Industry Overview - The Zacks Medical - Products industry is facing rising uncertainty due to the reinstatement of tariffs on medical devices, with rates ranging from 10% to 145% on Chinese-made parts, which could disrupt U.S. MedTech economics [1] - U.S. PPE manufacturers are expected to benefit from these tariffs, potentially reducing competition from heavily subsidized Chinese products, although some suppliers may shift assembly to Mexico and Canada instead of fully onshoring production [2] - U.S. hospitals are likely to see budget increases due to improving demand and lower interest rates, which may boost medical product sales despite ongoing challenges such as declining demand for COVID-19-related products and weak performance in the Chinese market [3] Key Trends - The industry is witnessing significant advancements in AI, medical mechatronics, and robotics, with a growing adoption of minimally invasive robot-assisted surgeries and IT in patient care [7] - 3D printing technology is transforming the medical devices industry, enabling the production of complex biological structures such as stem cells and prosthetic organs [8] - The COVID-19 pandemic has led to increased global demand for diagnostic testing kits, shifting the IVD product pipeline towards rapid, point-of-care devices [9] Emerging Markets - Emerging economies are showing solid demand for medical products due to rising medical awareness, economic prosperity, and an aging population, making these markets attractive for global medical device players [10][11] Industry Performance - The Zacks Medical Products industry has collectively risen by 6.3% over the past year, outperforming the Zacks Medical sector, which declined by 10%, but underperforming the S&P 500, which increased by 8% [14] - The industry is currently trading at a forward 12-month price-to-earnings (P/E) ratio of 20.3X, slightly above the S&P 500's 19.9X and the sector's 19.4X [16] Company Highlights - Insulet (PODD) is focused on diabetes management with its Omnipod Insulin Management System and is expanding its global presence, with a projected revenue growth of 18.1% for 2025 [19][22] - MacroGenics (MGNX) reported a significant revenue increase to $150 million in 2024, driven by collaborations and product sales, while also advancing its oncology pipeline [26][27] - Cellectar Biosciences (CLRB) is developing targeted cancer therapies with strong clinical data supporting its lead asset, although it faces challenges such as a delay in NDA submission [31][33] - Allurion Technologies (ALUR) is dedicated to obesity management with its innovative weight loss platform, but it has faced revenue declines and operational challenges [35][37]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 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) (State or other jurisdiction of incorporatio ...

Allurion Technologies Inc. (NYSE:ALUR) Q4 2024 Earnings Conference Call March 26, 2025 8:30 AM ET Company Participants Mike Cavanaugh - Investor Relations Shantanu Gaur - Founder and Chief Executive Officer Conference Call Participants Matthew Taylor - Jefferies Josh Jennings - TD Cowen Jason Wittes - ROTH Capital Partners Keay Nakae - Chardan Capital Operator Hello, everyone, and welcome to Allurion Fourth Quarter Earnings Call. Please note that this call is being recorded. After the speaker's prepared rem ...

Company Performance - Allurion Technologies, Inc. reported a quarterly loss of $7 per share, which was worse than the Zacks Consensus Estimate of a loss of $5, and an improvement from a loss of $15.75 per share a year ago, indicating a significant year-over-year reduction in losses [1] - The company posted revenues of $5.59 million for the quarter ended December 2024, missing the Zacks Consensus Estimate by 0.16%, and down from $8.24 million in the same quarter last year [2] - Over the last four quarters, Allurion has surpassed consensus EPS estimates only once, indicating challenges in meeting market expectations [2] Stock Performance - Allurion Technologies, Inc. shares have declined approximately 71.1% since the beginning of the year, contrasting sharply with the S&P 500's decline of only 1.8% [3] - The current consensus EPS estimate for the upcoming quarter is -$22.91 on revenues of $5.6 million, and for the current fiscal year, it is -$18.53 on revenues of $31.63 million [7] Industry Outlook - The Medical - Products industry, to which Allurion belongs, is currently ranked in the bottom 31% of over 250 Zacks industries, suggesting a challenging environment for companies in this sector [8] - The performance of Allurion's stock may be influenced by the overall outlook for the industry, as historical data shows that the top 50% of Zacks-ranked industries outperform the bottom 50% by more than 2 to 1 [8]

Investor Presentation March 2025 Disclaimer This presentation, the information contained herein and the materials accompanying it (together, this "presentation") contains confidential, material and non-public information regarding Allurion Technologies, Inc. (the "Company" or "us") and is provided to the recipients ("you") of this presentation on the condition that you agree to hold it in strict confidence and not reproduce, disclose, forward or distribute it in whole or in part to others at any time withou ...

Revenue and Financial Performance - Revenue for the nine months ended September 30, 2024, was $26.519 million, compared to $45.232 million in the same period in 2023, reflecting a significant decrease[9] - Gross profit for the nine months ended September 30, 2024, was $18.970 million, compared to $35.067 million in the same period in 2023[9] - Total revenues for the three months ended September 30, 2024 were $5.367 million, a significant decrease from $18.2 million in the same period in 2023[75] - Revenue from Turkey dropped to $966,000 in Q3 2024 from $3.517 million in Q3 2023, representing a 72.5% decline[75] - All Other Countries contributed $3.347 million (62.4% of total revenue) in Q3 2024, down from $11.122 million (61.1% of total) in Q3 2023[75] - For the nine months ended September 30, 2024, total revenues were $26.519 million compared to $45.232 million in the same period in 2023, a 41.4% decrease[78] - No revenue was generated in the United States for both the three and nine months ended September 30, 2024[78] - The Company recognized a reduction to revenues of $1.2 million due to customer returns of the Allurion Balloon following its suspension in France[190] Net Loss and Profitability - Net loss for the nine months ended September 30, 2024, was $5.580 million, compared to a net loss of $61.427 million in the same period in 2023, showing a substantial improvement[9] - Net loss per share for the nine months ended September 30, 2024, was $2.62, compared to $50.01 in the same period in 2023[9] - Net loss for the nine months ended September 30, 2024 was $5.58 million, compared to a net loss of $61.43 million for the same period in 2023[17] - The company incurred losses from operations of $33.1 million and $53.3 million for the nine months ended September 30, 2024 and 2023, respectively[37] - Basic and diluted net loss per share for Q3 2024 was $(3.51), compared to $(13.56) in Q3 2023, showing a significant improvement[168] - Net loss attributable to common shareholders for Q3 2024 was $(9.004 million), compared to $(21.885 million) in Q3 2023[168] Cash Flow and Liquidity - Cash and cash equivalents decreased to $28.654 million as of September 30, 2024, from $38.037 million as of December 31, 2023[6] - Net cash used in operating activities for the nine months ended September 30, 2024 was $29.03 million, compared to $43.11 million for the same period in 2023[17] - Net cash provided by financing activities for the nine months ended September 30, 2024 was $20.26 million, compared to $116.39 million for the same period in 2023[17] - Cash and cash equivalents and restricted cash at the end of September 30, 2024 was $29.05 million, compared to $80.10 million at the end of September 30, 2023[17] - Cash outflows from operating activities were $29.0 million and $43.1 million for the nine months ended September 30, 2024 and 2023, respectively[37] - The company repaid $48 million for the Fortress Term Loan on April 16, 2024, including $43.1 million principal repayment and $4.6 million in fees[96] - The company recorded an $8.7 million loss on extinguishment of debt related to the Fortress Term Loan repayment in the nine months ended September 30, 2024[96] Assets and Liabilities - Accounts receivable decreased to $9.935 million as of September 30, 2024, from $18.194 million as of December 31, 2023[6] - Inventory decreased to $4.568 million as of September 30, 2024, from $6.171 million as of December 31, 2023[6] - Total current assets decreased to $44.829 million as of September 30, 2024, from $64.816 million as of December 31, 2023[6] - Total liabilities decreased to $114.510 million as of September 30, 2024, from $142.199 million as of December 31, 2023[6] - Inventory decreased to $4.568 million as of September 30, 2024 from $6.171 million at December 31, 2023, with finished goods inventory down 19.8%[79] - Property and equipment net value decreased to $3.08 million as of September 30, 2024 from $3.381 million at December 31, 2023[81] - Total accrued expenses and other current liabilities decreased to $7.973 million as of September 30, 2024 from $15.495 million at December 31, 2023[82] - Long-lived assets in the United States decreased from $5,381 thousand in 2023 to $4,690 thousand in 2024, while in France, they decreased from $1,010 thousand to $673 thousand[194] Stock and Equity Transactions - The company issued 2,260,159 shares of preferred stock in connection with a private placement, net of issuance costs, raising $979,000[15] - The company issued 653,351 shares of common stock in connection with a public offering, net of issuance costs, raising $5.07 million[15] - The company's total stockholders' deficit decreased from $70.49 million as of January 1, 2024 to $64.79 million as of September 30, 2024[15] - The company's accumulated deficit increased from $212.80 million as of January 1, 2024 to $218.38 million as of September 30, 2024[15] - The company's other comprehensive income increased from a loss of $700,000 as of January 1, 2024 to a gain of $2.89 million as of September 30, 2024[15] - The company completed a 1-for-25 reverse stock split effective January 3, 2025[31][32] - Following the reverse stock split, each public warrant is exercisable for 0.056818 shares of common stock at an exercise price of $202.50 per share[33] - Legacy Allurion common stock holders received Allurion Common Stock at an exchange ratio of approximately 0.9780[52] - The total number of Allurion Common Stock shares outstanding after the Business Combination and Reverse Stock Split was 1,892,058[56] - PIPE Investors purchased 215,468 shares of Allurion Common Stock at $176.00 per share, totaling $37.9 million[58] - Legacy Allurion convertible notes totaling $21.8 million were converted into 132,049 shares of Allurion Common Stock[72] - The company assumed 528,277 public warrants to purchase 750,394 shares of Allurion Common Stock at $202.50 per share, valued at $13.8 million[73] - Earn-Out liabilities for potential issuance of additional shares were initially valued at $53.0 million[74] - The company issued 2,260,159 shares of Series A Preferred Stock and 90,407 Private Placement Warrants, raising net proceeds of $2.5 million after deducting $0.2 million in offering costs[147] - The company issued 576,261 shares of Common Stock and 662,701 Public Offering Warrants, raising net proceeds of $15.2 million after deducting $1.0 million in underwriting discounts and $1.0 million in offering costs[156] - As of September 30, 2024, the company had 2,574,783 shares of Common Stock outstanding, up from 1,907,529 shares as of December 31, 2023[155] - The company has 769,257 warrants outstanding to purchase Common Stock, with a weighted average exercise price of $30.00[162] - The company entered into a Chardan Equity Facility, allowing it to sell up to $100 million in Common Stock, with 5,730 shares sold for $0.4 million as of September 30, 2024[166][167] - The company has 528,269 outstanding Public Warrants exercisable for 750,383 shares of Common Stock, with no redemptions as of September 30, 2024[165] - The company has reserved 2,294,777 shares of Common Stock for potential conversion or exercise of its securities as of September 30, 2024[159] Debt and Financing - The company borrowed $60.0 million under the Fortress Term Loan, used to repay the 2021 Term Loan[63] - Interest expense for the three months ended September 30, 2023 related to the Fortress Term Loan was $1.7 million, with an average interest rate of 14.94%[97] - Interest expense for the nine months ended September 30, 2024 related to the Fortress Term Loan was $2.3 million, with no interest expense for the three months ended September 30, 2024 due to loan extinguishment[98] - The 2021 Convertible Notes were converted into 5,345 shares of Allurion Common Stock with a corresponding recognition of APIC of $2.2 million on August 1, 2023[101] - The 2022 Convertible Notes were converted into 3,329 shares of Allurion Common Stock with a corresponding recognition of APIC of $1.2 million on August 1, 2023[104] - The 2023 Convertible Notes were issued for gross proceeds of $28.7 million with a stated interest rate of 7.0% per annum[105] - Interest expense for the nine months ended September 30, 2023 related to the 2023 Convertible Notes was $0.5 million[107] - The RTW Convertible Notes were issued for $48.0 million with an annual interest rate of 6% and a maturity date of April 16, 2031[115] - The fair value of the RTW Convertible Notes at issuance was $49.1 million, with a corresponding $1.1 million loss recognized in Other income, net[116] - RTW paid Allurion an aggregate of $40.0 million Investment Amount, with revenue interest payments up to 6.0% of annual net sales prior to December 31, 2026, and up to 10.0% thereafter until December 31, 2030[120] - If RTW has not received at least 100% of the Investment Amount by December 31, 2027, the company must make a cash payment to catch up to 100%, and if not 240% by December 31, 2030, a payment to reach 240%, with a Hard Cap of 260%[121] - The company has made $3.6 million in royalty payments to RTW as of September 30, 2024[122] - The RIFA Amendment increased the rate of revenue interest payments to 12% for net sales ≤ $100 million prior to December 31, 2026, and after January 1, 2027[123] - The fair value of the Revenue Interest Financing and PIPE Conversion Option were $38.5 million and $9.9 million, respectively, as of September 30, 2024[126] - For the three months ended September 30, 2024, the company recorded a $6.7 million loss and a $5.8 million gain on the Revenue Interest Financing[127] - The fair value of RTW Convertible Notes was $36.09 million as of September 30, 2024, classified under Level 3[128] Stock-Based Compensation and Employee Benefits - Stock-based compensation expense for the nine months ended September 30, 2024 was $2.22 million, compared to $6.35 million for the same period in 2023[17] - Total stock-based compensation expense for Q3 2024 was $860,000, compared to $5.539 million in Q3 2023[172] - As of September 30, 2024, 284,332 stock options were outstanding with a weighted average exercise price of $57.00 per option[173] - The company has $5.6 million of unrecognized compensation costs related to unvested stock options, expected to be recognized over 3.0 years[173] - Total stock compensation expense related to RSUs for Q3 2024 was $0.2 million, with $1.0 million of unrecognized compensation costs remaining[178] - The company's 2023 ESPP reserves 89,045 shares of Common Stock for issuance, with no shares issued as of September 30, 2024[180] - The company's 401(k) retirement plan matching contributions were less than $0.1 million for both Q3 2024 and Q3 2023[181] Leases and Real Estate - The company has 51,000 square feet of leased office, manufacturing, and laboratory space across six leases, expiring between March 2025 and March 2028[184] - Operating lease costs for Q3 2024 were $259,000, compared to $285,000 in Q3 2023[186] - Future commitments under non-cancelable operating lease agreements total $2,810 thousand, with a present value adjustment of $354 thousand, resulting in total lease liabilities of $2,456 thousand[187] - The weighted-average remaining lease term decreased from 3.7 years in 2023 to 2.9 years in 2024, while the weighted-average discount rate remained at 9.9%[187] Fair Value Measurements - The fair value of Public Warrants was $531,000 as of September 30, 2024, based on a Level 1 input[128] - The fair value of Legacy Allurion Common Stock Warrant Liabilities was $71,000 as of September 30, 2024, classified under Level 3[128] - The fair value of the PIPE Conversion Option was $9.85 million as of September 30, 2024, classified under Level 3[128] - The fair value of Preferred Stock Warrants decreased from $2,679 thousand to $715 thousand from June 30, 2023, to September 30, 2023, a decline of 73.3%[132] - The fair value of Common Stock Warrants decreased from $1,351 thousand to $207 thousand from June 30, 2023, to September 30, 2023, a decline of 84.7%[132] - The fair value of Public Offering Warrants was $5,970 thousand as of September 30, 2024, following a fair value issuance of $13,157 thousand and a change in fair value of $(7,187) thousand[132] - The fair value of Private Placement Warrants was $810 thousand as of September 30, 2024, following a fair value issuance of $1,670 thousand and a change in fair value of $(860) thousand[132] - The fair value of the Revenue Interest Financing was remeasured as of September 30, 2024, using a discount rate of 23.5%[136] - The fair value of the PIPE Conversion Option was measured using a stock price of $15.25 and an expected volatility of 130.0% as of September 30, 2024[137] - The fair value of the Earn-Out Liability was measured using a stock price of $15.25 and an expected volatility of 105.0% as of September 30, 2024[138] - The fair value of the RTW Convertible Notes was remeasured as of September 30, 2024, using a stock price of $15.25 and an expected volatility of 90.0%[142] Taxes - The company recorded income tax expense of $0.1 million for the three months ended September 30, 2024, representing an effective tax rate of (0.8%)[144] - The company maintained a full valuation allowance against its net deferred tax assets as of September 30, 2024, due to significant operating losses[145] Customer Concentration - Customer A accounted for 18% and 19% of total revenue for the three months ended September 30, 2024 and 2023, respectively[46] - Customer A accounted for 15% and 16% of accounts receivable as of September 30, 2024 and December 31, 2023, respectively[46] - Customer B accounted for 11% of total revenue for the three months ended September 30, 2023[46] Going Concern and Future Outlook - The company has concluded there is substantial doubt about its ability to continue as a going concern for one year from the date of the financial statements[38] - The company expects to continue generating significant operating losses for the foreseeable future[37] - As of September 30, 2024, the company had an accumulated deficit of $218.4 million[37] Other Transactions and Agreements - The company incurred $22.7 million in transaction costs, including $15.2 million recorded to additional paid-in capital and $5.0 million as general and administrative expenses[54] - Net proceeds from the Business Combination were $61.652 million after deducting transaction costs and other liabilities[56] - RTW paid $40.0 million for revenue interest payments, with rates up to 6.0% of annual net sales before December 31, 2026, and up to 10.0% thereafter[59] - The Company recorded gains of $1.8 million and $3.1 million for the three months ended September 30, 2024 through the condensed consolidated statements of operations and other comprehensive income (loss), respectively[117] - The Company is in compliance with the financial maintenance covenants in the Amended Note Purchase Agreement as of September 30, 2024[118] - The Company entered into a consulting agreement with KKG Enterprises and Remus Group Management, paying $0.2 million and $0.3 million respectively, which were terminated in June 2023[196] - Allurion sold $13 million of 2023 Convertible Notes to Hunter Ventures Limited, a related party

Core Viewpoint - Allurion Technologies, Inc. (ALUR) has shown a significant price increase of 58.1% over the past four weeks, with a mean price target of $28.67 indicating a potential upside of 374.7% from the current price of $6.04 [1] Price Targets and Analyst Estimates - The mean estimate includes three short-term price targets with a standard deviation of $18.58, where the lowest estimate of $16 suggests a 164.9% increase, and the highest estimate predicts a surge of 727.8% to $50 [2] - A low standard deviation among price targets indicates strong agreement among analysts regarding the stock's price movement, which can serve as a starting point for further research [7] Earnings Estimates and Analyst Optimism - Analysts have shown growing optimism regarding ALUR's earnings prospects, as evidenced by a 17.1% increase in the Zacks Consensus Estimate for the current year, with three estimates moving higher and no negative revisions [10] - ALUR holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimates, suggesting a strong potential upside in the near term [11] Caution on Price Targets - While price targets are often sought after by investors, they can mislead more than guide, as empirical research indicates that they rarely reflect actual stock price movements [5] - Analysts may set overly optimistic price targets due to business incentives, which can inflate expectations [6] - Investors should approach price targets with skepticism and not rely solely on them for investment decisions [8]

Core Viewpoint - Allurion Technologies is experiencing a rise in share price following the announcement of a planned clinical study to evaluate the combination of its Allurion Program with GLP-1 agonists [1] Group 1: Clinical Study and Weight Loss - The company is addressing concerns regarding muscle loss associated with GLP-1 treatments, which can lead to a reduction of approximately 40% in lean mass relative to total weight lost [2] - Allurion's previous studies indicate that its gastric balloon, along with the Virtual Care Suite, has enabled patients to lose weight while maintaining or even increasing muscle mass [2] - The planned study aims to confirm if the combination of the Allurion Balloon and Virtual Care Suite with GLP-1 therapy can provide a more metabolically healthy approach to weight loss, potentially positioning the Allurion Program as a leading option in obesity treatment [3] Group 2: Financial Developments - The company has entered into a securities purchase agreement to raise approximately $7.4 million in gross proceeds through the sale of 1.24 million shares at $6.00 per share [4] - Roth Capital Partners is acting as the exclusive placement agent for this offering, which is expected to close on or around January 27, 2025, pending customary closing conditions [5] - The net proceeds from the offering are intended for working capital and general corporate purposes [5] Group 3: Market Reaction - Allurion shares increased by 120% to $8.15 at the time of publication, reflecting positive market sentiment following the announcements [5]

Core Insights - Allurion Technologies (ALUR) shares tripled as the company aims to leverage the growing obesity drug market by testing its gastric balloon in combination with GLP-1 medications [1][4] - Previous research indicated that GLP-1 treatments resulted in approximately 40% reduction in lean mass as a proportion of total weight lost, while Allurion's gastric balloon users maintained or even increased muscle mass [2][4] - The CEO highlighted the significance of muscle mass decline in GLP-1 users and suggested that the combination of the gastric balloon and GLP-1 could set a new standard in obesity care [3] Company Developments - Allurion Technologies announced plans to conduct a study to evaluate the effectiveness of its gastric balloon alongside popular GLP-1 drugs [1][4] - The company has faced a challenging year, with shares down over 85% from their peak in summer 2023, despite the recent surge [3][4] Market Context - The obesity drug market is experiencing significant growth, prompting Allurion to explore innovative solutions to enhance weight loss outcomes while preserving muscle mass [1][3]

Financial Performance - Allurion generated revenue of $26.5 million for the nine months ended September 30, 2024, a decrease of 41.5% compared to $45.2 million for the same period in 2023[149] - The company incurred a net loss of $5.6 million for the nine months ended September 30, 2024, significantly reduced from a net loss of $61.4 million for the same period in 2023[149] - Revenue decreased by $12.8 million, or 71%, to $5.4 million for the three months ended September 30, 2024, and decreased by $18.7 million, or 41%, to $26.5 million for the nine months ended September 30, 2024, compared to the same periods in 2023[171] - The net loss for the three months ended September 30, 2024, was $9.0 million, compared to a net loss of $21.6 million for the same period in 2023, reflecting a decrease of $12.6 million[170] - The loss from operations was $12.3 million for the three months ended September 30, 2024, compared to a loss of $26.2 million for the same period in 2023, indicating an improvement of $13.8 million[170] - The company incurred a net loss of $61.4 million for the nine months ended September 30, 2023, compared to a net loss of $5.6 million for the same period in 2024[182] Cash Flow and Financing - Cash outflows from operating activities were $29.0 million for the nine months ended September 30, 2024, down from $43.1 million in the same period in 2023[182] - Cash provided by financing activities was $20.3 million for the nine months ended September 30, 2024, compared to $116.4 million in the same period of 2023[195][197] - The company received $15.2 million in net proceeds from the issuance of common stock and warrants on July 1, 2024[185] - The Company issued $48 million in convertible senior secured notes with a 6.0% annual interest rate, maturing on April 16, 2031[152] - The company received $40.0 million upfront from the Revenue Interest Financing Agreement with RTW, obligating it to remit certain revenue interest payments until December 31, 2030[203] Expenses and Cost Management - Cost of revenue decreased by $2.0 million, or 47%, to $2.3 million for the three months ended September 30, 2024, and decreased by $2.6 million, or 26%, to $7.5 million for the nine months ended September 30, 2024, compared to the same periods in 2023[172] - Gross profit decreased by $10.9 million, or 78%, to $3.1 million for the three months ended September 30, 2024, and decreased by $16.1 million, or 46%, to $19.0 million for the nine months ended September 30, 2024, compared to the same periods in 2023[173] - Sales and marketing expenses decreased by $8.8 million, or 63%, to $5.2 million for the three months ended September 30, 2024, and decreased by $18.1 million, or 50%, to $18.0 million for the nine months ended September 30, 2024, compared to the same periods in 2023[174] - Research and development expenses decreased by $4.0 million, or 55%, to $3.2 million for the three months ended September 30, 2024, and decreased by $8.4 million, or 39%, to $13.2 million for the nine months ended September 30, 2024, compared to the same periods in 2023[174] - General and administrative expenses decreased by $11.9 million, or 63%, to $7.0 million for the three months ended September 30, 2024, and decreased by $9.9 million, or 32%, to $20.7 million for the nine months ended September 30, 2024, compared to the same periods in 2023[175] Regulatory and Compliance Issues - The French regulatory authority suspended sales of the Allurion Balloon, prompting the Company to implement a remediation plan[159] - The Company was notified by NYSE that its common stock's average closing price was below $1.00, triggering compliance measures[160] - The Company must obtain stockholder approval for the conversion of notes into common stock, with a proposal due by December 31, 2025[152] Product and Market Development - Allurion completed the enrollment of 550 patients in the AUDACITY clinical trial across 17 sites in the United States, with the last patient treated in September 2024[149] - The Allurion Program includes the world's first swallowable intragastric balloon, which is designed to assist in weight loss without surgery or anesthesia[145] - The Allurion Virtual Care Suite (VCS) provides AI-powered remote patient monitoring tools and a behavior change program, enhancing patient engagement and support[147] - The Allurion VCS was launched in the United States in April 2024 for patients utilizing various weight loss treatments, including anti-obesity medications and bariatric surgery[148] - Allurion's products are currently sold in multiple regions, including Europe, the Middle East, Africa, Latin America, Canada, and the Asia-Pacific region[149] Future Outlook and Strategic Plans - The company expects to continue incurring net losses as it focuses on regulatory approvals, sales strategies, and research and development efforts[150] - The company anticipates needing additional funding for operational expenses, including selling, marketing, and research and development[150] - The company expects to continue generating significant operating losses for the foreseeable future and may need to raise additional capital[184] Stock and Shareholder Information - Allurion's stock began trading on the New York Stock Exchange under the ticker symbol "ALUR" following the completion of its Business Combination on August 2, 2023[151] - The Company raised $15.2 million in net proceeds from a public offering of 14,406,508 shares at an offering price of $1.20 per share[157] - The Company terminated and repaid all outstanding obligations under the Fortress Credit Agreement[155] Risk Factors - The company is exposed to foreign currency risks, particularly in Europe, the Middle East, and the Asia-Pacific region, with a potential 10% adverse change in exchange rates impacting revenues by approximately 6% and net income by about 2%[209] - The company has not engaged in any foreign currency hedging activities to date but will reassess its approach as international operations grow[209] - A hypothetical 10% change in interest rates would not have a material impact on the value of the company's cash, cash equivalents, net loss, or cash flows[209] Accounting and Reporting - The company is classified as an emerging growth company under the JOBS Act, allowing it to delay adopting new accounting standards[208] - The company is also a smaller reporting company, which provides certain exemptions from disclosure requirements, potentially complicating financial comparisons with other public companies[208] - The company may choose to early adopt new accounting standards when permitted for private companies[208] - The fair value of the Revenue Interest Financing Agreement is calculated using a discounted cash flow method based on future revenue projections[203] - The estimated fair value of Legacy Allurion shares was determined by the board of directors, considering various factors including market conditions and financial performance[205]