Summary of Allurion Conference Call Company Overview - **Company**: Allurion - **Industry**: Medical Technology, specifically in obesity treatment - **Founded**: 2009 - **Core Product**: Allurion balloon, a swallowable weight loss device that is non-invasive and can be deployed in a 15-minute office visit [2][3] Key Points Product and Technology - Allurion focuses on "metabolically healthy weight loss," combining a swallowable balloon with a behavior change program and virtual care suite [2][3] - The Allurion balloon has been used in over 150,000 patients and is paired with AI-powered coaching for long-term weight maintenance [3][4] - The program has shown to help patients lose an average of 15% of total body weight, with 95% of that weight loss maintained after one year [6] Clinical Results - Patients using the Allurion program alone see significant reductions in comorbidities such as diabetes and hypertension [7] - When combined with low doses of GLP-1 therapy, patients can lose over 20% of their total body weight while maintaining or gaining muscle mass [8][9] - The recent Audacity trial demonstrated a stellar safety profile and impressive efficacy, with over half of participants losing more than 5% of their body weight [12][13] Market Dynamics - The obesity market is valued at $50 billion, with Allurion seeing growth in various geographies [11] - The company has reduced operating expenses by nearly 50% and is focused on achieving sustainable profitability [11][36] - Allurion is preparing to re-enter the French market and is optimistic about its upcoming U.S. launch, which is expected to be the largest market opportunity [12][22] Financial Performance - In Q1, Allurion reported a significant improvement in gross margins due to restructuring and an increase in direct sales [34] - The company ended Q1 with approximately $20 million in cash and expects to reduce cash burn significantly in 2025 [36] Competitive Landscape - Allurion does not view GLP-1s as competition but rather as complementary to its balloon technology [40] - Bariatric surgery volumes have decreased by approximately 40% due to the rise of GLP-1 therapies, indicating a shift in obesity management [41] Future Outlook - Allurion plans to launch its full program in the U.S., including the balloon and virtual care suite, with a focus on sustainable growth [26][23] - The company is enhancing its AI capabilities with Coach Iris, which will provide real-time feedback and support for patients [27][28] - Allurion aims to achieve positive EBITDA by 2026, contingent on the success of its U.S. launch strategy [36] Research and Data - Allurion has over 26 peer-reviewed publications and has collected millions of data points from its patient population, demonstrating consistent weight loss and muscle maintenance [43][44] Additional Insights - The integration of AI in the Allurion program is expected to enhance patient outcomes and engagement [27][31] - The company is focused on building a strong ecosystem of clinics and providers to ensure a positive patient experience upon U.S. entry [24][23]

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]