Financial Performance - Allurion generated revenue of 26.5millionfortheninemonthsendedSeptember30,2024,adecreaseof41.545.2 million for the same period in 2023[149] - The company incurred a net loss of 5.6millionfortheninemonthsendedSeptember30,2024,significantlyreducedfromanetlossof61.4 million for the same period in 2023[149] - Revenue decreased by 12.8million,or715.4 million for the three months ended September 30, 2024, and decreased by 18.7million,or4126.5 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 9.0million,comparedtoanetlossof21.6 million for the same period in 2023, reflecting a decrease of 12.6million[170]−Thelossfromoperationswas12.3 million for the three months ended September 30, 2024, compared to a loss of 26.2millionforthesameperiodin2023,indicatinganimprovementof13.8 million[170] - The company incurred a net loss of 61.4millionfortheninemonthsendedSeptember30,2023,comparedtoanetlossof5.6 million for the same period in 2024[182] Cash Flow and Financing - Cash outflows from operating activities were 29.0millionfortheninemonthsendedSeptember30,2024,downfrom43.1 million in the same period in 2023[182] - Cash provided by financing activities was 20.3millionfortheninemonthsendedSeptember30,2024,comparedto116.4 million in the same period of 2023[195][197] - The company received 15.2millioninnetproceedsfromtheissuanceofcommonstockandwarrantsonJuly1,2024[185]−TheCompanyissued48 million in convertible senior secured notes with a 6.0% annual interest rate, maturing on April 16, 2031[152] - The company received 40.0millionupfrontfromtheRevenueInterestFinancingAgreementwithRTW,obligatingittoremitcertainrevenueinterestpaymentsuntilDecember31,2030[203]ExpensesandCostManagement−Costofrevenuedecreasedby2.0 million, or 47%, to 2.3millionforthethreemonthsendedSeptember30,2024,anddecreasedby2.6 million, or 26%, to 7.5millionfortheninemonthsendedSeptember30,2024,comparedtothesameperiodsin2023[172]−Grossprofitdecreasedby10.9 million, or 78%, to 3.1millionforthethreemonthsendedSeptember30,2024,anddecreasedby16.1 million, or 46%, to 19.0millionfortheninemonthsendedSeptember30,2024,comparedtothesameperiodsin2023[173]−Salesandmarketingexpensesdecreasedby8.8 million, or 63%, to 5.2millionforthethreemonthsendedSeptember30,2024,anddecreasedby18.1 million, or 50%, to 18.0millionfortheninemonthsendedSeptember30,2024,comparedtothesameperiodsin2023[174]−Researchanddevelopmentexpensesdecreasedby4.0 million, or 55%, to 3.2millionforthethreemonthsendedSeptember30,2024,anddecreasedby8.4 million, or 39%, to 13.2millionfortheninemonthsendedSeptember30,2024,comparedtothesameperiodsin2023[174]−Generalandadministrativeexpensesdecreasedby11.9 million, or 63%, to 7.0millionforthethreemonthsendedSeptember30,2024,anddecreasedby9.9 million, or 32%, to 20.7millionfortheninemonthsendedSeptember30,2024,comparedtothesameperiodsin2023[175]RegulatoryandComplianceIssues−TheFrenchregulatoryauthoritysuspendedsalesoftheAllurionBalloon,promptingtheCompanytoimplementaremediationplan[159]−TheCompanywasnotifiedbyNYSEthatitscommonstock′saverageclosingpricewasbelow1.00, 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 15.2millioninnetproceedsfromapublicofferingof14,406,508sharesatanofferingpriceof1.20 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]