growing. Generally, I know you had some one offs in in the recent quarter, but, yeah, maybe you can summarize what happened last quarter and the market trends there and how they’ve continued into February?

Shantanu Gore, Founder and CEO, Allurion: The the obesity market is extremely exciting right now, highly dynamic. It’s a $50,000,000,000 market opportunity, and what we have seen at Allurion is a real flourishing of new approaches to weight loss and weight maintenance that combine, mix, and match, different types of modalities of care. In the first quarter, of this year, we were, very fortunate to demonstrate that our program has real traction in many of our geographies and territories while still maintaining good discipline on the bottom line. We reduced operating expenses by close to 50%, reduced our operating loss by close to 50% and we’re able to demonstrate that with our growing sales force and our new b to b to c commercial strategy that we can achieve much more sustainable and one day profitable business outcomes for the company. We’re also very pleased in the first quarter to come back on the market in France, which is historically an important market for us and one that has been had been growing in the past and now we’re very excited to be back in the market.

Very recently, we also announced that we’ve made our first shipments now back into France and we’ll begin to start treating patients as early as this month. In the first quarter also we read out the Audacity trial data which is a big milestone for us. For those of you who are new to the Ilureon story, all of our revenue today comes from outside The United States. Inside The United States, we’re moving through our modular PMA submission and we were thrilled with the outcome of the AUDASITY study. It’s the first study in The US done in a FDA pivotal protocol where we were able to report out outcomes beyond nine months.

So it’s a study that took place over the course of one full year. We had a stellar safety profile, the lowest serious adverse event rate, on record for a liquid filled intragastric balloon. And we were able to show, really, impressive efficacy with over half of our patients losing more than the 5% total body weight loss that is the threshold for FDA with over half of our patients qualifying as responders. And keep in mind that study was done without our virtual care suite and without our proprietary behavior change program. So we believe that when we enter The United States, the clinical results and outcomes should mirror what we are seeing outside The United States.

Michael Toomey, US Med Tech Analyst, Jefferies: Yeah. And on the Audacity trial, think the FDA, announced in the last quarter you said that you can do some sub analysis of of the data. Maybe you can touch on that and talk about how that benefits, Elurion.

Shantanu Gore, Founder and CEO, Allurion: Yeah, it’s really wonderful to actually dive deeper into the data and understand some of the nuances in our study. We ran an open label weight loss study which typically results in a high rate of dropout in the control group. You can imagine the psychology here where if you are a subject in an open label trial and you get randomized to the control group because it’s open label and there’s no blinding, you know from day one that you’re not going to get the balloon and you’re not going to get the treatment. That leads to high rates of dropout in the control group early in the study. When you run a weight loss study and there are dropouts, typically FDA wants you to fill in those gaps using something called imputation where you look at the people who finish the study and use those to model out and impute the missing data earlier in the study.

The issue with weight loss studies is that people who finish the study for a full year after not getting any treatment are typically a pretty unique subset of subjects who have high motivation, have high levels of discipline and can get through an entire study and lose a significant amount of weight. And so if you recall, when we read out our top line data, we noted that the control group actually lost a significant, significantly more weight than we had expected. And that was primarily driven by this imputation strategy where we took the best of the best who finished the study and then imputed that data back on the missing subjects. When we had our most recent interaction with FDA and presented these preliminary results, one thing that came up in that conversation is that there isn’t there doesn’t necessarily have to be a one size fits all imputation strategy. And what we took away from that was the openness and flexibility of the FDA to consider other forms of imputation which put that control group weight loss in a much more favorable light for Allurion and also, I think, a much more realistic light in terms of what those patients would have lost over the course of the study.

So we’re very pleased with that outcome and we will be including those analyses when we submit the fourth and final module of the PMA this month.

Michael Toomey, US Med Tech Analyst, Jefferies: Okay. So that’ll be submitted this month. And then maybe you can talk about the timeline or the range of timelines from here, I guess. A lot of that’s with the FDA, yeah, your baseline expectations, I guess.

Shantanu Gore, Founder and CEO, Allurion: Typically with PMAs, it takes FDA approximately nine to twelve months to review the total file. We have one benefit in that we have done a modular PMA submission where the entire PMA was broken up into four different modules. We had already submitted the first three modules. The fourth and final module was the clinical study report which we’ll be submitting this month. And so FDA has already had the opportunity to review the first three modules, ask questions, and we’ve had the opportunity to address those questions.

And with the fourth module their focus will really be on the clinical study results which we’ve already previewed with them in our pre PMA meeting. So I do believe that that nine to twelve month timeline it may have an opportunity to be pulled in given that FDA has already had significant exposure to our file and has had time to review it in anticipation of an eventual approval. And so in preparation for a potential US launch, we’re already starting to, map out the different types of, sales strategies that we could employ in The US, whether that’s a direct strategy, a hybrid strategy with, distributors and a direct sales force, or something more strategic, where we can leverage, some existing infrastructure that’s already built in The US. So all of that work is now in, full gear as we prepare to submit this last module and then get ready for an eventual US launch.

Michael Toomey, US Med Tech Analyst, Jefferies: Yep. And how does that ramp look like from your experience OUS, you know, when you’re entering a new market? And of them being much bigger, where do you see the differences for The US launch?

Shantanu Gore, Founder and CEO, Allurion: The potential in The US is massive. 40% of the adult population in The United States has obesity. Close to seventy percent is either obese or overweight. So it will be from a TAM perspective the biggest market in the world for Allurion. So I like to say the best is still yet to come for for the company given that The US is on the come.

In The US market, there has been a long history of weight loss devices that have come and gone. And many of those devices required surgery, and many of them required endoscopy and anesthesia. We will be the first device to enter The US market that doesn’t require endoscopy, anesthesia or any type of surgery. And so I do believe that there’s going to be a significant amount of demand for this product once we enter The US market. The key for us will be to launch this product in The US in a sustainable manner.

We don’t want to be in a position where we partner with the wrong clinics or the wrong physicians and have a poor patient experience from the get go. The ecosystem that we’ve built outside The United States where we’ve now treated over 150,000 patients, we’ve learned quite a bit on the type of clinics we partner with, how they use the technology, how they screen patients, how they provide the right follow-up care to get the best results. So we’ll be very intentional when we launch the product in The US and get those early adopters in, and the early innovators in as quickly as possible and let them organically start to build our brand and our credibility in The US before we expand to other channels, other call points, and potentially a different type of consumer as well. Yeah.

Michael Toomey, US Med Tech Analyst, Jefferies: And will that be launched with Coach Iris in The US at the same time? Is it the full Allurion program? Right?

Shantanu Gore, Founder and CEO, Allurion: Yes. We will we will launch the full program in The United States, balloon plus virtual care suite, plus all of our proprietary behavior change knowledge. And with Coach Iris, technically, we’ve already launched Coach Iris in The US. We do have some clinics in The US using Coach Iris to manage their GLP one patients and manage their non allurion balloon patients. And over the course of the next year, we are making some, improvements, to Coach Iris, transitioning the coach from just a generative AI coach that responds in real time to questions to more of an AI agent that can proactively examine data, look at data, make decisions, and then convey those decisions to the patient or to the customer, in our case, who’s using the Allurion app.

There’s so much data that we collect with our Bluetooth scale, our integration with Apple Health and Google Health, that Coach Iris actually has a treasure trove of data to examine and provide real time feedback to patients. We’re also in the process of improving the Allurion Insights experience, which is what our physicians and their care team uses. And we’re working on a feature where they can simply query Allurion Insights. And using, generative AI, we can actually help them analyze all of the data that they’ve collected on their patients to answer any number of different questions that they may have. So the future of AI inside Allurion is extremely bright and I just I see use cases everywhere for it as patients and providers go through this weight loss experience.

Michael Toomey, US Med Tech Analyst, Jefferies: And how can we think about the monetization of of Coacharis? Is that something that would just be bundled with with the Illyrian program, or do you expect that to be a material solo contributor?

Shantanu Gore, Founder and CEO, Allurion: Currently, what the way we commercialize Coach Iris in the virtual care suite is alongside the balloon, providers and patients have an option for premium tiers, which include Coach Iris and a lot of these AI features. We intend to have a similar structure in The US when we launch. But also, what we have found is that once a clinic, or in some cases a chain of clinics starts to use our Allurion balloon in their practice and the software, they begin to realize that the software has real value for other types of obesity care that they may be offering. So for example, we partner with a lot of clinics in Europe that offer our balloon, they offer GLP-1s, and they also do bariatric surgery. Many of them are now using CoachIris and using the virtual care suite to manage all of those patients.

And that is a SaaS model that we have that monetizes the VCS and Coach IRIS in a standalone manner. And I see something similar potentially playing out in The United States, especially as we add some of these new features to Coach IRIS.

Michael Toomey, US Med Tech Analyst, Jefferies: And you’ve even got that in the studies, you show the impact of when you add Coach Iris that there’s more weight loss, more muscle retention, even muscle gain?

Shantanu Gore, Founder and CEO, Allurion: Yeah, exactly. You know, typically what we see when you just look at the balloon alone, and this comes across in our Audacity trial results, patients will lose between 78% of their total body weight. In reality, the results that we’re seeing, which are fourteen to fifteen percent, indicate that about half of that is coming from the balloon and the other half is coming from the program, the follow-up, and coach hires. And that’s a lesson we learned over a decade ago when we launched the balloon on its own for the first time in Europe. Our patients were losing weight but not that much.

And we very quickly realized that and I believe the GLP-one users are now quickly realizing that it’s not just about the device or the drug it’s about the full program that you put around it. And that’s why we’re so focused on this concept of metabolically healthy weight loss because weight loss has been around for a long time through multiple modalities. But weight maintenance and muscle maintenance, that’s a different different ballgame. And what we found with Coach Iris and the virtual care suite is, one, when you actually track muscle mass and lean mass, you can manage it. And that’s what the virtual care suite allows.

And then through Coach Iris and through our behavior change program, through proper nutrition, high protein diet, weight bearing exercise, can actually maintain muscle quite easily when you’re on a weight loss journey.

Michael Toomey, US Med Tech Analyst, Jefferies: Maybe we can move on to gross margins. They improved a You said that’s a good run rate for the rest of the year. Yeah, maybe you can talk about the trajectory of the gross margin and how The U. S.

Might impact that.

Shantanu Gore, Founder and CEO, Allurion: Yeah, gross margin was a real highlight of our Q1 results. We were very pleased with the uptick in margin compared to the fourth quarter of last year. And a lot of that was attributed to the restructuring and reorganization that we did at Allurion that allowed us to leverage a lot of the overhead that we have already built inside the company. But second, we are starting now as we increase the size of our direct sales force to penetrate further into our direct markets, which are higher ASP. And that also is contributing to the favorable margin profile.

So yes, I do think what we saw in Q1 is a good run rate to use for the remainder of the year and in The United States not only is it probably our biggest market from a TAM perspective it’ll most likely also have the most favorable pricing for Allurion as well. So from a margin perspective, that should be another nice catalyst entering The US market. And

Michael Toomey, US Med Tech Analyst, Jefferies: then you did the cost reduction program as well. It’s kind of right size everything. Maybe you can talk about the cash where you finish 1Q and that run rate and the path to profitability.

Shantanu Gore, Founder and CEO, Allurion: Yeah. We are, again, very pleased with the discipline we showed on the bottom line. We expect to burn approximately half the amount of cash that we burned in 2024, in 2025. In 2024, we burned approximately $34,000,000 of cash. And in Q1, after the financings that we conducted in January and February we closed the quarter with approximately $20,000,000 of cash on the balance sheet and with our go forward burn we feel very good about our balance sheet as we hit some of these key milestones submitting the FDA file in module four, getting FDA approval.

And this is all with the goal of setting us up so that in 2026, can achieve a positive EBITDA on our ex US business. And then depending on the type of launch model that we use in The United States or that we deploy in The United States, that will determine, you know, how much cash we would need to invest to get The US market up and running.

Michael Toomey, US Med Tech Analyst, Jefferies: When do you think we’ll hear the launch strategy for The US? Is that, yeah, this year or next year?

Shantanu Gore, Founder and CEO, Allurion: How do

Michael Toomey, US Med Tech Analyst, Jefferies: you think about that?

Shantanu Gore, Founder and CEO, Allurion: We’re working on it now. I I would say that as we get closer to an approval, we will we will be able to share a little bit more about what we are thinking. But for now, it’s it’s in the the early stages in terms of planning. Okay.

Michael Toomey, US Med Tech Analyst, Jefferies: Any changes in competition, I guess, you know, on either similar technologies or other weight loss technologies that could eat into your market or just add more competitive pressure? Are you seeing any changes there?

Shantanu Gore, Founder and CEO, Allurion: On the device side, we haven’t seen any changes. In fact, there have been some endoscopic therapies that I think are going to fail to compete with GLP-1s. We don’t really view GLP-1s as competition anymore. I think we’ve shown time and again that they’re synergistic with the balloon and that we have a lot to gain from the side effects, the poor adherence, and the muscle wasting issues that a lot of patients experience. We have noted, however, that bariatric surgery continues to be continues to suffer in the presence of GLP-1s.

The most recent data from The US indicates that surgical volumes are probably down approximately 40% and they haven’t really recovered over the past two years. My view on that is that GLP-1s were a shock to the system in obesity management. And the therapies that are most invasive will take the longest to recover because GLP ones are such a great first line therapy for many patients. And the ones that are less invasive like the Alerion balloon, I think are gonna be much more resilient Yep. In this marketplace.

Michael Toomey, US Med Tech Analyst, Jefferies: And maybe, guess, a few minutes left. Maybe you can just talk about the the real world experience data that you have, any other study data that that you’d like to highlight before we finish.

Shantanu Gore, Founder and CEO, Allurion: Yeah. Absolutely. We have you know, we could be here all day talking about the data that we have. We have over 26 peer reviewed journal publications. We’ve treated now over 150,000, patients with the program.

And we’ve collected literally millions of data points because every time someone steps on our scale, that data point goes to our cloud. And, we have the unique privilege of seeing how these patients have done over a very long period of time. We are going to be publishing some even larger case series later this year but what we can say just looking at the tens of thousands of patients where we have good data on is that typically our patients very consistently around four months will lose between 10 to 15% of their total body weight. As they continue to use the behavior change program, virtual care suite, they will maintain a significant amount of that weight loss. And now what we are seeing, no matter what almost no matter what territory we look at, we’re seeing very, very good maintenance of muscle with the Allurion program used on its own and of course we’re seeing similar results in the combination of GLP-1s and Allurion.

So later this year we’ll have some even larger case series for you to dive into But suffice it to say, it’s a very consistent experience around the world.

Michael Toomey, US Med Tech Analyst, Jefferies: Great. I think we’ll leave it there. But thanks so much for your time. Thanks, everyone, for logging in.

Shantanu Gore, Founder and CEO, Allurion: Thank you very much.

Michael Toomey, US Med Tech Analyst, Jefferies: Thank you.

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