Allurion Technologies Q2 2024 Earnings Call Transcript

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Provided by Quartr
August 13, 2024

There are 7 speakers on the call.

Operator

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 Allureon Second Quarter Earnings Call. All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question and answer session.

Operator

I would now like to turn the call over to Mike Kavanaugh, Investor Relations. You may begin.

Speaker 1

Good morning, and thank you all for joining us today. Earlier today, Alerion 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. Alerion.com.

Speaker 1

With me on the call today are Shantanu Ghore, Founder and Chief Executive Officer and Chris Gebberth, 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-one drugs or use of the Ilurion program in combination with GLP-one drugs, timing and expectations regarding our ongoing clinical trials and expectations regarding our ability to launch our products in new markets and growth in procedure volumes. Actual results may differ materially from those expressed or implied as a result of certain risks and uncertainties.

Speaker 1

These risks and uncertainties are described in detail in our Securities and Exchange Commission filings, including our most recent 10 ks filed on March 26, 2024. Our SEC filings can be found through our company website at investors. Alerion.com or the SEC's website. Investors are cautioned not to place undue reliance on such forward looking statements, and Alleron undertakes no obligation publicly update or release any revision 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 Presentations section on our Investor Relations page shortly after the conclusion of this call.

Speaker 1

Today's press release and supplementary financial data tables have been posted to our website. And with that, I will turn the call over to Shantanu.

Speaker 2

Good morning, and as always, thank you for joining us today. 2nd quarter revenue was $11,800,000 which is a sequential increase of $2,400,000 or 25 percent from the Q1 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 earlier this year. The Allergan 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.

Speaker 2

Procedure volume in the Q2, as estimated by new app users, grew by 12% compared to the same period in 2023 and 4% sequentially from the Q1 of 2024.

Speaker 3

This is a new record

Speaker 2

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 Olureon balloon. Growth was driven by our direct markets, particularly in Europe, despite the growing availability of low priced GLP-one drugs. Comparing revenues with our estimated procedure volumes indicates that some destocking did take place in the Q2. However, we believe that the destocking is largely completed.

Speaker 2

We've been able to achieve a significant increase in operational efficiency in the first half of twenty twenty four, which is the tangible result of the cost reduction and efficiency improvement activities we undertook at the end of last year. In the Q2, operating expenses and loss from operations reduced by 21% 30% respectively, compared to the prior year period and by 29% 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 twenty twenty four. 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 ovarian balloon, we successfully treated our last patient with their 2nd balloon in the Q2.

Speaker 2

This puts us on track to complete the trial by the end of the year. On July 1, we took an important step to strengthen our financial footing, raising $22,000,000 in gross proceeds through a public offering and a 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, ANSOME, suspended sales of the Eleurion 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.

Speaker 2

While we disagree with the French regulatory authorities' 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 Allergan balloon. And to date, there have been no other similar actions taken by any regulatory authority outside of France. The complication rate for the Olureon 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 Olorien balloon and has not mandated that existing balloons be removed from patients.

Speaker 2

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 ANSEM'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 UroLion 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 twenty twenty four. Therefore, we have adjusted our full year procedure volume growth forecast to between 10% 15% and expect our full year revenue to range between $40,000,000 $45,000,000 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.

Speaker 2

However, we believe it is becoming clear that GLP-1s will not be the ideal therapy for all of the 1,000,000,000 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-one use before reaching a clinically meaningful health benefit and 30% discontinued use within the 1st 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 2 years later. This equates to millions of patients who will need another treatment solution.

Speaker 2

This should be a meaningful tailwind for Allergan 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. Allurean also has a competitive advantage with its data on muscle mass. Approximately 40% of the weight that is lost during GLP-one 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 Ulerion program.

Speaker 2

In June, we announced the publication of a third party study in 571 patients across 3 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 Illyrian program. In this study, body composition and physical activity were tracked in real time with the Illurion 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 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 Allergan'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.

Speaker 2

To that end, in the Q2, 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 20 fourseven AI powered weight loss coach. In the Q2, we began on boarding our first patients onto the VCS in the United States.

Speaker 2

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.

Speaker 2

Clinical partners to help their patients achieve better, more sustainable weight loss. With GLP-1s constantly in the new 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 Q2, we advanced our vision to create a verticalized conversational AI agent for weight loss, including for patients on GLP-one therapy.

Speaker 2

In May, we announced the expansion of Coach Iris to support patients prescribed GLP-one and other anti obesity medications. We train 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 and Allureon 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-one patients, we believe that IRIS could be a game changer for fast growing U. S.

Speaker 2

Obesity practices. We plan on continuing to pursue additional clinical data, which supports the safety and efficacy of the Ulerion program, particularly regarding long term outcomes. In May, we announced 3 oral scientific presentations at the 12th Congress of the International Federation For the Surgery of Obesity and Metabolic Disorders, European Chapter, otherwise known as IBSO EC held in Vienna, Austria. The presentations included data from a survey of 133 patients across 7 international obesity centers, demonstrating that patients on the Allureon program lost just over 15% of total body weight at 4 months and maintained over 80% of their total body weight loss 3 years after completing the program. In addition, 72% of patients reported that 3 years after the program, their eating habits had remained healthier.

Speaker 2

This data offers a longer term view on weight maintenance and is highly differentiated in the industry. In June, we announced 3 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 OBC centers treated with 2 consecutive 4 month Allergan balloons showed patients achieved 22.1% weight loss on average at 1 year. In comparison, studies show that patients treated with 12 month endoscopic intragastric balloons achieved between 15.4% 16.2% total body weight loss on average. We believe this study showed that the Olorion program can achieve superior results to other introgastric balloons and perhaps approach the weight loss results achieved by surgery.

Speaker 2

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. Butch 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.

Speaker 2

His industry experience and leadership skills will be instrumental in driving innovation and scaling our business globally. And I look forward to OGIS 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?

Speaker 4

Thank you, Shantanu. Our revenue for the Q2 of 2024 was $11,800,000 marking a sequential increase of $2,300,000 or 25 percent from the Q1 of 2024 and a decrease of $1,200,000 from the Q2 of 2023. The year over year decrease in revenue of $1,200,000 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.

Speaker 4

Sales and marketing expenses of $6,700,000 decreased by $3,600,000 or 35% for the quarter, driven largely by increased operating efficiency and our cost reduction initiatives implemented in the Q4 of 2023. Research and development expenses decreased by $2,300,000 to $4,300,000 in the quarter, driven by reduced costs related to our FDA ODESP trial. General and administrative expenses of $7,300,000 increased by $900,000 driven by $1,900,000 of financing costs incurred during the Q2 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 $900,000 less than the prior year due to our cost reduction initiatives. Loss from operations for the 2nd quarter decreased by $3,900,000 or 30 percent to $9,300,000 compared to $13,300,000 in the same period in 2023.

Speaker 4

The decrease in loss from operations was driven by our efforts to reduce operating costs and was partially offset by $1,900,000 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 $19,300,000 and our cash burn during the quarter was approximately $10,400,000 In July, we raised gross proceeds of $22,000,000 and incurred $4,000,000 of financing costs, bringing our cash position to approximately $37,000,000 in the beginning of July. I will now turn the call back over to Shantanu.

Speaker 2

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.

Speaker 2

Operator, please open the call up for questions.

Operator

And your first question comes from the line of Keay Nakae. Your line is open.

Speaker 5

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

Speaker 3

Hi, Kei. Good morning. Thanks for the question. Yes, as we mentioned, really the French regulatory authority was focused on 3 primary areas. 1 is our advertising and promotion in France, our follow-up program related to the balloon and any patient and physician training programs related to the balloon.

Speaker 3

Importantly, there is this decision of the end zone 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 published in the literature and remain far lower than what has been published for similar devices that remain on the market in France. So 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.

Speaker 3

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.

Speaker 5

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?

Speaker 3

Yes. Nothing that we can see from our adverse event reporting or complication reporting that alarms us. And 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. And we're very confident that the areas that Hanson is focusing on are not directly related to anything related to the design or manufacturing of the balloon.

Speaker 5

Okay. 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?

Speaker 3

That is going to be a big part of the equation, expense management over the next 18 months and just extracting more efficiencies out of the business is going to contribute to that path to profitability. We're also seeing good growth in our direct markets related to the Allureon Balloon. And 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 drive the company to profitability near the end of next year.

Speaker 5

Okay. Thanks.

Operator

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

Speaker 6

Hi, thanks for taking the question. I've got a couple of 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?

Speaker 3

Yes. So those are the 3 main categories, Matt, and thank you for the question. The reduction due to the action taken by ANSEM in France, 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 2 different things. 1, it's led to a reduction in our anticipated procedural volume in the second half of the year.

Speaker 3

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 9 months. And now we're really assessing where that inventory is going to stabilize. And given some of these macro headwinds, we believe it will stabilize at slightly lower levels than we had projected. So those are the 3 variables that are really driving the revision to guidance for the second half of the year and the full year.

Speaker 6

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?

Speaker 3

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 are seeing some signs of improvement over the past couple of weeks. But we do believe that going into next year, we will be able to achieve top line revenue growth again. But our focus really is going to be on bottom line profitability and increasing the efficiency of the business much like we did going from 2023 to 2024.

Speaker 6

Okay. And I just had a follow-up on France. Is there something that you were 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 the UK or other places to avoid other issues like this in other geographies?

Speaker 3

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 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.

Speaker 6

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

Speaker 5

Thanks, Matt.

Operator

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

Speaker 3

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 Allureon 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 going to be instrumental to our future success. I look forward to updating all of you in the next quarter.

Speaker 3

Thank you. Have a great day.

Operator

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

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