Q2 2024 Allurion Technologies Inc Earnings Call

Bailey: 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 Illurion second quarter earnings call. All lines have been placed on mute to prevent any background noise.

Operator: At this time, I would like to welcome everyone to the Elurion Second Quarter Earnings Call. All lines have been placed on mute to prevent any background noise.

Operator: At this time, I would like to welcome everyone to the Allurion second quarter earnings call. I'll line to them place on mute to prevent any background noise.

Operator: After the speakers are marked, 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.

Operator: 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 1 on your telephone keypad. If you would like to withdraw your question, again, press star and the number 1.

Bailey: After the speaker's remarks, there will be a question and answer session.

Bailey: 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 Cavanaugh, Investor Relations. You may begin.

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

Mike Cavanaugh: 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.alurion.com. With me on the call today are Shantanu Gaur, Founder and Chief Executive Officer, and Chris Gebber, Chief Financial Officer. Shantanu will begin the call by discussing the quarter's business and operational highlights and our 2024 financial outlook.

Mike Cavanaugh: Good morning and thank you all for joining us today. Earlier today, Larian Technologies Inc. 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.

Mike Kavanaugh: 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 Gore, 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.

Speaker Change: You can access a copy of the announcement on the company's website at www.investors.allerion.com.

Speaker Change: With me on the call today are Shantanu Gaur, Founder and Chief Executive Officer, and Chris Gebber, Chief Financial Officer.

Speaker Change: Shantanu will begin the call by discussing the quarter's business and operational highlights and our 2024 financial outlook.

Speaker Change: Chris will then provide a review of our financial results and we will close the call with a question and answer session.

Mike Kavanaugh: 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 Lurion 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 in procedure volumes.

Mike Cavanaugh: 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.

Speaker Change: 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.

Chris Gebber: The market and demand for our products and elective procedures.

Chris Gebber: The impact of cost reduction initiatives on cash burn and runway, the ability to compete with GLP-1 drugs or use of the Elurian program in combination with GLP-1 drugs, timing and expectations regarding our ongoing clinical trials.

Mike Cavanaugh: And expectations regarding our ability to launch our products in new markets and growth and procedure volume. However, 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. RFCC filings can be found through our company website at investors.allurion.com for the SEC's website.

Chris Gebber: expectations regarding our ability to launch our products in new markets and growth and procedure volumes.

Mike Kavanaugh: 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 file on March 26, 2024. Our SEC filings can be found through our company website at investors.lurion.com or the SEC's website. Investors are cautioned not to place undue reliance on such forward-looking statements, and the Lurion undertakes no obligation to publicly update or release any revisions to these forward-looking statements.

Chris Gebber: Actual results may differ materially from those expressed or implied as a result of certain risks and uncertainties.

Chris Gebber: These risks and uncertainties are described in detail in our Securities and Exchange Commission filings, including our most recent 10K filed on March 26, 2024.

Chris Gebber: Our SEC filings can be found through our company website at investors.olarion.com or the SEC's website.

Mike Cavanaugh: Investors are cautioned not to place undue reliance on such forward-looking statements, and Alurion 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 event 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 on our website. And with that, I will turn the call over to Shantanu.

Elurion: Investors are cautioned not to place undue reliance on such forward-looking statements and Elurion undertakes no obligation to publicly update or release any revisions to these forward-looking statements.

Mike Kavanaugh: Please note that this conference call is being recorded and will be available for audio replay on our website at lurion.com, under the event 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.

Elurion: Please note that this conference call is being recorded and will be available for audio replay on our website at alureon.com under the event and presentation section on our investor relations page shortly after the conclusion of this call.

Elurion: Today's press release and supplementary financial data tables have been posted to our website.

Shantanu Gore: And with that, I will turn the call over to Shatanael. 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.

Shantanu Gaur: 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 Lurion program is strong, and we are seeing reordering in many distributor markets where inventory levels have normalized following the de-stocking that took place in 2023 and earlier this year.

Elurion: And with that, I will turn the call over to Shantanu.

Shantanu Gaur: Good morning, and as always, thank you for joining us today. 2nd quarter revenue was $11.8 million, which is a sequential increase of $2.4 million, or 25% from the 1st quarter of 2024.

Shantanu Gaur: Strong sequential revenue growth coupled with accelerating procedure volumes demonstrates that demand for the Elerion 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.

Shantanu Gaur: The EurLurion 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 2nd quarter, as estimated by new app users, grew by 12% compared to the same period in 2023 and 4% sequentially from the 1st quarter of 2024. This is a new record for Elurion that equates to over 10,000 Elurion balloon placements for a second quarter in a row.

Shantanu Gaur: The Eulerion 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.

Shantanu Gore: 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.

Shantanu Gaur: 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.

Shantanu Gaur: This is a new record for Elerion that equates to over 10,000 Elerion balloon placements for a second quarter in a row.

Shantanu Gaur: Since 2016, we now estimate that over 150,000 patients have been treated with the Olurion balloon. Growth was driven by our direct markets, particularly in Europe, despite the growing availability of low-priced GLP-1 drugs. Comparing revenues with our estimated procedure volumes indicates that some de-stocking did take place in the second quarter. However, we believe that the de-stocking is largely completed.

Shantanu Gaur: Since 2016, we now estimate that over 150,000 patients have been treated with the illurion balloon.

Shantanu Gaur: Growth was driven by our direct markets, particularly in Europe, despite the growing availability of low-priced GLP-1 drugs.

Shantanu Gaur: Comparing revenues with our estimated procedure volumes indicates that some de-stocking did take place in the second quarter. However, we believe that the de-stocking is largely completed.

Shantanu Gore: 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 in 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.

Shantanu Gaur: 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 losses from operations were reduced by 21% and 30%, respectively, compared to the prior year period, and by 29% and 44%, respectively, when one-time expenses related to financing are removed. We believe that the restructuring you will carry out at the end of 2023 will continue to lead to increased efficiencies in the second half of 2024.

Shantanu Gaur: 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.

Shantanu Gaur: 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.

Shantanu Gaur: 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.

Shantanu Gore: 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 1, we took an important step to strengthen our financial footing, raising $22 million in gross proceeds through a public offering and a concurrent private placement of securities.

Shantanu Gaur: 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 1st, we took an important step to strengthen our financial footing, raising $22 million in gross proceeds through a public offering and a concurrent private placement of security.

Shantanu Gaur: Regarding the audacity trial, our FDA pivotal study for the Lurion 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.

Shantanu Gaur: On July 1st, 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.

Shantanu Gore: 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.

Shantanu Gaur: 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, Ansem, suspended sales of the Lurion balloon and that we were 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 program.

Shantanu Gaur: 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.

Shantanu Gore: I want to take a minute to touch on the news we recently announced regarding the French market. On August 6, 2024, we announced the French regulatory authority, Hanson, 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.

Shantanu Gaur: 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 Elurion Balloon, and to date, there have been no other similar actions taken by any regulatory authority outside of France. The complication rate for the Eururion 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 Oumarion, and has not mandated that existing boobooms be removed from patients.

Shantanu Gaur: 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 Allurion and the impact our products have had on their patients. France represents approximately 15% of our business in 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.

Shantanu Gaur: 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, ANSEM, suspended sales of the Elyrian Balloon.

Shantanu Gaur: 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 procedures. 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.

Shantanu Gaur: 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.

Shantanu Gaur: 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 Elerion to resume commercialization of our balloon in France.

Shantanu Gore: This decision is not a result of any new public 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.

Speaker Change: This decision is not a result of any new published scientific evidence regarding the Illyrian balloon, and to date, there have been no other similar actions taken by any regulatory authority outside of France.

Speaker Change: The complication rate for the Eulerion 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.

Speaker Change: The French regulatory authority has not requested any changes to the design or manufacturing of the Elyrian balloon, and has not mandated that existing balloons be removed from patients.

Shantanu Gore: 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 answers 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 to 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 inventories stocking than originally expected in the second half of 2024.

Speaker Change: We have had a productive dialogue with the French regulators and have already provided and discussed a remediation plan with them.

Speaker Change: which focuses on changes to our advertising, patient follow-up, and physician and patient education to address Ansem's concerns as quickly as possible.

Speaker Change: In the meantime, we have been pleased to see our physician partners from around the world express their support for Lurion and the positive impact our products have had on their patients.

Speaker Change: 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.

Shantanu Gore: 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 ones have been widely available for several quarters at a fraction of the price in the United States. However, we believe it has become clear that GLP ones 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.

Speaker Change: 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.

Speaker Change: 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.

Shantanu Gaur: 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, a number of other treatments, such as ours, will be very necessary. According to a recent study from Blue Cross Blue Shield and 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.

Speaker Change: However, we believe it is becoming clear that GLT1s 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.

Shantanu Gore: According to a recent study from Blue Cross Blue Shield and 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 GLP1's or 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 tail-in for Alurion in the future, and we are actively exploring partnerships with pharmacies and providers to offer Alurion to patients for whom GLP ones have not been the answer.

Speaker Change: According to a recent study from Blue Cross Blue Shield and 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.

Shantanu Gaur: In an analysis of pharmacy claims by Prime Therapeutics, only 15% of patients prescribed GLP-1s for weight loss were still taking the medication two years later. This equates to millions of patients who will need another treatment solution.

Speaker Change: 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.

Shantanu Gaur: This should be a meaningful story for Allurion in the future, and we are actively exploring partnerships with pharmacies and providers to offer Allurion to patients for whom GLP ones 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 a 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.

Speaker Change: This equates to millions of patients who will need another treatment solution. This should be a meaningful tailwind for Lurion in the future, and we are actively exploring partnerships with pharmacies and providers to offer Lurion to patients for whom GLP-1s have not been the answer.

Shantanu Gore: Alurion also has a competitive advantage with its data on muscle mass; approximately 40% of the weight that is lost during GLP1 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 Alurion program. In June, we announced a 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, had four months on the Alurion program.

Speaker Change: Eulerian 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.

Shantanu Gaur: 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 after four months on the Eulerion program. In this study, body composition and physical activity were tracked in real-time with the Alurion app, Connect2Scale, and Health Tracker, and follow-up was provided through the AI-powered Alurion Virtual Care Suite, or VCM. These results indicate that it is indeed possible to lose significant amounts of weight while maintaining or even increasing muscle mass.

Speaker Change: We are observing something very different in patients going through the Eulerian 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%.

Speaker Change: while still losing an average of 14% of their total body weight at four months on the Illyrian program.

Shantanu Gore: In this study, body composition and physical activity were tracked in real time with the Alurion app, connect the scale and health tracker, and follow-up was provided through the AI-powered Glurion virtual care suite or VCF. These results indicate that it is indeed possible to lose significant amounts of weight while maintaining or even increasing main 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 a Lurion's AI platform in combination with other modalities, including GLP1s, where muscle mass loss is a significant risk, may be a promising path forward.

Speaker Change: In this study, body composition and physical activity were tracked in real-time with the Allurion app, Connect2Scale, and HealthTracker, and follow-up was provided through the AI-powered Allurion Virtual Care Suite, or VCS.

Speaker Change: These results indicate that it is indeed possible to lose significant amounts of weight while maintaining or even increasing lean muscle mass.

Shantanu Gaur: Furthermore, we believe these results also underscore the impact of real-time monitoring of body composition and personalized recommendations through our AI-powered VC app. In fact, we believe that using Lurion'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 U.S.

Speaker Change: Furthermore, we believe these results also underscore the impact of real-time monitoring of body composition and personalized recommendations through our AI-powered VCS.

Speaker Change: In fact, we believe that using a Lorient AI platform in combination with other modalities, including GLP-1s, where muscle mass loss is a significant risk, may be a promising path forward.

Shantanu Gore: 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 Cochirus, 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.

Speaker Change: To that end, in the second quarter, we made significant strides in advancing our digital platform, both in the United States and abroad.

Speaker Change: 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.

Shantanu Gaur: 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.

Speaker Change: The VCS also features Coach Iris, our 24-7 AI-powered weight loss coach.

Speaker Change: 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.

Shantanu Gaur: 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 Cogirus can help ease the burden and lead to better long-term outcomes.

Shantanu Gore: It demands close follow-up and lifestyle modification coaching at scale for sustained results. We believe that the VCS and specifically Cochirus 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.

Speaker Change: 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.

Shantanu Gaur: We are excited to work with our U.S. clinical partners to help their patients achieve a better, more sustainable weight. 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 we are assessing the optimal path to accelerate VCS utilization by providers in the United States and abroad.

Speaker Change: We are excited to work with our U.S. clinical partners to help their patients achieve better, more sustainable weight loss.

Speaker Change: With GLP-1s constantly in the news cycle, weight loss clinics in the United States are experiencing explosive growth due to high patient demand.

Speaker Change: 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.

Shantanu Gore: 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 Cochirus to support patients to prescribe GLP-1 and other anti-obesity medications. We train cochirus 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.

Speaker Change: 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.

Shantanu Gaur: 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.

Speaker Change: 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.

Shantanu Gaur: We train cochairs on evidence-based guidelines for the proper coaching and follow-up that patients on GLP1 need in order to increase adherence and achieve longer-term 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 Elurion 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 Coach Iris could be a game changer for fast-growing U.S. obesity practices.

Speaker Change: 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.

Shantanu Gore: This update goes several levels deeper than your average chatbot that pulls disjointed in the times and accurate information from various sources to provide answers to patient questions. If our previous experience with cochirus in the Lurion 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.

Speaker Change: 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.

Speaker Change: If our previous experience with Coach Iris and Illyrian 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.

Shantanu Gore: We plan on continuing to pursue additional clinical data, which supports the safety and advocacy of the Lurion Program, particularly regarding long-term efforts.

Shantanu Gaur: We plan on continuing to pursue additional clinical data which supports the safety and efficacy of the Allurion program, particularly regarding long-term applications. In May, we announced three oral scientific presentations at the 12th Congress of the International Federation for the Surgery of OVC and Metabolic Disorders, European Chapter, otherwise known as IFSO-EC-HELDEN-VNR. The presentations included data from a survey of 133 patients across seven international obesity centers, demonstrating that patients on the Lurion program lost just over 15% of their 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 and remained healthy.

Speaker Change: We plan on continuing to pursue additional clinical data, which supports the safety and efficacy of the Eulerion program, particularly regarding long-term outcomes.

Shantanu Gore: In May, we announced three oral scientific presentations at the 12th Congress of the International Federation for the Surgery of Obesity and Metabolic Disorders, European Chapter, otherwise known as IFSO-EC, Health and 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.

Speaker Change: In May, we announced three oral scientific presentations at the 12th Congress of the International Federation for the Surgery of Obesity and Metabolic Disorders, European Chapter, otherwise known as IFSO-EC, held in Vienna, Austria.

Speaker Change: The presentations included data from a survey of 133 patients across seven international obesity centers.

Speaker Change: Demonstrating that patients on the Illurion program lost just over 15% of total body weight at four months.

Speaker Change: and maintained over 80% of their total body weight loss three years after completing the program.

Speaker Change: In addition, 72% of patients reported that three years after the program, their eating habits had remained healthier.

Shantanu Gore: This data offers a longer-term view on weight maintenance and is highly differentiated in the industry.

Shantanu Gaur: 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 Lurion 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.

Speaker Change: This data offers a longer-term view on weight maintenance and is highly differentiated in the industry.

Shantanu Gore: In June, we announced three scientific presentations at the American Society for Metabolic and Bariatric Surgery's annual meeting, ASNBS, 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 intra gastric 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 intra gastric balloons and perhaps approach the weight loss results achieved by surgery.

Speaker Change: 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.

Speaker Change: Data from a study of 121 patients across 11 obesity centers treated with two consecutive four-month Elerion balloons showed patients achieved 22.1% weight loss on average at one year.

Speaker Change: 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.

Shantanu Gaur: We believe this study shows that the Ulurion 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. OGIS brings extensive experience in the healthcare industry, having previously held leadership positions at GE Healthcare, St. Jude Medical, Care Fusion, Philips, and Pentax Medical.

Speaker Change: We believe this study showed that the Eulerian program can achieve superior results to other intragastric balloons and perhaps approach the weight loss results achieved by surgery.

Shantanu Gore: This is all very encouraging and exciting, and I look forward to sharing more data in the future.

Speaker Change: This is all very encouraging and exciting, and I look forward to sharing more data in the future.

Shantanu Gore: Finally, we have taken steps to strengthen the management team, welcoming OJSA Butch as our new chief operating officer. OJSA 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 OJSA being a key member of our team for years to come.

Speaker Change: Finally, we have taken steps to strengthen the management team, welcoming Ojas A. Butch as our new Chief Operating Officer.

Speaker Change: OGIS brings extensive experience in the healthcare industry, having previously held leadership positions at GE Healthcare, St. Jude Medical, Care Fusion, Philips, and Pentax Medical.

Shantanu Gaur: 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. Thank you, Shantanu.

Speaker Change: 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.

Chris Geberth: With that, I'll hand the call over to Chris to review our financials. Chris, thank you; Sean knew. Our revenue for the second quarter of 2024 was $11.8 million, marking a sequentially 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-to-year decrease in revenue of $1.2 million reflected back economic height wins in certain markets, and we reduced or paused sales to certain accounts to manage credit risk. While revenue decreased year-to-year, procedure volume has estimated by new app users grew by 12%, indicative of ongoing destocking of inventory.

Speaker Change: With that, I'll hand the call over to Chris to review our financials. Chris?

Chris Gebber: 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 in 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.

Chris Gebber: 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%, 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-ODESI 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 cash 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.

Chris Gebber: 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.

Speaker Change: 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.

Speaker Change: While revenue decreased year-over-year, procedure volume, as estimated by new app users, grew by 12%, indicative of ongoing de-stocking of inventory.

Chris Geberth: Gross profit in the quarter was 76% to rate the 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 a quarter, driven by reduced costs related to our FDA or Destiny trial. The 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 cash receivable reserves recorded in the prior period.

Speaker Change: Gross profit in the quarter was 76% compared to 77% for the same period a year ago.

Speaker Change: 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.

Speaker Change: Research and development expenses decreased by $2.3 million to $4.3 million in a quarter, driven by reduced costs related to our FDA-ODESI trial.

Speaker Change: The general and administrative expenses of $7.3 million increased by $0.9 million.

Speaker Change: Driven by 1.9 million of financing costs incurred.

Speaker Change: during the second quarter relate to refinancing our debt.

Speaker Change: our public offering, and concurrent private placement, and partially offset by accounts receivable reserves recorded in the prior period.

Chris Geberth: 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 in the same period in 2023. The decrease in loss in 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 30th, 2024, we had cash and cash equivalents of 19.3 million, and our cash burned during the quarter was approximately $10.4 million.

Speaker Change: 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.

Chris Gebber: Loss from operations for the second quarter decreased by 3.9 million, or 30%, to 9.3 million, compared to 13.3 million in the same period last year. The decrease in loss from operations was driven by our efforts to reduce operating costs, although it was partially offset by $1.9 million in financing costs. Operating losses excluding those financing costs were 44% less than the prior year.

Speaker Change: Loss from operations for the second quarter decreased by 3.9 million, or 30% to 9.3 million, compared to 13.3 million in the same period in 2023.

Speaker Change: The decrease in the loss from operations was driven by our efforts to reduce the operating costs and was partially offset by $1.9 million in financing costs.

Speaker Change: Operating loss excluding those financing costs were 44% less than the prior year.

Chris Gebber: As of June 30th, 2024, we had cash and cash equivalents of $19.3 million, and our cash burned 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 at the beginning of July. I will now turn the call back over to Shantanu. Thanks, Chris. We are seeing steady recovery in our markets, and our differentiated offerings continue to support our progress globally.

Speaker Change: As of June 30, 2024, we had cash and cash equivalents of $19.3 million, and our cash burned during the quarter of approximately $10.4 million.

Chris Geberth: 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.

Speaker Change: 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.

Shantanu Gore: I will now turn the call back over to Shantanu. 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.

Speaker Change: I will now turn the call back over to Shantanu.

Shantanu Gaur: 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.

Chris Gebber: 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 answers portion of the call. Operator, please open the call up for questions. At this time, I would like to remind everyone that in order to ask a question, press the star and the number one on your telephone keypad.

Shantanu Gaur: 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.

Operator: 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. At this time, I would like to remind everyone that 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.

Speaker Change: 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.

Speaker Change: 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.

Operator: And your first question comes from the line of Kay Nikai.

Operator: We'll pause for a moment to allow the Q&A roster to compile, and your first question comes from the line of Kay Nakai. Your line is open.

Kay Nikai: Your line is open. Yes, a couple of questions, sirs. What prompted the action by the French regulatory authority?

Speaker Change: And your first question comes from the line of Kay Nakai. Your line is open.

Kay Nakai: Yes, a couple of questions. First, what prompted the action by the French Regulatory Authority? Hi Kay. Good morning.

Kay Nakai: Yes, couple questions. First, what prompted the action by the French Regulatory Authority?

Shantanu Gore: Okay, good morning. Thanks for the question. As we mentioned, really the French regulatory authority was focused on three primary areas. One 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. And importantly, this decision of Vansomes is not based on any new public scientific evidence regarding the balloon. And as I mentioned, the complication rates for our balloon remain in line with what we publish in the literature and remain far lower than what has been published for similar devices that remain on the market in France.

Shantanu Gaur: Thanks for the question. Yeah, as we mentioned, the French regulatory authority was focused on three primary areas. One was 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. Importantly, this decision of Anson's is not based on any new published scientific evidence regarding the balloon.

Speaker Change: Hi Kay, good morning. Thanks for the question. Yeah, as we mentioned, really the French Regulatory Authority was focused on

Kay Nakai: on three primary areas. One is...

Kay Nakai: our advertising and promotion in France.

Kay Nakai: our follow-up program related to the balloon, and any patient and physician training programs.

Kay Nakai: related to the balloon. Importantly, this decision of Ansem's 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 publish in the literature and remain far lower than what has been published for similar devices that remain on the market in France. So thank you.

Shantanu Gaur: And as I mentioned, the complication rates for our balloon remain in line with what we publish 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 Anson has not requested any changes to the design or manufacturing. 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.

Shantanu Gore: So, combine those facts with the fact that Hansen 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.

Kay Nakai: you know, combine those facts with the fact that Anson has not requested any changes to the design or manufacturing of the balloon.

Speaker Change: 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 Illurion balloon or the device.

Shantanu Gaur: We've had a very productive dialogue with them so far. We've engaged them in our remediation plan, and believe that we can take the steps necessary in order to get the product back. Let me just push back on that a little bit, because to have them actually pull it off the market seems, would be a pretty aggressive move on their part if something isn't coming up that's alarming. Yeah, nothing that we can see from our adverse event reporting or complication reporting that alarms us, and as I mentioned, there's been no other similar action taken by any other competent authority or regulatory body around the world.

Speaker Change: 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.

Shantanu Gore: 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. Yeah, nothing that we can see from our adverse event reporting or complication reporting that alarms us. And you know, as I mentioned, there's 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 you're very confident that the areas that Handsome is focusing on are not directly related to anything related to the design or manufacturing of the balloon.

Speaker Change: Let me just push back on that a little bit.

Speaker Change: because to have them actually pull it off the market seems...

Speaker Change: to be a pretty aggressive move on their part if something isn't coming up that's alarming.

Speaker Change: Yeah, nothing that we can see from our adverse event reporting or complication reporting that alarms us.

Speaker Change: 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.

Shantanu Gaur: Every regulatory authority has its own way of functioning, has its 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 design or manufacturing.

Shantanu Gaur: 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 of operating expenses from where you're currently at? That is going to be a big part of the equation.

Shantanu Gore: 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? 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 past profitability. We're also seeing good growth in our direct markets related to the operating 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 Change: Let's move on to the plan to reach profitability by the end of next year. How much of that is predicated on

Speaker Change: a continued lowering operating expense from where you're currently at.

Shantanu Gaur: 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 Elurion 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 the top line but also expense management and efficiency extraction very closely over the next 18 months to drive the bottom line and drive the company to profitability.

Speaker Change: 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 Illyrian Balloon, and there may be an opportunity for continued growth there in the future, which should drive some modest revenue growth.

Speaker Change: 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.

Kay Nikai: Okay, thanks.

Speaker Change: Okay, thanks.

Matt Taylor: In your next question, comes from the line of Matt Taylor with Jeffries; your line is open. Hi, thanks for taking the question. I'll put a couple questions.

Shantanu Gaur: Okay, okay. Your next question comes from the line of Matt Taylor with Jefferies. Your line is open. Hi, thanks for taking the question. I've got a couple of questions. Could you first maybe unpack the guidance reduction?

Matt Taylor: Could you first maybe impact a guidance reduction? You called out several factors there, including France, but I was wondering you could help quantify the impact of France, inventory, macro, and other headwinds in terms of reduction for the rest of the year.

Speaker Change: 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 talk a little bit about the guidance reduction.

Matt Taylor: 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? Yeah, so those are the three main categories, Matt, and thank you for the question. The reduction due to the action taken by Ansem in France. We mentioned that France was approximately 15% of our business in the last two quarters.

Speaker Change: 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 Gore: Yes, so those are the three main categories, Matt, and thank you for the question. The reduction due to the action taken by Handsome in France. We mentioned that France has 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. Given some of these macro headwinds, we believe it will stabilize at slightly lower levels than we have projected.

Matt Taylor: And the other two categories, the macro headwinds that we're facing in Latin America and also in Asia Pacific, have 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 the 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.

Speaker Change: Yeah, so those are the three main categories, Matt, and thank you for the question. The reduction due to the action taken by Ansem in France, you know, we mentioned that France has approximately 15% of our business over the last two quarters.

Speaker Change: 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.

Matt Taylor: 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 three variables that are really driving the revision to guidance for the second half. Okay.

Speaker Change: 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.

Shantanu Gore: So those are the three variables that are really driving the revision to guidance for the second half. for the year and the full year.

Matt Taylor: Okay, gotcha.

Shantanu Gaur: 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 whether these other macro headwinds could improve? So we can't give a definitive timeline right now on France. Our hope is that, yes, France will contribute to revenue next year. But 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.

Shantanu Gore: 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? 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.

Speaker Change: Okay, gotcha. 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 Change: 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.

Shantanu Gaur: 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 going to be on bottom-line profitability and increasing the efficiency of the business, much like we did in 2023. Okay, and instead of following up on France, is there something that you are doing there differently with regard 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 U.K. or other places to avoid, you know, other issues like this in other geographies?

Speaker Change: 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 going to be on bottom line profitability and increasing the efficiency of the business, much like we did going from 2023 to 2024.

Shantanu Gore: 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.

Shantanu Gore: Okay, and I'm set a follow up on France. Is there something that you're 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? There are some learnings around the edges that we plan to incorporate in our marketing strategies and also follow-up strategies and other parts of Europe. But every European country, every competent authority, every regulatory authority has different processes and different rules and regulations.

Speaker Change: 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, you know, the UK or other places to avoid?

Shantanu Gaur: 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, at 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 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. Okay, great. I'll leave it be. Thank you very much. Thanks, Matt.

Speaker Change: and other issues like this in other geographies.

Speaker Change: 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.

Speaker Change: 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.

Shantanu Gore: 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 Change: 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.

Matt Taylor: Okay, great.

Matt Taylor: I'll leave it there.

Operator: Thank you very much.

Operator: Thanks, Matt. There are no further questions at this time.

Speaker Change: Okay, great. I'll leave it there. Thank you very much. Thanks, Matt.

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

Operator: 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. Thank you. Have a great day. Thank you. This concludes today's conference call. You may now disconnect. Allurion Technologies

Shantanu Gore: I will turn the call back over to our presenters. Closing remarks. Thank you very much.

Speaker Change: And there are no further questions at this time. I will turn the call back over to our presenters for closing remarks.

Shantanu Gore: 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 Elurion. And I really appreciate the continued support and loyalty of our shareholders, our customers around the globe. And of course, our employees.

Speaker Change: 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 Elerian, and I really appreciate the continued support and loyalty of our shareholders, our customers around the globe.

Operator: At this time, I would like to welcome everyone to the Allurion Second Quarter Earnings Call. I'll line to them place on mute to prevent any background noise. After the speakers are marked, 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.

Shantanu Gore: 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. Thank you. Have a great day. Thank you.

Speaker Change: 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. Thank you. Have a great day.

Operator: This concludes today's conference call. You may now disconnect.

Mike Kavanaugh: I would now like to turn the call over to Mike Kavanaugh investor relations you may begin.

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

Mike Kavanaugh: 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.

Mike Kavanaugh: With me on the call today are Shantanu Gore, founder and chief executive officer and Chris Geberth chief financial officer.

Mike Kavanaugh: 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 meeting 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 lurion 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.

Mike Kavanaugh: 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 10K file on March 26, 2024. Our SEC filings can be found through our company website at investors.lurion.com or the SEC's website. Investors are cautioned not to place undue reliance on such forward-looking statements and the lurion undertakes no obligation can publicly update or release any revisions to these forward-looking statements.

Mike Kavanaugh: Please note that this conference call is being recorded and will be available for audio replay on our website at lurion.com, under the event 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.

Shantanu Gore: And with that, I will turn the call over to Shatanael.

Shantanu Gore: 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.

Shantanu Gore: 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.

Shantanu Gore: 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 in efficiency improvement activities we undertook at the end of last year.

Shantanu Gore: 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.

Shantanu Gore: 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.

Shantanu Gore: 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.

Shantanu Gore: This puts us on track to complete the trial by the end of the year.

Shantanu Gore: On July 1, we took an important step to strengthen our financial footing, raising $22 million in gross proceeds through a public offering and a concurrent private placement of securities.

Shantanu Gore: 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.

Shantanu Gore: I want to take a minute to touch on the news we recently announced regarding the French market. On August 6, 2024, we announced the French regulatory authority, Hanson, 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 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.

Shantanu Gore: This decision is not a result of any new public 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.

Shantanu Gore: 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 answers 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 to 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 inventories stocking than originally expected in the second half of 2024.

Shantanu Gore: 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.

Shantanu Gore: 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 ones have been widely available for several quarters at a fraction of the price in the United States.

Shantanu Gore: However, we believe it has become clear that GLP ones 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 and approximately 170,000 commercial health plan members, 58% of patients discontinued GLP1 use before reaching a clinically meaningful health benefit, and 30% discontinued use within the first month.

Shantanu Gore: In an analysis of pharmacy claims by Prime Therapeutics, only 15% of patients prescribed GLP1's or 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 tail-in for Alurion in the future, and we are actively exploring partnerships with pharmacies and providers to offer Alurion to patients for whom GLP ones have not been the answer. Alurion also has a competitive advantage with its data on muscle mass, approximately 40% of the weight that is lost during GLP1 therapy comes from loss of muscle mass.

Shantanu Gore: 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 Alurion program. In June, we announced a 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 had four months on the Alurion program.

Shantanu Gore: In this study, body composition and physical activity were tracked in real time with the Alurion app, connect the scale and health tracker, and follow-up was provided through the AI-powered glurion virtual care suite or VCF. These results indicate that it is indeed possible to lose significant amounts of weight while maintaining or even increasing main 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.

Shantanu Gore: In fact, we believe that using a Lurion's AI platform in combination with other modalities, including GLP1s 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.

Shantanu Gore: The VCS also features cochirus, 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 cochirus can help ease the burden and lead to better long-term outcomes.

Shantanu Gore: 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.

Shantanu Gore: 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 cochirus to support patients to prescribe GLP-1 and other anti-obesity medications. We train cochirus 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 in the times and accurate information from various sources to provide answers to patient questions. If our previous experience with cochirus in the Lurion 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?

Shantanu Gore: 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 Advocacy of the Lurion Program, particularly regarding long-term efforts.

Shantanu Gore: In May, we announced three oral scientific presentations at the 12th Congress of the International Federation for the Surgery of Obesity and Metabolic Disorders, European Chapter, otherwise known as IFSO-EC, Health and 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.

Shantanu Gore: In June, we announced three scientific presentations at the American Society for Metabolic and Bariatric Surgery's annual meeting, ASNBS, 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 intra gastric balloons achieved between 15.4% and 16.2% total body weight loss on average.

Shantanu Gore: We believe this study showed that the Allurion program can achieve superior results to other intra gastric 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.

Shantanu Gore: Finally, we have taken steps to strengthen the management team, welcoming OJSA Butch as our new Chief Operating Officer. OJSA brings extensive experience in the healthcare industry, having previously held leadership positions at GE Healthcare, Stay in Jude Medical, Care Fusion, Phillips, 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 OJSA being a key member of our team for years to come.

Chris Geberth: With that, I'll hand the call over to Chris to review our financials. Chris, thank you, Sean Knew. Our revenue for the second quarter of 2024 was $11.8 million, marking a sequentially 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.

Chris Geberth: The year-to-year decrease in revenue of $1.2 million reflected back economic height wins in certain markets and we reduced or paused sales to certain accounts to manage credit risk. While revenue decreased year-to-year, procedure volume has estimated by new app users grew by 12% indicative of ongoing destocking of inventory. Gross profit in the quarter was 76% to rate the 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.

Chris Geberth: Research and development expenses decreased by $2.3 million to $4.3 million in a quarter driven by reduced costs related to our FDA or Destiny trial. The 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 refinancing our debt, our public offering, and concurrent private placement, and partially offset by cash 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.

Chris Geberth: Loss from operations for the second quarter decreased by $3.9 million or 30% to $9.3 million compared to $13.3 million in the same period in 2023. The decrease in loss in 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 30th, 2024, we had cash and cash equivalents of 19.3 million, and our cash burned during the quarter was approximately $10.4 million.

Chris Geberth: 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.

Shantanu Gore: I will now turn the call back over to Shantanu. Thanks, Chris. We are seeing steady recovery in our markets and our differentiated offerings continue to support our progress globally.

Shantanu Gore: 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.

Operator: 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. 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.

Kay Nikai: And your first question comes from the line of Kay Nikai. Your line is open. Yes, a couple of questions, sirs.

Shantanu Gore: What prompted the action by the French regulatory authority?

Shantanu Gore: Okay, good morning. Thanks for the question. As we mentioned, really the French regulatory authority was focused on three primary areas. One 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. And importantly, there's this decision of Vansomes is not based on any new public scientific evidence regarding the balloon. And as I mentioned, the complication rates for our balloon remain in line with what we publish in the literature and remain far lower than what has been published for similar devices that remain on the market in France.

Shantanu Gore: So, combine those facts with the fact that Hansen 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.

Shantanu Gore: 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. Yeah, nothing that we can see from our adverse event reporting or complication reporting that alarms us. And you know as I mentioned there's been no other similar action taken by any other competent authority or regulatory body around the world.

Shantanu Gore: Every regulatory authority has their own way of functioning, has their own processes and protocols. And you're very confident that the areas that handsome is focusing on are not directly related to anything related to the design or manufacturing of the balloon.

Shantanu Gore: 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? 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 past profitability. We're also seeing good growth in our direct markets related to the operating 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.

Kay Nikai: Okay, thanks.

Matt Taylor: In your next question comes from the line of Matt Taylor with Jeffries, your line is open. Hi, thanks for taking the question. I'll put a couple questions.

Shantanu Gore: Could you first maybe impact a guidance reduction? You called out several factors there, including France, but I was wondering you could help quantify the impact of France, inventory, macro, and other headwinds in terms of reduction for the rest of the year. Yes, so those are the three main categories Matt and thank you for the question. The reduction due to the action taken by handsome in France. We mentioned that France has 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.

Shantanu Gore: 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 will stabilize at slightly lower levels than we have projected.

Shantanu Gore: So those are the three variables that are really driving the revision to guidance for the second half, for the year and the full year. Okay, gotcha.

Shantanu Gore: 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? 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.

Shantanu Gore: 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 going to be on bottom line profitability and increasing the efficiency of the business. Much like we did going from 2023 to 2024.

Shantanu Gore: Okay, and I'm set a follow up on France. Is there something that you're doing there differently with regards to promotion or training than you're doing in other markets or maybe ask differently? Are there any learning from France that you need to apply to the UK or other places to avoid other issues like this in other geographies?

Matt Taylor: There are some learnings around the edges that we plan to incorporate in our marketing strategies and also follow-up strategies and 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.

Matt Taylor: 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. Okay, great. I'll leave it there. Thank you very much. Thanks, Matt. There are no further questions at this time. I will turn the call back over to our presenters.

Shantanu Gore: Closing remarks. 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 Elurion. 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 out of forward to updating all of you in the next quarter. Thank you. Have a great day. Thank you.

Operator: This concludes today's conference call.

Operator: You may now disconnect.