All right, we can make a start here. I'm Michael Toomey, covering for Matt Taylor, U.S. Medtech Analyst at Jefferies. Pleased to be joined by Shantanu Gaur, Founder and CEO of Allurion. Thank you for joining us today. 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.
Thank you for having us here, Mike, and to all the ALUR shareholders out there and to my fellow Allurions, thank you for tuning in. We're pioneering something at Allurion called Metabolically Healthy Weight Loss, where we're focused on helping people lose weight, keep it off, and also maintain muscle in the process. When we founded this company in 2009, we were really focused on developing device solutions that were truly non-invasive and really easy and frictionless for patients and providers to use. What we ended up developing was the Allurion program, where at the heart of it is the Allurion Balloon, which is a swallowable weight loss device that can be deployed in a 15-minute office visit, spends four months inside the stomach, and then automatically opens up and passes out of the body.
As you can imagine, with that type of device, patients feel full, they have early satiety, and they lose weight. 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. 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.
Very recently, we've started to present and collect some very interesting data on how our program can actually intersect with GLP-1 therapy, in fact, lower doses of GLP-1 therapy.
Yeah, maybe we can start there and compare some of the results you see with the Allurion program versus GLP-1 use. Yeah, maybe some of the differences in maybe the muscle retention and the fat loss and comparing those figures.
One of the things that we pride ourselves on with the Allurion 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 are not getting any combination therapy with GLP-1s, typically our patients will lose on average 15% of their total body weight. One year later, they will have maintained 95% of that weight loss. Typically, they will actually gain muscle mass as a percentage of total body weight over the 4-12 month period of the Allurion program. Even with the Allurion program by itself, without any combination therapy, patients achieve best-in-class outcomes. 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 Allurion program with a low dose of GLP-1s, and here we're talking about 1 mg 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-1 act synergistically. The balloon typically works by inducing satiety. The GLP-1 works by reducing hunger. 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.
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 are taking the balloon and the GLP-1. 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 do not get the side effects. We do not get the muscle wasting. 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.
That's great. Maybe we can touch on the most recent quarter and how the market's growing. Generally, I know you had some one-offs 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 2Q.
The obesity market is extremely exciting right now, highly dynamic. It's a $50 billion market opportunity. 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 1st 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 were able to demonstrate that with our growing sales force and our new B2B2C commercial strategy, we can achieve much more sustainable and one-day profitable business outcomes for the company.
We're also very pleased in the 1st quarter to come back on the market in France, which is historically an important market for us and one that had been growing in the past. We are 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 1st quarter, we read out the AUDACITY trial data, which is a big milestone for us. For those of you who are new to the Allurion story, all of our revenue today comes from outside the U.S. Inside the U.S., we're moving through our modular PMA submission. We were thrilled with the outcome of the AUDACITY Study.
It's the first study in the U.S. done in an FDA-pivotal protocol where we were able to report out outcomes beyond nine months. It is 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. 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. Keep in mind, that study was done without our Virtual Care Suite and without our proprietary behavior change program. We believe that when we enter the United States, the clinical results and outcomes should mirror what we are seeing outside the United States.
Yeah, and on the AUDACITY trial, I think the FDA announced in the last quarter you said that you can do some sub-analysis of the data. Maybe you can touch on that and talk about how that benefits 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. If you recall, when we read out our top-line data, we noted that the control group actually lost significantly more weight than we had expected.
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 the FDA and presented these preliminary results, one thing that came up in that conversation is that there does not necessarily have to be a one-size-fits-all imputation strategy. 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. We are very pleased with that outcome.
We will be including those analyses when we submit the fourth and final module of the PMA this month.
Okay, so that'll be submitted this month. Maybe you can talk about the timeline or the range of timelines from here. I guess a lot of that's with the FDA, but yeah, your baseline expectations, I guess.
Typically, with a PMA, it takes FDA approximately 9-12 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. FDA has already had the opportunity to review the first three modules, ask questions, and we've had the opportunity to address those questions. 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.
I do believe that that 9-12 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. In preparation for a potential U.S. launch, we're already starting to map out the different types of sales strategies that we could employ in the U.S., 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 U.S.. All of that work is now in full gear as we prepare to submit this last module and then get ready for an eventual U.S. launch.
Yeah. How does that ramp look like from your experience OUS when you're entering a new market? Of them being much bigger, where do you see the differences for the U.S. launch?
The potential in the U.S. is massive. 40% of the adult population in the United States has obesity. Close to 70% is either obese or overweight. It will be, from a TAM perspective, the biggest market in the world for Allurion. I like to say the best is still yet to come for the company, given that the U.S. is on the come. In the U.S. market, there has been a long history of weight loss devices that have come and gone. Many of those devices required surgery, and many of them required endoscopy and anesthesia. We will be the first device to enter the U.S. market that does not require endoscopy, anesthesia, or any type of surgery. I do believe that there is going to be a significant amount of demand for this product once we enter the U.S. market.
The key for us will be to launch this product in the U.S. 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.
We'll be very intentional when we launch the product in the U.S. 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 U.S. before we expand to other channels, other call points, and potentially a different type of consumer as well.
Yeah. Will that be launched with Coach Iris in the U.S. at the same time? Is it the full Allurion program, right?
Yes, we will launch the full program in the United States, the Balloon plus Virtual Care Suite plus all of our proprietary behavior change knowledge. With Coach Iris, technically, we've already launched Coach Iris in the U.S. We do have some clinics in the U.S. using Coach Iris to manage their GLP-1 patients and manage their non-Allurion Balloon patients. 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. We're working on a feature where they can simply query Allurion Insights. 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. The future of AI inside Allurion is extremely bright. I see use cases everywhere for it as patients and providers go through this weight loss experience.
How can we think about the monetization of Coach Iris? Is that something that will just be bundled with the Allurion program, or do you expect that to be a material solo contributor?
Currently, the way we commercialize Coach Iris and 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 U.S. when we launch. 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. 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 Coach Iris and using the virtual care suite to manage all of those patients.
That is a SaaS model that we have that monetizes the VCS and Coach Iris in a standalone manner. I see something similar potentially playing out in the United States, especially as we add some of these new features to Coach Iris.
You've even got that in the studies, right? You show the impact of when you add Coach Iris, there's more weight loss, more muscle retention, or even muscle gain.
Yeah, exactly. 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 7% and 8% of their total body weight. In reality, the results that we're seeing, which are 14%-15%, 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 Iris. 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. We very quickly realized that, and I believe the GLP-1 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.
That is why we are so focused on this concept of metabolically healthy weight loss, because weight loss has been around for a long time through multiple modalities. Weight maintenance and muscle maintenance, that is a different ball game. 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. That is what the Virtual Care Suite allows. Through Coach Iris and through our behavior change program, through proper nutrition, high-protein diet, weight-bearing exercise, you can actually maintain muscle quite easily when you are on a weight loss journey.
Maybe we can move on to gross margins. They improved a lot at 1 Q. You said it'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.
Yeah, gross margin was a real highlight of our Q1 results. We were very pleased with the uptick in margin compared to the 4th quarter of last year. 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. 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. That also is contributing to the favorable margin profile. Yes, I do think what we saw in Q1 is a good run rate to use for the remainder of the year.
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. From a margin perspective, that should be another nice catalyst entering the U.S. market.
You did the cost reduction program as well. It's kind of right-sized everything. Maybe you can talk about the cash where you finished 1Q and that run rate and the path to profitability.
Yeah, we're, 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 million of cash. In Q1, after the financings that we conducted in January and February, we closed the quarter with approximately $20 million of cash on the balance sheet. 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. This is all with the goal of setting us up so that in 2026, we can achieve a positive EBITDA on our ex-U.S. business.
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 how much cash we would need to invest to get the U.S. market up and running.
When do you think we'll hear the launch strategy for the U.S.? Is that, yeah, this year or next year? How do you think about that?
We're working on it now. I would say that as we get closer to an approval, we will be able to share a little bit more about what we are thinking. For now, it's in the early stages in terms of planning.
Okay. Any changes in competition, I guess, 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?
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 suffer in the presence of GLP-1s. The most recent data from the U.S. 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.
The therapies that are most invasive will take the longest to recover because GLP-1s are such a great first-line therapy for many patients. The ones that are less invasive, like the Allurion Balloon, I think are going to be much more resilient in this marketplace.
I guess, a few minutes left, maybe you can just talk about the real-world experience data that you have. Any other study data that you'd like to highlight before we finish?
Yeah, absolutely. 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. We've collected literally millions of data points because every time someone steps on our scale, that data point goes to our cloud. 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. 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%-15% of their total body weight.
As they continue to use the behavior change program and the Virtual Care Suite, they will maintain a significant amount of that weight loss. Now what we are seeing, 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. Of course, we're seeing similar results in the combination of GLP-1s and Allurion. Later this year, we'll have some even larger case series for you to dive into. Suffice it to say, it's a very consistent experience around the world.
Great. I think we'll leave it there. Thanks so much for your time. Thanks, everyone, for logging in.
Thank you very much.
Thank you.