Allurion Technologies - Earnings Call - Q4 2024

Executive Summary

• Q4 revenue was $5.591M, down 32% year over year due to the temporary suspension in France and macro headwinds; gross margin fell to 45% from 78% YoY and 58% in Q3.
• EPS materially beat Wall Street consensus in Q4 (actual -$6.99 vs. -$30.25 consensus; bold beat), while revenue was in-line and EBITDA missed (more negative than consensus) [Values retrieved from S&P Global].
• Management initiated 2025 guidance of approximately $30M revenue, with operating expenses expected to decline ~50% versus 2024; they reiterated a path to EBITDA positive in 2026 and profitability in ex-U.S. by end-2025.
• Strategic catalysts include PMA submission for U.S. approval of the Allurion Balloon (AUDACITY topline positive), clearance to resume sales in France (Feb 12, 2025), and accelerating B2B2C commercial pivot with pilot accounts tracking >30% procedure volume growth in Q1 2025 vs. Q4 2024.

What Went Well and What Went Wrong

What Went Well

• “Momentum built in the fourth quarter as our new commercial strategy began to take hold,” with FY24 procedure volume up 4%; clearance to resume sales in France and positive AUDACITY topline readout strengthen the regulatory and growth backdrop.
• Initial data on the balloon + low‑dose GLP‑1 combination showed promising weight loss, lean mass preservation, and adherence; management plans prospective studies to validate the approach.
• Restructuring lowered Q4 operating expenses by 39% YoY and set up ~50% OpEx reduction in 2025; pilots in key markets indicate >30% procedure volume growth potential under B2B2C strategy.

What Went Wrong

• Revenue declined YoY in Q4 due to France suspension and macro headwinds; gross margin compressed to 45% driven by lower volumes and inventory obsolescence related to France.
• Q3 revenue was hit by a $1.2M recall adjustment and broader destocking/credit risk management; France contributed >$1M lost sales plus the recall adjustment against Q3 revenue.
• EBITDA in Q4 missed consensus (more negative), reflecting restructuring/financing costs and lower absorption of manufacturing overhead; cash fell to $15.4M at year‑end prior to subsequent financings.

Transcript

Speaker 3

Good morning, and thank you for joining us. Earlier today, Allurion Technologies issued a press release announcing Financial Results for the Quarter Ended December 31, 2024, and provided a business update. You can access a copy of the announcement on the company's website at investors.allurion.com.

With me on the call today is Shantanu Gaur, Founder and Chief Executive Officer. Before we begin, I would like to inform you that comments mentioned on today's call contain forward-looking statements within the meaning of federal securities laws. Actual results may differ materially from those expressed or implied as a result of certain risks and uncertainties. These risks and uncertainties are described in detail in our Securities and Exchange Commission filings, including our quarterly report on Form 10-Q filed on November 13, 2024. 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. Today's press release and supplementary financial data tables have been posted to our website.

With that, I will turn it over to Shantanu.

Shantanu Gaur (Co-Founder and CEO)

Good morning, and as always, thank you for joining us today. Before discussing our fourth 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 Allurion can bring this vision to reality and can have a significant and positive impact for shareholders in 2025 and beyond. While GLP-1s have become a popular first-line weight loss therapy, challenges for them persist in becoming the long-term solution for obesity. 30% of patients on GLP-1s discontinue their medication within the first month, and 50%-75% discontinue during the first year. The adherence obstacle for GLP-1s is caused by three factors: side effects, muscle mass loss, and high costs. Importantly, each of these issues is exacerbated when higher doses are needed to achieve clinically meaningful weight loss, which is the standard path.

We believe that combining the Allurion Program with low-dose GLP-1s could become a new standard of care for obesity. A combination approach has several advantages. First, at lower doses of GLP-1s, side effects, including muscle mass loss, are mitigated. It is well established that the gastrointestinal side effects of GLP-1s are dose-dependent, and that the loss of lean muscle when on GLP-1s alone can be up to 40% of the total weight loss. Thus, a lower dose of GLP-1s can help to limit side effects, loss of lean muscle, and may lead to better adherence. Second, the rapid weight loss achieved through the Allurion Balloon, the lifestyle modification strategies offered through the Allurion Program, and the remote monitoring through the Allurion Virtual Care Suite are all synergistic with low-dose GLP-1s. Third, from a physiological perspective, the Allurion Balloon and GLP-1s are highly synergistic.

The Allurion Balloon induces satiety, while GLP-1s reduce hunger. This dual action across two different mechanisms of action has shown to lead to greater weight loss when the two are used in conjunction, and further opportunities for behavior change as patients learn to control their hunger while feeling full faster. We believe all of these synergies ultimately will lead to long-term weight maintenance and preservation of muscle mass, something we call metabolically healthy weight loss inside Allurion. Strong data have already been generated on such combination use, and it appears to be very promising. A study in 181 patients showed that starting liraglutide, which was a previous generation GLP-1 drug, after the first month of the Allurion Balloon can lead to a 19% total body weight loss at eight months, or four months after the Allurion Balloon passes.

A double-blind, randomized controlled study in 115 patients in which patients who received the Allurion Balloon and oral semaglutide lost 18% of their total body weight and had improved resolution of type 2 diabetes, hypertension, and obstructive sleep apnea. Initial data in 52 patients treated with the Allurion Program and low-dose semaglutide who lost 20% of their total body weight at eight months increased lean body mass by 15% and remained fully adherent to their GLP-1 medication. On this point, at an Allurion Academy event in March, I had the opportunity to speak to our physicians in Europe who are using the Allurion Balloon. Many of them were bariatric surgeons who have observed a drop in bariatric surgery volume due to the rise of GLP-1s.

These physicians are either already using or considering using the balloon in combination with GLP-1s to both deliver better clinical results to their patients, but also offer an option to patients that can mimic the effects of bariatric surgery without an invasive procedure. In fact, one physician called the combination of the Allurion Balloon with a low-dose GLP-1 a non-surgical sleeve gastrectomy because of the weight loss that can be achieved and the dual effects on both satiety and hunger that mimic what is accomplished in bariatric surgery. We believe there is gold to mine in combination therapy where the Allurion Balloon is paired with low-dose GLP-1s and intend to launch additional prospective studies to confirm our initial findings.

The trials that we intend to conduct, for which we have already begun to select sites and formalize our protocols, will study the weight loss, muscle mass, and GLP-1 adherence results in patients treated with the Allurion Balloon and low-dose GLP-1 therapy. We believe that, assuming these results validate our hypotheses, this clinical trial pipeline could define a new paradigm in obesity care where Allurion will be right at the center. I have deep conviction in this vision for the future and the importance of our clinical pipeline, and I look forward to providing additional updates on future calls. Shifting now to the fourth quarter and full year 2024, we ended the year with clarity and excitement about our path forward in 2025, a year where we expect several rich catalysts.

Fourth quarter revenue was $5.6 million, and full year revenue was $32.1 million, in line with our pre-announcement in January. Operating expenses in the fourth quarter decreased by 39% compared to the prior year as the restructuring and reorganization we conducted began to bear fruit. Despite these reductions, procedure volumes grew by 4% in 2024, higher than our previously issued guidance, something we believe is driven in part by patients entering the funnel after trying and stopping GLP-1 medications. Our excitement for 2025 stems from a clear plan that we shared on our last call. Our plan 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 business models. Fifth, resuming commercialization in France. In the fourth quarter of 2024 and thus far in the first quarter of 2025, we have made significant progress across many of these fronts. Regarding our new commercial plan, in the fourth quarter, we reorganized our sales and marketing teams, developed hiring plans for our direct markets where we plan on increasing the number of reps, and established new relationships with distributors in key markets. Thus far, in the first quarter, we have begun hiring new reps experienced in B2B2C commercial approaches, conducted our first Allurion Academy focused on core customers in direct markets, and shifted the mindset and culture at Allurion to one that prioritizes profitability.

We believe momentum is building in the first quarter of 2025 as our new commercial strategy and new commercial team takes hold. As I mentioned on our previous call, we have begun to pilot our new strategy with focus accounts in direct markets. In these accounts, procedure volumes are on track to increase by over 30% in the first quarter of 2025 compared to the fourth quarter of 2024, suggesting that our new plan could lead to significant future growth once rolled out globally. Regarding our pathway to FDA approval, in January, we announced positive top-line results for the AUDACITY trial that we believe will support the completion of our PMA application in the first half of this year. We have also begun to evaluate various models for a U.S. launch to enable the most efficient utilization of capital.

The U.S. represents a massive opportunity for Allurion due to the high rates of obesity and widespread use of GLP-1s. With over 40% of adults in the U.S. with obesity, 9% with severe obesity, and wide availability of GLP-1s, we believe the combination approach that I touched on at the beginning of the call could become the standard of care when the Allurion Balloon launches in the United States. With the restructuring we completed in the fourth quarter of 2024, we moved Allurion one step closer to being EBITDA positive in 2026. We expect operating expenses to decline by approximately 50% in 2025 compared to 2024 as the cost savings from the restructuring take hold and are expecting revenues of approximately $30 million in 2025.

Despite this reduction in operating expenses, we continue to invest in key areas at Allurion that will support our future growth. We expect our sales team to actually grow in 2025 compared to 2024. We also will continue to advance the design of the Allurion Balloon by launching our next-generation balloon with a smaller capsule, more radiopaque catheter, and enhanced filling valve in additional markets, and add new features to the Allurion Virtual Care Suite to increase the productivity of our partner clinics. In the first quarter of 2025, we also raised additional capital through financings that provide the company with cash runway into 2026 and through expected FDA approval. With this additional financing in place, we have a strong balance sheet that can lead us through milestones that we believe will create significant value for shareholders.

In February, we were pleased to announce that we were clear to resume sales in France after ANSM, the French regulatory authority, reviewed the changes we made to our advertising, physician training, and patient follow-up programs. In addition to that review, ANSM also performed a bottoms-up review of the Allurion Balloon's safety and efficacy profile and ultimately concluded that the benefits of our technology outweigh the risks. We are thrilled to be back on the French market and have begun re-engaging with clinics so that we can once again serve French patients who are struggling with 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 fourth quarter of 2024 was $5.6 million compared to $8.2 million for the same period in 2023. The year-over-year decrease in revenue was primarily due to the temporary suspension of sales in France and macroeconomic headwinds in certain markets leading to lower reorder rates. Gross profit for the fourth quarter ended December 31, 2024, was $2.5 million, or 45% of revenue, compared to $6.4 million, or 78% of revenue for the same period in 2023. Gross profit for the fourth quarter ended December 31, 2024, was negatively impacted by the reduction in revenue in the period and lower production volumes, which resulted in less manufacturing labor and overhead being absorbed into inventory costs.

We also recorded an adjustment of excess and obsolete scrap related to inventory on hand with a shelf life of less than six months, which was primarily due to the reduction in revenue and temporary suspension of sales in France. For the full year ended December 31, 2024, gross profit was $21.5 million, or 67% of revenue. Gross profit margin is expected to expand in 2025 with inventory levels normalizing and sales resuming in France. Sales and marketing expenses for the fourth quarter of 2024 were $7.9 million compared to $10.7 million for the same period in 2023 and included $3.1 million of restructuring costs. 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 fourth quarter of 2024 were $4.1 million compared to $6.1 million for the same period in 2023 and included $0.3 million of restructuring costs. 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 fourth quarter of 2024 were $7.7 million compared to $15.4 million for the same period in 2023 and included restructuring and financing costs of $1.1 million.

The reduction was primarily driven by decreases in bad debt expense and in stock-based compensation, as well as the restructuring initiatives implemented during the fourth quarter of the year. Loss from operations for the fourth quarter was $17.1 million compared to $25.7 million for the same period in 2023 and included $4.6 million of restructuring and financing costs. The reduction was driven by restructuring initiatives implemented during the fourth quarter. As of December 31, 2024, we had cash and cash equivalents of $15.4 million.

I will now turn the call back over to Shantanu.

Shantanu Gaur (Co-Founder and CEO)

Thanks, Tara. The organizational and financial restructuring that we recently executed and the implementation of the new commercial plan have right-sized and focused Allurion to be a much more efficient business. We believe that 2025 will be a year full of rich catalysts that will redefine the future of Allurion. The clinical data we are generating on the combination of Allurion with low-dose 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. In the year ahead, I'm looking forward to executing across our five-point plan and building out what we call Allurion 2.0. The future has never been brighter, and our conviction has never been higher.

With that, I will now turn to the questions and answer portion of the call. Operator, please open up the call for questions.

Operator (participant)

Perfect question and answer session. If you'd like to ask a question, please press star followed by one on your telephone keypad. Kindly limit your questions to one question and one follow-up. Your first question comes from the line of Matt Taylor from Jefferies. Your line is now open.

Matthew Taylor (Managing Director)

Hi, good morning. Thanks for taking the question. I wanted to follow up on these interesting results that you presented looking at using the balloons with the low-dose GLP-1. I was wondering if you could just expand on some of the reasons why you think the results were so good there in terms of both weight loss and the lean muscle or lean mass gain.

Shantanu Gaur (Co-Founder and CEO)

Yeah, thanks for the question, Matt. A couple of things to point out there. One, this study that we reported out on combined the Allurion Balloon with a low-dose of semaglutide or GLP-1 medication. What we know historically is that there is a very clear dose-response relationship between GLP-1 drug dosing and muscle wasting and side effects. Part of the results that we were able to demonstrate were driven by the fact that we were using a lower dose of the GLP-1 versus a higher dose, which protects lean body mass and, in particular, muscle tissue. At those low doses of GLP-1s, you still get a weight loss effect, and that's really where the synergistic mechanisms of action come into play.

At the low dose of GLP-1, you suppress the patient's hunger, and with the Allurion Balloon on board, you can induce early satiety. When you actually stimulate both of those mechanisms simultaneously, you get the synergistic results in terms of weight loss. That is how we were able to achieve a 20% reduction in body weight through that synergistic stimulation of those two mechanisms while maintaining and actually increasing lean body mass.

The second piece is all of the tools that we surround the balloon and the low-dose GLP-1 with. That includes the Allurion Virtual Care Suite, our connected scale that actually measures and tracks muscle mass, and the Allurion app, which is providing behavior change and lifestyle modification strategies, and also Coach Iris, our 24/7 AI coach. With all of that support, the patient is actually doing things in their day-to-day life, like eating a higher protein diet, maybe pursuing weight-bearing exercise. All of that also leads to preservation and, in our case, an actual increase in lean body mass and muscle mass.

Really, when you take a step back, actually, when you combine these two approaches, the Allurion Balloon with a lower dose of GLP-1s, you really get the best of both worlds, and that's what drives not only the weight loss and the muscle mass preservation, but also the better adherence to the GLP-1 in the long run.

Matthew Taylor (Managing Director)

Great. Thank you. I just wanted to ask a separate question on the 2025 guidance of $30 million. Could you talk about any key assumptions in there in terms of volumes, pricing, France? Anything that might help us understand how you're looking to get to the $30 million for the year?

Shantanu Gaur (Co-Founder and CEO)

Yeah, it's a good question. When we took a look at 2025 and took a look at how resilient our procedure volume was in 2024, despite the significant reductions that we made in operating expenses in 2024, we feel very confident going into 2025 that we'll be able to preserve the procedure volume that we saw in 2024, despite additional reductions in operating expense, even in sales and marketing in 2025. As we look geographically in 2025, we're seeing, as we saw in 2024, the highest procedural volume increases in countries and territories where GLP-1s were actually the most mature, which suggests to us that GLP-1 patients may be stopping the drug and entering our funnel after having tried the drug, discontinuing it, maybe having regained weight, and now finding themselves back in the doctor's office looking for an alternative treatment.

Looking at 2025, we're really doubling down on the regions where GLP-1s are most mature because that's where we see the most traction, specifically in the second half of 2024. With regards to France, we're excited to be back on the market there and serving patients again. It'll take some time for us to re-engage with customers, re-engage with clinics, and have them turn their machines back on. I know for a fact that French physicians who we've worked with historically are very excited to get the balloon back in their practice. I don't expect a material contribution from France in 2025, but I do expect late in this year and going into 2026 there to be a much larger contribution from France on a go-forward basis.

Matthew Taylor (Managing Director)

One final one from me. I guess you talked about the potential for the U.S. approval in 2026. What are some of the guideposts that you would point investors to to track your progress in the U.S. along the regulatory pathway this year?

Shantanu Gaur (Co-Founder and CEO)

The next big milestone will be completing the PMA submission, which we anticipate happening in the first half of this year. After that, we'll be receiving feedback from the FDA on our PMA application, which we expect to respond to and continue the dialogue with FDA. The real next milestone is submission of the PMA, and then we'll be updating the market subsequent to that with any future milestones.

Matthew Taylor (Managing Director)

Great. Thank you so much.

Operator (participant)

Your next question comes from the line of Josh Jennings from TD Cowen. Your line is now open.

Joshua Jennings (Managing Director)

Hi, good morning. Thanks for taking the question. Wanted to just follow up on your call out of the momentum in the fourth quarter in these terms of procedure volume growth where GLP-1s are relatively mature. I just wanted to ask about seeing the brand of the first quarter. Are you seeing that momentum continue? I mean, that's what we're assuming, but just wanted to hear any commentary you can share just on first-quarter trends.

Shantanu Gaur (Co-Founder and CEO)

Yeah, Josh, thanks for the question. We are seeing those trends continue in the markets where GLP-1s are most mature. Layering on top of that, as I mentioned previously, with the initiation of our new commercial plan under new commercial leadership, we've been piloting several aspects of our new commercial plan that's really focused more on B2B2C marketing strategies, helping our core accounts specifically in our direct markets actually grow their productivity and utilization.

In our pilot markets and in our pilot accounts in those markets, we're seeing significant growth in procedure volume. We're looking forward now that many of these pilots are coming to completion, and we're looking forward to expanding those strategies into other markets as the year goes on. That's partly why we expect a steady build of revenue as the year goes on quarter over quarter.

Joshua Jennings (Managing Director)

Excellent. You presented publicly the case series for the combo therapy of Allurion Balloon, GLP-1s, and the VCS platform. I mean, it sounds like in your remarks today that that approach is already being implemented by bariatric surgeons internationally. Just was hoping maybe you could help us think through the combo approach's potential before some of the clinical development, before the clinical development program builds that you're planning. I just have one follow-up.

Shantanu Gaur (Co-Founder and CEO)

Yeah. The results of that study were outstanding. I mean, the weight loss that we were able to generate, the lean body mass gains, the adherence that we were able to show with the GLP-1s. Part of the reason that I think the results were so promising and so positive is for something that you mentioned, which is this just makes natural sense to both physicians and patients. From a biological standpoint, when you stimulate two different mechanisms of actions, you typically unlock the type of synergy that we saw in these results. As we plan our prospective studies to validate these results, commercially, this combination approach is already happening.

What we've seen and what we've observed is that the combination approach really serves two different purposes for our physicians. One, it delivers outstanding clinical results and allows physicians, particularly bariatric surgeons, to participate in this rise of GLP-1s and the popularity of GLP-1s among their patients while also delivering the Allurion Balloon and delivering best-in-class clinical outcomes. With that comes additional revenue to their practice. As I mentioned previously, with many bariatric surgeons, the bariatric surgery volumes have dropped significantly, and their practices have been impacted as a result. The Allurion Balloon in combination with GLP-1s presents not only a great clinical option for their patients, but also a fantastic opportunity for them to grow their practices and recover some of the revenue that they've lost.

For those reasons, I actually expect commercially that this combination approach will continue to flourish, not just in Europe and Italy and Spain where we have the academy, but really globally. In parallel, we will generate or we expect to generate the prospective studies to further validate from a clinical perspective what we've already seen commercially and from this first case series.

Joshua Jennings (Managing Director)

Excellent. Just on the clinical development program and the prospective studies, I know it's very early, but can you share any high-level color on clinical trial design or just when do you expect to have readouts where those prospective study results could have a bigger impact in terms of driving this combo therapy approach? Thanks for taking the question.

Shantanu Gaur (Co-Founder and CEO)

No specific—thank you, Josh. No specific details at this point. We are developing the protocols actively internally. We've already begun discussing the protocols with several of the sites that we are very interested in working with.

What we do know now, though, is that these protocols will be prospective in nature, and they will focus on the same metrics that this case series focused on, which was weight loss, lean body mass, or muscle mass gains, and also GLP-1 adherence. I believe that by testing that in a prospective manner, we'll learn a little bit more about this approach in a broader population and also get the validation that comes with any sort of prospective study design.

Joshua Jennings (Managing Director)

Appreciate that, Shantanu. Thanks.

Operator (participant)

Your next question comes from the line of Jason Wittes from Roth Capital. Your line is now open.

Jason Wittes (Analyst)

Hi. Thanks for taking the questions. In terms of the B2B2C rollout, has that been fully implemented, or is that something that's going to take place throughout the remainder of 2025?

Shantanu Gaur (Co-Founder and CEO)

It's something that we've piloted so far in key markets, Jason. Thank you for the question. It's something that we will continue to roll out as we get more validation on some of the approaches that we have implemented. So far, the pilots that we have done have worked extremely well, and we will be rolling those strategies out as the year goes on.

Jason Wittes (Analyst)

Okay. Great. In terms of the patients that you're getting traction for and the regions you're getting traction for, you mentioned that the more mature markets, that is, the more mature markets with GLP-1s, are seeing, it sounds like, the most growth. Are there any metrics you can provide in terms of what regions those are and how they're performing?

Shantanu Gaur (Co-Founder and CEO)

Yeah. What we saw in the second half of 2024, specifically in the Middle East, was very promising. In the Middle East, much like the United States, GLP-1s launched really about 12 to 18 months ago in earnest to a lot of fanfare and a lot of hype. They took off as a first-line therapy for anyone with obesity who was looking to lose weight. What we observed is that after that rapid takeoff, what happened subsequently was patients stopped using these GLP-1 medications. The data indicates that 30% of patients will stop within the first month, 50%-75% will stop within the first year. As a result, after about a year, what happened was patients stopped using the drugs and probably came back to the doctor's office looking for an alternative.

We saw that also in Latin America, where patients got access to lower-cost and earlier-generation versions of the GLP-1s but had a similar effect on the market. In Europe, now that GLP-1s have launched and have had some time to settle in, I do expect to see that sort of similar trend occurring as 2025 goes on.

Jason Wittes (Analyst)

Great. That's helpful. Maybe one last question. On sort of OpEx, the reduction, are all those changes in place, or is there going to be continued reductions throughout the rest of this year? How do we think about modeling those OpEx changes for the year?

Shantanu Gaur (Co-Founder and CEO)

The OpEx changes for 2025 were put into effect -- at the end of 2024 through the restructuring process. In the fourth quarter, as you saw, we incurred some one-time restructuring fees and expenses across every single department. Those were all related to the restructuring that we performed, and those restructuring changes are what leads to the OpEx reduction in 2025 compared to 2024.

Jason Wittes (Analyst)

Got it. Great. I'll jump back in queue. Thank you.

Shantanu Gaur (Co-Founder and CEO)

Thanks, Jason.

Operator (participant)

Next question comes from the line of Keay Nakae from Chardan. Your line is now open.

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

Thank you. Just wondering if you could provide a little more granularity about the cadence of the revenue you expect to get to $30 million for the full year.

Shantanu Gaur (Co-Founder and CEO)

Thanks for the question, Keay. Yeah, the cadence that we expect for the year is just a steady build quarter over quarter as the year goes on. That's really driven by a couple of factors. The first is new commercial plan under new commercial leadership, rolling out these new B2B2C strategies, specifically in our direct markets as the year goes on. That is also going to be driven by the buildup of our sales team.

As I mentioned previously, while we are reducing operating expense 50% year over year, we're actually increasing the size of our sales force. We've already begun hiring new reps in our existing territories, and we expect that that hiring process will continue as the year goes on. As a rep joins Allurion and gets onboarded and takes a quarter or two to become productive, that's actually what's driving the steady revenue build as the year goes on.

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

When do you expect to see sort of a meaningful contribution from France start to show up in revenue?

Shantanu Gaur (Co-Founder and CEO)

Really not until the end of this year going into 2026, primarily because it does take time to reengage with accounts, turn those accounts back on, have them begin reaching out to patients, and also just building and expanding our feet on the street in France in terms of reps and other sort of infrastructure that we really dialed down as of August of last year when we were taken off the market there. I would expect a material contribution really in 2026 at earliest near the end of 2025.

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

Okay. I guess similarly in terms of the gross margin, obviously down in Q4, but you're expecting year-over-year improvement. Again, how does that look sort of throughout the year in terms of building back to that number?

Shantanu Gaur (Co-Founder and CEO)

The recovery in gross margin should occur more quickly than sort of our sales build and revenue build as the year goes on. The drop in margin in Q4 was really driven by the events in France with the recall that was initiated there last year. That led to inventory that we had to obsolete, and that really drove margin down specifically in the fourth quarter. We expect starting in Q1 for margin to be much more similar to where we were in the first half of 2024 and then expand further again as the year goes on. Our revenue is expected to increase. That leads to more absorption in manufacturing, which should drive more margin accretion.

I will say too that going into 2026, when we do expect more of a material contribution from France, that should also drive further expansion of margin because France is a direct market with a high ASP.

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

Okay. How does the timing of launching the smaller balloon impact margin?

Shantanu Gaur (Co-Founder and CEO)

We do not expect a significant impact in 2025 in terms of gross margin from our next-gen balloon design. As the balloon design gets approvals, key regulatory approvals, especially in direct markets going into 2026, that may lead to further margin expansion next year. For now, in 2025, given that we have just launched the next-gen balloon in one key market and expect further regulatory approvals as the year goes on, we do not expect a contribution from that to expand gross margin further than where we expect it to be in Q1 and the rest of 2025.

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

Okay. Great. That's helpful. Thanks.

Operator (participant)

I'd now like to hand back the call over to Shantanu Gaur for final remarks.

Shantanu Gaur (Co-Founder and CEO)

Thank you very much, Operator. As we close our call today, I just want to extend my gratitude and thanks to all of you who joined us today. We really appreciate all of your time and interest in Allurion. In particular, I really appreciate the continued loyalty and support of our shareholders, all of our partners all over the world, and most importantly, all of our employees and team members here at Allurion. Your belief in our mission and your commitment to our company really are instrumental to our future success. We look forward to updating everyone on our progress as the year goes on and in the next quarter.

Thank you, everyone. Have a great day. Thanks for joining us.

Operator (participant)

Thank you for attending today's call. You may now disconnect. Goodbye.