Allurion Technologies - Earnings Call - Q1 2025

Transcript

Operator (participant)

Hello, and welcome to the Allurion first quarter earnings call. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question-and-answer session, and if you would like to ask a question during this time, please press star one on your telephone keypad. I would now like to turn the conference over to Tara Brady. You may begin.

Tara Brady (Interim CFO)

Good morning, and thank you for joining us. Earlier today, Allurion Technologies Inc issued a press release announcing financial results for the quarter ended March 31st, 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 the 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 27th, 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. 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. In addition to the company's GAAP results, management will also provide supplementary results on a non-GAAP basis. Please refer to the press release issued today and the accompanying supplementary financial data tables for a detailed reconciliation of GAAP and non-GAAP results, which can be accessed from the investor relations section of the company's website. With that, I will turn it over to Shantanu.

Shantanu Gaur (Founder and CEO)

Good morning, everyone, and thank you for joining us as we kick off an exciting 2025 for Allurion, a year we expect to be rich in catalysts. We were pleased to deliver the first quarter in line with expectations, setting us up to deliver on the year ahead. First quarter revenue of $5.6 million was achieved on adjusted operating expenses of $10.1 million, a decrease in expense of 45% compared to the prior year. Adjusted net operating loss of $5.9 million narrowed by 48% compared to prior year, and gross margin expanded to 75% compared to 73% in the prior year and 45% in the previous quarter. Our financial results reflect increased efficiency as we move toward profitability, with expenses continuing to reduce, gross margin expanding, and operating loss narrowing. As we have stated previously, we have a new vision for the future of Allurion.

That vision begins with our plan for 2025, which is built around five pillars. First, a new commercial plan focused on key geographies with deeper penetration within these geographies and a business-to-business-to-consumer, or B2B2C, direct sales model versus a direct-to-consumer, or DTC, marketing model. Second, gaining FDA approval for the Allurion Balloon and preparing for U.S. launch. Third, achieving profitability for the ex-U.S. business by the end of 2025. Fourth, scaling our now proven AI product platform and leveraging a variety of new business models. Fifth, resuming commercialization in France. Thus far in 2025, I am extremely proud of our team for the significant progress we have made across all five pillars. Regarding our new commercial plan, our first quarter results speak to the efficiency of our B2B2C model.

We piloted several aspects of the B2B2C model in clinics in Europe in the first quarter and observed over 40% growth quarter-over-quarter and year-over-year, giving us confidence in the model as we expand its implementation globally. In the first quarter, we also filled several open positions in our direct markets and will continue to attract top talent in the second quarter. We expect revenues to ramp as the year progresses, as the use of our B2B2C model expands and our enhanced sales team onboards. As part of our new commercial plan, we are increasingly leaning into the areas where Allurion products, either our entire program or just our AI-powered Virtual Care Suite, intersect with GLP-1 therapy.

In addition to the combination of the Allurion Program with low doses of GLP-1s, which I will provide an update on later in the call, we are seeing a number of different approaches being taken by clinicians organically that combine Allurion with normal doses of GLP-1s. As we announced yesterday, we presented two abstracts at the European Congress on Obesity that touch on this. In one study of 138 patients who were prescribed GLP-1s with normal dose escalation and used our VCS, through which they received behavioral support and had changes in lean body mass tracked, lean body mass increased by 6.1% and muscle mass increased by 6.4%, while fat mass decreased by 10.2%.

In another study of 60 patients who were treated with the Allurion Balloon and semaglutide with a normal dose escalation, the average reduction in total body weight was 21.2%, with improvement in LDL cholesterol, triglycerides, and hemoglobin A1c after 10 months. This approach led to outcomes similar to those achieved with bariatric surgery without the risks inherent to surgery. While we believe that the best option for most patients seeking higher weight loss is likely a combination of the Allurion Program with a low dose of GLP-1s, these studies speak to the versatility of Allurion's product portfolio. The first study supports our thesis that even at normal doses of GLP-1s, Allurion's Virtual Care Suite can be useful in driving better weight loss outcomes and maintaining muscle compared to what patients can achieve using GLP-1s alone.

The second study describes an option that may be attractive for patients with severe obesity who are seeking an alternative to bariatric surgery and may be more willing to tolerate the higher side effects observed with normal dose escalation. Commercially, we believe this versatility will open new doors for us that will ultimately drive higher Balloon and software revenues. Regarding our path to FDA approval, we recently completed our pre-PMA meeting with FDA, where we presented our top-line results from AUDACITY. We were very pleased with FDA's openness to considering additional analyses that address the control group performance we observed in AUDACITY. We believe these analyses will further underscore the strength of our data and overall application.

We were very encouraged by FDA's feedback, and we very much look forward to completing our PMA submission, which we expect will occur by the end of June, and working collaboratively with FDA toward an approval. Regarding our path to profitability, we believe our first quarter results demonstrate the increased efficiency of our business following the restructuring we implemented at the end of 2023. With the financings we conducted in the first quarter, along with our continued discipline in our cash use, we ended the first quarter with cash and cash equivalents of $20 million, which provides the company the runway we believe we need to achieve our FDA approval, profitability, and other milestones that could generate significant value for shareholders. Looking forward to the rest of the year, our direct exposure to tariffs is negligible.

As many of you know, the Allurion Balloon and almost all of its components are manufactured in the U.S., and we do not expect any impact on gross margin from tariffs for the balance of the year. We are maintaining our guidance of revenues of approximately $30 million, with a reduction in operating expenses of approximately 50% compared to 2024. Turning now to our digital product, with the shortages of compounded GLP-1s now officially over, we have started to build out AllurionMeds to offer brand-name GLP-1s. We have performed pilot work with pharmacy partners that offer these medications at low and high doses and are in discussions to perform a more complete integration later this year. We believe that having brand-name GLP-1s available through AllurionMeds could be an attractive option for U.S. patients, especially at lower doses in combination with the Allurion Balloon.

With over 40% of adults in the U.S. with obesity and 9% with severe obesity, we believe the combination approach could become the standard of care when the Allurion Balloon launches in the United States. Finally, we are making good progress in treating patients in France again. We have re-engaged clinics, retrained providers, and are now in the final phases of updating our collateral to reactivate placements. We look forward to providing further updates on this in future calls. Before I turn it over to Tara, I want to provide an update on our vision for the future of obesity care that I shared on our last call and how we believe Allurion can bring this vision to reality and have a significant positive impact for shareholders in 2025 and beyond. We believe that combining the Allurion Program with low-dose GLP-1s could become a new standard of care for obesity.

By combining the two approaches, our initial data indicate that patients can achieve sustained weight reduction of greater than 20% while maintaining muscle mass and increasing long-term adherence to GLP-1 therapy, driven in part by the fewer side effects experienced at lower doses. This trifecta—losing weight, keeping it off, and maintaining muscle—is what we call metabolically healthy weight loss. The science behind our focus on muscle, use of low doses of GLP-1s, and long-term engagement to enable behavior change is clear and continues to be elucidated at physiological, cellular, and psychological levels. First, from a physiological perspective, muscle mass is crucial for driving weight loss and weight maintenance. Compared to fat, muscle burns 2x-3x more energy per kilo at rest, and during exercise, increased muscle leads to increased energy expenditure.

Muscle is also the primary site for glucose storage, removing it from the blood, leading to increased insulin sensitivity and less fat storage. Muscle also releases myokines during exercise, which increase satiety, reduce appetite, and actually stimulate release of endogenous GLP-1. Second, from a cellular perspective, high doses of GLP-1s stimulate pathways that lead to protein degradation and inhibit pathways that lead to protein synthesis, leading to a breakdown of muscle and muscle wasting. Using lower doses of GLP-1s in combination with the Allurion Balloon mitigates these effects without impacting overall weight reduction. Further, as discussed on the previous call, the combination of the Allurion Balloon with GLP-1s is highly synergistic, as the Allurion Balloon primarily works by inducing satiety and GLP-1s work by reducing hunger, two mechanisms of action that are distinct at the cellular and molecular level.

Third, from a psychological perspective, behavior change is key for weight maintenance and takes time. Adopting new eating behaviors typically takes 2-3 months, and it usually takes 6 months for these behaviors to become second nature. Data from the National Weight Control Registry, which studies individuals who have successfully maintained a weight loss of at least 30 pounds for at least a year, clearly indicates that maintaining weight loss for one year significantly improves the chances to sustain long-term behavior change. While we have already reported out retrospective data on the combination approach, we now intend to launch a prospective trial, the details of which I am pleased to share today. The trial will be conducted across three obesity centers of excellence in Europe and will enroll subjects with a BMI greater than 30.

Subjects will receive the Allurion Balloon and will start 0.25 mg semaglutide 30 days after balloon placement. Semaglutide dose will increase over the subsequent 11 months to a maximum of 1.0 mg. For reference, standard dosing for semaglutide typically reaches between 1.7 mg and 2.4 mg, so the maximum dose that will be used in this study is approximately half. Body weight, muscle mass, and compliance with semaglutide will be evaluated throughout the study using the Allurion Scale and Allurion Virtual Care Suite. Subjects will receive lifestyle modification and behavior change counseling through the Allurion App. With the sites selected and the protocol now drafted, we will begin the process to seek IRB approvals to conduct the trial and expect enrollment to start by the end of this year. We are extremely excited to begin this clinical program.

We believe that if successful and validated in larger sample sizes, this combination protocol could become a new standard of care for the treatment of obesity. I will now turn the call over to Tara Brady, our Interim Chief Financial Officer. Tara?

Tara Brady (Interim CFO)

Thank you, Shantanu. Our revenue for the first quarter of 2025 was $5.6 million compared to $9.4 million for the same period in 2024. The year-over-year decrease in revenue was primarily due to the temporary suspension of sales in France, as well as lower investments in sales and marketing. Gross profit for the first quarter was $4.2 million, or 75% of revenue, compared to $6.9 million, or 73% of revenue for the same period in 2024, and 45% compared to the fourth quarter of 2024. The increase in gross profit was driven by increased manufacturing efficiencies resulting from the restructuring initiatives implemented in the fourth quarter of 2024.

Sales and marketing expenses for the first quarter were $3.6 million compared to $6.1 million for the same period in 2024. The reduction in expense was primarily driven by increased operating efficiency and the restructuring initiatives implemented during the fourth quarter of 2024, which refocused spend on more efficient channels. Research and development expenses for the first quarter were $2.6 million compared to $5.7 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 the year. General and administrative expenses for the first quarter were $5.2 million compared to $6.4 million for the same period in 2024. Adjusted general and administrative expenses were $3.8 million, excluding one-time financing costs of $1.4 million. The reduction year-over-year was primarily driven by the restructuring initiatives implemented during the fourth quarter of 2024.

Loss from operations for the first quarter was $7.3 million compared to $11.4 million for the same period in 2024. Adjusted loss from operations was $5.9 million, excluding one-time financing costs of $1.4 million. The reduction was driven by restructuring initiatives implemented during the fourth quarter and expansion in gross margin year-over-year. As of March 31st, 2025, we had cash and cash equivalents of $20.4 million. I will now turn the call back over to Shantanu.

Shantanu Gaur (Founder and CEO)

Thanks, Tara. We are excited by the start to 2025, clearly demonstrating that we have restructured our business to run more efficiently while still fulfilling a massive unmet medical need around the world. We are making solid progress against our five-point plan for 2025, and with our pre-PMA meeting now behind us, see a clear path to completing our PMA and advancing our application toward FDA approval.

The prospective clinical data we intend to collect on the combination of Allurion with GLP-1 therapy could define a new standard of care in obesity management, and we are excited about its potential in our existing markets and, once approved, the U.S. market. With our sales team growing and new B2B2C strategy coming to life globally, we believe we are putting Allurion on a path to profitable, sustainable growth. We believe that if executed correctly, this strategy could lead to significant decreasing of shareholder value, with millions of patients entering the funnel and being treated with the Allurion program. With that, Operator, please open up the call for questions.

Operator (participant)

Thank you. If you would like to ask a question, please press star one on your telephone keypad. If you would like to withdraw your question, simply press star one again.

Please ensure that your phone is not on mute when called upon. Thank you. Your first question comes from Jason Wittes with ROTH Capital Partners. Your line is open.

Jason Wittes (Managing Director)

Hi. Thanks for taking the questions. Lots of positive things going on this quarter. Maybe to start, can you give any indication in terms of what might some of the trends that are going on regionally, whether that be Middle East or Europe, ex-France, of course, in terms of momentum, especially with the new change in marketing strategy?

Shantanu Gaur (Founder and CEO)

Yeah. Thanks for the question, Jason. What we're seeing regionally is really following the expansion of our B2B2C marketing strategy, specifically in territories where there are two phenomena going on. One, mature markets from a GLP-1 perspective are creating some tailwinds for us with patients who have previously tried GLP-1s, now re-entering the funnel looking for an alternative.

Also, with the launch of our focus on metabolically healthy weight loss and the combination of the balloon with a low dose of GLP-1s, we're starting to see that in markets where GLP-1s are available, they are being combined organically with the Allurion Balloon. The second phenomenon is really the expansion of our direct sales force as we hire new sales reps, specifically in our direct markets in Europe. They will take some time to onboard, but as they do onboard, we start to see an acceleration in new account openings and also going deeper into some of our existing accounts. As the year progresses, we expect those two trends to continue, and that is why we expect revenues to steadily ramp as the year goes on.

Jason Wittes (Managing Director)

Can I ask also about the trial with GLP-1s?

Did you state how long you think it might take, how many patients, and those types of things in terms of how we should be thinking about when we can see some data from that trial?

Shantanu Gaur (Founder and CEO)

Yeah. We expect enrollment in that study to begin this year, probably in the latter half of this year, and with a one-year follow-up, those patients will be going through the combination therapy for most of 2026. We are still considering whether or not to build in some interim looks into the data and are also finalizing the size of the study, but we're expecting the study to be at least 75 subjects across multiple sites in Europe, but we may increase the size, especially if the enrollment demand is there.

Jason Wittes (Managing Director)

Okay. That's helpful. Maybe one last question related to that.

In terms of the arms, are you considering doing an arm with the AI suite alone and with the AI suite in combination with the balloon and GLP-1s, or is there any thought about how that in terms of how you might design the arms for this trial?

Shantanu Gaur (Founder and CEO)

With this trial in particular, our goal is to validate what we have seen previously in our retrospective work with a prospective study. With all of the data that is available now with diet and exercise controls and all the data that we have with patients who are just using the Allurion Virtual Care Suite with or without GLP-1s, we actually have a lot of historical data to compare this prospective trial against.

For now, we're moving forward with a single-arm prospective trial design, and we're going to use a lot of the historical data that we have at our fingertips as comparators. That will do two things. One, it will accelerate the execution of the study, but it'll also make it much more efficient to run, which ties into one of our goals for this year, is to accelerate our path to profitability. We'll have plenty of data here to compare our results against.

Jason Wittes (Managing Director)

Okay. Thank you. One last small question. That's just the gross margin had a nice rebound here. Is this kind of the gross margin we should anticipate for the rest of the year, or is there further improvements?

Shantanu Gaur (Founder and CEO)

Yeah. For the first quarter, we were very pleased with the margin expansion.

It was driven by some of the restructuring and reorganization that we did in the second half of 2024, but also part of this was driven by increased efficiency on the manufacturing floor as well through some of the new initiatives that we launched during calendar year 2024. As the year goes on, we expect margins to remain in that ballpark. We will obviously ramp revenues as the year goes on, which may also increase the margin profile, especially in the second half of the year. For now, on a go-forward basis, I would say what we did in the first quarter, we should be in that same ballpark for the remainder of the year.

Jason Wittes (Managing Director)

Got it. Thanks. I'll jump back in here. Thank you very much.

Operator (participant)

Your next question comes from Josh Jennings with TD Cowen. Your line is open.

Josh Jennings (Managing Director)

Good morning. Thanks for taking the question.

Shantanu, I was hoping to just get a better handle on the pre-PMA meeting and just the path from here. I think you called out that there will be some further analyses of the control group. Any more specifics you can share just in terms of last remaining steps before you submit that final module around mid-year?

Shantanu Gaur (Founder and CEO)

Yeah. Thanks for the question, Josh. We were very pleased with that pre-PMA meeting with the FDA. Just to provide a little bit more color on some of the things that we discussed, we presented the preliminary data from AUDACITY to the FDA. As you may recall, one of the issues that we highlighted when we announced the top-line results was the performance of the control group.

As we've done more analysis on the data and as we've shared some of that analysis with FDA, it's becoming clear that part of the control group performance was really driven by the statistical methods that we were using in order to impute the missing data in the control subjects. Some of the methods that we had been using may introduce some bias into the results that doesn't necessarily need to be there. With our conversation with FDA, we were actually very pleased to see their receptivity to alternative methods that we can use to analyze that control group data that puts us in a much stronger position compared to our pre-specified endpoints.

We were very encouraged by that conversation, and that really paves the way for us to complete our clinical study report in module number four on the timeline that we discussed in the call. I think moving forward, we will have, I believe, a much more accurate representation of that control group performance, which vis-à-vis our Allurion Balloon patients should reflect favorably on the overall data. As a reminder too, we were very pleased with the performance of our Allurion Balloon subjects in the study. Through our further analysis, their performance has remained unchanged. We are moving in the right direction, I believe, in terms of completion of the report and getting the PMA into the FDA.

Josh Jennings (Managing Director)

I appreciate those details. Just a follow-up question on that.

I mean, are there any analyses to be performed around higher levels of GLP-1 use in the control arm, or is that just not obtainable?

Shantanu Gaur (Founder and CEO)

Right now, there are a few variables that we've identified that could have been leading to that overperformance in the control group, GLP-1s being one of them. What's interesting about these analyses that we've performed is really no matter what was driving some of that control group overperformance, it really does not matter in terms of how the missing data is imputed. Whatever was driving that final outcome for the control subjects, we can actually, through alternative statistical methods, potentially correct for all of that, which puts us much more in line with our pre-specified endpoints. We are very pleased with how that analysis is going.

In addition to the solid safety profile that we had in the AUDACITY trial, we're feeling very good about this upcoming submission to the FDA.

Josh Jennings (Managing Director)

Excellent. It's great to hear about moving forward with the trial for the Allurion Program and low-dose GLP-1s. I was hoping to just hear from you about the current algorithm that your centers, adopters of the Allurion Balloon and VCS, are following. Are you seeing centers adopt and realizing the synergies of the Allurion Program plus low or normal dosing GLP-1s already? And could that be a base of registry data that will also accrue to help support this combo therapy approach you're moving forward with?

Shantanu Gaur (Founder and CEO)

Yeah. It's a very good question, Josh. We're seeing this happen organically in the field.

In fact, the retrospective data that we presented a few months ago was a result of low-dose GLP-1s being used in combination with Allurion organically by one of our physician partners in Italy. I was actually on the phone yesterday with one of our physician partners in Mexico who told me that he is opening up a new branch to his clinic that is going to focus on prescribing GLP-1s. He feels like that's going to do two things. He's a bariatric surgeon by training. He feels like that's going to bring more patients into the front door. He also knows that as patients escalate their GLP-1 dose, their adherence drops, they have side effects, and they want to go back down to a low dose, which, of course, will impact their overall weight loss.

He is well-positioned to plug in the Allurion Balloon into those patients as part of his treatment algorithm. We are seeing it happen in markets where GLP-1s have matured. That is what gives us confidence that this prospective trial that we are doing is going to speak to a lot of physicians around the world who are probably doing something very similar in their practice. On a go-forward basis, even after this prospective trial is done, one of the strengths of the Virtual Care Suite is that physicians and their teams can input in the Virtual Care Suite the treatment regimen that they are using.

For a patient who gets the Allurion Balloon, if that patient starts on a low-dose GLP-1 with a check of a box, the physician and their team can put into our system that the patient has started semaglutide or tirzepatide at a specific dose, which then allows us globally to track this performance. I suspect that there's going to be a lot of this combination therapy happening in the field, and we will have that data at our fingertips through the Virtual Care Suite, but also through some of these more structured clinical studies and registries that we can launch in the future.

Josh Jennings (Managing Director)

Understood. Just one last one. I think you've already addressed this, but just to make sure we understand the layers of, I guess, sequential revenue performance to get you to the full-year guidance.

I mean, all the work you've done on the commercial reorganization and the commercial strategy on a go-forward basis seems to have, but maybe just help us think through the cadence of the improvement in sales over the next couple of quarters in 2025 and include just how you see the recovery in France going. Thanks so much.

Shantanu Gaur (Founder and CEO)

Thank you. Thank you, Josh. When it comes to the rest of this year, we expect to see a steady increase in revenue as the year goes on. That's really being driven by onboarding of new sales team members, much of which is happening this quarter and at the end.

Keay Nakae (Director of Research and a Senior Research Analyst)

Thank you. Good morning. A couple of questions about the prospective combo study. I guess the first question, any estimate of what you plan to spend for the study?

Shantanu Gaur (Founder and CEO)

Yeah. Thanks for the question, Keay.

As I mentioned earlier, one of our goals is to increase and accelerate our path to profitability. One of the nice parts about this prospective study is that we can leverage our existing patient flow, commercial patient flow, leverage our existing clinics that are using GLP-1s in combination with the Allurion Program, and also leverage the lower cost of GLP-1s overseas compared to the U.S. We actually do not expect this prospective trial to have any material impact on our budget or overall expenses. Some of that expense will hit in 2025, and some of it will hit in 2026. Because the study is going to, between enrollment and actual execution, will take 1-2 years, we will also be able to space out that expense over time.

We're not providing a specific number at this point, but all I can say is we feel comfortable funding it with our existing budget.

Keay Nakae (Director of Research and a Senior Research Analyst)

Okay. From a regulatory perspective, as far as expanded label, is that part of the strategy, or is it simply by doing a prospective study, having that data, it would support a marketing effort to utilize the combination with low-dose GLP as opposed to an end goal of an expanded label to that same effect?

Shantanu Gaur (Founder and CEO)

In the short term, Kay, I think it's more about the commercial implications of a study like this and providing physicians additional comfort that this is a valid strategy. As I mentioned previously, a lot of this is already happening organically amongst physicians who are doing both Allurion and GLP-1s.

This study will, I think, provide a bit of a cherry on top in terms of validating that approach. That being said, what we do believe that this study will also allow us to do is start the conversation with regulators and with payers about the merits of combination therapy, both from the perspective of increased clinical outcomes or improved clinical outcomes, longer-term weight loss, improved muscle mass maintenance, but also the health economic implications of this type of approach. As you can imagine, GLP-1s at high doses cost a lot of money and are bleeding a lot of payers dry, whether they are commercial payers or even self-insured employers.

I believe that as we get closer to the U.S. market, with some of this data in hand, it could provide a very compelling option for payers who are struggling to cope with the high cost of GLP-1 therapy and also regulators who are looking for additional options for treating patients with obesity. I do think in the long term, this data could be very useful for that. In the short term, we're really focused on the commercial and clinical impact at our existing centers.

Keay Nakae (Director of Research and a Senior Research Analyst)

Okay. Thanks.

Shantanu Gaur (Founder and CEO)

The next question comes from Mike Toomey with Jefferies. Your line is open.

Mike Toomey (VP and Medtech Analyst)

Hey, guys. Thanks for taking my question. I'm on for Matt Taylor. Could you talk about the procedure growth in the quarter and maybe procedure growth ex-France, if you have that?

I guess any trends you're seeing in Q2 on that procedure growth since all the tariff announcements? I know you said there's not a material impact on cost, but are you seeing any impact on the procedures there?

Shantanu Gaur (Founder and CEO)

Thanks for the question. When it comes to procedure growth, now that inventory levels have really normalized globally, procedures and our top-line revenue are moving in lockstep with one another. Quarter-over-quarter, we see stability in procedure volume. Ex-France, in certain territories, we're seeing some growth in procedure volume. In other territories that were more dependent on that DTC marketing that we were doing in the early part of 2024, we're starting to see a recovery in procedure volume. On a go-forward basis, we'll really just be reporting out our top-line revenue numbers, which will give you an indication of how procedure volume is trending.

When it comes to France in particular, we do expect that in the second half of the year, we'll start seeing some placements, not nearly at the volume as they were in the second half of 2024, but they will add to our overall global procedure volume. When it comes to tariffs and their impact on our business, yes, as I mentioned, we don't expect any impact on our gross margin as a result of tariffs. In Europe and elsewhere, we really haven't seen an impact of tariffs from a macro perspective. It's something that we're tracking very closely, obviously. Again, when it comes to the actual ground-level impact of these tariffs on consumers who are interested in weight loss, we see the impact being fairly minimal here.

Mike Toomey (VP and Medtech Analyst)

Okay. All right. That's very clear. Thank you. You mentioned the additional analysis, the FDA.

Was that due to any concerns that the balloon would not be approved without the additional analysis, or is that just kind of normal in the process?

Shantanu Gaur (Founder and CEO)

No, it was not due to any additional concerns. It was actually just due to the further analysis that we did after seeing the top-line data internally. Also, after presenting that data to FDA, they actually invited some of these additional analyses that, frankly, work in our favor in terms of that second pre-specified endpoint. We are very pleased that that door was opened and that we have that flexibility. We were very pleased with the overall results of the trial to begin with from a safety perspective and also from a balloon performance perspective.

Now that we have additional analyses that we can do when it comes to the control group, I think it just further strengthens and underscores the quality of the study and the quality of the data. We are feeling very good about the outcome there and what it means for the rest of the process with the FDA.

Mike Toomey (VP and Medtech Analyst)

Okay. Awesome. One final question just on the AI-powered Virtual Care Suite. Impressive study results from yesterday where you combined with the GLP-1. Could you talk about when you would expect those Virtual Care Suite revenues to be material? Yeah, when you expect that to ramp up and be material to the top line?

Shantanu Gaur (Founder and CEO)

Yeah. It is a good question. The data that we presented at the European Congress on Obesity, I think, really just underscores the versatility of the program.

We were able to show that in combination with normal-dose GLP-1s, our VCS can power higher weight loss results. It can also power better muscle mass maintenance and, in fact, muscle mass improvement as a percentage of body composition. When you combine Allurion's VCS and Balloon with high-dose GLP-1s, you get excellent weight loss. Obviously, in those patients, they may actually experience the side effects of high doses and may not be on that high-dose therapy for very long. In the short term, at least, you get two results for patients with severe obesity that are similar to what they could achieve with bariatric surgery without, as we mentioned, the risks of bariatric surgery. What we really see from a software perspective is the U.S. most likely being the bigger contributor of our software revenue ramp.

We do have clinics overseas, large chains that are using the Virtual Care Suite to manage all of their different weight loss patients, whether they're getting GLP-1s, our balloon, or bariatric surgery. I really believe the bigger uptake is going to be in the U.S., especially when we combine the Virtual Care Suite with our ability in the U.S. to prescribe GLP-1s through the AllurionMeds platform. I do not expect there to be a material contribution to our revenue from software this year or early next year. As we start ramping in the U.S., I do believe it can become a more meaningful part of our business.

Mike Toomey (VP and Medtech Analyst)

Great. Thanks for taking my questions.

Operator (participant)

This concludes the question and answer session. I'll turn the call to Shantanu Gaur for closing remarks.

Shantanu Gaur (Founder and CEO)

Thank you very much, Operator.

As we close our call today, I'd just like to extend my thanks and gratitude to everyone who's joining us today, particularly all my fellow Allurions who are on the call, who are building Allurion 2.0 side-by-side with me, and our loyal shareholders, of course, who have backed us for many years now. Your unwavering belief in our mission and our commitment to our company have really set us up for success. We look forward to updating all of you on the progress that we make over the next several months. Thank you, everyone, for joining, and have a great day.

Operator (participant)

This concludes today's conference call. Thank you for joining. You may now disconnect.