Company Performance - Allurion Technologies, Inc. reported a quarterly loss of $0.57 per share, which was better than the Zacks Consensus Estimate of a loss of $0.65, representing an earnings surprise of +12.31% [1] - The company posted revenues of $3.38 million for the quarter ended June 2025, missing the Zacks Consensus Estimate by 43.21%, and a significant decline from year-ago revenues of $11.77 million [2] - Over the last four quarters, Allurion has surpassed consensus EPS estimates three times but has not beaten consensus revenue estimates [2] Stock Performance - Allurion Technologies' shares have lost about 78% since the beginning of the year, contrasting with the S&P 500's gain of 9.7% [3] - The current Zacks Rank for Allurion is 4 (Sell), indicating expectations for the stock to underperform the market in the near future [6] Future Outlook - The current consensus EPS estimate for the coming quarter is -$0.54 on revenues of $7.15 million, and for the current fiscal year, it is -$3.14 on revenues of $24.53 million [7] - The outlook for the Medical - Products industry, where Allurion operates, is currently in the top 39% of over 250 Zacks industries, suggesting potential for better performance compared to lower-ranked industries [8]

[Explanatory Note and Restatement](index=2&type=section&id=Explanatory%20Note) [Restatement Background](index=2&type=section&id=Restatement%20Background) The company is restating financial statements for prior periods, including Q2 2024, due to an accounting error from a material weakness in internal controls, impacting net income and equity components but not revenue or cash - An accounting error was identified, leading to the restatement of financial statements for multiple periods, including the quarter ended June 30, 2024[6](index=6&type=chunk)[7](index=7&type=chunk) - The error caused misstatements in Other comprehensive income (loss), Other income (expense), Net income (loss), Accumulated other comprehensive income (loss), and Accumulated deficit[9](index=9&type=chunk) - The error was attributed to an existing material weakness related to a lack of sufficient staff with public company and technical accounting experience, but importantly, the error did not affect revenue, gross profit, operating profit, or cash balances[9](index=9&type=chunk) - As a result of the error and restatement, management concluded that the Company's disclosure controls and procedures were not effective as of June 30, 2025[11](index=11&type=chunk) [PART I. FINANCIAL INFORMATION](index=6&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements (Unaudited)](index=6&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) Unaudited financial statements for H1 2025 show a **$10.8 million net loss** and a **$64.0 million stockholders' deficit**, raising substantial doubt about the company's going concern due to recurring losses [Condensed Consolidated Financial Statements](index=6&type=section&id=Condensed%20Consolidated%20Financial%20Statements) H1 2025 saw revenue decline to **$9.0 million** and a **$10.8 million net loss**, with cash at **$12.7 million** and a **$64.0 million stockholders' deficit** Condensed Consolidated Statements of Operations Highlights (Six Months Ended June 30, In thousands) | Metric | 2025 | 2024 (Restated) | | :--- | :--- | :--- | | Revenue | $8,959 | $21,152 | | Gross Profit | $6,658 | $15,859 | | Loss from Operations | $(14,234) | $(20,736) | | Net Loss | $(10,836) | $(6,326) | | Net Loss Per Share (Basic & Diluted) | $(1.79) | $(3.30) | Condensed Consolidated Balance Sheet Highlights (In thousands) | Metric | June 30, 2025 | December 31, 2024 (Restated) | | :--- | :--- | :--- | | Cash and cash equivalents | $12,722 | $15,379 | | Total Assets | $28,169 | $32,813 | | Total Liabilities | $92,145 | $110,791 | | Total Stockholders' Deficit | $(63,976) | $(77,978) | Condensed Consolidated Statements of Cash Flows Highlights (Six Months Ended June 30, In thousands) | Metric | 2025 | 2024 (Restated) | | :--- | :--- | :--- | | Net cash used in operating activities | $(17,082) | $(17,563) | | Net cash used in investing activities | $0 | $(539) | | Net cash provided by (used in) financing activities | $14,428 | $(673) | | Net decrease in cash | $(2,654) | $(18,775) | [Notes to Unaudited Condensed Consolidated Financial Statements](index=13&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) Notes disclose a 'Going Concern' warning due to recurring losses, detail financial restatements and debt agreements, and reveal a post-quarter strategic restructuring with a **65% workforce reduction** - The company has concluded there is substantial doubt about its ability to continue as a going concern for one year, due to recurring losses, negative operating cash flows, and the need to raise additional capital[47](index=47&type=chunk) - On August 5, 2025, the company announced a strategic restructuring plan to focus on GLP-1 combination therapy and U.S. market entry, which includes a reduction of approximately 70 employees (**65% of its workforce**) with expected severance charges of **$1.5 million**[214](index=214&type=chunk) - The company is involved in a legal proceeding with Vanderbilt University Medical Center, which is seeking damages of approximately **$2.5 million** for an alleged breach of a Clinical Trial Agreement[199](index=199&type=chunk)[350](index=350&type=chunk) - In August 2024, sales of the Allurion Balloon were suspended in France by the regulatory authority ANSM, but sales were cleared to resume in February 2025 after the company implemented a remediation plan[202](index=202&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=62&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses a **58% revenue decline** in H1 2025, reduced operating expenses, and critical liquidity issues, with substantial doubt about going concern, necessitating financing and a strategic restructuring including workforce reduction [Results of Operations](index=74&type=section&id=Results%20of%20Operations) H1 2025 revenue fell **58% to $9.0 million**, with gross profit also down **58%**, while total operating expenses decreased **43% to $20.9 million**, improving loss from operations to **$14.2 million** Comparison of Results for the Six Months Ended June 30 (In thousands) | Metric | 2025 | 2024 (Restated) | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Revenue | $8,959 | $21,152 | $(12,193) | -58% | | Gross Profit | $6,658 | $15,859 | $(9,201) | -58% | | Total Operating Expenses | $20,892 | $36,595 | $(15,703) | -43% | | Loss from Operations | $(14,234) | $(20,736) | $6,502 | 31% | - The **58% decrease in revenue** for the first half of 2025 was primarily caused by distributor transitions, lower investment in sales and marketing, the temporary suspension of sales in France, and efforts to manage credit risk with certain distributors[272](index=272&type=chunk)[291](index=291&type=chunk) - Sales and marketing expenses decreased by **53%** due to lower headcount from a Q4 2024 restructuring and a strategic reorganization of marketing spend towards more efficient channels[276](index=276&type=chunk) - Research and development expenses decreased by **56%**, mainly due to a **$3.0 million reduction** in costs related to the AUDACITY clinical trial as the PMA submission was completed[278](index=278&type=chunk) [Liquidity and Capital Resources](index=78&type=section&id=Liquidity%20and%20Capital%20Resources) As of June 30, 2025, the company held **$12.7 million in cash** but faces substantial doubt about its going concern due to recurring losses and negative cash flows, necessitating **$14.4 million** in H1 2025 financing activities - The company had **$12.7 million in cash and cash equivalents** as of June 30, 2025, and an accumulated deficit of **$233.0 million**[290](index=290&type=chunk) - Management explicitly states that based on recurring losses and the need for additional capital, there is substantial doubt about the company's ability to continue as a going concern for one year from the report's issuance date[292](index=292&type=chunk) - During the first six months of 2025, the company raised **$14.4 million** from financing activities, primarily through public offerings and private placements[327](index=327&type=chunk) - Key financing arrangements include the RTW Convertible Notes (**$43.0 million outstanding**), the Chardan Equity Facility, and a Revenue Interest Financing Agreement with RTW[301](index=301&type=chunk)[302](index=302&type=chunk)[304](index=304&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=86&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company faces low interest rate risk but significant foreign currency exchange risk, primarily in Europe, with a **10% adverse change** potentially impacting net income by **3%**; no hedging activities are currently employed - The company does not have significant interest rate risk, with cash equivalents in money market funds and no variable rate debt as of June 30, 2025[334](index=334&type=chunk)[335](index=335&type=chunk) - The company is exposed to foreign currency risk from transactions denominated in currencies other than the U.S. dollar, with primary exposure in Europe, where a **10% adverse change** in exchange rates would have impacted net income by approximately **3%** for the six months ended June 30, 2025[336](index=336&type=chunk)[338](index=338&type=chunk) - The company has not engaged in any foreign currency hedging activities to date[338](index=338&type=chunk) [Item 4. Controls and Procedures](index=86&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls were ineffective as of June 30, 2025, due to material weaknesses in internal control over financial reporting, including staffing and IT issues, with a remediation plan underway - The CEO concluded that the Company's disclosure controls and procedures were not effective as of June 30, 2025[341](index=341&type=chunk) - The ineffectiveness is due to material weaknesses in internal control over financial reporting, including: insufficient segregation of duties, lack of staff with public company/technical accounting experience, and insufficient IT controls[342](index=342&type=chunk) - A remediation plan is underway, which involves hiring more experienced accounting staff, implementing a new ERP system, adding more review controls, and hiring a national accounting firm to assist with control design[344](index=344&type=chunk)[347](index=347&type=chunk) [PART II. OTHER INFORMATION](index=89&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=89&type=section&id=Item%201.%20Legal%20Proceedings) The company faces a legal proceeding from Vanderbilt University Medical Center, seeking approximately **$2.5 million** for an alleged breach of a Clinical Trial Agreement, which the company intends to defend - On August 12, 2025, Vanderbilt University Medical Center filed a complaint against the Company, alleging breach of a Clinical Trial Agreement and seeking damages of approximately **$2.5 million**[350](index=350&type=chunk) [Item 1A. Risk Factors](index=89&type=section&id=Item%201A.%20Risk%20Factors) Material risk factors include potential disruptions and resource strain from the August 2025 strategic restructuring and workforce reduction, alongside adverse impacts from changes in U.S. fiscal and tax policies like the OBBBA - The August 2025 strategic restructuring and workforce reduction may not yield anticipated savings, could disrupt business operations, and may strain the company's limited resources[352](index=352&type=chunk)[353](index=353&type=chunk) - The company faces risks from potential changes in U.S. federal policies, including the 'One Big Beautiful Bill Act' (OBBBA) signed into law on July 4, 2025, which could affect the tax treatment of R&D expenses[354](index=354&type=chunk) [Other Part II Items](index=92&type=section&id=Other%20Part%20II%20Items) This section confirms no reportable events for unregistered equity sales, senior security defaults, or mine safety disclosures, and no Rule 10b5-1 trading plan adoptions or terminations by directors/officers - There were no unregistered sales of equity securities, defaults upon senior securities, or mine safety disclosures to report for the period[356](index=356&type=chunk)[357](index=357&type=chunk)[358](index=358&type=chunk) - No directors or officers adopted or terminated a Rule 10b5-1 trading plan during the fiscal quarter[359](index=359&type=chunk)

Financial Data and Key Metrics Changes - Revenue for Q2 2025 was $3.4 million, a decrease from $11.8 million in Q2 2024, primarily due to distributor transitions and lower investments in sales and marketing [17][19] - Gross profit for the second quarter was $2.5 million, or 74% of revenue, compared to $9 million, or 76% of revenue in the same period in 2024 [17] - Operating expenses decreased by 48% year-over-year, leading to an operating loss improvement of 26% compared to the prior year [16][19] Business Line Data and Key Metrics Changes - Clinics utilizing the combination approach for obesity management grew by 20% compared to 2024, indicating potential for future growth [15] - Sales and marketing expenses were reduced to $2.4 million from $6.7 million in Q2 2024, reflecting increased operational efficiency [18] - Research and development expenses decreased to $1.8 million from $4.3 million in Q2 2024, driven by cost reductions related to the Audacity trial [18] Market Data and Key Metrics Changes - The company is focusing on international markets where GLP-1s are less expensive, which is expected to drive adoption of the combination therapy [24][30] - The U.S. market presents a significant opportunity, with 40% of adults classified as obese, yet only 8 million currently using injectable obesity therapy [15] Company Strategy and Development Direction - The new strategy emphasizes metabolically healthy weight loss through combination therapy of the Allurion balloon and low-dose GLP-1s [6][7] - The company is transitioning away from distribution partners lacking access to accounts that can deliver comprehensive obesity care, focusing instead on high-performing accounts [9][10] - A term sheet was signed with a strategic partner to expand manufacturing capabilities and explore the development of a novel GLP-1 drug-eluting intragastric balloon [11] Management's Comments on Operating Environment and Future Outlook - Management acknowledges that the transition to the new strategy may cause short-term disruptions but believes it will lead to long-term growth [15][16] - The company is optimistic about the potential for FDA approval of its PMA submission, which could accelerate its U.S. market entry [37] - Management is confident that the combination therapy will establish a new standard of care in obesity management [21] Other Important Information - Cash and cash equivalents as of June 30, 2025, were $12.7 million, providing a runway for future operations [19] - The company anticipates recording charges of approximately $1.5 million related to the new strategic direction [16] Q&A Session Summary Question: How should we think about low-dose GLP-1s plus Allurion gastric balloon impacting overall costs for obesity care? - Management noted that GLP-1s are inexpensive internationally, and combining them with the Allurion program incurs minimal costs for patients, driving adoption [24][30] Question: Can you provide guidance on operating expenses for R&D and G&A? - Management indicated that R&D expenses of $1.8 million are appropriate for the near term, with overall operating expenses expected to decrease by approximately 50% due to restructuring [41][42] Question: What is the cash runway associated with the U.S. launch? - Management stated that cash needs will depend on the commercial strategy in the U.S., but they feel confident about the current cash position [45][46] Question: How will the new strategy impact reengagement with accounts in France? - Management expressed optimism that the combination therapy approach will positively impact reengagement with accounts in France, especially as GLP-1s become more accessible [51]

[Form 8-K: Allurion Technologies, Inc. (August 5, 2025)](index=1&type=section&id=Form%208-K%3A%20Allurion%20Technologies%2C%20Inc.%20%28August%205%2C%202025%29) [Item 2.02 Results of Operations and Financial Condition](index=3&type=section&id=Item%202.02%20Results%20of%20Operations%20and%20Financial%20Condition) The company announced preliminary unaudited Q2 2025 financial results, emphasizing they are not finalized and may materially differ from final figures - The company announced select preliminary unaudited financial results for the second quarter ended June 30, 2025[7](index=7&type=chunk) - These financial results have not yet been finalized by management or reviewed by the company's independent auditors, Deloitte & Touche LLP[8](index=8&type=chunk) - The company cautions that subsequent information may lead to material differences from these preliminary results, and investors should not place undue reliance on them[8](index=8&type=chunk) [Item 2.05 Costs Associated with Exit or Disposal Activities](index=3&type=section&id=Item%202.05%20Costs%20Associated%20with%20Exit%20or%20Disposal%20Activities) The company adopted a strategic restructuring plan, reducing its workforce by **65%** and incurring **$1.5 million** in charges, to refocus on key strategic areas - A strategic restructuring plan was adopted by the board of directors on July 23, 2025[9](index=9&type=chunk) - The company is shifting its focus to low-dose GLP-1 combination therapy, muscle mass maintenance, and U.S. market entry[9](index=9&type=chunk) Restructuring Plan Details | Metric | Value | | :--- | :--- | | **Workforce Reduction** | ~70 employees (~65% of workforce) | | **Expected Completion** | End of Q3 2025 | | **Estimated Charges** | ~$1.5 million (severance-related) | [Item 7.01 Regulation FD Disclosure](index=3&type=section&id=Item%207.01%20Regulation%20FD%20Disclosure) A press release detailing the company's new strategic direction was issued, with information furnished, not filed, under the Exchange Act - A press release was issued on August 5, 2025, titled "Allurion Announces New Strategic Direction With Increasing Focus on Low-Dose GLP-1 Combination Therapy, Muscle Mass Maintenance, and US Market Entry"[10](index=10&type=chunk) - The information provided under Items 2.02 and 7.01 (including Exhibit 99.1) is considered "furnished" and not "filed" under the Exchange Act, limiting its legal liability under Section 18[11](index=11&type=chunk) [Item 9.01 Financial Statements and Exhibits](index=3&type=section&id=Item%209.01%20Financial%20Statements%20and%20Exhibits) This section lists the exhibits accompanying the Form 8-K filing, with the press release on strategic direction as the primary exhibit Exhibits Filed | Exhibit | Description | | :--- | :--- | | 99.1 | Press Release issued by Allurion Technologies, Inc. on August 5, 2025 | | 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |

This presentation contains financial forecasts with respect to the Company's projected financial results for the Company for the periods indicated. These projections should not be relied upon as being necessarily indicative of future results. The assumptions and estimates underlying the prospective financial information are inherently uncertain and are subject to a wide variety of significant business, economic and competitive risks and uncertainties that could cause actual results to differ materially from ...

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]

Industry Overview - The Zacks Medical - Products industry is facing increased uncertainty due to the reimposition of tariffs on medical devices, particularly a rise from 10% to 30% on Chinese-made components, which may disrupt U.S. MedTech economics [1] - Companies in the industry are primarily focused on research and development, catering to vital therapeutic areas such as cardiovascular, nephrology, and urology devices, with increasing procedure volumes driving sales [4] - Supply-chain disruptions, inflationary pressures, and labor shortages are straining gross and operating margins, with these challenges expected to persist into 2025 [5] Major Trends - The adoption of AI, medical mechatronics, and robotics is transforming the industry, with innovations in minimally invasive surgeries and automated patient management [6] - 3D printing is reshaping the landscape by producing various medical products, highlighting a shift towards precision and improved clinical outcomes [7] - The COVID-19 pandemic has led to a significant rise in demand for diagnostic testing kits, with many rapid, point-of-care devices entering development [8] - Emerging markets are showing strong demand for medical products due to factors like aging populations and government investment in healthcare infrastructure [9] Industry Performance - The industry has outperformed its own sector, rising 10% over the past year, while the Zacks Medical sector declined by 15.6% [13] - The industry is currently trading at a forward 12-month price-to-earnings (P/E) ratio of 20.3X, compared to the S&P 500's 19.9X and the sector's 19.4X [16] Company Highlights - **Insulet (PODD)**: Focused on diabetes management with the Omnipod Insulin Management System, experiencing an 18.1% revenue growth forecast for 2025 and a 32.1% growth in earnings [25] - **MacroGenics (MGNX)**: Reported a revenue increase to $150 million in 2024 from $58.7 million in 2023, driven by collaboration revenues and milestone payments [29] - **Cellectar Biosciences (CLRB)**: Developing cancer detection and treatment agents, with a lead asset showing a 98.2% clinical benefit rate in trials [36] - **Allurion Technologies (ALUR)**: Focused on obesity treatment with a weight loss platform, but faced a 32% revenue decline year-over-year in Q4 2024 due to operational challenges [42]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________________ to _________________ Commission File Number: 001-41767 Allurion Technologies, Inc. (Exact Name of Registrant as Specified in its Charter) | De ...

Core Viewpoint - Allurion Technologies, Inc. reported a quarterly earnings of $0.43 per share, significantly beating the Zacks Consensus Estimate of a loss of $1.53 per share, marking an earnings surprise of 128.10% [1] Financial Performance - The company posted revenues of $5.58 million for the quarter ended March 2025, missing the Zacks Consensus Estimate by 2.11%, and a decline from $9.39 million in the same quarter last year [2] - Over the last four quarters, Allurion has surpassed consensus EPS estimates two times but has not beaten consensus revenue estimates [2] Stock Performance - Allurion shares have declined approximately 78.1% since the beginning of the year, contrasting with the S&P 500's gain of 0.1% [3] - The current consensus EPS estimate for the upcoming quarter is -$1.15 on revenues of $6.05 million, and for the current fiscal year, it is -$4.19 on revenues of $28.6 million [7] Industry Outlook - The Medical - Products industry, to which Allurion belongs, is currently ranked in the bottom 31% of over 250 Zacks industries, indicating potential challenges for stock performance [8] - Empirical research suggests a strong correlation between near-term stock movements and trends in earnings estimate revisions, which could impact Allurion's stock performance [5]

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]