Allurion Technologies - Q2 2024

Executive Summary

• Q2 2024 revenue was $11.8M, up 25% sequentially from Q1’s $9.4M, with gross margin at 76%; diluted EPS was $(0.05) driven by sizable fair‑value gains offsetting an operating loss.
• Management cut FY 2024 revenue guidance to $40–$45M and procedural volume growth to 10–15% due to the French regulator (ANSM) suspending balloon sales, more conservative inventory stocking, and macro headwinds; prior guidance was $60–$65M revenue and 20% volume growth.
• Operational execution improved: sales & marketing and R&D expenses declined materially YoY; procedure volume set a quarterly record (>10,000 placements) for the second straight quarter.
• Balance sheet bolstered by ~$22M gross proceeds from July’s public offering and concurrent private placement, improving runway toward management’s plan to achieve profitability by end of next year; Q2 cash was $19.3M (pre-offering).

What Went Well and What Went Wrong

What Went Well

• Sequential top‑line acceleration: revenue rose to $11.8M (+$2.4M, +25% q/q) on record procedure volume, with gross margin steady (76%).
• Leaner cost base: sales & marketing fell to $6.7M (−$3.6M YoY) and R&D to $4.3M (−$2.3M YoY), reflecting 4Q23 restructuring and lower AUDACITY trial spend.
• Product and platform advances: launched GLP‑1 support in Coach Iris and introduced the U.S. Virtual Care Suite, reinforcing the AI‑enabled weight‑management stack; “we now believe we have the cash runway to execute through significant milestones… working toward a plan to achieve profitability by the end of next year.” — CEO Dr. Shantanu Gaur.

What Went Wrong

• Guidance reset: FY24 revenue cut to $40–$45M and volume growth to 10–15% on France suspension (ANSM), stocking conservatism, and macro headwinds; prior revenue guide was $60–$65M and 20% volume growth.
• Geographic disruption: France (~mid‑teens % of recent business per call highlights) halted, creating near‑term growth pressure despite management’s remediation plan and disagreement with ANSM’s decision.
• Financing costs and cash burn: G&A rose to $7.3M (+$0.9M YoY) on $1.9M financing costs; cash burn during Q2 was ~$(10.4)M, raising focus on runway and capital structure until offering proceeds arrived.

Transcript

Operator (participant)

Thank you for standing by. My name is Bailey, and I will be your conference operator today. At this time, I would like to welcome everyone to the Allurion second 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. If you would like to ask a question during this time, simply press star followed by the number one on your telephone keypad. If you would like to withdraw your question, again, press star and the number one. I would now like to turn the call over to Mike Cavanagh, Investor Relations. You may begin.

Mike Cavanaugh (Head of Investor Relations)

Good morning, and thank you all for joining us today. Earlier today, Allurion Technologies Incorporated issued a press release announcing financial results for the quarter ended June 30, 2024, as well as a review of the company's recent business highlights. You can access a copy of the announcement on the company's website at www.investors.allurion.com. With me on the call today are Shantanu Gaur, Founder and Chief Executive Officer, and Chris Geberth, Chief Financial Officer. Shantanu will begin the call by discussing the quarter's business and operational highlights and our 2024 financial outlook. Chris will then provide a review of our financial results, and we will close the call with a question and answer session.

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, including, but not limited to, the financial outlook for 2024 and our expectations regarding profitability in the future, the market and demand for our products and elective procedures, the impact of cost reduction initiatives on cash burn and runway, the ability to compete with GLP-1 drugs, or use of the Allurion Program in combination with GLP-1 drugs, timing and expectations regarding our ongoing clinical trials, and expectations regarding our ability to launch our products in new markets, and growth and procedure volumes. 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 most recent 10-K filed on March 26, 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 at allurion.com under the Events and Presentation 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 the call over to Shantanu.

Shantanu Gaur (CEO)

Good morning, and as always, thank you for joining us today. Second quarter revenue was $11.8 million, which is a sequential increase of $2.4 million, or 25%, from the first quarter of 2024. Strong sequential revenue growth, coupled with accelerating procedure volumes, demonstrates that demand for the Allurion Program is strong, and we are seeing reordering in many distributor markets where inventory levels have normalized following the destocking that took place in 2023 and earlier this year. The Allurion team has achieved quite a lot this quarter as we work towards both an FDA approval and achieving profitability. We are increasing our operational efficiencies while procedure volumes continue to grow.

Procedure volume in the second quarter, as estimated by new app users, grew by 12% compared to the same period in 2023, and 4% sequentially from the first quarter of 2024. This is a new record for Allurion that equates to over 10,000 Allurion balloon placements for a second quarter in a row. Since 2016, we now estimate that over 150,000 patients have been treated with the Allurion balloon. Growth was driven by our direct markets, particularly in Europe, despite the growing availability of low-price GLP-1 drugs. Comparing revenues with our estimated procedure volumes indicates that some destocking did take place in the second quarter. However, we believe that the destocking is largely completed.

We've been able to achieve a significant increase in operational efficiency in the first half of 2024, which is the tangible result of the cost reduction and efficiency improvement activities we undertook at the end of last year. In the second quarter, operating expenses and loss from operations reduced by 21% and 30%, respectively, compared to the prior year period, and by 29% and 44%, respectively, when one-time expenses related to financings are removed. We believe that the restructuring we performed at the end of 2023 will continue to lead to increased efficiencies in the second half of 2024. We also believe there is more to accomplish here, and that our efforts could take us to profitability near the end of 2025 and prior to our prospective launch in the United States.

Regarding the AUDACITY trial, our FDA pivotal study for the Allurion Balloon, we successfully treated our last patient with their second balloon in the second quarter. This puts us on track to complete the trial by the end of the year. On July first, we took an important step to strengthen our financial footing, raising $22 million in gross proceeds through a public offering and concurrent private placement of securities. With this financing complete, we believe we now have sufficient cash to execute on key operational milestones and are working toward achieving profitability by the end of next year. I want to take a minute to touch on the news we recently announced regarding the French market.

On August 6, 2024, we announced that the French regulatory authority, ANSM, suspended sales of the Allurion Balloon, and that we are withdrawing supply of the balloon in France, pending implementation of a remediation plan to reduce certain risks associated with the advertising of the balloon and our patient follow-up and physician education programs. While we disagree with the French regulatory authority's request, we are fully cooperating with them to execute on a remediation program that, when approved and executed, will enable Allurion to resume commercialization of our balloon in France. This decision is not a result of any new published scientific evidence regarding the Allurion Balloon, and to date, there have been no other similar actions taken by any regulatory authority outside of France.

The complication rate for the Allurion Balloon in France, as well as globally, remains in line with the published literature and well below the published rates for other weight loss products that are still on the market in France. The French regulatory authority has not requested any changes to the design or manufacturing of the Allurion Balloon and has not mandated that existing balloons be removed from patients. We have had a productive dialogue with the French regulators and have already provided and discussed a remediation plan with them, which focuses on changes to our advertising, patient follow-up, and physician and patient education to address ANSM's concerns as quickly as possible. In the meantime, we have been pleased to see our physician partners from around the world express their support for Allurion and the impact our products have had on their patients.

France represents approximately 15% of our business over the past two quarters, and we continue to face macroeconomic headwinds in certain markets in Latin America and Asia Pacific, which we believe will lead to slower procedure growth and more conservative inventory stocking than originally expected in the second half of 2024. Therefore, we have adjusted our full-year procedure volume growth forecast to between 10% and 15%, and expect our full-year revenue to range between $40 million and $45 million. On the commercial front, we have been pleased with our performance in our direct markets, where we have achieved record levels of revenue and procedure volume. Importantly, in many of these markets, GLP-1s have been widely available for several quarters at a fraction of the price in the United States.

However, we believe it is becoming clear that GLP-1s will not be the ideal therapy for all of the 1 billion people globally with obesity, and with adherence remaining a major issue, that a number of other treatments, such as ours, will be very necessary. According to a recent study from Blue Cross Blue Shield, in approximately 170,000 commercial health plan members, 58% of patients discontinued GLP-1 use before reaching a clinically meaningful health benefit, and 30% discontinued use within the first month. In an analysis of pharmacy claims by Prime Therapeutics, only 15% of patients prescribed GLP-1s for weight loss were still taking the medications two years later. This equates to millions of patients who will need another treatment solution.

This should be a meaningful tailwind for Allurion in the future, and we are actively exploring partnerships with pharmacies and providers to offer Allurion to patients for whom GLP-1s have not been the answer. Allurion also has a competitive advantage with its data on muscle mass. Approximately 40% of the weight that is lost during GLP-1 therapy comes from loss of muscle mass. In the absence of proper follow-up, with an emphasis on balanced nutrition and physical activity, this is no surprise. We are observing something very different in patients going through the Allurion program.

In June, we announced the publication of a third-party study in 571 patients across three obesity centers, which showed active patients actually gained an average lean mass of 5.6%, while still losing an average of 14% of their total body weight at 4 months on the Allurion Program. In this study, body composition and physical activity were tracked in real time with the Allurion App, connected scale, and health tracker, and follow-up was provided through the AI-powered Allurion Virtual Care Suite, or VCS. These results indicate that it is indeed possible to lose significant amounts of weight while maintaining or even increasing lean muscle mass. Furthermore, we believe these results also underscore the impact of real-time monitoring of body composition and personalized recommendations through our AI-powered VCS.

In fact, we believe that using Allurion's AI platform in combination with other modalities, including GLP-1s, where muscle mass loss is a significant risk, may be a promising path forward. To that end, in the second quarter, we made significant strides in advancing our digital platform, both in the United States and abroad. On our last call, I discussed the first commercial agreements for the VCS in the United States. As a reminder, the VCS offers remote patient monitoring, predictive analytics, telehealth, and care team collaboration for patients undergoing the full gamut of surgical, medical, or minimally invasive weight loss procedures. The VCS also features Coach Iris, our 24/7 AI-powered weight loss coach. In the second quarter, we began onboarding our first patients onto the VCS in the United States.

Working with our first partners in the United States, I have seen firsthand how difficult it is for providers to offer best-in-class care for patients living with obesity. It demands close follow-up and lifestyle modification coaching at scale for sustained results. We believe that the VCS, and specifically Coach Iris, can help ease the burden and lead to better long-term outcomes. We are excited to work with our U.S. clinical partners to help their patients achieve better, more sustainable weight loss. With GLP-1s constantly in the news cycle, weight loss clinics in the United States are experiencing explosive growth due to high patient demand, and we believe there is a significant opportunity for our digital products and AI-powered technology to help clinics and providers meet the demand, maintain positive patient outcomes, and continue to grow.

We have been approached by partners to potentially distribute the VCS to providers for exactly this purpose and are assessing the optimal path to accelerate VCS utilization by providers in the United States and abroad. In the second quarter, we advanced our vision to create a verticalized conversational AI agent for weight loss, including for patients on GLP-1 therapy. In May, we announced the expansion of Coach Iris to support patients prescribed GLP-1 and other anti-obesity medications. We trained Coach Iris on evidence-based guidelines for the proper coaching and follow-up that patients on GLP-1s need in order to increase adherence and achieve longer-lasting outcomes. This update goes several levels deeper than your average chatbot that pulls disjointed and, at times, inaccurate information from various sources to provide answers to patient questions.

If our previous experience with Coach Iris in Allurion Balloon patients, where providers have reported increased patient accountability, improved practice efficiencies, and enhanced patient engagement, is any indication of the success we will have with GLP-1 patients, we believe that Iris could be a game-changer for fast-growing U.S. obesity practices. We plan on continuing to pursue additional clinical data, which supports the safety and efficacy of the Allurion Program, particularly regarding long-term outcomes. In May, we announced three oral scientific presentations at the Twelfth Congress of the International Federation for the Surgery of Obesity and Metabolic Disorders, European Chapter, otherwise known as IFSO EC, held in Vienna, Austria.

The presentations included data from a survey of 133 patients across seven international obesity centers, demonstrating that patients on the Allurion Program lost just over 15% of total body weight at four months and maintained over 80% of their total body weight loss three years after completing the program. In addition, 72% of patients reported that three years after the program, their eating habits had remained healthier. This data offers a longer-term view on weight maintenance and is highly differentiated in the industry. In June, we announced three scientific presentations at the American Society for Metabolic and Bariatric Surgery's annual meeting, ASMBS, held in San Diego, California. Data from a study of 121 patients across 11 obesity centers treated with two consecutive four-month Allurion balloons showed patients achieved 22.1% weight loss on average at one year.

In comparison, studies show that patients treated with 12-month endoscopic intragastric balloons achieved between 15.4% and 16.2% total body weight loss on average. We believe this study showed that the Allurion Program can achieve superior results to other intragastric balloons and perhaps approach the weight loss results achieved by surgery. This is all very encouraging and exciting, and I look forward to sharing more data in the future. Finally, we have taken steps to strengthen the management team, welcoming Ojas A. Buch as our new Chief Operating Officer. Ojas brings extensive experience in the healthcare industry, having previously held leadership positions at GE Healthcare, St. Jude Medical, CareFusion, Philips, and Pentax Medical.

His industry experience and leadership skills will be instrumental in driving innovation and scaling our business globally, and I look forward to Ojas being a key member of our team for years to come. With that, I'll hand the call over to Chris to review our financials. Chris?

Christopher Geberth (CFO)

Thank you, Shantanu. Our revenue for the second quarter of 2024 was $11.8 million, marking a sequential increase of $2.3 million or 25% from the first quarter of 2024, and a decrease of $1.2 million from the second quarter of 2023. The year-over-year decrease in revenue of $1.2 million reflected macroeconomic headwinds in certain markets, and we reduced or paused sales to certain accounts to manage credit risk. While revenue decreased year over year, procedure volume, as estimated by new app users, grew by 12%, indicative of ongoing destocking of inventory. Gross profit in the quarter was 76%, compared to 77% for the same period a year ago.

Sales and marketing expenses of $6.7 million decreased by $3.6 million or 35% for the quarter, driven largely by increased operating efficiency and our cost reduction initiatives implemented in the fourth quarter of 2023. Research and development expenses decreased by $2.3 million to $4.3 million in the quarter, driven by reduced costs related to our FDA AUDACITY trial. General and administrative expenses of $7.3 million increased by $0.9 million, driven by $1.9 million of financing costs incurred during the second quarter related to refinancing our debt, our public offering, and concurrent private placement, and partially offset by accounts receivable reserves recorded in the prior period. Excluding those financing costs, general and administrative expenses would have been $0.9 million less than the prior year due to our cost reduction initiatives.

Loss from operations for the second quarter decreased by $3.9 million, or 30% to $9.3 million, compared to $13.3 million the same period in 2023. The decrease in loss from operations was driven by our efforts to reduce operating costs, and was partially offset by $1.9 million in financing costs. Operating loss, excluding those financing costs, were 44% less than the prior year. As of June 30, 2024, we had cash and cash equivalents of $19.3 million, and our cash burn during the quarter was approximately $10.4 million. In July, we raised gross proceeds of $22 million and incurred $4 million of financing costs, bringing our cash position to approximately $37 million in the beginning of July. I will now turn the call back over to Shantanu.

Shantanu Gaur (CEO)

Thanks, Chris. We are seeing steady recovery in our markets, and our differentiated offerings continue to support our progress globally. The work we did at the end of last year in restructuring and refocusing the organization is allowing us to grow more sustainably while we progress towards profitability. Even while taking into account the current situation in France and some of the headwinds we are facing, we are working towards a plan to achieve profitability by the end of next year. With that, I will now turn the call over to the questions and answer portion of the call. Operator, please open the call up for questions.

Operator (participant)

At this time, I would like to remind everyone, in order to ask a question, press star and the number one on your telephone keypad. We'll pause for a moment to allow the Q&A roster to compile. Your first question comes from the line of Keay Nakae. Your line is open.

Keay Nakae (Analyst)

Yes, a couple questions. First, what prompted the action by the French regulatory authority?

Shantanu Gaur (CEO)

Hi, Keay. Good morning. Thanks for the question. Yeah, as we, as we mentioned, really, the, the French regulatory authority was focused on, on three primary areas. One is, our advertising and promotion in France, our follow-up program related to the balloon, and any, you know, patient and physician training programs, related to the balloon. Importantly, there's this decision of ANSM is not based on any new published scientific evidence regarding the balloon. And as I mentioned, the complication rates for our balloon remain in line with what we've published in the literature and remain far lower, than what has been published for similar devices that remain on the market in France.

So, you know, combine those facts with the fact that ANSM has not requested any changes to the design or manufacturing of the balloon, and I think you can see here that the focus areas that they have chosen to emphasize really deal with things that are not directly related to the Allurion balloon or the device. We've had a very productive dialogue with them so far. We've engaged them on our remediation plan and believe that we can take the steps necessary in order to get the product back on the market.

Keay Nakae (Analyst)

Well, well, let me just push back on that a little bit, because to have them actually pull it off the market seems to be a pretty aggressive move on their part if something isn't coming up that's alarming.

Shantanu Gaur (CEO)

Yeah, nothing that we can see from our adverse event reporting or complication reporting that alarms us. You know, as I mentioned, there has been no other similar action taken by any other competent authority or regulatory body around the world. Every regulatory authority has their own way of functioning, has their own processes and protocols. We're very confident that the areas that ANSM is focusing on are not directly related to anything related to the design or manufacturing of the balloon.

Keay Nakae (Analyst)

Okay, well, let's move on to the plan to reach profitability by the end of next year. How much of that is predicated on a continued lowering operating expense from where you're currently at?

Shantanu Gaur (CEO)

That is gonna be a big part of the equation. Expense management over the next 18 months, and just extracting more efficiencies out of the business is gonna contribute to that path to profitability. We're also seeing good growth in our direct markets related to the Allurion Balloon. And there, there may be an opportunity for continued growth there in the future, which should drive some modest revenue growth. So we're really looking at those two variables, continuing to grow top line, but also expense management and efficiency extraction very closely over the next 18 months to drive bottom line and, and drive the company to profitability near the end of next year.

Keay Nakae (Analyst)

Okay. Thanks.

Operator (participant)

Your next question comes from the line of Matt Taylor with Jefferies. Your line is open.

Matthew Taylor (Analyst)

Hi, thanks for taking the question. So a couple questions. Could you first maybe unpack the guidance reduction? You called out several factors there, including France, but I was wondering if you could help quantify the impact of France inventory, macro, and other headwinds in terms of the reduction for the rest of the year.

Shantanu Gaur (CEO)

Yeah, so those are the three main categories, Matt, and thank you for the question. The reduction due to the action taken by ANSM in France, you know, we mentioned that France is approximately 15% of our business over the last two quarters, and the other two categories, the macro headwinds that we're facing in Latin America and also in Asia Pacific, that has led to two different things. One, it's led to a reduction in our anticipated procedural volume in the second half of the year. And then it has also led to more conservative assumptions on restocking of inventory. As you know, we've been destocking inventory and normalizing inventory levels in many of our markets over the past nine months.

And now we're really assessing where that inventory is going to stabilize, and given some of these macro headwinds, we believe it'll stabilize at slightly lower levels than we had projected. So those are the three variables that are really driving the revision to guidance for the second half of the year and the full year.

Matthew Taylor (Analyst)

Okay, got you. And as we look into next year, could you talk at a high level about your ability to grow, and I guess whether you think you could have France back next year and these other macro headwinds could improve?

Shantanu Gaur (CEO)

So we can't give a definitive timeline right now on France. Our hope is that yes, France will contribute to revenue next year. We also believe that some of these macro headwinds are temporary, especially in Latin America, where we're seeing some signs of improvement over the past couple of weeks. But we do believe that going into next year, we'll be able to achieve top-line revenue growth again. But our focus really is gonna be on bottom-line profitability and increasing the efficiency of the business, much like we did going from 2023 to 2024.

Matthew Taylor (Analyst)

Okay. And as a follow-up on France, is there something that you are doing there differently with regards to promotion or training than you're doing in other markets? Or maybe ask differently, are there any learnings from France that you need to apply to, you know, the UK or other places to avoid, you know, other issues like this in other geographies?

Shantanu Gaur (CEO)

There are some learnings around the edges, that we plan to incorporate in our marketing strategies and also follow-up strategies in other parts of Europe. But every European country, every competent authority, every regulatory authority has different processes and different rules and regulations. And so, you know, we think that this problem in France is really, as of this point, isolated to France and isolated to some very particular views they have on how products like this should be marketed, and how patients and physicians should be followed up and trained on a product like this. So, we will potentially incorporate some of these learnings in other countries, but for the most part, it will be business as usual outside of France.

Matthew Taylor (Analyst)

Okay, great. I'll leave it there. Thank you very much.

Shantanu Gaur (CEO)

Thanks, Matt.

Operator (participant)

There are no further questions at this time. I will turn the call back over to our presenters for closing remarks.

Shantanu Gaur (CEO)

Thank you very much. As we close our call today, I just want to extend my thanks to everyone who joined us on the line today. We really appreciate your time and interest in Allurion, and I really appreciate the continued support and loyalty of our shareholders, our customers around the globe, and of course, our employees. I really believe that our collective belief in this company is gonna be instrumental to our future success. I look forward to updating all of you in the next quarter. Thank you. Have a great day.

Operator (participant)

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