Allurion Technologies(ALUR) - 2023 Q4 - Annual Report

PART I Business Allurion Technologies is a medical device company dedicated to ending obesity through its Allurion Program, which combines a swallowable gastric balloon with an AI-powered Virtual Care Suite Overview - Allurion is focused on ending obesity with its Allurion Program, which features the world's first swallowable, procedure-less intragastric balloon and an AI-powered Virtual Care Suite (VCS)[11] - Over 130,000 patients have been treated commercially in over 50 countries outside the United States[11] - The Allurion Balloon is swallowed as a capsule and placed during an approximate 15-minute outpatient visit without surgery, endoscopy, or anesthesia[12] Fiscal Year Financial Performance | Year | Revenue (USD Million) | YoY Change | Gross Profit Margin | Net Loss (USD Million) | | :--- | :--- | :--- | :--- | :--- | | 2023 | $53.5 | -17% | 78% | $80.6 | | 2022 | $64.2 | +68% | 79% | $37.7 | Our Market Opportunity - According to the World Health Organization (WHO), over two billion people globally are overweight, and by 2030, one billion will have obesity[19] - The annual global economic impact of obesity is estimated to be over $2 trillion, according to McKinsey[20] Our Platform - The Allurion Balloon is a procedure-less intragastric balloon that is swallowed in a capsule, filled with 550ml of fluid, and passes naturally after approximately four months via a patented ReleaseValve™[35] - The Virtual Care Suite (VCS) provides patients with an app and connected scale to monitor metrics, while providers get access to the Allurion Insights dashboard with AI-powered remote patient monitoring[40][41] - Clinical trials have shown that patients lose an average of 14% of total body weight after four months, with 95% of that loss maintained at one year[43] Clinical Trials - The company is conducting the AUDACITY trial in the U.S, a 48-week, prospective, randomized, open-label trial to support a Premarket Approval (PMA) submission to the FDA[44] - Enrollment of 550 patients across 17 sites in the U.S for the AUDACITY trial was completed in the third quarter of 2023[44] - The AUDACITY trial design improves upon the prior ENLIGHTEN trial by using an open-label design (no sham), multiple balloon cycles, and aligning with updated FDA guidance for weight loss devices[48] Our Growth Strategy - Expand revenues in key existing markets by increasing productivity of existing accounts and acquiring new ones[59] - Launch the Allurion Program in new international markets, building on existing registrations in over 50 countries[59] - Obtain FDA approval to enter the U.S market, supported by the ongoing AUDACITY clinical trial[60] - Expand the Virtual Care Suite (VCS) as a Software as a Service (SaaS) model for patients undergoing other weight loss interventions[60] Intellectual Property Patent Portfolio as of December 31, 2023 | Jurisdiction | Issued Patents | Pending Applications | | :--- | :--- | :--- | | United States | 18 | 5 | | Outside U.S. | 36 | 4 | - The company's issued patents are expected to expire between February 2033 and November 2040[69] - As of December 31, 2023, the company has 69 registered trademarks and one pending application across 15 jurisdictions[71][72] Government Regulation - In the U.S, the Allurion Balloon is classified as a Class III medical device and will require Premarket Approval (PMA) from the FDA, a more rigorous process than 510(k) clearance[87][91] - The company is subject to ongoing FDA regulations, including Quality System Regulation (QSR), medical device reporting (MDR), and labeling/promotion rules[108][109] - In the European Union, the company must comply with the Medical Devices Regulation (MDR), which replaced the previous Medical Devices Directive (MDD) and imposes stricter requirements for market access and surveillance[128][133] Human Capital Resources - As of December 31, 2023, the company had 252 employees, with 249 being full-time[143] - Of the total employees, 114 are located in the U.S; none of the U.S employees are unionized, but employees in France are subject to a collective bargaining agreement[143] Risk Factors The company faces significant risks including a history of net losses, dependence on the Allurion Balloon's success, challenges in obtaining FDA approval, intense competition, a self-pay model, and has identified material weaknesses in financial controls with a "going concern" warning from its auditors Risks Related to Development and Commercialization - The company expects to incur losses for the foreseeable future, and profitability depends on the commercial success of the Allurion Balloon[147] - The Allurion Balloon is not currently approved for sale in the United States, and obtaining FDA approval is a costly, time-consuming, and uncertain process[174] - Success depends on patients' willingness to pay out-of-pocket, as third-party reimbursement is not expected for the Allurion Program[151] Risks Related to Business and Industry - The weight loss industry is highly competitive, with competition from other medical devices and pharmaceutical therapies, including GLP-1s from major companies like Novo Nordisk and Eli Lilly[189][191] - The company depends on a limited number of single-source suppliers for critical components, making it vulnerable to supply shortages and price fluctuations[202] - In January 2024, the company announced a restructuring plan to reduce its global workforce by approximately 30% to align costs with revenue expectations and accelerate the path to profitability[221] Risks Related to Government Regulation - The regulatory approval process is expensive and uncertain; failure to obtain or maintain approvals, particularly from the FDA, would prevent the marketing of products[234] - Upon approval, the company will be subject to ongoing regulatory review and obligations, and failure to comply can result in significant penalties, including product withdrawal[241] - Adverse events or undesirable side effects from products could lead to withdrawal of regulatory approvals, restrictive labeling, and damage to the company's reputation and commercial prospects[242] Risks Related to Intellectual Property - The medical device industry is characterized by frequent patent litigation, which could be costly and divert management's attention, regardless of the outcome[266] - Failure to obtain and maintain sufficient intellectual property protection for products and technologies could erode the company's competitive position[273] - The company's products incorporate third-party open-source software, which carries risks such as potential license breaches that could require costly re-engineering or making proprietary code public[309] Risks Related to Financial Condition and Capital Requirements - The company has a history of net operating losses, with an accumulated deficit of $212.8 million as of December 31, 2023, and expects to incur losses for the foreseeable future[326] - The company's independent registered public accounting firm has expressed substantial doubt about its ability to continue as a going concern due to recurring losses, negative cash flow, and potential non-compliance with debt covenants[326] - The company has a significant amount of debt ($83.1 million as of Dec 31, 2023), and financial covenants related to minimum liquidity and revenue may affect its ability to operate and secure future financing[329] Risks Related to Ownership of Our Securities - The company's share price may be volatile, and future sales of a substantial number of shares, including from a $100 million committed equity facility with Chardan, could cause the market price to decline[336][341] - The company has identified material weaknesses in its internal control over financial reporting, which could adversely affect its ability to report financial results accurately and timely, and may harm investor confidence[357][358] - Warrants and Earn-Out Shares are accounted for as liabilities, and changes in their fair value could cause material volatility in the company's financial results[381][382] Cybersecurity Allurion has implemented a cybersecurity risk management program managed by a cross-disciplinary committee, but to date, no incidents have materially affected the company - The company's cybersecurity risk management program is managed by an Information Security Management Committee, with day-to-day oversight by an acting Chief Information Security Officer (CISO)[391] - The program utilizes third-party support for services like penetration testing and includes written policies such as an incident response plan[388] - No cybersecurity incidents or threats have been identified that have materially affected or are reasonably likely to materially affect the company[390] Properties Allurion's primary facilities are leased in Natick, Massachusetts, with its largest sales office in a leased space in Paris, France - The company's main facilities, including corporate headquarters, R&D, and manufacturing, are leased in Natick, Massachusetts[393] - The largest international sales office is located in a leased space in Paris, France[393] PART II Management's Discussion and Analysis of Financial Condition and Results of Operations In 2023, revenue decreased 17% to $53.5 million and net loss widened to $80.6 million due to business combination delays and higher expenses, with substantial doubt raised about its ability to continue as a going concern despite new financing Recent Developments - On August 1, 2023, Allurion consummated its Business Combination with Compute Health Acquisition Corp, becoming a publicly listed company on the NYSE under the ticker "ALUR"[406][407] - In connection with the Business Combination, the company secured several financing arrangements, including a $37.9 million PIPE investment, a $40.0 million revenue interest financing agreement, and a new $60.0 million term loan facility[411][412][414] - On December 18, 2023, the company entered into a committed equity facility (ChEF) with Chardan Capital Markets, allowing it to sell up to $100 million of its common stock at its discretion over three years[424] Results of Operations Comparison of Results of Operations (Years Ended Dec 31) | (In thousands) | 2023 | 2022 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Revenue | $53,467 | $64,211 | ($10,744) | -17% | | Gross profit | $41,497 | $50,726 | ($9,229) | -18% | | Sales and marketing | $46,857 | $50,405 | ($3,548) | -7% | | Research and development | $27,694 | $16,966 | $10,728 | +63% | | General and administrative | $46,024 | $15,365 | $30,659 | +199% | | Loss from operations | ($79,078) | ($32,010) | ($47,068) | -147% | | Net loss | ($80,607) | ($37,744) | ($42,863) | -114% | - Revenue decreased by 17% in 2023 due to a delay in the Business Combination, which led to reduced investment and lower re-order rates as distributors adjusted inventory[440] - Research and Development expenses increased by 63% primarily due to a $9.8 million increase in costs related to the AUDACITY clinical trial[444] - General and Administrative expenses increased by 199%, largely due to a $12.0 million increase in accounts receivable reserves, a $7.8 million increase in stock-based compensation, and higher professional fees associated with the Business Combination[445] Liquidity and Capital Resources - As of December 31, 2023, the company had $38.0 million in cash and cash equivalents and an accumulated deficit of $212.8 million[455] - The company has concluded there is substantial doubt about its ability to continue as a going concern for one year, citing recurring losses, expected future losses, and the potential inability to comply with financial covenants[459] Summary of Cash Flows (Years Ended Dec 31) | (In thousands) | 2023 | 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | ($63,982) | ($46,981) | | Net cash used in investing activities | ($1,606) | ($1,550) | | Net cash provided by financing activities | $95,986 | $30,537 | Quantitative and Qualitative Disclosures About Market Risk The company is exposed to market risks from interest rates on its variable rate debt and foreign currency exchange rates from its international operations - The company has interest rate risk from its $43.1 million in variable rate debt outstanding with Fortress; a 10% change in interest rates would impact annual expense by about $0.4 million[498][499] - The company is exposed to foreign currency exchange risk, primarily from operations in Europe, the Middle East, and the Asia-Pacific region; a 10% adverse change in exchange rates in 2023 would have impacted revenues by approximately 5% and expenses by 2%[501][502] Controls and Procedures Management concluded that disclosure controls and procedures were not effective as of December 31, 2023, due to material weaknesses in internal control over financial reporting - Management concluded that disclosure controls and procedures were not effective as of December 31, 2023[506] - Material weaknesses were identified in internal controls over financial reporting, specifically related to insufficient segregation of duties, lack of sufficient staff with public company experience, and insufficient information systems controls[507] - Remediation efforts include hiring additional experienced staff, implementing a new ERP system, and engaging an external accounting firm to help design and implement controls[508] PART III Directors, Executive Compensation, Security Ownership, and Accountant Fees Information for these items is incorporated by reference from the company's definitive proxy statement for its 2024 Annual Meeting of Stockholders - Information regarding Directors, Executive Officers, Corporate Governance, Executive Compensation, Security Ownership, Related Transactions, and Principal Accountant Fees and Services is incorporated by reference from the company's forthcoming proxy statement[513][514][515][516][517] PART IV Exhibits and Financial Statement Schedules This section lists all exhibits filed with the Form 10-K, including material contracts and governance documents, while financial statement schedules are omitted - This item lists the financial statements, notes that financial statement schedules are omitted, and provides a detailed list of all exhibits filed with the report[518]