Core Insights - Allurion Technologies has announced initial results indicating that combining the Allurion Program with low-dose tirzepatide therapy can optimize muscle mass and improve adherence to GLP-1 medications, achieving an average total weight loss of 23% and a 14% increase in lean body mass after 12 months [1][3][4] Study Details - The study involved 76 patients who were treated with the Allurion Smart Capsule and started on low-dose tirzepatide after 45 days of balloon therapy, with doses starting at 2.5mg and increasing to a maximum of 5.0mg over two months, significantly lower than the standard dosing of up to 15mg [2][4] - The follow-up period lasted 12 months, with patients monitored using the AI-powered Virtual Care Suite as part of the Allurion Program [2][3] Results - After 12 months, patients experienced an average total body weight loss of 23%, and lean body mass as a percentage of total body weight increased from 62% to 70% [3][4] - All patients remained adherent to tirzepatide throughout the study, with no early discontinuations [3][4] Expert Commentary - Dr. Luigi Flagiello highlighted the advantages of combining the Allurion Smart Capsule with GLP-1 medications, noting that this approach can lead to increased weight loss while preserving lean mass, and that lower doses of GLP-1s can enhance adherence [4][6] - Dr. Shantanu Gaur emphasized that the initial data addresses significant challenges associated with GLP-1 therapies, such as muscle wasting and adherence issues, and expressed optimism about validating these results in future clinical trials [6][7] Future Directions - Additional data on the combination approach is being collected and is expected to be presented at upcoming medical meetings [7]

Financial Data and Key Metrics Changes - First quarter revenue was $5,600,000, a decrease from $9,400,000 in the same period of 2024, primarily due to the temporary suspension of sales in France and lower investments in sales and marketing [21][22] - Adjusted net operating loss narrowed by 48% to $5,900,000 compared to the prior year, with gross margin expanding to 75% from 73% in the prior year and 45% in the previous quarter [5][21] - Cash and cash equivalents at the end of the first quarter were $20,400,000, providing a runway to achieve FDA approval and profitability [23][11] Business Line Data and Key Metrics Changes - Sales and marketing expenses decreased to $3,600,000 from $6,100,000 in the same period in 2024, driven by increased operating efficiency [22] - Research and development expenses were reduced to $2,600,000 from $5,700,000, primarily due to reduced costs related to the IDISSIPPI trial [22] - General and administrative expenses decreased to $5,200,000 from $6,400,000, with adjusted expenses at $3,800,000 excluding one-time financing costs [23] Market Data and Key Metrics Changes - The company observed over 40% growth quarter over quarter and year over year in its B2B2C model pilot in clinics in Europe [7] - The company expects revenues to ramp as the year progresses with the expansion of the B2B2C model and enhanced sales team onboarding [8] Company Strategy and Development Direction - The company’s 2025 plan focuses on five pillars: a new commercial plan, gaining FDA approval for the Allurion balloon, achieving profitability for the ex-U.S. business, scaling the AI product platform, and resuming commercialization in France [6][7] - The company aims to combine the Allurion program with low doses of GLP-1s to create a new standard of care for obesity management [16][24] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the efficiency of the new B2B2C model and the potential for significant shareholder value as the strategy is executed [25] - The company is optimistic about completing the PMA submission to the FDA by June and is encouraged by the FDA's feedback during the pre-PMA meeting [10][11] Other Important Information - The company is making progress in treating patients in France and has reengaged clinics and retrained providers [14] - The company does not expect any impact on gross margin from tariffs for the balance of the year [12] Q&A Session Summary Question: Trends in regional markets with the new marketing strategy - Management noted that mature markets for GLP-1s are creating tailwinds, and the expansion of the direct sales force is expected to accelerate new account openings [27][28] Question: Timeline and patient enrollment for the GLP-1 trial - Enrollment is expected to begin in the latter half of this year, with a one-year follow-up for at least 75 subjects across multiple sites in Europe [30][31] Question: Design of the trial arms - The trial will focus on validating previous retrospective work with a single arm prospective trial design, using historical data as comparators [32] Question: Future gross margin expectations - Management expects margins to remain in the same range as the first quarter for the remainder of the year, with potential increases as revenues ramp up [34][35] Question: Details on the pre-PMA meeting and next steps - The FDA was receptive to alternative analyses for the control group data, which could strengthen the overall application [39][41] Question: Procedure growth and trends in Q2 - Procedure volume is stable, with some growth in certain territories, and a recovery is expected in France in the second half of the year [57][58]

Financial Data and Key Metrics Changes - First quarter revenue was $5.6 million, a decrease from $9.4 million in the same period in 2024, primarily due to the temporary suspension of sales in France and lower investments in sales and marketing [22][5] - Adjusted net operating loss narrowed by 48% to $5.9 million compared to the prior year, with gross margin expanding to 75% from 73% in the prior year and 45% in the previous quarter [5][22] - Cash and cash equivalents at the end of the first quarter were $20.4 million, providing a runway for achieving FDA approval and profitability [25][12] Business Line Data and Key Metrics Changes - Sales and marketing expenses decreased to $3.6 million from $6.1 million in the same period in 2024, driven by increased operating efficiency [23] - Research and development expenses were reduced to $2.6 million from $5.7 million, primarily due to cost reductions related to the IDISSIPPI trial [23] - General and administrative expenses decreased to $5.2 million from $6.4 million, with adjusted expenses at $3.8 million excluding one-time financing costs [24] Market Data and Key Metrics Changes - The company observed over 40% growth quarter over quarter and year over year in its B2B2C model pilot in clinics in Europe [7] - The company expects revenues to ramp as the year progresses with the expansion of the B2B2C model and enhanced sales team onboarding [8] Company Strategy and Development Direction - The company’s 2025 plan focuses on five pillars: a new commercial plan, gaining FDA approval for the Allurion balloon, achieving profitability for the ex-U.S. business, scaling the AI product platform, and resuming commercialization in France [6][7] - The company aims to combine its program with low doses of GLP-1s to create a new standard of care for obesity, targeting a sustained weight reduction of over 20% while maintaining muscle mass [16][20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the efficiency of the new B2B2C model and the potential for significant shareholder value as millions of patients could be treated with the Elerion program [26][27] - The company is optimistic about completing its PMA submission to the FDA by June and is encouraged by the FDA's feedback during the pre-PMA meeting [12][39] Other Important Information - The company has resumed treating patients in France and is in the final phases of updating marketing collateral to reactivate placements [15] - The company does not expect any impact on gross margin from tariffs for the remainder of the year, as most components are manufactured in the U.S. [12][13] Q&A Session Summary Question: Trends in regional markets, especially with the new marketing strategy - Management noted that mature markets for GLP-1s are creating tailwinds, with patients seeking alternatives and the expansion of the direct sales force expected to drive revenue growth [29][30] Question: Timeline and patient enrollment for the GLP-1 trial - Enrollment is expected to begin in the latter half of this year, with a one-year follow-up and a target of at least 75 subjects across multiple sites in Europe [31][32] Question: Design of the trial arms - The trial will focus on validating previous retrospective work with a single arm prospective trial design, leveraging historical data for comparison [33][34] Question: Future gross margin expectations - Management expects margins to remain in the same range as the first quarter, with potential increases as revenues ramp up [35][36] Question: Details on the pre-PMA meeting and next steps - The FDA was receptive to alternative analyses for the control group data, which could strengthen the overall application [39][40] Question: Current adoption of the Elerion program and GLP-1s - There is organic adoption of the combination therapy in the field, with physicians integrating GLP-1s with the Allurion balloon [45][46] Question: Revenue performance cadence for 2025 - Management anticipates steady revenue increases driven by the onboarding of new sales team members and recovery in France [49][50] Question: Expected costs for the prospective study - The prospective trial is not expected to have a material impact on the budget, as existing patient flow and lower costs overseas will be leveraged [51][52] Question: Regulatory strategy regarding expanded labeling - The focus is on the commercial implications of the study, with potential long-term benefits for discussions with regulators and payers [53][54] Question: Procedure growth trends - Procedure volume is stable, with some growth in certain territories, and management expects a recovery in France in the second half of the year [57][58]

Financial Data and Key Metrics Changes - Fourth quarter revenue was $5.6 million, down from $8.2 million in the same period in 2023, primarily due to the temporary suspension of sales in France and macroeconomic headwinds [28] - Full year revenue for 2024 was $32.1 million, in line with pre-announcement guidance [17] - Gross profit for Q4 2024 was $2.5 million, or 45% of revenue, compared to $6.4 million, or 78% of revenue in Q4 2023 [29] - Operating expenses in Q4 decreased by 39% year-over-year, driven by restructuring and increased operational efficiency [18][31] - Loss from operations for Q4 was $17.1 million, down from $25.7 million in the same period in 2023 [32] Business Line Data and Key Metrics Changes - Procedure volumes grew by 4% in 2024, higher than previously issued guidance, attributed to patients entering the funnel after discontinuing GLP-1 medications [18] - Sales and marketing expenses for Q4 2024 were $7.9 million, down from $10.7 million in Q4 2023, including $3.1 million of restructuring costs [30] - Research and development expenses for Q4 2024 were $4.1 million, down from $6.1 million in Q4 2023 [31] Market Data and Key Metrics Changes - The U.S. market represents a significant opportunity due to high obesity rates and widespread use of GLP-1s, with over 40% of adults in the U.S. classified as obese [24] - The company expects to see the highest procedural volume increases in regions where GLP-1s are most mature, indicating a trend of patients returning for alternative treatments after discontinuing GLP-1s [46][73] Company Strategy and Development Direction - The company plans to focus on a new commercial strategy emphasizing B2B2C sales models and deeper penetration in key geographies [19] - Aiming for FDA approval for the Allurion Balloon and preparing for a U.S. launch [19] - The company intends to achieve profitability for its ex-U.S. business by the end of 2025 [19] - Plans to scale its AI product platform and resume commercialization in France [19][26] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of the combination therapy of the Allurion Balloon with low-dose GLP-1s to redefine obesity care [16][35] - The company anticipates a revenue of approximately $30 million in 2025, with a steady build quarter-over-quarter driven by new commercial strategies and an expanded sales team [24][82] - Management expects operating expenses to decline by approximately 50% in 2025 compared to 2024 due to restructuring [24] Other Important Information - The company raised additional capital in Q1 2025, providing a cash runway into 2026 [26] - The French regulatory authority, ANSM, has cleared the company to resume sales in France, which is expected to contribute significantly in 2026 [26] Q&A Session Summary Question: Follow-up on results using balloons with low-dose GLP-1 - Management explained that the positive results were due to the lower dose of GLP-1 protecting lean body mass while achieving weight loss through synergistic mechanisms [40][41] Question: Key assumptions for 2025 guidance of $30 million - Management highlighted that the guidance is based on maintaining procedure volumes and re-engaging with clinics in France, expecting a gradual contribution from that market [44][46] Question: Progress on U.S. approval timeline - The next milestone is the completion of the PMA submission, anticipated in the first half of the year, with ongoing dialogue with the FDA [48][49] Question: Trends in procedure volume growth - Management confirmed that momentum continues in markets where GLP-1s are mature, with significant growth observed in pilot accounts [54][55] Question: B2B2C rollout status - The B2B2C strategy has been piloted in key markets and will continue to roll out as validation is obtained [68][69] Question: Metrics on regions with traction - Management noted promising results in the Middle East and Latin America, where GLP-1s have been widely used [71][73] Question: Operating expense reductions - The changes in operating expenses were implemented at the end of 2024, with no further reductions expected throughout 2025 [75]

Financial Data and Key Metrics Changes - Fourth quarter revenue was $5.6 million, down from $8.2 million in the same period in 2023, primarily due to the temporary suspension of sales in France and macroeconomic headwinds [28] - Full year revenue for 2024 was $32.1 million, in line with pre-announcement expectations [17] - Gross profit for Q4 2024 was $2.5 million, or 45% of revenue, compared to $6.4 million, or 78% of revenue in Q4 2023 [29] - Operating expenses in Q4 decreased by 39% year-over-year, driven by restructuring and reorganization efforts [18] Business Line Data and Key Metrics Changes - Procedure volumes grew by 4% in 2024, higher than previously issued guidance, attributed to patients entering the funnel after trying and stopping GLP-1 medications [18] - Sales and marketing expenses for Q4 2024 were $7.9 million, down from $10.7 million in Q4 2023, including $3.1 million of restructuring costs [30] - Research and development expenses for Q4 2024 were $4.1 million, down from $6.1 million in Q4 2023, also including restructuring costs [31] Market Data and Key Metrics Changes - The U.S. market represents a significant opportunity due to high obesity rates and widespread use of GLP-1s, with over 40% of adults in the U.S. classified as obese [24] - The company expects to see the highest procedural volume increases in regions where GLP-1s are most mature, indicating a trend of patients returning for alternative treatments after discontinuing GLP-1s [46] Company Strategy and Development Direction - The company’s strategy for 2025 is built around five pillars, including a new commercial plan focused on key geographies, gaining FDA approval for the Allurion Balloon, achieving profitability for the ex-U.S. business, scaling the AI product platform, and resuming commercialization in France [19] - The company plans to launch additional prospective studies to confirm initial findings on the combination of the Allurion Balloon with low-dose GLP-1s, aiming to define a new paradigm in obesity care [16] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the momentum building in Q1 2025, with procedure volumes on track to increase by over 30% compared to Q4 2024 [22] - The company anticipates operating expenses to decline by approximately 50% in 2025 compared to 2024, while still investing in key growth areas [24] - Management highlighted the importance of the clinical data generated on the combination therapy, which could redefine obesity management standards [35] Other Important Information - The company raised additional capital through financings, providing a cash runway into 2026 and through expected FDA approval [26] - The company resumed sales in France after regulatory review, which is expected to contribute to future revenue growth [26] Q&A Session Summary Question: Follow-up on results using balloons with low-dose GLP-1 - Management explained that the positive results were driven by using lower doses of GLP-1, which protects lean body mass while still achieving weight loss through synergistic mechanisms [41][42] Question: Key assumptions for 2025 guidance of $30 million - Management indicated confidence in preserving procedure volumes and highlighted the importance of regions where GLP-1s are mature for future growth [44][46] Question: Progress on U.S. approval timeline - The next milestone is completing the PMA submission in the first half of the year, with updates to follow [49] Question: Trends in procedure volume growth - Management confirmed that momentum is continuing in markets where GLP-1s are mature, with significant growth observed in pilot accounts [55] Question: Cadence of revenue to reach $30 million - Management expects a steady build of revenue quarter-over-quarter, driven by the new commercial plan and an increase in the sales team [80][82] Question: Timing for meaningful contribution from France - Management does not expect a material contribution from France until late 2025 or early 2026 due to the time required to reengage with accounts [85] Question: Gross margin recovery expectations - Management anticipates a quicker recovery in gross margin than revenue build, starting in Q1 2025 [87] Question: Impact of launching the smaller balloon on margin - Management does not expect significant impact on gross margin from the next-gen balloon in 2025, but potential for expansion in 2026 [90]

Table of Contents As filed with the Securities and Exchange Commission on September 30, 2024 Registration No. 333-279902 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 1 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 ALLURION TECHNOLOGIES, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 3841 92-2182207 (Primary Standard Industrial Classification Code Number) 11 Huro ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 1 to FORM S-1 REGISTRATION STATEMENT Table of Contents As filed with the Securities and Exchange Commission on October 20, 2023 Registration No. 333-274564 UNDER THE SECURITIES ACT OF 1933 ALLURION TECHNOLOGIES, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 3841 92-2182207 (Primary Standard Industrial Classification Code Number) 11 Huron ...

Table of Contents As filed with the Securities and Exchange Commission on September 18, 2023 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 ALLURION TECHNOLOGIES, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 3841 92-2182207 (Primary Standard Industrial Classification Code Number) 11 Huron Drive Natick, MA 01760 ...